chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain assessment, Trismus
Clinical narrative: My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Maternal exposure during pregnancy, Nausea, Off label use, Product use issue
Clinical narrative: Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes; Dizziness;nausea;fever; This is a spontaneous report from a contactable nurse. This is the maternal report. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 11Jan2021 14:30 at a single dose on right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included prenatal vitamins. The patient experienced dizziness, nausea, and fever on 12Jan2021 10:00. Treatment was not received for the events. The outcome of the events dizziness, nausea, and fever was recovering. The mother reported she became pregnant while taking bnt162b2 (Pregnant at the time of vaccination?: Yes). The events were assessed as non-serious. The mother was 24 Weeks (gestational period) pregnant at the onset of the event. The mother was due to deliver on 03May2021. Last menstrual date: 24Jul2020. Patient did not receive any other vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes; Dizziness;nausea;fever; This is a spontaneous report from a contactable nurse. This is the maternal report. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 11Jan2021 14:30 at a single dose on right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included prenatal vitamins. The patient experienced dizziness, nausea, and fever on 12Jan2021 10:00. Treatment was not received for the events. The outcome of the events dizziness, nausea, and fever was recovering. The mother reported she became pregnant while taking bnt162b2 (Pregnant at the time of vaccination?: Yes). The events were assessed as non-serious. The mother was 24 Weeks (gestational period) pregnant at the onset of the event. The mother was due to deliver on 03May2021. Last menstrual date: 24Jul2020. Patient did not receive any other vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Inappropriate schedule of product administration, Insomnia, Pain
Clinical narrative: back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, first dose was given on 19Dec2020; This is a spontaneous report from a contactable physician (reported for herself). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), via an unspecified route of administration (left arm) on 08Jan2021 (10:00 AM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 19Dec2020 (10:00 AM). Medical history included Celiac disease and allergies to medications, food, or other products: Latex, salicylate, wheat (celiac). Concomitant medication included melatonin (MELATONIN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that at around 30 hours after second vaccine dose (09Jan2021, 05:00 PM), the patient experienced back ache. At 36 hours post vaccine she developed intense achy and rigors and chill that lasts about 6 hours. The patient could not sleep during that time (10pm-330am). The patient took Tylenol at 1:30am. The symptoms abruptly stopped and felt perfectly fine after. There was a treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for herself.  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 08Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies. Concomitant medications included omeprazole and Multivitamin. The patient historic vaccine included the first dose of BNT162B2 received on 18Dec2020 07:30 AM at Left arm for covid-19 immunization, 1st dose symptoms started about 4hrs after: Nausea, body aches, fatigue, severe headache-all lasting 3-4 days. The patient experienced on and off headaches, body aches, fatigue all starting around 18-20 hours post second injection on 09Jan2021 and lasting less than 48 hours. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included vitamin c [ascorbic acid].  The patient previously took Benzoyl peroxide and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) intramuscular (right arm) first dose on 18Dec2020 for Covid-19 immunization and experienced flu like symptoms for 48 hours plus bilateral cheek numbness for two weeks. On 08Jan2021, after the second dose the patient experienced myalgia body ache fever axillary lymph node swelling and pain dizziness nausea. This was day 4 post vaccine, still have severe dizziness and fatigue. On 04Jan2021, the patient underwent lab tests and procedure which includes Coronavir Pan 2019-NCOV, NAA with the result of Negative and Nasal Swab with the result of Negative. The patient did not receive any treatment for the events.  The outcome of the events was not recovered. 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. The patient was not diagnosed with COVID-19 Prior to vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nucleic acid test, Pain, Pyrexia, Smear test
Clinical narrative: After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included vitamin c [ascorbic acid].  The patient previously took Benzoyl peroxide and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) intramuscular (right arm) first dose on 18Dec2020 for Covid-19 immunization and experienced flu like symptoms for 48 hours plus bilateral cheek numbness for two weeks. On 08Jan2021, after the second dose the patient experienced myalgia body ache fever axillary lymph node swelling and pain dizziness nausea. This was day 4 post vaccine, still have severe dizziness and fatigue. On 04Jan2021, the patient underwent lab tests and procedure which includes Coronavir Pan 2019-NCOV, NAA with the result of Negative and Nasal Swab with the result of Negative. The patient did not receive any treatment for the events.  The outcome of the events was not recovered. 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. The patient was not diagnosed with COVID-19 Prior to vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Viral test
Clinical narrative: Tiredness; Headache; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and headache on 12Jan2021 at 16:00. The patient did not receive treatment for the events. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 with Nasal swab on an unspecified date since the vaccination, with unknown result. The outcome of the events was resolved in Jan2021.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 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 experienced lymph node swelling on an unspecified date. The clinical outcome of lymph node swelling was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Vomiting
