chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Computerised tomogram normal, Hypoaesthesia, Laboratory test normal, Pain in extremity, Paraesthesia
Clinical narrative: The Patient came into facility seeking medical services and advice in regards to an adverse reaction he received after receiving his Jynneos vaccine.  The patient complains of tingling numbness and pain on the left arm all the way down to his fingertips.  Patient stated that he needs to massaging his left arm and fingertips every morning.  He states he went to the hospital and received a CAT scan but the hospital did not report any problems with the patient. Per the patient, the hospital also checked his heart to make sure there were no problems and the hospital reported no issues as well. The patient advised that this pain and numbness happens every morning.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Ear discomfort, Insomnia, Intrusive thoughts
Clinical narrative: PATIENT REPORTS EXPERIENCING DIZZINESS, FEELING DISORIENTED, HAVING INTRUSIVE THOUGHTS, INSMONIA, RINGING IN EARS, AND FEELINGS OF INCREASED PRESSURE IN THEIR EARS
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PATIENT REPORTS EXPERIENCING DIZZINESS, FEELING DISORIENTED, HAVING INTRUSIVE THOUGHTS, INSMONIA, RINGING IN EARS, AND FEELINGS OF INCREASED PRESSURE IN THEIR EARS
Age: 36.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently given out of age range for MMRV. Age range is not present on box.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/no PQC; Pharmacist called and reported the following AE for ZOSTAVAX: Pharmacist states patient inadvertently received the ZOSTAVAX vaccine twice, once at Pharmacy and then at another Pharmacy, rather than a one-time dose series as i; This spontaneous report as received from a pharmacist and refers to a 78-year-old patient of unknown gender. No information on patient's medical history and current conditions was provided. Concomitant therapies included influenza vaccine (FLUZONE [INFLUENZA VACCINE]) administered at 31-OCT-2017.  On unknown date, the patient was vaccinated with first dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 02-NOV-2017 the patient was vaccinated with second dose zoster vaccine live (ZOSTAVAX) lot # N025566 and expiration date 13-DEC-2018 for prophylaxis (exact dose, route and site of administration were not provided). Pharmacist stated that patient inadvertently received the zoster vaccine live (ZOSTAVAX) vaccine twice, once at Pharmacy and then at another Pharmacy, rather than a one-time dose series as indicated. No additional adverse events reported (extra dose administered and no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic events/No additional AE; HCP called to report that a dose of GARDASIL 9 that was involved in a below range not supported Temperature Excursion (02623969) was inadvertently administered to a patient. No symptomatic events were reported. No additional information was provided.; This spontaneous report was received from a nurse referring to a patient with unknown age and gender. The patient's pertinent medical history and drug reactions/ allergies and concomitant medication were not reported.   On 21-JUN-2024, the patients were vaccinated inadvertently with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #x022737, expiration date: 12-APR-2026, administered for prophylaxis (strength, anatomical location and route of administration were not provided) following a not supported temperature excursion occurred on 19-JUN-2024 (the temperature was 28.9 Fahrenheit (F), time frame was 18 hours 0 minutes 0 seconds, previous temperature excursion not reported) (Product storage error). No symptomatic events were reported. No additional information was provided. No additional adverse event (AE) (No adverse event).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that VARIVAX and PROQUAD were inadvertently administered concomitantly to a patient on 6/12/2024; This spontaneous report has been received from a nurse, regarding a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 12-JUN-2024, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection in the left thigh (lot number: X025096, which was determined to be valid,, with an expiration date on 16-APR-2025) and a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection in the right thigh (lot number: X026326, which was determined to be valid, with an expiration date on 07-NOV-2025), both as prophylaxis (strength, dose, scheme and route of administration were not reported) (Accidental overdose).  No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported. No additional information/clarification provided. No additional AE/PQC; HCP calling to report MMRII was inadvertently administered on 6/22/2024 after its labeled expiry date of 6/20/2024. HCP reports the vaccine had no previous temperature excursions. No side effects reported. No additional information/clarification prov; This spontaneous report was received from a physician and refers to a 4-year-old patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 22-JUN-2024 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W019422 and expiration date 20-JUN-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided). No side effects reported (expired product administered and no adverse event).
