chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposed to COVID 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (Herself and her partner). This is 1st of two reports. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. It was reported that she and her partner received their first dose of the Pfizer COVID vaccine on 28Jan2021. Caller states they are both scheduled to receive their second dose on 18Feb2021. Caller states on this past Saturday night her granddaughter was there with them and she left this morning and her daughter called her and told her that somebody at her office tested positive for COVID. Caller states that someone who had tested prior and was negative also tested positive for COVID. Caller states she was unsure if her granddaughter being present in the house has exposed them to the virus. Caller would like to know if she should receive the second dose of the vaccine on 18Feb2021 if she was exposed to COVID 19. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201340 Same Vaccine/event, different  patient
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Slight arm soreness and headache; Slight arm soreness and headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 1st of 2nd report.  A 73-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05Mar2021 02:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunization.  The patient's medical history and concomitant medica-tions were not reported. He took her dose 1 Caller, and her husband had the first dose via an un-specified route of administration, administered in Arm Right (Batch/Lot Number: EN6200) as sin-gle dose for covid-19 immunization.  Caller and her husband had the first dose vaccine on 12Feb and are scheduled to have the second dose on 12Feb2021 2:15 She called the vaccination site and they told her that they could only be given the vaccine at the end of Mar. She is concerned since it will be 6 weeks after the first dose rather than 3 weeks. Is it ok. Had the first dose on 12Feb2021 and scheduled to get the second dose on 15Mar2021 but the caller stated that she tried to call the facility to confirm it, but the available date for her to take the second dose will be by the end of Mar as per the Facility. Caller and her husband had the first dose of the vaccine. she stated that her husband and herself both got the shot on the same day and experienced slight arm soreness and headache on Mar2021. The outcome of the events was recovered on Mar2021  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021201092 Same Vaccine/event, different  patient
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP follow-up letter sent in cross reference case. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EK7176) second dose via an intramuscular, administered in right arm on 08Jan2021 at 15:50 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 18Dec2020 at 15:50 (Batch/Lot no: EH9899) as single dose for COVID-19 immunization and experienced headache and fatigue. On 09Jan2021 at 08:00, the patient experienced headache and fatigue. The patient reported that the events recur on re-administration of product and provided the time lag from stop date as 12 hours post 2nd injection. The reporter considered a reasonable possibility that the event is related to suspect product. The outcome of the events was recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: in a contact with a distant relative who tested positive to COVID-19; cough; sore throat; This is a spontaneous report from a contactable consumer (Patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID Prevention (age at vaccination was 24 years). She does have regular allergies, her whole family does, so she gets sick easily and it is not abnormal for her. She had no other vaccines on the same days as her doses of the COVID vaccine. Patient received concomitant therapy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for COVID-19 immunisation (age at vaccination was 24 years). The patient reported that She explained she was in a contact with a distant relative who tested positive to COVID-19 therefore, she got tested for COVID-19 and spent 10 days in quarantine. She specified her test result came back "inconclusive". She works at a shelter service. Patient got her second dose of the COVID vaccine on 26Jan2021, and last week, patient's husband received a text from his daughter's mom, saying that their house has tested positive for COVID. Patient's husband is in healthcare. They were both fully vaccinated, but her worker put her on quarantine. She went to get tested for COVID on Tuesday of last week and her husband tested negative but her test was inconclusive. Patient stated that a couple days after she got the COVID test, she started with a cough and sore throat on an unknown date in Feb2021 and she had that for a few days. She did also develop a cough and sore throat for a few days following her COVID test. She had her COVID test on 09Feb2021 and it came back inconclusive, she indicated it was not a rapid test, but she does not know the official name for the test she got, it was a drive through nasal swab test. Outcome of events cough and sore throat was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she experienced pain on the right arm after the first dose.; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, she experienced pain on the right arm after the first dose. (pain in extremity). The Caller is scheduled for her second dose on the 22Feb and asking if it's safe to take Tylenol for the fever. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Nipple pain, Nipple swelling
