chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 about 2 weeks after receiving the 1st dose of COVID vaccine; Patient tested positive for COVID-19 about 2 weeks after receiving the 1st dose of COVID vaccine; This is a spontaneous report from a contactable consumer reported that a male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient is a health care worker who works with COVID patients as part of his daily work duties. He tested positive for COVID-19 about 2 weeks after receiving the 1st dose of BNT162B2. Outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 35-year-old female patient received BNT162B2 (lot: EKS730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received 1st COVID vaccine dose on 17Dec2020 and tested positive on 23Dec2020. Patient was exposed to COVID. She was curious if and when she should get a second dose having tested positive after her first dose. Outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event SARS-CoV-2 test positive based on the known safety profile. However given the short duration of 6 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a contactable consumer (patient). This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Dec2020 between 12:30 and 1:30 for COVID-19 immunisation. Medical history and concomitant medication were not reported. She got the first vaccine on the 16Dec2020 between 12:30 and 1:30 and had symptoms 12 to 13 hours post injection. She had joint pain which was normal. She didn't think it was necessary to call about that. The outcome of event was unknown.   Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. A 6 decades male patient (reported as in his 50's) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. the patient experienced extreme fever, chills, shortness of breath after receiving the vaccine. Outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After first dose of Moderna COVID-19 vaccine, patient started to experience mild pruritus on her forehead. The patient was monitored for 30 minutes and did not experience worsening of symptoms. Patient was discharged home in stable condition.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate irregular, Terminal insomnia
Clinical narrative: I have 2-3 good beats and then kind of has like 2 or 3 slower beats, missing beats, they are not as strong/ Heartbeat seems to be a little erratic; I have 2-3 good beats and then kind of has like 2 or 3 slower beats, missing beats, they are not as strong; Woke me last night, at 3 o' clock this morning; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (Afib), gastrooesophageal reflux disease (Reflux), macular degeneration, ongoing It's for heart, ongoing bleeding disorder. Concomitant medication included metoprolol for heart; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for macular degeneration; fish oil for Omega 3; Vitamins. Clinical course: She had a bleeding disorder, she was on a blood thinner (unspecified medication), they didn't know she took a blood thinner. She had noticed with her heartbeat seems to be a little erratic, but she also had AFib. So, it seems like she had 2-3 good beats and then kind of has like 2 or 3 slower beats, missing beats, they are not as strong. But she thought that would have been AFib but seems to be a little bit different. It woke her last night, at 3 o' clock this morning on 01Jan2021. She wanted to know if it would have an effect on her heartbeat by taking the blood thinner. The outcome of events was unknown.  Information about Batch/Lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 38-year-old female patient received the first dose of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 05Jan2021 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included COVID 19 (prior to vaccination). Past drug history included allergy to penicillin. Relevant concomitant medication included birth control pill. The patient was vaccinated at hospital, age at vaccination was 38-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed. On 05Jan2021 at 20:00, the patient developed fever. The patient was not treated for the event. The patient recovered from the event on unknown date.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 38-year-old female patient received the first dose of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 05Jan2021 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included COVID 19 (prior to vaccination). Past drug history included allergy to penicillin. Relevant concomitant medication included birth control pill. The patient was vaccinated at hospital, age at vaccination was 38-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed. On 05Jan2021 at 20:00, the patient developed fever. The patient was not treated for the event. The patient recovered from the event on unknown date.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: RED, ITCHY, ROUND, 4 INCH DIAMETER RAISED, WARM RASH
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Migraine, Myalgia
Clinical narrative: Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site muscle soreness/pain; This is a spontaneous report from a contactable pharmacist (patient himself).  This 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 05Jan2021 at 17:30 at single dose for COVID-19 immunisation. Age at vaccination was 26-year-old. Vaccine location was left arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 06Jan2021 at 08:00, the patient developed injection site muscle soreness/pain. The patient was not treated for the event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: C/o shortness of breath  routine oxygen increased cannula changed to mask oxygen sats at 88%
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: allergic reaction; hives; This is a spontaneous report from a contactable consumer. (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the Covid vaccine last week and she think she was having like a slight allergic reaction like hives and stuff on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Illness
