chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died a few months after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died a few months after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Consumer called to find out the status of the safety effects she reported 13 months ago after getting the Pfizer BioNTech Covid-19 Vaccine and asked why no one was able to follow up on her. Consumer stated that she had called pfizer's (option 1) and was referred to Pfizer to inquire about the adverse event status she had reported 13 months ago. consumer stated that she experienced 30 hours after she got the second dose of the Pfizer BioNtech Covid-19 vaccine on 13Apr2021. Consumer also stated that she had to be put on a walker/wheelchair because of the side effect and stated that she was previously active and doing "ms 150 backride" prior to getting the vaccine. Consumer also stated that she was connected with 2 other people who got the same lot number of the vaccine, one was a 16 year old who died a few months after getting the vaccine (still connected with the father) and the other one was a mother who had "intravenous globular syndrome. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a few months after getting the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Sleep disorder
Clinical narrative: sleep/dream disturbance; sleep/dream disturbance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: ABNORMAL DREAMS (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "sleep/dream disturbance".  Additional information: The reporter reported that, After further discussion with my 40-year-old daughter, my mom was no longer frightened. My daughter told her she had very similar sleep/ dream disturbances after dose#4. We feel the problem was a side effect due to 4th dose and having had covid in May2022. We feel it was just the way my Mom's 94-year-old body reacted and that there was nothing wrong with the serum, as the same thing happened to my daughter who is 54 yrs. Younger and her dose #4 in a clinic setting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EL3247), on 29Mar2021 as dose 2, single (Lot number: EP6955) and on 01Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovered" (May2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: PNC20
Symptoms: Pain, Pyrexia
Clinical narrative: whole body aches; fever; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "whole body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Description of event: Patient has whole body aches, late fever 1 week post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After receiving my booster shot (dose 4) of 01May2022, I tested positive via a PCR test on 15May2022; After receiving my booster shot (dose 4) of 01May2022, I tested positive via a PCR test on 15May2022; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (unknown if pregnant) received BNT162B2 (BNT162B2), on 01May2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years intramuscular, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. The patient took concomitant medications (pre-natal vitamins). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022 at 09:00, outcome "recovered with sequelae" and all described as "After receiving my booster shot (dose 4) of 01May2022, I tested positive via a PCR test on 15May2022". The event "after receiving my booster shot (dose 4) of 01may2022, I tested positive via a pcr test on 15may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: At home antigen: (13May2022) Negative, notes: Nasal Swab; (14May2022) Negative, notes: Nasal Swab; PCR test: (15May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Headache, Nausea, Rhinorrhoea
Clinical narrative: mild nausea; runny nose; mild headache / headache; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), on 31May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 31May2022 at 11:00 as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE: 3, I hadn't experienced headaches or other side effects with any of the previous Comirnaty doses. My previous dose (first booster) was on 12Oct2021.), administration date: 12Oct2021, for COVID-19 immunization; Comirnaty (DOSE: 1, I hadn't experienced headaches or other side effects with any of the previous Comirnaty doses.), for COVID-19 immunization; Comirnaty (DOSE: 2, I hadn't experienced headaches or other side effects with any of the previous Comirnaty doses.), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Jun2022 at 06:00, outcome "unknown", described as "mild headache / headache"; NAUSEA (non-serious) with onset 01Jun2022 at 12:00, outcome "unknown", described as "mild nausea"; RHINORRHOEA (non-serious) with onset 01Jun2022 at 12:00, outcome "unknown", described as "runny nose".  Additional information: Patient received second booster of Comirnaty and first dose Shingrix yesterday, 31May2022 at 11 AM. Patient noticed a mild headache starting overnight and had a headache in the morning, walking up at 6 AM. At the time, also noticed very mild nausea, and eventually started having a runny nose at around 12 PM today. Patient had not experienced headaches or other side effects with any of the previous Comirnaty doses  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: mild covid; mild covid; This is a spontaneous report received from contactable reporters (consumers). A 43-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), as dose 1, single (lot number unknown), as dose 2, single (lot number unknown) and as dose 3 (booster), single (lot number unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) with onset 31May2022, outcome "recovering" and described as "mild covid". The patient underwent the following laboratory tests and procedures: nasal swab: (31May2022) unknown results. Therapeutic measures were not taken as a result of drug ineffective and suspected covid-19. Clinical course: Mild covid (symptoms sore throat, fever, tiredness, headache).    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, SARS-CoV-2 test, Tachycardia
