chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: Given through IV route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 46-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number K9XLS, expiry date 30-JUN-2025) for prophylaxis.   On 30-OCT-2024, the patient received Fluarix 2024-2025 season (intravenous). On 30-OCT-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Given through IV route). The outcome of the intramuscular formulation administered by other route 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: 05-NOV-2024 The pharmacy director reported that there was an administration of Fluarix to patient which was given via intravenous route, which led to intramuscular formulation administered by other route The Vaccine Administration Facility was the same as Primary Reporter.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Device connection issue, Underdose
Clinical narrative: CPT was administering Fluarix to a patient and the needle came off, HCP states only a little bit of the drug got in; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 8-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 94J52, expiry date 30-JUN-2025) for prophylaxis.   On 05-NOV-2024, the patient received Fluarix 2024-2025 season. On 05-NOV-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced accidental underdose (Verbatim: CPT was administering Fluarix to a patient and the needle came off, HCP states only a little bit of the drug got in). The outcome of the accidental underdose 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: 05-NOV-2024 Pharmacist stated a CPT was administered Fluarix to a patient and the needle came off. HCP (healthcare professional) stated only a little bit of the drug got in, which led to an accidental underdose. Reporter probed (to rule out a PQC) and healthcare professional assumed the nurse did not screw the needle on tightly enough (appeared to be no issue with the actual PFS and needle not supplied from GSK). The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Limb discomfort, Pain
Clinical narrative: headache; Body aches; Dizziness; Heaviness in head; Received Shingrix first dose in February 2022 and received second dose on 29 October 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2022). Concurrent medical conditions included depression and suicidal ideation. Family history included shingles (The patient's father had shingles in the past.).   On 29-OCT-2024, the patient received the 2nd dose of Shingrix. On 29-OCT-2024, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: headache), general body pain (Verbatim: Body aches), dizziness (Verbatim: Dizziness /Heaviness in head), heaviness of head (Verbatim: Dizziness /Heaviness in head) and drug dose administration interval too long (Verbatim: Received Shingrix first dose in February 2022 and received second dose on 29 October 2024). The patient was treated with paracetamol (Tylenol). The outcome of the headache and general body pain were not resolved and the outcome of the dizziness and heaviness of head were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, general body pain, dizziness and heaviness of head to be related to Shingrix.     It was unknown if the company considered the headache, general body pain, dizziness and heaviness of head to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-NOV-2024 The reporter stated that the patient had first dose of Shingrix and she did not realize that there was a second dose needed. The patient received second dose and that day she experienced body aches, headache and dizziness or heaviness in head. The patient took Tylenol for headache.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received HAV (Havrix) (batch number TF27T, expiry date 05-FEB-2026) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) and KINRIX.   On 01-NOV-2024, the patient received the 2nd dose of Havrix and the 2nd dose of Kinrix. On 01-NOV-2024, an unknown time after receiving Havrix and Kinrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2024 LPN requests data on what to expect with early dosing of Kinrix and Havrix. Healthcare professional reported Kinrix and Havrix were administered on 01 August 2024 and again on 01 November 2024. HCP reported that the vaccine schedule was due to a catch-up schedule for twins who were born premature. The patients received Pediarix on 02 October 2019 and 22 January 2020. HCP reported that patients had received 4 doses of DTAP/IPV vaccines. HCP stated that Kinrix and Havrix were due on February 2025 but was administered early on November 1, 2024. The patient received 2nd dose of Kinrix and Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.; Sender's Comments:  US-GSK-US2024137617:SAME REPORTER
