chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: fully vaccinated father died from COVID-19 / lack of efficacy; fully vaccinated father died from COVID-19 / lack of efficacy; This is a spontaneous report from a non-contactable consumer. This consumer reported for an adult male patient received bnt162b2 (COVID-19 vaccine), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced lack of efficacy. The reporter's fully vaccinated father died from COVID-19. The patient died on an unspecified date. It was not reported if an autopsy was performed. Doctors said the condition of the father could have been worse if he was not vaccinated at all.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fully vaccinated father died from COVID-19 / lack of efficacy; fully vaccinated father died from COVID-19 / lack of efficacy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Menstruation irregular, Muscle spasms, Ovarian cyst
Clinical narrative: it felt like my ovaries were on fire; horrible cramps; Two days later I was on my kitchen floor in pain; Had cyst on my ovaries; monthly cycle has been irregular since. Severe bloating and random periods; Brain fog is huge as well; This is a spontaneous report from a contactable Other HCP. This 37-year-old female Other HCP (patient) reported for self that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL9265), dose 1 via unspecified route in left Arm on 28Jan2021 16:30 as dose 1, single for COVID-19 immunization (age at time of vaccination 37 years). The patient medical history was none, and concomitant medications were not reported. The patient was not taking other vaccine in four weeks and also did not take other medications in two weeks. The patient did not have COVID prior vaccination and she was COVID tested post vaccination. On 28Jan2021 17:00 The patient experienced felt like her ovaries were on fire and horrible cramps. Two days later she was on her kitchen floor in pain. Went to several doctors and ended up at the gynecologist. Had cyst on her ovaries and went through several test to rule out fibroids. Her monthly cycle had been irregular since. Severe bloating and random periods. Brain fog is huge as well. The patient received treatment included Pap smears, ultrasounds. The patient had an allergy including Iodine, codeine. The outcome of all events was not recovered yet.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: it felt like my ovaries were on fire; horrible cramps; Two days later I was on my kitchen floor in pain; Had cyst on my ovaries; monthly cycle has been irregular since. Severe bloating and random periods; Brain fog is huge as well; This is a spontaneous report from a contactable Other HCP. This 37-year-old female Other HCP (patient) reported for self that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL9265), dose 1 via unspecified route in left Arm on 28Jan2021 16:30 as dose 1, single for COVID-19 immunization (age at time of vaccination 37 years). The patient medical history was none, and concomitant medications were not reported. The patient was not taking other vaccine in four weeks and also did not take other medications in two weeks. The patient did not have COVID prior vaccination and she was COVID tested post vaccination. On 28Jan2021 17:00 The patient experienced felt like her ovaries were on fire and horrible cramps. Two days later she was on her kitchen floor in pain. Went to several doctors and ended up at the gynecologist. Had cyst on her ovaries and went through several test to rule out fibroids. Her monthly cycle had been irregular since. Severe bloating and random periods. Brain fog is huge as well. The patient received treatment included Pap smears, ultrasounds. The patient had an allergy including Iodine, codeine. The outcome of all events was not recovered yet.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Got Vaccine on his left side and then feeling sore, like it hurts on his chest; This is a spontaneous report from a contactable consumer. This contactable consumer (Parent) reported for a male patient (reporter's son) of an unspecified age that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181, NDC Number, UPC Number, Expiry Date: Unknown), via an unspecified route of administration on Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got vaccine on his left side and then feeling sore, like it hurts on his chest on Aug2021. Reporter had a question, about the patient that he got Pfizer Covid vaccine 2 days ago on his left side and then he felt sore like it hurts on his (chest). The reporter wanted to know whether it was normal or not. Reporter stated that not on his hand, it hurts like on his chest. The outcome of event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected."