Clinical narrative: Headache; Neckache; tachycardia; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3. , Manufacturer Unknown), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 05Apr2022 at 21:00, outcome "recovered"; NECK PAIN (non-serious) with onset 05Apr2022 at 21:00, outcome "recovered", described as "Neckache"; NAUSEA (non-serious) with onset 05Apr2022 at 21:00, outcome "recovered"; TACHYCARDIA (non-serious) with onset 05Apr2022 at 21:00, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative. Therapeutic measures were not taken as a result of headache, neck pain, tachycardia, nausea.  Additional information: Patient did not received any other vaccine in four weeks. Patient did not had covid prior vaccination. Patient has been tested for covid post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: my arm hurt quite a bit.  I felt a lot of pain; injection area was very hot and red and it felt sore; injection area was very hot and red and it felt sore; injection area was very hot and red and it felt sore; My arm also felt very heavy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete;, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "my arm hurt quite a bit.  I felt a lot of pain"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "injection area was very hot and red and it felt sore"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "My arm also felt very heavy". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, vaccination site erythema, vaccination site warmth, limb discomfort.  Clinical course: Patient would like to report an adverse event after receiving the Pfizer booster shot on 07Apr22. I felt alright for several hours after the shot, but around 8 hours later, my arm hurt quite a bit. I felt a lot of pain, the injection area was very hot and red and it felt sore. My arm also felt very heavy and I could not even raise it without raising my shoulder. My husband gave me 2 tablets of Aleve and it continued to hurt until I went to bed. The next day, I experienced no pain or discomfort and did not experience any pain or discomfort after that. I am sorry I did not think to report it, I just figured it was an expected side effect. I had asked the healthcare professional that administered the booster shot if it would hurt like the last one and she said that it would hurt more and recommended I take aspirin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already". The date and cause of death for the patient were un-known. It was not reported if an autopsy was performed. It was reported that, as reporter was not willing to provide further details and abruptly hung up the call. Hence product details (LOT#, expiration date, NDC# and UPC#), purchased details and further probing could not be done. Limited information was available over the call and appropriate response could not be provided.  QR comment:- AE Filed conservatively.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test; Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 25Mar2021 as dose 2, single (Lot number: EP6955) and on 09Apr2022 as dose 3 (booster), single (Lot number: FK9894) at the age of 63 years, all in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM; VIT D [VITAMIN D NOS]; FISH OIL; BIOTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "recovered" and all described as "Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Covid test type post vaccination=Nasal Swab,covid test name post vaccination=BinaxNOW,covid test date=14May2022, covid_test_result=Positive. Therapeutic measures included ibuprofen (ADVIL) for aches, guaifenesin (MUCINEX) for other symptoms, were taken as a result of drug ineffective, covid-19.  Additional information: Patient got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness. No fever but tested positive using home test kit from Abbott. Patient has no covid prior vaccination, no other vaccines taken if four weeks, and no known allergies.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 12Apr2021 as dose 2, single (Lot number: EP6955) at the age of 43 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09May2022, outcome "unknown", COVID-19 (medically significant) with onset 09May2022, outcome "recovered" (2022) and all described as "Patient tested positive for COVID".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) positive.  Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient tested positive for COVID on 09May2022. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: COVID Infection; COVID Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER9737), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 44 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "recovered", COVID-19 (medically significant) with onset 14May2022, outcome "recovered" and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (19May2022) Positive, notes: Nasal Swab; SARS-CoV-2 test: (29May2022) Negative, notes: Other; (16May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792657 same patient and drug, different event separated in time.