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV, DTAPIPV, HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Havrix were administered on 01st AUG 2024 and again on 01st NOV 2024; Kinrix were administered on 01st AUG 2024 and again on 01st NOV 2024; receive 2nd dose of Kinrix on 01-AUG-2024; receive 2nd dose of Pediarix on 22-JAN-2020; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number TF27T, expiry date 05-FEB-2026) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   Additional patient notes included patient who were born premature. Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) and PEDIARIX.   On 01-NOV-2024, the patient received the 2nd dose of Kinrix and the 2nd dose of Havrix. On 01-AUG-2024, the patient received the 1st dose of Kinrix. On 22-JAN-2020, the patient received the 2nd dose of Pediarix. On 22-JAN-2020,an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: receive 2nd dose of Pediarix on 22-JAN-2020). On 01-AUG-2024, the patient experienced inappropriate schedule of vaccine administered (Verbatim: receive 2nd dose of Kinrix on 01-AUG-2024). On 01-NOV-2024, the patient experienced drug dose administration interval too short (Verbatim: Havrix were administered on 01st AUG 2024 and again on 01st NOV 2024) and extra dose administered (Verbatim: Kinrix were administered on 01st AUG 2024 and again on 01st NOV 2024). The outcome of the drug dose administration interval too long, drug dose administration interval too short, extra dose administered and inappropriate schedule of vaccine administered 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: 05-NOV-2024 The reporter reported that the vaccine schedule was due to a catch-up schedule for twins who were born premature. The reporter requested data on what to expect with early dosing of Kinrix and Havrix. The patient received 2nd dose of Pediarix vaccine later than the recommended interval and 2nd dose of Havrix vaccine earlier than the recommended interval, which led to lengthening of the vaccination schedule and shortening of vaccination schedule. The patient received the Kinrix on 01st August 2024 and again on 01st November 2024 which led to extra dose administered and inappropriate schedule of vaccine administrated. The reporter stated that the Kinrix and Havrix were due in February 2025 but was administered early. This case had been link with US2024137620, reported by the same reporter.; Sender's Comments:  US-GSK-US2024137620:SAME REPORTER
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache). The outcome of the headache was not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-NOV-2024 The patient experiencing a headache after receiving Shingrix. The patient's date of birth, initials and gender were not available.
Sex: U
Vaccine: FLU3
Symptoms: Device leakage
Clinical narrative: Dose was partially administered; leakage between the leur lok adapter and syringe; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in specified number of patients who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number jz4j4, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: Dose was partially administered), syringe leak (Verbatim: leakage between the leur lok adapter and syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05 Nov 2024 The physician reporter stated that patients took two doses of Flulaval. The physician stated that the needle was leaked between the leur lok adapter and the syringe body when administering doses to two different patients and doses had been partially administered. The reporter confirmed that luer lok needle was used but demographic information for both patients unavailable at this time. The syringe was pre-assembled with needle less than five minutes before administration and 25 size gauge needle was used and no tray and/or carton damaged. No leaking from plunger stopper and there any liquid traces observed on the plunger stopper rings. No luer lok damaged, needle connection procedure applied and not experienced a rotating or detached luer lok adaptor when screwing the needle on the syringe prior to the leakage observation. The used needle was not available, and no needles were disposed of was there any damage/breakage on the syringe barrel. The Suspect product was not available for returned as both doses were disposed.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Less than the recommended dose; a patient received a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 34-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Less than the recommended dose) and adult use of a child product (Verbatim: a patient received a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-NOV-2024  A pharmacist reported that a patient received a pediatric dose, whilst the patient was an adult, which led to adult use of child product and underdose. The reporter Consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter .
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis.   On 04-NOV-2024, the patient received Bexsero. On 04-NOV-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Bexsero). 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: 07-NOV-2024 The nurse reported that a patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis.   On 07-NOV-2024, the patient received Bexsero. On 07-NOV-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). 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: 07-NOV-2024 The nurse reported that the Meningococcal B (Men B) vaccine was expired and was given to a patient and confirmed that brand name of the vaccine was Bexsero, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: received a FluLaval which was supposed to be a covid vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4LM54, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On 07-NOV-2024, the patient received FluLaval 2024-2025 season. On an unknown date, the patient received COVID-19 vaccine. On 07-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: received a FluLaval which was supposed to be a covid vaccine). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2024 The medical assistant called to inform that a 65 year old female was supposed to receive a flu shot and a covid vaccine, instead the medical assistant chose the fluzone, and also received a FluLaval which was supposed to be a covid vaccine which led to wrong vaccine administered. The reporter mentioned that such thing had already been reported to Sanofi.  The vaccine administration facility was the same as primary reporter.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Needle issue, Underdose
Clinical narrative: so about half of the product leaked; so the patient only received about half of the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 46-year-old female patient who received HBV (Engerix B) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis.   On 07-NOV-2024, the patient received the 1st dose of Engerix B. On 07-NOV-2024, an unknown time after receiving Engerix B, the patient experienced accidental underdose (Verbatim: so the patient only received about half of the dose). On an unknown date, the patient experienced needle leak (Verbatim: so about half of the product leaked). The outcome of the accidental underdose and needle leak were unknown.   It was unknown if the reporter considered the needle leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the needle leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-NOV-2024 The nurse reported that 46 year old female patient was administered first dose in Engerix-B series.  The nurse reported that during administration the needle was not secure enough on the syringe, so about half of the product leaked out on the floor, so the patient only received about half of the dose which led to accidental underdose.  The product did not leak onto the patient's skin.  At the time of reporting, a repeat dose had not been administered.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: female patient received Priorix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received MMR (Priorix) (batch number 53F2A, expiry date 01-NOV-2024) for prophylaxis.   On 18-NOV-2024, the patient received Priorix. On 18-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: female patient received Priorix 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: 19-NOV-2024 The medical assistance reported that on 18th November 2024 a female patient received Priorix expired dose which led to expired vaccine used. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired dose of infanrix was administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-month-old male patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 20-NOV-2024, the patient received Infanrix. On 20-NOV-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: an expired dose of infanrix was administered to patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2024 The medical assistance reported that on the day of reporting an expired dose of Infanrix was administered to patient which led to expired vaccine administered. The dose expired on 02th November 2024.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Herpes zoster, Rash, Skin mass, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old 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 2nd dose of Shingrix and the 1st dose of Shingrix. On 18-NOV-2024, 5 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-NOV-2024 The reporter reported that she received both doses of Shingrix in 2019. On 18-NOV-2024, she began having symptoms of left side of head and face with a small lump,the next day awoke with a pimple under her chin.  The following day there were two bumps under her chin.  She was diagnosed with shingles on either 20-NOV-2024 or 21-NOV-2024. This case was considered as suspected vaccination failure since the details regarding  laboratory confirmation of 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 Shingrix (1st dose)and Shingrix(2nd dose) .
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 3 year 2month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 19-NOV-2024, the patient received the 1st dose of Kinrix. On 19-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 3 year 2month old patient). The outcome of the inappropriate age at vaccine administration 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: 25-NOV-2024 The nurse practitioner reported there was administration of Kinrix to a 3 year 2 month old patient and who was completely unvaccinated, which led to inappropriate age at vaccine administration. This was the patient's 1st Kinrix (DTap, IPV) dose.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in both hands; pain in both hips; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Nov2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 22Nov2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Nov2024, outcome "not recovered", described as "pain in both hands"; ARTHRALGIA (non-serious) with onset 24Nov2024, outcome "not recovered", described as "pain in both hips". Therapeutic measures were not taken as a result of pain in extremity, arthralgia. Additional information: The 76 year-old female patient received two vaccines, Cominarty and Fluad on November 22, 2024 at a pharmacy at approximately 6:30pm. On November 24, 2024, the patient began to experience moderate pain in both hands as well as pain in both hips. She has continuously had the pain in both hands and intermittently in both hips as of the date of this report. The hand pain has gradually gotten worse while the hip pain has stayed the same.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Neuropathy peripheral, Vitamin test
