chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: 4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered.   Information on the lot/ batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; fever; headache; This is a spontaneous report from a contactable nurse.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:Ek9231, via an unspecified route of administration on the left arm on 08Jan2021 22:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paroxetine (PAROXETINE), finasteride (FINASTERIDE), testosterone (TESTOSTERONE) and rosuvastatin calcium (ROSUVASTATIN VIAL). The patient experienced fatigue, fever and headache on 09Jan2021 11:00 with outcome of recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on left arm on 08Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included lymphoma, and red food coloring allergy. The patient received her first dose of BNT162B2 on 22Dec2020. The patient's concomitant medications were not reported. The patient reported she had swelling and pain in her underarm on the same side as her shot. Her arm was still sore, and the swelling has not decreased. It started Saturday morning (09Jan2021 at 6am) after her 2nd vaccine dose on Friday night. It was unknown if patient received any treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.    Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Heart rate, Vaccination site haemorrhage, Vaccination site movement impairment
Clinical narrative: more stiffness at the vaccination site; tiredness/fatigue; slight bleeding after the injection; when lifting my left arm/It felt heavier; pain at the time of syringe injection; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 06Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 for COVID-19 immunization and experienced vaccination site pain, vaccination site stiffness and  vaccination site movement impairment. The patient completed the second administration and had finalized his vaccination process. At first vaccine administration the patient mentioned it was no different from regular influenza vaccine. There was no special side effect. The patient woke up in the morning and there was pain at the time of syringe injection the same as 1st administration but there wasn't much feeling of the syringe being injected. After the administration, the patient was watched for around 30 minutes, but had no specific allergic reaction, just like the 1st administration. When he woke up this morning, and also in the evening of the vaccination day, although it is not sure if it is due to the vaccine, the patient had tiredness. His wife and child checked body temperature and pulse every 30 minutes. At the time of report, the patient woke up slightly early, but anyhow the difference was feeling of tiredness. Also there was more stiffness at the vaccination site that was felt more strongly than at 1st vaccination, especially when lifting left arm compared to the first vaccination. It felt heavier and sorer. The patient is feeling better and without any pain now. When talked about the second vaccination that he received, the patient look as though he was in pain when receiving it and reporter replied yes, slightly. At 1st administration there was no bleeding after the injection. But at 2nd administration there was slight bleeding after the injection so the patient was surprised. In summary, the patient had pain at injection with the syringe at 2nd administration,when the syringe was injected and also had pain a little after the injection, other than that, he had no special side effect. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: more stiffness at the vaccination site; tiredness/fatigue; slight bleeding after the injection; when lifting my left arm/It felt heavier; pain at the time of syringe injection; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 06Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 for COVID-19 immunization and experienced vaccination site pain, vaccination site stiffness and  vaccination site movement impairment. The patient completed the second administration and had finalized his vaccination process. At first vaccine administration the patient mentioned it was no different from regular influenza vaccine. There was no special side effect. The patient woke up in the morning and there was pain at the time of syringe injection the same as 1st administration but there wasn't much feeling of the syringe being injected. After the administration, the patient was watched for around 30 minutes, but had no specific allergic reaction, just like the 1st administration. When he woke up this morning, and also in the evening of the vaccination day, although it is not sure if it is due to the vaccine, the patient had tiredness. His wife and child checked body temperature and pulse every 30 minutes. At the time of report, the patient woke up slightly early, but anyhow the difference was feeling of tiredness. Also there was more stiffness at the vaccination site that was felt more strongly than at 1st vaccination, especially when lifting left arm compared to the first vaccination. It felt heavier and sorer. The patient is feeling better and without any pain now. When talked about the second vaccination that he received, the patient look as though he was in pain when receiving it and reporter replied yes, slightly. At 1st administration there was no bleeding after the injection. But at 2nd administration there was slight bleeding after the injection so the patient was surprised. In summary, the patient had pain at injection with the syringe at 2nd administration,when the syringe was injected and also had pain a little after the injection, other than that, he had no special side effect. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash lower back, itching on back, leg, lower stomach.; Rash lower back, itching on back, leg, lower stomach.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) solution for injection, via an unspecified route of administration on left arm on 07Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension, kidney disease stage 3, UTI (urinary tract infection), enlarged prostate, and known allergy to penicillin. Concomitant medication included amlodipine, benazepril, tamsulosin, ergocalciferol (VIT D), and unspecified multivitamin. The patient experienced rash lower back, itching on back, leg, lower stomach on 09Jan2021 at 2pm. No treatment received. The events were reported as non-serious. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Feeling of body temperature change, Headache, Pain in extremity
Clinical narrative: arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient).  A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at  13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported.  The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water.  They kept her for 30 minutes on observation.  She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00.  She took Motrin 600mg and it helped out. The outcome of the events was recovered.  The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient).  A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at  13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported.  The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water.  They kept her for 30 minutes on observation.  She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00.  She took Motrin 600mg and it helped out. The outcome of the events was recovered.  The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Ligament injury, Myalgia, Pain in extremity