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Infection; COVID Infection; Additional information: Report about covid vaccine: Yes Reporting type: AE Patient name: Patient name withheld Dob: DOB withheld Age group: Elderly (65+ Years) Gender: Male Race: Race withheld Ethnicity: Ethnicity withheld reporter occupation: None of the above  dose received: 3 most recent dose details: [{product=COVID 19, brand=Pfizer, brand unknown=False, lot number=FF8831, lot unknown=False, administrator route=Intramuscular, administration date=20Oct2021, dose number=3}]  previous dose details:  [{prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EN6208, prev dose lot unknown=False, prev dose administrator route=Intramuscular, prev dose administration date=19Mar2021, prev dose dose number=2}, {prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EN6200, prev dose lot unknown=False, prev dose administrator route=Intra muscular, prev dose administration date=26Feb2021, prev dose dose number=1}]  facility type vaccine: Doctor's office/urgent care  if other vaccine in fourweeks: No  adverse event: COVID Infection adverse event start date: 13May2022  ae resulted in: [None of the above] if patient recovered: Recovered  if treatment ae: Yes ae treatment: Over the counter medicine if covid prior vaccination: No if covid tested post vaccination: Yes covid test post vaccination: [{covid test type post vaccination=Nasal Swab, covid test name post vaccination=Rapid Test Binax, covid test date=16May2022, covid test result=Positive}]
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Infection; COVID Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), on 19Mar2021 as dose 2, single (Lot number: EN6208) and on 21Oct2021 as dose 3 (booster), single (Lot number: FF8831) at the age of 71 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "recovered" and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 22Mar2021 as dose 2, single (Lot number: EL3247), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: EW0196), in left arm and on 21Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 55 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTIN; CITALOPRAM; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported the patient tested positive on 17May2022 via nasal swab.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 2, single (Batch/Lot number: FF2593) at the age of 77 years and on 09May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 78 years; all for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 007M20A) at the age of 76 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" in 2022 and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: COVID-19 rapid test (nasal swab) on 16May2022, which was positive. Therapeutic measures were not taken as a result of drug ineffective or COVID-19.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 2, single (Batch/Lot number: FF2593) at the age of 77 years and on 09May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 78 years; all for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 007M20A) at the age of 76 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" in 2022 and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: COVID-19 rapid test (nasal swab) on 16May2022, which was positive. Therapeutic measures were not taken as a result of drug ineffective or COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 48 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE QUADRIVALENT, on 03Oct2021 as dose 1, single; PRISTIQ; BUPROPION; SYNTHROID; VYVANSE. The following information was reported: COVID-19 (medically significant) with onset 16Jan2022, outcome "recovered" (2022), described as "COVID infection"; VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "recovered" (2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2022) Positive, notes: COVID test type post vaccination nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received Fluzone quad 2021-2022 Sanofi with 4 weeks prior to the BNT162b2 vaccine. Treatment medication included Loratadine and Symbicort.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hypophagia
Clinical narrative: Resident reported a headache along with back pain around 2330.  Resident was provided PRN oxycodone and PRN Tylenol primarily for the back pain. Resident was noted to be sleeping throughout the rest of the night. Resident has a history of headaches and has taken medication in the past for this. She also reported not eating dinner due to the back pain which may have contributed to the headache.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Grip strength decreased, Injection site erythema, Injection site pain, X-ray abnormal
Clinical narrative: Redness at injection site started 24-48 hours after injection. Currently still having pain at injection site and trouble lifting or grabbing thing with left arm.  Xray completed to see if it was broken.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: , Additional Details: Patient passed out/fainted. Per patient it happens with any vaccination/injection.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Loss of consciousness