Clinical narrative: severe bilateral lower extremity neuropathy; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "severe bilateral lower extremity neuropathy". The event "severe bilateral lower extremity neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: T2DM: Negative; Vitamin test: Negative. Therapeutic measures were taken as a result of neuropathy peripheral. Clinical course: Patient received COVID 19 vaccine (annual, not booster) in Sep2023 within a couple of months, patient developed severe bilateral lower extremity neuropathy. Patient sought MD care visiting several Neurologists in (withheld) but none could determine the origin of the neuropathy (as all std tests for T2DM, vitamin deficiency, etc. were negative). Patient made appointment with Neurologist at (withheld) in spring 2024. Neurologist told patient that neuropathy was most likely caused by COVID-19 vaccine. Only TX offered was std neuro txs such as Lyrica which were not effective. Neurologist stated only tx that may work would be IVIG therapy to reverse neuropathy and advised patient not to get any more COVID 19 vaccines.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Metamorphopsia
Clinical narrative: Major distortion on the right side of the whole eye; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Nov2024 at 11:30 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 29Nov2024 at 11:30 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, start date: 2008 (ongoing); ASPIRIN BAYER, start date: 2008 (ongoing). The following information was reported: METAMORPHOPSIA (non-serious) with onset 29Nov2024 at 13:30, outcome "recovered" (29Nov2024 at 13:38), described as "Major distortion on the right side of the whole eye". Therapeutic measures were not taken as a result of metamorphopsia.  Additional Information: It was reported that two hours after getting the COVID shot on 29Nov2024, the patient experienced a major distortion on the right side of the whole eye, everything was distorted, it was distortion. The whole vision just went all haywire. The patient was taking the concomitant medications and she never had a problem with it.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: received the vaccine previously and has gotten covid twice and does not feel it was effective; received the vaccine previously and has gotten covid twice and does not feel it was effective; received the vaccine previously and has gotten covid twice and does not feel it was effective; This is a spontaneous report received from an Other HCP, Program ID.  A 36-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 35 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "received the vaccine previously and has gotten covid twice and does not feel it was effective".; Sender's Comments: Based on the known drug safety profile, the reported events Drug ineffective, Covid-19, Disease recurrence are assessed as related to suspect drug .
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Covid 19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose number unknown (booster), single (Lot number: fh8028) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "high fever " (unspecified if ongoing); "confusion with dialing phone numbers, she can't organize her thoughts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant), outcome "unknown", described as "Covid 19". Clinical course: Caller had the covid vaccine booster in 2021 and fh8028 administered 09Nov2021. She had a reaction before to Pfizer covid 19 which is high fever, confusion with dialing phone numbers, she can't organize her thoughts. She wanted to know the ingredients of the Pfizer covid 19 booster. She has concerned about getting the tablets for her prep which was polyethylene glycol also for propylene glycol. She wanted to know the solutions for Covid 19. She wanted to know if it was safe to take a Dulcolax tablet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400157484 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Pyrexia, Thinking abnormal
Clinical narrative: high fever; confusion with dialing phone numbers; can't organize her thoughts; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose number unknown (booster), single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever"; CONFUSIONAL STATES (non-serious), outcome "unknown", described as "confusion with dialing phone numbers"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "can't organize her thoughts". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had the COVID vaccine booster in 2021 and FH8028 administered 09Nov2021. She had a reaction to Pfizer COVID-19 which is high fever, confusion with dialing phone numbers, she can't organize her thoughts. She wanted to know the ingredients of the Pfizer COVID-19 booster because her doctor scheduled her for colonoscopy in Dec. She was concerned about getting the tablets for her prep which is polyethylene glycol also for propylene glycol. She wanted to know the solutions for COVID-19. She wanted to know if it was safe to take a Dulcolax tablet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400157483 Same patient, partial same dose, different events;
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: pain when injecting, "but doesn't last long and similar to a flu shot."; Initial information received on 26-Nov-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to US-SA-2024SA351103 (Cluster case).  This case involves a 8 years old male patient who experienced pain when injecting Influenza vaccine.  The patient's past medical history included Respiratory tract infection with about 1 month ago. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization).  On an unknown date the patient developed pain when injecting, "but doesn't last long and similar to a flu shot." (injection site pain) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event pain.; Sender's Comments:  US-SA-2024SA351103:same patient (for vaccine)