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC; HCP called for TE for MMR II. Product was administered after being improperly stored.  See TE case 02624776. HCP provided patient information and administration date at the time of the call. Consent to contact is yes. No adverse side effects were rep; This spontaneous report was received from a consumer and refers to a 4-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 24-JUN-2024 the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # X007686 and expiration date 14-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). No adverse side effects were reported (product storage error and no adverse event).
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient missed RabAvert second dose on day three and having it administered one day later; Case reference number US-BN-2023-001520 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23- 1471) on 13-Sep-2023 and concerns male patient of unknown age.   The patient had no relevant medical history.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient had exposure to rabies.  On unspecified date, the patient was vaccinated with the first dose of Rabavert (batch number unknown), at an unknown dose, route or site of administration, for post exposure to rabies.   It was reported that four doses of Rabavert was scheduled which were on day zero, three, seven and fourteen however, the patient missed his second dose on the day three and had it administered on day four (explicitly coded as 'Inappropriate schedule of vaccine administered').  Reporter wants to know if patient can continue the third and fourth doses as scheduled or if the dates have to be re-arranged according with the date of second dose.     At the time of initial report, it was unknown if the patient experienced any adverse event due to Rabavert vaccine.  Additional information received on 14-Sep-2023 included local case ID.; Reporter's Comments: A male patient of unknown age missed his second dose on the day three and had it administered on day four which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabavert vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age missed his second dose on the day three and had it administered on day four which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabavert vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Three patients were vaccinated with first dose of RabAvert vaccine two to three months ago; Case reference number US-BN-2024-000124 is a spontaneous case report initially received from other health care professional via (reference number: USBAV24-0215) on 31-Jan-2024 and concerns three patients of unspecified age.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, reported as two to three months ago, three patients were vaccinated with first dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route of site of administration, for pre-exposure to rabies (explicitly coded as 'Incomplete course of vaccination').  At the time of initial report, it was unknown if the patients experience any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: Three patients of unspecified age were vaccinated with the first dose of RabAvert vaccine, reported as two to three months ago, for pre-exposure to rabies, which is considered as incomplete course of vaccination. It was unknown if the patients experience any adverse event due to RabAvert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Three patients of unspecified age were vaccinated with the first dose of RabAvert vaccine, reported as two to three months ago, for pre-exposure to rabies, which is considered as incomplete course of vaccination. It was unknown if the patients experience any adverse event due to RabAvert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not come on day three to receive second dose and came at day nine, the vaccination was reinitiated as if that was days zero, so patient received additional doses on day three, day seven and day 14; Case reference number US-BN-2024-000459 is a spontaneous case report initially received from pharmacist via Agency (reference number: USBAV24-0381) on 26-Feb-2024 and concerns a male patient.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, reported as day zero, the patient was vaccinated with first dose of RabAvert vaccine (batch number: unknown), at unknown dose, route, or site of administration for post-exposure.  As reported, patient did not come on day three to receive second dose and came at day nine, the vaccination was reinitiated as if that was day zero, so patient received additional doses on day three, day seven and day 14. Patient received a total of five doses (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information provided.; Reporter's Comments: A male patient did not come on the day 3 to receive the second dose of Rabipur for post-exposure, and came on the day 9, hence, the vaccination was reinitiated as if that was day 0, so the patient received additional doses on the days 3, 7 and 14, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient did not come on the day 3 to receive the second dose of Rabipur for post-exposure, and came on the day 9, hence, the vaccination was reinitiated as if that was day 0, so the patient received additional doses on the days 3, 7 and 14, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have full blown case on right side of body; I am in a lot of pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received first vaccine at age 60 years).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have full blown case on right side of body) and pain (Verbatim: I am in a lot of pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.   