chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Decreased appetite, Fatigue, Hypersomnia, Pain
Clinical narrative: She has been experiencing extreme fatigue; She has been sleeping non-stop; gets up to eat barely; she has been in bed; body aches on bright side of the body/aches on entire right side of her body; This is a spontaneous report from a contactable consumer.  A 76-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 28May2021 at 14:00 (lot number: EM9809) (age at vaccination 76-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history heart disorder, blood pressure abnormal, mental disorder, vitamin supplementation and colitis. The patient concomitant medications included aspirin, bentyl, atenolol, atorvastatin, escitalopram and vitamin D. The patient did not had prior vaccinations (within 4 weeks). The patient had no medical history including any illness at time of vaccination. The family medical history and relevant test were reported as none. The patient experienced aches on entire right side of the body and has been in bed on 01Feb2021, got the first dose of the COVID 19 vaccine Sunday 31Jan2021/next dose of the vaccine is scheduled for 28Feb2021, experienced extreme fatigue, sleeping non-stop and gets up to eat barely. The patient did not required a visit to physician or ER for AE(s). The outcome of the event aches on entire right side of her body, has been in bed was not recovered and the outcome of the other events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Infection
Clinical narrative: infection in her eye brow; eye is swollen; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date of Jan2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021 the patient experienced infection in her eyebrow and eye is swollen. Patient clarifies that she was taking antibiotics and a steroid for a possible spider bite. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Swollen tongue
Clinical narrative: she had an allergic reaction to the first dose; tongue swelled; her bottom lip went number for 1/2 hour; Swollen tongue and her lips was numb; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in arm right on 22Jan2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she had an allergic reaction to the first dose, tongue swelled, her bottom lip went number for 1/2 hour, swollen tongue and her lips was numb, all on an unspecified date in 2021. Patient is scheduled to have the second dose of the Pfizer COVID-19 vaccine tomorrow (12Feb2021). Her vaccination provider said that she cannot give her the second dose since she had an allergic reaction to the first dose. Patient went to her doctor but her doctor said that he does not have access to the vaccine. Patient claims her allergic reaction is not severe. Patient only have a few days before her second dose. What do I do if I can't take it on time. Patient stated that she took the first Pfizer shot and tomorrow is the due date for the second one. Stated she cannot get it because she had small allergic reaction to the first one. Stated that her doctor can give it but she cannot because she cannot get it to her clinic. Wanted to know what to do. Is for the Pfizer Covid 19 shot. Stated that her tongue swelled and her bottom lip went number for 1/2 hour. Event details: Stated that her tongue swelled three weeks ago. Recovered completely. Stated that her bottom lip went numb three weeks ago. Recovered completely. Verbatim and event description: Swollen tongue and her lips was numb after she took the 1st dose of vaccine. The patient did not receive treatment for the events. Outcome of the events tongue swelled, her bottom lip went number for 1/2 hour was recovered on an unspecified date in 2021 and outcome of remaining events was unknown.  Follow-up (PRD/SRD 14May2021): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: fever; chills; nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A 53-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL9267; Expiration Date: May2021), intramuscular, administered in Arm Left on 10Feb2021 11:30 ,at the age of 53 years old,as dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever, chills and nausea on 11Feb2021 03:00. Therapeutic measures were taken as a result of fever, chills and nausea.Additional Context: Received a call from consumer or patient herself who reported regarding the Pfizer COVID vaccine. She took it yesterday and she had a fever all night, chills and nausea. Her fever went to 102. She took Motrin twice. Nothing seems to be helping. She did not provide a dose, lot or expiration for the Motrin. She would like to know how long this process will last. The chills are unbearable.The patient provided the details of the 2nd dose of Pfizer covid19 vaccine.She also provided number # on the vaccine card as well. Vaccination facility was reported as specialty hospital.The patient previously received her 1st dose of Pfizer covid19 vaccine on 20Jan2021,Lot EL9261, expiration May2021.The outcome of the events was not recovered. Follow-up (11Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that patient age was reported to be 53 years old,weight 108.86 kg,Height (cm): 175 and gender female.start date of reaction was reported to be 11 feb2021.The patient reported about the events chills,nausea and fever.The patient also provided her 1st dose of vaccination date.The patient also reported about product complaint that is : She took Motrin twice and nothing is helping. She still has a fever, chills and nausea. No further details provided. additional lot no,product packaging details was unknown.  