chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate swellinf, redness at injection site, fever, pain in both shoulders and tenderness in both arms from shoulder to elbow.  SLight redness still is evident at site of injections (about the size of a tennis ball).  Tenderness in arms continues and placement with the arms changes throughout the day.  Pain in shoulder and at site at times requires me to take a pain reliever.  I also have weakness in both of my legs as well as my arms,  About a month after receiving the vaccine, I wen to my primary and she have me a course of antibiotics as well as a course of steriods.  Neither of these helped and I have not sought and further intervention,
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Muscular weakness, Pyrexia, Tenderness
Clinical narrative: Immediate swellinf, redness at injection site, fever, pain in both shoulders and tenderness in both arms from shoulder to elbow.  SLight redness still is evident at site of injections (about the size of a tennis ball).  Tenderness in arms continues and placement with the arms changes throughout the day.  Pain in shoulder and at site at times requires me to take a pain reliever.  I also have weakness in both of my legs as well as my arms,  About a month after receiving the vaccine, I wen to my primary and she have me a course of antibiotics as well as a course of steriods.  Neither of these helped and I have not sought and further intervention,
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blindness transient, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Acute onset of severe headache, body aches, dizziness, left arm pain/numbness, nausea 1 hour after injection. Presyncopal with acute dizziness and transient loss of vision without loss of consciousness. Patient returned to clinic where she was given oral fluids and ibuprofen, which she promptly vomited. Given IM keterolac and SL ondansetron with moderate improvement of headache and nausea; resolution of arm numbness. Released home for rest and follow up care.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Presyncope, Vomiting
Clinical narrative: Acute onset of severe headache, body aches, dizziness, left arm pain/numbness, nausea 1 hour after injection. Presyncopal with acute dizziness and transient loss of vision without loss of consciousness. Patient returned to clinic where she was given oral fluids and ibuprofen, which she promptly vomited. Given IM keterolac and SL ondansetron with moderate improvement of headache and nausea; resolution of arm numbness. Released home for rest and follow up care.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Pain, Sleep disorder
Clinical narrative: Moderate pain at injection since date of injection.  Hurts when I do aerobics and weight lifting, can't sleep on my left side anymore, too uncomfortable.  It's been 4 months now!
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Pediatric Hep B vaccine administered inadvertently instead of pneumococcal vaccine. Parent reports side effect noted from night prior was slight fever, no other adverse reactions noted.
Age: 78.0
Sex: M
Vaccine: COVID19, HEPAB, VARZOS
Symptoms: Hallucination
Clinical narrative: Hallucination on the day and the night of the vaccination.
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediatric Hep B vaccine administered inadvertently instead of PCV vaccine. Parent reports no known adverse side effects next day.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood pressure increased, Dizziness, Face injury, Fall, Lip injury
Clinical narrative: After receiving vaccine client had a vasovagal syncope response. Fell to the floor on her face, received an abrasion to her lower inner and outer lip. Treatment immediately given, elevated feet after response, given ice pack and water. Vomited up water, had blurry vision, and felt dizzy. After this happened mother stated that client had not slept the night before, woke up at noon and only had coffee to drink no food. Mother also stated that client had this type of response before to a vaccination, but she was not sure since she did not witness this. Was taken per ambulance to ER. Spoke with mother the next day, had high BP in ER, was given fluids and released home.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Syncope, Vision blurred, Vomiting
Clinical narrative: After receiving vaccine client had a vasovagal syncope response. Fell to the floor on her face, received an abrasion to her lower inner and outer lip. Treatment immediately given, elevated feet after response, given ice pack and water. Vomited up water, had blurry vision, and felt dizzy. After this happened mother stated that client had not slept the night before, woke up at noon and only had coffee to drink no food. Mother also stated that client had this type of response before to a vaccination, but she was not sure since she did not witness this. Was taken per ambulance to ER. Spoke with mother the next day, had high BP in ER, was given fluids and released home.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Neck pain
Clinical narrative: Sudden neck and chest pain
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Extra dose administered
