chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMRV
Symptoms: Brain injury, Febrile convulsion
Clinical narrative: "brain damage"; febrile seizure; This spontaneous report was received from a consumer and refers to a male patient (reporter's 4th son). His medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, lot #, expiry date, route of administration, vaccination site, and indication were not provided) (suspect reported as MMRV).  On unknown date, the patient experienced febrile seizure and brain damage. At the time of reporting, the outcome of the events febrile seizure was unknown. The action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding both of the events was not reported.   The causal relationship between both events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  Upon internal review, the event "brain damage" was determined to be medically significant.
Sex: U
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: was accidentally given the Arexvy vaccine. So, if you do choose to get it, just make sure you're getting Abryvso.; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2024, the patient received Arexvy. In SEP-2024, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: was accidentally given the Arexvy vaccine. So, if you do choose to get it, just make sure you're getting Abryvso.). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The patient received Arexvy vaccine at the beginning of this month. Unfortunately, the patient was accidentally given Arexvy vaccine, which led wrong vaccine administered. So, if choose to get it, just make sure receive Abryvso vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm still hurts). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-OCT-2024 The case was received from the patient via interactive digital media. The patient was the reporter. The reported that patient had a horrible reaction to the shingles shot so the doctor before get one of the patient arm still hurts at the time of reporting and it has been almost over two years.
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: it exploded back into my face; it exploded back into my face; it squirted back out from the needle puncture area of the stopper; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of exposure via skin contact in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37, expiry date 01-JUL-2025) and (batch number ZJ9FF, expiry date 11-OCT-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced exposure via skin contact (Verbatim: it exploded back into my face), occupational exposure while preparing product for administration (Verbatim: it exploded back into my face), needle leak (Verbatim: it squirted back out from the needle puncture area of the stopper) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, occupational exposure while preparing product for administration, needle leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the needle leak to be related to Arexvy.     It was unknown if the company considered the needle leak to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-OCT-2024 The nurse reported that she was about to reconstitute Arexvy, she had withdrawn the liquid, and as she did (put the liquid in the powder vial) it exploded back into his/her face. The nurse was going to insert it (the liquid) into the second vial, and as she was doing that it shot back out. This was the first time the nurse has administered Arexvy.  The nurse reported that when she began to slowly transfer the contents of the syringe (that contained the adjuvant) into the antigen vial, liquid squirted back out at her face from the antigen vial. The nurse reported that the defect was discovered during preparation for administration. The nurse reported it was unknown if it was after the partial or end of use of the multipack (1 dose of Arexvy was dispensed to the resident at the nursing facility). The product was not administered. The nurse reported, 0.5 ml of air was injected into the Adjuvant Vial only, same needle was used for both vials. The nurse reported that it happened so fast that it appears that it squirted back out from the needle puncture area of the stopper.  The needle was placed in the designated circular area of the stopper. The nurse only removed the plastic flip off, the vials were intact. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to device use error, Underdose
Clinical narrative: Menveo, less volume than recommended dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-AUG-2025) for prophylaxis.   On 30-AUG-2024, the patient received Menveo. On 30-AUG-2024, an unknown time after receiving Menveo, the patient experienced accidental underdose (Verbatim: Menveo, less volume than recommended dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 04-OCT-2024 A medical assistant called to report a Menveo vaccine was administered to a pediatric patient and while administering the patient yank his arm away and close to half (of the volume of the vaccine) came out. The patient got probably a little more than half injected into his arm which led to accidental underdose.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU3, HEPA, HIBV, MENB, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Hiberix, Rotarix (liq) stored at 8.6C x 28 mins on August 2, 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Hib (Hiberix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Bexsero, FluLaval 2024-2025 season, Havrix, Pediarix, Boostrix, Infanrix, Hiberix, Rotarix lyophilized formulation and Kinrix. On 02-AUG-2024, an unknown time after receiving Bexsero, FluLaval 2024-2025 season, Havrix, Pediarix, Boostrix, Infanrix, Hiberix, Rotarix lyophilized formulation and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Hiberix, Rotarix (liq) stored at 8.6C x 28 mins on August 2, 2024). The outcome of the incorrect storage of drug 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-OCT-2024 The medical assistant requested stability data for Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Hiberix, Rotarix (liq) stored at 8.6 degree celcius for 28 minutes on 02nd August 2024. All vaccines had been administered to patients which led to incorrect storage of drug.