chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium decreased, Blood urea increased, Glomerular filtration rate, Glomerular filtration rate decreased, Haematocrit
Clinical narrative: Glucose high; Urea Nitrogen high; Creatinine high; EGFR low; Sodium low; Red Blood Cell Count low; Hemoglobin low; Hematocrit low; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID:.  An 88-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (COVID-19. mRNA. LNP-S. PF. 30 mcg/0.3 mL dose (Pfizer- BioNTech)), administration date: 08Feb2021, when the patient was 88-year-old, for COVID-19 Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose high"; BLOOD UREA INCREASED (non-serious), outcome "unknown", described as "Urea Nitrogen high"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "Creatinine high"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "EGFR low"; BLOOD SODIUM DECREASED (non-serious), outcome "unknown", described as "Sodium low"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Red Blood Cell Count low"; HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "Hemoglobin low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "Hematocrit low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter Occupation/Specialty: MD. HPI:  f/u CKD 4/5, recovering from COVID. Fasting reference interval, For someone without known diabetes, a glucose value >125 mg/dL indicates that they may have diabetes and this should be confirmed with a follow-up test. The eGER was based on the CKD-EPI 2021 equation. To calculate the new eGFR from a previous Creatinine or Cystatin C result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Red blood cell count, Red blood cell count decreased
Clinical narrative: Glucose high; Urea Nitrogen high; Creatinine high; EGFR low; Sodium low; Red Blood Cell Count low; Hemoglobin low; Hematocrit low; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID:.  An 88-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (COVID-19. mRNA. LNP-S. PF. 30 mcg/0.3 mL dose (Pfizer- BioNTech)), administration date: 08Feb2021, when the patient was 88-year-old, for COVID-19 Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose high"; BLOOD UREA INCREASED (non-serious), outcome "unknown", described as "Urea Nitrogen high"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "Creatinine high"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "EGFR low"; BLOOD SODIUM DECREASED (non-serious), outcome "unknown", described as "Sodium low"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Red Blood Cell Count low"; HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "Hemoglobin low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "Hematocrit low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter Occupation/Specialty: MD. HPI:  f/u CKD 4/5, recovering from COVID. Fasting reference interval, For someone without known diabetes, a glucose value >125 mg/dL indicates that they may have diabetes and this should be confirmed with a follow-up test. The eGER was based on the CKD-EPI 2021 equation. To calculate the new eGFR from a previous Creatinine or Cystatin C result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Malaise/did not feel good for a day or so; felt kind of tired and yucky; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: MALAISE (non-serious), outcome "unknown", described as "Malaise/did not feel good for a day or so"; FATIGUE (non-serious), outcome "unknown", described as "felt kind of tired and yucky".  Additional information: The reporter had questions about Prevnar 20. Upon further discussion, reporter stated that his doctor had recommended Prevnar 20 since he just turned 65 years old. He was planning to get it today. He was expecting same side effects as he had had with other vaccinations.  He had always heard the debate whether or not he should take Motrin or to just allow the immune response to occur to have vaccine more effective. After response, he stated he was a nurse anesthetist. The reporter usually had some type of side effects with vaccines like Shingrix, 2 doses, both times he had flu like symptoms for a day or two; Covid the same thing he felt kind of tired and yucky and stuff like that. He was a nurse anesthetist in hospital so was on the first round of getting COVID shots; every time, he had had malaise and did not feel good for a day or so. That's how he reacted to most vaccines. Upon further clarification of which "Covid" vaccination, he stated that it was Pfizer's Covid 19 vaccine. No additional information. The reporter was initially calling for information on Prevnar 20 that his doctor was recommending that he get but reported that he had issues with other vaccinations in the past including Shingrix and the Pfizer Covid-19 Vaccine. He reported that he had malaise and did not feel good for a day or so after receiving the Pfizer Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss/Hair Falling out like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 Completed, Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss/Hair Falling out like crazy".  