chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hot flush, Presyncope, Swelling face, Swollen tongue
Clinical narrative: She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeling cold, Feeling jittery, Hot flush, Respiratory tract congestion
Clinical narrative: She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Throat irritation, Throat tightness
Clinical narrative: She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchiness of the vaccine; This is a spontaneous report from a contactable consumer via Medical Information Team and from a Pfizer sponsored program. A female patient of an unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not provided) via an unspecified route of administration in an unspecified anatomical location on 30Mar2021 as single dose for covid-19 immunization. Relevant medical history and concomitant medications were not reported. The patient wants to know how long the itchiness of the vaccine will last. Outcome of the event itchiness was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm's a little bit sore, but otherwise I feel fine; This is a spontaneous report received from a contactable physician. This male physician of unspecified age reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported on social media that his arms were a little bit sore but otherwise he felt fine after receiving the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: son has a side affecst for the last week, feels dizzy; This is a spontaneous report received from Pfizer sponsor program. A contactable consumer reported for  female patient that: A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer and son both got final vaccine last week, son has a side effects for the last week, feels dizzy, on a roller costar. consumer wants to know if its normal for side effect to last that long. There were no unaddressed medical questions referred or for-warded to Medical Information. The outcome of the vent was unknown.   No Follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a Pfizer-sponsored. A contactable Male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number not reported), via unknown route of administration as a single dose on 02Apr2021 for covid 19 immunisation. The patient historical vaccine included first dose of BNT162B2 the vaccine on 12MAR2021. Medical history and concomitant medications were not reported. On 02Apr2021, patient reported having fever and chills after receiving second dose. The patient said that the vaccination provider told him that he can take Tylenol.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: had slight fever; headache; muscle and joint ache; muscle and joint ache; chills; a bit of stomach problem; extreme pain on the injection site; This is a spontaneous report from a consumer (Patient) via Pfizer-sponsored program.   A patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: UNKNOWN) via an unspecified route of administration at left arm, on 03Apr2021(Saturday), as a SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that one day before this report (04Apr2021), she  had slight fever, headache, muscle and joint ache, chills, a bit of stomach problem and extreme pain on the injection site (left arm). At the time of this report events outcome was unknown.  No follow up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: had slight fever; headache; muscle and joint ache; muscle and joint ache; chills; a bit of stomach problem; extreme pain on the injection site; This is a spontaneous report from a consumer (Patient) via Pfizer-sponsored program.   A patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: UNKNOWN) via an unspecified route of administration at left arm, on 03Apr2021(Saturday), as a SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that one day before this report (04Apr2021), she  had slight fever, headache, muscle and joint ache, chills, a bit of stomach problem and extreme pain on the injection site (left arm). At the time of this report events outcome was unknown.  No follow up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Both her hands are in pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were unknown), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, patient experienced both her hands are in pain. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dryness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: noticed a "light pink dry itchy area" at her injection site; noticed a "light pink dry itchy area" at her injection site; noticed a "light pink dry itchy area" at her injection site; This is a spontaneous report from a contactable consumer. A patient 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. the patient experienced light pink dry itchy area at her injection site about the size of a police badge, where she received the shot. Wanted to know if this could be a side effect from second dose. Attempted warm transfer to the DSU, all agents were assisting other callers, e-transmitting AE. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: her daughter is feeling a sore throat; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer (patient's mother) reported that a 17-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number and batch no were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported, on behalf of her daughter (patient's name withheld) A 17 years old and who will be getting her 2nd dose on 06Apr2021, but she stated that they were still waiting for the result of the exam because she mentioned that her daughter was feeling a sore throat. She was asking if it was confirmed that it was a sore throat can her daughter still get the 2nd dose vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Day after my first shot, my arm was sore. My arm hurt for days after with intensity; I had a significant headache where I took migraine over the counter medicine the day after. The headache was gone the second day after; This is a spontaneous report from a contactable other hcp. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Dec2020 19:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19. The patient's concomitant medications were not reported.  After my first shot, my arm was sore. I had a significant headache where I took migraine over the counter medicine the day after. The headache was gone the second day after. My arm hurt for days after with intensity decreasing. I did not have any effects after the second shot. Outcome of events was recovered. Case was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: some inflammation on neck part skin; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the caller, called to ask if it was okay for him to take the antibiotics (Cefalexin) prescribed to him by his physician due to some inflammation on neck part skin on an unspecified date in 2021 for 7 days before his second dose schedule on 06Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This is a spontaneous report from a Pfizer-sponsored Program. A contactable female consumer (patient) reported for herself that she received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number not reported), via an unspecified route of administration on 31Mar2021 as single dose for COVID 19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, patients husband was tested Covid-19 Positive, and she experienced loss of taste. The patients second dose schedule which will be on 11Apr2021. The outcome of the events was reported as unknown.  Information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction, Hypoaesthesia, Throat tightness
Clinical narrative: Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: nausea; chills; headache; This is a spontaneous report received form a Pfizer sponsored program via a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 04Apr2021 as single dose for COVID-19 immunization. The patient wants to know how long she will experience these side effects/reactions. The patient medical history and concomitant medications were not reported. The patient experienced nausea, chills, headache on an unspecified date in Apr2021. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Myalgia
Clinical narrative: She can hardly walk; experiencing something in the upper part of her leg, on the muscle in the back of her leg; Muscle pain; This is a spontaneous report from a contactable consumer. A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported.  The patient experienced something in the upper part of her leg on the muscle in the back of her leg. She can hardly walk. She had muscle pain. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm afterward; This is an initial spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm afterward on an unspecified date. She noted that she experienced no other side effects. The outcome of event was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: low grade fever/  fever went up to 101°; fatigue; headache; body ache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included the day before she got the vaccine she ran down a little, thinking she had allergies which she was not sure, like an allergy nasally. Concomitant medications were not provided. The patient received first dose and asked if her side effect was normal, she still experiencing a little bit of a fever, questioning if it was normal, was it okay to take Tylenol. Second dose is scheduled for 27Apr2021, she did not know if she wanna get it though, been feeling symptoms, she would call doctor and see what he recommends. On 06Apr2021, a couple of hours after receiving the shot, patient stated that she started experiencing low grade fever and fatigue. At night on 06Apr2021, she was having a headache, body ache and until the morning on 08Apr2021, she still had a little fever and aches which it had been two days ago. She also mentioned that her temperature of her fever went up to 101°, and in the morning of 08Apr2021, she took two paracetamol (TYLENOL). Wondering if that could have a combination with the vaccine, if having side effects is normal. Patient was still experiencing side effects (fever and fatigue), asked if this was normal. Outcome of the event headache was unknown, while not recovered from other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hot flush, Pain in extremity, Syncope
Clinical narrative: fainting; hot flashes; Fatigue; arm pain; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 26Feb2021 10:00 at single dose for COVID-19 immunisation. Medical history included Narcolepsy, dysautonomia and POTS (Postural orthostatic tachycardia syndrome). No known allergies. Concomitant medication included modafinil. No other vaccine in four weeks. The patient experienced fainting, hot flashes, fatigue, arm pain, diarrhea, all on 26Feb2021. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Foaming at mouth, Headache, Pain, Syncope