Follow-up (12May2021): Follow-up attempts are completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue the day after the shot; This is a spontaneous report from a contactable consumer reported for herself. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:30 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation at the clinic. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (Lot number: EL3247) via an unspecified route of administration, administered in right arm on 19Jan2021 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. The patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue the day after the shot on 10Feb2021. No treatment received for the event. Seriousness criteria included none and the event was not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical outcome of events was recovered on unspecified date.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inappropriate schedule of product administration, Pain, Vision blurred
Clinical narrative: Start Date/Time: [Pfizer] 27-JAN-2021 05:00 PM/Start Date/Time: [Pfizer] 10-FEB-2021 01:30 PM; my resting heart rate escalated to 140 BPM; my vision got blurry; feel sore today; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on 10Feb2021 13:30 (at the age of 30-year-old) as dose 2, single for covid-19 immunisation. Medical history included substance use from an unknown date and unknown if ongoing smoked weed it made my lungs feel strange. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on 27Jan2021 05:00 PM (at the age of 30-year-old) as dose 1, single for covid-19 immunisation and experienced lungs feel strange. Patient concomitant medications were not specified. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021, the patient experienced start date/time: pfizer 27-jan-2021 05:00 pm/start date/time: pfizer 10-feb-2021 01:30 pm. On the second dose patient had an edible instead and just little smoke (weed). For some reason his resting heart rate escalated to 140 BPM and his vision got blurry about six hours from the second dose maybe an hour or two after eating the edible. It stayed above 100 for at least 2 hours until he fell asleep. Patient put his hands above head and breathed deeply trying to calm himself down. Patient felt like he was running a marathon while laying in bed. Patient had a small edible and he was very used to eating weed. Patient stated that he was worried if someone is ingesting marijuana or smoking weed on their second dose that it could hurt their heart if they have a pre existing heart condition. Patient feel sore today and his pulse was stable. The patient underwent lab tests and procedures which included heart rate: 140 bpm on 10Feb2021 escalated to 140 BPM. The reporter assessed the events as non serious. No treatment was taken as a result of heart rate increased, blurry vision, pain. The outcome of the events heart rate increased, blurry vision, pain were recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Adds that she had 2 shots of the pfizer covid vaccine recently and is experiencing fever, chills, headache for the last 2 days; Adds that she had 2 shots of the pfizer covid vaccine recently and is experiencing fever, chills, headache for the last 2 days; Adds that she had 2 shots of the pfizer covid vaccine recently and is experiencing fever, chills, headache for the last 2 days; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date (at the age of 70-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. On an unspecified date, the patient experienced fever, chills, headache for the last 2 days. Caller calling about skipping this medication until her side effects from the COVID vaccine passes or for 2 days. She questioned for today, if she don't take Vyndaqel for 2 days for the time that her side effects from the Covid vaccine will last, will something bad happen or will she die from not taking it. States she has been unable to reach her doctor-it's been a couple of days so far. Initially caller had asked if it was ok to skip a couple of days. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: chills; abdominal pain/stomach pains; is very tired; her arms became swollen; the arm where the vaccine was given was swollen and a bit sore and a bit painful; the arm where the vaccine was given was swollen and a bit sore and a bit painful; Pain is not as bad, but it is a really tight feeling; Fatigue; Rash; she had a big red, and painful round rash; area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling; area swollen, a bit sore, a bit painful/it's not quite as sore/soreness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL8982 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On an unspecified date the patient experienced her arms became swollen, chills, abdominal pain/stomach pains, the arm where the vaccine was given was swollen and a bit sore and a bit painful. On 09Feb2021 the patient experienced had a big red, and painful round rash, is very tired, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, on 10Feb2021 the patient experienced rash, on 11Feb2021 the patient experienced pain is not as bad, but it is a really tight feeling, fatigue. The outcome of events her arms became swollen, chills , abdominal pain/stomach pains , is very tired , the arm where the vaccine was given was swollen and a bit sore and a bit painful was unknown while the outcome of events she had a big red, and painful round rash, rash, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, area swollen, a bit sore, a bit painful/it's not quite as sore/soreness, pain is not as bad, but it is a really tight feeling , fatigue was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash erythematous, Swelling, Vaccination site pain