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Neck pain, Pain
Clinical narrative: intense pain that radiated from elbow to shoulder and up into her neck that was rather significant; Initial information received on 27-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 52 years old female patient who had intense pain that radiated from elbow to shoulder and up into her neck that was rather significant after receiving Influenza Trivalent Recombinant Vaccine [Flublok Tiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Nov-2024, the patient received a  dose of 0.5 ml of suspect Influenza Trivalent Recombinant Vaccine (solution for injection) lot U8509BA via intramuscular route in unknown administration site for Influenza Vaccination (Influenza immunization) (strength, expiry date was unknown).  On 26-NOV-2024 the patient developed intense pain that radiated from elbow to shoulder and up into her neck that was rather significant (pain) (latency : same day) following the administration of Influenza Trivalent Recombinant Vaccine.  Reportedly "No induration, no redness at site."  Action taken was not applicable.  The patient was treated with Paracetamol (Tylenol) for Pain and Ibuprofen (Ibuprofen) for Pain.  At time of reporting, the outcome was Recovering / Resolving for the event intense pain that radiated from elbow to shoulder and up into her neck that was rather significant.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient started to feel a itchiness in her scalp; Patient covered in hives all the way down to her feet/welts are unbelievable; This spontaneous case, initially received on 15-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 11-Nov-2024, the patient received Fluad (TIV) for Not reported, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: No batch number available and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 11-Nov-2024, the patient experienced Patient started to feel a itchiness in her scalp (outcome: Recovered / Resolved, stop date: 11-Nov-2024), Patient covered in hives all the way down to her feet/welts are unbelievable (outcome: Not recovered / Not resolved).  The patient received her flu vaccine on 11-Nov-2024, on Monday, the Fluad Trivalent 2024-2025 year, and a couple of hours after receiving it, she started to feel a itchiness in her scalp, and in a few hours it went from her scalp, she was covered in hives all the way down to my feet. And it has been steady every day, it was gotten unbelievable. She never had anything like this happen. She went to see an allergist because she was so desperate, and she was wondering the ingredients of what she had received. Adds that gets worst at night, she was on prednisone, all kin d of things, she got a shot. On 14-Nov-2024 was torture her body just as soon as it warms up, the welts are unbelievable and she never had this happen, it has been scary.  Fluad (TIV) action taken: Not Applicable.  Treatment medication: Prednisone.  Reporters' assessment: The reporter provide the seriousness of the events as unknown and did not provide the causality of the events.; Reporter's Comments: The company causality considered as related
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Injected limb mobility decreased; Pain in extremity; This spontaneous case, initially received on 15-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  Concomitant medication: refer to appropriate report section.  Medical history was unknown.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine., Dose regimen: 0.5 ml, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Oct-2024, same day of vaccination, the patient experienced Injected limb mobility decreased (outcome: Not recovered / Not resolved, stop date: 09-Oct-2024), Pain in extremity (outcome: Not recovered / Not resolved, stop date: 09-Oct-2024).  It was reported that an elderly patient experienced INJECTED LIMB MOBILITY DECREASED and PAIN IN EXTREMITY after taking Novavax and Fluad.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non serious but did not provide a causality assessment.; Reporter's Comments: Events assessed as related.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Heart rate increased, Hyperhidrosis, Sleep disorder
Clinical narrative: RAPID HEART RATE, CHILLS ALTERNATING WITH SWEATING, 2 EPISODES OF MILD DIZZINESS, NOT ABLE TO SLEEP,. SYMPTOMS WERE GONE IN ABOUT 22 HOURS
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling
Clinical narrative: Right thigh rash at vaccine site for Dtap and Hep A, 10cmx7.5cm, slightly raised, blaches white,
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 month old received high dose Fluzone. No abnormalities at this time.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Malaise, Nausea, Vomiting
Clinical narrative: Patient felt immediate discomfort upon injection.   Provider administered both vaccines in the left arm.  Patient states the injection toward the back of her arm was immediately painful.  She was concerned about bone.  Verified per patient size, 1" needle would be appropriate and default needle.  Patient reports she experienced significant malaise starting that evening as well as nausea and vomiting.  She felt malaise and pain for days following injection.  Patient reported feeling warm and laying on cool tile, but did not check temperature.  Patient reports it has taken nearly two months for the pain to elevate mostly.  Patient reports she still has tenderness at the site of the injection today (12/05/2024) when it is pushed on.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient complaints of itchy rash down both arms a day after vaccine was given. She continues to experience the itchy rash to both arms off and on to this today. She feels that it might be related to the Hep. B vaccine that she received on 11/13/2024.