Clinical narrative: Pt. received an extra dose of Havrix vaccine from medication error (Vaccine dates: 8/2/23; 2/2/24; 5/2/24). Pt initially had no reaction. However 2 hours later, the pt reported feeling short of breath. The pt. was monitored and treated w/ vistiril 25mg PO.  No other issues occurred after this event.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site warmth, Joint swelling, Pain, Peripheral swelling
Clinical narrative: On 6-12-2024  Patient complains of right arm swelling, pain, subjective fever, and injection site feels hot after receiving her Tetanus injection on 6/7/24.  Mentioned she also has some redness and swelling on the elbow. Her symptoms started the following day on 6/8/24. Patient denies shortness of breath or chest pain. Per Dr. patient was advised to go to same day clinic within 24 hours for evaluation. Patient reports will go to same day clinic today after work at 4 pm. Patient was advised if worsening symptoms to call EMS or  go to nearest Emergency Center for evaluation. Instructed to call ask my nurse if has any further questions or concerns. Instructed to schedule follow up appointment with PCP after evaluation at same day clinic.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: On 6-12-2024  Patient complains of right arm swelling, pain, subjective fever, and injection site feels hot after receiving her Tetanus injection on 6/7/24.  Mentioned she also has some redness and swelling on the elbow. Her symptoms started the following day on 6/8/24. Patient denies shortness of breath or chest pain. Per Dr. patient was advised to go to same day clinic within 24 hours for evaluation. Patient reports will go to same day clinic today after work at 4 pm. Patient was advised if worsening symptoms to call EMS or  go to nearest Emergency Center for evaluation. Instructed to call ask my nurse if has any further questions or concerns. Instructed to schedule follow up appointment with PCP after evaluation at same day clinic.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: The patient came in on Monday, June 11, for their 2-month well-vaccines. The following morning, the patient was brought to the ER unresponsive. CPR was performed, but the patient did not survive. The doctors do not believe the vaccine was the cause, but due to the proximity of the events, we are filing this report.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reports a tingling/numbing like sensation on arm of vaccine site that goes down her entire arm to her wrist. Reports it began about 3 days after the vaccine was administered and has remained but gotten better over time. I informed her about Guillian Barre Syndrome and how it presents which sounded like what she was experiencing. Told her she needed to inform her doctor immediately so they can evaluate her for GBS and also to not get second shingrix dose until MD completes evaluation for GBS.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 3/1/24
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Primary Care Physician ordered MMR, Pt was given MMRV.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Hemiplegia, Intensive care, Neurologic neglect syndrome
Clinical narrative: Dysphasia, Lt hemiplegia, Lt side neglect
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Nurse administered adult dose (1.0mls) of Hepatitis A vaccine into 18 month old patient during standard well-check visit (Normal dosage for this age is 0.5mls).
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Nurse administered adult dose (1.0mls) of Hepatitis A vaccine into 18 month old patient during standard well-check visit (Normal dosage for this age is 0.5mls).
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult dose hepatitis A instead of a pediatric dose hepatitis A vaccinations. Currently no observed signs, symptoms.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an adult dose hepatitis A instead of a pediatric dose hepatitis A vaccinations. Currently no observed signs, symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: The patient came to pharmacy and reported the reaction. The pharmacist on duty assessed and advised to seek urgent care. The urgent care provider confirmed it as cellulitis and prescribed clindamycin. The patient picked up.
Age: 79.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site mass
Clinical narrative: Patient called stating that he has a bump on his arm where the vaccines were administered (since 6/3)
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Illness, Lymphoedema, Peripheral swelling, Swelling
Clinical narrative: On 12/06/2024 the patient (who is an Associate) called me at a.m. and reported that from the Fluzone Prefilled 2024 vaccine she has been swelling. I looked for her record with her and she went directly through the window. This vaccine was administered on 04/04/2024 by the technician under the supervision of the pharmacist. Patient notifies me that on 04/28/2024 she left due to illness because she was swelling
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: patient was given vaccine with diluent from Merck diluent instead of the 0.4% sodium chloride that it comes with.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HPV was given too early, no adverse reaction noted. Called manufacture, Patient 2nd dose is considered invalid will need to repeat HPV vaccine dose.