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Disease recurrence, Pulmonary embolism, X-ray
Clinical narrative: DVT in her right leg; DVT; multiple pulmonary embolisms; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), via an unspecified route on 06Feb2021 ((age at time of vaccination 78 years) as dose 2, single for COVID-19 immunization. The patient medical history included she had a blood clot DVT in 1950 during her first pregnancy. The concomitant medications were not reported. The historical vaccine included bnt162b2 dose 1, single via an unspecified route on 16Jan2021 for COVID-19 immunization. On 18Feb2021, she was hospitalized with multiple pulmonary embolisms in both lungs and DVT in her right leg. She was in the hospital for 2 days and discharged her on Eliquis that she is still taking. It had been a long time. She still have blood clot in her right leg. She was saw a hematologist and has seen multiple doctors. Hematologist says, she could not take the booster shot. Non-occlusive thrombus within distal right main pulmonary artery as well as occlusive and nonocclusive pulmonary emboli within the right upper middle and lower lobar segmental and sub segmental branches. Occlusive and nonocclusive pulmonary emboli within the lobar segmental and sub segmental branches of left lower lobe pulmonary artery. Occlusive and non-occlusive pulmonary emboli within the segmental and sub segmental branches of left upper lobe of pulmonary artery. The patient had x ray test on an unknown date in 2021 and result was unknown. The outcome of the events 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, Tinnitus, Vertigo
Clinical narrative: tinnitus; vertigo; dizziness; This is a spontaneous report from a contactable pharmacist. A 61-years-old female patient received second 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 Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 15Mar2021, the patient experienced tinnitus, vertigo, dizziness. Clinical Trial. A search of adverse events reported at 1 month after Dose 2 in the Pfizer-BioNTech COVID-19 Vaccine Phase 3 trial, which included 21,926 individuals who received vaccine and 21,921 individuals who received placebo, did not identify a safety signal. There were similar rates of tinnitus in those individuals who received the vaccine as those who received placebo injection.2. The outcome of the events was not recovered.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of tinnitus, vertigo, dizziness. 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: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on his stomach and back; This is a spontaneous report from a contactable consumer (patient sister). A 38-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET9096), via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter was calling on behalf of her 38-year-old brother who had the first dose of the Pfizer Covid-19 vaccine on 04Aug2021 and on 13Aug2021 started seeing shingles on his stomach and back. The reporter was asking if her brother can get the second dose of the Pfizer Covid-19 vaccine due to the above complaints. Outcome of the event was unknown.  Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: extremely ill; had a severe case of COVID-19; This is a spontaneous report from a contactable consumer A 63-year-old male patient (consumer husband) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)) via an unspecified route of administration on Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller speaking on behalf of her husband (patient). Caller stated that her husband received the first dose of the Pfizer-BioNTech COVID-19 Vaccine in last March. Seven days later, he "became extremely ill", was brought to the hospital, had a severe case of COVID-19 and was in intensive care. Caller mentioned that his doctors and healthcare providers agreed that he should not get revaccinated until 3-4 months after. Caller stated that it would be around this time and asked if he needs to restart the vaccination series given. The outcome of the events was unknown.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died two weeks ago after his 2nd dose; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 Immunization. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The reporter knew their personal situation where a man died two weeks ago after his 2nd dose so, the reporter was horrified that they will not considered the safety of the public before taking that emergency FDA approval because they know that it took more than just a minute of the time to determine the safety and the reporter would hope that have the integrity too consider that over the money at this point in time. When probed if the concern is with Pfizer COVID-19 vaccine, reporter stated, "Yes of course." It was unknown if autopsy was performed. Outcome of the event was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died two weeks ago after his 2nd dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant, and was in the hospital. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042703 Same reporter/event/drug, different patient;US-PFIZER INC-202101095250 Same reporter/event/drug, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program Regulatory Authority, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant, and was in the hospital. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042703 Same reporter/event/drug, different patient;US-PFIZER INC-202101094644 Same reporter/event/drug, different patient
