chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, UNK
Symptoms: Chills, Eye pain, Fatigue, Headache, Lip swelling
Clinical narrative: Swollen lip; Hives; Swollen throat; Headache; Pain in right eye with swelling; Nausea; Bodyache; Chills; Fatigue; Pain in right eye with swelling; This spontaneous case initially received on 08-Oct-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: US-FDA-2792387-1), was reported by a health authority, was reported by a health authority and concerns an adult female patient.  At the time of the event the patient had dairy, sulfur medicine, dog, cat, blue grass, Latex allergy. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) used for an unknown indication, Anatomical site: Left arm, Lot number: 946589. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Swollen lip (outcome: Recovered / Resolved), Hives (outcome: Recovered / Resolved), Swollen throat (outcome: Recovered / Resolved), Headache (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved), Nausea (outcome: Recovered / Resolved), Bodyache (outcome: Recovered / Resolved), Chills (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events are considered related
Sex: F
Vaccine: FLU3, UNK
Symptoms: Pain, Pharyngeal swelling, Swelling, Urticaria
Clinical narrative: Swollen lip; Hives; Swollen throat; Headache; Pain in right eye with swelling; Nausea; Bodyache; Chills; Fatigue; Pain in right eye with swelling; This spontaneous case initially received on 08-Oct-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: US-FDA-2792387-1), was reported by a health authority, was reported by a health authority and concerns an adult female patient.  At the time of the event the patient had dairy, sulfur medicine, dog, cat, blue grass, Latex allergy. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) used for an unknown indication, Anatomical site: Left arm, Lot number: 946589. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Swollen lip (outcome: Recovered / Resolved), Hives (outcome: Recovered / Resolved), Swollen throat (outcome: Recovered / Resolved), Headache (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved), Nausea (outcome: Recovered / Resolved), Bodyache (outcome: Recovered / Resolved), Chills (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events are considered related
Sex: F
Vaccine: FLU3, UNK
Symptoms: Chills, Eye swelling, Fatigue, Lip swelling, Nausea
Clinical narrative: Swollen lip; Hives; Swollen throat; Headache; Pain in right eye with swelling; Nausea; Bodyache; Chills; Fatigue; Pain in right eye with swelling; This spontaneous case initially received on 08-Oct-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: US-FDA-2792387-1), was reported by a health authority, was reported by a health authority and concerns an adult female patient.  At the time of the event the patient had dairy, sulfur medicine, dog, cat, blue grass, Latex allergy. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) used for an unknown indication, Anatomical site: Left arm, Lot number: 946589. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Swollen lip (outcome: Recovered / Resolved), Hives (outcome: Recovered / Resolved), Swollen throat (outcome: Recovered / Resolved), Headache (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved), Nausea (outcome: Recovered / Resolved), Bodyache (outcome: Recovered / Resolved), Chills (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events are considered related
Sex: F
Vaccine: FLU3, UNK
Symptoms: Pain, Pharyngeal swelling, Urticaria
Clinical narrative: Swollen lip; Hives; Swollen throat; Headache; Pain in right eye with swelling; Nausea; Bodyache; Chills; Fatigue; Pain in right eye with swelling; This spontaneous case initially received on 08-Oct-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: US-FDA-2792387-1), was reported by a health authority, was reported by a health authority and concerns an adult female patient.  At the time of the event the patient had dairy, sulfur medicine, dog, cat, blue grass, Latex allergy. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) used for an unknown indication, Anatomical site: Left arm, Lot number: 946589. CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Swollen lip (outcome: Recovered / Resolved), Hives (outcome: Recovered / Resolved), Swollen throat (outcome: Recovered / Resolved), Headache (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved), Nausea (outcome: Recovered / Resolved), Bodyache (outcome: Recovered / Resolved), Chills (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Pain in right eye with swelling (outcome: Recovered / Resolved).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events are considered related
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Caffeine consumption, Dizziness, Gait disturbance, Vertigo