Additional information : The patient stated he had the Pfizer COVID bivalent booster vaccine for 12 years of age and older. His hair was falling out like crazy. He was wondering what information they had on that and declined to complete a report. Caller stated, The Pfizer booster shot was causing hair loss. And his hair had been falling out pretty fast. His beard. He used to shave it every other day. Now He can go a week and a half without shaving. He saw this on the news that it was causing hair loss. He was near bald now. he wasn't like that before. Caller stated he was calling about the Booster Shot for Covid 19 that he took. Caller stated his hair was falling out like crazy and he saw that was being reported with the Pfizer booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing), notes: 13 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300200096 same  patient/reporter, different drug/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Nephropathy, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Anemia; Kidney Disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID. A female patient received BNT162b2 (BNT162B2 NOS), 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: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia"; NEPHROPATHY (non-serious), outcome "unknown", described as "Kidney Disease". Clinical course: That she had watched that vaccine put her sister through and she hate it! It gave her Rheumatoid Arthritis; Anemia; Kidney Disease.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300092438 same reporter/drug, different pts/event;
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Fatigue, Feeling abnormal, Hypotension, Influenza like illness
Clinical narrative: low blood pressure; tired; feel so crappy/feel poorly; really weak, like I have the flu; low blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy:", "low blood pressure". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure"; FATIGUE (non-serious), outcome "unknown", described as "tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel so crappy/feel poorly"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "really weak, like I have the flu"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was asking how to limit side effects from the Pfizer booster vaccine, reported when the patient got the vaccine she had low blood pressure and wanted to know how to limit and if she should take another dose. The caller confirmed inquiry. Caller also referenced the booster dose she previously received and was considering getting the bivalent dose. Caller said she had 5 shots so far and was debating about getting the next dose. Caller was tired every time afterwards, she felt so crappy. Caller said specifically after the last bivalent booster that she felt really weak, like she had the flu. She said the first booster was brutal, she had fever, chills, aches and was really miserable. Caller also said that it may be lowblood sugar  that caused her to feel poorly after the vaccine dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: low blood pressure; tired; feel so crappy/feel poorly; really weak, like I have the flu; low blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy:", "low blood pressure". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure"; FATIGUE (non-serious), outcome "unknown", described as "tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel so crappy/feel poorly"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "really weak, like I have the flu"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was asking how to limit side effects from the Pfizer booster vaccine, reported when the patient got the vaccine she had low blood pressure and wanted to know how to limit and if she should take another dose. The caller confirmed inquiry. Caller also referenced the booster dose she previously received and was considering getting the bivalent dose. Caller said she had 5 shots so far and was debating about getting the next dose. Caller was tired every time afterwards, she felt so crappy. Caller said specifically after the last bivalent booster that she felt really weak, like she had the flu. She said the first booster was brutal, she had fever, chills, aches and was really miserable. Caller also said that it may be lowblood sugar  that caused her to feel poorly after the vaccine dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 5 (booster), single (Lot number: 656796), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6208), in right arm, on 09Nov2021 as dose 3 (booster), single (Lot number: 32030BD), in right arm and on 14May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "borderline diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obese" (unspecified if ongoing). Concomitant medication(s) included: REFRESH OPTIVE, start date: Apr2003; HYDROCHLOROTHIAZIDE, start date: Apr2005; METFORMIN, start date: Apr2010; RESTASIS, start date: Apr2010; LISINOPRIL, start date: Apr2019; ATORVASTATIN, start date: Apr2020, stop date: 16May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received COVID 19 Treatment with Paxlovid from 17May2023 to 21May2023. Lot number: 6665318. Indication: Treatment of COVID-19. Adverse event: paxlovid didn't help much. finished last dose Sunday night and by Tuesday had temperature again (99.1) bad coughing that hurt chest. Slight headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300200912 Same reporter/patient, different product/events;
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Pfizer, Dose: 5 / Moderna, Dose: 4; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 83 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 at 10:00 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 at 10:00 as dose 2, single (Lot number: EN6203), in left arm and on 01Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing); "Zetia Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer, Dose: 5 / Moderna, Dose: 4". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 11May2023 to 15May2023. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201027 Same patient, different drug, different event.
