chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border; Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1) on 03-Mar-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.    On 28-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 28-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.).    No concomitant information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: AE filed as it has been greater than 37 days since first dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.).    Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Muscle spasms, Muscle twitching, Palpitations
Clinical narrative: heart palpitations; muscle twitching; spasms; high blood pressure; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had no allergies and no medical history.  Previously administered products included for COVID-19 prophylaxis: COVID 19 Vaccination (Dose 1 and(lot number 067F21A) site of administration; left arm) on 11-Jan-2022. Past adverse reactions to the above products included No adverse event with COVID 19 Vaccination. Concurrent medical conditions included Low blood pressure.    On 15-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure). At the time of the report, PALPITATIONS (heart palpitations), MUSCLE TWITCHING (muscle twitching), MUSCLE SPASMS (spasms) and HYPERTENSION (high blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: it was close to 140/mid-to-upper 90s.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient had concomitant medication include blood pressure medication that patient took once a day, It was reported that the patient's symptoms started about 3 months after the second vaccine. Before the vaccine, he had really low blood pressure, but after the vaccine, it's been really high. It's been recorded at each doctor visit where it's been significantly higher. The last time, it was close to 140/mid-to-upper 90s. Prior to the vaccine, it was 100-110/high 50s to low 60s. Patient went to the emergency room and prescribed a muscle relaxer, called Flexeril. Patient went to the emergency room about two weeks ago.
Age: 0.5
Sex: U
Vaccine: PNC13
Symptoms: Device issue, Scratch
Clinical narrative: ended up scratching the baby; a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 17Apr2023 at 15:00 as dose 3, single (Lot number: GD1168) at the age of 6 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumococcal vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Immunization; Pneumococcal vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Immunization. The following information was reported: DEVICE ISSUE (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination"; SCRATCH (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "ended up scratching the baby".  Additional information: It is PREVNAR 13 vaccination and a part of the needle or a part of the, what you call the vaccination two things fell apart while giving the vaccination to a baby. It happened on 17Apr2023 at 15:00, this was the third dose of the baby. The blue portion of the syringe of the vaccine shot came off while injecting. The nurse pulled it out quickly. However, it scratched the child, and she ended up pricking herself with the needle. When probed if the needle got injected to nurse accidentally, no. The blue part on the syringe or the needle broke off while giving the vaccine to the baby. So, when she pulled it out knowing that it is already broken, ended up scratching the baby and poking herself at the same time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300164496 Same reporter/ drug, different patients;
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, Poor quality product administered
Clinical narrative: Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe; Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe; This is a spontaneous report received from a contactable reporter (Nurse) from the Medical Information Team.  A patient (no qualifiers provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe."  Additional information: Caller is seeking guidance because 2 patients were given doses of the Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe. Caller also asked what to do with the box they have, since some of it has bubble accumulation or floaters as well.  The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300170337 same product, same event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 as dose 5 (booster), single (Lot number: GH9694), 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: "non-Hodgkins lymphoma" (unspecified if ongoing), notes: In remission. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: followed by 3 days testing negative (at-home test); Negative, notes: followed by 3 days testing negative (at-home test); Negative, notes: followed by 3 days testing negative (at-home test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Other medication in 2weeks, Patient received Paxlovid Treatment from16Apr2023 to 20Apr2023 for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; FENOFIBRATE; LISINOPRIL; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 as dose 2, single at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 18Apr2023 to 22Apr2023.  Clinical course: No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA, start date: 04Jun2007; ZOLOFT, start date: 04Jun2007; TRAZODONE, start date: 04Jun2007; NUVIGIL, start date: 04Jun2007; METOPROLOL, start date: 04Jun2007; LISINOPRIL, start date: 04Jun2007. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Apr2023 to 24Apr2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173554 same reporter/patient, different product/AE;
