chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called and reported that PROQUAD was administered to 1 patient following a temperature excursion; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-May-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y018156, expiration date reported as: 29-Apr-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection.  On 29-May-2025, the vaccine was administered to one patient following a temperature excursion (temperature: -13.49C; time frame: 1 hour and 15 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided.   This case was considered to be invalid due to lack of patient's identifiers.
Vaccine: HEP
Symptoms: Adverse event following immunisation, Product administered to patient of inappropriate age
Clinical narrative: HCP was looking to see if a 23 year old who had previously received a single pediatric dose, have sufficient immunity for Hepatitis B.; No additional  AE/PQC; This spontaneous report was received from a healthcare professional (HCP) and refers to a currently 23 year old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a single pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (exact dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis (inappropriate schedule of product administration). The reporter was looking to see if the patient had sufficient immunity for Hepatitis B. The reporter refused to provide demographic information and no additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was noted.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Ultrasound findings indicate: Intussusception: Small bowel-small bowel intussusception.; This spontaneous report was received from a consumer or other non-health professional via company representative and refers to a 2-months-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 27-May-2025, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally administered (lot # and expiration date were not reported) for prophylaxis.  On 30-May-2025, he was taken to hospital for abdominal pain. Ultrasound was performed and findings indicated intussusception, small bowel-small bowel intussusception. No Ileocolic intussusception. He was released from the emergency department (ER) on 30-May-2025. At the reporting time, the outcome of the event was unknown.   The causal relationship between the event Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.   Additional information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: The patient received a partial dose of VARIVAX due to the patient moving during  administration.; This spontaneous report has been received from other health professional, regarding to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 22-MAY-2025, the patient was vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) suspension for injection, at a dose of 0.5 milliliter (ml), as prophylaxis (lot number U7899AA, expiration date: 31-AUG-2026). Also, it was reported that the patient received a partial dose due to the patient moving during administration.; Reporter's Comments:
Vaccine: RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse event; ROTATEQ was administered to 1 consumer following a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 22-May-2025, the patient received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #2051974 expiration date: 16-Nov-2025 (dose was not reported), administered by oral route for prophylaxis following a temperature excursion of 18.8C for 9 hours and 20 minutes (product storage error). There was no previous temperature excursion. No adverse event was reported.
Vaccine: MMR, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertent administration of MMR-2 after a temperature excursion; No additional AE/PQC; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot #Y015834, expiration date: 20-SEP-2026) (strength, dose description, route of administration was not reported) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose description, route of administration, lot # and expiration date were not reported) for prophylaxis following a temperature excursion of 14.8 C for 2 hours 42 minutes, no previous temperature excursion occurred. No additional adverse event reported.  This case was considered invalid due to lack of patient identifiers.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient received the first dose at age 15 and then forgot about completing the series.; No additional AE; This spontaneous report was received from a health care professional referring to a 25-year-old male patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, reported as when the patient was 15-year-old, he received the first dose of Human papillomavirus 9-valent vaccine recombinant suspension for injection (GARDASIL 9) as a dose of 0.5 ml administered for prophylaxis (route of administration, anatomical location, lot number, and expiration date were not reported), the patient forgot about completing the vaccine series. (Inappropriate schedule of product administration). There was not adverse event reported.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient that was Given HEPLISAV-B, But She's 17; Initial report received on 02-Jun-2025.  An office manager reported that a 17-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  On 05-May-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intramuscularly. The patient was 17 at the time. The physician did not realize this at the time. The office had recently switched to using HEPLISAV-B. The patient did not experience any adverse reactions.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Dizziness, Ear pain, Injection site pain, Migraine
Clinical narrative: Pain injection site; Migraine; Lightheadedness; tingling right arm; pain up right arm, shoulder ear; both hands throbbing and pulsating; pulsating in pain; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H) for prophylaxis.   On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, several hours after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site), migraine (Verbatim: Migraine), light headedness (Verbatim: Lightheadedness), tingling of extremity (Verbatim: tingling right arm), pain in arm (Verbatim: pain up right arm, shoulder ear), throbbing pain (Verbatim: both hands throbbing and pulsating) and sensation of blood flow (Verbatim: pulsating in pain). The outcome of the injection site pain, migraine and light headedness were resolved and the outcome of the tingling of extremity, pain in arm, throbbing pain and sensation of blood flow were unknown.   It was unknown if the reporter considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero 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: 28-MAY-2025 Other Health Professional reported that patient received Bexsero vaccine on 5-MAY-2025, a few hours later, he was lightheaded, right arm tingly and pain at injection site that migrated up arm shoulder to ear and Hands throbbing and pulsating in pain, He had migraine later that evening. This case US2025066674 reported by same reporter.; Sender's Comments:  US-GSK-US2025066674:1 of 2 report