Clinical narrative: had swelling around left nipple area; had tenderness around left nipple area; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL03249, NDC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 14Jan2021 at 10:40 in left arm as a single dose for covid-19 immunization. Patient received the second dose on 4Feb2021. There was no medical history reported. There was no history of previous immunization with the Pfizer vaccine. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no AE following prior vaccinations. Caller wanted to report a side effect from his first Pfizer dose. After 2-3 weeks the first dose, patient had swelling around the left nipple area and tenderness and wanted to know if this was a side effect. Clarified that it is for the Pfizer Covid 19 shot. AE did not require a visit to Emergency Room/Physician Office. There were no relevant tests done. Outcome of the event swelling around left nipple area was recovering while that of tenderness around left nipple area was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Supraclavicular lymphadenopathy noticed; Generalized blanching rash covering thighs abdomen chest and arms,around 24 hours after the second dose resolved within a day; This is a spontaneous report from a contactable Physician (patient) A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 13-FEB-2021 12:45 at single dose for COVID-19 immunization. Patient historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 23Jan2021,10:30 at single dose for COVID-19 immunization. medical history included Autoimmune urticaria. concomitant medication include Antihistamine. On 14Feb2021 13:00 patient experienced Generalized blanching rash coveringthighs abdomen chest and arms, around 24 hours after the second dose resolved within a day.Supraclavicular lymohadenopathy noticed 72 hours after. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19.The outcome of event was Recovering/Resolving.  Information on the lot/batch number has been requested
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pruritus, Swelling
Clinical narrative: Headache; Chills; Tired; Itching; Swelling at site of filler; This is a spontaneous report received from a contactable consumer (reporting on herself). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number: el9262 and Expiry date was not reported), via an unspecified route of administration in Arm Left on 28Jan2021 09:30 as single dose for COVID-19 immunization. Medical history included Very Slight to shrimp and other shellfish, other medical history none. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), in Left Arm on 07Jan2021 09:30 for COVID-19 immunization. Concomitant medication(s) included thyroid (ARMOUR THYROID); bupropion hydrochloride (WELL-BUTRIN) both taken for an unspecified indication, start and stop date were not reported. Patient did not have covid prior vaccination. Patient did not receive vaccine in four weeks. It was reported that patient experienced headache, chills, Tired, Itching-Swelling at site of filler-tired. The patient did not received any treatment for adverse events. Patient was not tested covid-19 post vaccination. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Throat irritation
Clinical narrative: throat was itching; Tested positive for virus 10 days after receiving 1st dose.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On 10Feb2021,The patient tested positive for virus 10 days after receiving 1st dose and her throat was itching.The patient underwent lab tests and procedures which included SARS-CoV-1 test:positive on 10Feb2021. The outcome of events were unknown.  Information on the Lot/Batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 but got COVID-19; Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 but got COVID-19; This is a spontaneous report from a contactable pharmacist from Pfizer sponsored program. A 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 (at 82-years age) as SINGLE DOSE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. After receiving the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 patient got COVID-19 and asked when was it recommended for him to get their second dose. Caller mentioned she was advised to transfer. Offered transfer and Caller accepted. Unsuccessful transfer due to long hold time. Caller preferred the online safety reporting tool instead. Call transferred. Pharmacist. Has questions about covid vaccine. Wants to know on when antibodies go into system. And if patients get 1st dose of covid vaccine and then test positive for covid virus when do they received 2nd dose. Clarified if knows anyone who has tested positive after 1st dose, said yes but unsure if it was Pfizer or Moderna vaccine, also doesn't know anyone with antibody issue or needing testing. Relayed number. Cold transferred due to hold time. Will fax into. 159558. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow up (17Feb2021): This is a spontaneous report received from Pfizer sponsored program. A contactable pharmacist reported no new reported for patient.; Sender's Comments: Based on the information provided, the causality between the event and the suspect drug cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test positive for Covid-19; Test positive for Covid-19; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E11284 and expiration date was not reported) via an unspecified route of administration in arm on 09Feb2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E11284 and expiration date was not reported) via unspecified route of administration in right arm on 19Jan2021 both as single dose for COVID-19 immunisation. The patient medical history included allergy to morphine and adhesive. Concomitant medications were not reported. The patient was on other medications within two weeks prior to vaccination. Patient did not take other vaccine within four weeks prior to vaccination. On 11Feb2021 the patient tested positive for Covid-19. The patient did not have covid prior to vaccination and had tested for covid post vaccination. The patient underwent lab test which included SARS-COV-2-PCR on 11Feb2021 and results positive. The outcome of the event was unknown.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mother) that: Caller submitted her mother's information and where it was given online. The lot number on the card is E11284 or EL1284 or EI1284. Given on 19Jan2021 and the second one was given on 09Feb2021.  Information about lot and batch number was requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Somnolence