Clinical narrative: , Additional Details: Patient passed out while RPh was signing his brother's immunization card. He fell on the chair but RPh got hold of him before he was on the ground. Patient remained conscious the whole time, immediately responsive, complained of dizziness and tiredness. Paramedics were called. All vitals were normal. Mother chose not to go to the ER as all seems well after about 5-10 mins. Patient was given some cold water by mother. He then regained full strength about 30 mins after the incident.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: I received the vaccine at about 4:45pm on the 31 of May in my left arm.  the arm was sore but nothing out of the usual.  I woke up the next morning with pain in my left chest, going into my left armpit, my left shoulder and arm.  This pain lasted all day until I went to bed.  I tried not to let it interfere with my activities..  It lasted until I went to bed that night.  I took tylenol , 500mg during the day and naproxen 220mg when I went to bed that night.  The next day I woke up feeling better and less pain.  today I am feeling better with no noticeable pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: severe vomiting for 5 hours and high fever, headache, fatigue for 18 hours
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Third does of Pfizer vaccine. This was my first booster shot. Experienced onset of Tinnitus in right ear that has not gone away. The ear, nose and throat doctor could not cure it. Ear tests suggested long term, chronic tinnitus and slight hearing loss. This was likely caused by the vaccine. There was no trauma to my right ear prior to the onset of tinnitus other than the vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles symptoms onset 4 days later, rash outbreak 5 days later.  Severe shingles pain continuing  now 3 weeks.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Inflammation, Insomnia, Pain
Clinical narrative: within 24 hours of receiving vaccine (2nd booster of `Pfizer, 1st booster received 12/3/21), I experienced building extreme upper arm pain.    As over the counter pain relief was ineffective, I went to clinic on 4/24/22 in attempt to get care.  X-ray was taken, negative, pain relievers were given.    The pain evolved to feeling like a "tight" and inflamed nerve throughout my arm and hand .  This cause considerable discomfort, loss of sleep and did not begin to lessen for at least 2 weeks.   As of 6/4/22 it is mostly gone but some residual numbness, tingling and pain occurs daily.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: within 24 hours of receiving vaccine (2nd booster of `Pfizer, 1st booster received 12/3/21), I experienced building extreme upper arm pain.    As over the counter pain relief was ineffective, I went to clinic on 4/24/22 in attempt to get care.  X-ray was taken, negative, pain relievers were given.    The pain evolved to feeling like a "tight" and inflamed nerve throughout my arm and hand .  This cause considerable discomfort, loss of sleep and did not begin to lessen for at least 2 weeks.   As of 6/4/22 it is mostly gone but some residual numbness, tingling and pain occurs daily.
Age: 54.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dyspnoea, Oxygen saturation decreased
Clinical narrative: PATIENT RECIEVED THE VACCINES LISTED ABOVE ON THE AFTERNOON OF JUNE 3 AND FELT FINE LAST NIGHT, BUT WOKE UP  THE MORNING OF JUNE 4 WITH SHORTNESS OF BREATH AND SELF-REPORTED LOW O2 SAT  (USED HOME FINGERTIP MONITOR).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Hypertension
Clinical narrative: Developed sudden dangerous hypertension. No family history of hypertension.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Blister, Skin irritation
Clinical narrative: Patient reported blister a day after vaccination, with slight irrigation. Referred patient to see primary care or urgent care for further evaluation, patient reported symptoms to the pharmacy 06/03/2022. Will follow up with patient 06/06/2022.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over upper thighs starting the morning I woke up two days after receiving the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Altered state of consciousness, Electrocardiogram, Full blood count, Hypotension
Clinical narrative: Very little side effects for the first 4 days,  then hypotension for 3 days,  BP got down to 85/42. In and out of consciousness,  fainted once,  had to lay down or have lots of pain in abdomen. Treatment forced fluid until I was well enough for them to bring me to urgent care.  Urgent care prescribed antibiotics and gave me a liter of fluids.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Syncope
Clinical narrative: Very little side effects for the first 4 days,  then hypotension for 3 days,  BP got down to 85/42. In and out of consciousness,  fainted once,  had to lay down or have lots of pain in abdomen. Treatment forced fluid until I was well enough for them to bring me to urgent care.  Urgent care prescribed antibiotics and gave me a liter of fluids.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, C-reactive protein increased, Dyspnoea exertional, Immunoglobulins increased, Lymphoedema
Clinical narrative: Activation/exacerbation of autoimmune process resulting in exertional dyspnea, generalized subcutaneous edema/lymphedema and pain. Sxs were minimal after the first dose, barely noticeable, but were progressively more prominent with the subsequent 2 doses.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema, Pain