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain injection site; Migraine; Lightheadedness; tingling right arm; pain up right arm, shoulder ear; both hands throbbing and pulsating; pulsating in pain; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H) for prophylaxis.   On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, several hours after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site), migraine (Verbatim: Migraine), light headedness (Verbatim: Lightheadedness), tingling of extremity (Verbatim: tingling right arm), pain in arm (Verbatim: pain up right arm, shoulder ear), throbbing pain (Verbatim: both hands throbbing and pulsating) and sensation of blood flow (Verbatim: pulsating in pain). The outcome of the injection site pain, migraine and light headedness were resolved and the outcome of the tingling of extremity, pain in arm, throbbing pain and sensation of blood flow were unknown.   It was unknown if the reporter considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero 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: 28-MAY-2025 Other Health Professional reported that patient received Bexsero vaccine on 5-MAY-2025, a few hours later, he was lightheaded, right arm tingly and pain at injection site that migrated up arm shoulder to ear and Hands throbbing and pulsating in pain, He had migraine later that evening. This case US2025066674 reported by same reporter.; Sender's Comments:  US-GSK-US2025066674:1 of 2 report
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: felt achy). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-JUN-2025 Consumer stated that patient received his first dose of Shingrix less than 6 months ago and he felt achy onset, resolve, area involved was not specified after receiving the vaccine.  No other information was provided or obtained.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: her whole arm (left) was swollen.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number MG5S9) for prophylaxis.   On 18-APR-2025, the patient received the 1st dose of Shingrix (intramuscular use, left arm) .5 ml. On 21-APR-2025, 3 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: her whole arm (left) was swollen.). The outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     It was unknown if the company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2025 The pharmacist reported that a patient was vaccinated with her first dose of Shingrix on 18-APR-2025.   Consumer informed to the health care professional that 72 hours later she had bad side effects and her whole arm (left) was swollen.   No further information was obtained/provided.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: reports not feeling "well" for a day or so after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: reports not feeling "well" for a day or so after each dose). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2025 The Patient reported that he had a dose of Shingrix. The patient reported not feeling well for a day or so after dose.; Sender's Comments:  US-GSK-US2025AMR072940:Same Patient/ 2nd dose
Sex: F
Vaccine: MEN
Symptoms: Illness
Clinical narrative: granddaughter was in the hospital for that, and she had got sick again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced sickness (Verbatim: granddaughter was in the hospital for that, and she had got sick again). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine.     It was unknown if the company considered the sickness to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 05-JUN-2025 This case was reported by a patient via interactive digital media. The reporter granddaughter was in the hospital for that and she had got sick again so they thought she did not get all the shots so asked what to do her now.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; broke out in shingles today; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 06-JUN-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: broke out in shingles today). 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 Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had his/her vaccine 5 years ago and broke out in shingles today (on the day of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; I'm just getting over shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I'm just getting over shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and he/she was just getting over shingles.  The reporter stated that you did not want shingles.  The rash was mild and the pain was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: needed to take an over the counter fever reducer; within a few hours he started to feel badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, several hours after receiving Shingrix, the patient experienced feeling bad (Verbatim: within a few hours he started to feel badly). On an unknown date, the patient experienced fever (Verbatim: needed to take an over the counter fever reducer). The outcome of the feeling bad and fever were resolved.   It was unknown if the reporter considered the feeling bad and fever to be related to Shingrix.     It was unknown if the company considered the feeling bad and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2025 Patient took first dose of Shingrix. He reported that within a few hours he started to feel badly and needed to take an over the counter fever reducer at 4:00 PM. He said he then went to bed and slept until the next morning and then felt fine the following day.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine; Unapproved age; 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 7-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 05-JUN-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 05-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Incorrect vaccine) and inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   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-JUN-2025 Office Manager called to report one of my Medical Assistants gave to, a 7 month old baby, a Kinrix vaccine instead of the Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  We wanted to know if we need to revaccinate the baby or is there going to be any side effects or reactions to, I mean for the baby. The patient was supposed to receive the 1st dose of Pediarix.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: she had administered only the liquid portion of Priorix; she had administered only the liquid portion of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received MMR (Priorix) (batch number 4MG3E, expiry date 01-DEC-2026) for prophylaxis.   