Age: 4.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: There were no adverse events or outcomes. This was a wrong vaccine and wrong patient age. Patient should have been given a Dtap.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site irritation, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient came in 2 days after vaccination to report fatigue for the previous 2 days as well as a red rash and some slight swelling at the injection site.  Rash and irritation was localized to the injection site. Advised patient to take Tylenol for pain as she has an NSAID allergy and to ice the injection site.  Advised patient to call if symptoms worsen.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Patient reports numbness, tingling, and loss of movement in all of small finger and part of ring finger on the left hand. Symptoms have been present for the past 2 to 3 hours
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: The patient did not have any adverse side effects
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: FBE called to report that the HCP prescribed a 50 year old patient GARDASIL 9.; no additional AE; This spontaneous report was received from a health Care Professional via employee and referred to a 50-year-old patient with unknown gender. The subject's concurrent conditions, Concomitant therapies and medical history were not reported.  On an unknown date, health care professional (HCP) prescribed a 50 year old patient hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/ series for prophylaxis (strength, lot # and expiry date were not provided) (Product prescribing issue). It was unable to confirm if the patient was administered the product. No additional AE (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A FBE called on behalf of an HCP (not available to come one the line) reporting an AE in which the HCP stated that she (the HCP) received her first dose of GARDASIL 9 at age 21, and now the HCP is 38 years old and was wondering if she shou; No additional AE/ No PQC; This spontaneous report was received from physician and refers to a 38-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (also reported as patient age 21-years-old), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient want to known if she could continue the schedule of those vaccine after more than 1-year (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; inadvertently administering an expired dose of MMRII; This spontaneous report was received from a nurse 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 04-JUN-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot #X012185, expiration date: 03-JUN-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired product administered). No additional information provided. No additional AE/PQC reported (No adverse event).
Age: 1.0
Sex: U
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient on 05/14/2024; This spontaneous report was received from a nurse concerning a 12-month-old patient of unknown gender. The patient's medical history concurrent conditions and concomitant therapies were not reported.  The reporter called to report that the data logger in the vaccine refrigerator quit working on 08-MAR-2024 but was not realized and reset until 31-MAY-2024, which resulted in unknown temperature condition exposure to the vaccines. Then on 14-MAY-2024, a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliter (ml), injection, affected by the unknown temperature conditions, was inadvertently administered to the patient at a dose of 0.5 mL, once, lot number X019624 (lot number X019624 had been verified to be valid lot number for pneumococcal 15v conj vaccine [CRM197] [VAXNEUVANCE]), expiration date reported and confirmed as 07-NOV-2025 (route of administration and anatomical injection site were not provided) for prophylaxis (product storage error). Operator of device was a health professional.  The patient did not experience any adverse issue or side effects (no adverse event). No prior excursions reported and no other information was able to be provided during the call.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2406USA001684: US-009507513-2406USA001795: US-009507513-2406USA001818: US-009507513-2406USA001829: US-009507513-2406USA001844: US-009507513-2406USA001849: US-009507513-2406USA001859: US-009507513-2406USA001893: US-009507513-2406USA001974: US-009507513-2406USA001983: US-009507513-2406USA001987: US-009507513-2406USA002012: US-009507513-2406USA002143:
Age: 0.33
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any issues or side effects; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient on 05/03/2024.; This spontaneous report was received from a nurse concerning a 4-month-old patient of unknown gender. The patient's medical history concurrent conditions and concomitant therapies were not reported.  The reporter called to report that the data logger in the vaccine refrigerator quit working on 08-MAR-2024 but was not realized and reset (until 31-MAY-2024), which resulted in unknown temperature condition exposure to the vaccines. On 03-MAY-2024, a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliter (ml), injection, affected by the unknown temperature conditions, was inadvertently administered to the patient at a dose of 0.5 mL, once, lot number X019624 (lot number X019624 had been verified to be valid lot number for pneumococcal 15v conj vaccine [CRM197] [VAXNEUVANCE]), expiration date reported and confirmed as 07-NOV-2025 (route of administration and anatomical injection site were not provided) for prophylaxis (product storage error). Operator of device was a health professional.  The patient did not experience any adverse issue or side effects (no adverse event). No prior excursions reported and no other information was able to be provided during the call.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2406USA001816: US-009507513-2406USA001684: US-009507513-2406USA001795: US-009507513-2406USA001818: US-009507513-2406USA001844: US-009507513-2406USA001849: US-009507513-2406USA001859: US-009507513-2406USA001893: US-009507513-2406USA001974: US-009507513-2406USA001983: US-009507513-2406USA001987: US-009507513-2406USA002012: US-009507513-2406USA002143:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported an expired dose of MMRII was administered to a patient on 6/6/2024. Confirmed no other AE occurred. Case number provided. AE letter sent to customer. No other AE. No PQC.; Caller reported an expired dose of MMRII was administered to a patient on 6/6/2024. Confirmed no other AE occurred. Case number provided. AE letter sent to customer. No other AE. No PQC.; This spontaneous report was received from a registered nurse concerning to a patient of unspecified age and gender. Their medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 06-JUN-2024, the patient was vaccinated with 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) injection, lot #X005838, expiration date: 03-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used). However, it was confirmed that no other adverse events (AE) had occurred.