Clinical narrative: CAFFEINE CONSUMPTION; DIZZINESS; GAIT DISTURBANCE; VERTIGO; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2792448-1), and concerns an elderly male patient.  At the time of the event the patient had minor cold. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 10-Sep-2024, the patient received Afluria (TIV) for not reported., Lot number: no batch number available and would not be requested as the case was received from health authority.  Non-company suspect drugs: Pfizer BioNTech COVID-19 vaccine (Tozinameran), Indication: not reported.  Adverse reactions/events and outcomes: On 19-Sep-2024, the patient experienced CAFFEINE CONSUMPTION (outcome: Not recovered / Not resolved), DIZZINESS (outcome: Not recovered / Not resolved), GAIT DISTURBANCE (outcome: Not recovered / Not resolved), VERTIGO (outcome: Not recovered / Not resolved).  Patient awoke at around 5 am on thursday morning, 19-Sep-2024, with moderate to strong dizziness and vertigo. The ceiling was spinning and the room felt as If It were tilting. Patient had to hold onto furniture to get to the bathroom. This sensation lasted for most of the morning, diminishing mostly by around 12 noon. The next morning,  Patient experienced the same sensation and duration. Over the weekend, the symptoms abated somewhat on saturday, but on sunday, they worsened again, but not as pronounced as on 19-Sep-2024 or 20-Sep-2024. Patient did not drink or take any stimulants aside from caffeine. Patient was not on any medications. Patient have had no head trauma, and patient get plenty of sleep. Patient exercised regularly and consider herself in very good physical condition. Patient had never before experienced this kind of dizziness or vertigo. Patient visited her doctor on the afternoon of 20-Sep-2024 to explain her vertigo and dizziness, during which he administered several manual tests and verbal questions, and asked to patient stay in communication with him over the next several days to track symptoms.  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as not serious and causality was not reported.; Reporter's Comments: All events were considered related.
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS, COVID19, FLUA4, TDAP, UNK
Symptoms: Herpes virus infection
Clinical narrative: Outbreak of herpes; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority via Vaccine Adverse Event Reporting System (VAERS) (reference number: 2793053-1) and concerns an elderly female patient.  At the time of the event the patient had Herpes Infection.  Administration of company suspect drug: On 11-Sep-2024, the patient received Fluad Quadrivalent for an indication Not reported, Dose regimen: Not reported, Route of administration: Intramuscular, Injection site: Right Arm Lot number: 388461. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: Pfizer BioNTech COVID-19 vaccine (Tozinameran), Indication: Not reported. Dose regimen: Not reported Route of administration: Intramuscular, Injection site: Right Arm Lot number: LM2223 Tdap (Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid), Indication: Not reported. Dose regimen: Not reported Route of administration: Intramuscular, Injection site: Right Arm Lot number:5YB5G Zoster Immunoglobulin VF (Immunoglobulin varicella-zoster), Indication: Not reported. Dose regimen: Not reported Route of administration: Intramuscular, Injection site: Right Arm Lot number: KJ3N3  Adverse reactions/events and outcomes: On 13-Sep-2024, the patient experienced Outbreak of herpes (outcome: Unknown).  Patient came in 24-Sep-2024 stating that a couple of days following her Shingrix vaccine, the had an outbreak of herpes (which she had prior to the injection). She feels that the injection was the factor that lead to the outbreak. She did not confirm her suspicion with her primary care physician as far as we were able to ascertain.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: The event is considered related to Fluad Quadrivalent administration.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Blood test, Chest pain, Discomfort, Ear pain, Echocardiogram
Clinical narrative: pericarditis; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 12:00 as dose 1, single (Lot number: LM7786) at the age of 57 years, in right deltoid for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), on 01Oct2024 as dose 1, single (Lot number: DJ22N), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM;COLECALCIFEROL], start date: 03Jan2022.  The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 06Oct2024, outcome "recovering". The patient was hospitalized for pericarditis (start date: Oct2024, discharge date: Oct2024, hospitalization duration: 1 day(s)). The event "pericarditis" required emergency room visit. Therapeutic measures were taken as a result of pericarditis which included Toradol then IV Morphine, colchicine 0.6, and IBU 600mg. Clinical course: The patient went to ER 06Oct2024 12:30am with severe chest pain and diagnosed with pericarditis.; Sender's Comments: Based on the information available, known drug safety profile and plausible temporal association, the causal relationship between the reported event PERICARDITIS  and suspect drug BNT162B2 cannot be excluded. 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