The company considered the vaccination failure to be related to Shingrix. The company considered the shingles and pain to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2024 This case was reported by a patient via (social media) interactive digital media. The patient got the first vaccine at the age of 60 then got Shingrix vaccine 4 years ago then guess what at 76 the patient had full blown case on right side of body. The patient could not believe it until after a week of getting worse and went to dermatologist. The patient said it could not be and the patient was in a lot of pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. Herpes zoster  and Pain are unlisted event which are considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; an outbreak of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: an outbreak of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2024 This case was reported by a patient via interactive digital media. The patient got the shot and as a matter of fact he/she got two shingles vaccines. At the time of reporting he/she got an outbreak of shingles every 30 to 40 days since. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles dose I and Shingles dose II.  Vaccination failure is listed event which is considered related to GSK vaccine Shingles dose I and Shingles dose II.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Condition aggravated, Fatigue, Hallucination, Oropharyngeal pain
Clinical narrative: Hallucinations aggravated; abdominal pain; tired; sore throat; This serious case was reported by a consumer via call center representative and described the occurrence of hallucinations aggravated in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hallucination and alzheimer's disease.   On 14-JUN-2024, the patient received the 2nd dose of Shingrix. On 15-JUN-2024, 1 days after receiving Shingrix, the patient experienced hallucinations aggravated (Verbatim: Hallucinations aggravated) (serious criteria GSK medically significant), abdominal pain (Verbatim: abdominal pain), tiredness (Verbatim: tired) and sore throat (Verbatim: sore throat). The outcome of the hallucinations aggravated and tiredness were not resolved and the outcome of the abdominal pain and sore throat were resolving.   It was unknown if the reporter considered the hallucinations aggravated, abdominal pain, tiredness and sore throat to be related to Shingrix.     The company considered the hallucinations aggravated to be unrelated to Shingrix. It was unknown if the company considered the abdominal pain, tiredness and sore throat to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2024 The reporter was the patient's daughter. The patient experienced side effects of sore throat, tired, abdominal pain and hallucinations. The reporter states that the sore throat was going away, still tired, abdominal pain was getting better, and she had very little as of yesterday 19-JUN-2024. The reporter states that the hallucinations were continuing, and had accelerated since she received the Shingrix vaccine.  The reporter states that the patient did have Alzheimer's, and a history of hallucinations due to the Alzheimers.  The reporter did not have any of the patient's paperwork from the vaccine, and could not provide lot number, expiry date, route of administration or location of administration to verify the product. The reporter consented to follow up.; Sender's Comments: Hallucination is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: did not realize the two vials of Menveo needed to be mixed, and only administered the liquid portion and not the powder; did not realize the two vials of Menveo needed to be mixed, and only administered the liquid portion and not the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA986A, expiry date 30-SEP-2025) for prophylaxis.   On 19-JUN-2024, the patient received Menveo. On 19-JUN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: did not realize the two vials of Menveo needed to be mixed, and only administered the liquid portion and not the powder) and inappropriate dose of vaccine administered (Verbatim: did not realize the two vials of Menveo needed to be mixed, and only administered the liquid portion and not the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 20-JUN-2024 A nurse reported that a certified medical assistant did not realize the two vials of Menveo needed to be mixed, and only administered the liquid portion and not the powder which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, Muscle atrophy, Tissue injury
Clinical narrative: tissue and muscle wasting; tissue and muscle wasting; big indentation" at injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE ATROPHY (tissue and muscle wasting), TISSUE INJURY (tissue and muscle wasting) and INJECTION SITE INDENTATION (big indentation" at injection site) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031416) for COVID-19 prophylaxis.     The patient's past medical history included Pain, Lung nodule, Adverse reaction, COVID-19, Pain in arm and Shoulder pain. Concurrent medical conditions included Ehlers-Danlos syndrome, Hard of hearing and Spinal disorder.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 24-Jan-2024, the patient experienced MUSCLE ATROPHY (tissue and muscle wasting), TISSUE INJURY (tissue and muscle wasting) and INJECTION SITE INDENTATION (big indentation" at injection site). At the time of the report, MUSCLE ATROPHY (tissue and muscle wasting), TISSUE INJURY (tissue and muscle wasting) and INJECTION SITE INDENTATION (big indentation" at injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   She had medical conditions and regularly wears long sleeve shirts. However, she was not attentive until she glanced at her left arm and noticed a significant indentation at the injection site. This observation was made approximately three weeks ago, but she initially did not give it much consideration. Later, while conducting research, she discovered that it could potentially be one of the extremely rare side effects. She described the condition as a substantial hole on her arm and concluded that it would be prudent to report it.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-770316 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-434048 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-770316:Repoter case
