chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Priorix expired on 11 May 2024 and it was accidentally given on 14 June 2024 to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received MMR (Priorix) (batch number 447N4, expiry date 11-MAY-2024) for prophylaxis.   On 14-JUN-2024, the patient received Priorix. On 14-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Priorix expired on 11 May 2024 and it was accidentally given on 14 June 2024 to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUL-2024 The office administrator called and informed that an expired dose of Priorix vaccine was accidently given to a patient, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in SEP-2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUL-2024 Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This case was linked with case US2024083033 for same reporter.; Sender's Comments:  US-GSK-US2024083033:Same reporter/Different patient
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix was reconstituted with an mmr diluent; Shingrix was reconstituted with an mmr diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUL-2024, the patient received Shingrix. On 03-JUL-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix was reconstituted with an mmr diluent) and inappropriate dose of vaccine administered (Verbatim: Shingrix was reconstituted with an mmr diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-JUL-2024 A nurse reported that Shingrix was reconstituted with an 'mmr diluent' and administered to a patient Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Myalgia, Oral herpes
Clinical narrative: Clarifying her left arm was sore in the muscle; Blisters between left ring finger and middle finger and between her breast; left arm just didnt feel good/Clarifying her left arm was sore in the muscle; Fever blisters break out on left side of mouth.; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 13-APR-2024, 2 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm just didnt feel good/Clarifying her left arm was sore in the muscle) and fever blister (Verbatim: Fever blisters break out on left side of mouth.). On 04-JUN-2024, the patient experienced blister (Verbatim: Blisters between left ring finger and middle finger and between her breast). On an unknown date, the patient experienced muscle soreness (Verbatim: Clarifying her left arm was sore in the muscle). The outcome of the blister, pain in arm, fever blister and muscle soreness were not resolved.   It was unknown if the reporter considered the blister, pain in arm, fever blister and muscle soreness to be related to Shingrix.     It was unknown if the company considered the blister, pain in arm, fever blister and muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUL-2024 The patient self-reported. She received her 1st Shingrix vaccine on 11 April 2024 and stated that she felt fine, then on day 2 noticed her left arm didn't feel good.  Clarifying her left arm was sore in the muscle, this had been going on since the day of the vaccine.  Reporter also complains of fever blisters breaking out on her left side of mouth, between her breast and on her left hand between the ring finger and middle finger.  Reporter stated she was supposed to get her 2nd Shingrix vaccine on 11 October 2024 and was awaiting her doctor to let her know if she should receive it or not.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose administered; 2nd dose received late; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered) and drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 01-JUL-2024 The reporter was the patient. He contacted GlaxoSmithKline via web form. He wrote that he had a 1st shot several years ago and then a 2nd shot. I received notification that a 3rd shot was due. This was more than a year after receiving the 2nd shot. The pateint consulted with physician, and he said I did not need to worry about the time period having elapsed.  The patient went to the pharmacist he had been worried about giving a second shot after so long a time period had elapsed. The pharmacist gave the patient a 3rd shot which led to extra dose administered, but told that another shot the 2nd part should be taken. The patient clarified to pharmacist that he was asking about the shingles vaccine. The pharmacist informed him that Shingrix was administered as a 2 dose series. The FDA approved schedule did not  include a booster dose of Shingrix or a repeat of the series. The patient also asked him if he knows for sure that all of the shots he received were Shingrix (not Zostavax). He said he was not sure but that he would double check. He said that his providers kept saying that there was a third dose. (No further information gathered as caller wanted to get off the phone). The patient said that he got a second dose but missed the deadline by a year. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I still have enlarged right axillary nodes from 2.5 years ago that developed days after the first vaccination in the right arm; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (I still have enlarged right axillary nodes from 2.5 years ago that developed days after the first vaccination in the right arm) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced LYMPHADENOPATHY (I still have enlarged right axillary nodes from 2.5 years ago that developed days after the first vaccination in the right arm). At the time of the report, LYMPHADENOPATHY (I still have enlarged right axillary nodes from 2.5 years ago that developed days after the first vaccination in the right arm) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient was experienced enlarged right axillary nodes from 2.5 years ago and which was developed after the first vaccination. It was also reported that days after the first vaccination in the right arm patient experienced inflamed and cause pain all the way to the fingertips. No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Limb operation