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; Arm soreness; nausea; This is a spontaneous report from a non-contactable other HCP. This 23-year-old female Other HCP (patient) reported for herself.  A 29-years-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY, Lot number: unknown), on left arm on 08Feb2021 at 03.45 (at the age of 23-year-old) as dose 2, single as COVID-19 immunisation. Medical history was not reported. Concomitant medication included Mirena IUD. Patient previously received first dose bnt162b2 (COMIRNATY, Lot number: unknown), on left arm on 17Jan2021 at 10.00 (at the age of 23-year-old) as a single dose as COVID-19 immunisation. Patient had no other vaccine in four weeks, no covid prior vaccination and tested covid post vaccination. On 09Feb2021 at 02:00 am, patient experienced fever, chills, arm soreness and nausea. Patient underwent laboratory test included Nasal Swab resulted negative on 05Feb2021. No treatment was given. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: extremely dizzy/lightheaded; everything went "topsy turvy"; This is a spontaneous report from a contactable consumer (patient). A 84-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581, Expiry date: not reported, age at vaccination: 84-year-old), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 14:15 as dose 2, single for covid-19 immunisation administered in Doctor's office/urgent care. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's Thyroiditis from an unknown date and unknown if ongoing (taking Synthroid daily). The patient had known allergies many and she avoids them all. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL3249), in Arm left on 18Jan2021 at 14:15 for covid-19 immunization. The patient did not receive any other vaccines in four weeks and did not receive other medications in two weeks. No covid prior vaccination and not tested for covid post vaccination. The patient had her second Pfizer vaccine dose yesterday, Monday, 08Feb at 2:15 pm and felt fine the rest of that day. This morning (09Feb2021) at 08:30 Am she got up to go to the bathroom and took one step and suddenly feeling extremely dizzy. She reached out to grab hold of the dresser and everything went "topsy turvy". Her head hit the side of the wall on a framed picture and she fell totally out of control ending up in the corner of the room. Her hip hit the floor hard and head hit the wall. She was in a half reclining position. she never had this happen before. She sat for a few minutes and still felt dizzy. Then got up slowly and got into bed. In bed she continued experiencing waves of dizziness. Throughout the morning she felt waves of dizziness and light headed but nothing like she experienced when she first got up out of bed. It is now around 1 pm 09Feb2021. She was feeling better and hoping she will not have another episode. She wanted to known is this an adverse side effect to the vaccination or not. No treatment was received for the events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: he experienced dizziness described as a balance issue and when standing up, he was unstable; he experienced dizziness described as a balance issue and when standing up, he was unstable; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN9581 and expiration date not reported), via an unspecified route of administration, administered in left arm, on 05Feb2021 12:00 (at the age of 73-years-old), as dose1, single for Covid-19 immunization. The patient's medical history included Type 2 diabetes mellitus from 2016. Concomitant medications were not reported. No prior vaccinations within 4 weeks. Patient stated that, when he got up this morning (09Feb2021), he experienced dizziness described as a balance issue and when standing up, he was unstable. Patient experienced something for the first time. He woke up feeling like he never has had before. He was not dizzy. He was imbalanced and was not stable. The room was not spinning but when he stands, he has to get his balance. No relevant lab tests reported. Outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb injury, Myalgia, Pain
Clinical narrative: a lot of joint pain; muscle pain; she can barely walk; she puts pressure it hurts horrible; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 05Feb2021 (at the age of 80 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated, "she was calling because she got her vaccine shot Friday her second one and on 06Feb2021, Saturday she got lot of muscle and joint pain in her left, she means her right leg at the top, and it's so terrible that she can barely walk on it when she puts pressure it hurts horrible, and she don't know what to take for it. She stated, "Yeah it terrible the pain, she can't even walk, it been since she put pressure on it, and it's been since Saturday when she got the shot, Friday, if this was abominated, it was the second one that was bothering her. Department role and responsibility of the department was told to the consumer. She stated, now this pain, won't this pain go away, oh it's terrible. she was 80 years old and she can barely even walk. She needs to talk to somebody that can tell her what to do to help this so that she can start walking. She would like to know if there's anything she can do. She would like to know how long these symptoms will last. The outcome of events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis
