chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at injection site; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable Female consumer reported.  A 71-year-old female consumer (patient) who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number ER2613, Expiration date unknown), via an intramuscular route of administration in upper left arm on 17Mar2021 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number EN6202, Expiration date unknown), via an intramuscular route of administration in upper left arm on24Feb2021, as a single dose for covid-19 immunization. The patient did not receive prior vaccination within 4 weeks. Patient's concomitant medications included METOPROLOL taken for hypertension, LEVOTHYROXINE for thyroid, SIMVASTATIN for lipase, all are taken via oral route. The patient took 400 mg acyclovir for herpes simplex on or around the 3-week time frame of receiving the Pfizer covid vaccine. The patient did not consume acyclovir whether the 2 weeks prior to or during vaccination for covid. On an unspecified date, the patient had no side effects to where vaccine administrations other than mild soreness at injection site. The outcome of event was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: he felt like a Zombie; This is a spontaneous report from contactable Consumer from Pfizer-sponsored program. A Male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & expiry date not reported) via unspecified route of administration on 06Feb2021 (age at vaccination was unknown) as single dose for COVID-19 immunization. Patients medical history and concomitant medications were not reported. On 06Feb2021 (On day of vaccination) Patient experienced he felt like a Zombie, he mentioned that he was already okay. He wanted to know if he will feel the same after the 2nd dose. The Outcome of event was recovered on an unspecified date in 2021.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Potentiating drug interaction
Clinical narrative: Immediately after the nurse injected me, she told me not to take NSAIDs for that day.  I had taken one an hour prior to the shot.; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3248) dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 10:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient was 57-year-old at the time of vaccination. The patient medical history and concomitant medications was not reported. The patient had no other vaccine in four weeks. The patient's other medications in two weeks: NSAID-1 hour before shot. Allergies to medications, food, or other products was none. The patient had no covid prior vaccination. The patient had not been tested for COVID-19 since the vaccination. On 11Mar2021 10:45, the patient reported immediately after the nurse injected, she told not to take NSAIDs for that day. The patient had taken one, an hour prior to the shot. The patient stated that "It would have been important to be warned prior to the injection, rather than after as it was too late then. I would like to know what the reduced efficacy is going to be as a result of having had an NSAID an hour prior to the vaccine." It was reported that "Patient was informed of this after the injection, rather than prior to which the would have given me the opportunity to come back a different day and have the vaccine when I had not taken an NSAID that morning. No treatment was given for AE. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Induration, Myalgia
Clinical narrative: Tiredness; Muscle and joint pain; Muscle and joint pain; Hardness; This is a spontaneous report from a contactable consumer (patient self-reported. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not provided), via an unspecified route of administration, on 05Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she spoke with an RN at Pfizer earlier today to report her side effects. On an unknown date, since vaccination, she experienced tiredness, hardness, and muscle and Joint pain and wanted to know if these were reported side effects of the vaccine. The patient expressed concern about getting the second dose because she didn't want to have the same or worse side effects. The patient got response like that Pfizer was unable to make treatment recommendations. The patient was scheduled for her second dose on 26Mar2021. The patient declined to filing a safety report, no further information or details were captured. Outcome of the events was unknown.  Follow up needed, follow up questionnaire attached for further information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid positive a week later; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced got covid positive a week later on an unspecified date. Reported stated Got covid vaccine and got covid positive a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: positive an unspecified date. The event got covid positive a week later was non-serious. The outcome of the event got covid positive a week later was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer via Medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 10Mar2021 as first dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he had been around daughter and son in law, tested positive this morning on 11Mar2021. Patient wanted to know can they still receive their next dose on 31Mar2021. The patient underwent lab tests and procedures which included covid-19 test positive on 11Mar2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268905 same drug/reporter/ event, different patient
