chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Hiberix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number cH392, expiry date 22-MAR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Hiberix. On 03-MAY-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Hiberix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was medical assistant. The reporter did not consent to follow up. The patient was administered an expired dose of Hiberix which led to expired vaccine used. This case is linked with US2023064469, reported by same reporter.; Sender's Comments:  US-GSK-US2023064469:Same reporter (male patient)
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Extra Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received HAV (Havrix) (batch number 2YZ9B, expiry date 07-DEC-2023) for prophylaxis.   Previously administered products included Havrix (2 doses received on an unknown date ).   On 17-APR-2023, the patient received the 3rd dose of Havrix. On 17-APR-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Extra Havrix administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter reported that a female patient was the administered an extra Havrix dose. The patient had already received 2 doses of Havrix but by mistake she received an extra dose which led to extra dose administered. The reporter asked if had some information regarding this situation. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Jul2021, 2nd March 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2021 ).   In MAR-2022, the patient received the 2nd dose of Shingrix. In MAR-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Jul2021, 2nd March 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The pharmacist reported that no exact vaccination dates or lot number for the vaccine were available because it was at a different facility. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 23t73, expiry date 30-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Infanrix. On 04-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Infanrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 Reporter's Comment: The medical office staff member reported that the patient received a dose of Infanrix, which was already expired on 30th April 2023 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Extra Boostrix and Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 9th November 2022) and Menveo (received 1st dose on 9th November 2022).   On 02-MAY-2023, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 02-MAY-2023, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: Extra Boostrix and Menveo administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 Reporter's Comment: The nurse practitioner reported that the patient accidentally received a dose of Boostrix and Menveo, which led to extra dose administered. The reporter wished to ask how to proceed. The reporter only had information about the patient and vaccination date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with distilled water; reconstituted with distilled water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 80-year-old patient who received Herpes zoster (Shingrix) (batch number TY2TY, expiry date 09-FEB-2024) for prophylaxis.   On 03-MAY-2023, the patient received the 1st dose of Shingrix. On 03-MAY-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with distilled water) and inappropriate dose of vaccine administered (Verbatim: reconstituted with distilled water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-MAY-2023 The nurse called to inform that a patient received the 1st dose of Shingrix, but such dose was reconstituted using distilled water instead of the approved diluent of Shingrix.  The reporter was consented to follow up. The patient received Shingrix dose which was reconstituted using distilled water instead of the approved diluent of Shingrix, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   Concomitant products included MENVEO.   On 04-MAY-2023, the patient received the 2nd dose of Menveo. On 04-MAY-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 04-MAY-2023 A nurse reported that a patient received an accidental additional dose on the day of reporting.  The vaccine administration facility is the same as primary reporter. The HCP noted the patient's parents speak another language and the extra dose was given due to miscommunication with the language barrier. The reporter consented to follow-up via email. The patient received an accidental additional dose of Menveo, which led to extra dose administered.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Treatment medications were not reported.  The number was reported.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Fever; Wrong vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, the patient experienced PYREXIA (Fever) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). On 19-Jan-2023, PYREXIA (Fever) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had fever for one day.   Treatment information was not reported.  The number was reported.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Apr-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   No treatment information was provided.  The number was reported.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided.  The number was reported.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: 2 days with fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (2 days with fever) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, the patient experienced PYREXIA (2 days with fever). On 20-Jan-2023, PYREXIA (2 days with fever) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The number was reported. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Malaise, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 antibody test