Clinical narrative: not feeling well; mild cold; This is a spontaneous report from a contactable consumer. This male consumer (patient himself) reported for himself.  A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number: not reported), dose 1 via an unspecified route on 17Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. He was scheduled to receive his second dose of the vaccine on 07Feb2021. He cancelled his appointment for the second dose because he was not feeling well and states he had a mild cold on an unspecified date in 2021. He has rescheduled his appointment for this Friday, 12Feb2021. The patient wanted to know If patient does not feel totally well, how long can he postpone between first and second. He was already one week over because he was supposed to have it two days ago and now is scheduled for 12Feb2021. He feels much better, but he wants to be covered. If he does not feel well by Friday, he will have to postpone. The outcome of evenst was unknown.  Information on the lot/ batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Investigation, Nasopharyngitis, Vaccination site pain
Clinical narrative: diarrhea; cold; Arm soreness at injection site; Chills; This is a spontaneous report from a contactable consumer.   A male patient of 77-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EK4176), first dose on left arm via an un-specified route of administration on 26Jan2021, 11:30 at unknown dose 1, single for COVID-19 immunization. Patient medical history includes Heart transplant, Has a compromised immune system. Diabetes, Asthma, Soreness in arm with Flu shot and shingles shot/Received Flu shot in Dec2020, Soreness in arm with Flu shot and shingles shot/Can't remember when he received shingles shot, Had Norovirus before and was hospitalized with diarrhea and other symptoms. Doesn't feel like he did with Norovirus. Was throwing up, had dehydration, and diarrhea./Confirmed Norovirus and hospitalization occurred prior to COVID-19 Vaccine, Gastro doctor took samples of stool and he ended up in the hospital with Norovirus. Was shaking so bad because of the dehydration and diarrhea. Family history included Parents had heart problems. Mother recently passed last year and was 100 years old. Mother didn't' have too much going on except age. No concomitant medications were reported. On 26Jan2021 patient experienced diarrhea, cold, Arm soreness at injection site and chills (Also had chills, but is always cold) on unspecified date. Diarrhea: Occurred on 26Jan2021 then stopped. Began again on 06Feb2021 and is ongoing. Arm soreness: First day and second day it was worse. By the third and fourth day it was better. Clarified it was his left arm. The patient wanted to know Is the effectiveness of the Pfizer COVID-19 Vaccine just as good as someone with a normal immune system, Is he protected as well as someone with no medical issues at all that had received the COVID-19 Vaccine and wanted to know if both are protected the same or will his issues make his protection not as good. Because he is a heart transplant patient, he wants to bring it to attention. If there is a problem with heart transplant patients who are not having the same immunity or protection as a person who does not have those problems. Did not have prior vaccinations within 4 weeks. Relevant tests: not recently. Gastro doctor took samples of stool and he ended up in the hospital with Norovirus. The outcome of event diarrhea was reported as not recovered, while that for Arm soreness at injection site was reported as recovering and for others event it was unknown.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: totally numb right foot. I sat up, shook it and no feeling came back for about 10 minutes.; plus tingling lasted for about an hour; It still feels a bit strange; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:00 (at the age of 68-years-old)(Lot Number: EL3249) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included high blood pressure but normal under my medication and slight arthritis in back and knees. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), tramadol, citalopram, olmesartan medoxomil (BENICAR), nicotinic acid (NIASPAN) all were taken for an unspecified indication, start and stop date were not reported. It was reported that patient woke up at 5 am the morning (09FEB2021) following my 1st vaccination by a totally numb right foot. she sat up, shook it and no feeling came back for about 10 minutes. she almost never have a foot fall asleep at night and i was lying totally float when I woke up. And if some limb falls asleep it comes right back after shaking it. Not this time plus tingling lasted for about an hour. It still feels a bit strange. Her right foot was totally numb. Perhaps it was everything below the knee. It scared the heck out of her. She had never had anything fall asleep like this. She was laying totally flat with nothing on her leg. She shook it and it took about 15 minutes and it slowly started to come back. She reported this online. She had tingling that lasted for hours. It still feels a bit strange. She called her doctor and was told to take Tylenol. It still feels weird and tingly. It is in the back of her foot and big toe. When reporting online she may have left out the specifics about the tingling. After an hour most of the tingling went away. patient still have some tingling.  The only testing she has had was a mammogram 2-3 months ago. post vaccination Patient did not test Covid. Patient has no allergy. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: woke up feeling bad again; woke up so dizzy/the dizziness "wasn't that bad." Caller stated that this feeling of dizziness did not go away; couldn't stand up; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported for herself. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 26Jan2021 08:00 as dose 1, single (age at vaccination: 74 years) for COVID-19 immunisation. Medical history included ongoing allergy to mountain cedar on an unknown date diagnosed at the age of 30. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. Patient received the first dose of the Covid vaccine on 26Jan2021 and was scheduled to receive the second dose on 16Feb2021. On 28Jan2021 at 08:00, patient experienced that she woke up so dizzy and couldn't stand up, and her husband had to hold her, this feeling lasted for two hours and then eased off. On 29Jan2021, she woke up feeling bad again and on the morning of 30Jan2021, the dizziness was not that bad and stated that this feeling of dizziness did not go away until that next Tuesday in February. She called her doctor in which they believe she may be experiencing this because of cedar allergies. Patient wants to know if she should receive her second dose of the vaccine. She does not felt dizzy anymore. Stated that she had allergies to cedar and had never got that dizzy. The clinical outcome of the event woke up feeling bad again was unknown and rest of the events on 02Feb2021 was resolved.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: sore arm; swelling; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 79 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation..Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced sore arm and swelling on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test, Symptom recurrence
Clinical narrative: suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation; Had severe fatigue; myalgias; headache/suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation; This is a spontaneous report from a contactable Physician (patient). This adult non-pregnant female patient (physician) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left (left arm) on 20Jan2021 (Lot Number: EJ1686) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not have COVID prior vaccination. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number unknown) as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient had severe fatigue, myalgias, headache for about 36 hours after second dose. On 08Feb2021 15:00, 19 days after second dose the patient suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation. The patient underwent COVID test post vaccination (Nasal Swab Covid test) result: Negative on 08Feb2021. The patient did not receive any treatment for the events. Therapeutic measures were not taken as a result of events. The outcome of the events was unknown.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Bone pain, Burning sensation, Erythema, Swelling
Clinical narrative: his right foot pain is more like a bone pain now; he had about a 3" red mark on the top of his right foot that ran on a diagonal from the outside of where his right foot and right leg meet to his right 2nd toe; he has swelling along with the right top foot burning sensation; right top foot burning sensation; This is a spontaneous report from a contactable consumer. A male patient of 76-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EM9810, Expiration date-30Jun2021), dose 1 on left arm via an unspecified route of administration on 05Feb2021 at 16:00 at single dose for COVID-19 immunization. Medical history includes surgery and Heart problems. Concomitant medications includes Warfarin 5mg tablet, once a day, Monday thru Saturday, and a 1/2 tablet (2.5mg) as Anticoagulant therapy, Losartan 25mg tablet, takes a 1/2 tablet daily, Metoprolol 25mg tablet, once daily on oct2017. On 05Feb2021 patient experienced burning sensation his right top foot that started within 2 hours after receiving his first COVID-19 Vaccine. On 06Feb2021 patient experienced about a 3" red mark on the top of his right foot that ran on a diagonal from the outside of where his right foot and right leg meet to his right 2nd toe. On 05Feb2021 patient experienced swelling along with the right top foot burning sensation. On 08Feb201 he noticed that his right foot pain was more like a bone pain now. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment includes Tylenol 500mg caplets. He said he took 2 (name) brand Tylenol 500mg caplets in the morning yesterday, between 6:00-7:00AM, and another 2 (name) brand Tylenol 500mg caplets at about 10:00PM last night before he went to sleep. The patient underwent Blood Test result was everything ok. The outcome of Event for Burning sensation and Bone pain was recovering and for Erythema was unknown and for Swelling was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nerve block
