chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal discomfort, Pain in extremity, Rhinorrhoea, Sinusitis
Clinical narrative: runny nose; "expectorant" sensation in his throat; producing a flehm, kind of like a sinus infection type thing; soreness in the arm; felt unconfirmable; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on Jan2021 as unknown single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in Jan2021, the patient reported that he had a shot about 8 days ago, it was Thursday last week (as reported), early in the morning and he had just soreness of arm and felt uncomfortable. But 8 days after, he experienced runny nose and an "expectorant" sensation in his throat. He wants to know if this is a side effect observed with the vaccine since he was not able to find any information on it in the literature. But on 04Feb2021 (yesterday as reported) and on 05Feb2021 (today as reported) he was developing like a runny nose and was producing flehm, kind of like a sinus infection type thing, he was not sure if people have been experiencing this. He said he just wanted to see, he doesn't know if it was a Pfizer or if he just picked up a cold. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Muscular weakness, Nausea
Clinical narrative: flu-like symptoms; chills; nausea; legs have felt rubbery when I got out of bed.; legs are a little prickly; felt tired/tiredness; sore arm; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient, reported for self)  A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2- PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch number: not reported), via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not report-ed. The patient (reporter) stated that she received the 1st dose of the Pfizer COVID 19 vaccine on Jan 22. She initially felt tired and had a sore arm. She felt good for about 5-6 days, then on Jan 28 she started to get flu-like symptoms. She began to get chills, tiredness and nausea. She has felt like that off and on since then. The patient mentioned that her legs have felt rubbery when she got out of bed. Patient was feeling better for today (as reported), but her legs were a little prickly. The clinical outcome of event, legs were a little prickly was unknown; the outcome of other events were recovering;   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: flu-like symptoms; chills; nausea; legs have felt rubbery when I got out of bed.; legs are a little prickly; felt tired/tiredness; sore arm; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient, reported for self)  A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2- PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch number: not reported), via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not report-ed. The patient (reporter) stated that she received the 1st dose of the Pfizer COVID 19 vaccine on Jan 22. She initially felt tired and had a sore arm. She felt good for about 5-6 days, then on Jan 28 she started to get flu-like symptoms. She began to get chills, tiredness and nausea. She has felt like that off and on since then. The patient mentioned that her legs have felt rubbery when she got out of bed. Patient was feeling better for today (as reported), but her legs were a little prickly. The clinical outcome of event, legs were a little prickly was unknown; the outcome of other events were recovering;   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Vaccination site mass
Clinical narrative: Bump at the sight of the vaccination.; Extremely itchy.; Also little red bruise; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EL9264) via unknown route of administration on 28Jan2021 06.00 PM in left arm as dose 1, single for COVID-19 immunization at Hospital. Medical history and Concomitant medications received within 2 weeks of vaccination were reported as none. 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. No allergies to medications, food, or other products. It was reported that patient had bump at the sight of the vaccination. extremely itchy. also, little red bruise on 04Feb2021 06:00 PM. Don't have any pain. No treatment received for the adverse events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: After the 1st shot her arm got really sore, could  not sleep that night; After the 1st shot her arm got really sore, could  not sleep that night; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 76 (Units: Unknown)-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: not reported), via an unspecified route of administration, administered in arm on an unspecified date as 1ST SINGLE DOSE for COVID-19 immunisation. The patient medical history included insomnia. The concomitant medications were not reported. It was reported that after the 1st shot her arm got really sore, could not sleep that night. The patient tried treatment with Melatonin and Benadryl, but it worked backwards on her. the patient received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021142435 same product, different patient and event.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Pain