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pruritus, Rash, Rash macular, Rash maculo-papular
Clinical narrative: rashes all over his body; small raised red spots on my arms, legs, back chest, stomach and neck; small raised red spots on my arms, legs, back chest, stomach and neck; They constantly itch./itch like crazy; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in Arm Left on 15Feb2021 at 11:00 (at the age of 72 years) as single for COVID-19 immunization. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 12:15 pm (at the age of 72 years) as single for COVID-19 immunization. Medical history included diabetes, polycythaemia vera, vasculitis. The patient had allergies to Penicillin, Doxycycline and Sulfa. The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not experience COVID prior vaccination. The patient's concomitant medications were not reported. On 18Feb2021, the patient experienced small raised red spots on arms, legs, back chest, stomach and neck, they constantly itch/itch like crazy. Patient had the raised bumps 20 to 30 counts that itch like crazy. On an unspecified date, patient experienced rashes all over the body. Reporter stated patient has had it since the first shot and it had gotten worse. Reporter stated it is driving patient crazy. The patient was not received any treatment for adverse events. The outcome of small raised red spots on arms, legs, back chest, stomach and neck, they constantly itch/itch like crazy was not recovered while for the rash was unknown.   No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Herpes zoster
Clinical narrative: Shingles along the T4 dermatome pathway/red eruption; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Arm Left on 01Mar2021 13:15 (Lot Number: EL 3247) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. On 08Mar2021, the patient shingles along the T4 dermatome pathway, one week after vaccine dose. Burning, stabbing pain in left breast spreading to outer side and al along left upper back. Noticed red eruption 2 days ago and went to PCP who diagnosed as shingles. The events resulted in doctor or healthcare professional office/clinic visit. 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 been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The outcome of the events was recovering. The events were treated with Valtrex 1GM TID for 7 days and Prednisone 20 mg 2 tabs once a day for 5 days.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive today for Covid; This is a spontaneous report from a contactable consumer. This (age: 37; unit: unknown) male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Eight days later, on 24-Mar-2021 the patient tested positive for Covid and wanted to know if that was the reason for which Pfizer called him. He wanted to know the dosing intervals between the first and second dose of the Pfizer BioNTech Covid vaccine and if he could still get his second dose as planned because he got Covid between doses one and two. The patient had some symptoms, so he went and got tested and experienced loss of taste of smell, congestion and slight cough. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he got the first dose of the Pfizer Covid vaccine on 03Mar2021 and tested positive for Covid a week later on 09Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient (age: 37; unit: unknown; as reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got the first dose of the pfizer covid vaccine on 03mar2021 and tested positive for covid a week later on 09mar2021. The patient underwent lab tests and procedures which included covid-19 virus test: positive on 09Mar2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, COVID-19, Cold sweat