Clinical narrative: chills; abdominal pain/stomach pains; is very tired; her arms became swollen; the arm where the vaccine was given was swollen and a bit sore and a bit painful; the arm where the vaccine was given was swollen and a bit sore and a bit painful; Pain is not as bad, but it is a really tight feeling; Fatigue; Rash; she had a big red, and painful round rash; area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling; area swollen, a bit sore, a bit painful/it's not quite as sore/soreness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL8982 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On an unspecified date the patient experienced her arms became swollen, chills, abdominal pain/stomach pains, the arm where the vaccine was given was swollen and a bit sore and a bit painful. On 09Feb2021 the patient experienced had a big red, and painful round rash, is very tired, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, on 10Feb2021 the patient experienced rash, on 11Feb2021 the patient experienced pain is not as bad, but it is a really tight feeling, fatigue. The outcome of events her arms became swollen, chills , abdominal pain/stomach pains , is very tired , the arm where the vaccine was given was swollen and a bit sore and a bit painful was unknown while the outcome of events she had a big red, and painful round rash, rash, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, area swollen, a bit sore, a bit painful/it's not quite as sore/soreness, pain is not as bad, but it is a really tight feeling , fatigue was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: chills; abdominal pain/stomach pains; is very tired; her arms became swollen; the arm where the vaccine was given was swollen and a bit sore and a bit painful; the arm where the vaccine was given was swollen and a bit sore and a bit painful; Pain is not as bad, but it is a really tight feeling; Fatigue; Rash; she had a big red, and painful round rash; area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling; area swollen, a bit sore, a bit painful/it's not quite as sore/soreness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL8982 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On an unspecified date the patient experienced her arms became swollen, chills, abdominal pain/stomach pains, the arm where the vaccine was given was swollen and a bit sore and a bit painful. On 09Feb2021 the patient experienced had a big red, and painful round rash, is very tired, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, on 10Feb2021 the patient experienced rash, on 11Feb2021 the patient experienced pain is not as bad, but it is a really tight feeling, fatigue. The outcome of events her arms became swollen, chills , abdominal pain/stomach pains , is very tired , the arm where the vaccine was given was swollen and a bit sore and a bit painful was unknown while the outcome of events she had a big red, and painful round rash, rash, area swollen, a bit sore, a bit painful/it's still somewhat swollen/swelling, area swollen, a bit sore, a bit painful/it's not quite as sore/soreness, pain is not as bad, but it is a really tight feeling , fatigue was not recovered.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Insomnia
Clinical narrative: Chills; body aches; fatigue; headache; nausea; lack of appetite; trouble sleeping; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ELO 142 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 10:30 as DOSE 1 (age at vaccination: 66-years-old, SINGLE for covid-19 immunisation. Medical history included colitis ulcerative, tachycardia (tackacardia) and seborrhoea. Concomitant medication included metoprolol tartrate (LOPRESSOR). There was no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, body aches, fatigue, headache, nausea, lack of appetite and trouble sleeping on 03Feb2021 at 15:00. No treatment was received for the adverse events. Outcome of all the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Chills; body aches; fatigue; headache; nausea; lack of appetite; trouble sleeping; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ELO 142 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 10:30 as DOSE 1 (age at vaccination: 66-years-old, SINGLE for covid-19 immunisation. Medical history included colitis ulcerative, tachycardia (tackacardia) and seborrhoea. Concomitant medication included metoprolol tartrate (LOPRESSOR). There was no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, body aches, fatigue, headache, nausea, lack of appetite and trouble sleeping on 03Feb2021 at 15:00. No treatment was received for the adverse events. Outcome of all the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypotension, Migraine, Nausea
Clinical narrative: headache; migraine; sensation of bilateral eye pressure; severe nausea; photophobia; low blood pressure at 90/62; This is a spontaneous report from a contactable other hcp.   A 47-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb202116:00 (Batch/Lot Number: EL9265) as dose 1 single for covid-19 immunisation. Medical history included glaucoma, bilateral high eye pressures (early glaucoma- treated with Vyzulta), hypersensitivity. Concomitant medication(s) included latanoprost (VYZULTA). Patient had key lime allergy. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced headache, migraine, sensation of bilateral eye pressure, severe nausea, photophobia, low blood pressure at 90/62 on 11Feb2021 05:00 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 90/62 on. Therapeutic measures were taken Advil 600mg and Tylenol 1000 mg total as a result of headache (headache), migraine (migraine), sensation of bilateral eye pressure (ocular discomfort), severe nausea (nausea), photophobia (photophobia), low blood pressure at 90/62 (hypotension).  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Photophobia