Clinical narrative: sleepy; cold; achy; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female (Non pregnant) patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, formulation: Solution for injection, lot number: EN6201, Expiration date; unknown), in the left arm on 15Feb2021 at 15:00 pm, at a single for COVID-19 immunization at doctor's office/urgent care. Patient medical history included unspecified chronic health conditions. Patient concomitant medication was not reported. Patient took unspecified other medications in two weeks. Patient had known allergies. On 15Feb2021 at 17:00 PM, the Patient became very sleepy had cold and achy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events were not treated. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the post vaccination. The outcome of the events was recovering.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discomfort
Clinical narrative: his arm is hurting; he experienced injection site discomfort during administration of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Medical Information Team. An 87-years-old male patient (Husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in left arm on 14Jan2021 and second dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left arm on 04Feb2021 at 17:30 both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Feb2021 05:30 pm, the patient experienced injection site discomfort during administration of the vaccine and on an unspecified date, patient experienced his arm is hurting. Reporter mentioned that the same thing happened on the first shot. Outcome of the events was resolved on unspecified date in 2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastrointestinal pain, Headache, Injection site pain
Clinical narrative: site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 10Feb2021 at 11:45(at the age of 77-year-old ) as a single dose for COVID-19 immunization. Patient medical history included asthma, some mild arthritis, osteopenia. Concomitant medications included Mometasone Furoate(ASMANEX) (MANUFACTURER UNKNOWN), Esomeprazole sodium (NEXIUM) (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN),  (FLUTICASONE), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, on the 2nd and 3rd day, the patient experienced site pain, tiredness, headache.   On the 6th day, the patient experienced chills without fever, tiredness, unwell/sourgut, headache. The outcome of the events was Recovered on an unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Weight
Clinical narrative: borderline crazy; This is a spontaneous report from a contactable consumer (Patient). A 92-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration in Arm Left on an Unspecified date in Jan2021 as single dose for covid-19 immunisation. Patient did not take other vaccine within 4 weeks prior of vaccination. Medical history included and concomitant medications. The patient experienced borderline crazy. The patient underwent lab tests which included weight: pounds is close enough. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: second dose on 27Jan. Caller stated on 11Feb she was tested positive for covid.; second dose on 27Jan. Caller stated on 11Feb she was tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer . A 90 (age unit unknown) old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route of administration on 06Jan2021 and 27Jan2021 respectively both at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient reported that she received her first dose of the Pfizer covid vaccine on the 6Jan2021, second dose on 27Jan2021 and 11Feb2021 she was tested positive for covid. She wanted to know if she can go see her family, will she be contagious after being quarantined for 10days. Reporter assessed the case as non-serious. There was no PQC present. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Headache, Hypotension
Clinical narrative: low blood pressure for a few days; Lymph node swelling left side below collarbone; Mildly more tired; slight headache; slight chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.     A 68-years-old Non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809, Expiry date: 30Jun2022) via an unspecified route of administration, administered in left arm on 04Feb2021 at 15:00 as SINGLE DOSE for covid-19 immunization. The patient medical history included atrial fibrillation, ventricular tachycardia, cardiac pacemaker insertion, essential hypertension. The patient was allergic to Propafenone 150mg critical, Penicillin, and related antibiotics i.e., Lincosin serious, sulfa drugs, Statins, any products with alcohol taken internally, MSG, asprin sensitivity (ears ring, nose red), antihistamine sensitivity. The patient's concomitant medications included metoprolol ER 50mg, losartan 50mg and furosemide 20mg.  