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HIBV, MMR, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liq), Priorix stored at 9.5C x 2hr 18 mins; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Hib (Hiberix) for prophylaxis, Rota (Rotarix liquid formulation) for prophylaxis and MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Menveo, Havrix, Pediarix, Kinrix, Boostrix, Infanrix, Engerix B, Hiberix, Rotarix liquid formulation and Priorix. On an unknown date, an unknown time after receiving Menveo, Havrix, Pediarix, Kinrix, Boostrix, Infanrix, Engerix B, Hiberix, Rotarix liquid formulation and Priorix, the patient experienced incorrect storage of drug (Verbatim: Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liq), Priorix stored at 9.5C x 2hr 18 mins). The outcome of the incorrect storage of drug 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: 14-OCT-2024 The healthcare professional requested stability data for Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liquid), Priorix stored at 9.5 degree celcuis for 2 hours 18 minutes. No prior excursions. The patient involvement (HCP unsure which vaccines have been administered to patients since multiple excursions starting on 03rd September 2024) which led to incorrect storage of drug.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number D252F, expiry date 10-APR-2027) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season and Pediarix. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 21-OCT-2024 The caller reported that their fridge had a temperature excursion, so called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered. The HCP mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix HCP reported to administer this vaccines to 13 different patients, the info for all of the patients can be found in the Description area for the case which eld to incorrect storage of drug. The HCP mentioned that all of this patients received the vaccines in 18 October 2024. This was 1 of the 14 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133246:Same Reporter, Different Patient US-GSK-US2024AMR133247:Same Reporter, Different Patient US-GSK-US2024AMR133248:Same Reporter, Different Patient US-GSK-US2024AMR133249:Same Reporter, Different Patient US-GSK-US2024AMR133250:Same Reporter, Different Patient US-GSK-US2024AMR133251:Same Reporter, Different Patient US-GSK-US2024AMR133252:Same Reporter, Different Patient US-GSK-US2024AMR133253:Same Reporter, Different Patient US-GSK-US2024AMR133244:Same Reporter, Different Patient US-GSK-US2024129452:Same Reporter, Different Patient US-GSK-US2024AMR133242:Same Reporter, Different Patient US-GSK-US2024AMR133245:Same Reporter, Different Patient
Age: 12.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediarix was administered to 12 years old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis.   On 16-SEP-2024, the patient received Pediarix. On 16-SEP-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: pediarix was administered to 12 years 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: 21-OCT-2024 A pharmacist informed that Pediarix was administered to 12 years old patient . The reporter was trying to find out about the efficacy of the dose and whether or not they need to administer additional individual vaccines which led to inappropriate age at vaccine administration. The patient was due to all three vaccines at that time so instead of giving three individual shots, the decision was made to administer Pediarix.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vertigo
Clinical narrative: I am still experiencing vertigo and it has been over a week since the immunization; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (I am still experiencing vertigo and it has been over a week since the immunization) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    The patient's past medical history included Fistula (middle ear fistula) and Vertigo (intense vertigo).   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (I am still experiencing vertigo and it has been over a week since the immunization). At the time of the report, VERTIGO (I am still experiencing vertigo and it has been over a week since the immunization) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was reported that, patient had nausea and vertigo. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Febrile convulsion
Clinical narrative: daughter had a febrile seizure for the first time at about 30 hours post getting her shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEBRILE CONVULSION (daughter had a febrile seizure for the first time at about 30 hours post getting her shot) in a 4-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 22-Oct-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced FEBRILE CONVULSION (daughter had a febrile seizure for the first time at about 30 hours post getting her shot). The patient was treated with Ibuprofen (Motrin) 22-Oct-2024 for Fever, at a dose of 1x does within 1 hour of the seizure and Ibuprofen (Motrin) from October 2024 to October 2024 for Fever, at a dose of 1x dose 6hours after that. On 23-Oct-2024, FEBRILE CONVULSION (daughter had a febrile seizure for the first time at about 30 hours post getting her shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2024, Body temperature: 104F.     The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter's daughter had a febrile seizure for the first time at about 30 hours post getting her shot. She had no fever or other symptoms till walking up from nap but suddenly spiked a fever of 104F within 20 minutes and started convulsing. She recovered once ice was applied and her fever reduced over the next 5 hours with Motrin. No fever or any other symptoms since then.  