chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Pruritus
Clinical narrative: got a ball in her left breast; itch in her left arm; This spontaneous case was reported by a patient and describes the occurrence of BREAST MASS (got a ball in her left breast) and PRURITUS (itch in her left arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST MASS (got a ball in her left breast) and PRURITUS (itch in her left arm). At the time of the report, BREAST MASS (got a ball in her left breast) and PRURITUS (itch in her left arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2024: Live follow-up received that contains non-significant information, reference number updated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue
Clinical narrative: COVID-19; tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and FATIGUE (tired) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.     On 12-Aug-2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 12-Aug-2024, the patient experienced COVID-19 (COVID-19) and FATIGUE (tired). At the time of the report, COVID-19 (COVID-19) and FATIGUE (tired) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: Atrial Fibrillation; Tachycardia; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ATRIAL FIBRILLATION (hospitalization, life threatening) with onset 01Dec2023 at 13:30, 3 years 9 months 3 days 13 hrs 30 min after the suspect product(s) administration, outcome "recovered with sequelae" (08Jul2024); TACHYCARDIA (hospitalization, life threatening) with onset 01Dec2023 at 13:30, 3 years 9 months 3 days 13 hrs 30 min after the suspect product(s) administration, outcome "recovered with sequelae" (08Jul2024). The patient was hospitalized for atrial fibrillation, tachycardia (hospitalization duration: 10 day(s)). Therapeutic measures were taken as a result of atrial fibrillation, tachycardia. Clinical course: Atrial Fibrillation and tachycardia that was persistent and took multiple ablations to resolved. Patient has no history of hypertension, diabetes or high cholesterol. Recovered with lasting effects. Cardio Ablation twice and three other procedures. Patient had no known allergies. Patient did not receive other vaccine on same date, other vaccine in four weeks and other medications in two weeks of vaccination date.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "no side effects"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "no side effects"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "no side effects". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid: (Start: 15Aug2024 Stop: Ongoing). Clinical course: Reporter was calling about the medication Paxlovid and reported that she took her first dose right away when she got it yesterday at noon. Covid was a horrible illness. She had never had it before did not know how she got it and reported that she had been vaccinated with the Pfizer Covid-19 shots and boosters. Reporter did not have any NDC'', lot numbers, or expiry dates to provide for the Pfizer Covid-19 vaccines and boosters at the time of the call.    Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Head discomfort, Headache
Clinical narrative: Increase in headache's; tiredness; heavy head; anxiety; Safety information originally reported under manufacturer case 202300009554 has been nullified and re-entered under this new manufacturer report number 202400239022.  This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: ZOLOFT; VYVANSE. Vaccination history included: BNT162b2 (Dose Number: 1; Location of injection: Arm Left), administration date: 11Nov2022, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 09Dec2022, outcome "not recovered", described as "Increase in headache's"; ANXIETY (non-serious) with onset 09Dec2022, outcome "not recovered"; HEAD DISCOMFORT (non-serious) with onset 09Dec2022, outcome "not recovered", described as "heavy head"; FATIGUE (non-serious) with onset 09Dec2022, outcome "not recovered", described as "tiredness". The events "increase in headache's", "tiredness", "heavy head" and "anxiety" required physician office visit. Therapeutic measures were not taken as a result of headache, fatigue, head discomfort, anxiety. Additional information: The patient was not tested with Covid post vaccination. No known allergies.  Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information:Seriousness criteria Disability Unchecked and Case downgraded to non-serious.  Follow-up (05Mar2023): Follow-up attempts are completed. No further information is expected.  Follow-up (19Aug2024): This is a follow-up report to notify that the case 202300009554 and 202400239022 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400239022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The event "covid" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller was told by the pharmacy to call Pfizer as she had been in the emergency room this morning with Covid and doctor wrote her a prescription for Nirmatrelvir and Ritronavir 300/100 and they won't filled it and said she had to have approval first because it costs 1700 dollar. Caller also said she had all Covid shots and but somehow still came up with it. Product: Paxlovid.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Arthralgia
Clinical narrative: left hand first finger joint pain at hand articulation point, and second finger joint pain at hand articulation point; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Aug2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset Aug2024, 22 hrs after the suspect product(s) administration, outcome "unknown", described as "left hand first finger joint pain at hand articulation point, and second finger joint pain at hand articulation point". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Colon cancer stage IV
Clinical narrative: I got Stage 4 turbo colon cancer from your damn covid vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLON CANCER STAGE IV (medically significant, life threatening), outcome "unknown", described as "I got Stage 4 turbo colon cancer from your covid vaccine".