Clinical narrative: Leg surgery; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources]. Upon receipt of follow-up information on [09Jul2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB OPERATION (medically significant), outcome "unknown", described as "Leg surgery". Clinical course: Entire Biontech connect was violation of international decorum, was human trespassing, not warranted by place name. 4 years ago, was trespassed, injected with BioNTech on or about 4Apr2020, while having leg surgery. Had never given authorization or signed to be injected with vaccine. That began all thought sharing through thought connect. Was hearing children farting in his ears, random thoughts put on Instagram live, intercoms up in sky. Clarified, this was not first time this has all been reported with Pfizer. When caller asked to provide reference number for previous reports and calls made with Pfizer, he stated he had those numbers, he stated, he called Pfizer many times, they have blocked his number.  Wanted attorney to give intrusion of BioNTech connect to stop causing damage to both him and his family. They did not have his permission. Wanted to stop being force connected through life connect, being put on catch and release, random children in his ears, chirping in his ear.  Wants all files regorging Name disposed of and all acts of BioNTech to stop immediately. Did not want ringing in ears, does not want any form of violation of his human rights. Was going to have attorney contact Pfizer, there will be lawsuit.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400174153 Same patient/same product, different dose/event;US-PFIZER INC-202300272914 Same patient/same product, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: cysts; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (non-serious), outcome "unknown", described as "cysts".  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: because it would be very hard on them since everytime they get covid; because it would be very hard on them since everytime they get covid; 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 included: "asthma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "because it would be very hard on them since everytime they get covid". Clinical course: Caller said that there was a new form of Covid and wanted to know if the last year's version of Covid vaccine covered that. She said that the new form of Covid attacks the lungs and her two daughters have asthma and the only reason that she was asking because it would be very hard on them since every time they got covid, it was really bad. She said that she needs to get them the vaccine that would cover this summer's version of Covid.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400090151 Same reporter, drug and event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: it killed him; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "it killed him". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: It was reported that patient got the Pfizer Covid vaccine and it killed him.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: it killed him
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Blood creatinine, Glomerulonephritis minimal lesion, Immunology test
Clinical narrative: minimal change disease; This is a literature report.  Kidney injury has now become one of the known complications following COVID-19 infection and vaccination. Only few cases of minimal change disease following administration of COVID-19 vaccination and infection have been reported. This study was to highlight incidence of minimal change disease following COVID-19 infection or vaccination. An 18-year-old female with no significant past medical history presented with a chief complaint of generalized swelling, which started around the same time she received her 1st dose of Pfizer COVID vaccine (the 2nd dose 2 months later). She had a nephrotic range proteinuria and hypoalbuminemia, but normal level of serum creatinine. A renal biopsy after 4 months of vaccination showed unremarkable glomeruli by light microscopy, negative immunofluorescent study, but diffuse effacement of foot processes involving more than 80% of the examined loops by electron microscopy. This biopsy findings were consistent with a minimal change disease. Both patients did not receive any treatment before the renal biopsies. Results (if a Case Study enter NA): NA. Conclusion: Minimal change disease can be a rare complication following COVID-19 infection or Pfizer COVID-19 vaccination, raising a question if there are similar antigens induced by the infection or by the vaccination that trigger the minimal change disease. Further studies are needed to determine the incidence and pathophysiology of minimal change disease either post COVID-19 vaccines or following COVID-19 infections.; Sender's Comments: The event glomerulonephritis minimal lesion is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Microscopy, Protein urine
Clinical narrative: minimal change disease; This is a literature report.  Kidney injury has now become one of the known complications following COVID-19 infection and vaccination. Only few cases of minimal change disease following administration of COVID-19 vaccination and infection have been reported. This study was to highlight incidence of minimal change disease following COVID-19 infection or vaccination. An 18-year-old female with no significant past medical history presented with a chief complaint of generalized swelling, which started around the same time she received her 1st dose of Pfizer COVID vaccine (the 2nd dose 2 months later). She had a nephrotic range proteinuria and hypoalbuminemia, but normal level of serum creatinine. A renal biopsy after 4 months of vaccination showed unremarkable glomeruli by light microscopy, negative immunofluorescent study, but diffuse effacement of foot processes involving more than 80% of the examined loops by electron microscopy. This biopsy findings were consistent with a minimal change disease. Both patients did not receive any treatment before the renal biopsies. Results (if a Case Study enter NA): NA. Conclusion: Minimal change disease can be a rare complication following COVID-19 infection or Pfizer COVID-19 vaccination, raising a question if there are similar antigens induced by the infection or by the vaccination that trigger the minimal change disease. Further studies are needed to determine the incidence and pathophysiology of minimal change disease either post COVID-19 vaccines or following COVID-19 infections.; Sender's Comments: The event glomerulonephritis minimal lesion is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Drug ineffective, Lung disorder
Clinical narrative: only have half of left lung / lung collapsed due to long haul covid taken the pfizer vaccine in 2021; only have half of left lung / lung collapsed due to long haul covid taken the pfizer vaccine in 2021; only have half of left lung / lung collapsed due to long haul covid taken the pfizer vaccine in 2021; had brain fog for 3 years; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 50-year-old patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN FOG (non-serious) with onset 2021, outcome "unknown", described as "had brain fog for 3 years"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), LUNG DISORDER (non-serious), outcome "unknown" and all described as "only have half of left lung / lung collapsed due to long haul covid taken the pfizer vaccine in 2021".  Clinical course: Patient stated they need this medication or they will actually die patient only have half of left lung / lung collapsed due to long haul covid taken the Pfizer vaccine in 2021 had brain fog for 3 years .