The patient did not experience any additional symptoms/events.   The patient had no concomitant disease, or risk factor.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: giving a dose of Spikevax (2024-2025) vaccine yesterday and the plunger would not plunge in, as if it was jammed; No Adverse Effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (giving a dose of Spikevax (2024-2025) vaccine yesterday and the plunger would not plunge in, as if it was jammed) and NO ADVERSE EVENT (No Adverse Effect) in an adolescent female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043333) for COVID-19 prophylaxis.    The suspect product reported as Pre-filled Syringe injection (batch no. 3043333) for COVID-19 prophylaxis.    No Medical History information was reported.   On 24-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (giving a dose of Spikevax (2024-2025) vaccine yesterday and the plunger would not plunge in, as if it was jammed) and NO ADVERSE EVENT (No Adverse Effect). At the time of the report, DEVICE ISSUE (giving a dose of Spikevax (2024-2025) vaccine yesterday and the plunger would not plunge in, as if it was jammed) and NO ADVERSE EVENT (No Adverse Effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medications were reported. No medical history/conditions, allergy, concomitant diseases and risk factor were reported. The reporter threw the dose out in the sharp's container and used a second prefilled syringe where it was successfully administered. The reporter does not prime the needle once attached it to the prefilled syringe. No side effects were reported by the patient,  No treatment medications were reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2024: Non-significant follow up received. Reference numbers were added. On 25-Oct-2024: Non-significant follow up received. Reference number was added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she got COVID/lung COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she got COVID/lung COVID) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030373) for COVID-19 prophylaxis.     The patient's past medical history included Lung disorder (lung reboot).    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In August 2024, the patient experienced COVID-19 (she got COVID/lung COVID). At the time of the report, COVID-19 (she got COVID/lung COVID) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient mentioned that she got COVID in August. HCP confirmed that she had lung COVID and she mentioned that previously she had lung reboot. She's currently had a fever she can't specify if it was because of her lungs. Reporter causality was not reported.  Treatment information was not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site irritation, Vaccination site pruritus
Clinical narrative: itching in the right arm; irritation on the injection site; inflammation and irritation on the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itching in the right arm), VACCINATION SITE IRRITATION (irritation on the injection site) and VACCINATION SITE INFLAMMATION (inflammation and irritation on the injection site) in an 82-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (received   a flu shot 3-4 before Spikevax). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Hypertension.    On 24-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 24-Oct-2024, the patient experienced VACCINATION SITE PRURITUS (itching in the right arm), VACCINATION SITE IRRITATION (irritation on the injection site) and VACCINATION SITE INFLAMMATION (inflammation and irritation on the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching in the right arm) outcome was unknown and VACCINATION SITE IRRITATION (irritation on the injection site) and VACCINATION SITE INFLAMMATION (inflammation and irritation on the injection site) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  It was reported that post vaccination patient experienced itching in the right arm where the shot was administered. It was also reported that patient had no significant soreness in the arm, but patient arm was not warm. But patient arm was tiny and was bit puffy.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2024: Live-non -significant information received in which new reference number was added. On 28-Oct-2024: Live -Significant information received in which reporter details were updated, patient demographic was added (date of birth, age), other relevant history was added, new event of Vaccination site inflammation and Vaccination site irritation was added, and new reference number was added.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The patient had two shots of the Abrysvo vaccine, and they were given one year apart; This is a spontaneous report received from a Pharmacist from medical information team.  An 81-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Abrysvo (Dose 1, single), for Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "The patient had two shots of the Abrysvo vaccine, and they were given one year apart".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer from medical information team.  A 73-year-old male patient received BNT162b2 omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing), notes: Not very high; "HbA1C prediabetic" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Joint tightness" (unspecified if ongoing); "Wife has COVID-19" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased, ankylosing spondylitis, stop date: 01Oct2024; METFORMIN taken for glucose tolerance impaired, stop date: 01Oct2024; CELEBREX taken for arthritis, pain, inflammation, joint stiffness, stop date: 01Oct2024. Vaccination history included: Bnt162b2 (Primary Immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". The patient had done all the vaccines, the Pfizer vaccines for COVID-19 in the past. The patient had not had any side effects from it but clarified to have very few side effects. So, the patient was okay with the COVID-19 vaccine. The patient was probably going to take one in a few months, whatever the most current one is. The patient thought that he had COVID-19 because his wife had COVID-19, and he subsequently travelled between countries, and he received some nirmatrelvir/ ritonavir (PAXLOVID) tablets from 01Oct2024 for 5 days as treatment.