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Electrocardiogram abnormal, Malaise, Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: pericarditis; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 12:00 as dose 1, single (Lot number: LM7786) at the age of 57 years, in right deltoid for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), on 01Oct2024 as dose 1, single (Lot number: DJ22N), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM;COLECALCIFEROL], start date: 03Jan2022.  The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 06Oct2024, outcome "recovering". The patient was hospitalized for pericarditis (start date: Oct2024, discharge date: Oct2024, hospitalization duration: 1 day(s)). The event "pericarditis" required emergency room visit. Therapeutic measures were taken as a result of pericarditis which included Toradol then IV Morphine, colchicine 0.6, and IBU 600mg. Clinical course: The patient went to ER 06Oct2024 12:30am with severe chest pain and diagnosed with pericarditis.; Sender's Comments: Based on the information available, known drug safety profile and plausible temporal association, the causal relationship between the reported event PERICARDITIS  and suspect drug BNT162B2 cannot be excluded. 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
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Pain in extremity, Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 12:00 as dose 1, single (Lot number: LM7786) at the age of 57 years, in right deltoid for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), on 01Oct2024 as dose 1, single (Lot number: DJ22N), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM;COLECALCIFEROL], start date: 03Jan2022.  The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 06Oct2024, outcome "recovering". The patient was hospitalized for pericarditis (start date: Oct2024, discharge date: Oct2024, hospitalization duration: 1 day(s)). The event "pericarditis" required emergency room visit. Therapeutic measures were taken as a result of pericarditis which included Toradol then IV Morphine, colchicine 0.6, and IBU 600mg. Clinical course: The patient went to ER 06Oct2024 12:30am with severe chest pain and diagnosed with pericarditis.; Sender's Comments: Based on the information available, known drug safety profile and plausible temporal association, the causal relationship between the reported event PERICARDITIS  and suspect drug BNT162B2 cannot be excluded. 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
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 12:00 as dose 1, single (Lot number: LM7786) at the age of 57 years, in right deltoid for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), on 01Oct2024 as dose 1, single (Lot number: DJ22N), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM;COLECALCIFEROL], start date: 03Jan2022.  The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 06Oct2024, outcome "recovering". The patient was hospitalized for pericarditis (start date: Oct2024, discharge date: Oct2024, hospitalization duration: 1 day(s)). The event "pericarditis" required emergency room visit. Therapeutic measures were taken as a result of pericarditis which included Toradol then IV Morphine, colchicine 0.6, and IBU 600mg. Clinical course: The patient went to ER 06Oct2024 12:30am with severe chest pain and diagnosed with pericarditis.; Sender's Comments: Based on the information available, known drug safety profile and plausible temporal association, the causal relationship between the reported event PERICARDITIS  and suspect drug BNT162B2 cannot be excluded. 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
Age: 42.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: the patient received a smaller dose than recommended; Pediatric RECOMBIVAX HB was administered to a 42 yo. adult; No reported signs/symptoms of adverse events.; This spontaneous report was received from a nurse regarding a 42-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unknown date, the 42-year-old patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (Product administered to patient of inappropriate age), hence, the patient received a smaller dose than recommended (Underdose), administered for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not provided).  No signs or symptoms of adverse events were reported in the patient.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Nurse reported that a patient received the second dose of ROTATEQ earlier than recommended.  The patient received the first dose on 8/13/2024 and the second dose on 9/6/2024.  Both vaccines had the same lot and expiry (x015248   12/10/2024).  No addi; This spontaneous report was received from a nurse regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were not reported.  On 13-AUG-2024, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid and on 06-SEP-2024, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid; both administered as prophylaxis (dose was not provided for any of the vaccines; both vaccines had the same lot number: X015248, that has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), with an expiration date reported as 10-DEC-2024 for both). Nurse reported that the patient received the second dose earlier than recommended (Inappropriate schedule of product administration).  No additional adverse event was reported for the patient.