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired PENTACEL vaccine, with no reported adverse event; Initial information received on 02-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics whom inadvertently administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], 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 an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site as immunization and reported that inadvertently administered an expired pentacel vaccine, with no reported adverse event (expired product administered) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is 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: 15.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Opened IPOL Max/low temperature reached: 34.5F/Duration out of labelled range: 18 minutes/ Reason: unknown cause /3 doses of IPOL administered post excursion,with no reported adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  Several cases (2024SA202458, 2024SA202323) have been created from this master case.  This case involves a 15-year-old female patient was reported to have an opened IPV (Vero) [IPOL] with a maximum temperature reached of 34.5°F, a duration outside of the labeled range of 18 minutes, and an unknown cause. Three doses of ipol were given after the excursion, with no adverse events reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (infanrix) and hepatitis a vaccine inact (havrix) for prophylactic vaccination and althaea officinalis root, cinnamomum camphora essential oil, citrus x aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (gardisil).  On 08-Jul-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (strength- standard) (lot- W1C741M and expiration date- 17-NOV-2025) via intramuscular route in the right deltoid for Immunisation (poor quality 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: 6.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Opened IPOL temperature reached: 34.5F Duration out of labelled range: 18 minutes with no adverse event; dose of IPOL administered post excursion with no adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case linked to Master case id 2024SA202456  This case involves a 6 years old male patient to whom a dose of IPV (VERO) [IPOL] administered post excursion an opened IPOL temperature reached: 34.5f duration out of labelled range: 18 minutes with no 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 Immunisation.  On an unknown date the opened IPV (VERO), Suspension for injection (lot W1C741M and Expiration date: 17-Nov-2025) was temperature reached: 34.5f duration out of labelled range: 18 minutes with no adverse event (product storage error) (unknown latency).  On 08-Jul-2024, the patient was administered 0.5 ml (dose 6) of suspect IPV (VERO), Suspension for injection (lot W1C741M and Expiration date: 17-Nov-2025) via intramuscular route in the right deltoid for Immunization post excursion with no adverse event (poor quality product administered) (latency: same day)  No Human error and Extended stability data does cover the unopened products, does not cover the opened IPOL MDV.  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: 17.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was given Menquadfi in FEB2024 after having received two Menactra vaccines (with no reported adverse event); Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who was given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] in feb2024 after having received two MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (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 in February 2024, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection dose 0.5 ml TOTAL lot U7939AC expiry date- 31-Mar-2024 via intramuscular route in the left arm for immunization (strength unknown) after having received two menactra vaccines (with no reported adverse event) (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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Electric shock sensation, Nausea, Pain
Clinical narrative: Body ache, difficulty breathing, nausea, weakness, sharp pain in lower extremities, 'shocks' through legs up to rectum, 'shocks' lower back down to rectum, testicular shocks, testicular 'twisting/crushing' pain. Emergency Room visit approximately 10pm that same day.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Testicular pain, X-ray abnormal
Clinical narrative: Body ache, difficulty breathing, nausea, weakness, sharp pain in lower extremities, 'shocks' through legs up to rectum, 'shocks' lower back down to rectum, testicular shocks, testicular 'twisting/crushing' pain. Emergency Room visit approximately 10pm that same day.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received spoiled vaccine that was involved in a temp excursion. Pt tolerated vaccine well and did not develop any adverse reactions. Pt is currently residing at place. Their Medical Director was informed by our Practice Manager and Board Director.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Provider administered in error the pediatric version of the Hep B Energix B to an adult patient. Patient had no adverse reaction, but did not get the full dose.   Called patient and she will be coming back to clinic to receive another 0.5ml (10mcg Dose) in order to  receive the full dose for dose 2 of 3 and she will return for her 3rd scheduled dose as planned to finish 3 dose series.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received spoiled vaccine that was involved in a temp excursion. Pt tolerated vaccine well and did not develop any adverse reactions. Patient currently resides at Academy. Their Medical Director was informed by our Practice Manager and Board Director.