Sex: M
Vaccine: COVID19
Symptoms: Skin cancer
Clinical narrative: skin cancer; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3246), on 17Feb2021 as dose 2, single (Lot number: EN9581), on 28Sep2021 as dose 3 (booster), single (Lot number: EW0183) and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "radical surgery" (unspecified if ongoing); "prostate cancer", start date: 2002 (unspecified if ongoing); "Has 2 titanium hips", start date: 2009 (unspecified if ongoing), notes: one put in in 2009 and the other in 2014; "Has 2 titanium hips", start date: 2014 (unspecified if ongoing), notes: one put in in 2009 and the other in 2014. The patient's concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "recovered". Therapeutic measures were taken as a result of skin cancer. Additional information: patient had 2 Pfizer COVID shots through school at clinic, and had 3 doses here. Caller just had skin cancer, but was okay, was a mole, read twice, took more, got it off, was in bicep.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Multiple sclerosis
Clinical narrative: GBS; Multiple Sclerosis; This is a spontaneous report received from a Pharmacist.  An adult female patient (not pregnant) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "recovered", described as "GBS"; MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "unknown". The patient was diagnosed simultaneously with Multiple Sclerosis. Therapeutic measures were taken as a result of guillain-barre syndrome. The patient received IVIG (intravenous immunoglobulin) and fully recovered.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome, multiple sclerosis, and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: I had a heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "I had a heart attack". Clinical course: Patient wanted to let them know that after the 3rd vaccination patient had a heart attack in 2021, since then patient had never been the same.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered with Act-Hib, and Pentacel, didn't realize that Pentacel has a Hemophilus B component as it is DTAP-IPV-Hib, thus the patient received an extra dose of Hib with no reported adverse event; Initial information received on 18-Jun-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to 2024SA184500 (master case).  This case involves a 15 months old female patient who was administered with HIB (PRP/T) vaccine [ACT-HIB], and pentacel, didn't realize that pentacel has a hemophilus b component as it is dtap-ipv-hib, thus the patient received an extra dose of hib 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 13V (CRM197) (PREVNAR 13); diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Pentacel) and polio vaccine INACT (IPV) all for Prophylactic vaccination.  On 18-Jun-2024, at 11:20 hours the patient received a dose of 0.5 ml (dose 4) once of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UK007AB; expiry date: 31-Dec-2024; strength: standard) via intramuscular route in the left lateral thigh for Immunization.  On 18-Jun-2024 the patient was administered with HIB (PRP/T) vaccine, and pentacel, didn't realize that pentacel has a hemophilus b component as it is dtap-ipv-hib, thus the patient received an extra dose of hib 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 and Module of the 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.
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was administered menquadfi subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 21-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was administered subcutaneously instead of intramuscularly 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 suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection expiry- 30-SEP-2025 via subcutaneous route in unknown administration site for immunization (strength, dose, batch number unknown) instead of intramuscularly with no reported adverse event (incorrect route of product administration) (latency same day). Information on batch number corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the 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: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Presented with parent for Covid vaccine and was accidentally given 0.25 ML of 12 years and older instead of 6 months to 11 years.  Nurse had patient to sit in lobby for 15 minutes to check for any adverse reaction, patient had no adverse reactions.  Patient was not seen by a physician.  Parent was notified via phone, but no answer and unable to leave a message due to mailbox has not been set up.
Age: 90.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt states that she received the vaccine on Monday 6/24/2024 and first starting experiencing soreness and redness of her arm below injection site 2 days later on 6/26/2024.  SHe stated she applied ice to the area which helped. Today on 6/27/2024 teh are still appeared red and itchy.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; Administration of an expired MMR II dose to one patient on 06/19/2024; This spontaneous report was received from a health care business professional via company representative concerning a male patient of unknown age. Patient's concurrent conditions, pertinent medical history, and concomitant therapies were not provided.  On 19-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot #W034593, with expiration date: 10-MAY-2024, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  No other adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; MMR II which expired on 03/01/2024 was inadvertently administered to a patient on 06/19/2024.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies.  On 19-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot #W007181, expiration date: 01-MAR-2024, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  No side effects or symptoms reported.