Clinical narrative: emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a contactable other health professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0142) via an unspecified route of administration at left arm on 10Jan2021 at a single dose (dose number: 2) for COVID-19 immunization. Medical history included allergies to cefaclor (CECLOR), azithromycin (ZITHROMAX Z-PACK, reported as z pack), pinapple, coconut. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included warfarin sodium (JANTOVEN), sertiline, metformin (reported as metforman, to be clarified). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 20Dec2020 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization and reported events included emesis within 40 minutes, upset stomach for 3 hours approx, sweating and headache, lasting about 4 hours. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. After the 2nd shot, it was reported emesis within 40 minutes and lasting all day, extremely tired, horrible headache, sweats and chills. This lasted 36 hours. Start date of adverse event was reported as 10Jan2021 at 10:30 AM. No treatment received for the adverse events. The outcome of events was resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Fever of up to 101.2 Fahrenheit; Chills; muscle soreness; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jan2021 11:00 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history was none. The patient had no known allergies. Concomitant medication included ibuprofen (IBUPROFEN). The Historical Vaccine included product=COVID, brand=Pfizer, lot unknown=False, administration date=22Dec2020, administration time=10:30 AM, vaccine location=Left leg, dose number=1. The patient experienced fever of up to 101.2 fahrenheit, chills, muscle soreness on 12Jan2021 23:30. The patient underwent lab tests and procedures which included body temperature: 101.2 fahrenheit on 12Jan2021 23:30. No treatment was received. The event outcome was recovering. The events reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore after vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old male patient that received BNT162B2 (COVID vaccine), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Arm was sore after vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Headache
Clinical narrative: injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself.  The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation.  Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Off label use, Pain, SARS-CoV-2 test
Clinical narrative: injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself.  The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation.  Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself.  The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation.  Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Muscle spasms, Pain
Clinical narrative: chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Has been experiencing a dull headache since receiving the first dose; This is a spontaneous report from a contactable Other HCP.  A patient (demographics unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. She has been experiencing a dull headache since receiving the first dose vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Ear infection, Sinusitis
Clinical narrative: ear infection; sinus infection; This is a spontaneous report from a contactable pharmacist (patient) received via the Pfizer Sales Representative. A female patient of unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included cochlear implants. Concomitant medications were not reported. The patient, who had cochlear implants, reported that she got an ear infection and then a sinus infection after her pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After he got his 2nd dose of the Covid-19 vaccine and his right axillary lymph nodes were swollen; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the second report out of 2 patients. This case is non-serious. The other case is serious, medically significant.   A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), 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. While reporting on another patient, the pharmacist also mentioned that after he got his 2nd dose of the Covid-19 vaccine and his right axillary lymph nodes were swollen. He said that it was not enough to report. He stated that a lot of people have reported it and it it was also reported during the clinical trials. The caller declined to complete a report on himself. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018520 same reporter and drug/similar event/different patients
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain; feeling a little more tired than normal; This is a spontaneous report from a non-contactable consumer (patient).  A 4-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm pain and feeling a little more tired than normal on an unspecified date with outcome of not resolved at time reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: he felt feverish; had a headache; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated the reporter's husband has a family call weekly with his siblings. The reporter participated in the call on 10Jan2021. During that call, one of his sisters mentioned her son had a second COVID vaccination and had a mild reaction. Later in the conversation, it was clarified that it was the Pfizer vaccine. It was reported that the patient got the vaccine on 'Friday' (unspecified date); on the next day, he felt feverish, had a headache and fatigue and was better by Sunday. The events were resolving.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; fever/low-grade fever; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration 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 stated that she had the first vaccine last month (pending clarification) then experienced sore throat and fever. The patient mentioned, "I got the Pfizer vaccine on the sixth which is Wednesday (pending larification) and over the weekend before that, it was new year's eve we went camping, of course, we were outside but we had canopy because it was raining and there were people keep showing off but I never had any symptoms or I've never heard from anybody that they have symptoms but since I had a sore throat even before so like a week and a half now, but since I got the vaccine I had a low-grade fever." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: Swelling in the arm; This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 42-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as pneumonia vaccination), via an unspecified route of administration in 2012 at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient stated she experienced swelling in the arm from a pneumonia vaccination, back in 2012, she had no lot number or expiry date of this vaccine. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.   No Follow-up attempts are needed, Information about lot/batch number cannot be obtained and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test, Sneezing