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tinea versicolour" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 26Apr2023. Clinical course: The patient did not had other medication in 2 weeks. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173623 Same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: six people with the same death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: DEATH (death), outcome "fatal", described as "six people with the same death". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173561 same reporter/product/AE, different patient;US-PFIZER INC-202300176094 same reporter/drug/event, different patient;US-PFIZER INC-202300177046 same reporter/drug/event, different patient;US-PFIZER INC-202300177045 same reporter/drug/event, different patient;US-PFIZER INC-202300177043 same reporter/drug/event, different patient;US-PFIZER INC-202300177044 same reporter/drug/event, different patient;; Reported Cause(s) of Death: six people with the same death
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: he experienced dizziness; headache; Nausea; Vomiting; Fever of 100; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose 5 (booster), single (Lot number: GL0447) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low Grade Prostate Cancer" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: , Date: 02Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6202), administration date: 02Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (2nd dose: , Date: 23Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6205), administration date: 23Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (3rd dose: , Date: 18Oct2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN0191), administration date: 18Oct2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (4th Dose: , Date: 12Apr2022 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: FK9729), administration date: 12Apr2022, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023), described as "Fever of 100"; NAUSEA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); VOMITING (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); DIZZINESS (non-serious) with onset 26Apr2023, outcome "not recovered", described as "he experienced dizziness"; HEADACHE (non-serious) with onset 26Apr2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, headache, nausea, vomiting, pyrexia.  Additional information: Reporter stated her son took the Pfizer Covid 19 Bivalent 2 days ago and he still feels dizzy and he felt nauseous and threw up yesterday. Repoter also reports the patient has pain is in head like a headache. She states he had a fever of 100 yesterday. Treatment: Extra Strength Tylenol. No Prior Vaccinations within 4 weeks to the first administration date of the suspect vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he experienced dizziness; headache; Nausea; Vomiting; Fever of 100; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose 5 (booster), single (Lot number: GL0447) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low Grade Prostate Cancer" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: , Date: 02Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6202), administration date: 02Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (2nd dose: , Date: 23Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6205), administration date: 23Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (3rd dose: , Date: 18Oct2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN0191), administration date: 18Oct2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (4th Dose: , Date: 12Apr2022 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: FK9729), administration date: 12Apr2022, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023), described as "Fever of 100"; NAUSEA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); VOMITING (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); DIZZINESS (non-serious) with onset 26Apr2023, outcome "not recovered", described as "he experienced dizziness"; HEADACHE (non-serious) with onset 26Apr2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, headache, nausea, vomiting, pyrexia.  Additional information: Reporter stated her son took the Pfizer Covid 19 Bivalent 2 days ago and he still feels dizzy and he felt nauseous and threw up yesterday. Repoter also reports the patient has pain is in head like a headache. She states he had a fever of 100 yesterday. Treatment: Extra Strength Tylenol. No Prior Vaccinations within 4 weeks to the first administration date of the suspect vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Penile pain, Proctalgia
Clinical narrative: Barely can walk; Pain around his penis and anus on both sides; Pain around his penis and anus on both sides; 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 33-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2021 as dose 2, 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), for COVID-19 immunization.  The following information was reported: PENILE PAIN (non-serious), PROCTALGIA (non-serious) all with onset 21Jul2021, outcome "unknown" and all described as "Pain around his penis and anus on both sides"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Barely can walk".  Additional information: The caller mentioned that he had pain around his penis and anus on both sides for almost 2 years provided after taking the second dose of the Pfizer COVID-19 vaccine. The pain started and he said he barely can walk and the pain comes back after 5 minutes of standing.  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: Pain in extremity
Clinical narrative: sore arm; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".   Additional information: Caller stated that when he received his 4 vaccines "the only thing he ended up with was a sore arm". The caller further stated that in Dec2022 he had Covid and he was annoyed, why was still getting Covid. He did not die but he was very sick not throwing up, a lot of chills and fever.  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: Pain in extremity