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration, in left arm on 23Mar2021 13:00 as first dose single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient did not receive prior Vaccinations (within 4 weeks). Patient states she received her first Pfizer Covid vaccine dose and then tested positive for Covid-19 on 29Mar2021. Patient asks, how long do I need to wait to get the second dose of the vaccine. The caller is calling about the Covid 19 vaccine. Patient received the Covid 19 vaccine, her first dose on 23Mar2021. Her husband and patient both got their first Covid 19 vaccines together. Both patient and her husband experienced their eye sockets just ached. They just did not feel well for a few days. Her husband is feeling better, he feels fine now. But now patient has a fever on 26Mar2021. Her temperature is a little over 100 F and her temperature usually runs low. Patient son-in-law took patient blood pressure today and it was 81/57 on 29Mar2021. She has been hydrating more. patient just feels generally awful. patient blood pressure has come back up. She is asking if she can still have symptoms this many days after receiving the Covid 19 vaccine. When probing for specific event details patient reports that patient and her husband eyes were achy immediately after receiving the Covid 19 vaccine. Patient has been taking Advil. Her husband thinks the Advil is masking her fever. patient also feels clammy on 26Mar2021. Today was the first time someone had taken her blood pressure. Patient started on Friday, feeling nauseated on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included blood pressure: 81/57/low mmhg, temperature: runs low/little over 100 fahrenheit and covid-19: positive on 29Mar2021. The outcome of the events aching eye socket, fever, Clammy was not recovered, blood pressure abnormal was recovering and unknown for other events.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration, in left arm on 23Mar2021 13:00 as first dose single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient did not receive prior Vaccinations (within 4 weeks). Patient states she received her first Pfizer Covid vaccine dose and then tested positive for Covid-19 on 29Mar2021. Patient asks, how long do I need to wait to get the second dose of the vaccine. The caller is calling about the Covid 19 vaccine. Patient received the Covid 19 vaccine, her first dose on 23Mar2021. Her husband and patient both got their first Covid 19 vaccines together. Both patient and her husband experienced their eye sockets just ached. They just did not feel well for a few days. Her husband is feeling better, he feels fine now. But now patient has a fever on 26Mar2021. Her temperature is a little over 100 F and her temperature usually runs low. Patient son-in-law took patient blood pressure today and it was 81/57 on 29Mar2021. She has been hydrating more. patient just feels generally awful. patient blood pressure has come back up. She is asking if she can still have symptoms this many days after receiving the Covid 19 vaccine. When probing for specific event details patient reports that patient and her husband eyes were achy immediately after receiving the Covid 19 vaccine. Patient has been taking Advil. Her husband thinks the Advil is masking her fever. patient also feels clammy on 26Mar2021. Today was the first time someone had taken her blood pressure. Patient started on Friday, feeling nauseated on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included blood pressure: 81/57/low mmhg, temperature: runs low/little over 100 fahrenheit and covid-19: positive on 29Mar2021. The outcome of the events aching eye socket, fever, Clammy was not recovered, blood pressure abnormal was recovering and unknown for other events.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Mild hives/itchiness on torso/ arms at 30-45 min post injection  Severe hives/itchiness on torso, arms and legs at 9 hours post injection  Respiration ok, unaffected; face/head unaffected as of 10 hrs post vax
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure during pregnancy, Fatigue, Headache, Injection site pain
Clinical narrative: This is my first pregnancy and the estimated date of delivery is August 28, 2021. Injection site was sore after vaccination, followed by tiredness and diarrhea in the evening. Woke up with pounding headaches from 05/09/2021-05/10/2021, which subsided after about 15min. On the morning of 05/10/2021, noticed hard lymph node swelling on left infraclavicular (approx. size of a small grape), felt sore to the touch. Made appointment with PCP to have it checked out on 05/17/2021. Noticed the swelling had been decreasing in size each day. Today, 05/15/2021, it feels to be about the size of a small pea, but will still keep appointment with PCP on 05/17/2021 to have it checked out.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This is my first pregnancy and the estimated date of delivery is August 28, 2021. Injection site was sore after vaccination, followed by tiredness and diarrhea in the evening. Woke up with pounding headaches from 05/09/2021-05/10/2021, which subsided after about 15min. On the morning of 05/10/2021, noticed hard lymph node swelling on left infraclavicular (approx. size of a small grape), felt sore to the touch. Made appointment with PCP to have it checked out on 05/17/2021. Noticed the swelling had been decreasing in size each day. Today, 05/15/2021, it feels to be about the size of a small pea, but will still keep appointment with PCP on 05/17/2021 to have it checked out.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Fatigue, Myalgia