Clinical narrative: 2 episodes of fainting with shaking; 2 episodes of fainting with shaking; foaming at mouth; Fatigue; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, on an unspecified date (Lot number was not reported), as single dose for covid-19 immunisation. Medical history included narcolepsy, dysautonomia and Postural orthostatic tachycardia syndrome (POTS). The patient was not pregnant. Concomitant medications included modafinil. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, as single dose in left arm, on 26Feb2021 at 10:00 for covid-19 immunisation and she experienced fatigue, arm pain, fainting, diarrhea, hot flashes after first dose all within 48 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 episodes of fainting with shaking, foaming at mouth, fatigue, body aches and headaches after second dose all within 48 hours. Events outcome was unknown.  Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: 2 episodes of fainting with shaking; 2 episodes of fainting with shaking; foaming at mouth; Fatigue; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, on an unspecified date (Lot number was not reported), as single dose for covid-19 immunisation. Medical history included narcolepsy, dysautonomia and Postural orthostatic tachycardia syndrome (POTS). The patient was not pregnant. Concomitant medications included modafinil. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, as single dose in left arm, on 26Feb2021 at 10:00 for covid-19 immunisation and she experienced fatigue, arm pain, fainting, diarrhea, hot flashes after first dose all within 48 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 episodes of fainting with shaking, foaming at mouth, fatigue, body aches and headaches after second dose all within 48 hours. Events outcome was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash, Throat tightness, Vaccination site rash
Clinical narrative: rashes on her elbow, wrist and inner thigh/ rash on her legs, arms; rash at the injection site; seriously ill; throat tightened; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number and expiration date was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Mar2021, she feel uncomfortable. Caller stated that the patient got her first dose of the Covid 19 vaccine last March 30, 2021. She waited 15 minutes after getting the vaccine and had no symptoms, after some time she experienced that her throat tightened. On 31Mar2021, she was seriously ill. Also added that 2 days later she had rashes on her elbow, wrist and inner thigh and rash on her legs, arms, and at the injection site. Mid December she said that she had covid. Caller asking if she should take her second dose of the vaccine. The caller's primary care provider told her to take 2 Benadryl's before the shot, but she knows the allergic reactions can be worse with the second dose and doesn't know if the 2 Benadryl's will do it. The patient did not receive any treatment. Outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: feel tired; muscle aches; This is a spontaneous report received from a contactable 74-year-old male consumer (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 28Mar2021 (at the age of 74-year-old male) as a single dose for COVID-19 immunization about 10 days ago. The patients past medical history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) for COVID-19 immunization on 08Mar2021. The concomitant medications was not reported. On an unspecified date, the patient experienced feel tired, fatigue, muscle aches which was still continuing ten days after vaccination. The patient told he got some after effects from the vaccine and was asking about how long he could expect to have a typical number or range of days and how long side effects last. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paranasal sinus discomfort, Sinus pain
Clinical narrative: environmental allergies; woke up with a lot of sinus pressure; sinus pain; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the first dose of the Covid vaccine on 18March2021 and was scheduled to receive the second dose today. Patient stated that she has environmental allergies and woke up with a lot of sinus pressure today. Patient asked if she is able to receive the second dose today. Patient asked if she can take an naproxen sodium (ALEVE) before receiving the vaccine today. She received her 1st dose of the vaccine last March 18 and she is due today which is April 8 for her 2nd dose. Patient said that she has environmental allergies and sinus pain. Patient was asking if she can put off getting her 2nd dose or how many days should she wait before getting the 2nd dose. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: Extremely dizzy; very tired; a little nauseous; Left Arm Pain/ in pain closer to the vaccine; This is a spontaneous report received from a contactable consumer. A consumer (patient) reported a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via unspecified route on left arm single dose for COVID-19 immunization on 03Apr2021 10:01, at 27-year-old. Medical history and concomitant medication were not reported. The patient had Left arm pain hurt so bad on Saturday (03Apr2021), 13:00, that she cried; took some ibuprofen (ADVIL) Saturday and Sunday to relieve her arm pain. The patient was nauseous on 04Apr2021 and very tired on 05Apr2021, reported extremely dizzy and difficult to wake up on 08Apr2021. The patient reported that she woke up this morning (08Apr2021) feeling really, really, really dizzy. She was a little nauseous and in pain closer to the vaccine. No emergency room or physician office visited. Outcome of the events left arm pain/ in pain closer to the vaccine, nauseous and very tired was resolving; outcome of the other event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Muscular weakness, Pyrexia
