chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Injection site pain
Clinical narrative: injection site itch; injection site swelling; injection site pain; gastrointestinal symptoms; fever; shivering; fatigue; myalgia; interrupted sleep; headache; the vaccine hit her like a truck; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thyroid disorder and gastric disorder. Concomitant products included omeprazole magnesium (Omeprazole) and levothyroxine sodium (Levothyroxine).   On 24-JUL-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site itching (Verbatim: injection site itch), injection site swelling (Verbatim: injection site swelling), injection site pain (Verbatim: injection site pain), gastrointestinal symptom nos (Verbatim: gastrointestinal symptoms), fever (Verbatim: fever), shivering (Verbatim: shivering), fatigue (Verbatim: fatigue), myalgia (Verbatim: myalgia), sleep disturbance (Verbatim: interrupted sleep), headache (Verbatim: headache) and feeling abnormal (Verbatim: the vaccine hit her like a truck). The outcome of the injection site itching was not resolved and the outcome of the injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal were resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-NOV-2024 The reporter stated that she received Shingrix in her left arm.  The patient concomitant medication included as vitamins (unknown name). The reporter stated that at the injection site she had swelling (size of a charcoal Briquette that encompasses a 4 x 4 area in size), injection site itch, injection site pain, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms. The reporter stated that the itch was so severe it interrupted her sleep.  The reporter stated that the vaccine hit her like a truck.  The reporter stated that all adverse reactions resolved approximately one month later except injection site itch.  She was examined by a dermatologist and given a cream to put on the area (unknown name of cream).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: injection site itch; injection site swelling; injection site pain; gastrointestinal symptoms; fever; shivering; fatigue; myalgia; interrupted sleep; headache; the vaccine hit her like a truck; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thyroid disorder and gastric disorder. Concomitant products included omeprazole magnesium (Omeprazole) and levothyroxine sodium (Levothyroxine).   On 24-JUL-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site itching (Verbatim: injection site itch), injection site swelling (Verbatim: injection site swelling), injection site pain (Verbatim: injection site pain), gastrointestinal symptom nos (Verbatim: gastrointestinal symptoms), fever (Verbatim: fever), shivering (Verbatim: shivering), fatigue (Verbatim: fatigue), myalgia (Verbatim: myalgia), sleep disturbance (Verbatim: interrupted sleep), headache (Verbatim: headache) and feeling abnormal (Verbatim: the vaccine hit her like a truck). The outcome of the injection site itching was not resolved and the outcome of the injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal were resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site swelling, injection site pain, gastrointestinal symptom nos, fever, shivering, fatigue, myalgia, sleep disturbance, headache and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-NOV-2024 The reporter stated that she received Shingrix in her left arm.  The patient concomitant medication included as vitamins (unknown name). The reporter stated that at the injection site she had swelling (size of a charcoal Briquette that encompasses a 4 x 4 area in size), injection site itch, injection site pain, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms. The reporter stated that the itch was so severe it interrupted her sleep.  The reporter stated that the vaccine hit her like a truck.  The reporter stated that all adverse reactions resolved approximately one month later except injection site itch.  She was examined by a dermatologist and given a cream to put on the area (unknown name of cream).