Clinical narrative: Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really tired/exhausted; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included Hashimoto's Goitre, migraine, Pacemaker, she just had her third one replaced, that was since I was 27. Concomitant medication included levothyroxine for Hashimoto's Goitre, sertraline, topiramate (TOPAMAX). The patient received the vaccine on 30Dec2020. She had congestion, she was still congested. That night on 30Dec2020 she was tired, just tired and exhausted and woke up Thursday on 31Dec2020, really tired. The patient had been really busy with work with everything, so, she just 'threw to the wind'. She was really tired on Thursday, 31st, just like, she really feel sick, coughing, really exhausted. she came home and just got to go to bed and 7 to 3:30. She felt warm but she didn't get hot and she took temp, she was 101.5. She had chills, a cough. She was so exhausted, everything hurts her. The patient don't feel like terrible, terrible, like mostly she would say Friday on 01Jan2021, she was mostly in bed. She just didn't want to just lay there. She thought that was worse laying there. She didn't know if I was positive with COVID in the middle of this, or was it the vaccine. About causality, the reporter stated that she didn't know, 50-50, it partly felt like she didn't know if she was having a reaction to the vaccine or she was positive for COVID or she was getting (incomplete sentence). She was congested and the all of a sudden, she didn't know if positive for this. She guessed if she get tested which she was assuming if she call or occupational health, they want her to get tested for COVID because she already have the symptoms. She didn't do anything yet for events. She had just been home and quarantined. Her brother who she have been around, he doesn't live with her but he lived down the street. He was in critical care right now in (state) and with COVID, so that's another concern, why she was thinking she could be COVID. The outcome of the events was unknown.  Information for Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really tired/exhausted; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included Hashimoto's Goitre, migraine, Pacemaker, she just had her third one replaced, that was since I was 27. Concomitant medication included levothyroxine for Hashimoto's Goitre, sertraline, topiramate (TOPAMAX). The patient received the vaccine on 30Dec2020. She had congestion, she was still congested. That night on 30Dec2020 she was tired, just tired and exhausted and woke up Thursday on 31Dec2020, really tired. The patient had been really busy with work with everything, so, she just 'threw to the wind'. She was really tired on Thursday, 31st, just like, she really feel sick, coughing, really exhausted. she came home and just got to go to bed and 7 to 3:30. She felt warm but she didn't get hot and she took temp, she was 101.5. She had chills, a cough. She was so exhausted, everything hurts her. The patient don't feel like terrible, terrible, like mostly she would say Friday on 01Jan2021, she was mostly in bed. She just didn't want to just lay there. She thought that was worse laying there. She didn't know if I was positive with COVID in the middle of this, or was it the vaccine. About causality, the reporter stated that she didn't know, 50-50, it partly felt like she didn't know if she was having a reaction to the vaccine or she was positive for COVID or she was getting (incomplete sentence). She was congested and the all of a sudden, she didn't know if positive for this. She guessed if she get tested which she was assuming if she call or occupational health, they want her to get tested for COVID because she already have the symptoms. She didn't do anything yet for events. She had just been home and quarantined. Her brother who she have been around, he doesn't live with her but he lived down the street. He was in critical care right now in (state) and with COVID, so that's another concern, why she was thinking she could be COVID. The outcome of the events was unknown.  Information for Lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Sensitive skin
Clinical narrative: Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Day 8-10 post moderna vaccine a red rash developed on my entire lateral upper arm of injection site, Area red, burning, itchy. I am breastfeeding 17 months and first time had breast pain that came not sure if related or not but same days the evening of day 8-10 after the rash started in the morning. Both came and returned to baseline but wanted to report to help for clinical data. I have had a history of allergic reactions.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Day 8-10 post moderna vaccine a red rash developed on my entire lateral upper arm of injection site, Area red, burning, itchy. I am breastfeeding 17 months and first time had breast pain that came not sure if related or not but same days the evening of day 8-10 after the rash started in the morning. Both came and returned to baseline but wanted to report to help for clinical data. I have had a history of allergic reactions.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: I received the vaccine around 12:15 pm and this reaction started around 9 pm that evening. I felt soreness and significant warmth 2 cm above the injection site. I felt a raised lump, the size of a quarter. It was very tender to touch. The actual injection site was not painful. This lasted for about 1 week, until complete resolution.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches after vaccine; This is a spontaneous report from a Pfizer-sponsored program, General Company Information, received via a contactable  consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced headaches after vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took valacyclovir (VALTREX) and experienced tingling sensation. On an unspecified date, the patient experienced tingling sensation. It was reported that the patient experienced tingling sensation a week and a half with valacyclovir before getting the vaccine. When the patient got the vaccination last Thursday and even after receiving the vaccine, the tingling started again. She's was asking if she can restart/retake the valacyclovir now that she had the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain on the injection site; swelling; Inflammation; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown) via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine yesterday (02Jan2021) around 6 O'clock and then late in the afternoon she was experiencing pain on the injection site and she is asking if that is normal or if she can take Ibuprofen to relieve the pain. It was further reported that there was also a little bit swelling and inflammation. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Tenderness, Urticaria
