chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle fatigue
Clinical narrative: Patient suffered from muscle fatigue on 1 side of her lower extremities 2 weeks post administration of GARDASIL 9; This spontaneous report was received from a physician concerning a 13-year-old female patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date in 2021 (reported as two years ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, route of administration, lot#, expiry date, and anatomical location not provided) (that was only vaccine she received that day).   On an unknown date in 2021 (reported as 2 years ago), the patient suffered from muscle fatigue on 1 side of her lower extremities 2 weeks post administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The physician was consultant with another physician at their practice regarding this effect, the other physician response was that she had seen 1 other similar case with similar effect with this vaccine (2308USA007430). No additional adverse event (AE) was reported. The outcome of muscle fatigue was not provided. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not applicable.  The causal relationship between muscle fatigue and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007430:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms or side effects; a patient received their first dose of PROQUAD at the age of 14; This spontaneous report was received from a pharmacist referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.       On 11-AUG-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X009733, expiration date was not reported, but upon internal validation established as 02-SEP-2024; strength, dose and route were not reported) for prophylaxis at the age of 14 years (Product administered to patient of inappropriate age). No symptoms or side effects were reported (no adverse event). No further details was provided. No other adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Pharmacist called to report PROQUAD and VARIVAX given together 2 different sites to a 12month old.; No additional AE/No PQC.; This spontaneous report has been received from a pharmacist, regarding a 12-months-old patient of unknown gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, both as prophylaxis together at different sites (Overdose) (strengths, doses, schemes, routes and anatomical locations of administrations, lot numbers and expiration dates were not reported).  Pharmacist had no information on immunization schedule for patient.  No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC; inadvertent non-simultaneous administration of MMR-II and VARIVAX less than one month apart to a patient.; This spontaneous report was received from a health care professional and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-AUG-2020, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 01-SEP-2020, the patient was also administered with a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided). Both vaccines were administered for prophylaxis. The reporter stated that it was inadvertent, non-simultaneous administration of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) with less than one month apart (inappropriate schedule of vaccine administered). There was no additional adverse event reported.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: felt awful for several days; shingles / suspected vaccination failure; In June I had shingles/she has had a cse of shingles every month since June 2023; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, the patient received the 1st dose of Shingrix. In JUN-2023, between 3 and 5 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: In June I had shingles/she has had a cse of shingles every month since June 2023). On an unknown date, the patient experienced feels awful (Verbatim: felt awful for several days).     The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the feels awful was resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feels awful to be related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the company considered the feels awful to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-AUG-2023 and 21-AUG-2023 The patient self-reported this case. The patient noted that when she received her second Shingrix vaccine, she had a robust response and felt awful for several days. In June 2023, the patient had shingles and was treated with Valacyclovir HCI 1 gram, 3 times a day for 7 days. In July 2023 had Shingles again, about 3 weeks after finishing above treatment. Doctor stated to take same treatment for 2 full weeks. The patient finished that and about 10 days later in August, the patient had Shingles again. Now doctor wants her to take above treatment for 3 months. The patient thought this was an adverse reaction to the Shingles vaccine, Shingrix. The reporter wants GSK to follow-up with her healthcare professional since she had a case of shingles every month since June 2023. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain, Pain, Rash, Vaccination failure