Clinical narrative: Blowing his nose a lot; Sore throat; Soreness in his injection site; Malaise feeling; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise feeling), NASAL CONGESTION (Blowing his nose a lot), OROPHARYNGEAL PAIN (Sore throat) and INJECTION SITE PAIN (Soreness in his injection site) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022 and COVID-19 in May 2022. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 02-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 29-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (sulfa).    On 29-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-May-2023, the patient experienced MALAISE (Malaise feeling), OROPHARYNGEAL PAIN (Sore throat) and INJECTION SITE PAIN (Soreness in his injection site). On an unknown date, the patient experienced NASAL CONGESTION (Blowing his nose a lot). On 03-May-2023, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, MALAISE (Malaise feeling) and INJECTION SITE PAIN (Soreness in his injection site) had not resolved and NASAL CONGESTION (Blowing his nose a lot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient had COVID twice. Both times it started with a sore throat. The last time patient caught COVID and tested negative at the hospital at the emergency room. Patient called his doctor two months later. They did an antibody test, and the doctor told patient had COVID two months ago. Patient had to see neuro because of the side effects from the second time he caught COVID. Patient had all kinds of side effects. The patient states didn't had any side effects from Pfizer doses.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Local reaction, Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), 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), for COVID-19 immunization, reaction(s): "local reaction", "sore arm", "little fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore arm", "little fever".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown".  Additional information: Reporter stated that he took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. He also had one bivalent booster. He experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. He was eligible for the second bivalent booster however, He think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine and asked does it contain Polyethylene glycol.  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-202300180008 same reporter/product/AE, different patient;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Overdose, Pain
Clinical narrative: extreme body pain especially in the upper part of his body; Chills; Fatigue; nurse administered 0.5ml of the vaccine as opposed to 0.3ml; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dose 3 (booster), 0.5 ml single (Lot number: GJ6739, Expiration Date: 31Jul2023) at the age of 53 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: OVERDOSE (medically significant) with onset 14Apr2023, outcome "not recovered", described as "nurse administered 0.5ml of the vaccine as opposed to 0.3ml"; CHILLS (medically significant) with onset 15Apr2023, outcome "not recovered"; FATIGUE (medically significant) with onset 15Apr2023, outcome "not recovered"; PAIN (medically significant) with onset 15Apr2023, outcome "not recovered", described as "extreme body pain especially in the upper part of his body". Caller is a nurse practitioner calling about the Covid-19 Bivalent vaccine and reported that on the 14Apr2023, one of their nurse administered 0.5ml of the vaccine as opposed to 0.3ml. The patient initially felt fine, but 24 hours later, they complained about extreme body pain especially in the upper part of his body. Caller stated that they were body aches. The patient had no fever, but has chills and fatigue and is still experiencing all of this and reporting that it is the same or worse. Relatedness of drug to reaction(s)/event(s): Source of assessment: Method of assessment: Result of Assessment: Yes; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The reporter mentioned that he and his wife took the initial Pfizer COVID vaccine and the bivalent COVID vaccine last Oct and had a sore arm. His wife started taking Miralax (propylene glycol) and possibly had a reaction to it. He wants to know if vaccines have the same product.  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-202300180212 same patient/vaccine/event; different dose;
Age: 74.0
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 non-contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 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 on 28Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "TIA" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Epinephrine, reaction(s): "Known allergies: epinephrine". 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, patient received Paxlovid from 28Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7533), in left arm and on 22Apr2021 as dose 2, single (Lot number: ER8735) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypothyroidism" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (02May2023) Negative; (03May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180817 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Ventricular extrasystoles
Clinical narrative: heart arrythmia; PVCs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: EP7534) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand= pfizer,, Prev dose lot number=EN6203,, Prev dose dose number=1), administration date: Feb2021, for COVID-19 immunization. No known allergies. The following information was reported: VENTRICULAR EXTRASYSTOLES (disability) with onset May2021, outcome "not recovered", described as "PVCs"; ARRHYTHMIA (disability, medically significant) with onset May2021, outcome "not recovered", described as "heart arrythmia". The events "heart arrythmia" and "pvcs" required physician office visit. PVCs have steadily increased and have had to start medication to treat. Therapeutic measures were taken as a result of arrhythmia, ventricular extrasystoles, treatment includes Beta Blocker and now Calcium Channel.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report received from a 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: MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  Additional information: Reporter mentioned feeling unwell for a day or two after being vaccinated.   