Age: 59.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Ageusia, Anosmia, Asthenia, COVID-19, Eye pain
Clinical narrative: I'm not really sure about the timing in which this happened, but I know it happened in the winter of 2022. It probably took place in February or March. I began to feel weak at one point and like I had the flu. I had body aches, a fever, weakness, and achy eyes. I took both a rapid antigen and a PCR test at the the medical center, and the results on both were positive. I was prescribed a medication whose name I don't remember and then sent home. I stayed at home and had chicken noodle soup and orange juice for about three days or so. During my illness, I lost a little bit of my sense of smell and most of my sense of taste. The only thing I could taste was the chicken noodle soup. The loss of smell and taste lasted for maybe four days. After that, I started to feel better. I stayed at home from work for a week. When I went back to work, I felt fine, and I masked.
Age: 59.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Illness, Impaired work ability, Influenza like illness, Pain, Pyrexia
Clinical narrative: I'm not really sure about the timing in which this happened, but I know it happened in the winter of 2022. It probably took place in February or March. I began to feel weak at one point and like I had the flu. I had body aches, a fever, weakness, and achy eyes. I took both a rapid antigen and a PCR test at the the medical center, and the results on both were positive. I was prescribed a medication whose name I don't remember and then sent home. I stayed at home and had chicken noodle soup and orange juice for about three days or so. During my illness, I lost a little bit of my sense of smell and most of my sense of taste. The only thing I could taste was the chicken noodle soup. The loss of smell and taste lasted for maybe four days. After that, I started to feel better. I stayed at home from work for a week. When I went back to work, I felt fine, and I masked.
Age: 59.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I'm not really sure about the timing in which this happened, but I know it happened in the winter of 2022. It probably took place in February or March. I began to feel weak at one point and like I had the flu. I had body aches, a fever, weakness, and achy eyes. I took both a rapid antigen and a PCR test at the the medical center, and the results on both were positive. I was prescribed a medication whose name I don't remember and then sent home. I stayed at home and had chicken noodle soup and orange juice for about three days or so. During my illness, I lost a little bit of my sense of smell and most of my sense of taste. The only thing I could taste was the chicken noodle soup. The loss of smell and taste lasted for maybe four days. After that, I started to feel better. I stayed at home from work for a week. When I went back to work, I felt fine, and I masked.
Age: 1.42
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Ordered the wrong vaccine type, but patient needed DTaP and IPV. Patient was 17 months old. No adverse reactions were noted. Immediately called guardian, and left a voicemail to have guardian return the phone call. Immediately told supervisor as well of event.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Confusional state, Dizziness, Heart rate increased, Impaired driving ability
Clinical narrative: PATIENT CALLED PHARMACY COMPLAINING OF RAPID HEART BEAT, DIZINESS AND CONFUSION AFTER RECEIVING TETANUS VACCINE AT OFFICE. PT STATED THAT SHE HAD TO SIT IN HER CAR AFTER ADMINISTRATION AND THAT SHE WAS UNABLE TO PICK UP HE RX FROM THE PHARMACY BECAUSE SHE WAS UNABLE TO DRIVE. CALLED MD OFFICE AND SPOKE WITH SOMEONE. SHE STATED THAT THE PT RECEIVED TETATNUS AND DIPTHERIA VACCINE ( NO BRAND NAME, NO NDC) LOT#L015301 EX 06/3/2024. PER PATIENT SHE WILL GIVE PT A CALL
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac pacemaker insertion, Feeling abnormal, Palpitations