The patient did not take any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced, lymph node swelling left side below collarbone next day for several days, mildly more tired, slight chills and low blood pressure for a few days, slight headache and low. Due to events the patient had consulted physician (Doctor or other healthcare professional office/clinic visit). Events were not treated. The outcome of the events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: low blood pressure for a few days; Lymph node swelling left side below collarbone; Mildly more tired; slight headache; slight chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.     A 68-years-old Non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809, Expiry date: 30Jun2022) via an unspecified route of administration, administered in left arm on 04Feb2021 at 15:00 as SINGLE DOSE for covid-19 immunization. The patient medical history included atrial fibrillation, ventricular tachycardia, cardiac pacemaker insertion, essential hypertension. The patient was allergic to Propafenone 150mg critical, Penicillin, and related antibiotics i.e., Lincosin serious, sulfa drugs, Statins, any products with alcohol taken internally, MSG, asprin sensitivity (ears ring, nose red), antihistamine sensitivity. The patient's concomitant medications included metoprolol ER 50mg, losartan 50mg and furosemide 20mg.  The patient did not take any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced, lymph node swelling left side below collarbone next day for several days, mildly more tired, slight chills and low blood pressure for a few days, slight headache and low. Due to events the patient had consulted physician (Doctor or other healthcare professional office/clinic visit). Events were not treated. The outcome of the events was recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes on the right side of my neck on the 4th day after the first dose of vaccine. This rash has gone worse the next day, going down the right side of my neck and also on my face, and forehead.; Rash is raised, red and some had small yellow pinpoint in the center that was very itchy .; Rash is raised, red and some had small yellow pinpoint in the center that was very itchy .; This is a spontaneous report from a contactable Nurse. This 65-year-old female (non-pregnant) nurse reported for herself she received first dose of BNT162B2 (solution for injection, lot number: EL1283, Expiration date; unknown), in right arm on 10Feb2021,13:00 pm at single dose for COVID-19 immunization. Patient medical history included Left Stage 3 Breast Cancer in Feb2020, mild hypertension. Concomitant medications included Losartan and Amlodipine, Vitamin C and D3.Patient had no known allergies. The patient was not tested for COVID-19 since the vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.On 14Feb2021 06:00 am, the patient experienced rashes on the right side of my neck on the fourth day after the first dose of vaccine. This rash has gone worse the next day, going down the right side of my neck and on my face, and forehead. Rash is raised, red and some had small yellow pinpoint in the centre that was very itchy. Patient not received treatment for the events. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Injection site pain; Body Ache; Tiredness/Exhaustion feeling; This is a spontaneous report from a contactable consumer (patient).  A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration in right arm on 17Feb2021 at 08:30 pm as single dose for COVID-19 immunization. The patient medical history included hypertension, blood cholesterol and overweight. There were no known allergies to patient. there was no COVID prior vaccination. The concomitant medications included metoprolol, simvastatin and amlodipine. On 18Feb2021, the patient experienced injection site pain, body ache, tiredness/exhaustion feeling. Patient did not receive any treatment for adverse event. There was no COVID tested post vaccination. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 10Mar2021 at 08:15 am as single dose for COVID -19 immunization. The outcome of the events was not recovered.  No follow-up attempts possible. No furthermore information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (Herself and husband). This is a 1st of 2 reports. This 70-year-old female consumer (patient) reported for herself. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported) via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The caller says that she had her first vaccine shot and was ready to get her second shot but she got the COVID week after first dose in 2021. She says that she had her appointment for on the second, then on the first she tested positive. Caller says something about her husband and daughter two days later, and a week after. Unable to clarify with caller due to poor sound quality and caller speaking over call handler. She says her question was can she get the second dose of the vaccine still and how soon she can get it. She says her husband is 84, and she is 70, and they had very mild symptoms, so she thinks the vaccine helped them, which her daughter had it worse. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021180363 same reporter/vaccine/AE, different patients