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-202300180963 Same reporter/ drug/ event for different patients.;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 004M20A), on 05Mar2021 as dose 2, single (Lot number: 023M20A) and on 29Oct2021 as dose 3 (booster), single (Lot number: 0047C21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Jul2022, outcome "unknown", described as "Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: extreme dizziness; vertigo (room was spinning); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Lot No: Unknown), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Sep2022, outcome "recovered", described as "extreme dizziness"; VERTIGO (non-serious) with onset Sep2022, outcome "recovered", described as "vertigo (room was spinning)". Therapeutic measures were not taken as a result of dizziness, vertigo.  Additional Information: It was reported that the events occurred in the first 24 hours after receiving his second Pfizer covid booster. It was not known if this was a monovalent or bivalent booster. It was also reported that the events resolved on its own.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRALAX. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  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-PV202300080184 Same patient/event, different vaccine dose;US-PFIZER INC-PV202300080185 Same patient, product, and event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Miralax, reaction(s): "reaction". Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "Pain in arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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-PV202300080183 Same patient/event, different vaccine dose;US-PFIZER INC-PV202300080185 Same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a non-contactable consumer, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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. Past drug history included: Miralax, reaction(s): "Reaction". Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 2), 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 patient and her husband took the initial Pfizer COVID-19 vaccine and the bivalent COVID-19 vaccine last Oct2022 and had a sore arm. The patient started taking MIRALAX (reported as propylene glycol) and possibly had a reaction to it. The patient's husband wants to know if vaccines have the same product.  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-PV202300080183 Same patient, product, and event; different dose;US-PFIZER INC-PV202300080184 Same patient, product, and event; different dose;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Incorrect route of product administration, Suspected COVID-19
Clinical narrative: she contracted COVID-19 in Feb of this year; she contracted COVID-19 in Feb of this year; patient received BNT162B2 via subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 35-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE]; SPIRIVA [TIOTROPIUM BROMIDE]; SYMBICORT; ALBUTEROL [SALBUTAMOL SULFATE]; PEPCID [FAMOTIDINE]; TRULANCE. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2021, outcome "unknown", described as "patient received BNT162B2 via subcutaneously"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" and all described as "she contracted COVID-19 in Feb of this year". Clinical course: A female patient with a history of asthma reported in market research that she contracted COVID-19 in Feb of this year. Her most recent Pfizer COVID-19 vaccine was in Aug2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: gullian barre syndrome; This is a spontaneous report received from contactable reporter(s) (Other 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "gullian barre syndrome". Clinical course: the patient got gullian barre syndrome after getting Covid shot and then got the syndrome again a year later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and considering the possible temporal relationship based on the description of the reporter, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event "gullian barre syndrome" conservatively. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Rash
Clinical narrative: a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body; fatigue; symptoms of a minor cold; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0170) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot no: ER8733, Expiration date not provided.), administration date: 31Mar2021, for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body"; FATIGUE (non-serious) with onset 2021, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "symptoms of a minor cold". The events "a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body", "fatigue" and "symptoms of a minor cold" required physician office visit.  Additional Information: The patient was a healthy individual. After 2nd dose, patient experienced a moderate to severe rash that appeared within 2-5 days after injection. The rash had persisted till 03May2023, in the form of mild to moderate rashes on hands and other parts of body. He had sought out medical attention from a dermatologist and would have an appointment with allergist within next month. Dose 3 with lot number lot number FJ8762 was administered on 15Dec2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dysphoria
Clinical narrative: dizziness; dysphoria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; DYSPHORIA (non-serious), outcome "unknown".  Additional information: patient reported that he was involved in a recent clinical trial but he didn't know whether he was in the study.  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.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: on 5/4/23 pt woke up with redness, warmth and itching of injection site,  redness has cont to increase over last several day
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt came in for Bivalent booster to which patient received. However upon follow-up review, patient had received bivalent booster 10/18/22.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired work ability, Paranasal sinus discomfort, Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test
Clinical narrative: I was having some issues with my throat being clogged and my sinus' were really irritated. I did take a COVID-19 Home Test and that was negative, but I called and had a virtual visit. They had me come in the next day and I was tested for strep throat. They got me on antibiotics, and I watched for a fever as well. I was able to go back to work after two days of being on the antibiotics.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Dyspnoea exertional
