chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Device connection issue, No adverse event, Syringe issue
Clinical narrative: IM injection of Bexsero given into Left deltoid. Area cleansed with alcohol prior to injection. During pushing down on plunger to administer vaccine- syringe/needle/hub leaked vaccine out.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: inappropriate dose per age
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Injection site pain, Myalgia, Purpura, Rash
Clinical narrative: muscle ache/pain at site of injection, small area of papular rash by left elbow and distal tricep (c8 dermatome, about 7-8cm in length), initially painful (dull pain) and puritic. improved over the days. rash no erythema, no vesicles, no discharge, nontender (examined 6 days after vaccine). pt also had right flank pain/muscle ache also improving with time and no pain when examined. no urinary sx, no falls, no trauma. no fevers/chills.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: muscle ache/pain at site of injection, small area of papular rash by left elbow and distal tricep (c8 dermatome, about 7-8cm in length), initially painful (dull pain) and puritic. improved over the days. rash no erythema, no vesicles, no discharge, nontender (examined 6 days after vaccine). pt also had right flank pain/muscle ache also improving with time and no pain when examined. no urinary sx, no falls, no trauma. no fevers/chills.
Age: 9.0
Sex: F
Vaccine: COVID19, HEP, HEPA, IPV, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event noted at this time. Child received adult dose of Hep B.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: inappropriate dose per age
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus in both ears. A high pitch ringing sound that is most prevalent in the right ear, but audible in both ears. The ringing never subsides or goes away. This has been a permanent symptom since November 2021.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient became faint while sitting in chair, fell out of chair hitting the desk then fell into floor.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: NAUSIA, DIZZY HEAD ACHE SEVERE
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Pt received injection, then a syncopal episode occurred while waiting in lobby post injection. Nurses alerted by staff that pt had fell on right shoulder, Pt stated "I passed out.", BP was taken 140/83 pulse 83, cbg 105, applied cold compress, notified, EMS, pt refused to go to ER for eval.  encouraged and provided fluids, pt AOx4, denied any further feelings of discomfort or dizziness.
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Blood blister
Clinical narrative: blood blister in nose
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/No additional AE; TE where patients have received the product; This spontaneous report has been received from a licensed practical nurse and refers to a 4-year-old patient of unknown age. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 20-JUN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, as prophylaxis (lot number Y003881 has been verified to be valid, expiration date 05-AUG-2025; route of administration and anatomical location were not provided) after a temperature excursion (TE) of -14 Celsius degrees (C) for 8 hours and -10 C for 6 hours (product storage error). No symptoms or additional adverse events were reported. No previous temperature excursions were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2406USA007273:MSD
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/No additional AE/PQC reported.; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.; This spontaneous report has been received by a nurse regarding a 4-years-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.  On 01-MAR-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin [rHA]) (PROQUAD) injection, dose of 0.5mL (strength, frequency, route of administration, vaccination scheme, and site of vaccination were not provided; lot number X022920, which has been validated, and expiration date reported and validated as 12-MAR-2025) as prophylaxis. However, the vaccine was administrated after experiencing a temperature excursion (T/E) (product storage error). No symptoms were reported. No additional adverse event reported.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: impaired response to Pneumovax-23 (vaccine failure); This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 56-year-old male patient.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included selective IgM deficiency (sIgMD).  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). At the time of reporting, the outcome of the event was not provided.  The authors considered the event to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article is attached as further documentation of the patient's experience.   Lot is being requested and will be submitted if received.  This is one of several reports derived from the same literature article (cross referenced with #2407USA001987, 2407USA003227, 2407USA003228 and 2407USA003229).; Sender's Comments:  US-009507513-2407USA001987: US-009507513-2407USA003227: US-009507513-2407USA003228: US-009507513-2407USA003229:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Starting my 6th week with 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Starting my 6th week with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2024 The case was received from the patient via interactive digital media. The patient starting his/her 6th week with shingles even after getting the vaccine, not fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccine schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain
