chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headaches; fever; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 57-years, on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had headaches and fever as side effects of the vaccine. By Wednesday (17Mar2021) she had a fever for 1 night and it broke that evening. She didn't take anything and let it ride it out. Until Thursday night (18Mar2021); everything was fine. Side effects which was mentioned and not overly ill. The outcome of the events was resolved in 18Mar2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 antibody test
Clinical narrative: negative antibody detection against SARS COV-2 spike protein; received the vaccine first dose on December 30 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine at the same time he got it; received the vaccine first dose on December 30th 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine at the same time he got it; This is a spontaneous report from a contactable physician (reported for himself). A 62-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 20Feb2021 (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine first dose on December 30th 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine, none antibodies developed as expected and negative laboratory results for antibody detection against SARS COV-2 spike protein (vaccination failure and SARS COV-2 antibody test negative), received the vaccine first dose on december 30th 2020 and the second dose on february 20th 2021/got administered with pfizer covid-19 vaccine at the same time he got it (off label use and inappropriate schedule of product administration), physician called requesting information regarding appropriateness of administering to himself a booster dose of Pfizer's COVID-19 vaccine considering his negative laboratory results for antibody detection against SARS COV-2 spike protein. Physician reported that he and his colleague, another health professional, who got administered with Pfizer's COVID-19 vaccine at the same time. The patient underwent lab tests and procedures which included antibody test: negative results for antibody detection against SARS COV-2 spike protein, blood test: rapid blood one, physician reported that results throwed 3 when the expected for a positive result of immune response is 10. Physician reported he has no concomitant conditions that limit his immune response. The outcome of the events was unknown.  Follow-up activities have been completed and information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021326452 same drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: negative antibody detection against SARS COV-2 spike protein; received the vaccine first dose on December 30 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine at the same time he got it; received the vaccine first dose on December 30th 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine at the same time he got it; This is a spontaneous report from a contactable physician (reported for himself). A 62-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 20Feb2021 (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine first dose on December 30th 2020 and the second dose on February 20th 2021/got administered with Pfizers COVID-19 vaccine, none antibodies developed as expected and negative laboratory results for antibody detection against SARS COV-2 spike protein (vaccination failure and SARS COV-2 antibody test negative), received the vaccine first dose on december 30th 2020 and the second dose on february 20th 2021/got administered with pfizer covid-19 vaccine at the same time he got it (off label use and inappropriate schedule of product administration), physician called requesting information regarding appropriateness of administering to himself a booster dose of Pfizer's COVID-19 vaccine considering his negative laboratory results for antibody detection against SARS COV-2 spike protein. Physician reported that he and his colleague, another health professional, who got administered with Pfizer's COVID-19 vaccine at the same time. The patient underwent lab tests and procedures which included antibody test: negative results for antibody detection against SARS COV-2 spike protein, blood test: rapid blood one, physician reported that results throwed 3 when the expected for a positive result of immune response is 10. Physician reported he has no concomitant conditions that limit his immune response. The outcome of the events was unknown.  Follow-up activities have been completed and information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021326452 same drug/AE, different patient
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paralysis, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via antibodies test on an unspecified date with positive result. On an unspecified date, a day after receiving the vaccine, the patient developed a fever and said that she felt paralyzed and nauseous. The patient needed to go to the hospital in order to recover and tested positive for antibodies. The outcome of events, fever, felt paralyzed and nauseous was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Lethargy, Paralysis
Clinical narrative: felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via antibodies test on an unspecified date with positive result. On an unspecified date, a day after receiving the vaccine, the patient developed a fever and said that she felt paralyzed and nauseous. The patient needed to go to the hospital in order to recover and tested positive for antibodies. The outcome of events, fever, felt paralyzed and nauseous was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Feeling abnormal, Malaise, Muscle contracture
Clinical narrative: felt unwell; tensed, nerves tensed; flinching and involuntary jerking; flinching and involuntary jerking; Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself; This is a spontaneous report from a contactable consumer (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced side effects included, 5 or 10 minutes after she received first dose of BNT162B2, she felt unwell and tensed, nerves tensed, flinching and involuntary jerking. Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself, felt that way for at least 3 days. On the 4th day it had gone away. Events reported as non-serious. The outcome of the event was Recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: felt unwell; tensed, nerves tensed; flinching and involuntary jerking; flinching and involuntary jerking; Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself; This is a spontaneous report from a contactable consumer (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced side effects included, 5 or 10 minutes after she received first dose of BNT162B2, she felt unwell and tensed, nerves tensed, flinching and involuntary jerking. Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself, felt that way for at least 3 days. On the 4th day it had gone away. Events reported as non-serious. The outcome of the event was Recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; Chills; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (reported as two weeks ago last Saturday, as of 22Mar2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Consumer stated he and his wife received the first dose of the Pfizer COVID vaccine two weeks ago last Saturday and last night his wife experienced some side effects. Consumer stated his wife had a fever and chills but also had a couple glasses of hot water before her temperature was taken. Consumer stated the fever went away fairly quickly and it may not be related to the vaccine but he just wanted to call to check. Consumer stated they were scheduled to receive the second dose this Saturday. Treatment measures received for fever and chills. The outcome of the event fever was recovered on unspecified date, while of the other event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known on available information and quite long time interval (more than 1 week) between event onset and vaccination, the event Fever is more likely represent an intercurrent condition and unrelated to suspect product BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive with COVID virus/getting cold/ lost taste and smell; positive with COVID virus/getting cold/ lost taste and smell; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced positive with COVID virus/getting cold/ lost taste and smell. 14 days after the first dose of the vaccine, the patient thought she was getting cold. That following Sunday, she lost taste and smell. She went in to get tested and was positive with COVID virus. Patient still didn't have taste or smell. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. The clinical outcomes of the events positive with COVID virus/getting cold/ lost taste and smell was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Body temperature, Chills, Dizziness
Clinical narrative: she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hunger, Myalgia, Pain
Clinical narrative: she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: she was hospitalized due to a stroke; This is a spontaneous report from a contactable nurse (patient herself). An 81-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in arm at age 81 years on 24Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 vaccination. Medical history was reported as none. Patient had not had any other recent vaccinations. The concomitant medication includes an unspecified medication since she started a new cancer drug that starts with a L.Registered nurse calling as patient says she was supposed to have her second Pfizer COVID-19 shot 17Mar2021, but she was in the hospital. She says she is trying to reschedule her second shot. She says the first dose was given at (Hospital Name), and it says BNOI on her vaccine card. Patient was admitted to the hospital this past Monday evening (15Mar2021) and it was (Hospital name). She says her admitting diagnosis was unknown. She says she was discharged from the hospital Thursday 18Mar2021. Hospitalization seriousness patient says it was not serious. Patient missed the 2nd dose (17Mar2021) because she was hospitalized due to a stroke on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of stroke.  The reported event likely represent intercurrent medical condition in this elderly patient.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Pain in extremity
Clinical narrative: didn't believe they actually put anything in my arm. It's just starting to hurt now; syringe snapped and my arm was sprayed with liquid; syringe snapped and my arm was sprayed with liquid; so not knowing if any at all went in my arm I asked them to redo it. They finally did; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the arm on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The facility where the patient was vaccinated was unknown. It was unknown if the patient received other vaccine in four weeks. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her 2nd Pfizer vaccine today (19Mar2021). Unfortunately, and nothing to do with the vaccine, it didn't go so well. The syringe snapped and her arm was sprayed with liquid, so not knowing if any at all went in her arm she asked them to redo it. They finally did but until a few minutes ago she didn't believe they actually put anything in her arm. It was just starting to hurt now. She thinks with mass vax sites there are a lot of people who are dolling out medical advice and they shouldn't. And in this case today, no one knew what they should actually do. The patient stated "Concerning but hopefully I feel some side effects to know I got some good juice in my arm!". It was unknown if the patient received treatment for the events. It was also unknown if the patient had COVID prior to vaccination and if the patient was tested for COVID post vaccination. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: she was getting soreness in her muscles that continued throughout the night; neck was becoming sore with some pain in her collarbone area; her warm was "very, very" sore and could not even lift it; feeling like "swollen jelly gland" and "pea size."; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported, expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included endometrial cancer, COVID-19 twice - once in May where she was asymptomatic and the second time in July, respiratory disorder where she had "every symptoms but respiratory problems" and was subsequently hospitalized and given steroids. The patient's concomitant medications were not reported.  The patient experienced little sore, getting soreness in her muscles (myalgia) on the day of vaccination, neck was becoming sore with some pain in her collarbone area, her arm was very, very sore and could not even lift it (pain in extremity), feeling like swollen jelly gland and pea size. (lymphadenopathy) on the next day of vaccination with the outcome of unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Illness, Pain, Pyrexia