Age: 20.0
Sex: F
Vaccine: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered tenivac instead of adacel to a patient with no reported adverse event; Initial information received on 13-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 20 years old female patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] instead of diphtheria/tetanus/5 ac pertussis/ipv (vero) vaccine [Adacel Polio] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Aug-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7920AA and expiration date- 25-OCT-2025) via intramuscular route in unknown administration site (strength- not provided) and a dose of suspect diphtheria/tetanus/5 ac pertussis/ipv (vero) vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received 2 doses of Polio on the same day (from the VAXELIS and IPOL) with no reported AE; Initial information received on 14-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old male patient who received 2 doses of polio on the same day (from POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS)) with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS A VACCINE (HEPATITIS A VACCINE); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Prophylactic vaccination.  On 13-Aug-2024, the patient received suspect IPV (VERO) 0.5 ml TOTAL, Suspension for injection lot W1C741M expiry-17-Nov-2025 via subcutaneous route in the left arm and VAXELIS not produced by Sanofi Pasteur via intramuscular route in unknown administration site for Immunization (strength unknown) with no reported ae (extra dose administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: pentacel was given to a patient but was not reconstituted with the act-hib component of the vaccine with no reported adverse event; Initial information received on 15-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old female patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] but was not reconstituted with the act-hib component of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine Inact (Havrix) For Prophylactic Vaccination; Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3) (M M R Ii) For Prophylactic Vaccination; Varicella Zoster Vaccine Live (Oka/Merck) (Varivax [Varicella Zoster Vaccine Live (Oka/Merck)]) for Prophylactic vaccination; and Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) for Prophylactic vaccination.  On 13-Aug-2024, the patient received a dose 1 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (lot UJ984AA, Expiry date: 12-Mar-2025, strength was unknown) via intramuscular route in the left thigh for Prophylactic vaccination (Immunization) and pentacel was given to a patient but was not reconstituted with the act-hib component of the vaccine with no reported adverse event (product preparation error) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: medication error/an inappropriate use due to administering an expired vaccine to a patient with no reported adverse event; Initial information received on 15-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who had medication error/an inappropriate use due to administering an expired Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 15-Aug-2024, the patient received a dose 1 of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U7299AC, Expiry date; 04-Aug-2024, Frequency : Total, strength was unknown via intramuscular route in the left deltoid for Immunization and medication error/an inappropriate use due to administering an expired vaccine to a patient with no reported adverse event (expired product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patient was administered only the DTaP-IPV component of PENTACEL, hib component wasn't reconstituted so it wasn't given with no reported adverse event; Initial information received on 15-Aug-2024 and live follow up received on same date regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered only the dtap-ipv component of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], hib component wasn't reconstituted so it wasn't given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; ROTAVIRUS VACCINE; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) all for Prophylactic vaccination.  On 14-Aug-2024, the patient received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK015AA and expiry 31-May-2025) (strength: unknown) only the dtap-ipv component hib component wasn't reconstituted so it wasn't given with no reported adverse event (single component of a two-component product administered) (latency same day) via intramuscular route in the left vastus lateralis for prophylactic vaccination (immunization).  Reportedly:- Nurse mentioned that the powder component of Hib was left on their desk since yesterday for less than 24 hours at room temperature of 69°F. She also mentioned that the vial wasn't punctured but the flip cap was removed. She wanted to know if it's okay to use  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTPPVHBHPB, IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: consumer was administered both ipol and vaxelis with no reported adverse event; Initial information received on 15-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old and unknown gender patient where consumer was administered both IPV (VERO) [IPOL] (poliomyelitis vaccine (inactivated) and vaxelis (diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site and received a dose of suspect VAXELIS not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation (inappropriate schedule of product administration) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Irritability, Thinking abnormal