Age: 58.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT SAID SHE FIRST NOTICED THE AREA WAS ITCHING AND SO WHEN SHE LOOKED AT IT SHE SAW THAT THE AREA WAS INFLAMMED, WARM TO TOUCH AND A REDDISH COLOR THE SIZE OF A COIN. PATIENT CONTACTED THE PHARMACY TO SHARE THE ADVERSE REACTION.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Contrast echocardiogram, Scan myocardial perfusion
Clinical narrative: Heart pains, Chest discomfort,
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccine was administered. Patient was seated during administration and did not fall. Regained consciousness
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A DUPLICATE DOSE OF AREXVY. HE HAD ALREADY RECEIVED ONE DOSE BACK IN JAN 2024.  PATIENT IS FEELING NORMAL WITH NO ISSUES.
Age: 0.42
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever (101.4 degrees), redness at injection site, irritability, lethargy
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given COVID 12+ dose instead of COVID 6mo-11yo dose.
Age: 51.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Bell's palsy, Facial paresis
Clinical narrative: I developed right-sided facial weakness 9 days after these two vaccines were given to me.  My treating physician (ENT specialist) diagnosed me with Bell's palsy and started me on immediate treatment of prednisone and valcylclovir.  I am currently not improving but I am only 4 days into treatment.  I did not have any viral illnesses in the days or weeks leading up to the Bell's Palsy.
Age: 82.0
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an extra dose of Arexvy. No A/e reported by the patient
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Blood pressure increased, Eye contusion, Somnolence, Swelling
Clinical narrative: Per patient, later on vaccination date her Blood Pressure went up to 180/130, her HR was 120, she felt sleepy, noticed some swelling, and a black eye. Symptoms went away on their own within 1-2 days.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Infection, Injection site pain, Mobility decreased, Pain
Clinical narrative: Shoulder pain started about 2 hours after infection. The infection was mildly painful. The onset of pain was rapid and severe. After another hour I can raise my arm with great difficulty.  The pain is severe and my arm shakes. I am able to raise it in front and to my side. There is a low level  pain constantly and the injection site is very tender.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Shoulder pain started about 2 hours after infection. The infection was mildly painful. The onset of pain was rapid and severe. After another hour I can raise my arm with great difficulty.  The pain is severe and my arm shakes. I am able to raise it in front and to my side. There is a low level  pain constantly and the injection site is very tender.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Immediate post-injection reaction, Pain, Product administered at inappropriate site
Clinical narrative: pt said she was injected on 12/3 way too high on her arm in a boney area which caused her to feel vaccine go into back area.  she said MD said she has arthritis up in that area and when rph injected it in caused the arthritis to be disrupted. it was an immediate response of pain right after she got the injection. she was given norco for the pain from MD on 12/5
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Hypoaesthesia, Vision blurred
Clinical narrative: Blurry vision and vision loss occurring in right eye (side of the injection). Right arm numbness. Symptoms had improved as of today (12/05/24), but the blurry vision is still present.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Culture urine negative
Clinical narrative: Abdominal pain, normal urine culture, no treatment
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rash, Somnolence, Vulvovaginal swelling
Clinical narrative: This vaccine has caused me much pain. I fight everyday to stay awake and live "normal". I experience extreme fatigue - worse than when I was pregnant with my children. There are times I have to excuse myself to lay down or pull over my car to sleep. I pray myself through the fatigue. I know if I had a second dose I would have died. I know many others have died. I know many are battling everyday. I have a lump near my vagina that appeared spring 2022. My skin started breaking out very bad spring 2022 and is just now starting to clear up in 2024.
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, HIBV, MMR, PNC20
Symptoms: Pyrexia
Clinical narrative: Called mother to notify. Other than a fever (the baby received multiple vaccines that day), the child is experiencing no adverse reactions. Provider notified and no further action needed.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Red rash encircling arm, painful, difficulty raising arm, generalized weakness, Benadryl PM, Claritin daily, Warm compress.