Clinical narrative: after 5hrs of getting the shot I lost movement in my left arm from the elbow  up the left side of my neck due to excruciating pain which lasted for 48 hours slowly got movement back the third day; after 5hrs of getting the shot I lost movement in my left arm from the elbow  up the left side of my neck due to excruciating pain which lasted for 48 hours slowly got movement back the third day; after 5hrs of getting the shot I lost movement in my left arm from the elbow  up the left side of my neck due to excruciating pain which lasted for 48 hours slowly got movement back the third day; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 72-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 10:45 (Age at vaccination: 72 Years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no other medical history. The patient was not diagnosed with COVID-19 prior to vaccination and not since the vaccination. She did not receive any prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications the patient received within 2 weeks of vaccination. The patient experienced after 5hrs of getting the shot I lost movement in my left arm from the elbow up the left side of my neck due to excruciating pain which lasted for 48 hours slowly got movement back the third day on 29Jan2021 at 16:45. She took a treatment as (8 Tylenol 500). Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Fatigue, Full blood count, Investigation, Metabolic function test
Clinical narrative: worsening fatigue after the second dose; This is a spontaneous report from a contactable consumer or other non hcp.A 41-years-old female patient received bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in left arm on 01Feb2021 18:00 (at 41-years-old) as single dose for Vaccination. The patient medical history was not reported and had not received other products. There was no Prior Vaccinations (within 4 weeks). There was no adverse events following prior vaccinations. There was no History of all previous immunization with the Pfizer vaccine considered as suspect and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. Concomitant medications included metoprolol ongoing from an unspecified date (12.5 mg, 1x/day) for an unspecified indication (Been on it for years never had any trouble). The patient previously received bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EL1283), dose 1 via an unspecified route of administration, administered in left arm on 11Jan2021 as single dose for Vaccination. On 02Feb2021, at 11:00 the patient experienced worsening fatigue after the second dose. It was reported that the patient was administered her second dose of Pfizer COVID-19 Vaccine 01Feb2021 at 18:00 and felt great afterwards. She started to have some fatigue 02Feb2021 around 11:00. She called to ask if it was normal for fatigue to go on this long and to worsen. On 04Feb2021, the patient was not admitted in hospital, but under observation in Emergency room for event fatigue and has not resulted in Physician Office. She reported that she might had a tiny scratch in her throat a couple of days before onset of fatigue, but it was very minor. The patient daughter had a little runny nose, so she was tested and was positive for Rhinovirus; not COVID; the patient assumed she may have gotten a little bit of her rhinovirus but she did not even develop stuffy nose; just a tiny scratch or tickle in her throat. Laboratory tests performed on 04Feb2021 in emergency room included Chest X- ray: showed nothing; full blood count (CBC): all normal and Basic Metabolic Panel-test, Result: normal; Mono: negative; tested for any respiratory illnesses in her nose: none, all normal. They sent her home from emergency room. Outcome of the event was reported as not recovered.  Follow-up (05Feb2021): Upon follow up, new information included: relevant lab tests, concomitant medication details, patient details.  No follow-up attempts are possible and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Nausea, Product use issue
Clinical narrative: possible interaction with her monoclonal antibody; severe nose bleed; nausea; This is a spontaneous report from a contactable physician. A 35-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as first dose, single for an COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The Patient's Physician stated that she experienced nausea 2 days after receiving her 1st dose of the vaccine and then 2 days later she had severe nosebleed. Wants to know if this could be a possible interaction with her monoclonal antibody therapy since she is currently on it and had received the Covid vaccine within 30 days of her therapy.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: tightness in her neck, jaw, ear, and face this morning/tightness in the left side of neck and jaw; tightness in her neck, jaw, ear, and face this morning/tightness in the left side of neck and jaw; arm was sore/Sore arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 74-years-old female patient received 1st Dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EM9810),  intramuscular, administered on 03Feb202110:30 as SINGLE DOSE for an unspecified indication  Medical history and concomitant medications.were not reported.  The patient experienced sore arm on 03Feb2021 and tightness in the left side of neck and jaw on 05Feb2021.The outcome of Sore arm was resolved on 03feb 2021 and tightness in left side of neck and jaw was resolved on 05 feb2021. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available.Caller mentioned seeing a number # on her vaccine record card, but she doesn't know what that is for.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: arm was sore; felt generally tired; She had fever (100.3F); chills; nausea; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Feb2021 at 15:30 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), on an unspecified date for COVID-19 Immunization. On 04Feb2021 at 12:00, the reporter stated that her arm was sore (in which she also experienced on her first dose). She also felt generally tired. She had fever (100.3 Fahrenheit), chills, and nausea. Her fever already went down to 99.5 Fahrenheit and it has been that way ever since. She wanted to know how long the fever would last. The reporter stated that she can take something other than Tylenol for the fever she has experiencing after getting the second dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit on 04Feb2021 and body temperature: 99.