Clinical narrative: sore arm; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 09Jul2021 as dose 2, 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), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".   Additional information: Caller states when he received his 4 vaccines "the only thing I ended up with was a sore arm.  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: Pain in extremity
Clinical narrative: sore arm; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (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), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose 2 single), administration date: 09Jul2021, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The case was reported as not serious. No PQC present. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than equal to 12 years - 15/15 mcg per dose. Calling regarding the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula. The caller stated in Dec2022 "I had Covid and I was annoyed, why am still getting Covid? I didn't die but I was very sick not throwing up, a lot of chills and fever. Caller stated when he received his 4 vaccines "the only thing I ended up with was a sore arm. My sister was very sick after her Covid vaccine." 1st dose-11Jun2021- Primary series, 2nd dose-09Jul2021 -Primary series, 3rd dose-21Jan2022-Booster, 4th dose-12Aug2022-Booster. Caller stated he had taken 4 Pfizer Covid vaccines in the past. On 12Aug2022, the patient did not think patient took the "newest one out there. I think they started making the newest one the end of that month I believe - What is the newest one, Covid vaccine, you have, is that still the newest one or is there a newer one? What is the name of the current recommended vaccine? What does Bivalent mean?" Question: -Caller is asking since his last dose, do I still have immunity to Covid? "If I got my last dose in August 2022 the ER doctor told me I should've still been immune? How long will the Bivalent dose last? How long does it take to work? I have no heart issue. Can these prior vaccines effect my heart down the road or will the newest vaccine? If I get the Pfizer covid vaccine today and in less than a week I get Covid 19. Then after I get Covid 19 I end up in a coma. I already had the vaccine before this, in a few weeks would I wake up from my coma? Once I take this vaccine will I have to take another one in a few months?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 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), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 2), administration date: 09Jul2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 3), administration date: 21Jan2022, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The caller stated in Dec2022 "I had Covid and I was annoyed, why am still getting Covid? I didn't die but I was very sick not throwing up, a lot of chills and fever. 2020 was a tough year for everybody, 1million people died. That is insane. That's worse than a war." "In 2023 the disease seems less severe than in 2020". Caller stated when he received his 4 vaccines the only thing he ended up with was a sore arm. His sister was very sick after her Covid vaccine." Caller stated he has taken 4 Pfizer Covid vaccines in the past. On 12Aug2022 he did not think he took the "newest one out there. He thought they started making the newest one the end of that month I believe" He wanted to know what is the newest one, Covid vaccine, you have, is that still the newest one or is there a newer one, What is the name of the current recommended vaccine, caller was asking What does Bivalent mean. Caller was asking since his last dose, does he still have immunity to Covid, he asked "If I got my last dose in August 2022 the ER doctor told me I should've still been immune" How long will the Bivalent dose last and How long does it take to work" also "I have no heart issue. Can these prior vaccines effect my heart down the road or will the newest vaccine", patient wanted to know "If he get the Pfizer covid vaccine today and in less than a week he get Covid 19. Then after he get Covid 19 he end up in a coma. He already had the vaccine before this, in a few weeks would he wake up from my coma", "Once he take this vaccine will he have to take another one in a few months".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sore arm; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 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), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 2), administration date: 09Jul2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 3), administration date: 21Jan2022, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The caller stated in Dec2022 "I had Covid and I was annoyed, why am still getting Covid? I didn't die but I was very sick not throwing up, a lot of chills and fever. 2020 was a tough year for everybody, 1million people died. That is insane. That's worse than a war." "In 2023 the disease seems less severe than in 2020". Caller stated when he received his 4 vaccines the only thing he ended up with was a sore arm. His sister was very sick after her Covid vaccine." Caller stated he has taken 4 Pfizer Covid vaccines in the past. On 12Aug2022 he did not think he took the "newest one out there. He thought they started making the newest one the end of that month I believe" He wanted to know what is the newest one, Covid vaccine, you have, is that still the newest one or is there a newer one, What is the name of the current recommended vaccine, caller was asking What does Bivalent mean. Caller was asking since his last dose, does he still have immunity to Covid, he asked "If I got my last dose in August 2022 the ER doctor told me I should've still been immune" How long will the Bivalent dose last and How long does it take to work" also "I have no heart issue. Can these prior vaccines effect my heart down the road or will the newest vaccine", patient wanted to know "If he get the Pfizer covid vaccine today and in less than a week he get Covid 19. Then after he get Covid 19 he end up in a coma. He already had the vaccine before this, in a few weeks would he wake up from my coma", "Once he take this vaccine will he have to take another one in a few months".