Clinical narrative: extreme neck shoulders head and body aches; Can't sleep due to pain; extreme neck shoulders head and body aches; body aches; Muscle ache; The second one is causing a shingles rash on one side of torso; Rash; Headache; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 02-MAY-2024, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On 28-JUN-2024, 57 days after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: The second one is causing a shingles rash on one side of torso) (serious criteria GSK medically significant), shingles (Verbatim: The second one is causing a shingles rash on one side of torso), rash (Verbatim: Rash), headache (Verbatim: Headache) and muscle pain (Verbatim: Muscle ache). On an unknown date, the patient experienced neck pain (Verbatim: extreme neck shoulders head and body aches), sleeplessness (Verbatim: Can't sleep due to pain), shoulder pain (Verbatim: extreme neck shoulders head and body aches) and general body pain (Verbatim: body aches). The outcome of the vaccination failure was unknown and the outcome of the shingles, rash, headache and muscle pain were not resolved and the outcome of the neck pain, sleeplessness, shoulder pain and general body pain were not reported.   The reporter considered the vaccination failure, shingles, rash, headache, neck pain, shoulder pain and general body pain to be related to Shingles vaccine. It was unknown if the reporter considered the sleeplessness and muscle pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure, shingles, rash, headache, neck pain, shoulder pain and general body pain to be related to Shingles vaccine. It was unknown if the company considered the sleeplessness and muscle pain to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUN-2024 The patient received first shingles shot and there was no problem. The second one was causing a shingles rash on one side of torso and extreme neck shoulders head and body aches. Could not sleep due to pain. The symptoms were not treated.  This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelled up; Arm pain; Patient didn't get second; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm (Verbatim: Arm swelled up), pain in arm (Verbatim: Arm pain) and incomplete course of vaccination (Verbatim: Patient didn't get second). The outcome of the swelling arm and pain in arm were resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the swelling arm and pain in arm to be related to Shingrix.     The company considered the swelling arm and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 29-JUN-2024 Reporter reported that after receiving first dose of Shingrix patient experienced arm swelled up, and arm was very painful. Reporter reported that the patient did not get the second dose. Till the time of reporting patient did not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like aching; This non-serious case was reported by a consumer via sales rep and described the occurrence of flu-like aching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUN-2024, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced flu-like aching (Verbatim: Flu-like aching). The outcome of the flu-like aching was resolved.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.     It was unknown if the company considered the flu-like aching to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2024 The patient suffered from flu-like aching after receiving Shingrix.
Age: 10.0
Sex: M
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: vomiting; vomited 1 hour later; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 10-year-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 26-JUN-2024, the patient received the 2nd dose of Rotarix lyophilized formulation. On 26-JUN-2024, 1 hr after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: vomiting) and accidental underdose (Verbatim: vomited 1 hour later). The outcome of the vomiting was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2024 The reporter was the father of the patient. The father of the patient stated that his son just got his second dose of Rotarix yesterday but vomited 1 hr after the shot which led to accidental underdose. The father was wondering if the vaccine still working after this vomiting. The reporter was not sure how fast did the vaccine get completely absorbed.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Oral herpes zoster
Clinical narrative: sick; oral shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick) and shingles (Verbatim: oral shingles). The outcome of the sickness was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the sickness and shingles to be related to Shingrix.     It was unknown if the company considered the sickness and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2024 The patient self-reported. He/she received first dose of Shringrix 5 years ago but didn't get second as first made him/her so sick and now recovering from oral shingles and had been advised to get second shot.  The patient wanted to know do he/she need to start over or can just get 2nd shot.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: got one Bexsero shot on 4/23/2021 then got Trumemba 6/23/2024 and got last Bexsero shot on 10/2/2023; Patient age 39 received Bexsero vaccine 2nd dose; Patient age 39 received Bexsero vaccine first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 39-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   Concomitant products included eculizumab (Soliris).   On 02-OCT-2023, the patient received the 2nd dose of Bexsero. On 23-APR-2021, the patient received the 1st dose of Bexsero. On 23-JUN-2024, the patient received Trumenba. On 23-APR-2021, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient age 39 received Bexsero vaccine first dose). On 02-OCT-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient age 39 received Bexsero vaccine 2nd dose). In JUN-2024, the patient experienced interchange of vaccine products (Verbatim: got one Bexsero shot on 4/23/2021 then got Trumemba 6/23/2024 and got last Bexsero shot on 10/2/2023). The outcome of the interchange of vaccine products, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2024 The reporter reported that, the patient was on medication called Soliris so they asked her to get Meningococcal vaccine before starting Soliris.  The patient got one Bexsero shot then got Trumemba vaccine on 23rd June 2024 and got last Bexsero vaccine, which led to interchange of vaccine product. The patient's age was reported as 39 and received Bexsero vaccine, which led to inappropriate age at vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error, Underdose
Clinical narrative: given only the saline solution of the Hiberix; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 15-month-old male patient who received Hib (Hiberix) (batch number 5C934, expiry date 14-MAR-2026) for prophylaxis.   On 27-JUN-2024, the patient received Hiberix (right thigh). On 27-JUN-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: given only the saline solution of the Hiberix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-JUN-2024 Caller is the HCP calling to report a Hiberix vaccine was prepared and administered incorrectly.  Caller reported a patient was given only the saline solution of the Hiberix vaccine in the right thigh today, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin M decreased, Herpes zoster, Rash