Clinical narrative: She got vaccine and still got shingles/suspected vaccination failure; She got vaccine and still got shingles; Neck pain; Skin rash; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: She got vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: She got vaccine and still got shingles), neck pain (Verbatim: Neck pain), rash (Verbatim: Skin rash) and pain (Verbatim: Pain).The outcome of the vaccination failure was unknown and the outcome of the shingles, neck pain and rash were not reported and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neck pain, rash and pain to be related to Shingrix.   It was unknown if the company considered the vaccination failure, shingles, neck pain, rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-AUG-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and it did not help. The patient had shingles twice since. The patient never imagined that what started as neck pain was actually shingles. The patient thought shingles was just a skin rash, so she was surprised by how much pain it caused her. The pain was so intense and it lasted for months. The patient wish she would had learnt more about shingles sooner. The reporter further stated that would not wait and talk to a doctor or pharmacist today about shingles prevention people aged 50 plus. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule , time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Herpetic lesions on both sides of torso; This non-serious case was reported by a physician and described the occurrence of herpetiform lesion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced herpetiform lesion (Verbatim: Herpetic lesions on both sides of torso).  The outcome of the herpetiform lesion was not resolved.   The reporter considered the herpetiform lesion to be related to Shingrix.     The company considered the herpetiform lesion to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: went out of recommended temperature range during delivery; This non-serious case was reported by a pharmacist and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number 52X45) for prophylaxis.   In AUG-2023, the patient received Menveo. On 11-AUG-2023, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: went out of recommended temperature range during delivery).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter stated that we would not be able to send back the 60 units of Menveo and currently had 38 units to be returned. We issued an investigation since the product was received in the system and customers were able to place orders (22 units). The feedback needed from Glaxo for investigation. The 22 units of Menveo vaccine temperature excursion on 11th August 2023. The tag alert alarm 2, 3 with 4 black squares. The Menveo vaccine had temperature excursion, which led to incorrect storage of vaccine.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: Product Complaint; when the plunger slipped out of the pre-filled syringe and the vaccine spilled out on both of her palms; vaccine spilled out on both of her palms; the plunger slipped out; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 25-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis. This case was associated with a product complaint.   On 15-AUG-2023, the patient received Bexsero. On 15-AUG-2023, an unknown time after receiving Bexsero, the patient experienced occupational exposure while preparing product for administration (Verbatim: when the plunger slipped out of the pre-filled syringe and the vaccine spilled out on both of her palms), exposure via skin contact (Verbatim: vaccine spilled out on both of her palms) and syringe issue (Verbatim: the plunger slipped out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint).     The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, syringe issue and pharmaceutical product complaint 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: 16-AUG-2023 The reporter reported that when one of the nurses in her facility was preparing a Bexsero vaccine yesterday (day before reporting), the nurse was about to prime the pre-filled syringe, and the plunger slipped out on both of her palms, which led to  The reporter stated that the nurse did immediately wash her hands and had not noticed any reaction and had no complaints today. The reporter stated the plunger stopper was loose.  The reporter did review the product information for use step by step. The reporter stated that the defect was discovered during preparation. Unknown where in the multi pack the syringe was located. They roll the syringe between their fingers until it reconstitutes. The syringe was not used for administration. The healthcare professional was new user. The syringe plunger was the component impacted. The defect was related to the plunger stopper. The plunger fell out completely during preparation. The detachment happened during use. The HCP did have the suspect syringe and would return it to GSK. Consent to follow up with healthcare professional was not asked.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Wrong Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-OCT-2025) for prophylaxis.   On 15-AUG-2023, the patient received Engerix B pediatric. On 15-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced wrong vaccine administered (Verbatim: Wrong Dose Administered).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 16 Aug 2023: The pharmacist reported a patient received the pediatric dose of Engerix-B inadvertently which led to wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: soreness at injection site; Injection site red rash; Redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at injection site), injection site rash (Verbatim: Injection site red rash) and injection site erythema (Verbatim: Redness at injection site). The outcome of the injection site pain, injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site rash and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-AUG-2023 The patient reported he administered 1st dose of Shingrix at a local pharmacy 2 days ago (14 August 2023). He reported red rash and soreness at the injection site. Lot and expiration date details of the vaccine were unknown. The reporter did not consented to follow up with healthcare professional.