Sex: F
Vaccine: FLU3, UNK
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema; hives on the face and back; This serious case was reported by a consumer via call center representative and described the occurrence of angioedema in a 36-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 2 hrs after receiving Fluarix 2024-2025 season, the patient experienced angioedema (Verbatim: angioedema) (serious criteria GSK medically significant) and hives (Verbatim: hives on the face and back). The outcome of the angioedema and hives were unknown.   It was unknown if the reporter considered the angioedema and hives to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the angioedema to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the hives to be related to Fluarix 2024-2025 season and Fluarix 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: 20-NOV-2024 The patient self-reported this case of herself. The patient reported that 2 hours after receiving Fluarix, she developed angioedema and hives on the face and back.; Sender's Comments: Angioedema  is a listed event which is considered related to GSK vaccine  Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Food refusal, Gait disturbance, Pyrexia, Seizure
Clinical narrative: Provider stated if he is not eating or drinking anything he needs to go to the ER for labs and evaluation. Mom was called back on 09/23/2024 and mom stated that in the last hour, son had decided to eat,  drink, and is now running around.  On 09/23/2024 our office received a medical record release from the Coroner's Office  stating the patient is DECEASED and they need medical records including immunization records and patient medical history.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Decreased appetite
Clinical narrative: Provider stated if he is not eating or drinking anything he needs to go to the ER for labs and evaluation. Mom was called back on 09/23/2024 and mom stated that in the last hour, son had decided to eat,  drink, and is now running around.  On 09/23/2024 our office received a medical record release from the Coroner's Office  stating the patient is DECEASED and they need medical records including immunization records and patient medical history.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no patient symptoms have been reported. No additional AE/no PQC reported.; a patient was inadvertently administered a 3rd dose of VAQTA on 11/27/2024. Caller stated the patient had received their 1st dose of VAQTA on 11/15/2021 and their 2nd dose on 5/17/2022.; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 15-NOV-2021 and 17-MAY-2022, the patient was vaccinated with the first and second dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 17-NOV-2024, the patient was inadvertently administered the 3rd dose of pediatric formulation Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (lot#: Y011643, expiration date: 25-OCT-2025; strength, dose, and route of administration were not reported) for prophylaxis (extra dose administered). No patient symptoms were reported. No additional adverse events were reported (no adverse event).  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like pain/sensations; This non-serious case was reported by a consumer and described the occurrence of flu-like aching in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced flu-like aching (Verbatim: flu-like pain/sensations). The outcome of the flu-like aching was not reported.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.     It was unknown if the company considered the flu-like aching to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter stated that she met a doctor aged 70 plus who said he had been vaccinated himself and experienced flu-like pain and sensations. The doctor do not wish to provide further details.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Vaccine positive rechallenge, Vomiting
Clinical narrative: double the aches/pains; vomiting; sickest she has ever been in 82 years; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number LD3N8) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 05-NOV-2019, for tolerance of 1st dose of Shingrix, refer case US2024AMR144860).   On 24-FEB-2020, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: double the aches/pains), sickness (Verbatim: sickest she has ever been in 82 years) and vomiting (Verbatim: vomiting). Rechallenge with Shingrix was positive. The outcome of the pain and vomiting were not reported and the outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the pain, sickness and vomiting to be related to Shingrix.     It was unknown if the company considered the pain, sickness and vomiting to be related to Shingrix.   Linked case(s) involving the same patient:US2024135630, US2024AMR144860   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient reported that she received the Shingrix and had a really bad reaction to Shingrix vaccines. The patient reported that she was the sickest she had ever been in 82 years after receiving both the first and second dose of Shingrix. The patient reported that she had double the aches, pains, vomiting, and length of time sick after both the first and second dose of Shingrix, as compared to how she felt after receiving Arexvy. The patient reported that she was sick for 3 full days/72 hours after both doses of Shingrix. This case was linked with US2024AMR144860 and US2024135630, reported by the same reporter , for a same patient.; Sender's Comments:  US-GSK-US2024135630:same reporter US-GSK-US2024AMR144860:same reporter
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who was 49 years old with no immunocompromising conditions received shingrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old 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 inappropriate age at vaccine administration (Verbatim: patient who was 49 years old with no immunocompromising conditions received shingrix first dose). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024 The pharmacist reported that he administered the first Shingrix dose to a patient who was 49 years old with no immunocompromised conditions, which led to inappropriate age at vaccine administration. The indication was patients older than 50 if no immunocompromised condition which led to inappropriate age at vaccine administration. He said he had no vaccine or patient details as he was not in the pharmacy at that time.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Overdose; 14 year of patient was accidentally given an adult dose of HAVRIX; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 15-year-old male patient who received HAV (Havrix adult) (batch number hr4rb, expiry date 18-DEC-2025) for prophylaxis.   On 04-NOV-2024, the patient received Havrix adult. On 04-NOV-2024, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: 14 year of patient was accidentally given an adult dose of HAVRIX). The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024 The pharmacist reported that a patient was accidentally given an adult dose of Havrix, which lead to accidental overdose and adult product administered to child.  The pharmacist intercepted a medication error on 30-Oct-2024 when he almost gave a second adult dose.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: 7 months old, they received a Kinrix vaccine, instead of a Pediarix; 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 female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 30-OCT-2024, the patient received Kinrix. On 30-OCT-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 7 months old, they received a Kinrix vaccine, instead of a Pediarix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter had a patient that was 7 months old, they received a Kinrix vaccine, instead of a Pediarix which led to wrong vaccine administered. The reporter needed to know if that was okay, because the Kinrix was for 4 to 6 years old. HCP mentioned to 2nd line agent, that Kinrix was the patient's 3rd dose of DTaP and 3rd dose of IPV. Also, the HCP rejected to save their personal information, however, she agreed to follow up from safety team.