Clinical narrative: Blood immunoglobulin M decreased; (shingles)/Shingles diagnosis; rash; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included immunocompromised.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 18-JUN-2024, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: (shingles)/Shingles diagnosis) and rash (Verbatim: rash). On 28-JUN-2024, the patient experienced blood immunoglobulin m decreased (Verbatim: Blood immunoglobulin M decreased). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles, rash and blood immunoglobulin m decreased were unknown.   It was unknown if the reporter considered the shingles, rash and blood immunoglobulin m decreased to be related to Shingrix.     It was unknown if the company considered the shingles, rash and blood immunoglobulin m decreased to be related to Shingrix.   Additional Information: GSK receipt date: 28-JUN-2024 The reporter asked if could vaccination with Shingrix cause a false positive IgM. Shingles diagnosis about two weeks after second vaccine.  The patient was wondering if it was false positive. The patient got the result today (on the day of reporting, the blood test was 6/24. When asked if HCP/patient was taking treatment for Shingles: they just called in Valtrex Consented to follow up
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Exposure via skin contact, Injection site discharge, Underdose
Clinical narrative: patient received about half of the dose; part of the vaccine leaked out onto patient's skin; part of the vaccine leaked out onto patient's skin; part of the vaccine leaked out onto patient's skin/there was not a product quality issue, it was an administration error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 1-year-old female patient who received HAV (Havrix) (batch number L9R92, expiry date 26-SEP-2025) for prophylaxis.   On 21-JUN-2024, the patient received the 2nd dose of Havrix. On 21-JUN-2024, an unknown time after receiving Havrix, the patient experienced accidental underdose (Verbatim: patient received about half of the dose), exposure via skin contact (Verbatim: part of the vaccine leaked out onto patient's skin), inadvertent exposure to vaccine (Verbatim: part of the vaccine leaked out onto patient's skin) and product administration error (Verbatim: part of the vaccine leaked out onto patient's skin/there was not a product quality issue, it was an administration error). The outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and product administration error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2024 The medical assistant reported that the patient was being administered second dose of Havrix series when part of the vaccine was leaked out onto the patient's skin and was estimated that the patient received about half of the dose, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose As per the reporter, there was not a product quality issue, it was an administration error, which led to product administration error. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number 25K3M, expiry date 02-JUN-2024) for prophylaxis.   On 28-JUN-2024, the patient received Engerix B. On 28-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). 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: 28-JUN-2024 The nurse practitioner reported that today (on the reporting day) they had administered an expired dose of Engerix B vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: floaters (muscae volitantes) in her right eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of muscae volitantes in a female patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 17-MAY-2026) for prophylaxis.   On 25-JUN-2024, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscae volitantes (Verbatim: floaters (muscae volitantes) in her right eye). The outcome of the muscae volitantes was not resolved.   It was unknown if the reporter considered the muscae volitantes to be related to Shingrix.     It was unknown if the company considered the muscae volitantes to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2024 Reporter was a pharmacy intern.  The reporter stated a patient received first dose of vaccine on 25th June 2024. Patient called pharmacy and reported two days after receiving vaccine she woke up with floaters (muscae volitantes) in her right eye. Patient described the floaters as a dot with a string and also stated adverse event had not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forget to get her second dose now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (gets her 1st dose of Shingrix vaccine 3 year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forget to get her second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-JUN-2024 The patient got her 1st dose of Shingrix vaccine 3 year ago but forget to get her second dose now, which led to incomplete course of vaccination. The patient asked if she needed to get another dose of Shingrix since the time between the 2 doses are so far apart.  The follow up was not possible to request.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID 19 Infection) in a 24-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. HF9300) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (fever and GI upset starting on 20OCT2023 lasting until 22OCT2023 and were related to the COVID-19 vaccination) on 20-Oct-2023 and COVID-19 vaccine (fever and GI upset starting on 20OCT2023 lasting until 22OCT2023 and were related to the COVID-19 vaccination) on 20-Oct-2023. Past adverse reactions to the above products included Fever with COVID-19 vaccine; and GI upset with COVID-19 vaccine.    On 21-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID 19 Infection). On 30-Mar-2024, COVID-19 (COVID 19 Infection) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High-pitched tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (High-pitched tinnitus) in a 46-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced TINNITUS (High-pitched tinnitus). At the time of the report, TINNITUS (High-pitched tinnitus) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  It was reported that patient experienced symptom of High-pitched tinnitus post vaccination and symptom continued for patient from last nine month.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Expired product administered