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine; Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 41-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA977A, expiry date 31-MAY-2024) for prophylaxis.   On 15-AUG-2023, the patient received Menveo. On 15-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine) and inappropriate dose of vaccine administered (Verbatim: Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine).     The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16 Aug 2023 The nurse called to report the administration of a Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine component. The HCP asked how long the patient had to wait in order to receive a properly reconstituted dose. The patient administration of a Menveo dose that was reconstituted using sterile water instead of the  liquid conjugate vaccine component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administration of Shingrix after the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28-AUG-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 22-NOV-2022, the patient received the 2nd dose of Shingrix. On 22-NOV-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: administration of Shingrix after the recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date:17-AUG-2023  A pharmacist called in to request information about the administration of Shingrix after the recommended interval and wished to know how to proceed.  Partial information was given about patient, event and vaccine. No follow-up consent. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Intensive care, Pain, Positive airway pressure therapy
Clinical narrative: Presented w/ SOB, body aches, fever, diagnosed Covid + on 10/24/21.  Admitted to Icu, requring HFNC/BIPAP and Tx w/ steroids, Remdesivir, IVF.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented w/ SOB, body aches, fever, diagnosed Covid + on 10/24/21.  Admitted to Icu, requring HFNC/BIPAP and Tx w/ steroids, Remdesivir, IVF.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: exposed to room temperatures; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In AUG-2023, the patient received Menveo. In AUG-2023, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: exposed to room temperatures).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter was looking on guidance and how to proceed regarding Menveo liquid formulation extended stability information.  The vaccines arrived on Friday night and they probably were exposed to room temperatures.  Somehow, vaccines were moved to a seller area.  The tag alert showed number 2 and 3 meaning that there was a temperature excursion, however 60 units were purchase and distributed and administered to patients. The reporter consented to follow up. The Menveo vaccines were exposed to room temperatures and administered to patients, which led to incorrect storage of vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Localised infection, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Presented w/ congestion, toe infection (currently on abx). Tested covid +. Tx w/ Remdesivir, IVF
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fall, SARS-CoV-2 test positive
Clinical narrative: Presented w/ weakness and fall at home. Throat irritation, mild cough, testex covid +, progressively felt more weak. Tx w/ Redesivir, steroids, O2
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Presented w/ weakness and fall at home. Throat irritation, mild cough, testex covid +, progressively felt more weak. Tx w/ Redesivir, steroids, O2
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash on left arm.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Fatigue, Hypoxia
Clinical narrative: Presented w/ sore throat and Covid+ test approx 1 week prior. Increasingly fatigued w/ weakness. Low grade fever. Tx w/ IX steroids, Remdesivir for Covid pneumonia, O2 support for hypoxia.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented w/ sore throat and Covid+ test approx 1 week prior. Increasingly fatigued w/ weakness. Low grade fever. Tx w/ IX steroids, Remdesivir for Covid pneumonia, O2 support for hypoxia.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Sepsis, Urinary tract infection
Clinical narrative: Hospitalization for Sepsis secondary to UTI and COVID-19 pneumonia on dates 8/15/2023- 8/19/2023. Treated with dexamethasone, baricitinib, and Remdesivir.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acute respiratory failure, COVID-19 pneumonia, Endotracheal intubation, Nausea
Clinical narrative: Presented w/ epigastric pain since yesterday and n/v. Tx for acute hypoxemic resp. failure req. intubation d/t exacerbation of CHF and secondary to Covid + infection/pneumonia.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: Presented w/ epigastric pain since yesterday and n/v. Tx for acute hypoxemic resp. failure req. intubation d/t exacerbation of CHF and secondary to Covid + infection/pneumonia.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure acute
Clinical narrative: Hospitalization for acute on chronic heart failure and COVID-19 on dates 8/14/2023- 8/21/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Fall, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: Chief Complaint: Fall.   .  Diagnosed with COVID yesterday.  COVID-19 NAAT Test Result: Positive.  Dexamethasone 6 mg daily due to tachypnea and O2 requirement. Interestingly no PNA on CXR O2 to keep spo2> 93%
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Hospitalization for abdominal pain on dates 8/14/2023- 8/19/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Metabolic encephalopathy
Clinical narrative: Hospitalization for COVID-19 infection with metabolic encephalopathy, POA on dates 8/1/2023- 8/22/2023. Treated with vitamin D 25 mcg PO daily.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: Vertigo 2 days so far