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm was sore; felt generally tired; She had fever (100.3F); chills; nausea; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Feb2021 at 15:30 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), on an unspecified date for COVID-19 Immunization. On 04Feb2021 at 12:00, the reporter stated that her arm was sore (in which she also experienced on her first dose). She also felt generally tired. She had fever (100.3 Fahrenheit), chills, and nausea. Her fever already went down to 99.5 Fahrenheit and it has been that way ever since. She wanted to know how long the fever would last. The reporter stated that she can take something other than Tylenol for the fever she has experiencing after getting the second dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit on 04Feb2021 and body temperature: 99.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Pain in extremity
Clinical narrative: There is something wrong her left knee; Pain went from her arm then went down to her knee/Pain in left knee; Pain went from her arm then went down to her knee/Pain in left knee; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9265, Expiration date: Unknown) via an unspecified route of administration, in left arm on 30Jan2021 (at the age of 85-year-old) as 1st dose, single for Covid 19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was in the hospital for 3-4 days, prior to vaccination, from 21Jan2021 to 23Jan2021, no further details provided. As per report it was reported that "patient got first dose of the Pfizer covid vaccine on Saturday, 30Jan2021 at the (Place name), stated that on Wednesday, Thursday and on that day (03Feb2021), the pain went from her arm then went down to her knee, she has the worst pain in her left knee and she stated that there is something wrong her left knee after getting the first covid vaccine shot. She cannot wear her prosthesis and she has a below the knee prosthesis and right above the kneecap was so painful. She could not stand the pressure, she was rubbing it with everything she has, using icy hot, biofreeze and arthritis Tylenol for the treatment. Stated the pain from the injection was gone. She stated that she was on another medication but did not believe it was relevant. The outcome of events arthropathy, pain extremity and arthralgia was not resolved.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some mild soreness in his arm; This is a spontaneous report from a contactable consumer (patient). A male patient (age and unit not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via unspecified route administered on 16Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some mild soreness in his arm. The outcome of the event was unknown. He has heard that the effects are much greater in the second dose. He wanted to know more information about that but disconnected before being offered to be transferred to the hospital. He read from an article that after first dose of the COVID-19 vaccine, you would have 52% efficacy. After waiting for all this time (long hold time), this was unhelpful.  Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands./tingling in hands; both legs swelled some; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in right arm on 03Feb2021 as single dose for COVID-19 immunisation. The patient had no medial history or concomitant medications. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 as 1st dose, single dose for COVID-19 immunisation. On 04Feb2021, the patient's both legs became numb from the knee down, they swelled some, but numb as they can be and experienced tingling in her hands. The numbness in her legs got real bad in the night of 04Feb2021. On the morning of 05Feb2021, the legs were still partially numb but not as numb as in the night of 04Feb2021. The fingers were also numb on both hands. The tingling was just in her fingers. The patient was wondering if these were after effects of the vaccine. She didn't have a prescribing doctor and was advised by her doctors to get it though. She wanted to know if this was one of the side effects. She stated that she know no other reason other than this that she would get this reaction. Outcome of the events Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands/tingling in hands was not recovered while that of the event both legs swelled some was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: some rash near the injection site, under her armpit; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received bnt162b2 (BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: EL9262), via an unspecified route of administration, administered in Arm Left on 31Jan2021 09:10 (at the age of 69-years-old) as a second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: EL3246) via unspecified route of administration, administered on 09Jan2021 16:00 (at the age of 69-years-old) as a first dose, single for covid-19 immunisation. After the first one, everything was okay. On 05Feb2021 the patient noticed some rash near the injection site, under her armpit. She had not treated the rash. The patient was recovered from the event in an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Muscle spasms, Myalgia, Nausea