Clinical narrative: expired on 04May2024 and was administered on 17May2024; Achy joint; This is a spontaneous report received from a Pharmacist from medical information team.  A 51-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17May2024 as dose 1, single (Lot number: HN0477, Expiration Date: 04May2024) at the age of 51 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 17May2024, outcome "recovered", described as "Achy joint"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 17May2024, outcome "unknown", described as "expired on 04May2024 and was administered on 17May2024". Therapeutic measures were not taken as a result of arthralgia.  Additional information: No PQC was present. NDC number of COVID Vaccine: 00069237701, UPC number of COVID Vaccine: Unknown. They reported a incident that the nurse in the clinic accidently gave a COVID vaccine that was expired. They sought a guidance regarding what should they do with the patient whether they should get another vaccine dose or any other option. Reporter stated that they didn't have that patient information at that point. Reporter did not have any other medical history information about patient. Reporter did not know about laboratory test. Stated that vaccine was administered around 2:15 on 17May2024. It was indicated as a booster. Stability information suggested that stability data demonstrated no impact to vaccine quality attributes up to 1 week after the printed expiry date when otherwise stored within labeled storage conditions. It was reported as medication error occured when product was dispensed. Error was not noticed and intercepted before the product was supplied to the patient. It is reported to be inadvertent human error. Patient had Achy joints (occurs per patient with each vaccine dose) on 17May2024 for 2 days. No treatment was taken for event achy joints.  Amendment: This follow-up report is being submitted to amend previous information: Updated product coding under GLASS LICENSE. Follow-up (30Jun2024): Follow-up attempts are completed.  Follow up (03Jul2024): This is a spontaneous report received from a Pharmacist in response to follow up letter. Updated information included: new event of achy joints and additional information.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood chloride, Blood glucose
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood phosphorus, Blood potassium, Blood sodium, Blood urea
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Carbon dioxide, Electrocardiogram, Fibrin D dimer
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Imaging procedure
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Lymphocyte count, Monocyte count, Nasopharyngeal swab, Neutrophil count
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Post-acute COVID-19 syndrome, Troponin I, White blood cell count
Clinical narrative: long covid; This is a spontaneous report received from an Other HCP.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6, single (Lot number: GJ6665) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, intramuscular, Deltoid left, Lot: 029L20A), administration date: 14Jan2021, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, intramuscular, Deltoid left, Lot: 030M204), administration date: 11Feb2021, for covid-19 immunization; janssen COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, intramuscular, Deltoid left, Lot: 213D2IA), administration date: 20Dec2021, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, intramuscular, Deltoid left), administration date: 18Jul2022, for covid-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE, intramuscular, Deltoid left, lot: GJ3275), administration date: 09Nov2022, for covid-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Productive cough, Sneezing
Clinical narrative: Chronic cough; horrible sneezing fits; The cough started out dry but I now have phlegm; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Chronic cough"; SNEEZING (non-serious), outcome "unknown", described as "horrible sneezing fits"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "The cough started out dry but I now have phlegm". The event "chronic cough" required physician office visit. Therapeutic measures were taken as a result of cough, productive cough. Additional information: The patient stated, "I'm a 76 yr old woman who has had a chronic cough since I got Pfizer Covid vaccine in Feb 2019. I got the boosters also and have never had Covid. This cough is so annoying, I've been to many doctors, given no diagnosis nor cure. It's been 2.5 yrs and I am miserable. The cough is tearing me up, I am having horrible sneezing fits. The cough started out dry but I now have phlegm. It's day and night. I've gone through many bags of cough drops. Can you help me please??!!"
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Productive cough, Sneezing
Clinical narrative: a chronic cough; horrible sneezing fits; The cough started out dry but I now have phlegm; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly female patient received BNT162b2 (BNT162B2), 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: COUGH (non-serious), outcome "unknown", described as "a chronic cough"; SNEEZING (non-serious), outcome "unknown", described as "horrible sneezing fits"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "The cough started out dry but I now have phlegm".  Additional information: The patient was a 76 yr old woman who had a chronic cough since she got Pfizer Covid vaccine in Feb 2019. She got the boosters also and had never had Covid. This cough was so annoying, she had been to many doctors, given no diagnosis nor cure. It had been 2.5 yrs and she was miserable. The cough was tearing her up, she was having horrible sneezing fits. The cough started out dry but she now have phlegm. It's day and night. She had gone through many bags of cough drops.  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-202400208063 same reporter/patient/product; different dose/events;
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms consistent with COVID infection. Positive PCR test. prescribed antiviral.; Symptoms consistent with COVID infection. Positive PCR test. prescribed antiviral.; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "chronic autoimmune disease" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2024, outcome "unknown" and all described as "Symptoms consistent with COVID infection. Positive PCR test. prescribed antiviral.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses is as follows: patient didn't receive any other vaccines on the same date as BNT162b2 omi xbb.1.5. Patient didn't receive any other vaccines within 4 weeks prior to BNT162b2 omi xbb.1.5. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had symptoms consistent with COVID infection. tested positive; Patient had symptoms consistent with COVID infection. tested positive; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years 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; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2024, outcome "unknown" and all described as "Patient had symptoms consistent with COVID infection. tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with prescribed antiviral. Clinical course: Patient neither received other vaccine on same date nor in four weeks. It was unknown if patient had other medications in two weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.