Clinical narrative: Activation/exacerbation of autoimmune process resulting in exertional dyspnea, generalized subcutaneous edema/lymphedema and pain. Sxs were minimal after the first dose, barely noticeable, but were progressively more prominent with the subsequent 2 doses.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Patient reports waking up in middle of night from pain from her shoulder to her elbow.  No redness or swelling in arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: See item 11.  No adverse event.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Neuralgia, Pain in extremity
Clinical narrative: Nerve pain running down my whole arm and reduced mobility. I can feel the pain in my shoulder going down through my ring and pinky finger. I have had this pain going on 4 months now.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Joint range of motion measurement
Clinical narrative: Pain and numbness to the right deltoid. Pain is a burning sensation that radiates down to the right wrist and has a shooting sensation of pins and needles, when I  move my arm forwards, backwards, flex and raise above elbow length.  The center of my right deltoid has  constant tingling sensation.  The pain has become so intolerable that I am unable to perform my daily activities without the constant use of Ibuprofen and Tylenol, that only dulls my pain and my children are now having to assist me with dressing, grooming, and bathing. The pain has increased from 6/10 to 10/10 with certain movements, and the medications are upsetting my stomach.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain and numbness to the right deltoid. Pain is a burning sensation that radiates down to the right wrist and has a shooting sensation of pins and needles, when I  move my arm forwards, backwards, flex and raise above elbow length.  The center of my right deltoid has  constant tingling sensation.  The pain has become so intolerable that I am unable to perform my daily activities without the constant use of Ibuprofen and Tylenol, that only dulls my pain and my children are now having to assist me with dressing, grooming, and bathing. The pain has increased from 6/10 to 10/10 with certain movements, and the medications are upsetting my stomach.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Dysstasia, Fall, Gait inability
Clinical narrative: My legs and feet are very weak and my feet start tingling. I can barely walk.  I have no strength and I get  wobbly and I also fall. I can hardly get out of the bath. I can't stand on my tip toes or I can't run at all, I also  have slurred speech. I have to work an by the end of the day I can't walk much.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: My legs and feet are very weak and my feet start tingling. I can barely walk.  I have no strength and I get  wobbly and I also fall. I can hardly get out of the bath. I can't stand on my tip toes or I can't run at all, I also  have slurred speech. I have to work an by the end of the day I can't walk much.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Head discomfort, Malaise, Paraesthesia, Swelling
Clinical narrative: On 6/1 Approximately 6 hrs post vaccination, I experienced swelling localized to the left eye and into the back of the head and cervical neck region, pressure and tingling which proceeded into the next day 6/2, later leading into the subsiding of swelling, and more of ?brain fog? or malaise on 6/3.   I had taken an antihistamine the night of the initial reaction, magnesium, quercetin, vitamin a,d,k, turmeric, colloidal silver, and zinc and oral arnica dissolvable  tablets. Symptoms had decently subsided, however the pressure on the left side of the head near the eye  and around onto the back of head toward the neck remained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Approximately 10 minutes after vaccination, patient began to feel lightheaded.  She recognized the symptoms and knew she was going to pass out.  Her boyfriend alerted the pharmacist and they had the patient lie down on the floor.  Patient got an ice pack and after 5 minutes some orange juice.  After another 15 minutes of observation she felt normal.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Irritability, Pain in extremity
Clinical narrative: Extreme irritability, increased heart rate, left arm soreness and numbness
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Nausea, Tremor
Clinical narrative: Night of vaccination: nausea and tremors Next day: headache, stomach pain, loss of appetite
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Hypoaesthesia, Interchange of vaccine products, Magnetic resonance imaging normal
Clinical narrative: Received booster shot on 5/19/2022, started severe vomiting and extremely dizzy stayed in bed all day 5/20/2022. May 21st 22nd and 23rd vertigo was bad. On May 25th sever vomiting again sever Vertigo, and numbing in left arm, went to the ER was there until May 27th.  EKG and MRI came back  normal, Hospital treated her for vertigo follow up with L. We were brought here. All other vaccines were Pfizer.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vertigo, Vomiting