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received spoiled vaccine that was involved in a temp excursion. Pt tolerated vaccine well and did not develop any adverse reactions. Patient currently resides at Academy. Their Medical Director was informed by our Practice Manager and Board Director.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received spoiled vaccine that was involved in a temp excursion. Pt tolerated vaccine well and did not develop any adverse reactions. Patient currently resides at school. Their Medical Director was informed by our Practice Manager and Board Director.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: I do not know the lot number it was given to my son at the doctor office. 5 inch x 5.5 inch hard reddened warm area surrounding the poke hole on thigh
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Burning sensation, Eye movement disorder, Fall, Moaning, Muscle twitching
Clinical narrative: He was sitting on the exam table and was given Menquadfi and Trumenba one right after the other, one in each arm. Within a few seconds he said, I f?eel nauseous " and began to sway. His face went pale. He began to moan and  swayed back and to his left. His eyes rolled back and the muscles around his eyes became tense and his eyes widened and  began to twitch. He did nor respond  when I said his name or asked if he was okay. He swayed forward and almost fell off the table. Nurse (male) caught him and kept him from falling. The nurse placed him in a laying position.  After many seconds (not sure how many) he came to and said "I thought I died" and a few seconds later, "my brain felt like it was on fire". He was told to stay down and was offered water. His pulse was  oral when the nurse xhecked. He remained naseus for several minutes. He had yogurt for breakfast and no water.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: He was sitting on the exam table and was given Menquadfi and Trumenba one right after the other, one in each arm. Within a few seconds he said, I f?eel nauseous " and began to sway. His face went pale. He began to moan and  swayed back and to his left. His eyes rolled back and the muscles around his eyes became tense and his eyes widened and  began to twitch. He did nor respond  when I said his name or asked if he was okay. He swayed forward and almost fell off the table. Nurse (male) caught him and kept him from falling. The nurse placed him in a laying position.  After many seconds (not sure how many) he came to and said "I thought I died" and a few seconds later, "my brain felt like it was on fire". He was told to stay down and was offered water. His pulse was  oral when the nurse xhecked. He remained naseus for several minutes. He had yogurt for breakfast and no water.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Hyperhidrosis, Lethargy
Clinical narrative: Vaccine given 6/24/24 in AM - Symptoms developed overnight 6/24/24 - Restless sleep, chills, sweats. 6/25/24 - Very weak, slept all day, no appetite. 6/26/24 - continued weakness, no appetite. Slept all day. lethargy 6/27/24 - Felt better, returned to normal activities
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Poor quality sleep, Somnolence
Clinical narrative: Vaccine given 6/24/24 in AM - Symptoms developed overnight 6/24/24 - Restless sleep, chills, sweats. 6/25/24 - Very weak, slept all day, no appetite. 6/26/24 - continued weakness, no appetite. Slept all day. lethargy 6/27/24 - Felt better, returned to normal activities
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood test, Blood test abnormal, Laboratory test, Urine analysis
Clinical narrative: got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1686), on 27Jan2021 as dose 2, single (Lot number: EL8982) and on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 64 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming". The patient underwent the following laboratory tests and procedures: Lab test: (08Jul2024) Unknown results, notes: I was there on Monday, it was the 8th. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient reported a potential adverse event on the Pfizer BioNTech COVID-19 vaccine. She reported that after having the vaccine she got COVID twice. She also mentioned that the vaccine was harming her.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202400203355 same patient/product, different dose/events;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1686), on 27Jan2021 as dose 2, single (Lot number: EL8982) and on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 64 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming". The patient underwent the following laboratory tests and procedures: Lab test: (08Jul2024) Unknown results, notes: I was there on Monday, it was the 8th. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient reported a potential adverse event on the Pfizer BioNTech COVID-19 vaccine. She reported that after having the vaccine she got COVID twice. She also mentioned that the vaccine was harming her.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202400203355 same patient/product, different dose/events;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test