Age: 65.0
Sex: F
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Menveo vaccine on May 26, 2022 and Bexsero vaccine on May 26, 2022 and a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024. Per HCP, "the patient didn't complete her series; Menveo vaccine on May 26, 2022 and Bexsero vaccine on May 26, 2022 and a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024. Per HCP, "the patient didn't complete her series; a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024; Menveo vaccine and Bexsero vaccine adminstered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26-MAY-2022, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On 19-SEP-2024, the patient received the 2nd dose of Bexsero and the 2nd dose of Menveo. On 26-MAY-2022, an unknown time after receiving Bexsero and Menveo and not applicable after receiving Bexsero and Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo vaccine and Bexsero vaccine adminstered). On 19-SEP-2024, the patient experienced drug dose administration interval too long (Verbatim: Menveo vaccine on May 26, 2022 and Bexsero vaccine on May 26, 2022 and a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024. Per HCP, "the patient didn't complete her series), extra dose administered (Verbatim: Menveo vaccine on May 26, 2022 and Bexsero vaccine on May 26, 2022 and a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024. Per HCP, "the patient didn't complete her series) and inappropriate age at vaccine administration (Verbatim: a Menveo vaccine on September 19, 2024 and Bexsero vaccine on September 19, 2024). The outcome of the inappropriate age at vaccine administration, drug dose administration interval too long, extra dose administered and inappropriate age at vaccine administration were 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: 01-OCT-2024 The pharmacist reported that patient who was in the risk evaluation and mitigation strategy program with Ultomeris received a Menveo vaccine and Bexsero vaccine which led to inappropriate age at vaccine administration and a Menveo vaccine and Bexsero vaccine which led extra dose administered and inappropriate age at vaccine administered. As per healthcare professional, the patient did not complete her series. The reporter asked that did she need to restart the series or what needs to happened.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first Shingrix dose 2 years ago (Nov 12th 2022) and never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12-NOV-2022 with batch number TM449 and expiry date 02-JUN-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first Shingrix dose 2 years ago (Nov 12th 2022) and never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-OCT-2024. A pharmacist reported that a patient received the first Shingrix dose and never got the second dose, which led incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Infertility
Clinical narrative: MENSTRUAL CYCLE STOPPED; FERTILITY ISSUES; This spontaneous report received from a consumer concerned a 5 decade (42 to 47 years) old female. Initial information was processed along with additional information received on 20-OCT-2024. The patient's height, and weight were not reported. The patient's concurrent conditions included: infertility and reproductive issues, and amenorrhea. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1)(suspension for injection, intramuscular, batch number was not reported) dose  was not reported, administered on 2020 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Consumer reported his wife took the Covid Vaccine back at the end of 2020, and immediately after, the very next month, he stated that his wife's menstrual  cycle stopped (dose number in series: 1). And they have had fertility issues (dose number in series: 1) ever since. Consumer reported Fertility physician told the consumer to contact manufacturer and report these issues, and said that the reason for all this issues had all stemmed from the  Covid vaccine and the physician told the consumer to call manufacturer to report. The consumer voiced concerns and being very upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fertility issues and menstrual cycle stopped was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000342375. The suspected product quality complaint has been confirmed to be 90000342375: Voided (This record indicates medical adverse events for the patient subsequently product administration. There is no product quality issue described and the case does not meet the definition for a product quality complaint (PQC) or explicitly allege a potency issue). Based on the PQC evaluation/investigation performed.
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, RV5, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event noted.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Got Covid and flu shot together same arm. Itching, hot red area 2x3 inches approximately developed within <48 hours still continues now
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she need to restart the series of 2 or just get the 2nd vaccine now; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (receive 1st dose of Shingrix over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she need to restart the series of 2 or just get the 2nd vaccine now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2024 The registered nurse asked about the patient need to restart the series of two doses or just get the 2nd dose vaccine now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: VITILIGO; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included citalopram. On an unspecified date, the patient experienced vitiligo (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vitiligo. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Electroencephalogram, Magnetic resonance imaging head, Tinnitus