Clinical narrative: headache; migraine; sensation of bilateral eye pressure; severe nausea; photophobia; low blood pressure at 90/62; This is a spontaneous report from a contactable other hcp.   A 47-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb202116:00 (Batch/Lot Number: EL9265) as dose 1 single for covid-19 immunisation. Medical history included glaucoma, bilateral high eye pressures (early glaucoma- treated with Vyzulta), hypersensitivity. Concomitant medication(s) included latanoprost (VYZULTA). Patient had key lime allergy. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced headache, migraine, sensation of bilateral eye pressure, severe nausea, photophobia, low blood pressure at 90/62 on 11Feb2021 05:00 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 90/62 on. Therapeutic measures were taken Advil 600mg and Tylenol 1000 mg total as a result of headache (headache), migraine (migraine), sensation of bilateral eye pressure (ocular discomfort), severe nausea (nausea), photophobia (photophobia), low blood pressure at 90/62 (hypotension).  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: having chills/has chills all over; Freezing all over/cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK4176, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm (left shoulder) on 10Feb2021 at the age of 64-years-old as dose 1, single for covid-19 immunisation. Medical history included Coagulation disorder from an unknown date. Concomitant medication included warfarin (WARFARIN, Dosage text: 10 mg 4 days a week, and 15 mg on the 3 days a week) taken as blood thinner from 1994 and ongoing. There was no investigation assessment. The reporter, 64 years old, stated that she called in earlier to report that she was having chills on 11Feb2021. She received her 1st shot of the Pfizer Covid Vaccine the previous day and wanted to know if this side effect would last and for how long. She had the chills. She had her shot the previous day. The Pfizer COVID Vaccine, and today she was cold. She was freezing all over on 11Feb2021. The reporter asked was that supposed to happen, and how many days should it last? She declined email It is like she was just cold. She has chills all over. On the paper they give when giving the shot it does mention blood thinners. She was on Warfarin 10 mg 4 days a week, and 15 mg on the 3 days a week. She started it in 1994. The doctor told her to get it. The case was reported as non-serious. The outcome of events at the time of last observation was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated
Clinical narrative: severe lower back pain; pain from his hip down to his right leg; it is getting worse; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient woke up with severe lower back pain, and pain from his hip down to his right leg. He said that it is getting worse and wants to know if this is a common side effect that is associated with the vaccine. He said he called to ask for guidance on what to do. The Outcome of the events was unknown.  No follow-up attempts are possible. Information on batch/lot number could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Varicella
Clinical narrative: Lichen planus outbreak; It makes her skin break out like chicken pox; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing lichen planus. Reported that patient had lichen planus on her scalp and skin. Usually it is more prevalent in the mouth. It makes her skin break out like chicken pox. She has had it for 3 years. She was told that maybe it was going to start to fade after 3 years. It comes and goes from time to time. It was about cleared up. After the first shot, she started with a fairly decent break out with it. It is an autoimmune problem. Not that many people have it on skin. They think drugs could cause it. She doesn't know what to do. She thinks she wants to report it to her Dermatologist first and see what she says. But she doesn't even know the vaccine was related. She thinks it is just associated with it being an autoimmune disease. The shot probably just put stress on her body. There were no concomitant medications. Historical vaccine included flu shots on an unspecified date for immunization and didn't have this problem with the flu shot. Reported that patient and her husband received the 1st dose of the vaccine on 26Jan2021. They were supposed to receive the 2nd dose on 16Feb2021 but due to problems at their vaccination facility, they were rescheduled to get the vaccine this Saturday, which is 17 days as opposed to the 21 days. She asked her granddaughter who was a pharmacist and she said she wasn't sure about it. She read up on the CDC guidelines and wants to confirm her understanding of what she read with Pfizer. They were notified by their doctor office that the clinics had to change the date. They moved them way ahead. Patient was uncomfortable about it, so called to confirm because the clinic said that this was acceptable. On an unspecified date, the patient experienced lichen planus outbreak, it makes her skin break out like chicken pox. The outcomes of events were unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: shaky; numbish; heart was kind of racing; my arm is like super numb and kind of hurting; voice is kind of breaking; dizzy; fatigued; shaking; tingling sensation; head throbbing; my back is not pain but feels like pressure; had a little slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9266; Expiration date was not reported) via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021 the patient experienced