Clinical narrative: I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing; This is a spontaneous report from a contactable nurse (patient).   This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # not clarified, Expiry Date 30Apr2021) intramuscular at single dose in the deltoid on 08Jan2021 15:00 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified several drugs. On 08Jan2021 22:00, the patient experienced loss of taste, loss of smell, sneezing with outcome of unknown. No treatment required. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Jan2021.   Nurse stated: "I just wanted to know the Covid Vaccine would it have given me that symptoms I mean obviously I'm exposed you know I do the testing at my office at school." When probed for causality, Nurse stated, "No, I don't think it would be from the vaccine, probably you know just exposure."  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient reported that got second dose of bnt162b2 yesterday (09Jan2021) and now the patient had fever in Jan2021, patient wanted to know if its okay to take paracetamol (TYLENOL) or fever reducer or no. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Ear congestion, Erythema, Hypoacusis, Pruritus
Clinical narrative: My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure.  The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl?  The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever all the way up to 103.9.; Vomiting; My head hurt uncontrolled like it's excruciating pain in my head; Chills; Severe body aches; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient reported she got the vaccine shot on Monday (unspecified date) and since Thursday night she had severe body aches. She have had the fever all the way up to 103.9. She have had fever for three days straight now (at reporting time). She had body aches, had been vomiting, head hurt uncontrolled like it's excruciating pain in head. She have chills. As treatment, the patient had taken Tylenol 500 mg, Ibuprofen is 200, NyQuil, Theraflu. The reporter stated, "I am a 'line person' (not clarified), I am a first responder." The patient wanted to know if for these symptoms it was recommended going to the doctor. Fever had not resolved, while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever all the way up to 103.9.; Vomiting; My head hurt uncontrolled like it's excruciating pain in my head; Chills; Severe body aches; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient reported she got the vaccine shot on Monday (unspecified date) and since Thursday night she had severe body aches. She have had the fever all the way up to 103.9. She have had fever for three days straight now (at reporting time). She had body aches, had been vomiting, head hurt uncontrolled like it's excruciating pain in head. She have chills. As treatment, the patient had taken Tylenol 500 mg, Ibuprofen is 200, NyQuil, Theraflu. The reporter stated, "I am a 'line person' (not clarified), I am a first responder." The patient wanted to know if for these symptoms it was recommended going to the doctor. Fever had not resolved, while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Pain, Pyrexia
Clinical narrative: Fever; My body is aching so bad; I can't walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 second dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was having reaction to the vaccine, patient had fever, body was aching so bad, can't walk, going to the bathroom is so painful. Patient feel like need to go to the emergency room or don't know. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cheilitis, Lip oedema, Lip swelling, Nasal discomfort, Nasal oedema
Clinical narrative: My nasal passage got swollen and sore and puffy; My nasal passage got swollen and sore and puffy; upper lip little bit the same which seems to be a reaction from the vaccine; My nasal passage got swollen and sore and puffy and my upper lip little bit the same which seems to be a reaction from the vaccine; My nasal passage got swollen and sore and puffy and my upper lip little bit the same which seems to be a reaction from the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 07Jan2021 to 07Jan2021 at a single dose for COVID-19 vaccination. It was reported by the patient that the nasal passage got swollen and sore and puffy and the upper lip little bit the same on unspecified dates. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling, Malaise
Clinical narrative: Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction; purple and red; continuing to increase in size and it is red and swollen and hard now; Made me really, really sick like bedridden for 2 days; Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; This is a spontaneous report from a contactable Other HCP (patient). An unknown age and gender patient received BNT162B2 (lot# unknown) on Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated, "I just have a question, my Pfizer COVID Vaccine made me really, really sick like bedridden for 2 days which I am finding out is probably normal. But the spot on my arm where I got the vaccine, it was probably 4 days ago that I got it and it's continuing to increase in size and it is red and swollen and hard now. Like I am a Nurse Practitioner, this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction, should I be concerned, do I need to go to the hospital?" Outcome of the event was unknown.  Information on the lot/ batch number has been requested.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Bone pain, Gait disturbance, Malaise
Clinical narrative: I have felt horrible; Every bone in my body ached except my eyebrows and eyelashes; I am so weak I have no energy; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The patient medical history included autoimmune disease and "bad back", both from an unknown date and ongoing. The patient's concomitant medication included prednisone for autoimmune disease and tramadol 75 mg daily for back pain. On an unspecified date, the patient reported that: "I felt horrible, every bone in my body ached except my eyebrows and eyelashes, I am just wiped out when does this go away, I am so weak I have no energy, I can hardly walk". The patient underwent lab tests and procedures which included blood test: unknown result, on an unspecified date. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Have some swelling in my lymph node and one of my armpits and it is like going down the side of my body now; This is a spontaneous report from a contactable consumer (Patient). A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date (reported as the other day) as a single dose for COVID-19 immunization, lot number: EK9231. Medical history and concomitant medications were not provided. Patient stated that had some swelling in lymph node and one of armpits and it was like going down the side of patient's body at the time of the report. Patient wanted to know if this was a normal side effect or if was needed to see a doctor. Outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events "Tested positive for Covid/had the (Covid) infection" (coded to Drug ineffective / COVID-19) and  swollen lymph nodes and BNT162B2 vaccine cannot be completely excluded.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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my first one I had a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. It was reported that when she received the first dose of BNT162B2, she had a lot of pain in her arm on an unspecified date. Outcome of event was unknown.  Information on the lot/Batch number has been requested.