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: My heart is in pain; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "'hole' in my heart" (unspecified if ongoing), notes: Intent: History, when I was a little kid.; "operated in my lungs" (not ongoing), notes: Intent: History, when I was a little kid. The patient's concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "My heart is in pain". Clinical course: Patient got their three COVID-19 vaccines (Clarified as COVID-19 Vaccine), Patient got 3 out of 4. Patient stated, " he can't even see his wife. His heart was in pain. He had a 'hole' in heart and was operated on lungs, for heart (Intent: History) when he was a little kid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400288468 Same patient and product, Different dose and events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the COVID-19, first I took the Pfizer vaccine; I got the COVID-19, first I took the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "'hole' in my heart" (unspecified if ongoing); "I was operated in my lungs, for my heart" (not ongoing), notes: Intent: History. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got the COVID-19, first I took the Pfizer vaccine". Clinical course: It was stated that first, patient got the COVID-19, first he took the Pfizer vaccine. Patient 'took' the Pfizer or the other one (Further clarification was not available), patient knew he got two. Patient couldn't even see his wife. Patient had a 'hole' in heart and was operated in the lungs, for his heart (Intent: History) when he was a little kid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400288465 same reporter/patient/product, different event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Photosensitivity reaction, Vision blurred
Clinical narrative: signficant inflammation of eyelids; eyes blurred; photosensitivity; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HF9275) at the age of 64 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's", start date: 2004 (unspecified if ongoing). The patient's 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), SINGLE ; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE ; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE ; unknown manufacturer), for COVID-19 immunisation. The following information was reported: BLEPHARITIS (non-serious), outcome "unknown", described as "signficant inflammation of eyelids"; VISION BLURRED (non-serious), outcome "unknown", described as "eyes blurred"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "photosensitivity".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400247190 same reporter/patient/product; different dose/event.;
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Small welt/swelling and redness at injection site(right arm only), warm to the touch
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Hypotension
Clinical narrative: Patient returned to pharmacy on 10/28/24 claiming he experienced low blood pressure and had to go to the Emergency room. He claimed this happened because he received 2 vaccines in the same arm. Patients are given a choice for the arm of choice. Abrysvo and Shingrix) .  Patient received a prescription for ondansetron from the ER. This is normally for nausea/vomiting
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Lacrimation increased, Oropharyngeal pain
Clinical narrative: Paitent stated that day after got this Comirnaty covid shot experienced burning ears, watering eyes, and a sore throat. Patient wanted this reported as it happened the day after she had the covid vaccination and took about a week to recover.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure increased, Blood sodium decreased, Cervical spinal stenosis, Chest X-ray normal
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head abnormal, Computerised tomogram spine abnormal, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Influenza like illness, Influenza virus test negative, Intervertebral disc degeneration, Laboratory test normal
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Metabolic function test, Nausea, Neck pain
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Peripheral coldness, Phalen's test positive, Respiratory symptom
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: SARS-CoV-2 test negative, Spinal ligament ossification, Spinal osteoarthritis, Streptococcus test negative, Subgaleal haematoma
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Tinel's sign
Clinical narrative: 9/18/24 was a BP follow-up visit (no-show on 8/26/24 for f/u). He c/o general bodyaches, arms, fingers and shoulder pain. Also c/o finger numbness, cold feeling, and nausea. Denied  chest pain, headache, neck pain. History of cervicalgia--seen in ER 9/16/2024. Also was treated for flu-like symptoms with a Medrol dose pack. He only took a few pills and didn't follow package instructions. Since his URI symptoms were better, he was advised to stop.  Neuro: cranial nerves NML, + tinel's and phalen's bil.  He was referred to neurology at that visit. Labs: BMP, CBC, EKG was done. C/o feeling dizzy and BP was elevated at the visit 192/102. Losartan was increased to 50mg. BP f/u was scheduled on 9/20/24, but patient wasn't seen since.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: 6 hours after J&J COVID 19 injection, this gentleman started hallucinating on his job site. He drove home while continueing to hallucinate and the hallucinations continued for about 24 hours. This consisted of seeing  a bolt twist up above concrete setting in a home he was building to once in bed at home feeling like the bed was trying to swallow him and the ceiling was wavering and moving above him.