Clinical narrative: Can't use his hands; fever; Tiredness; felt very bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got his first dose on 02Apr2021 and experienced Fever, Tiredness, Can't use his hands and felt very bad in Apr2021. His doctor gave him a medicine which is prednisone tablet. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable consumer (Patient friend). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6199), via an unspecified route of administration, on Arm Left (Left shoulder) on 23Mar2021 16:00 as single dose for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus from 2020 and blood thinner from 2020. The patient concomitant medication included unspecified blood thinner (Caller thinks the patient started this medication within the last year). Patient had no family medical history. Additional vaccines administered on same date of the Pfizer suspect was None. The patient did not receive any other vaccines within 4 weeks Prior Vaccinations. It was reported that, the patient contracted Covid between the first and second Pfizer COVID-19 vaccine. Patient got the first dose of the Pfizer Covid 19 vaccine 2 weeks ago (on 23Mar2021) and was diagnosed with COVID yesterday morning (on 07Apr2021). His second dose of the vaccine was due next Tuesday, 13Apr2021. Around the time he tested positive, the caller stated she didn't think her friend had. She went on to say that he may have taken Tylenol extra strength though. Today (08Apr2021) the patient's fever was not as bad, he was very weak and laying on the couch. Caller and patient received their vaccine at the same place, within a few days of each other. The nurse that tested the patient yesterday told him that she believes the vaccine was causing people to get Covid. The patient was tested at a drive through yesterday because he wasn't feeling well. The patient did not visit emergency room and did not visit Physician office/ department. The outcome of the events was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Diarrhoea, Dyspepsia, Influenza like illness, Viral infection
Clinical narrative: she felt like she had a virus; Had to keep going to the bathroom; Flu like symptoms; feeling really sore in under armpit and certain spot, sometimes she does not feel it and sore spot in her underarm is the same arm she got the vaccine in; I had burning in my stomach; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunization. Patient received the second dose of the Pfizer COVID 19 vaccine on 05Apr2021 (Monday). Patient stated that flu like symptoms started on Tuesday (06Apr2021). Caller reported that yesterday (07Apr2021) she felt like she had a virus, saying she had to keep going to the bathroom yesterday (07Apr2021). Patient also reported that she was really sore in certain spots of her underarm pit. Caller stated that sometimes she does not feel it. Caller stated this is happening in the same arm that she got the vaccine. Patient stated that she felt fine until she took the shot. Patient had burning in stomach but her concern was soreness in armpit. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: little headache; pain in the arm for 1 day; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose on 04Apr2021 and second dose on 22Apr2021. She did not experience any reaction after getting the first dose, only a little headache and pain in the arm for 1 day in Apr2021. She was asking if it's possible that she will get reactions after the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Eyelid ptosis, Facial paralysis, Headache
Clinical narrative: her mouth drooped; her eyes drooped; she started to stutter while talking; headache; This is a spontaneous report received from a Pfizer-sponsored Program.  A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration on 06Mar2021 (batch/lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if she receives the 2nd dose of the vaccine will she experience the same adverse events after she received her first dose. She experienced headache, her mouth drooped, her eyes drooped, and she started to stutter while talking after receiving the first dose. Event onset dates were not reported. The outcome of the events was unknown. The patient's second dose is on 09Apr2021.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: slight fever; Headache; Fatigue; Pain in her entire arm; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 18-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced slight fever, headache, fatigue, and pain in her entire arm with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Flushing, Headache, Oesophagitis
Clinical narrative: severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; was going from shivering to over heating; esophagitis; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the right arm on 29Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose (at the age of 30-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient was negative for the nasal swab on 03Mar2021. The patient received the first dose of BNT162B2 intramuscularly on the right arm on 08Mar2021 16:00 (at the age of 30-years-old) for COVID-19 immunization. The patient had no other medication in two weeks and no other vaccine in four weeks. The patient had no COVID prior to vaccination. After about 4 hours of receiving second dose (29Mar2021, 19:00), the patient had a very bad headache, body aches, and was going for shivering to overheating. She began to vomit non-stop, couldn't keep food or liquids down. She ended up going to urgent care on 30Mar2021 and was sent to the ER.  She was admitted to the hospital on that day for severe dehydration from vomiting and was told she had esophagitis. The adverse events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for three days. The patient received unspecified IV's, medications and had scans (unknown results). The patient was recovering from the events.; Sender's Comments: The events was considered related to suspect vaccine BNT162B2 based on strong temporal association and known safety profile of the drug. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scan, Vomiting