Clinical narrative: severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: exposed to COVID; runny nose; This is a spontaneous report from a Pfizer-sponsored Program. A contactable nurse (patient) reported that a female patient (age: 68, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and is asking if she can receive the second dose of vaccine after being exposed to COVID. She has not tested positive on an unspecified date. She does have a runny nose, and this is not uncommon for her. Patient asked "If I do get symptoms of COVID, what do I do? Can I get the second dose? How long is recommended quarantine after exposure to COVID-19? Can I get the second dose later than the 3-week mark? since her second dose is scheduled for tomorrow. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Inappropriate schedule of product administration, Tremor
Clinical narrative: Became very light headed; cold chills with shaking for 45-60 minutes; cold chills with shaking for 45-60 minutes; Sweating for next 12 hours; Date of start of drug: 08Jan2021, Dose number: 2; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 08Jan2021 08:30, at single dose, for COVID-19 immunization, in the doctor's office/urgent care. Medical history included depression, anxiety and COVID-19, all on unspecified dates. The patient has no known allergies. Concomitant medication included vilazodone hydrochloride (VIIBRYD 40 mg) and folic acid 1 mg. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 19Dec2020 12:30, at single dose, for COVID-19 immunization. On 08Jan2021 at 21:00 (reported as 12 hours after the shot), the patient became very light headed. He experienced cold chills with shaking for 45-60 minutes and was sweating for next 12 hours. The patient had no fever. All events subsided by 10:00 next day, 09Jan2020. The patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 09Jan2020 at 10:00.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested (COVID-19 virus test) positive after receiving first dose of vaccine; tested (COVID-19 virus test) positive after receiving first dose of vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported.  It was reported that patient tested (COVID-19 virus test) positive after receiving first dose of vaccine. It was also reported that they are looking for administration recommendations following receipt of monoclonal antibodies and interval information. Outcome of the events was unknown.  Information of the lot number/batch number was requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Mobility decreased
Clinical narrative: really extreme high blood pressure (202/104); feeling very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included strokes and bleeding disorder (gene that makes blood clot). The patient's concomitant medications were not reported. The patient experienced really extreme high blood pressure (202/104) and feeling very sick on an unspecified date. The clinical course was reported as: The patient received the vaccine on 04Jan2021 and experienced a lot of side effects, the most concerning of which was really extreme high blood pressure. The patient went to the emergency room (ER) on an unspecified date and her blood pressure was 202/104 on an unspecified date. The patient stated that she had been very sick and in bed for days. The patient had a follow-up appointment with her doctor on the day of the report. The clinical outcome of really extreme high blood pressure (202/104) and feeling very sick was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Flushing
Clinical narrative: light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also 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. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lethargy, Lymphadenopathy, Pain
Clinical narrative: Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek5730 expiration date not provided), intramuscular (arm left) first dose on 17Dec2020 13:00 at single dose for covid-19 immunisation. There were no medical history. The patient concomitant medication includes Multivitamin. On 01Jan2021, the patient experienced Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extremely enlarge lymph nodes under left arm that continues 3 days after first seeing it. No treatment was given for the events. The outcome of the events was recovering. On 07Jan2021 01:15 the patient received second dose intramuscular (arm left) at single dose (lot number EL1283 and expiration date not provided) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient did not tested positive for COVID-19. Also, patient did not test positive prior vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Muscle ache; fever; This is a spontaneous report from a contactable consumer (parent). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization in a hospital. Medical history included patient was positive for COVID-19 from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on an unspecified date. It was unknown if the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021, the patient experienced muscle ache and fever. The patient was given ibuprofen as treatment for the events. The patient underwent lab test which included COVID-19 test: positive in Sep2020. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old adult female patient received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old adult female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 26Dec2020 17:00 (reported as 5:00 PM) at single dose on the right arm for COVID-19 immunisation.  Medical history included asthma, thyroid cancer 2 years ago (2019) and shellfish allergies. The patient's concomitant medications were not reported. The patient previously took  gadoxetate disodium (EOVIST) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. The patient experienced right swollen painful lump in armpit on 30Dec2020. It was unknown if treatment was received.  The event resulted in doctor or other healthcare professional office/clinic visit. The event was assessed non-serious. Outcome of the event was recovered with sequel on an unspecified date (reported as "Recovered with lasting effects"). The patient has not been tested for COVID-19 since the vaccination.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Vomiting