Clinical narrative: Irritable; Crying; Cannot maintain thoughts; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of irritability in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G, expiry date 09-OCT-2026) for prophylaxis.   On 10-AUG-2024, the patient received Boostrix (intramuscular). In AUG-2024, less than a day after receiving Boostrix, the patient experienced irritability (Verbatim: Irritable), crying (Verbatim: Crying) and abnormal thinking (Verbatim: Cannot maintain thoughts). The outcome of the irritability, crying and abnormal thinking were not resolved.   It was unknown if the reporter considered the irritability, crying and abnormal thinking to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the irritability, crying and abnormal thinking to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 12-AUG-2024 The reporter was a pharmacist calling on behalf of a female patient that received Boostrix and starting yesterday (day before reporting), 11th August 2024, the patient reported being irritable, a lot of crying, and could not maintain a thought.  The patient reported to the pharmacist that all these adverse events were getting worse today (on the day of reporting), 12th August 2024.  They have reported all that was provided about these adverse events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise
Clinical narrative: The caller said she just spoke with her pharmacy and she was told to call Pfizer to get a coupon for her Paxlovid medication; The caller said she just spoke with her pharmacy and she was told to call Pfizer to get a coupon for her Paxlovid medication; fell very sick; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller said she just spoke with her pharmacy and she was told to call Pfizer to get a coupon for her Paxlovid medication"; MALAISE (non-serious), outcome "unknown", described as "fell very sick". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: The caller said she just spoke with her pharmacy and she was told to call Pfizer to get a coupon for her Paxlovid medication. The caller stated that she felt very sick when she had the COVID booster shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: M
Vaccine: FLU4, HEPAB, HPV9
Symptoms: Dizziness, Dreamy state, Gaze palsy, Musculoskeletal stiffness, Pallor
Clinical narrative: Twinrix given first then Fluzone in Left arm then switched chairs and administered Garasil in right arm. After talking for a few minutes patient stated he was feeling light headed. Told him he could sit in our waiting area for 10-15 min but he stated he didn't think he could walk and asked for a drink or snack in case his blood sugar dropped but pt is not diabetic. I was going to get OJ when I saw pt look like they were going to faint then his eyes rolled to the top left corner and he began to seize. His body got stiff and was starting to convulse when I ran to the door to get a collegue to call EMS. When I got back to him he became alert. I asked how he was feeling and he was okay and I asked if he knew where he was and he was able to say store name. He stated he felt like he was in a dream. Pts face was pale.  At this point patient started drinking the OJ was feeling better and cancelled the EMS call. After watching patient and talking, pt said he was starting to feel light headed again and so we called EMS again and Paramedics arrived at 5:34pm. Patient left on his own accord and did not go with ambulance.
Age: 41.0
Sex: M
Vaccine: FLU4, HEPAB, HPV9
Symptoms: Seizure
Clinical narrative: Twinrix given first then Fluzone in Left arm then switched chairs and administered Garasil in right arm. After talking for a few minutes patient stated he was feeling light headed. Told him he could sit in our waiting area for 10-15 min but he stated he didn't think he could walk and asked for a drink or snack in case his blood sugar dropped but pt is not diabetic. I was going to get OJ when I saw pt look like they were going to faint then his eyes rolled to the top left corner and he began to seize. His body got stiff and was starting to convulse when I ran to the door to get a collegue to call EMS. When I got back to him he became alert. I asked how he was feeling and he was okay and I asked if he knew where he was and he was able to say store name. He stated he felt like he was in a dream. Pts face was pale.  At this point patient started drinking the OJ was feeling better and cancelled the EMS call. After watching patient and talking, pt said he was starting to feel light headed again and so we called EMS again and Paramedics arrived at 5:34pm. Patient left on his own accord and did not go with ambulance.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Clostridium test negative, Diarrhoea, Nausea
Clinical narrative: Patient says she has had very bad watery diarrhea starting 2 weeks after her vaccination. Patient says this is the only new thing that she has changed in her medications or routine. No new medications, no surgeries or procedures.  Patient has had stomach discomfort and nausea. Patient says the doctors tested her for Clostridioides difficile (C. diff) twice and she was negative both times. Patient says the doctors did give her some antibiotics for a possible C. diff infection and they have not worked.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported client had large red swollen area on thigh that was hot to touch and hard where he received his shot, she said he also communicated that the area hurt.  Each day since the redness/swelling/pain has improved but hardness still remains.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: HIB component was reconstituted with sterilized diluent instead of the Dtap-IPV component.  Then it was administered to patient, meaning pt did not receive the Dtap-IPV liquid component.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Immediately following administration of vaccination to left deltoid , patient reports experiencing severe decreased ROM, stiffness, pain. He applied heat to affected area as well as otc advil for symptom management with some improvement. Patient states he regained 75 percent relief of symptoms over the last 6 days when presents to clinic for oral steriods (medrol dose pack) to aid in further symptom resolution.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient enrolling in college healthcare program. Titer shows loss of immunity. Repeating Hep B series. Dose #2 pediatric given instead of adult. Patient is 19yo. No adverse reactions reported at time of patient being informed on 8/15/24 at discovery of error.