Clinical narrative: Patient received first vaccine (12.29.20) and experienced injection site reaction for 3 days. 10 days later the redness and tenderness re-appeared. The area is approximately 1.5 by 1.5 inches, somehwat round "wheal" urticarial center. Patient has been taking benadryl for symptom relief with little change in symptoms or appearance. No other complaints.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza virus test, Pain
Clinical narrative: Fever; Chills; Body aches; Headaches; This is spontaneous report from a contactable Other HCP.   A male patient (age unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, after vaccination, the patient had  fever, chills, body aches, and headaches. Fever was high. Sunday night his fever was 102 which went away with ibuprofen (ADVIL). He had no respiratory issues. He had body aches, but they were not severe. He had headaches. He has had 2 negative COVID tests and he was negative for the flu. The patient asked if he could not take the second dose of the vaccine planned for 13Jan2021. Fever resolved on unknown date while the outcome of the remaining events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Body aches; Headaches; This is spontaneous report from a contactable Other HCP.   A male patient (age unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, after vaccination, the patient had  fever, chills, body aches, and headaches. Fever was high. Sunday night his fever was 102 which went away with ibuprofen (ADVIL). He had no respiratory issues. He had body aches, but they were not severe. He had headaches. He has had 2 negative COVID tests and he was negative for the flu. The patient asked if he could not take the second dose of the vaccine planned for 13Jan2021. Fever resolved on unknown date while the outcome of the remaining events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: gets an enlarged lymph node; This is a spontaneous report from a contactable physician (patient) received via a Pfizer-sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reiceved the Pfizer COVID vaccine a week ago. She typically gets an enlarged lymph node after receiving the influenza vaccine and had the same reaction to the COVID vaccine on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Erythema, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: I have a cyst developed on my arm; Injection site is very swollen and very painful; Injection site is very swollen and very painful; redness on my forearm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration from 02Jan2021 in the morning (yesterday of 03Jan2021) at single dose for covid-19 immunization. Vaccine location was upper arm and it was the first dose. None medical history. The patient's concomitant medications were not reported. The patient start to develop some redness on her forearm, injecting site is in her upper arm. Patient have a cyst developed on her arm. The cyst, it is on the same arm but on the forearm, it (cyst) was very small like pen tip right now it is like a 2 mm or like 4 mm. She was not sure if it is going to get dissolve or not but it is not recovering for now and it had some yellowish fluid inside the cyst. Patient also stated the injection site was very swollen and very painful. Patient stated she took one Tylenol 400 mg last night and took another one this morning. Patient think she had the lab test for Covid, PCR test within two weeks. The outcome of event "cyst on arm" was not recovered, the other events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Insomnia, Myalgia
Clinical narrative: Day 1 Night:  Sleeplessness Day 2:  Muscle aches in left arm, left shoulder, neck.  Fullness in ear, dizziness.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, SARS-CoV-2 test positive
Clinical narrative: started to feel a little sick; had COVID-19 test and results came back positive; had COVID-19 test and results came back positive; This is a spontaneous report from a contactable healthcare professional. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899/expiration date unknown) via an unspecified route of administration on 27Dec2020 at a single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications were not reported. The patient stated that he got the vaccination on the 27th and then that same night he started to feel a little sick. He was assuming that it has just to be the side effect of the vaccine (unspecified vaccine). On 28Dec2020, he was feeling pretty sick; he did not go to the work. He had COVID-19 test (Dec2020) and results came back positive. He added that he didn't know if it was the COVID because he was reading up on the vaccines and it said that one could not get COVID from the vaccine. The outcome of the events was unknown.; Sender's Comments: The reported positive with COVID-19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Tremor
Clinical narrative: feeling kind of shaky/got a little shaky; severe headache; super nauseous; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 13:00 (lot number: EK9231), and first dose on 16Dec2020 (Lot Number: ETT9899 as provided), via an unspecified route of administration in left arm at single dose for covid-19 immunization. Vaccine was not administered at Facility but in hospital. Medical history was none. There were no concomitant medications. No additional administered vaccines. Prior vaccinations (within 4 weeks) was none. Relevant tests were None. Caller was a phlebotomist calling regarding Pfizer's COVID vaccine, the second one. It's been an hour since she received the second vaccine. She was feeling kind of shaky. She had a severe headache and she was super nauseous. She mentioned she was probably going to be sent home. The caller explained it's like she would rather be in bed right now than dealing with patients. It's the nausea and headache that was the main thing, she just got a little shaky right now. The caller stated she received the vaccine about an hour ago, around 1:00 p.m. The caller explained her symptoms have stayed the same so far. The events were occurred on 05Jan2021 did not require a visit to emergency room or physician Office. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reported for herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly on 16Dec2020 at single dose at right upper arm for COVID-19 immunization. Medical history included Asthma: She explained she had seasonal asthma as a kid and as she got older, it got worse, she couldn't remember when. The patient's concomitant medications were not reported. The patient received the first COVID vaccine on 16Dec2020. She clarified further with the first vaccine, she was fine. She had a sore arm and that's it in Dec2020. With the first COVID vaccine, she had a sore arm but has recovered completely from it. She got the first vaccine and it didn't hurt or anything. Her arm started to get sore in the early hours of the morning like 1am. She thought it took her 2 days to recover completely and then she was fine. Investigation Assessment was no. Vaccination Facility Type was Hospital, not Administered at Military Facility. The outcome of the event was recovered on an unspecified date in Dec2020.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Lip tingling and lower lip swelling. Patient carries epinephrine but does not use it. She was treated in the emergency department with Benadryl 50 mg IM and solumedrol 125 mg IV.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Erythema, Lip pruritus, Lip swelling, Paraesthesia oral
Clinical narrative: Lip tingling and lower lip swelling. Patient carries epinephrine but does not use it. She was treated in the emergency department with Benadryl 50 mg IM and solumedrol 125 mg IV.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: Lip tingling and lower lip swelling. Patient carries epinephrine but does not use it. She was treated in the emergency department with Benadryl 50 mg IM and solumedrol 125 mg IV.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: fever; chills; body aches; headache; hand swelling; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Dec2020 at single dose on one of the deltoids, but not sure which one for COVID-19 immunization. The medical history and concomitant medications were not reported. It was known if the patient had prior vaccinations within 4 weeks. By the next day on 30Dec2020, she started to experience chills, fever, body aches, headache, and also hand swelling which all lasted for four days. Seriousness Criteria was stated as not significant. What was odd was the hand swelling. She did not have any redness or itchiness with it. It was just swelling that lasted four days and the patient thought this was odd. The outcome of the events was recovered on 03Jan2021. The Pharmacist want to known if the patient should still get the booster on the 19th.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: fever; chills; body aches; headache; hand swelling; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Dec2020 at single dose on one of the deltoids, but not sure which one for COVID-19 immunization. The medical history and concomitant medications were not reported. It was known if the patient had prior vaccinations within 4 weeks. By the next day on 30Dec2020, she started to experience chills, fever, body aches, headache, and also hand swelling which all lasted for four days. Seriousness Criteria was stated as not significant. What was odd was the hand swelling. She did not have any redness or itchiness with it. It was just swelling that lasted four days and the patient thought this was odd. The outcome of the events was recovered on 03Jan2021. The Pharmacist want to known if the patient should still get the booster on the 19th.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: fever; chills; body aches; headache; hand swelling; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Dec2020 at single dose on one of the deltoids, but not sure which one for COVID-19 immunization. The medical history and concomitant medications were not reported. It was known if the patient had prior vaccinations within 4 weeks. By the next day on 30Dec2020, she started to experience chills, fever, body aches, headache, and also hand swelling which all lasted for four days. Seriousness Criteria was stated as not significant. What was odd was the hand swelling. She did not have any redness or itchiness with it. It was just swelling that lasted four days and the patient thought this was odd. The outcome of the events was recovered on 03Jan2021. The Pharmacist want to known if the patient should still get the booster on the 19th.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: fever; chills; body aches; headache; hand swelling; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Dec2020 at single dose on one of the deltoids, but not sure which one for COVID-19 immunization. The medical history and concomitant medications were not reported. It was known if the patient had prior vaccinations within 4 weeks. By the next day on 30Dec2020, she started to experience chills, fever, body aches, headache, and also hand swelling which all lasted for four days. Seriousness Criteria was stated as not significant. What was odd was the hand swelling. She did not have any redness or itchiness with it. It was just swelling that lasted four days and the patient thought this was odd. The outcome of the events was recovered on 03Jan2021. The Pharmacist want to known if the patient should still get the booster on the 19th.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Swelling; Tingling; hand swollen; This is spontaneous report from a contactable Pharmacist.   A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EH9899, Expiration Date Mar2021, intramuscular in deltoid, on an unspecified date at 0.3 mL, single for COVID-19 immunisation. Medical history was none.  There were no concomitant medications. On an unspecified the patient experienced swelling, tingling, and hand swollen. The events were non serious. Therapeutic measures for the events included treatment with BENADRYL. The outcome of the events swelling and tingling was unknown. The outcome of the event hand swollen was recovering. Causality provide by the Pharmacist: "Most probably."