On 01-JUN-2025, the patient received the 1st dose of Priorix. On 01-JUN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: she had administered only the liquid portion of Priorix) and inappropriate dose of vaccine administered (Verbatim: she had administered only the liquid portion of Priorix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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-JUN-2025 A pharmacist reported that she had administered only the liquid portion of priorix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The shot was administered on 1 June 2025 and corresponded to the first dose.  She wanted to know how to proceed and how to get a new diluent portion for reconstituting the lyophilized part as usual.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: urine that has turned a much brighter yellow; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Leukemia", start date: 2004 (unspecified if ongoing), notes: Diagnosed 21 years ago. Concomitant medication(s) included: ROSUVASTATIN CALCIUM taken for blood cholesterol (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (had maybe 10 or 11 Covid shots up until now, Last Covid vaccine received was Oct2024), for COVID-19 immunization. The following information was reported: CHROMATURIA (non-serious) with onset 30May2025, outcome "unknown", described as "urine that has turned a much brighter yellow".  Additional information: Caller was calling in regards to the covid vaccine booster. After caller got the covid vaccine booster last Friday i.e. 30May2025, noticed urine had turned a much brighter yellow. Agent wanting to know if there was any information about urine that has turned a much brighter yellow and if she should be concerned or what she should test for. Caller stated that she did see online there were some urological complications after the vaccine. Caller was wondering if she should be concerned. If she brought a urine sample into her doctor's office, what should they test for. Has been drinking a lot more so urine has gotten a little bit better but just her usual for her. The patient had might be 10 or 11 covid shots up until now. Later in call, clarified the last covid vaccine received was Oct2024. Caller cannot confirm manufacturer, has had both Moderna and Pfizer. No NDC, lot or expiry to provide on any covid vaccine received. Has all the paperwork but not with her. Takes a thyroid drug. It starts with an L, it was a generic, not Synthroid. Takes one of the lowest doses, a pill taken once a day. Has been taking several months and is currently taking.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Injury, Post-acute COVID-19 syndrome
Clinical narrative: Vaccine injuries; Long Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "Vaccine injuries"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid".  Additional Information: Reporter states, her primary care doctor was retiring this month. Patient need a primary care physician who knows something about long covid and vaccine injuries. Symptoms are constantly changing. She was going to all sorts of doctors, heart, skin, gastroenterologist, physical therapy, & ENT. Patients need medical doctor to oversee my issues.  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, PNC20, RSV
Symptoms: Febrile convulsion
Clinical narrative: The patient had a febrile seizure after getting 3 vaccines at one time.; This is a spontaneous report received from a Physician from a sales representative.  An elderly male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; 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: "stroke" (unspecified if ongoing), notes: Previous history of stroke. The patient's concomitant medications were not reported. The following information was reported: FEBRILE CONVULSION (hospitalization), outcome "recovered", described as "The patient had a febrile seizure after getting 3 vaccines at one time.". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), rsv vaccine prot.subunit pref 2v, BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 and ABRYSVO in triggering the onset of febrile seizure cannot be fully excluded, considering the plausible temporal relationship.  Previous history of stroke and elderly age are major confounders.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: They made vaccines for Covid that I don't think worked that well; They made vaccines for Covid that I don't think worked that well; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacture), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "They made vaccines for Covid that I don't think worked that well". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Severe pain in arm that received injection; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe pain in arm that received injection". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "Covid".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of adacel post expiry with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid  non-serious case received from nurse.  This case involves an unknown age and unknown gender patient who had received an expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown expired dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection with :expiration date of 05/01 (lot number, and strength  not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency:same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: administering PENTACEL to a patient 8 years of age with no reported adverse event; Initial information received on 10-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 years old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-May-2025, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UK015AA, expiry date 30-May-2025, strength: standard and frequency: once) via intramuscular route in the left deltoid for immunisation with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No  adverse reaction.  Gave 19+ vaccine.  Should have given  - 18 yo vaccine
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Local swelling  measuring 7 inches long by 2 inches wide per patient 6 days post vaccination no adverse effects until 06/11/2025 noted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No physical adverse event. Patient received an extra dose of the Shingrix vaccination in error
Age: 79.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Pt had swelling after the injection on her whole arm and part of her chest. She was given the injection over a month ago and she states that it is still swollen. She says the arm still aches and that she is having tingling and numbness in her hand when she drives. The patient will follow up with her PCP today.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Insomnia
Clinical narrative: Loss of appetite, headache, tiredness, muscle and joint pain, irritability and inability to sleep well.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Myalgia
Clinical narrative: Loss of appetite, headache, tiredness, muscle and joint pain, irritability and inability to sleep well.