Age: 66.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Choking, Dysarthria, Dysphagia, Salivary hypersecretion
Clinical narrative: Pt states it started with excessive saliva.  Then he noticed issues with slurred speech.  Next he started having issues with swallowing and choking on saliva.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient enrolling in healthcare and requests to receive Hep A series.  Dose # 1 given as pediatric instead of adult. Patient 22yo at time of administration. No reported side effects.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Patient was sitting in our waiting room after receiving vaccine. Shortly after, she started to pass out and her head went backwards. She started to slip down chair. Our intern went out to catch her along with the person who was waiting with her. Our pharmacist called 911.  She came too within a minute or so and started talking. She sipped a tiny bit of water then was instructed to take nothing by mouth until EMS arrived. They arrived at 5:58pm.  She said may have been due to her not eating a lot today. Said had a history of passing out in past, did not disclose before vaccine. Did not fully disclose to what medical service was provided. Opted out of going to hospital.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Dyskinesia, Syncope
Clinical narrative: Patient fainted for about 7-10 seconds, was observed for about 30 minutes. Symptoms, patient only jerked body and cried.
Age: 56.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Itching entire body head to toe less than 5 minutes after vaccines given. Patient began to present with welts or hives on arms and back. Patient took 2 tablets of Benadryl 25 mg.  Welts/hives began to disappear. Patient continued to have severe itching all over body. Around 7:35 p.m. Patients' arms started to present with two larger areas of elevation of skin and bumps around inner biceps. Then patient took Zyrtec 10 mg tablet. Around 7:55 patient started to feel less itching. the redness in arms began to subside. Patient left at 8:11 p.m. and feeling better, some itching but significantly less.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received 2 Fluad Trivalent vaccines in the same month (08/01/24 and 08/19/24). Patient has not experienced or reported any known adverse reactions yet.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: The next morning 7/13/2024 soon after I woke up I started having an itch in my hands and feet. Then it progressed to a burning feeling. Like pins and needles and then my hands were red. It hurt to grab things like the door handle. I stayed in bed most of the day. The next day (7/14) it was more mild and mostly some numbness in the hands and some pins and needles just not as intense. By 7/15 it had mostly resolved. To this day tho there is some numbness in the pinky of the left hand and it goes up to the elbow  following that part of the forearm. It hurts more when really using that muscle. It only happened after receiving the second dose of the HPV shot. I did get a covid vaccine a month prior and I read the PNS symptoms have occurred with that but I also feel a good amount of time had passed between both vaccines. I just really want to know if I can get my last HPV shot in November or covid shot when the new one comes out. Or should I be concerned about something worse happening.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Tenderness
Clinical narrative: The next morning 7/13/2024 soon after I woke up I started having an itch in my hands and feet. Then it progressed to a burning feeling. Like pins and needles and then my hands were red. It hurt to grab things like the door handle. I stayed in bed most of the day. The next day (7/14) it was more mild and mostly some numbness in the hands and some pins and needles just not as intense. By 7/15 it had mostly resolved. To this day tho there is some numbness in the pinky of the left hand and it goes up to the elbow  following that part of the forearm. It hurts more when really using that muscle. It only happened after receiving the second dose of the HPV shot. I did get a covid vaccine a month prior and I read the PNS symptoms have occurred with that but I also feel a good amount of time had passed between both vaccines. I just really want to know if I can get my last HPV shot in November or covid shot when the new one comes out. Or should I be concerned about something worse happening.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Injection site swelling, Wrong product administered
Clinical narrative: MenB Bexsero dose #1 administered 8/16/24. Pt. returned to clinic 8/19/24 needing additional vaccine for school. Second dose of MenB administered in error. Pt. needing TDAP. Pt. reports swelling at immunization site of 2nd dose MenB the evening it was given. Symptoms resolved by next day. CDC contacted for information related to early vaccine administration.