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: I had Covid and I was annoyed, why am still getting Covid; I had Covid and I was annoyed, why am still getting Covid; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Batch/Lot number: unknown), on 09Jul2021 as dose 2, single (Batch/Lot number: unknown), on 21Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 12Aug2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "I had Covid and I was annoyed, why am still getting Covid".  Clinical course: The Reporter stated in Dec2022 he had Covid, and he was annoyed, why he was still getting Covid. He didn't die but he was very sick not throwing up, a lot of chills and fever. The reporter stated when he received his 4 vaccines the only thing, he ended up with was a sore arm. The reporter stated he had taken 4 Pfizer Covid vaccines in the past. On 12Aug2022 he doesn't think he took the newest one out there. He thought they started making the newest one at the end of that month he believed. The reporter was asking since his last dose, whether he still has immunity to Covid. If he got his last dose in August 2022 the ER doctor told him he should've still been immune. He queried if he gets the Pfizer covid vaccine today and in less than a week does he get Covid 19. Then after he gets Covid 19 if he would end up in a coma. Once he takes this vaccine would he have to take another one in a few months."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had Covid and I was annoyed, why am still getting Covid; I had Covid and I was annoyed, why am still getting Covid; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Batch/Lot number: unknown), on 09Jul2021 as dose 2, single (Batch/Lot number: unknown), on 21Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 12Aug2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "I had Covid and I was annoyed, why am still getting Covid".  Clinical course: The Reporter stated in Dec2022 he had Covid, and he was annoyed, why he was still getting Covid. He didn't die but he was very sick not throwing up, a lot of chills and fever. The reporter stated when he received his 4 vaccines the only thing, he ended up with was a sore arm. The reporter stated he had taken 4 Pfizer Covid vaccines in the past. On 12Aug2022 he doesn't think he took the newest one out there. He thought they started making the newest one at the end of that month he believed. The reporter was asking since his last dose, whether he still has immunity to Covid. If he got his last dose in August 2022 the ER doctor told him he should've still been immune. He queried if he gets the Pfizer covid vaccine today and in less than a week does he get Covid 19. Then after he gets Covid 19 if he would end up in a coma. Once he takes this vaccine would he have to take another one in a few months."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment/Drug ineffective; COVID-19 treatment/COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HBP" (unspecified if ongoing); "OA" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: 01Apr1979; SINGULAIR, start date: 01Feb2001; VALSARTAN, start date: 12May2008; PROZAC, start date: 01Jun2015; ALPRAZOLAM, start date: 01Mar2022; MELATONIN; TRAMADOL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", described as "COVID-19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "recovering", described as "COVID-19 treatment/COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID-19 treatment. Therapeutic measures 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-PV202300077535 Same patient, same product, different events;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Wrong vaccine administered; 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 63-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL3302), on 12Mar2021 as dose 2, single (Lot number: EN6207), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA) and on 08Apr2023 as dose 5 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Proxysmal AFib (post ablation)", start date: 2019 (unspecified if ongoing); "Proxysmal AFib (post ablation)", start date: 2019 (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Oct2021, stop date: 19Apr2023; METOPROLOL SUCCINATE, start date: Oct2021. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Apr2023, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2023) positive, notes: due to positive Ag rapid test; (25Apr2023) negative; (26Apr2023) negative; (27Apr2023) positive, notes: COVID-19 Ag rapid test positive too; (18Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Took Paxlovid for 5 days due to positive Ag rapid test and positive PCR. Cold-like symptoms that started on 18Apr2023 disappeared on 20Apr2023. COVID-19 Ag rapid test negative on 25Apr2023 and 26Apr2023. On 27Apr2023 rebound of cold-like symptoms starting, COVID-19 Ag rapid test positive too.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173740 Same patient, different event/drug;US-PFIZER INC-202300175119 Same patient and product, Different dose and events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Benadryl injection 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 15Apr2023 to 19Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300077566 same patient, different drug/events;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 39 years, 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Started testing positive  again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.