Age: 4.0
Sex: U
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient got a flushot at an off site event on  both 10/16/24 and 10/30/24
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Intense shivering, fever of 104, and vomiting for approximately 4 hours.  Temperature and shivering reduced after I was able to keep Tylenol down.  Fever of 100 and elevated heart rate and blood glucose was experienced until Wednesday 10/30/2024
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient was given an IM injection and noticed the inability for him to raise his arm later in the evening. Per the patient's mother, the patient woke up at 2 AM in 3/5 pain and unable to move his arm. His primary care was contacted and he was told to alternate tylenol and advil and ice the shoulder. Primary care provider will follow up with him on Friday, Nov 1, 2024. The pharmacist that administered the vaccination said she felt some resistance during injection. She states she thought the syringe may have been screwed on too tightly which impacted the flow on medication through the syringe.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram neck, Culture urine, Dysphagia, Full blood count, Gingival bleeding
Clinical narrative: 10/10/24COVID SHOT AND FLU SHOT 10/17 HEADACHES NAUSIA AND SLEEPINESS.10/19 SORES IN MOUTH LIPS BLISTERING SWALLOWING VERY DIFFICULY, PAIN IN LOWER PART OF MOUTH GUMS BLEED SKIN PEELS OFF INNER CHEEK WE SAW 5 DOCTORS INCLUDING EMERGECY ROOM, MEDICATION PERIDEX,VIT C LYSINE 2 MG FOLIC ACID NON WORKED  FILLED MAGIC MOUTH WASH 10/30 WAITING FOR RESULTS AS OF TODAY ALL MOUTH SYMPTOMS EXIST NAUSIA AND HEADACHES DISAPPERED READ AN ARTICLE FROM LIBRARY OF MEDICINE DESCRIBES CONDITION EXACTLY MEDICATIONS ARE MENTIONED BUT NO DOCTOR KNOW ABOUT IT WE NEEC THE MEDS
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Lip blister, Metabolic function test, Nausea, Oral mucosal exfoliation
Clinical narrative: 10/10/24COVID SHOT AND FLU SHOT 10/17 HEADACHES NAUSIA AND SLEEPINESS.10/19 SORES IN MOUTH LIPS BLISTERING SWALLOWING VERY DIFFICULY, PAIN IN LOWER PART OF MOUTH GUMS BLEED SKIN PEELS OFF INNER CHEEK WE SAW 5 DOCTORS INCLUDING EMERGECY ROOM, MEDICATION PERIDEX,VIT C LYSINE 2 MG FOLIC ACID NON WORKED  FILLED MAGIC MOUTH WASH 10/30 WAITING FOR RESULTS AS OF TODAY ALL MOUTH SYMPTOMS EXIST NAUSIA AND HEADACHES DISAPPERED READ AN ARTICLE FROM LIBRARY OF MEDICINE DESCRIBES CONDITION EXACTLY MEDICATIONS ARE MENTIONED BUT NO DOCTOR KNOW ABOUT IT WE NEEC THE MEDS
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oral pain, SARS-CoV-2 test negative, Somnolence, Stomatitis, Urine analysis
Clinical narrative: 10/10/24COVID SHOT AND FLU SHOT 10/17 HEADACHES NAUSIA AND SLEEPINESS.10/19 SORES IN MOUTH LIPS BLISTERING SWALLOWING VERY DIFFICULY, PAIN IN LOWER PART OF MOUTH GUMS BLEED SKIN PEELS OFF INNER CHEEK WE SAW 5 DOCTORS INCLUDING EMERGECY ROOM, MEDICATION PERIDEX,VIT C LYSINE 2 MG FOLIC ACID NON WORKED  FILLED MAGIC MOUTH WASH 10/30 WAITING FOR RESULTS AS OF TODAY ALL MOUTH SYMPTOMS EXIST NAUSIA AND HEADACHES DISAPPERED READ AN ARTICLE FROM LIBRARY OF MEDICINE DESCRIBES CONDITION EXACTLY MEDICATIONS ARE MENTIONED BUT NO DOCTOR KNOW ABOUT IT WE NEEC THE MEDS
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: Patient said she felt a little anxious about receiving her flu and COVID vaccines, but that she would be fine and wanted to get them done. After administering the second vaccine, she sat for a minute then said she was okay and her husband helped her over to another seat. When she sat on that bench, she fainted and started to fall over on the bench but her husband and I held her upright. After about 15 seconds, she came to and we gave her water and she said she was fine.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dizziness, Feeling cold, Headache, Hot flush