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Mobility decreased, Needle issue
Clinical narrative: Felt intense pain at time of injection. Pharmacist bent needle in half, said "that's never happened before."  Immediately unable to move my arm, have INTENSE  pain, unable to sleep through the night, no range of motion.  Constant symptoms for 2 months and getting worse each day.
Sex: U
Vaccine: FLU4
Symptoms: Pain, Sleep disorder
Clinical narrative: Felt intense pain at time of injection. Pharmacist bent needle in half, said "that's never happened before."  Immediately unable to move my arm, have INTENSE  pain, unable to sleep through the night, no range of motion.  Constant symptoms for 2 months and getting worse each day.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a sore arm; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced "just a sore arm" on an unspecified date. The patient outcome of the event was unknown.    This follow-up is being submitted to notify that the batch number is not available despite follow-up attempts made.  Follow-up attempt have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little soreness; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Dec2020 at a single dose as Covid Vaccine. The patient's medical history and concomitant medications were not reported. Patient got the vaccine on 29Dec2020. Patient stated that so far so good just a little soreness since an unknown date. The patient was feeling good and happy. The outcome of the event little soreness was unknown.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Limb discomfort, Musculoskeletal chest pain
Clinical narrative: arm sore; heaviness on my left side of the body upper/upper back kind a like sore a little bit in my rib cage; heaviness on my left side of the body upper/upper back kind a like sore a little bit in my rib cage; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on 28Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced just arm sore and heaviness on left side of the body upper/ and upper back kind a like sore a little bit in my rib cage on an unspecified date. The outcome of events was recovered after 24hrs.  No follow-up attempts are possible. Information on Lot/Batch cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a Pfizer-sponsored program, from a non-contactable consumer.  A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unknown date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced sore arm. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face; This is a spontaneous report from a contactable nurse. A 36-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) injection, lot number EL0140, expiration date Mar2021, unspecified route of administration, on 29DEC2020 10:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization.  Medical history was none. There were no concomitant medications. nurse reported that they had their Pfizer Clinic on 29Dec2020 and she had a nurse that started having hives on 02Jan2020 after having received the Pfizer COVID- 19 Vaccine on 29Dec2020. The patient reported as everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face. It was bothersome. Her second dose is scheduled to be administered on 19Jan2021, but she was not sure if she will or will not continue with therapy and receive the second dose. The patient was thinking it could be related but was unsure. Outcome of the event was unknown (reported as unknown but ongoing, hives come and go).
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposure to someone that tested positive; This is a spontaneous report from a contactable pharmacist, who is also the patient. This male pharmacist of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced exposure to someone that tested positive. The outcome of the event was unknown.  The information on the Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: Injection site numbness and pain; Injection site numbness and pain; The whole arm where injected was numb and was in pain.; The whole arm where injected was numb and was in pain.; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced injection site numbness and pain, the whole arm where injected was numb and was in pain. The events were non-serious with outcome of recovered: the events went away by the 2nd day.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Injection site pain, Injection site swelling, Pain in extremity, Palpitations
Clinical narrative: I received the Vaccine on Wednesday 1/6/2021 . Later that evening, my right deltoid was slightly swollen and painful. I would rate the pain 5/10. The next day Thursday 1/7/21, I noticed intermittent heart flutter/palpitations. I had my routine morning coffee and I thought the combination of the vaccine and the coffee might be the caused.  The flutter/palpitations continue to the present. I don't have shortness of breath. The left deltoid pain and swelling subsided. The flutter is intermittent and last 10 to 15 seconds.