Clinical narrative: Pt stated feeling like her heart was racing after first injection.  She did not know what date.  First vaccine 08/19/2021 038B21A  the second on 09/16/2021 Lot # 007C21A and the third Bivalent on 02/17/2022 Lot 045L212 .  She continued to  feel off and ended up with a pacemaker on 05/02/2023.  The provider feels this is in relation to the vaccination and requested a report.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The correct vaccine was administered but it was expired by 15 hours and 34 minutes. It was opened 05/24/23 at 12:00 pm.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: BODY RASH, ITCHING AND SWELLING AROUND EYES AT NIGHT
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Brain fog, Cardiac ablation, Cardiac stress test, Depression
Clinical narrative: SVT,  bad menstrual cycles , migraines, insomnia, nausea, non-epileptic, seizures, vasovagal, syncope, hot and cold flashes, paralysis of the lower extremity, brain, fog and depression,
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram, Electroencephalogram, Feeling of body temperature change, Flushing, Insomnia
Clinical narrative: SVT,  bad menstrual cycles , migraines, insomnia, nausea, non-epileptic, seizures, vasovagal, syncope, hot and cold flashes, paralysis of the lower extremity, brain, fog and depression,
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Magnetic resonance imaging, Menstrual disorder, Migraine, Monoplegia
Clinical narrative: SVT,  bad menstrual cycles , migraines, insomnia, nausea, non-epileptic, seizures, vasovagal, syncope, hot and cold flashes, paralysis of the lower extremity, brain, fog and depression,
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Ovarian cyst, Ovarian cystectomy, Presyncope, Seizure
Clinical narrative: SVT,  bad menstrual cycles , migraines, insomnia, nausea, non-epileptic, seizures, vasovagal, syncope, hot and cold flashes, paralysis of the lower extremity, brain, fog and depression,
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Supraventricular tachycardia, Syncope, Ultrasound scan vagina, Uterine dilation and curettage
Clinical narrative: SVT,  bad menstrual cycles , migraines, insomnia, nausea, non-epileptic, seizures, vasovagal, syncope, hot and cold flashes, paralysis of the lower extremity, brain, fog and depression,
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: Chills, fever, runny nose, almost uncontrollable shakes in response to iced water, elevated blood pressure  I was taking Coricidin HBP Severe Flue tablets and was advised to continue taking; Paxlovid was not prescribed despite my risk factors.  As my symptoms were mild I wasn't offered monoclonal antibodies (?) eitherure
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after best use date
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave Expired dose of Kinrix (Dtap/IPV) Lot H9FM5 Ex: 5/7/2023 No Adverse effects or symptoms
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pyrexia
Clinical narrative: Woke up with fever next day. Left arm was swollen, red and bothered pt. Mom took pictures. Lasted 6 days gave her steroid cream and motrin
Sex: M
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Diarrhoea
Clinical narrative: Persistent diarrhea x 4-6 weeks. Elevated ALT, AST
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Chest pain, Hypoaesthesia, Illness
Clinical narrative: 2 days after the second dose of the Pfizer vaccination experienced deep chest pain that last about 1-2 weeks. Later developed numbness in two fingers on the right hand. In December experienced about 2 weeks of sickness that led to a visit at the emergency room. Diagnosed with COVID 19, pneumonia, numbness and loss of feeling in fingers on the right hand and stroke.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Sensory loss
Clinical narrative: 2 days after the second dose of the Pfizer vaccination experienced deep chest pain that last about 1-2 weeks. Later developed numbness in two fingers on the right hand. In December experienced about 2 weeks of sickness that led to a visit at the emergency room. Diagnosed with COVID 19, pneumonia, numbness and loss of feeling in fingers on the right hand and stroke.