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness 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 sickness (Verbatim: sick). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The patient self reported this case. The patient received his first dose of Shingrix 7 months ago (from the reporting date). The reporter stated the first dose of Shingrix made him sick.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: inadvertently screwed the needle on the sterile water and did not mix it; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received MMR (Priorix) (batch number x3m3d, expiry date 01-APR-2025) for prophylaxis.   On 03-JUN-2024, the patient received Priorix. On 03-JUN-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently screwed the needle on the sterile water and did not mix it) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The reporter reported that they had a new nurse who had given her client MMR, Priorix vaccine and inadvertently screwed the needle on the sterile water and did not mix it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had a question was he/she know they have to revaccinate, can they use sterile water that comes with other MMR, just regular sterile water for live vaccines. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). 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: 04-Jun-2024 The nurse reported that he or she need to find out that they had a 4 month old patient received the Kinrix vaccine, which led to inappropriate age at vaccine administration. The reporter need to find what recommendations they had for future vaccinations for this patient and anything to watch out specifically for the patient, since it was not indicated for his age group. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: accidently gave a patient an expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number DN7GL, expiry date 09-FEB-2024) and (batch number TY2TY, expiry date 09-FEB-2024) for prophylaxis.   On 04-JUN-2024, the patient received Shingrix. On 04-JUN-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: accidently gave a patient an expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The healthcare professional reported that, they accidently gave a patient an expired vaccine. The reporter called to saw the effectiveness and how long its effective after the expiration date.
Age: 14.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 01-JUN-2024, the patient received Kinrix. On 01-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age). 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: 04-JUN-2024 The physician assistant (PA) reported that patient received a Kinrix vaccine according to vaccine records. The reporter called to inquire if the dose was valid, any guidance on doses and if the dose should be repeated. Healthcare professional (HCP) explained the patient was not from the X and never had a previous Kinrix dose. The reporter was unable to provide any vaccine or patient details. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 997K5, expiry date 07-APR-2024) for prophylaxis.   On 04-JUN-2024, the patient received Boostrix. On 04-JUN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The medical assistant had a patient who inadvertently received an expired dose of Boostrix and wanted to know if they should revaccinate. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Boostrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never got the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The healthcare professional reported that he received 1st dose of Shingrix vaccine 5 year ago and never received the 2nd dose. The healthcare professional asked if he should restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: his sisters were also both affected by the vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (his sisters were also both affected by the vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (his sisters were also both affected by the vaccine.). At the time of the report, IMMUNISATION REACTION (his sisters were also both affected by the vaccine.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient had similar reaction as the reporter. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-760217 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2024: Live follow up received and updated suspect product coding.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760217:Master Case (Brother case)
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 10 of her clients now have blood clots.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "10 of her clients now have blood clots.".  Additional information: Mother mentioned that she owns a salon and 10 of her clients now have blood clots because of the Pfizer Covid Vaccine. She was blowing up big time and she feels sorry for anybody that took the vaccine especially little kids.  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-202400187507 Same reporter/drug/event, different patient.;US-PFIZER INC-202400191707 same reporter/drug/event, different patient;US-PFIZER INC-202400192005 same reporter/drug/event, different patient;US-PFIZER INC-202400192006 same reporter/drug/event, different patient;US-PFIZER INC-202400192007 same reporter/drug/event, different patient;US-PFIZER INC-202400192008 same reporter/drug/event, different patient;US-PFIZER INC-202400192009 same reporter/drug/event, different patient;US-PFIZER INC-202400192010 same reporter/drug/event, different patient;US-PFIZER INC-202400192011 same reporter/drug/event, different patient;US-PFIZER INC-202400192012 same reporter/drug/event, different patient;
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Premature labour