Clinical narrative: Short of breath started about 30 min after vaccine. Worse if I move around
Age: 0.67
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Moderna vaccine administered. For 2nd dose in series and CDC recommendations patient should have received Moderna dark blue cap/gray label as her 2nd dose.  Patient experienced no side effects. Family aware of error and recommendation to repeat with additional dose.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Carbohydrate antigen 125 increased, Computerised tomogram abnormal, Endometriosis, Magnetic resonance imaging abnormal, Mass
Clinical narrative: After my 1st vaccine ever administered on 17-Mar-2021, I had my first ovarian cyst rupture in August 2021. I followed up with imaging since then with my gynecologist, Dr and have had multiple cysts on my ovaries. My second cyst ruptured on April 7, 2023, about 4 months after my 2nd Pfizer booster. Please note all Pfizer vaccine dates and lot #'s have been reported through Pfizer Safety Reporting #COV-2305-Prxw9z. It was then that the ER physician discovered a mass after I had a CT scan w/ and w/o contrast. I followed up with Dr. and this was thought to be an ovarian endometrioma per transvag ultrasound. However, I was referred to a gynecologic oncologist b/c my CA-125 biomarker was elevated at Anything over 35 is above the normal range. I had an MRI w/ and w/o contrast and it showed that the ovarian endometrioma was approximately 6 x 10 x 6 cm and located unusually in front of my bladder. No lymph node inflammation noted. No ascites noted. Uterus unremarkable. I am having surgery tomorrow, 09-May-2023, to remove the endometrioma, get it biopsied, and I also need a salpingo-oophorectomy with a hysterectomy.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ovarian cyst ruptured, Scan with contrast abnormal, Ultrasound scan vagina abnormal
Clinical narrative: After my 1st vaccine ever administered on 17-Mar-2021, I had my first ovarian cyst rupture in August 2021. I followed up with imaging since then with my gynecologist, Dr and have had multiple cysts on my ovaries. My second cyst ruptured on April 7, 2023, about 4 months after my 2nd Pfizer booster. Please note all Pfizer vaccine dates and lot #'s have been reported through Pfizer Safety Reporting #COV-2305-Prxw9z. It was then that the ER physician discovered a mass after I had a CT scan w/ and w/o contrast. I followed up with Dr. and this was thought to be an ovarian endometrioma per transvag ultrasound. However, I was referred to a gynecologic oncologist b/c my CA-125 biomarker was elevated at Anything over 35 is above the normal range. I had an MRI w/ and w/o contrast and it showed that the ovarian endometrioma was approximately 6 x 10 x 6 cm and located unusually in front of my bladder. No lymph node inflammation noted. No ascites noted. Uterus unremarkable. I am having surgery tomorrow, 09-May-2023, to remove the endometrioma, get it biopsied, and I also need a salpingo-oophorectomy with a hysterectomy.
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Incorrect Moderna vaccine administered. For 2nd dose in series and CDC recommendations patient should have received Moderna dark blue cap/gray label as her 2nd dose.  Patient experienced no side effects. Family aware of error and recommendation to repeat with additional dose. Vaccine administered by,CMA.  VAERS completed by CMA.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash below deltoid where shot was administered. "Feels hot". Normal post vaccine soreness on area of injection. No SOB or other symptoms reported.
Age: 0.67
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Moderna vaccine administered. For 2nd dose in series and CDC recommendations patient should have received Moderna dark blue cap/gray label as her 2nd dose.  Patient experienced no side effects. Family aware of error and recommendation to repeat with additional dose. Vaccine administered by LPN.  VAERS completed by CMA.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 03/12/2023. I took Paxlovid medication prescribed by my doctor. for one day only because it made me sicker.  I got really tired and exhausted, flu like symptoms.  My symptoms lasted about ten days.  I tested negative ten days afterwards. I did a telehealth with my doctor.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Moderna vaccine administered. For 2nd dose in series and CDC recommendations patient should have received Moderna dark blue cap/gray label as her 2nd dose.  Patient experienced no side effects. Family aware of error and recommendation to repeat with additional dose. Vaccine administered by LPN.  VAERS completed by CMA.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Pain, Pruritus, Rash
Clinical narrative: I received my first dose of Pfizer COVID-19 vaccine on 8/21/2021. Three days later, on 8/24/2021, I began getting itchy skin in the area of the left side of my abdomen. On the left midsection of my torso, I had itching and small bumps to the left of my spinal column. Over about the following two weeks, the bumps enlarged, though the itching was then less pronounced. By around 9/1/2021, I had a constant burning, painful sensation in the affected area. At this point, the lesions had blistered and were seeping clear fluid. The discomfort was at its worst around 9/6/2021, and they finally crusted over and stopped oozing around 9/8/2021. During my illness, I constantly applied calamine lotion to the lesions. I had a virtual appointment with my PCP on 9/10/2021. She said that it was likely shingles with encrusted lesions. She said that since so much time had elapsed since the onset of symptoms, I was not eligible to receive Valtrex. However, she did give me gabapentin for pain relief. I only took the gabapentin twice, because the pain became more manageable afterwards. I continued to go through the recovery process. The pain finally stopped around 9/17/2021. Eventually, the sores healed, and I still have residual scarring on the left side of my back.