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was accidently given a vaccine that was 2 days past the beyond use date (BUD). The Pfizer vaccine lot had been placed in the refrigerator and therefore was only good for 10 weeks from the date removed from the ultra-cold freezer. The BUD was 08/21/2023 and this vaccine was administered on 08/23/2023.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Blood test, Electrocardiogram, Heart rate increased, Immunisation reaction, Sinus tachycardia
Clinical narrative: I began having a rapid heartbeat around 7pm.  At 9:30 pm decided to go to ER to be evaluated. After being seen, ecg, bloodwork and examination, I was told  I had sinus tachycardia. I went home around 3:00 am as my heart rate started to go down. Dr. told me this was an  adverse reaction to the vaccine after all other causes were ruled out.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site pain, Pain, Swelling, Urticaria
Clinical narrative: redness, swelling, pain at sight, hurts to walk, scattered hives from knee to groin area
Age: 1.58
Sex: F
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Unauthorized Mix and Match for age group - 2 previous doses of Monovalent Moderna / this dose given was Bivalent Pfizer
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with 3 boosters
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: 8/24/23: 8 pm - injection site soreness  11 pm - restlessness   8/25/23: 2:30 am - Muscle aches, shivers, headache, fatigue   6 am - muscle aches, fatigue, headache
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: 8/24/23: 8 pm - injection site soreness  11 pm - restlessness   8/25/23: 2:30 am - Muscle aches, shivers, headache, fatigue   6 am - muscle aches, fatigue, headache
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received an extra dose of DTap-IPV instead of Tdap.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Pt was incidentally given a 4th dose of Hep A when not needed. Pt had already completed series on time with previous vaccine dates of Havrix being done 06/22/2015 and 01/08/2016  and incidentally had additional Havrix Hep A vaccine on record at another facility 06/26/2018 as well.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Pyrexia
Clinical narrative: Patient was in for preventive visit and received vaccination for COVID on 8/21/23. On 8/21/23 it was discovered that that lot number had expired on 8/1/23. The error likely occurred due to confusion with multiple expiration dates, one being a revised manufacturer date and one being the 10 week "out of freezing" date.  Patient's mother notified the day after the event. Patient had a little fever,  but is otherwise feeling normal. No pain at injection site.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose; Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix adult) (batch number 797f9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) (batch number 327e3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix adult (1st dose was received in June 2017 with batch number: b9h95 expiration date was unknown).   On 08-AUG-2023, the patient received the 3rd dose of Twinrix adult. On 07-APR-2023, the patient received the 2nd dose of Twinrix adult. On 07-APR-2023, not applicable after receiving Twinrix adult and an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 08-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 17-AUG-2023 The pharmacist reported that the patient received 1st dose of Twinrix adult in June 2017, 2nd dose on 7th April 2023 and 3rd dose on 8th August 2023. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix adult, earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 9.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was in preventive visit and received vaccination for COVID on 8/15/23. On 8/21/23 it was discovered that that lot number had expired on 8/1/23. The error likely occurred due to confusion with multiple expiration dates, one being a revised manufacturer date and one being the 10 week "out of freezing" date.  No documentation of any patient adverse event.
Age: 18.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: 08/24/2023  Noted itchy rash at her left upper back and left upper extremity .  She denies burning in the area.  The patient states she noticed it while running cross-country.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered Peds Pfizer COVID Vaccine for age 5-11 on 8/8/23 that had expired 8/1/23 per the 10 week "out of freezing" expiration date.  No patient adverse events documented.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Headache, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: itchy throat won't let me sleep  I am constantly coughing sore arm  high fever  headache
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Throat irritation
Clinical narrative: itchy throat won't let me sleep  I am constantly coughing sore arm  high fever  headache
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging, Nasoendoscopy, Parosmia