Clinical narrative: I have tinnitus that is usually mild, with some moderate flare-ups. Two days after taking the vaccine, my tinnitus suddenly became very loud, and it is still very loud and persistent (nonstop); This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I have tinnitus that is usually mild, with some moderate flare-ups. Two days after taking the vaccine, my tinnitus suddenly became very loud, and it is still very loud and persistent (nonstop)) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043334) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    The patient's past medical history included COVID-19 on 21-Dec-2023. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer. Concurrent medical conditions included Tinnitus.   On 06-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 08-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TINNITUS (I have tinnitus that is usually mild, with some moderate flare-ups. Two days after taking the vaccine, my tinnitus suddenly became very loud, and it is still very loud and persistent (nonstop)). At the time of the report, TINNITUS (I have tinnitus that is usually mild, with some moderate flare-ups. Two days after taking the vaccine, my tinnitus suddenly became very loud, and it is still very loud and persistent (nonstop)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2024, Magnetic resonance imaging head: showed nonspecific FLAIR hypertense white matter foci (may be related to underlying small vessel disease). In August 2024, Electroencephalogram: EEG with left temporal intermittent slowing with sharp components.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient had any risk factor. No concomitant medications were reported.  Two days after taking the vaccine, the patient's tinnitus suddenly became very loud, and it was still very loud and persistent (nonstop). And she meant LOUD, as she had never experienced before. This was her first Moderna vaccine, as she had only taken the Pfizer vaccine before. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension
Age: 1.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Extra dose administered
Clinical narrative: Wrong medication was given.  Patient was needing MMR but was given MMRV, along with Varicella . resulting in two doses of Varicella given.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left deltoid area
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Persistent shoulder pain, decreased mobility, unable to fully lift arm over head
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Scratch, Underdose
Clinical narrative: Patient hit the syringe with her hand mid administration of this vaccine. The needle was knocked out of the patient resulting in a small scratch on her thigh and incomplete vaccine dose.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Hep A & Hep B given to patient from pediatric supply vs adult dosing.  Did not realize until after patient had left.  Pt had remained in nurse visit with RN at time of administration.  No adverse reactions noted.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Eye swelling, Pain, Pyrexia
Clinical narrative: my entire face was swollen and red. my eyes were almost entirely swollen shut. small white bumps appeared above my eyes chin and forehead. My skin was extremely dry and flakey.  This happened approximately a week after receiving the Covid 19 vaccine. The day after I received the vaccine, I was sick with body aches and a slight fever, to me this was normal and I took an aspirin . the third day I felt better. Never have a had a reaction over a week after the shot was administered.  some of the adverse reactions continue today, (length of time over 8 days )
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin exfoliation, Swelling face
Clinical narrative: my entire face was swollen and red. my eyes were almost entirely swollen shut. small white bumps appeared above my eyes chin and forehead. My skin was extremely dry and flakey.  This happened approximately a week after receiving the Covid 19 vaccine. The day after I received the vaccine, I was sick with body aches and a slight fever, to me this was normal and I took an aspirin . the third day I felt better. Never have a had a reaction over a week after the shot was administered.  some of the adverse reactions continue today, (length of time over 8 days )
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: patient had vasovagal episodes after vaccine was administered.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: A second dose of Abrysvo was given to patient. First dose was 11/2/23, second dose 10/23/24.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Night sweats
Clinical narrative: Cold sweets thru out night
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: I got the vaccine on Thursday October 10, 2024. It was mandatory through employment at the hospital. It was sore for 2 days at site of injection. I rubbed it every few hours so it wouldn't be stiff. On Monday, October 14, 2024, my left arm at the site of injection hurt really bad going up into my shoulder and down to my shoulder blade. It hurts to move my arm, to stretch on the left or right side, it hurts to lift my arm, it hurts to put on my clothes, it hurts to move my neck to the left, right, or to even look down. My arm hurts just in general, and I can't sleep on my left side, it hurts to carry or grab anything. I have tried at home remedies such as heating pad, ice, icy hot, Tylenol, Ibuprofen, rest and I take nerve pain medicine daily and nothing is helping me.  For the past 2 weeks, I have been in pain.
Age: 52.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cast application, Chills, Limb operation, Lower limb fracture, Nausea
Clinical narrative: Chills, nausea, fainted and broke my leg
Age: 52.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Syncope
Clinical narrative: Chills, nausea, fainted and broke my leg
Age: 75.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure increased, Chest pain, Feeling hot, Malaise, Pain in jaw
Clinical narrative: administered Vaccines at 1200. At 1215 patient stated she did not feel well. She stated her chest was hurting and felt hot all over. v/s taken and patient with increased blood pressure from baseline. denied any breathing issues- sob, throat irritation. Continued talking with patient and symptoms worsened and she stated she was having pain in jaw area. vital signs showed increase in blood pressure. Explained to patient that EMS would be notified and epi would be administered. PIV inserted and NS bolus initiated. EMS called. Epi 0.3mg IM administered x2 prior to arrival of EMS. EMS took over care upon arrival. Patient hesitant to go to ER however after talking with EMS personnel patient agreed to be transported to hospital. Patient alert, awake, respiration even and unlabored. talking with EMS and family upon departure.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Entire upper arm red, swelling of the entire arm with hardness
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Client called and reported that on the day of vaccination she started running a temperature at approximately 6pm.  She reports the fever lasted two days and reached 102 degrees.  She reported that she called and spoke with someone at the Health  Department while having the fever and was told it was a normal .   She did not see a doctor.  She called on 10/24/2024 and requested a school excuse as she missed time during the fever. I am completing a Vaers report as unsure if a fever of 102 degrees is a normal response.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Child received a dose of Flulaval on 09/26/2024 and then again at a school based clinic event on 10/18/2024.  Called and talked with mom and she reported that child did have a low grade fever, gave Tylenol and fever resolved.  No other issues.