Clinical narrative: fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe abdominal cramping and vomiting; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL3246), via an unspecified route of administration on the left arm on 07Jan2021 13:30 at SINGLE DOSE for COVID-19 immunization at the hospital. The patient had allergies with penicillin and sulfa drugs.  The patient's concomitant medications were not reported.  On 07Jan2021 22:30 (9 hours after vaccine), the patient had sudden onset of chills/shaking , severe abdominal cramping and vomiting which lasted about 1 hr 15 min and then resolved on 07Jan2021 23:45. It was reported that the patient had no other effects than fatigue the next day (08Jan2021). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.  Outcome of the event of fatigue was unknown while remaining events recovered on 07Jan2021 23:45.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site bruising, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Left shoulder and arm pain; arm pain; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old male patient received the second dose of BNT162B2 (Lot number: EL1283), via an unspecified route of administration from 09Jan2021 08:30 at single dose in the left arm for COVID-19 immunization. Historical vaccine included BNT162B2 (Lot number: EH9899), received first dose via an unspecified route of administration on 19Dec2020 10:45 at single dose in the left arm for COVID-19 immunization. There were no medical history. Concomitant medication included ibuprofen on 11Sep2020 11:00. On 09Jan2021 09:00, the patient experienced dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch. Left shoulder and arm pain. Did not alleviate as of 10Nov2020 when report submitted. No treatment received for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Investigation, Pain in extremity, Paraesthesia
Clinical narrative: Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received the first dose of BNT162B2 (lot number: ER5730), via an unspecified route of administration on 30Dec2020 08:30 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported.  Concomitant medication included metformin. The patient experienced swollen lymph node above collar bone on right side on 07Jan2021. The patient did not receive any treatment for the event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital.  The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Hot flush, Malaise
Clinical narrative: lightheaded/dizzy; nauseous; fatigued; feels like hot flashes; feel lousy/don't feel well overall; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 57-year-old female patient who received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine) , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that "COVID19 vaccine:  Are these side effects and wondering about second dose?  I had gotten the Pfizer COVID vaccine on 06Jan2021. Yesterday (10Jan2021), I was lightheaded, dizzy, nauseous, really fatigued. Today (11Jan2021), the fatigue is gone but still lightheaded and nauseous. I don't have a fever. At times, it feels like hot flashes and I take my temperature and I am fine. I feel lousy and don't feel well overall. As far as having COVID19, are these symptoms (per REQ#: lightheaded, dizzy, nauseous, really fatigued) and should I get tested?" The outcome of the event fatigued was recovered. The outcome of the events feels like hot flashes and feel lousy/don't feel well overall was unknown. The outcome of the other events was not recovered.   Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: lightheaded/dizzy; nauseous; fatigued; feels like hot flashes; feel lousy/don't feel well overall; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 57-year-old female patient who received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine) , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that "COVID19 vaccine:  Are these side effects and wondering about second dose?  I had gotten the Pfizer COVID vaccine on 06Jan2021. Yesterday (10Jan2021), I was lightheaded, dizzy, nauseous, really fatigued. Today (11Jan2021), the fatigue is gone but still lightheaded and nauseous. I don't have a fever. At times, it feels like hot flashes and I take my temperature and I am fine. I feel lousy and don't feel well overall. As far as having COVID19, are these symptoms (per REQ#: lightheaded, dizzy, nauseous, really fatigued) and should I get tested?" The outcome of the event fatigued was recovered. The outcome of the events feels like hot flashes and feel lousy/don't feel well overall was unknown. The outcome of the other events was not recovered.   Information about Batch/Lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Daily Headaches; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on left arm, on 20Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included allergy to bacteria. The patient is not pregnant. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VIT D3), choline, ascorbic acid, pyrroloquinoline quinone, tocopherol (PQQ), and lavandula angustifolia extract, melissa officinalis extract, origanum vulgare extract (MELATON [LAVANDULA ANGUSTIFOLIA EXTRACT;MELISSA OFFICINALIS EXTRACT;ORIGANUM VULGARE EXTRACT]). The patient had no prior Covid vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020, the patient experienced daily headaches but did not receive any treatment. The patient underwent lab tests and procedures which included nasal swab PCR test on 30Dec2020 and on 08Jan2021, both showed negative. Outcome of the event daily headaches was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 21Dec2020 at 0.3 mL single in left deltoid for preventative. Medical history included she only had one kidney from 25Feb2020. There were no concomitant medications. It was reported that the patient was supposed (was scheduled) to get her second dose today (11Jan2021) but this past weekend she tested positive for COVID on 09Jan2021. The patient wanted to know if it would affect getting the second dose of the vaccine. The patient supposed to be quarantining right now and she was not symptomatic. On 09Jan2021 she found out she was positive for covid. The outcome of the event was unknown.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness, Lymphadenopathy, Pain
Clinical narrative: sick; fever; body aches; sinus; lymph nodes swelled; joint pain; headaches; This is a spontaneous report from a contactable nurse reported for self (patient). This 44-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E51685), intramuscular on 21Dec2020 at 07:30 at single dose on left arm for COVID-19 immunisation. There was no medical history or allergies to medications, food, or other products.  The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose on 21Dec2020, the patient had sick, fever, body aches, sinus, lymph nodes swelled, joint pain, headaches. All of the events considered as non-serious and no treatment was received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the second dose of BNT162B2 (lot: Ek9231) on 11Jan2021 on the left arm.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: sick; fever; body aches; sinus; lymph nodes swelled; joint pain; headaches; This is a spontaneous report from a contactable nurse reported for self (patient). This 44-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E51685), intramuscular on 21Dec2020 at 07:30 at single dose on left arm for COVID-19 immunisation. There was no medical history or allergies to medications, food, or other products.  The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose on 21Dec2020, the patient had sick, fever, body aches, sinus, lymph nodes swelled, joint pain, headaches. All of the events considered as non-serious and no treatment was received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the second dose of BNT162B2 (lot: Ek9231) on 11Jan2021 on the left arm.