Sex: U
Vaccine: MNQ
Symptoms: Injection site nodule, Product preparation issue
Clinical narrative: Menveo error, nurse practitioner who routinely does not administer vaccines, only injected the a part mixed with saline and did not properly reconstitute the vaccine. Post vaccination large subcutaneous nodule formed. Nurse practitioner reporter error but failed to recommend re-vaccination and failure to give data on this error.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling, Vaccination site induration, Vaccination site mass
Clinical narrative: After vaccination, developed hard, painful lump at vaccination site. Swelling increased and became red and itchy, spreading to 3 inches in diameter over 3 days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Fatigue, Gait inability, Hyperacusis, Impaired driving ability
Clinical narrative: After receiving the Pfizer vaccine, patient experienced severe vertigo that made her unable to work, walk, drive for many months; nonstop migraines; extreme fatigue. It was a disabling event that caused her to miss weeks of work and then have to change from full time to part time employment eventually. To this day she experiences extreme fatigue after any mild physical or mental exertion lasting more than a day; vertigo; loud noises make her feel nasueas and she cannot work full time.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Migraine, Nausea, Vertigo
Clinical narrative: After receiving the Pfizer vaccine, patient experienced severe vertigo that made her unable to work, walk, drive for many months; nonstop migraines; extreme fatigue. It was a disabling event that caused her to miss weeks of work and then have to change from full time to part time employment eventually. To this day she experiences extreme fatigue after any mild physical or mental exertion lasting more than a day; vertigo; loud noises make her feel nasueas and she cannot work full time.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The MA gave the patient two Hep B vaccines. Patients parent informed. 1 multi dose and 1 single dose "above listed" No reactions reported.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Given expired Rotateq vaccine.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Dry itchy raised patch of skin on face, then, lesions, sores, extremely itchy blister like bumps, all over body.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dry skin, HIV test negative, Pruritus, Rash, Rash pruritic
Clinical narrative: Dry itchy raised patch of skin on face, then, lesions, sores, extremely itchy blister like bumps, all over body.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin lesion, Treponema test negative
Clinical narrative: Dry itchy raised patch of skin on face, then, lesions, sores, extremely itchy blister like bumps, all over body.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, Chest pain, Hypoaesthesia, Illness
Clinical narrative: numbness in two fingers on the right hand; deep chest pain for 1-2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EB8731, Vaccine location: Left arm), administration date: 17Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10May2021, outcome "recovered", described as "deep chest pain for 1-2 weeks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in two fingers on the right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2 days after the second dose experienced deep chest pain for 1-2 weeks. Later experienced numbness in two fingers on the right hand. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not have COVID prior to vaccination and had no known allergies. Sender's Comments: Linked Report(s): US-PFIZER INC-202300201111 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: numbness in two fingers on the right hand; deep chest pain for 1-2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EB8731, Vaccine location: Left arm), administration date: 17Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10May2021, outcome "recovered", described as "deep chest pain for 1-2 weeks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in two fingers on the right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2 days after the second dose experienced deep chest pain for 1-2 weeks. Later experienced numbness in two fingers on the right hand. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not have COVID prior to vaccination and had no known allergies. Sender's Comments: Linked Report(s): US-PFIZER INC-202300201111 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: numbness in two fingers on the right hand; deep chest pain for 1-2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EB8731, Vaccine location: Left arm), administration date: 17Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10May2021, outcome "recovered", described as "deep chest pain for 1-2 weeks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in two fingers on the right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2 days after the second dose experienced deep chest pain for 1-2 weeks. Later experienced numbness in two fingers on the right hand. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not have COVID prior to vaccination and had no known allergies. Sender's Comments: Linked Report(s): US-PFIZER INC-202300201111 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: numbness in two fingers on the right hand; deep chest pain for 1-2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EB8731, Vaccine location: Left arm), administration date: 17Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10May2021, outcome "recovered", described as "deep chest pain for 1-2 weeks"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in two fingers on the right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2 days after the second dose experienced deep chest pain for 1-2 weeks. Later experienced numbness in two fingers on the right hand. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not have COVID prior to vaccination and had no known allergies. Sender's Comments: Linked Report(s): US-PFIZER INC-202300201111 same reporter/patient/product, different doses/AEs;
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report that a patient was administered an expired dose of RECOMBIVAX ( expiration date 04/28/2023).  The list states the administration period is supported. No additional AE/PQC; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 05-MAY-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #T035865, expiration date: 28-APR-2023, administered for prophylaxis (expired product administered) (dose, route of administration, and anatomical location were not provided).  The list stated that the administration period was supported. No additional adverse event was reported.