Clinical narrative: Patient received a Moderna vaccine at another facility on 05/12/2021. On 05/13/2021, he had chills, fatigue, and myalgias. These symptoms resolved on 05/14/2021. However on 05/14/2021 at 10 AM he developed pleuritic chest pain. He was admitted to hospital on the evening of 05/14/2021 with dramatic elevations in high-sensitivity troponin to 1700 and EKG with diffuse ST elevations and PR depressions, concerning for myopericarditis. He was initially treated with ibuprofen and colchicine. We have ordered an echocardiogram and a cardiac MRI. Workup and treatment are ongoing.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pleuritic pain, Troponin increased
Clinical narrative: Patient received a Moderna vaccine at another facility on 05/12/2021. On 05/13/2021, he had chills, fatigue, and myalgias. These symptoms resolved on 05/14/2021. However on 05/14/2021 at 10 AM he developed pleuritic chest pain. He was admitted to hospital on the evening of 05/14/2021 with dramatic elevations in high-sensitivity troponin to 1700 and EKG with diffuse ST elevations and PR depressions, concerning for myopericarditis. He was initially treated with ibuprofen and colchicine. We have ordered an echocardiogram and a cardiac MRI. Workup and treatment are ongoing.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pyrexia
Clinical narrative: Fever 102 f started 27th day after vaccination  and fluctuate between 100-104.  After 5 th days went to ER walk in and hospital team put him into ecmo in the evening due to sudden drop in oxygen level.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, C-reactive protein increased, Cardiac imaging procedure abnormal
Clinical narrative: Fever 102 f started 27th day after vaccination  and fluctuate between 100-104.  After 5 th days went to ER walk in and hospital team put him into ecmo in the evening due to sudden drop in oxygen level.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Ejection fraction abnormal, Endotracheal intubation, General physical health deterioration, Lung assist device therapy
Clinical narrative: Fever 102 f started 27th day after vaccination  and fluctuate between 100-104.  After 5 th days went to ER walk in and hospital team put him into ecmo in the evening due to sudden drop in oxygen level.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myocarditis, Pyrexia, Troponin increased, Ventricular assist device insertion
Clinical narrative: Fever 102 f started 27th day after vaccination  and fluctuate between 100-104.  After 5 th days went to ER walk in and hospital team put him into ecmo in the evening due to sudden drop in oxygen level.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immobile, Nausea, Pyrexia
Clinical narrative: High fever 102.3F ~15hrs after injection Severe back pain, to the point of immobilization ~30hrs after injection  Nausea ~30hrs after injection
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Itching; Hives; Tongue & Mouth swelling.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 3 hours after second dose, soreness and chills began, about 9pm. Second and third day filled with on and off fevers of 100.2 F and all over aches, very tired. Arm swollen and tender to the touch.  Day 4 fevers and aches stopped but redness, swelling and itchiness at injection site began. Redness and itchiness also occurred 1 week after the first dose too, but itchiness feels worse for this second dose.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: 3 hours after second dose, soreness and chills began, about 9pm. Second and third day filled with on and off fevers of 100.2 F and all over aches, very tired. Arm swollen and tender to the touch.  Day 4 fevers and aches stopped but redness, swelling and itchiness at injection site began. Redness and itchiness also occurred 1 week after the first dose too, but itchiness feels worse for this second dose.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore on my toe; This is a spontaneous report from a contactable consumer (reporting for herself).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced sore on her toe on an unspecified date. The patient reported on an unspecified date she went to a walk in clinic for a sore on her toe. They gave her a shot of penicillin. She also stated she is on oral antibiotics. She wanted to know if she can still get her second BNT162B2 dose. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site induration
Clinical narrative: my skin bubbled up; I pointed the bubble out, I also bled quite a bit; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 13Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 13Apr2021, Immediately after injection the patient experienced skin bubbled up and bled quite a bit The patient wanted to know if that would be an indication of not being administered correctly. The patient had given her dog subcutaneous fluids before and it had bubbled up like this. The person that administered the vaccine said everyone reacts differently. The outcome of skin bubbled up and bled quite a bit were unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: pulled a muscle under her left breast; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE  (at the age of 61 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The consumer received the first dose of the Covid vaccine and is scheduled to receive the second dose today at 1 p.m.  On unspecified date, the patient pulled a muscle under her left breast.  Outcome of the event was unknown.  No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site rash