Clinical narrative: Patient called in to report that she became very dizzy several hours after receiving her Influenza vaccine.  She reported she had dizziness, felt faint, and had to lay on the floor.  She stated this had happened before.  She reported she had vomiting and diarrhea while on the floor.  She said she couldn't move.  Later she felt better and said she was shaking with hot and cold flashes.  She reported a headache that evening and took a tylenol which didn't help.  Then at 5 am she took a motrin and her headache went away.  She said during the evening she had a 100.5 degree fever.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient called in to report that she became very dizzy several hours after receiving her Influenza vaccine.  She reported she had dizziness, felt faint, and had to lay on the floor.  She stated this had happened before.  She reported she had vomiting and diarrhea while on the floor.  She said she couldn't move.  Later she felt better and said she was shaking with hot and cold flashes.  She reported a headache that evening and took a tylenol which didn't help.  Then at 5 am she took a motrin and her headache went away.  She said during the evening she had a 100.5 degree fever.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anal incontinence, Chills, Dizziness, Feeling of body temperature change, Insomnia
Clinical narrative: Patient called in to report that she became very dizzy several hours after receiving her Influenza vaccine.  She reported she had dizziness, felt faint, and had to lay on the floor.  She stated this had happened before.  She reported she had vomiting and diarrhea while on the floor.  She said she couldn't move.  Later she felt better and said she was shaking with hot and cold flashes.  She reported a headache that evening and took a tylenol which didn't help.  Then at 5 am she took a motrin and her headache went away.  She said during the evening she had a 100.5 degree fever.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tinnitus, Vomiting
Clinical narrative: Patient called in to report that she became very dizzy several hours after receiving her Influenza vaccine.  She reported she had dizziness, felt faint, and had to lay on the floor.  She stated this had happened before.  She reported she had vomiting and diarrhea while on the floor.  She said she couldn't move.  Later she felt better and said she was shaking with hot and cold flashes.  She reported a headache that evening and took a tylenol which didn't help.  Then at 5 am she took a motrin and her headache went away.  She said during the evening she had a 100.5 degree fever.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives on the body, especially when evening and midnight during the sleep.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Dyspnoea, Increased upper airway secretion, Pruritus
Clinical narrative: Reported as feeling like an asthma attack from employee.  Reported it was hard to breathe, with mucous build up in throat, itching on the skin, wheezing, coughing, and gurgling noises.  Employee reported she does not have asthma but took benadryl and her symptoms slowly subsided.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Reported as feeling like an asthma attack from employee.  Reported it was hard to breathe, with mucous build up in throat, itching on the skin, wheezing, coughing, and gurgling noises.  Employee reported she does not have asthma but took benadryl and her symptoms slowly subsided.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Inflammation, Skin warm, Urticaria
Clinical narrative: Arm developed a red welt, become inflammed, and was warm to touch. Doctor recommended benedryl and warm compress.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling of the right hand, specifically the right thumb. Have not yet fully recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Lethargy, Pyrexia, Respiratory tract congestion, Secretion discharge
Clinical narrative: Patient has been lethargic, congested with lots of mucous with dry throat, had fever but subsided since 10/23/2024 after the vaccination.