Sex: F
Vaccine: PNC13, PNC20, PPV
Symptoms: Cellulitis, Feeling hot, Infusion, Rash, Skin warm
Clinical narrative: Cellulitis; Cellulitis; superficial blood clot in arm; This spontaneous report has been received from a consumer via Pfizer, regarding a 56-years-old female patient. The patient's pertinent medical history included Small lymphocytic lymphoma (SLL), previous drug reactions or allergies and concomitant medications were not reported.  On 25-FEB-2017, the patient was vaccinated with one shot of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, and a shot of pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) intramuscularly in the left deltoid (lot number: R12276), both as prophylaxis.   Then on the same date, soon after receiving the vaccination, the patient's arm had a rash and was hot, which continued growing (Cellulitis). The patient took oral antibiotics with no relief and then an antibiotic shot from ER. But then, on an unspecified date (reported as next day) she had to be admitted the hospital, where she spent two days for intravenous antibiotic treatment.   On 25-MAR-2023, the patient was vaccinated with a single dose of pneumococcal vaccine conj 20v (CRM197) (PREVNAR20), intramuscularly in the left deltoid (lot number: GF7610) as prophylaxis.  On that same date, after receiving the vaccine, the patient experienced again rash and a felling of warmth (Cellulitis) again she was given oral antibiotics and then, the next day, the patient was admitted on 6-day hospitalization for IV infusion. It was reported that from that infusion she developed a superficial blood clot (thrombosis) leaving her arm extremely swollen.   The patient stated she only had cellulitis after receiving the pneumonia vaccines, therefore she would like to know the ingredients of the vaccines to potentially rule out an allergic reaction. It was reported that the patient was good by the time of the report(recovered).  The causal relationship between the events and the suspect therapies was not provided.   Upon internal review, the event thrombosis was determined to be medically significant.
Sex: F
Vaccine: PNC13, PNC20, PPV
Symptoms: Superficial vein thrombosis
Clinical narrative: Cellulitis; Cellulitis; superficial blood clot in arm; This spontaneous report has been received from a consumer via Pfizer, regarding a 56-years-old female patient. The patient's pertinent medical history included Small lymphocytic lymphoma (SLL), previous drug reactions or allergies and concomitant medications were not reported.  On 25-FEB-2017, the patient was vaccinated with one shot of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, and a shot of pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) intramuscularly in the left deltoid (lot number: R12276), both as prophylaxis.   Then on the same date, soon after receiving the vaccination, the patient's arm had a rash and was hot, which continued growing (Cellulitis). The patient took oral antibiotics with no relief and then an antibiotic shot from ER. But then, on an unspecified date (reported as next day) she had to be admitted the hospital, where she spent two days for intravenous antibiotic treatment.   On 25-MAR-2023, the patient was vaccinated with a single dose of pneumococcal vaccine conj 20v (CRM197) (PREVNAR20), intramuscularly in the left deltoid (lot number: GF7610) as prophylaxis.  On that same date, after receiving the vaccine, the patient experienced again rash and a felling of warmth (Cellulitis) again she was given oral antibiotics and then, the next day, the patient was admitted on 6-day hospitalization for IV infusion. It was reported that from that infusion she developed a superficial blood clot (thrombosis) leaving her arm extremely swollen.   The patient stated she only had cellulitis after receiving the pneumonia vaccines, therefore she would like to know the ingredients of the vaccines to potentially rule out an allergic reaction. It was reported that the patient was good by the time of the report(recovered).  The causal relationship between the events and the suspect therapies was not provided.   Upon internal review, the event thrombosis was determined to be medically significant.
Sex: F
Vaccine: MENB
Symptoms: Attention deficit hyperactivity disorder, Autism spectrum disorder, Fatigue, Pyrexia
Clinical narrative: Autism spectrum disorder; fatigue; Fever/101.3 F tempature orally taken; ADHD; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 2 , single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Trumenba (DOSE 1, SINGLE), for Immunization. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever/101.3 F tempature orally taken"; ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious), outcome "unknown", described as "ADHD". The patient underwent the following laboratory tests and procedures: Body temperature: 101.3 Fahrenheit. Therapeutic measures were taken as a result of autism spectrum disorder (Autism spectrum disorder medications). Additional information: Fever fatigue at the 4 hour mark after 2nd dose administered.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available the serious event Autism spectrum disorder is coincidental and unrelated to TRUMENBA.  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