Age: 44.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: pt. arrived today 6/12/25 at the clinic stating that she began experiencing generalized hives and itchiness all over her body at around 6pm yesterday 6/11/25 after having received the Varicella, MMR, HepB, and IPV vaccine at around 12p that same day. Pt. stated that she took cleratin and it helped with the itching but it came back this morning and she stated that she also had slight itching in her throat. RN recommended pt. seek immediate medical care at the local urgent care or ER as the signs and symptoms she is exhibiting are similar to those of an allergic reaction. Pt. stated that she would go straight to the urgent care/ER  for f/u and treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute sinusitis, Injection site discolouration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Itching started the day following vaccination (5/29).  Around that time the patient was prescribed a medrol dosepak for an unrelated condition (acute sinusitis) which she started on 6/3.  We think this may have helped the symptoms of the localized vaccine reaction subside.  After completing the steroid, patient noticed the itching again at the vaccination site around 6/11, then a large hard nodule formed at the injection site which became discolored and was accompanied by pain and tingling (described as a burning, stinging, throbbing feeling).  Patient will be advised to seek further evaluation from her primary care physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Itching started the day following vaccination (5/29).  Around that time the patient was prescribed a medrol dosepak for an unrelated condition (acute sinusitis) which she started on 6/3.  We think this may have helped the symptoms of the localized vaccine reaction subside.  After completing the steroid, patient noticed the itching again at the vaccination site around 6/11, then a large hard nodule formed at the injection site which became discolored and was accompanied by pain and tingling (described as a burning, stinging, throbbing feeling).  Patient will be advised to seek further evaluation from her primary care physician.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Prolonged pain in arm after injection
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacy unknowingly administered unneeded rsv shot. Pt was previously immunized with arexvy on 10/4/23.  Spoke to pt on 6/12/25. She is well, feeling great, noted no side effects from the vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh became red, swollen, and painful to touch. Patient was seen in the ER due to these symptoms. Patient is doing better now
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Inflammation, Neck pain, Pain, Rash erythematous
Clinical narrative: GSK is the manufacturer for (Shingrix).  I went into the pharmacy 2 days ago to do a pickup and the Pharmacist gave me a slip that recommended several vaccines for people over 50.  Now, 54, I opt to get the Shingles Vaccine.  The person that administered the injection explained that I should "ONLY" experience soreness .   Day 1 - Soreness (as expected and I slept ALLLLL day).  Day 2 - still sore, but expected.  By 11pm that night, I started scratching my upper back on the left side, below the shoulder blade.  When I woke up this morning, I noticed the same area was irritated.  Upon showering, I noticed a red rash there.  I rubbed some alcohol on it and continued on with my day.  An hour later, (I'd say 9:30am), I noticed it turning really "red" and "irritating."  I took another look so I applied desonide ointment to help with the inflammation/pain.  I continued on with my day.  By 10:45am, I noticed the same pain on the left side of my neck.   WTH??   I thought I was bitten by something but I haven't left the home in 2 days so what is happening.  I feels like a thousand mosquitoes are biting me and sensitive to the touch.  WHAT THE HELL?  I've never ever experienced this before.  I called the Pharmacy to speak with pharmacist but she wasn't in today, another Pharmacist suggested I take Ibprophen, Tylenol and/or Benadryl.   Ughhh.  HAd I known taking the vaccine would "CAUSE" this sort of reaction I'd have just taken my chances without it. SMH  Now what?  How long will this last?