Clinical narrative: She stated that she had corona virus and got the first dose of the Pfizer Covid vaccine.; got very sick; body ache; chills; high fever; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that the patient had corona virus and got the first dose of the Pfizer Covid vaccine. On an unspecified date, the patient got very sick, body ache, chills and high fever within 48 hours. The consumer asked if the patient could get the second dose of the Pfizer Covid vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization, and paracetamol (TYLENOL) on 18Mar2021 for unknown indication. Medical history and concomitant drug were not reported. The patient reported that she received the second dose of the vaccine last Thursday 18Mar2021. She had a headache today (23Mar2021). She went for emergency dental work right the next morning of her vaccine appointment. She took paracetamol 2 hours before receiving the vaccine and the nurse told her shouldn't have. It also stated in the fact sheet not to take paracetamol before getting the vaccine. The patient asked that did she need to restart the vaccination series again? Caller states that it made her suspicious because she had no symptoms at all after receiving the vaccine." The outcome of the event was unknown.   Information on the lot number and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Full blood count, Pain, Pyrexia
Clinical narrative: aches/pains; low grade fever around 100; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. Reporter's wife got her first shot 4 weeks ago and the last two weeks she has had aches, pains, low grade fever around 100. She has had 4 Covid tests, chest x ray for pneumonia, a blood panel. X ray and blood panel were negative. Advil and Tylenol is what suppresses the temperature. She was scheduled for the second shot last Thursday. She keeps moving it back and it's supposed to be this going this Thursday. The doctor advised not to take the second shot because her symptoms may have come from the first shot. Event outcome of low grade fever around 100 was recovered, of the remaining was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: aches/pains; low grade fever around 100; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. Reporter's wife got her first shot 4 weeks ago and the last two weeks she has had aches, pains, low grade fever around 100. She has had 4 Covid tests, chest x ray for pneumonia, a blood panel. X ray and blood panel were negative. Advil and Tylenol is what suppresses the temperature. She was scheduled for the second shot last Thursday. She keeps moving it back and it's supposed to be this going this Thursday. The doctor advised not to take the second shot because her symptoms may have come from the first shot. Event outcome of low grade fever around 100 was recovered, of the remaining was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: It hurt a little where the shot was; there is a slight lump; still warm; This is a spontaneous report from a contactable 76-years-old female consumer reported for herself that she received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 11Mar2021, as single dose in left arm for covid-19 immunization. Medical history included neurological condition (she is unable to receive vaccine in her right arm). Concomitant medications were not reported. On an unspecified date in Mar2021, the patient had it hurt a little where the shot was and there was a slight lump, and it was still warm. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: It hurt a little where the shot was; there is a slight lump; still warm; This is a spontaneous report from a contactable 76-years-old female consumer reported for herself that she received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 11Mar2021, as single dose in left arm for covid-19 immunization. Medical history included neurological condition (she is unable to receive vaccine in her right arm). Concomitant medications were not reported. On an unspecified date in Mar2021, the patient had it hurt a little where the shot was and there was a slight lump, and it was still warm. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: muscle pain under her rib cage and sides; Chills; This is a spontaneous case received from a contactable female consumer(patient) A 63-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown), via an unspecified route of administration for COVID-19 immunization. On 16-MAR-2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 19 MAR 2021 patient experienced muscle pain under her rib cage and sides and chills. The caller would like to know if this is normal to experience these side effects a couple days after receiving the vaccine. How long will the side effects last and what can be done about the side effects. The outcome of event was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Sore throat; Fever; Headache; Feeling unwell; Achiness; Fatigue; Swollen lymph nodes; Chills; Sore arm; Congestion; This is a spontaneous report received from contactable female consumer (patient herself). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 03Mar2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A day after vaccination, patient experienced sore throat, fever, headache, feeling unwell, achiness, fatigue, swollen lymph nodes, chills and sore arm. Patient currently had sore throat and congestion and was getting better now. The second dose of patient scheduled on 31Mar2021, and wanted to postpone the second dose as her husband will have a heart surgery pacemaker on the following day - She does not want to feel sick since she will take care of her husband post-surgery. The outcome of events Sore throat and Congestion were recovering and for other events outcome was unknown.  Information on lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore throat; Fever; Headache; Feeling unwell; Achiness; Fatigue; Swollen lymph nodes; Chills; Sore arm; Congestion; This is a spontaneous report received from contactable female consumer (patient herself). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 03Mar2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A day after vaccination, patient experienced sore throat, fever, headache, feeling unwell, achiness, fatigue, swollen lymph nodes, chills and sore arm. Patient currently had sore throat and congestion and was getting better now. The second dose of patient scheduled on 31Mar2021, and wanted to postpone the second dose as her husband will have a heart surgery pacemaker on the following day - She does not want to feel sick since she will take care of her husband post-surgery. The outcome of events Sore throat and Congestion were recovering and for other events outcome was unknown.  Information on lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on Thursday and developed a headache on Saturday. Outcome of the event was unknown. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Hypoaesthesia oral