had a little slight headache, on 11Feb2021 experienced shaky, numbish, heart was kind of racing, my arm is like super numb and kind of hurting, voice is kind of breaking, dizzy, fatigued, shaking, tingling sensation, head throbbing, my back is not pain but feels like pressure. Caller (female,30 years old) got first dose of PFIZERBIONTECH COVID-19 VACCINE , caller said: it says Pfizer EL9266, yesterday, (10Feb2021), stated that she was fine yesterday, just had a little slight headache but today, caller stated I started feeling very shaky, kind of like numbish, my body kind of numbish and like my heart was kind of racing and my arm is like super numb and kind of hurting and I don't know if you can tell but even my voice is kind of breaking and I don't know if that's normal or do I need to go to the doctor, hospital. Caller wanted to know that to do. Explained that I will be happy to check if what she is reporting was reported in clinical studies, explained to the caller that she needed to reach out to her HCP regarding her symptoms. Call got disconnected, I called back spoke to the caller. Upon a callback caller provided additional side effects, caller stated: I felt dizzy , fatigued, my body was shaking, heart racing, my arm started getting numb, I got this tingling sensation all over my body, head throbbing, my back is not pain but feels like pressure which is weird" Did not speak to the doctor yet. Do I need to go to the ER or this is just normal. Refer caller to HCP/if allergic reaction ER/hospital. DSU: Caller was not transferred to safety as she needed to get in touch with HCP regarding her symptoms. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nervousness, Pain, Palpitations, Paraesthesia
Clinical narrative: shaky; numbish; heart was kind of racing; my arm is like super numb and kind of hurting; voice is kind of breaking; dizzy; fatigued; shaking; tingling sensation; head throbbing; my back is not pain but feels like pressure; had a little slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9266; Expiration date was not reported) via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021 the patient experienced had a little slight headache, on 11Feb2021 experienced shaky, numbish, heart was kind of racing, my arm is like super numb and kind of hurting, voice is kind of breaking, dizzy, fatigued, shaking, tingling sensation, head throbbing, my back is not pain but feels like pressure. Caller (female,30 years old) got first dose of PFIZERBIONTECH COVID-19 VACCINE , caller said: it says Pfizer EL9266, yesterday, (10Feb2021), stated that she was fine yesterday, just had a little slight headache but today, caller stated I started feeling very shaky, kind of like numbish, my body kind of numbish and like my heart was kind of racing and my arm is like super numb and kind of hurting and I don't know if you can tell but even my voice is kind of breaking and I don't know if that's normal or do I need to go to the doctor, hospital. Caller wanted to know that to do. Explained that I will be happy to check if what she is reporting was reported in clinical studies, explained to the caller that she needed to reach out to her HCP regarding her symptoms. Call got disconnected, I called back spoke to the caller. Upon a callback caller provided additional side effects, caller stated: I felt dizzy , fatigued, my body was shaking, heart racing, my arm started getting numb, I got this tingling sensation all over my body, head throbbing, my back is not pain but feels like pressure which is weird" Did not speak to the doctor yet. Do I need to go to the ER or this is just normal. Refer caller to HCP/if allergic reaction ER/hospital. DSU: Caller was not transferred to safety as she needed to get in touch with HCP regarding her symptoms. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaky; numbish; heart was kind of racing; my arm is like super numb and kind of hurting; voice is kind of breaking; dizzy; fatigued; shaking; tingling sensation; head throbbing; my back is not pain but feels like pressure; had a little slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9266; Expiration date was not reported) via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021 the patient experienced had a little slight headache, on 11Feb2021 experienced shaky, numbish, heart was kind of racing, my arm is like super numb and kind of hurting, voice is kind of breaking, dizzy, fatigued, shaking, tingling sensation, head throbbing, my back is not pain but feels like pressure. Caller (female,30 years old) got first dose of PFIZERBIONTECH COVID-19 VACCINE , caller said: it says Pfizer EL9266, yesterday, (10Feb2021), stated that she was fine yesterday, just had a little slight headache but today, caller stated I started feeling very shaky, kind of like numbish, my body kind of numbish and like my heart was kind of racing and my arm is like super numb and kind of hurting and I don't know if you can tell but even my voice is kind of breaking and I don't know if that's normal or do I need to go to the doctor, hospital. Caller wanted to know that to do. Explained that I will be happy to check if what she is reporting was reported in clinical studies, explained to the caller that she needed to reach out to her HCP regarding her symptoms. Call got disconnected, I called back spoke to the caller. Upon a callback caller provided additional side effects, caller stated: I felt dizzy , fatigued, my body was shaking, heart racing, my arm started getting numb, I got this tingling sensation all over my body, head throbbing, my back is not pain but feels like pressure which is weird" Did not speak to the doctor yet. Do I need to go to the ER or this is just normal. Refer caller to HCP/if allergic reaction ER/hospital. DSU: Caller was not transferred to safety as she needed to get in touch with HCP regarding her symptoms. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore muscle on left upper arm near injection site; This is a spontaneous report from a non-contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administrated in Left arm on 10Feb2021 14:00 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have known allergies to medications, food, or other products. On 10Feb2021, the patient experienced Sore muscle on left upper arm near injection site. No treatment was received for the adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmalgia, Myalgia