Clinical narrative: the patient believes that her dose was given subcutaneously; a rash at the injection site; This is a spontaneous report from a contactable pharmacist. A female patient "around 50 years old" received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient believed her dose was given subcutaneously. The patient also experienced a rash at the injection site. The outcomes of believed her dose was given subcutaneously and rash were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date after the first dose of the vaccine the patient experienced some severe side effects and vertigo. The patient asked if she should get the second dose. The outcomes of severe side effects and vertigo were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart rate; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she experienced a fast heart rate on an unknown date with the first dose of BNT162B2 and inquired if there was any information about that. The patient inquired how many people had reported this side effect and if anyone had died from it, further stating she was concerned about taking the second vaccine dose. The patient also inquired how protected she was from the first dose if she didn't take the second dose. The clinical outcome of fast heart rate was unknown.   No follow-up attempts are possible; information about the lot number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Night sweats; Fever; This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), via an unspecified route of administration on an unspecified date at the age of 60 years old (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Night sweats and fever for 2 days before subsiding. Events took place after use of product. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Caller was calling on behalf of the patient who took the first dose vaccine yesterday 17Apr2021 and she was experiencing headache and pain right now (Apr2021). The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Nausea, Night sweats
Clinical narrative: nausea; diarrhea; night sweats; This is a spontaneous report from a Pfizer-sponsored program received from a contactable other healthcare professional and a consumer. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Apr2021 (at 51-years-old) at unknown, single for COVID-19 immunisation and tofacitinib citrate (XELJANZ XR tablet 11 mg) on 16Feb2021 at 11 mg. Medical history and concomitant medications were not reported. The patient experienced nausea, diarrhea, night sweats and 8 missed doses of tofacitinib citrate when he had his COVID vaccine, in Apr2021. The action taken with tofacitinib citrate was temporarily withdrawn on 19Apr2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. The patient experienced Fever and chills 1 day after receiving second dose of Pfizer COVID vaccine. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: pain in her stomach; This is a spontaneous report from a non-contactable consumer (patient's daughter). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 for COVID-19 immunization (Brand: Pfizer biotech, Vaccine name: COVID 19, Dose: 1). The patient's concomitant medications were not reported. Patient got the Pfizer COVID vaccine, first dose on 11Mar2021, second dose on 01Apr2021, she started experiencing pain in her stomach. Pain in her stomach started 3 weeks ago on 06Apr2021 (reported as approximately five days after the second dose). The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging
Clinical narrative: severe facial paralysis; This is a spontaneous report from a contactable consumer.   A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 14:00 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other vaccine same date with lot number=EW0170, dose number=2, right arm. The patient stated 9 days later, on 14Apr 12:00 PM, I woke up with severe facial paralysis... I had to go to the ER immediately to determine if I was having a silent stroke, MRI result determine it was Bells Palsy... despite the adverse affect doctors still advised that it was safe for me to take the 2nd shot. Was diagnosed with prednisone to treat Bells Palsy. Doctor or other healthcare professional office/clinic visit and  emergency room/department or urgent care visit. Facility where the most recent COVID-19 vaccine was administered was other. Treatment received as prednisolone. Outcome was not recovered. The case reported as non serious.