Clinical narrative: Nerve block; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was on the line asking what the rationale was to have to wait for 2 weeks after receiving the Pfizer-BioNTech Covid19 vaccine before getting a diagnostic nerve block. Patient was 90 years old aunt was turned away when she went for her nerve block. Patient was responded; no information about avoiding procedures before or after vaccination listed in the fact sheet. Referred caller back to HCP performing the nerve block for more information. (LAB; Revised: Jan2021). The patient experienced nerve block on an unknown date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: She experienced swelling at the injection site and sorenes; She experienced swelling at the injection site and sorenes; This is a spontaneous report from a Non-contactable consumer. This consumer reported for a 08 Decade female (friend) patient that:  A 8-decade-old (in her 70s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included hypersensitivity. The patient's concomitant medications were not reported. The patient experienced she experienced swelling at the injection site and soreness from her neck to her wrist on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: just sick/Just been sick as a dog; tiredness; muscle pain; chills; joint pain; fever; nausea; feeling unwell; headache; I'm not able to get up and get dressed; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, NDC number and Expiry Date: Unknown) via an unspecified route of administration in arm right on 06Feb2021 at 10:30 (Saturday) as dose 2, single for COVID-19 immunisation. The patient's medical history included she has been diagnosed with cancer from an unknown date and unknown if ongoing, chemotherapy from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number EL32 plus 9 (Lot: It was hard to understand their writing, but she thinks it was EL32+9, she specified it looks like a plus sign between the 2 and 9 of Lot number.) via an unspecified route of administration in arm left on 16Jan2021 at 13 as dose 1, single for COVID-19 immunisation. The patient reported that she had experienced multiple adverse reactions since 07Feb2021, a day after her 2nd dose "I have been just sick, she had all of these (Adverse Events, 08Feb2021) tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, her body cannot handle this COVID shot I was not going to radiation because she was just so sick from the shot and was not able to get up and get dressed. The patient had scheduled for radiation starting Monday, 08Feb2021 for 2 weeks, she reported that she had just been sick as a dog since then, clarified onset of event was Sunday, she wanted to know if she should or should not be getting radiation treatments while her body was fighting the Pfizer COVID-19 Vaccine shot right now, because she does not think she should. After yesterday (unspecified date) radiation therapy she said no, she cannot do this, she was just too sick. She asked if it was true that it takes 10-14 days to fight off the vaccine and build up immunity. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Quality of life decreased
Clinical narrative: just sick/Just been sick as a dog; tiredness; muscle pain; chills; joint pain; fever; nausea; feeling unwell; headache; I'm not able to get up and get dressed; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, NDC number and Expiry Date: Unknown) via an unspecified route of administration in arm right on 06Feb2021 at 10:30 (Saturday) as dose 2, single for COVID-19 immunisation. The patient's medical history included she has been diagnosed with cancer from an unknown date and unknown if ongoing, chemotherapy from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number EL32 plus 9 (Lot: It was hard to understand their writing, but she thinks it was EL32+9, she specified it looks like a plus sign between the 2 and 9 of Lot number.) via an unspecified route of administration in arm left on 16Jan2021 at 13 as dose 1, single for COVID-19 immunisation. The patient reported that she had experienced multiple adverse reactions since 07Feb2021, a day after her 2nd dose "I have been just sick, she had all of these (Adverse Events, 08Feb2021) tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, her body cannot handle this COVID shot I was not going to radiation because she was just so sick from the shot and was not able to get up and get dressed. The patient had scheduled for radiation starting Monday, 08Feb2021 for 2 weeks, she reported that she had just been sick as a dog since then, clarified onset of event was Sunday, she wanted to know if she should or should not be getting radiation treatments while her body was fighting the Pfizer COVID-19 Vaccine shot right now, because she does not think she should. After yesterday (unspecified date) radiation therapy she said no, she cannot do this, she was just too sick. She asked if it was true that it takes 10-14 days to fight off the vaccine and build up immunity. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache the following morning.; This is a spontaneous report from a contactable patient. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number: EN5318) dose 2 via an intramuscular route of administration, administered in Right Arm on 02Feb2021 13:15 (at the age of 49-years) as dose 2, single for covid-19 immunization. The patient medical history reported as none. The patient past drug history included BNT162B2 (dose number 1, Lot number: EK9231, administration route: intramuscular, administered in right arm) for covid-19 immunization on 12Jan2021 12:00PM. The patient concomitant mediation was not reported. The patient had no allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. The patient experienced severe headache the following morning on 03Feb2021 07:00. Patient did not received treatment for adverse event. The outcome of the event was recovered on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.