Clinical narrative: Preterm labor; contractions; This is a spontaneous report received from a physician from a sales representative.  An adult female patient (pregnant) received RSV vaccine prot.subunit pref 2v (ABRYSVO), on 06Dec2023 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THREATENED LABOUR (hospitalization) with onset 11Dec2023, outcome "recovered" (12Dec2023), described as "Preterm labor; contractions". No other medication given in two weeks. No other vaccine was administered within four weeks. No other vaccine was administered on the same day. The patient received Abrysvo on 06Dec2023 and started preterm labor on 11Dec2023. The patient required medication to cease her contractions. She was evaluated in the hospital and was hospitalized in Dec2023 for 1 day. Treatment to the event included IV hydration, muscle relaxer, and IV paracetamol (TYLENOL). The delivery date was at 39 (unit unspecified) gestational period (pending clarification).; Sender's Comments: The event threatened labour is conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature labour
Clinical narrative: Patient received Abrysvo 21Feb2024 and started preterm labor on 22Feb. She required medication to cease her contractions. She was evaluated in the hospital.; This is a spontaneous report received from a Physician from a sales representative.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Feb2024 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PREMATURE LABOUR (hospitalization), described as "Patient received Abrysvo 21Feb2024 and started preterm labor on 22Feb. She required medication to cease her contractions. She was evaluated in the hospital.". The patient was hospitalized for premature labour (hospitalization duration: 1 day). Therapeutic measures were taken as a result of premature labour. Additional information: Gestational period: 39. The patient did not receive other vaccines on same date and in four weeks. The patient did not receive other medications in two weeks. Treatment included IV fluids, IV Tylenol, narcotics.; Sender's Comments: The event premature labour is conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "recovered" (Jun2024) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2024) Negative, notes: Tested negative after having covid and paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 27May2024 to 01Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Feb2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gloucoma" (unspecified if ongoing); "heart/ hole L ventricle" (unspecified if ongoing); "Tinnitus /both ears" (unspecified if ongoing); "IBS" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 6,Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 5,Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 4,Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid from 31May2024 to 05Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: Patient experienced a rash at the injection site 10 days after being vaccinated with Prevnar 20.; This is a spontaneous report received from an Other HCP from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Patient experienced a rash at the injection site 10 days after being vaccinated with Prevnar 20.". Therapeutic measures were taken as a result of vaccination site rash. Additional information: Benadryl was given for rash No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2021 as dose 1, single (Lot number: EW0202) and on 16Sep2021 as dose 2, single (Lot number: 30145BA) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "ASD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Chronic idopathic constipation via slow transit" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Reglan, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29May2024 to 03Jun2024.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 30May2024 to 04Jun2024.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 10 of her clients now have blood clots.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "10 of her clients now have blood clots.".  Additional information: Mother mentioned that she owns a salon and 10 of her clients now have blood clots because of the Pfizer Covid Vaccine. She was blowing up big time and she feels sorry for anybody that took the vaccine especially little kids.  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-202400187516 same reporter/drug/event, different patient;US-PFIZER INC-202400187507 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 10 of her clients now have blood clots.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "10 of her clients now have blood clots.".  Additional information: Mother mentioned that she owns a salon and 10 of her clients now have blood clots because of the Pfizer Covid Vaccine. She was blowing up big time and she feels sorry for anybody that took the vaccine especially little kids.  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-202400187516 same reporter/drug/event, different patient;US-PFIZER INC-202400187507 Same reporter/drug/event, different patient.;US-PFIZER INC-202400187516 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 10 of her clients now have blood clots.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "10 of her clients now have blood clots.".  Additional information: Mother mentioned that she owns a salon and 10 of her clients now have blood clots because of the Pfizer Covid Vaccine. She was blowing up big time and she feels sorry for anybody that took the vaccine especially little kids.  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-202400187516 same reporter/drug/event, different patient;US-PFIZER INC-202400187507 same reporter/drug/event, different patient;US-PFIZER INC-202400187516 same reporter/drug/event, different patient;
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a dose of IPOL that was two days past expiration with no reported adverse event; Initial information received on 03-Jun-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 4-month-old male patient who was administered a dose of IPV (VERO) [IPOL] that was two days past expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (TET TOX) (Acthib) for Prophylactic vaccination.  On 03-Jun-2024, the patient received a 0.5 ml total dose of suspect IPV (VERO), Suspension for injection (strength: unknown) (lot: V1B891M, expiry date: 01-Jun-2024) via intramuscular route in unknown administration site as immunization and administered a dose of ipol that was two days past expiration with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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.