Age: 16.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: fever of 102 to 103 Fahrenheit; leg pain; vomited; patient given an extra dose of Prevnar 20; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 16-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Jun2024 as dose 5, single (Lot number: HH4722, Expiration Date: 20May2025) at the age of 16 years intramuscular, in right thigh for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (DOSE 1, SINGLE), for immunization; Prevnar 20 (DOSE 2, SINGLE), for immunization; Prevnar 20 (DOSE 3, SINGLE), for immunization; Prevnar 20 (DOSE 4, SINGLE), for immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 12Jun2024, outcome "unknown", described as "patient given an extra dose of Prevnar 20"; PYREXIA (non-serious), outcome "unknown", described as "fever of 102 to 103 Fahrenheit"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "vomited". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity.  Additional information: Caller is a medical assistant calling about a patient given an extra dose of Prevnar 20. She wants to know what the next steps to take are. After clarifying that the patient already completed the 4 dose series and that what was administered is already the fifth dose. Treatment for fever and pain: Tylenol and Motrin. NDC number of Prevnar 20: 0005-2000-01.  Follow-up (13Jun2024): This is a spontaneous follow-up report received from the same consumer: Updated information: reporter details, patient details, suspect drug detail (Lot. provided), reaction data ( "fever", "leg pain" and "vomited" added as additional adverse events).  This follow-up report is being submitted to amend previously reported information: Event's coding updated from "Vomited" to "Infantile vomiting".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "CAD" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing); "Allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment received from 13Jun2024 to 17Jun2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Dyes" (unspecified if ongoing); "Known allergies: pecans" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "Mental health" (unspecified if ongoing); "RA" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 13Jun2024 to 18Jun2024. This case was reported as non-serious. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP. The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). No Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Jun2024 to 18Jun2024. This case was reported as non-serious. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: his attorney who took the booster had covid again; his attorney who took the booster had covid again; This is a spontaneous report received from a Consumer or other non HCP from product quality group and medical information team, Program ID.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETE, MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "his attorney who took the booster had covid again". Clinical course: Caller is asking what is in the COVID-19 Pfizer vaccine. Caller is asking why everyone who took the vaccines or boosters still got Covid. Caller said his attorney who took the booster had covid again.   Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2024, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: Tested positive for COVID with antigen test on 17Jun2024. Had fever, body aches, cold symptoms. Took Paxlovid from 17Jun2024 to 21Jun2024 for COVID-19 and felt pretty good by 20Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Haemorrhage, Muscle spasms
Clinical narrative: hemorrhage; spasms; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (non-serious) with onset 2024, outcome "unknown", described as "hemorrhage"; MUSCLE SPASMS (non-serious) with onset 2024, outcome "unknown", described as "spasms".  Clinical course: Caller is calling on behalf of his 79 year old wife that took the RSV vaccine last Oct2023, she was ok for 8 months after which she started suffering spasms and hemorrhage, Caller wants to know if his wife should receive the booster dose for the vaccine even though she had this side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: since patient received, had been left with tinnitus; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HM7010) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "since patient received, had been left with tinnitus".
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported.  It was discovered 6 months after the Tdap vaccination on 12/23/23 that this was the 8th dose of Tdap since 04/30/2018.  Pt  came to the pharmacy on 6/27/24 and requested Tdap and Hepatitis.  The vaccine database was queried, resulting in a listing of 8 previous doses of Tdap, 5 Hepatitis B, and 3 Hepatitis A since 4/30/2018  Pt was informed that additional doses of these vaccines are not indicated at this time.  Pt reported feeling fine with no adverse effects.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rashes
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Infected bite, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: 2 days after injection, I had tenderness and soreness at the injection site, which was high on my arm, I thought this was normal site pain. As the week continued, the soreness worsened and my arm started to tingle, by Sunday night, a week later, I had intense severe pain at the injection site, as well my whole shoulder, deltoid muscle area, and had very limited range of motion.  By the 25th, I went back to Urgent Care, with the shoulder pain, I was told that it was probably the dog bites infection, as that was the initial reason I had a tetanus shot in the first place. I was put on antibiotics and given a Toradol shot. The shoulder pain was not really addressed, and when I suggested that their nurse screwed up and injected me too high on my arm, the Dr. expressed that my pain was due to the dog bite infection. He didnt even listen when I told him that the tenderness started within 48 hours of the injection, but the real severe pain was a week later. I ended up at the ER that night, with the severe pain. The Dr. there knew that I probably had SIRVA, got exrays to view extent of damage to rotator cuff and other shoulder  areas, I was given a Toradol shot, Muscle Relaxer, a cortizone shot, sent home with lidocaine patches, muscle relaxers, told to schedule MRI on shoulder, schedule PT, and take Ibuprofen and tylenol.