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: felt very tired/became tired then more tired; was very cold/very cold for 6-7 hours; Chills; Lethargic; her temperature and it was 100.8; slept most of day; no appetite; pain where the shot was given; arm hurt more, it had hurt through the night; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 06Feb2021 10:15 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced pain where the inoculation was given in the left upper arm started on that day but got worse the next day. She explains that the next day when she woke up at 7:30 am she felt ok but then at 10 am she felt very tired and noticed her arm hurt more, it had hurt through the night. She was very, very tired and then about 10:30 am she was very cold. She had fireplace and electric heater on plus had 2 blankets on her. She asked her husband to go to the car to get her winter gloves and she was wearing scarf. This lasted 6 hours before it resolved. Her husband took her temperature, and it was 100.8. It was reported that she had no appetite during the day. Upon follow-up (16Mar2021), was reported that, 24 hours after first dose of Pfizer chills started, become tired then more tired; then slept most of day. Fever occurred throughout the day topping at 100.3 and was very cold for 6-7 hours, with 2 blankets, scarf, winter gloves while lounging in front of fireplace, plus small electric heater. The patient underwent lab tests and procedures on unspecified date which included body temperature:100.8. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site pain, nasopharyngitis, decreased appetite and upon follow-up the events chills, slept most of the day, lethargic, fever was recovered and outcome for fatigue was recovering and unknown for Pain in extremity.  Follow-up (16Mar2021): this follow-up information was received from a contactable consumer and the new information reported includes, additional events was provided along with the onset date and time.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: felt very tired/became tired then more tired; was very cold/very cold for 6-7 hours; Chills; Lethargic; her temperature and it was 100.8; slept most of day; no appetite; pain where the shot was given; arm hurt more, it had hurt through the night; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 06Feb2021 10:15 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced pain where the inoculation was given in the left upper arm started on that day but got worse the next day. She explains that the next day when she woke up at 7:30 am she felt ok but then at 10 am she felt very tired and noticed her arm hurt more, it had hurt through the night. She was very, very tired and then about 10:30 am she was very cold. She had fireplace and electric heater on plus had 2 blankets on her. She asked her husband to go to the car to get her winter gloves and she was wearing scarf. This lasted 6 hours before it resolved. Her husband took her temperature, and it was 100.8. It was reported that she had no appetite during the day. Upon follow-up (16Mar2021), was reported that, 24 hours after first dose of Pfizer chills started, become tired then more tired; then slept most of day. Fever occurred throughout the day topping at 100.3 and was very cold for 6-7 hours, with 2 blankets, scarf, winter gloves while lounging in front of fireplace, plus small electric heater. The patient underwent lab tests and procedures on unspecified date which included body temperature:100.8. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site pain, nasopharyngitis, decreased appetite and upon follow-up the events chills, slept most of the day, lethargic, fever was recovered and outcome for fatigue was recovering and unknown for Pain in extremity.  Follow-up (16Mar2021): this follow-up information was received from a contactable consumer and the new information reported includes, additional events was provided along with the onset date and time.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication's included raloxifene hydrochloride (EVISTA), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. Patient stated that she wanted to know if the drugs interact with the Pfizer Covid vaccine. Stated that the drugs she took were Evista and Crestor. Wanted to know if she could take an Excedrin if she got a headache the next day. Patient stated that she had one dose of the vaccine already and got a headache two days later. Stated she gets headaches in the morning anyway. Stated that she was not sure that the headache was from the vaccine. The outcome of the event was unknown.  Information on lot/ batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: existing auto immune condation; This is a spontaneous report from a contactable nurse (Patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer BioNTech, COVID 19, solution for injection, lot number: unknown, Expiration date; unknown), in right arm on 23Dec2020, 12:00 PM at single dose for COVID-19 immunization. Patient medical history included rheumatoid arthritis. Concomitant medications included losartan. Patient had allergies to penicillin. After the first vaccination patient noticed a slight change. Patient also had existing auto immune condition on 24Dec2020. Patient received steroids as treatment for adverse event. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient's wife). A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, weeks after the first dose, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The reporter classified the event as non-serious. The outcome of the events was unknown.  Information regarding Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021178604 same reporter/vaccine/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: fatigue; Sore arm; low appetite; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient fatigue, sore arm, and low appetite. Clinical outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program CEP/PSP ID: 159558.  