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: GSK is the manufacturer for (Shingrix).  I went into the pharmacy 2 days ago to do a pickup and the Pharmacist gave me a slip that recommended several vaccines for people over 50.  Now, 54, I opt to get the Shingles Vaccine.  The person that administered the injection explained that I should "ONLY" experience soreness .   Day 1 - Soreness (as expected and I slept ALLLLL day).  Day 2 - still sore, but expected.  By 11pm that night, I started scratching my upper back on the left side, below the shoulder blade.  When I woke up this morning, I noticed the same area was irritated.  Upon showering, I noticed a red rash there.  I rubbed some alcohol on it and continued on with my day.  An hour later, (I'd say 9:30am), I noticed it turning really "red" and "irritating."  I took another look so I applied desonide ointment to help with the inflammation/pain.  I continued on with my day.  By 10:45am, I noticed the same pain on the left side of my neck.   WTH??   I thought I was bitten by something but I haven't left the home in 2 days so what is happening.  I feels like a thousand mosquitoes are biting me and sensitive to the touch.  WHAT THE HELL?  I've never ever experienced this before.  I called the Pharmacy to speak with pharmacist but she wasn't in today, another Pharmacist suggested I take Ibprophen, Tylenol and/or Benadryl.   Ughhh.  HAd I known taking the vaccine would "CAUSE" this sort of reaction I'd have just taken my chances without it. SMH  Now what?  How long will this last?
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pharmacy's system recommended a "second dose" of shingrix when the patient had already had two doses previously. Patient received a third dose.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Blood glucose, Fatigue, Feeling hot
Clinical narrative: Approx. 10-15 minutes following vaccination patient reported feeling hot head to toe, tired and weak. VS monitored and blood sugar checked. MD present for evaluation of patient. Patient monitored for approx 45 minutes in the clinic. Discharged to home with mother. VS stable. patient reported feeling much better and symptoms resolved.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Pt.  reports via telephone that two days after vaccine given she developed fever with right upper arm swelling, erythema and "lump". Lump persisted and she was recently seen by her PCP ae placed on an antibiotic.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: no adverse effects noted, no harm
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient came in to pharmacy on 6/12 at 12:00pm to ask about a reaction she says seems to be due to vaccine.  Her arm was red and warm to touch around where pt said injection site was.  It was also itchy.  Patient said for a few days it was just normal sore but then started getting red, warm and hurting then moving to itchy.    suggested pt see doctor incase it is somehow infected cannot guarantee pt went at this point
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient described pain and swelling in left arm that took several days to subside. patient has since fully recovered
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Pain in extremity, Pulmonary pain
Clinical narrative: I have a lot of soreness in my arm and i am having a hard time breathing it feels like shell breathing, and in my back where my lungs are it hurts a lot and is very painful.
Age: 62.0
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Inflammation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: patient presented 3 days post vaccine with an inflamed arm. the vaccine administration site was red, warm to the touch, and swelling. the affected area was roughly the size of a softball. we recommended she treat with ice, advil, and benadryl. patient states symptoms are improving from when we saw her yesterday.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head abnormal, Dyspnoea, Fatigue, Haemoglobin abnormal
Clinical narrative: Cerebral anerysm,, post exertional malaise, chronic fatigue, shortness of breath, tachycardia
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Intracranial aneurysm, Magnetic resonance imaging head abnormal, Malaise, Pulmonary function test abnormal, Red blood cell count abnormal
Clinical narrative: Cerebral anerysm,, post exertional malaise, chronic fatigue, shortness of breath, tachycardia
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Tachycardia
Clinical narrative: Cerebral anerysm,, post exertional malaise, chronic fatigue, shortness of breath, tachycardia
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Headache
Clinical narrative: Approximately 9:30 I got a terrible headache, muscles aches, dizziness, nauseous, my left arm where I received the shot was painful, and I had low energy level. My back aches the most. I felt drained and extremely fatigued. I didn't sleep because the aches and headache pain was awful. I did take a migraine Excedrin in the morning but I was very nauseous.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Sleep disorder
Clinical narrative: Approximately 9:30 I got a terrible headache, muscles aches, dizziness, nauseous, my left arm where I received the shot was painful, and I had low energy level. My back aches the most. I felt drained and extremely fatigued. I didn't sleep because the aches and headache pain was awful. I did take a migraine Excedrin in the morning but I was very nauseous.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Pharyngeal swelling
Clinical narrative: 5 minutes after vaccination, patient developed a sensation of throat swelling without signs of respiratory compromise. No other symptoms, vitals stable. Patient was monitored for 45 minutes, with complete resolution of symptoms without any additional treatment.