Clinical narrative: I got a second bivalent booster on May 19, 2023. It was my 6th covid vaccine (first 2, then 2 boosters, then first bivalent, then this second bivalent) all on advice from my primary care physician. About one week later, while having a bowel movement, I noticed a strong, strange smell - not at all like my stool usually smells. I thought something must be wrong with our septic system or even our well. My spouse checked everything - nothing was wrong with the septic or well.  Then, over the next few days, more things smelled exactly the same - my stool, my urine, when I pass gas, dog food, many types of cooked meats and other foods,  even Cherios. It is a strange, sweet, pungent smell. Now, 3 months later, the smell has gotten slightly less powerful, but the same number and types of things smell strange, yet all identical to each other.    I went to urgent care a few days after the smell started. The nurse practitioner I saw said it must be from a cold - except the last cold I had was in late March 2023 - two months eariler. She said to wait a few weeks. On June 28, 2023 I saw a physician in the same clinic as my primary doctor. She said it could be from several things and gave me a referral to an ENT. I saw the ENT on July 17, 2023. I have been  diagnosed with parasomia due to an unknown cause. I think it was the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: CLIENT STATES THAT ON THE DAY OF THE VACCINE BEING ADMINISTERED TO HER, THE NURSE GIVING THE SHOT USED A STABBING TECHNIQUE IN HSR LEFT UPPER ARM. STATES SHE ASKED THE NURSE WHY DID SHE GIVE HER SHOT THAT WAY AND WAS TOLD THAT THIS IS THE WAY THAT SHE WAS SUPPOSED TO GIVE IT. CLIENT STATES THAT S DAYS LATER SHE WOKE UP TO A SWOLLEN ARM AT THE INJECTION SITE AND IT HAS NOT GONE AWAY SINCE THAT DAY. SHE PRESENTED TO OUR FACILITY ON 08/11/2023 AT WHICH TIME i MEASURED THE AREA NOTING IT TO BE APPROXIMATELY 2 AND A HALF INCHES WIDE AND 3 AND A HALF INCHES LONG. NOT WARM TO TOUCH JUST SWOLLEN. STATES SHE HAS BEEN TO THE ER 2 MONTHS AGO FOR ANOTHER REASON AND THE ER DOCTOR NOTICED THE AREA BUT NOTHING WAS DONE ABOUT IT AT THAT VISIT. SHE HAS ALSO BEEN UNDER THE CARE OF 2 DOCTORS REGARDING HER RIGHT SHOULDER BECAUSE OF A FALL ON THAT SHOULDER. BOTH DOCTORS HAVE SEEN THE LEFT ARM BEING SWOLLEN AND ARE CHECKING TO SEE WHAT CAN BE DONE ABOUT IT BECAUSE CLIENT STATES THAT SHE HAS BEEN TOLD IN TIMES PAST THAT SHE COULD NOT GET A MRI DONE WITH HAVING THE PACEMAKER.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Acute disseminated encephalomyelitis, Anti-aquaporin-4 antibody negative, Antibody test negative, Antinuclear antibody positive, Atrophy
Clinical narrative: Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Brain stem syndrome, CSF oligoclonal band absent, Cardiac arrest, Cardiac function test normal, Confusional state
Clinical narrative: Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Demyelination, Double stranded DNA antibody positive, Encephalomyelitis, Laboratory test abnormal, Lumbar puncture normal
Clinical narrative: Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Noninfective encephalitis, Quadriplegia, Respiratory failure
Clinical narrative: Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Spinal cord disorder
Clinical narrative: Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient received the vaccine and stated that they felt a tingling down to their wrist at the time of administration. It resolved shortly after and he no longer felt the tingling.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site infection
Clinical narrative: Patient had received a Shingrix and COVID-19 Bivalent vaccine on 8/22/23. Patient received the Shingrix in the Left Deltoid and COVID-19 in the Right Deltoid. Patient returned on 8/25/23 reporting an infection at the injection site in the left arm. Patient had visited a local emergency room on 8/25/23 and brought in a prescription for a 10 day course of Doxycycline. Unknown when symptom onset occurred. Patient did not report any other adverse reactions.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness bilateral, Hypoxia, Respiratory failure
Clinical narrative: J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 BILAT HEARING LOSS R09.02 HYPOXIA 4/9/2023 BILAT HEARING LOSS
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Haematuria, Hyperglycaemia, Metastases to bone, Muscle spasms
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 GROSS HEMATURIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 DM 2 W HYPERGLYCEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 BILAT LEG CRAMPS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 CANCER METASTATIC TO BONE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Type 2 diabetes mellitus
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 GROSS HEMATURIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 DM 2 W HYPERGLYCEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 BILAT LEG CRAMPS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2023 CANCER METASTATIC TO BONE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pneumonia
Clinical narrative: Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung (POA: Yes) COVID-19 infection with not requiring oxygen. Continues azithromycin IV/ceftriaxone IV
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dyspnoea, Pleural effusion, Respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 5/1/2023 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/27/2023 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 5/1/2023 BILAT PLEURAL EFFUSION J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/27/2023 BILAT PLEURAL EFFUSION
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: this was then the patient's 4th dose of Hepatitis B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult female patient who received HAB (Twinrix) (batch number dk23d) for prophylaxis.   Previously administered products included Engerix b (received full Engerix-B series on an unknown date) and Havrix (received 1 dose of Havrix on an unknown date).   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: this was then the patient's 4th dose of Hepatitis B).     The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 17 August 2023: The pharmacist reported about lot number for vaccine and if it was for Twinrix or Havrix-lot number dk23d.  The pharmacist stated she believed a patient might have been given Twinrix when they only needed Havrix back in 2021. The patient received a full Engerix-B series in the MD's office and had received 1 dose of Havrix. The dose in question should have been their second dose of Havrix. The patient received Twinrix by mistake.  As a result, this was then the patient's 4th dose of Hepatitis B.  The reporter consented to follow up. The patient received 4th dose of Hepatitis B which led to extra dose administered.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury
Clinical narrative: Patient received initial dose of HPV, TDaP and Menquadfi. It was reported by vaccine administrator, CMA, that shortly after administration of HPV (which was the last vaccine administered), patient smiled at the administrator and proceeded to fall forward from exam table. CMA attempted to hold patient up while falling down but did manage to hit forehead on linoleum flooring.  Mom called for help immediately and physician went into exam room to assess patient and was kept in clinic for additional hour for observation. Vitals were stable and patient and oriented when dismissed home with mother.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity, Vaccination site warmth
Clinical narrative: Patient reported her right arm was extremely stiff and achey for 3 days following vaccine administration, was very hot to the touch, and red surrounding the vaccination site.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic left ventricular failure, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/25/2023 DIASTOLIC HEART FAILURE, CHRONIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/27/2023 DIASTOLIC HEART FAILURE, CHRONIC
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Hypoglycaemia, Pulmonary embolism
Clinical narrative: I20.8 STABLE ANGINA 3/24/2023 HYPOGLYCEMIA I26.99 ACUTE PULMONARY EMBOLISM 2/9/2023 HYPOGLYCEMIA
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: R09.02 HYPOXIA 3/23/2023 SHORTNESS OF BREATH
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 5/2/2023 NORMAL DELIVERY
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypercoagulation, Hypoxia, Respiratory failure
Clinical narrative: J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/27/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION R09.02 HYPOXIA 3/27/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Cough, Ocular hyperaemia, Periorbital swelling, Rhinorrhoea
Clinical narrative: cough, runny nose, red and puffy watery eyes
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Patient received Arexvy vaccine 8/23/23 IM in her left arm. Starting 8/24/23 she had large swelling/redness around the injection site, and swelling in her underarm believes it to be a lymph node. She states she had similar reaction to all of the covid vaccines. She is doing at home ice packs and ibuprofen to help with pain.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only; patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only; This non-serious case was reported by a medical representative via call center representative and described the occurrence of inappropriate dose of vaccine administered in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received Shingrix. On 16-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only) and inappropriate preparation of medication (Verbatim: patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only).     The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 17 Aug 2023 The  patient was apparently given a dose of Shingrix with only the reconstituted dose and provided partial information.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient was apparently given a dose of Shingrix with only the reconstituted dose adjuvant only which led to inappropriate dose of vaccine administered and inappropriate preparation of medication
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cervical radiculopathy, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 4/12/2023 CERVICAL RADICULOPATHY
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Bacterial sepsis
Clinical narrative: ACUTE NON ST ELEVATION MI 3/2/2023 OTHER GRAM-NEGATIVE SEPSIS
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Flushing, Hyperhidrosis, Pallor
Clinical narrative: 5 yr old was in office for back office visit to receive pneumococcal 23 vaccine per recommendations of the hematologist   The vaccine was given in the right deltoid   I was called into the room as patient begin becoming flushed, red in the face, sweaty and diaphoretic.   Pt. was coughing and gagging, no throwing up Breathing ok, in no distress Coughing and gagging continued for 1-2 minutes   Benadryl elixir ordered - 12.5 mg/5 mls - 7.5 mls given orally   The coughing and gagging resolved with in 1-2 minutes No further distress   Pulse ox thru out time was 96-97%   Patient was able to verbally reply "I am feeling better"   Patient was moved from sitting position on exam table w/ Mom standing next to her to the chair and was then sitting on Mom's lap   Continued to say she was feeling better   No coughing No gagging Breathing comfortably   Very pale and peaked looking   Continued to monitor and disc w/ mom sleepiness that may occur w/ the benadryl and need for close monitoring next 4-8 hours   Patient continued to be pale but comfortable and decision made to call EMS- to have child transported to ER for further evaluation and observation   Paramedics arrived and information regarding above given Vitals stable in office   Pt. able to stand up and walk to gurney where she was held by Mom for transport to ER   Asked which ER preferred   Patient left w/ paramedics about 5 pm