Age: 29.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Nasal injury, Nervousness, Pain in extremity, Tooth injury
Clinical narrative: Fell unexpectedly; I injured my nose, tooth; I injured my nose, tooth; My arm pain is 7 out of 10; scared to get up.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 28Apr2021 at 16:15 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 immunisation and ibuprofen (ADVIL) from an unspecified date to an unspecified date at an unspecified dose (2) and frequency for an unspecified indication. Medical history included anxiety/depression (mitigated with SSRI) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known drug allergies. Concomitant medications (taken within 2 weeks of vaccination) included escitalopram orally taken for an unspecified indication from an unspecified date to an unspecified date at 10mg, daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration an unspecified date as a single dose for COVID-19 immunisation. On 29Apr2021 at 03:00 the patient experienced fell unexpectedly, I injured my nose, tooth, my arm pain is 7 out of 10 and scared to get up. The course of events was reported as follows: "Got up at 3am in the morning to take some Advil. Took 2 Advil then fell unexpectedly. Partner was awake and stated that I did not trip on anything. I did not have any previous dizziness or indications that I was going to faint (no night sweats, no stars or blurry vision, no muscle weakness). I injured my nose, tooth (no significant damage), and was scared to get up. My arm pain is 7 out of 10. I have no previous medical history of fainting after a vaccine." No treatment was received for the adverse events. The clinical outcomes of the events fell unexpectedly, I injured my nose, tooth, my arm pain is 7 out of 10 and scared to get up were recovered/resolved on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Palpitations, Photophobia
Clinical narrative: 5 days of heart palpitations; racing heart; extreme light sensitivity; dizziness; fever; chills; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Dec2020 18:45 (Lot Number: EK9231) at age of 30 years as single dose for covid-19 immunisation. Medical history was not reported. Patient was not pregnant. Concomitant medications were reported as none. Patient reported 5 days of heart palpitations, racing heart, dizziness, fever, chills and extreme light sensitivity. These symptoms kept happening since vaccine off and on. The latest landed patient in the hospital for 5 days. Patient had been released but was bedridden with all euro symptoms listed above. Treatment received scans etc, IV fluid and medications to relieve sym. Since the vaccination, the patient had not been tested for COVID-19. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 5 days of heart palpitations; racing heart; extreme light sensitivity; dizziness; fever; chills; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Dec2020 18:45 (Lot Number: EK9231) at age of 30 years as single dose for covid-19 immunisation. Medical history was not reported. Patient was not pregnant. Concomitant medications were reported as none. Patient reported 5 days of heart palpitations, racing heart, dizziness, fever, chills and extreme light sensitivity. These symptoms kept happening since vaccine off and on. The latest landed patient in the hospital for 5 days. Patient had been released but was bedridden with all euro symptoms listed above. Treatment received scans etc, IV fluid and medications to relieve sym. Since the vaccination, the patient had not been tested for COVID-19. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular vascular disorder, Retinal vein occlusion, Visual impairment
Clinical narrative: A retinal vein occlusion, and I noticed right away; I scheduled an appointment with a retina specialist, and I was told I had a small blood clot in my right away; Exactly seven days after, something happened to my right eye that caused me issues with my vision.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 18:15 (Batch/Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes and thyroid issues, allergic to shellfish and to fluconazole. Concomitant medications included insulin and thyroid medication. Exactly seven days after (on 22Apr2021), something happened to patient's right eye that caused issues with her vision. Patient scheduled an appointment with a retina specialist and was told patient had a small blood clot in right away. A retinal vein occlusion and patient noticed right away because it was right in the middle of vision field/where the light enters through in the eye. Patient was type 1 diabetic with perfect control and patient had never had issues with vision (even got checked last year before COVID and no problems). Her endocrinologist did not think it was diabetes related either. The only different thing was the vaccine. Now patient was not sure if she should take the second dose and also her retina doctor wanted her to get checked for further blood clots to make sure she was okay. No treatment was received for the events. The events resulted in physician office visit and disability. Outcome of the events was not resolved.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (BNT162B2) via an unspecified route on left arm 1st dose, single for COVID-19 immunization on 28Apr2021 01:00 at 22-year-old. Medical history included cerebral palsy. There were no concomitant medications. The patient experienced multiple side effects throughout the day followed by seizures on 28Apr2021 17:00, reported as serious due to disability with outcome of recovering. Doctor or other healthcare professional office/clinic visited, emergency room/department or urgent care visited, reported as disability or permanent damage. The patient was treated by diphenhydramine hydrochloride (BENADRYL).  Information on Lot/Batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anaphylactic shock, Dyspnoea, Swelling face, Urticaria
Clinical narrative: anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation.  Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years).  The patient's concomitant medications were not reported.  Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.