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Formulation: Solution for injection, Lot# UNKNOWN), via unspecified route of administration on 04Feb2021 (at the age of 73 years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Feb2021, patient tested positive for COVID-19. The patient underwent lab test which included SARS-COV-2 Test: Positive on 13Feb2021. Patient was told by the health department that he needs to remain in isolation for 10 days. Patient was scheduled for his second dose of the Pfizer COVID-19 vaccine on 25Feb2021 and would like to know if he will be able to receive his second dose of the Pfizer COVID-19 vaccine on the scheduled appointment date.   Information of lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Her results were negative; 'chills and fever' nonstop until today and it is getting worse; chill; This is a spontaneous report from a non-contactable consumer via medical information team. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: not reported) via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation. On the night of 14Feb2021, the patient started to feel chills and fever nonstop until today and it was getting worse. The patient took a covid test, because during the week before the patient had been receiving physical therapy and they suspected that she had been infected. The results were negative. The doctor asked them to go to the ER for treatment. The patient did not lost taste or smell. The patient underwent lab tests and procedures which included oxygen levels have been between 95-97% and only once did it go down to 93%. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: headache; nausea; fatigue; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the second dose BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 57-year-old as reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, nausea, and fatigue after receiving the second dose of the vaccine on unspecified date. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Shot 1 - left arm ached 2 days; 5 days later diarrhea for a few days; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 01:15 PM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoporosis, sleep apnoea, reflux. Concomitant medication included VITAMIN D [VITAMIN D NOS], Multi Vitamin and omeprazole (PRILOSEC [OMEPRAZOLE]) at once a day taken for an unspecified indication. It was reported that after Shot 1 in left arm ached 2 days, 5 days later diarrhea for a few days. Outcome of the events was recovered on unspecified date.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A 70-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he had his first shot on 03Feb2021 and scheduled for the second one on 25Feb2021. After a day, he kind of got sick for a whole week. He run a test, and came out to be positive, that was after one week of the shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211673 same reporter, product and AE, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: fever began with chills/temp of 100; sore arm; didn't feel well; fatigue; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EL19581) via an unspecified route of administration in right arm on 10Feb2021 09:15 AM at single dose for COVID-19 immunization. Medical history included High blood pressure and moderate cholesterol. Patient has no known allergies. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included CRESTOR (rosuvastatin calcium) 10mg, losartan, ASA (acetyl salicylic acid) 81 mg, PROTINIX (omeprazole) 40mg (all received in two weeks). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EL3249) in right arm on 27Jan2021 at single dose at the age of 74 years for COVID-19 immunization. The patient experienced extremely sore arm, didn't feel well and fever began with chills 12 hours after 2nd injection on 10Feb2021 at 09:15 AM. All night and next day, fever and fatigue treated with Tylenol and one Aleve taken mid day. She usually run a subnormal temp, so subnormal temp so a temp of 100 (unit not provided) was bothersome to her especially with chills. The patient was not diagnosed with COVID-19 post to vaccination. The outcome of events was recovered in 2021.  Information about lot/ batch number has been updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: arms were tingling; Temporary numbness in left hand.; This is a spontaneous report received from a contactable consumer (patient) reporting on himself. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: em9810), via an unspecified route of administration on 12Feb2021 09:45 (at the age of 75-year-old) as SINGLE DOSE in Right arm for covid-19 immunization. The patient had no relevant medical history and no known allergies and have no concomitant medications. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient had no covid infection. On 12Feb2021, the patient had temporary numbness in left hand, approximately in 20 minutes, his hand returned to normal after event. The patient couldn't do anything with his hand and his arm was not effected. It hasn't happened again, two days later, on 14Feb2021, the patient had second event. He woke up at 4:45 AM both fore arms were tingling between the wrist and elbow. The tingling was sufficient to wake him up. It only lasted around 15 minutes. It has not reoccurred. The patient did not receive any treatment for the events. Post vaccination, the patient was not tested for covid. The outcome of event hypoaesthesia was recovered on 12Feb2021 and the outcome of event paraesthesia was recovered on 14Feb2021 at 05:00.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Nephropathy
Clinical narrative: kidneys and heart disease; kidneys and heart disease; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a male patient of an unspecified age (Age: 70; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced kidneys and heart disease on an unspecified date. Outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.