Clinical narrative: severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; was going from shivering to over heating; esophagitis; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the right arm on 29Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose (at the age of 30-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient was negative for the nasal swab on 03Mar2021. The patient received the first dose of BNT162B2 intramuscularly on the right arm on 08Mar2021 16:00 (at the age of 30-years-old) for COVID-19 immunization. The patient had no other medication in two weeks and no other vaccine in four weeks. The patient had no COVID prior to vaccination. After about 4 hours of receiving second dose (29Mar2021, 19:00), the patient had a very bad headache, body aches, and was going for shivering to overheating. She began to vomit non-stop, couldn't keep food or liquids down. She ended up going to urgent care on 30Mar2021 and was sent to the ER.  She was admitted to the hospital on that day for severe dehydration from vomiting and was told she had esophagitis. The adverse events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for three days. The patient received unspecified IV's, medications and had scans (unknown results). The patient was recovering from the events.; Sender's Comments: The events was considered related to suspect vaccine BNT162B2 based on strong temporal association and known safety profile of the drug. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: extreme sharp pain in shoulder to elbow. Patient felt this whenever patient activates arm, do push up or lift; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that after getting first dose of the Pfizer COVID 19 vaccine patient experienced extreme sharp pain in shoulder to elbow. Patient felt this whenever patient activates arm, do push up or lift. Added that patient was experiencing this for 15 days already. Second dose of vaccine was scheduled next week Wednesday (as of 08Apr2021). Outcome of the event was not resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood pressure increased, Blood pressure measurement, Stress
Clinical narrative: stressed; it makes his blood pressure go up and that makes him blind in one eye; it makes his blood pressure go up and that makes him blind in one eye; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number and expiration date were not reported) at the age of 70-years-old at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and his daughter (58 years old female) received their first dose of the Pfizer COVID vaccine on 06Apr2021 and second dose is scheduled 4 weeks later. The patient wanted to know how he can take the second dose in 3 weeks and stated that because he was stressed about the appointment time, it makes his blood pressure go up and that makes him blind in one eye. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: side affect of feeling drained and feverish; side affect of feeling drained and feverish; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer (patient)herself) of an unspecified age received first does of BNT162B2 (BNT162B2), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The medical history included covid-19 in Mar2021. The patient's concomitant medications were not reported. on Apr2021 with outcome of unknown. After receiving first dose on last Thursday 01Apr2021, the patient experienced feeling drained and feverish and thought she had covid back in march fears.  No follow-up attempts are needed. No further information is expected.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: very sore arm; body ache; body chills; nausea; headache; This is a spontaneous report from contactable consumer. A 71 years female consumer (patient) reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. The patient reported to have a very sore arm, body ache, body chills, nausea, headache, & 'about every one of the possible side effects'. The outcome of the event was unknown.  No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia, Vaccination site pain
Clinical narrative: left arm getting hot and numbing sensation; left arm getting hot and numbing sensation; tenderness where the  injection was; Tingling; This is a spontaneous report received from a contactable consumer. This 48-year-old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8734) on 07Apr2021 on her left arm for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient began to feel the following while walking to her car afterward: left arm getting hot and numbing sensation.  It is not as severe as of 08Apr2021.  She can feel numbness in her fingertips and tenderness where the injection was. The patient was wondering if she should get the second dose of it based off of her symptoms from the first dose. The patient stated her numbness, tingling, and tenderness in the injection was not preventing her from typing or working. She stated it was just something she felt. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.