Age: 7.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: right arm red from shoulder to elbow with increased swelling; advised to use ibuprofen, ice and benadryl
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is a duplicate Flu vaccine, it was administered to the patient on 09/24/2024 and on 10/24/2024 , patient has no adverse effect to either one.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Inpatient 10 yo male received updated COVID-19 vaccine on 10/5/2024. The same patient was administered an additional updated COVID-19 vaccine when not indicated. Patient is stable without adverse effect at this time.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mother brings in daughter to vaccine clinic. Mother had heard COVID was going back around so she wanted to get a Flu and COVID vaccine for her and her daughter. The clinic was ran by a pharmacy preceptor within University and pharmacy interns. Two pharmacy interns each prepped a Flu vaccine and a COVID vaccine. The students gave the vaccines simultaneously one in each arm. The daughter was scared of getting her vaccine and we were all worried about her in the pharmacy including the pharmacist. Once the parents had left with her daughter, the pharmacy asked the clinic how the vaccination went. The pharmacy intern had stated that the daughter was pretty scared and was pretty young. The pharmacist asked her age and the pharmacy intern stated  9 years old  which is when the pharmacist confirmed with the pharmacy preceptor what the correct age was. The pharmacy preceptor had not realized the age requirements of the COVID vaccine. Once we realized the event had occurred the pharmacist of vaccine clinic contacted the parents and the parents were worried about the side effects. We counseled the parents on potential side effects of the vaccine including sore arm, weakness, chills and the parents were grateful for us reaching out and showing concern. We ensured the parents that we would follow-up with them frequently. The event occurred on Friday and we followed up with them on Saturday, Sunday and Thursday to monitor any adverse effects. During the follow-up on Thursday, the parents reported that the daughter had experienced expected side effect discussed, but nothing of great concern. In order to prevent future events an email was sent to pharmacy interns and preceptors regarding the age requirements for vaccination. We also created neon stickers labeled ?Pediatric Pfizer dose ___ mL? along with a paper that states ?anytime a minor is to receive any vaccine affix an orange label to the Vaccine Administration Record on the back side where the vaccinator will input the vaccine information.? CDC vaccine administration schedules were placed in each room of the immunization clinic.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Blurry vision, smokey vision 2 hours after vaccine, continues for 2 hours, each day after vaccine was given
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Pain
Clinical narrative: Cold feeling, aches in joints, body soreness
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: More than usual swelling/redness at/around injection site. Patient was told to apply cold compress to the arm
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mother brings in daughter to vaccine clinic. Mother had heard COVID was going back around so she wanted to get a Flu and COVID vaccine for her and her daughter. The clinic was ran by a pharmacy preceptor within school and pharmacy interns. Two pharmacy interns each prepped a Flu vaccine and a COVID vaccine. The students gave the vaccines simultaneously one in each arm. The daughter was scared of getting her vaccine and we were all worried about her in the pharmacy including the pharmacist. Once the parents had left with her daughter, the pharmacy asked the clinic how the vaccination went. The pharmacy intern had stated that the daughter was pretty scared and was pretty young. The pharmacist asked her age and the pharmacy intern stated ?9 years old? which is when the pharmacist confirmed with the pharmacy preceptor what the correct age was. The pharmacy preceptor had not realized the age requirements of the COVID vaccine. Once we realized the event had occurred the pharmacist  contacted the parents and the parents were worried about the side effects. We counseled the parents on potential side effects of the vaccine including sore arm, weakness, chills and the parents were grateful for us reaching out and showing concern. We ensured the parents that we would follow-up with them frequently. The event occurred on Friday and we followed up with them on Saturday, Sunday and Thursday to monitor any adverse effects. During the follow-up on Thursday, the parents reported that the daughter had experienced expected side effect discussed, but nothing of great concern.  In order to prevent future events an email was sent to pharmacy interns and preceptors regarding the age requirements for vaccination. We also created neon stickers labeled ?Pediatric Pfizer dose ___ mL? along with a paper that states ?anytime a minor is to receive any vaccine affix an orange label to the Vaccine Administration Record on the back side where the vaccinator will input the vaccine information.? CDC vaccine administration schedules were placed in each room of the immunization clinic.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Skin discolouration
Clinical narrative: MOTHER REPORTED AT FOLLOW UP APPOINTMENT ON 10/11/2024 THAT PATIENT'S HANDS WERE "PURPLE FOR TWO WEEKS" AFTER INITIAL VACCINATIONS. DENIES ANY OTHER COMPLAINTS.