Clinical narrative: bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; Shortly after felt nauseous and had episodes of vomiting; Shortly after felt nauseous and had episodes of vomiting; Took temperature and had a mild fever at 100.4f.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in right arm on 04Feb2021 16:00 (age at the vaccination 34-year-old) as second dose single for covid-19 immunisation. Medical history included intestinal disorder (unknown gastric intestinal illness that is still be diagnosed). Concomitant medications included dexlansoprazole (DEXILANT) and vitamin d2. Historical vaccine included first dose of BNT162B2 (Lot number: EL3247), via an unspecified route of administration, administered in right arm on 14Jan2021 04:00 PM for COVID-19 immunization. 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 felt fine after the injection and had no issues when patient went to sleep at 0600hrs. Woke up at the indicated time below to bad muscle spasms/chills and soreness. Shortly after felt nauseous and had episodes of vomiting. Took temperature and had a mild fever at 100.4 f on 05Feb2021 09:30. Patient Took a Goody's powder for fever and soreness. Symptoms have improved but nausea still persist. The outcome of the event nauseous was not recovered while for other events was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; Shortly after felt nauseous and had episodes of vomiting; Shortly after felt nauseous and had episodes of vomiting; Took temperature and had a mild fever at 100.4f.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in right arm on 04Feb2021 16:00 (age at the vaccination 34-year-old) as second dose single for covid-19 immunisation. Medical history included intestinal disorder (unknown gastric intestinal illness that is still be diagnosed). Concomitant medications included dexlansoprazole (DEXILANT) and vitamin d2. Historical vaccine included first dose of BNT162B2 (Lot number: EL3247), via an unspecified route of administration, administered in right arm on 14Jan2021 04:00 PM for COVID-19 immunization. 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 felt fine after the injection and had no issues when patient went to sleep at 0600hrs. Woke up at the indicated time below to bad muscle spasms/chills and soreness. Shortly after felt nauseous and had episodes of vomiting. Took temperature and had a mild fever at 100.4 f on 05Feb2021 09:30. Patient Took a Goody's powder for fever and soreness. Symptoms have improved but nausea still persist. The outcome of the event nauseous was not recovered while for other events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; Fatigued; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, approximately 1 week after administration of first dose of vaccine, the patient was achy and fatigued. The clinical outcome of events 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: Dysacusis, Feeling abnormal, Hypoacusis, Hypoaesthesia, Vaccination site pain
Clinical narrative: her right arm, where she receive the injection, was sore.; she had "an echo in the right ear and difficulty hearing.; she had "an echo in the right ear and difficulty hearing.; Weirdness around the neck area on the right side, numbness of some sort.; Weirdness around the neck area on the right side, numbness of some sort; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Not provided) via an unspecified route of administration in right arm on 24Jan2021 as first dose, single for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. On an unspecified date in 2021, on the first day her right arm, where she received the injection, was sore. The next day she woke up and had an echo in the right ear and difficulty hearing. Patient had to see someone that it was so difficult to hear. Patient experienced weirdness around the neck area on the right side, numbness of some sort. It felt full, but it did not feel like water in the ear. Patient did not have this issue before. It had gotten better but it was still there and bothering. Patient wants to know if this was a commonly reported side effect. Patient was inquiring about the efficacy of the Pfizer COVID-19 vaccine after the first dose and wanted to know if she should receive the second dose of the vaccine later than the recommended 3 weeks, which was scheduled for next week, since she experienced this uncommon side effect and was still experiencing residual symptoms. The outcome of the events 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: Lymphadenopathy
Clinical narrative: Sensitive lymph nodes on left side where injection occurred.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 70-years-old female patient received Bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included High Cholesterol, chronic neurogenic cough and allergies to penicillin. Concomitant medication included Prednisone. 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 not been tested for COVID-19. The patient experienced sensitive lymph nodes on left side where injection occurred on 27Jan2021. The patient did not receive any treatment for adverse event. The outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from 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, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's other History and products were not provided. It was reported that, she had the 2 doses of the Pfizer BioNTech COVID-19 vaccine. After the second dose the patient had an immediate reaction which was a little arm pain; experienced on an unspecified date. The patient had a reaction of arm pain from the first and second dose. It was already gone, and they were not concerned about it already. She wanted to know if there a had been reports about this in the clinical trials. The outcome of event was recovered on an unspecified date. Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she has been itching on her skin and it comes and goes./Itchy skin patches/appear in another place like on her leg; This is a spontaneous report from a contactable consumer(Patient). A 84-year-old Female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, ad-ministered in Upper Left arm on 30Jan2021 at 09:15 (at the age of 84-years-old) as 1st Dose, Single for COVID-19 immunization. The patient's Medical history included ongoing thyroid disorder. The patient's Concomitant medications included levothyroxine 0.75mg taken once daily ,taken for thyroid disorder from Start date in the 1970s, maybe 1974-1975 and ongoing. No History of all previous immunization with the Pfizer vaccine considered as suspect. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks of administration date of the suspect vaccine, No AE(s) following prior vaccinations. No Family Medical History Relevant to AEs. No Relevant Tests performed. About 21:00 on 30Jan2021,the patient experienced itching on her skin and it comes and goes, and sometime later appear in another place like on her leg; that the areas affected are variable .Itching is on different areas of her body but there is no rash. The event has just begun to improve today. There is no rash associated with the itchy skin patches. She asked if this is a normal reaction to the vaccine; and if she should or should not get the second dose as scheduled related to this event. If she does get the second dose and again experiences this event, are there any recommendations regarding treatment for the event. The patient did not visit any physician office/emergency room or was not hospitalized. The outcome for the event was recovering/resolving.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Nasal congestion, Nasopharyngitis, Pain in extremity
Clinical narrative: She is coughing stuff up; Sinus symptoms/congestion it's like having a cold; Terrible sinus congestion; Soreness in right arm; worried; Soreness in right arm; This is a spontaneous report from a consumer (patient) from Pfizer-sponsored program. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an unspecified route on 03Feb2021 (at the age of 74-years) as 1st dose, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced soreness in the right arm, on 05Feb2021 in the morning terrible sinus congestion and had sinus symptoms/congestion it's like having a cold. Patient stated that it felt liked she sounded liked she would if she had a cold which she had not in a long time. It was reported that arm soreness dissipated over the day yesterday. Patient stated that she was worried because they have a gathering this coming Sunday and asked if this is contagious. She said it was in her head. In the winter she did had sinus problems but this was sort of different. She was coughing stuffed up, blowing her nose, and in an exponential way that she had not had in the winter. She looked in her medicine chest and thought maybe she should take a Claritin but decided she shouldn't. She does not knew much about the vaccine. The outcome of the events soreness in right arm was recovered on 04Feb2021, terrible sinus congestion was not recovered and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She is coughing stuff up; Sinus symptoms/congestion it's like having a cold; Terrible sinus congestion; Soreness in right arm; worried; Soreness in right arm; This is a spontaneous report from a consumer (patient) from Pfizer-sponsored program. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an unspecified route on 03Feb2021 (at the age of 74-years) as 1st dose, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced soreness in the right arm, on 05Feb2021 in the morning terrible sinus congestion and had sinus symptoms/congestion it's like having a cold. Patient stated that it felt liked she sounded liked she would if she had a cold which she had not in a long time. It was reported that arm soreness dissipated over the day yesterday. Patient stated that she was worried because they have a gathering this coming Sunday and asked if this is contagious. She said it was in her head. In the winter she did had sinus problems but this was sort of different. She was coughing stuffed up, blowing her nose, and in an exponential way that she had not had in the winter. She looked in her medicine chest and thought maybe she should take a Claritin but decided she shouldn't. She does not knew much about the vaccine. The outcome of the events soreness in right arm was recovered on 04Feb2021, terrible sinus congestion was not recovered and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: fatigue; chills; pain in the injection site after getting the 1st dose; right arm soreness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 02Feb2021 09:30 (Batch/Lot Number: EL9264, Expiration date: Not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications were none. The patient historical vaccine includes Flu vaccine would stay sore for a while with Flu shots, she would generally get flu shot annually. It was reported that onset time was probably about 11:00, by the time she got home after being administered the first dose of Pfizer COVID-19 Vaccine around 09:30 that day. She had onset of painful injection site area of right arm, fatigue and some chills but that was the extent of it. The right arm painfulness was a little surprising. She expected soreness in the right arm but it was painful that first day. It has gradually. The majority is finally improved since