Clinical narrative: got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1686), on 27Jan2021 as dose 2, single (Lot number: EL8982) and on 11Dec2021 as dose 3 (booster), single (Lot number: 331308D) at the age of 64 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "got COVID-19 twice after getting the Pfizer COVID-19 vaccine/Vaccine is harming". The patient underwent the following laboratory tests and procedures: Lab test: (08Jul2024) Unknown results, notes: I was there on Monday, it was the 8th. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient reported a potential adverse event on the Pfizer BioNTech COVID-19 vaccine. She reported that after having the vaccine she got COVID twice. She also mentioned that the vaccine was harming her.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202400203355 same patient/product, different dose/events;
Age: 69.0
Sex: F
Vaccine: RSV, VARZOS, RSV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had rash on the arm that lasted about 3 days
Age: 69.0
Sex: F
Vaccine: RSV, VARZOS, RSV, VARZOS
Symptoms: Rash
Clinical narrative: Patient had rash on the arm that lasted about 3 days
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no patient symptoms have been reported; ROTATEQ was administered to a patient after the product was involved in a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 30-MAY-2024 , the patient was vaccinated with an improperly stored first dose (product storage error) of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot # 2003148, expiration date: 31-MAY-2025 (strength and dose were not provided) for prophylaxis.  The temperature excursión was of 8.94°C, time frame: 0 Hours 30 Minutes 0 Seconds and there was no previous temperature excursión.  No adverse events reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Patient moved (flinched) during gardasil 9 injection and did not receive the entire dose.; Patient moved (flinched) during gardasil 9 injection and did not receive the entire dose.; No adverse event; This spontaneous report was received from a registered nurse via company representative (reported as field-based employee [FBE]) and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). However, he moved (flinched) during the suspect vaccine injection and did not receive the entire dose (product administration interrupted / accidental underdose). No additional adverse events reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I have shingles after my first dose; This non-serious case was reported by a consumer and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2024, the patient received the 1st dose of Shingrix. On 01-JUL-2024, 45 days after receiving Shingrix, the patient experienced shingles (Verbatim: I have shingles after my first dose). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2024 The reporter if could got the second dose even though had shingles after my first dose.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol exposed on 19Apr for 30 minutes max 8.94 C and 10Jun for 30 minutes max 8.35 C due to human error with no reported adverse event; vaccine was administered post excursion with no reported adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old male patient whom IPV (VERO) [IPOL] was administered post excursion as exposed on 19-apr for 30 minutes max 8.94 c and 10-jun for 30 minutes max 8.35 c due to human error with no reported adverse event.  This case is linked to 2024SA202304 (master case)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  IPOL was exposed on 19-apr for 30 minutes max 8.94 c and 10-jun for 30 minutes max 8.35 c due to human error with no reported adverse event (product storage error).   On 03-Jul-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection of lot W1C751M and expiry date: 18-Nov-2025 (strength: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) and vaccine was administered post excursion with no reported adverse event (poor quality product administered) (latency: on 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Opened IPOL exposed to max/low temperature reached: 34.5F for 18 minutes was  administered post excursion, with no reported adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5-year-old male patient whom opened IPV (VERO) [IPOL] exposed to max/low temperature reached: 34.5f for 18 minutes was administered post excursion, with no reported adverse event.  This case is linked to 2024SA202456 (master case)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Jul-2024, the patient received 0.5 ml dose (dose 4) of suspect IPV (VERO) Suspension for injection (strength- standard, frequency; once) (lot- W1C741M and expiration date- 17-NOV-2025) via intramuscular route in the left thigh for Immunization (poor quality product administered) (latency- same day).  Reportedly, Human error? No Does extended stability data cover the excursion? Extended stability data does cover the unopened products, does not covered for opened IPOL MDV and TUBERSOL MDV  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: 0.25
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to the administration of menquadfi to a 3 month old patient with no reported adverse event; Initial information received on 09-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves inappropriate use due to the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] to a 3-month-old patient 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 pneumococcal vaccine conj 7V (CRM197) (Prevnar); rotavirus vaccine live oral 1V (Rotarix); and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination.  On 08-Jul-2024, the patient received a 0.5 ml dose (dose 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8193AB and expiry date: 30-Sep-2027 via intramuscular route in the right thigh as Prophylactic Vaccination (immunization) and reported inappropriate use due to the administration of menquadfi to a 3 month old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: on 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.