Age: 41.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported sfx repoted
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Continuous ringing in right ear/Tinnitus began about 1.5 hours after receiving vaccine; This non-serious case was reported by a consumer and described the occurrence of ringing in ears in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eosinophilic esophagitis. Concomitant products included budesonide and omeprazole (Omeprazol).   On 08-AUG-2024, the patient received Shingrix. On 08-AUG-2024, 1 hr 30 min after receiving Shingrix, the patient experienced ringing in ears (Verbatim: Continuous ringing in right ear/Tinnitus began about 1.5 hours after receiving vaccine). The outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.     It was unknown if the company considered the ringing in ears to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2024 and 12-AUG-2024 The patient self-reported this case for himself. The patient received Shingrix and had continuous ringing in right ear. The patient was taking Budesonide and Omeprazol for eosinophilic esophagitis. The patient reported that, the tinnitus began about 1.5 hours after receiving vaccine and had been ongoing till the time of reporting.
Age: 37.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: female patient 37 weeks pregnant was administered AREXVY; Wrong vaccine administered; female patient 37 weeks pregnant was administered AREXVY; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ge3s7, expiry date 13-OCT-2025) for prophylaxis.   On 12-AUG-2024, the patient received Arexvy. On 12-AUG-2024, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered) and product use in unapproved population (Verbatim: female patient 37 weeks pregnant was administered AREXVY). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: female patient 37 weeks pregnant was administered AREXVY). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not reported and the outcome of the wrong vaccine administered was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-Aug-2024 The reporter reported that the female patient 37 weeks pregnant was administered Arexvy on 12th August 2024 as wrong vaccine administered, which led to product use in unapproved population. No further information was known such as injection site.
Age: 37.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: female patient 37 weeks pregnant was administered AREXVY; Wrong vaccine administered; female patient 37 weeks pregnant was administered AREXVY; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ge3s7, expiry date 13-OCT-2025) for prophylaxis.   On 12-AUG-2024, the patient received Arexvy. On 12-AUG-2024, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered) and product use in unapproved population (Verbatim: female patient 37 weeks pregnant was administered AREXVY). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: female patient 37 weeks pregnant was administered AREXVY). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not reported and the outcome of the wrong vaccine administered was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-Aug-2024 The reporter reported that the female patient 37 weeks pregnant was administered Arexvy on 12th August 2024 as wrong vaccine administered, which led to product use in unapproved population. No further information was known such as injection site.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; a 6 month old child was given their first dose of ROTATEQ today, 8/5/2024; This spontaneous report was received from a physician, concerning a 6-month-old patient of unknown gender. No information was provided regarding the patient's medica history, concomitant medications, and drug reactions or allergies.  On 05-AUG-2024 reported as "today", the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), at a dose of 0.5 ml orally (lot # 2003173 has been verified to be a valid lot number, expiration date reported and upon internal review was established as 29-SEP-2025), as prophylaxis (product administered to patient of inappropriate age). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC; Caller reports  VARIVAX was administered after temperature excursion.; This spontaneous report has been received by a medical assistant, regarding a patient of unknown gender and age. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 08-AUG-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) formulation as default: injection (strength, dose, frequency, route of administration, vaccination scheme, and site of administration were not provided; lot # X021758, which has been verified to be a valid number, expiration date reported and validated as 23-FEB-2025) as a prophylaxis. The vaccine experienced a temperature excursion with a storage temperature of -6 degrees Celsius (C) for a time frame of 48 hours (product storage error). It was unknown if a data logger was used. There was no previous temperature excursion. No additional adverse events were provided. No other information provided.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous report was received from a health business professional (HBP), concerning a female patient of unknown age. No information was provided regarding the patient's medical history, concomitant medications, and previous drug reactions or allergies.  On 12-AUG-2024, the patient was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # W025277 has been verified to be a valid lot number, expiration date reported and upon internal review was established as 10-AUG-2024) (route of administration and anatomical location were not provided), as prophylaxis (expired product administered). No adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Consistent high blood pressure since receiving Covid vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HYPERTENSION (life threatening), outcome "not recovered", described as "Consistent high blood pressure since receiving Covid vaccine". Therapeutic measures were taken as a result of hypertension. Clinical course: Patient did not received any other vaccine on same date, any other medications in four weeks and any other medications in two weeks. Consistent high blood pressure since receiving Covid vaccine resulted in Life threatening illness (immediate risk of death from the event). Received Propanol for the treatment of high blood pressure. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 28.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Cough, Headache, Influenza virus test negative, Insomnia, Nasal congestion
Clinical narrative: Aggressive cough, fever, headache, insomnia, sore throat, stuffy nose
Age: 28.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Aggressive cough, fever, headache, insomnia, sore throat, stuffy nose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingle; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingle). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-AUG-2024 The patient self-reported this case. The patient got the shot of Shingles vaccine and thought that it was maybe six years ago and got the shingle. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.