Clinical narrative: has heavy pain in diaphragm area; muscle pain; This is a spontaneous report from a contactable consumer or other non health care professional. A female patient (consumer's sister) of an unspecified age (Age: 37; Unit: Unknown, as reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and experienced muscle pain. It was reported that, reporter calls on behalf of sister. He reports that his sister received second dose of vaccine and has heavy pain in diaphragm area and muscle pain. He reports that she did have muscle pain after first dose but not this form of pain. Reporter would like to know if this has been reported by others or what should they do. The reporter assessed the seriousness as non-serious. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I have a headache; fever; I am very aches and feel so tired; I am very aches and feel so tired; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 47-years), administered in arm left on 09Feb2021 at 13:00 as dose 1, single for COVID-19 immunization. Medical history included i am a little over weight from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Patient not had covid prior vaccination and had not been tested for covid post vaccination. The patient previously took CEFZIL and experienced known allergies. On 10Feb2021 at 04:00, the patient experienced i have a headache a slight fever, i am very aches and feel so tired. The treatment was not received for the event. The facility type of vaccine was reported as other. The clinical outcome for the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck; This is a spontaneous report from a contactable other HCP. This 37-year-old non pregnant female other HCP (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No known allergies. No other medical history. On 29Jan2021 patient experienced swollen lymph nodes in neck. The second dose was on 10Feb2021, administration time 01:15 PM, vaccine location Left arm, dose number 2, lot numberen6201. Event resulted in doctor or other healthcare professional office/clinic visit. No covid tested post vaccination. No treatment was received for event. The outcome of event was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100 +; This is a spontaneous report from a contactable consumer via medical information team. A 68 (units unknown) female patient received bnt162b2 (BNT162B2, solution for injection, lot/batch number unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose of vaccine and was now experiencing a fever of 100 +. The reporter would like to know what they should do for patient and if she should get the second dose. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: skin rash on back of neck, abdomen and groin area.; Smooth red rash with itching; Smooth red rash with itching; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 84-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 16:30 pm (Batch/Lot Number: EL9265) as dose 1, single for covid-19 immunization (at the age of 84-years-old). Medical history included Type 2 diabetes from an unknown date and unknown if ongoing and ongoing high blood pressure. Patient had no known allergies. Concomitant medication(s) included metformin taken for an unspecified indication, start and stop date were not reported and blood pressure pill for high blood pressure and daily vitamin taken for an unspecified indication and start and stop date were not reported for both. No other vaccine received in four weeks. It was reported that after receiving the first dose of vaccine on 01Feb2021, the patient experienced skin rash on back of neck, abdomen and groin area and smooth red rash with itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. As a therapeutic measure the patient was told to take Zyrtec. It was unknown if patient had covid prior vaccination. Patient was not tested for covid post vaccination. The outcome of the events was recovering at the time of report.   Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Fatigue, Pain in extremity
Clinical narrative: Chills but low temp (97.1); Chills but low temp (97.1); Tremors; sore arm but arm was mobile; Exhaustion; This is a spontaneous report from a non-contactable consumer. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 10Feb2021 at 08:15 (at the age of 76-years-old) as dose 2, single for COVID-19 immunisation. Medical history included hashimotos, hypertensive and known allergies to fentanyl. Concomitant medications included pregabalin (LYRICA), levothyroxine sodium (SYNTHROID), valsartan, vitamin supplements, and nasal spray. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL0142, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 18Jan2021 at 09:00 (at the age of 76-years-old) for COVID-19 immunisation. On 10Feb2021 at 18:00, the patient experienced chills but low temp (97.1), tremors, sore arm but arm was mobile, and exhaustion. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information expected.