then. To raise her arm up she can still feel something there, not what she would call pain or anything now, probably just soreness gone. On the second day the right arm soreness and pain moved down from the injection site and kind of stayed in that area for a while. It was apparent the soreness was still bothering her but yesterday was when she was finally improving.Took a Tylenol for side effects: taken before she heard the news cast. She took 1-500mg Extra Strength Tylenol caplet for adults on 02Feb2021 for side effects. Taken around 10 hours after she was administered the Pfizer COVID-19 Vaccine, so around 19:30, so that she could sleep. She was reluctant to do so because she does not normally take anything like that unless she really feels she needs to. She just thought she did not know how she was going to sleep with that arm pain radiating. No other vaccines were received within 4 weeks prior to the vaccination. Therapeutic measures were taken as a result of fatigue, chills, pain in the injection site and sore arm. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Following first dose - sore arm only; This is a spontaneous report from a contactable other hcp. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via intramuscular route, administered on Arm Left on 19Dec2020 at 11:30(age at vaccination: 25 years) at single dose for covid-19 immunization at hospital. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On an unspecified date, the patient experienced Following first dose - sore arm only. The patient did not receive any other treatment. The outcome of the event recovered on an Unspecified date.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Mobility decreased
Clinical narrative: 4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side.  severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; 4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side.  severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; circled around back to right side.  severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in Left arm on 26Jan2021 13:00 at the age of 77-years-old as 2nd dose, single dose for covid-19 immunisation. Medical history included CHF (Congestive heart failure) from an unknown date and unknown if ongoing, PE (pulmonary embolism) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included unspecified medication, Allioyrubikm; Dabigatran (DABIGATRAN) taken for an unspecified indication, metoprolol (METOPROLOL) taken for an unspecified indication, spironolactone (SPIRONOLACTONE) taken for an unspecified indication on unspecified date received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 05Jan2021 at 13:00 as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Covid test post vaccination was no. On 29Jan2021 at 06:00, 4th day after dose 2 the patient experienced pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain. still have pain 10 days after dose 2. No treatment was received for adverse events. The outcome of event, mobility decreased was unknown and for other events was not recovered.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue following the second dose only.; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL3248, Expiration Date was not reported), via an unspecified route of administration administered in right arm on 03Feb2021 16:00 (at the age of 25-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL3248) via an unspecified route of administration administered in right arm on 13Jan2021 04:00 pm for COVID-19 immunization. The patient previously took zofran [ondansetron] on an unspecified date and experienced drug allergies (hypersensitivity). No other vaccine received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 04Feb2021 the patient experienced fatigue following the second dose only. No treatment received for the AE. The outcome of the events was reported as recovered.  No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: elevated temperature the day after; This is a spontaneous report from a contactable consumer communicated to medical information team. A 72-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on 02Feb2021 (at the age of 72-year-old), as 1st dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021 (day after the vaccination), the patient had experienced elevated temperature. No ongoing side effects were reported. The patient was asking if it is ok to take Tylenol as she saw in the TV that Tylenol may diminish the effectiveness of the vaccine. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date. The 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: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Full blood count, Hepatitis, Investigation
Clinical narrative: he developed a fever and fever lasted for 10 days/2 days after receiving the second dose, he developed a low grade fever; This is a spontaneous report from contactable consumer (Patient). A 78-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899) via an unspecified route of administration on 12Jan2021 as 1st single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. On 22Jan2021, ten days later of first dose, he developed a fever and fever lasted for 10 days and on 03Feb2021, a day later receiving the second dose, he developed a low grade fever. Patient tested for COVID 5 times, did full bloodwork, chest x-ray, steph and flu test all tests were negative. On 01Feb2021, patient tested for hepatitis, urine analysis, CBC (full blood count) result was negative for all. The patient received treatment for the event was took Tylenol and Advil. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.