Clinical narrative: Received booster shot on 5/19/2022, started severe vomiting and extremely dizzy stayed in bed all day 5/20/2022. May 21st 22nd and 23rd vertigo was bad. On May 25th sever vomiting again sever Vertigo, and numbing in left arm, went to the ER was there until May 27th.  EKG and MRI came back  normal, Hospital treated her for vertigo follow up with L. We were brought here. All other vaccines were Pfizer.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO adverse event(s) or treatment noted at this time.  0.5ml dose given vs 0.25 ml dose for 1st Booster.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: , Additional Details: Patient jerked arm a little when shot was administered about 2:15pm 5/31/2022. Patient called back at 6:30pm 5/31/2022 to say her arm was really sore. She took tylenol and said she was using ice packs on her arm.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Loss of consciousness, Somnolence
Clinical narrative: PT sat down after the shot administration and very quickly lost conscience. His mother patted him and withing a couple of seconds he came to. He seemed very sleepy and unable to focus, but began feeling better soon.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Gait inability, Impaired self-care, Loss of personal independence in daily activities
Clinical narrative: Patient received shot and approx 23 hours later she lost strength in her legs and was unable to walk on her own with the use of her walker.  Patient has since been required to be transported in her house with the use of a wheelchair and helped off/on toilet.  Patient developed a low grade fever (99-100.3)  approx 27 hours after her shot which was controlled with acetaminophen.  Patient has had a significant decline in cognitive ability since receiving vaccine and now needs 24 hour care and has been placed on hospice approx one week after vaccine.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: Patient received shot and approx 23 hours later she lost strength in her legs and was unable to walk on her own with the use of her walker.  Patient has since been required to be transported in her house with the use of a wheelchair and helped off/on toilet.  Patient developed a low grade fever (99-100.3)  approx 27 hours after her shot which was controlled with acetaminophen.  Patient has had a significant decline in cognitive ability since receiving vaccine and now needs 24 hour care and has been placed on hospice approx one week after vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Ultrasound kidney normal
Clinical narrative: 3 Months after Report (March 30th, 2022):  27M 6'0" 190(s)lbs, pretty active  Shot 1-2: Pfizer, Booster: Moderna (early January)  Doctor's appointment (2hrs later) after booster, my BP was 168/110. My BP in November was 124/84.  24 hours after the booster, I got real bad stabbing chest pain and dizzy headaches. Went to ER 48hrs after booster. BP : 170+/100+, HR: 100+ after getting up from sleep, sweating a lot.  ECG: abnormal with possible enlarged heart  CT (d-dimer elevated), X-Ray, blood tests came back fine.  Discharged with "anxiety" like others here. BP was 155/105 when discharged.  PCP put me on a beta-blocker. Beta blocker kept it in the high 140s and sometimes high 130s. Helped with keeping HR low. The beta-blocker gives me dizzy spells so not ideal.  Had muscle twitches randomly throughout the day (entire body) for a month or so, has settled to extremely rarely now. I also had bad migraines on the right side of my head daily (5 secs - 2 min). Never had migraines ever before. My hands would also sometimes feel like falling asleep numbness. I also would get random hypnic jerks when trying to fall asleep for two months.  Tried to exercise about 3 weeks after the booster(very light, 1 mile), heart beating crazy out of my chest. Hours later, heart pain was back like day 1. Subsided back to manageable levels 24 hours later.  Tried lifting light weights and again light exercise (walking) a few weeks later. Was able to lift and walk but at the end of my workouts, heart pain would come back for a few hours.  My baseline BP seemed to change after my booster to 150s and 160s. Doing anything (walking to my car, laundry, etc) seemed to elevate my BP and HR a lot more than it should have. Also took exceedingly long to return to "normal".  Gave blood once (barely passed HR/BP conditions). It seemed to help. Tried giving Plasma but didn't meet conditions. I basically have a BP in public phobia now.  Got an Echocardiogram and Kidney ultrasound from my Cardiologist. Both came back fine, no myocarditis thankfully.  I was put on an ACE Inhibitor/diuretic a few weeks back and my BP is back to 120/70+ in the mornings and a bit higher later in the day. I am hoping to get off these as soon as I can.  First month was debilitating and I was basically bed-ridden. Second month I could function but couldn't do anything strenuous or inflammatory. Third month, I felt almost back to normal me with help of meds.  Currently I have very faint heart pain. Greatly reduced after starting the ACE Inhibitor. HR can still be somewhat high at rest. My BP is basically normal with anti-ace meds.  Helpful Solutions:  - Hibiscus Tea (acts like an ACE Inhibitor)  - Low dose aspirin (when needed)  - Small meals, healthy foods.  - Giving Blood/Plasma  - Sleep aids  Avoid/Harmful:  - Inflammatory meals and/or large meals (BP, HR, and chest pain skyrockets for hours after)  - Exercise (try walking for 20 minutes and then increase gradually)  - ALCOHOL (tried drinking a couple times (6 beers) and my HR would go crazy that night. I seem to be able to drink now with milder side effects)