Clinical narrative: her bottom lip went numb.; right eye twitched for about 0.5 minute; This is a spontaneous report from a non-contactable consumer (patient herself) of 53-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot number were not reported, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. About 11.5 hours after vaccination the patient experienced right eye twitched for about 0.5 minute and her bottom lip went numb. She reported her lip continues to remain numb on 23Mar2021. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID virus; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, COVAX US Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), via an unspecified route of administration on 02Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of COVID-19 vaccine on 02Mar2021, but last 12Mar2021, she tested positive for COVID virus. She was scheduled to receive her 2nd dose on 23Mar2021, but she wanted to know if she could get it or if she needs to reschedule it since she has COVID virus. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on the arm in Mar2021.  The patient was referred to a healthcare professional for treatment. 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-2021324105 same reporter/drug, different patient/events
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vomiting
Clinical narrative: he had severe chills, 101.7 F; He has been very fatigued and in bed all day; threw up small amount of fluid twice and then everything came up; This is a spontaneous report from a contactable consumer (patient's husband). A 88-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received second dose on Sunday. Monday evening after dinner he had severe chills, 101.7 F, his wife gave him some acetaminophen (TYLENOL). The patient threw up small amount of fluid twice and then everything came up. The patient went to bed from 11:30pm, woke up at 8am and had a temperature of 99.4 F. He took morning pills and fruit juice, and one spoon of oatmeal and some glasses of water. He had been very fatigued and in bed all day, which was not like him. He was usually very active. The outcome of events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 at the age of 73-year-old at SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020. Concomitant medications were reported as none. Patient mentioned she had COVID-19 last Dec2020, received the Pfizer-BioNTech COVID-19 Vaccine first dose this Mar2021. Patient reported to have the "normal reaction" of the vaccine (fever, chills, muscle ache). Patient mentioned that she saw doctors on TV that said it would be okay to not get the second dose if had COVID-19 before and experienced the "normal reaction" to the vaccine. Patient was seeking information on this. Treatment was received for fever, chills, muscle ache. Outcome of events was unknown.  Information on Batch/Lot number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 at the age of 73-year-old at SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020. Concomitant medications were reported as none. Patient mentioned she had COVID-19 last Dec2020, received the Pfizer-BioNTech COVID-19 Vaccine first dose this Mar2021. Patient reported to have the "normal reaction" of the vaccine (fever, chills, muscle ache). Patient mentioned that she saw doctors on TV that said it would be okay to not get the second dose if had COVID-19 before and experienced the "normal reaction" to the vaccine. Patient was seeking information on this. Treatment was received for fever, chills, muscle ache. Outcome of events was unknown.  Information on Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeding disorder, Somnolence
Clinical narrative: Heavy chills; Very weak; Could not eat; Asleep all day long, could not seem to wake up; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 19Mar2021 at 17:30  (last Friday night) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller mentioned she had the reverse problem. Caller mentioned that she fell asleep around 8 PM, and the next morning, reported to have experienced heavy chills, very weak; could not eat, asleep all day long and could not seem to wake up. Caller was asking if those were normal effects of the vaccine. Offered to transfer to Safety, but caller declined. Caller mentioned that she tried calling on Sunday but had the same recording and was not able to make it through the queue. Referred to HCP for further guidance. Patient questioned if vaccine have the virus. Caller mentioned that she did had it for a month. Patient questioned if the second dose more potent. Explained to caller that it would be the same dose, quantity and ingredients, and explained to caller that there are many factors to consider, gave disclaimer, and referred to HCP for further guidance. No PQC was present. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: There is at least between teaspoon and tablespoon of blood that has leaked out on to my ban; This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date as a single for COVID-19 immunization. The patient's medical history was not reported. The patient's historical vaccinations include having had a flu shot on an unspecified date "that didn't go in right ." The patient's concomitant medications were not reported. She explained further  that, "on Wednesday (also reported as "Thursday"), my husband and me got our first vaccine. When we took out bandage off he has no blood and I had a tablespoon of blood on my bandage ." She described this as "at least between teaspoon and tablespoon of blood that has leaked out on to my bandage." She added further that "neither one of us has had any symptoms or whatsoever on our first vaccine." The outcome of the event between a teaspoon a tablespoon of blood on bandage was unknown. Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing; the patient takes one medicine (unspecified medication) like once in a while of anxiety. The patient experienced pain in heart, it beats so fast in Mar2021 with outcome of unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I woke up in the middle of the night with a very high fever/ temperature of 101.5; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206 and expiration date not provided) via an unspecified route of administration on 20Mar2021 14:45 as a single dose for COVID-19 immunisation. Medical history included asthma and fibromyalgia. Concomitant medications included albuterol (SALBUTAMOL), oxcarbazepine (TRILEPTAL), sertraline hydrochloride (ZOLOFT), clonidine (CATAPRES) and artemether, lumefantrine (LUFART). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient received her second dose of the vaccine on 20Mar2021 and she woke up in the middle of the night (on 21Mar2021) with a very high fever. The temperature was perfectly fine before the vaccine and she wake up at around 4 oclock this morning (21Mar2021) with a temperature of 101.5 and it still hasn't gone down. She thought she should call and report it. No treatment was given in response to the event. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Drug ineffective, Ear infection
Clinical narrative: retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that:  "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea.  No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit.   Further information needed, further information expected.