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: 12 months old  received only the diluent of HIBERIX during administration; Inappropriate dose of vaccine administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 12-month-old female patient who received Hib (Hiberix) (batch number 5L527, expiry date 16-MAR-2026) for prophylaxis.   On 10-OCT-2024, the patient received Hiberix. On 10-OCT-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: 12 months old  received only the diluent of HIBERIX during administration) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-OCT-2024 Reporter reported that a female infant 12 months old received only the diluent of Hiberix during Administration. The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  This case had been linked with US2024135618, US2024135616 reported by the same reporter, same product, different patient.; Sender's Comments:  US-GSK-US2024135618:Same reporter/Different patient US-GSK-US2024135616:Same reporter/Different patient
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: scheduled to get Bexsero vaccine; scheduled to get Bexsero vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 72-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced circumstance or information capable of leading to medication error (Verbatim: scheduled to get Bexsero vaccine) and inappropriate age at vaccine administration (Verbatim: scheduled to get Bexsero vaccine). The outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter stated was scheduled to get Bexsero vaccine as she had spleen removed which was the reason why the vaccine had been prescribed which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2024, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at the injection site). The outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2024 HCP reported that a patient received Shingrix on September 5, 2 months later the patient developed redness at the injection site.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 9-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 495MK, expiry date 30-JUN-2025) for prophylaxis.   On 26-SEP-2024, the patient received FluLaval Quadrivalent 2024-2025 season (subcutaneous). On 26-SEP-2024, an unknown time after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Subcutaneous administration). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024 A patient received FluLaval subcutaneously which led to intramuscular formulation administered by other route. The case is linked with US2024136185, same reporter.; Sender's Comments:  US-GSK-US2024136185:Same reporter/Different patinet
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: arm  pain; stomach ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In OCT-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm  pain) and stomach pain (Verbatim: stomach ache). The outcome of the pain in arm and stomach pain were not resolved.   It was unknown if the reporter considered the pain in arm and stomach pain to be related to Shingrix.     It was unknown if the company considered the pain in arm and stomach pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-NOV-2024 Consumer stated that she received her second dose of Shingrix about 2 and 1/2 weeks ago in her left arm. Consumer stated she had a stomach ache and arm pain that has not resolved. Consumer stated that once she spit up in her mouth and swallowed it instead of spitting out.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix was administered instead Tdap; 11 year old patient was given Pediarix; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 01-NOV-2024, the patient received Pediarix. On an unknown date, the patient received Tdap Vaccine. On 01-NOV-2024, an unknown time after receiving Pediarix and not applicable after receiving Tdap Vaccine, the patient experienced wrong vaccine administered (Verbatim: Pediarix was administered instead Tdap) and inappropriate age at vaccine administration (Verbatim: 11 year old patient was given Pediarix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-NOV-2024 The reporter reported that she ordered Tdap for an 11 year old patient, but Pediarix was administered instead which led to, wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose of Pediarix was given to a female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 08-MAY-2022) for prophylaxis.   On 07-JUN-2022, the patient received the 4th dose of Pediarix. On 07-JUN-2022, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: expired dose of Pediarix was given to a female patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024 Pharmacist stated that an expired dose of Pediarix was given to a female patient as dose 4 in the series, and it was administered 3 months after the third dose, which reporter stated was too soon. Pharmacist declined permission to capture her contact details in the database, but she does gave safety permission to follow up via email.  Patient initials were not available at the time of the call, and no further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix (intramuscular, unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2024 The reporter was the patient, a currently 71-year-old female. About four years ago, she received her first Shingrix dose. For unknown reasons, she has not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deafness
Clinical narrative: COVID-19; Experiencing degenerative Inner ear hearing loss; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (Experiencing degenerative Inner ear hearing loss) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 027B27A and 032m20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     null Patient was diagnosed with Covid 19.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2022, the patient experienced DEAFNESS (Experiencing degenerative Inner ear hearing loss) (seriousness criterion medically significant). On 10-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, DEAFNESS (Experiencing degenerative Inner ear hearing loss) had not resolved and COVID-19 (COVID-19) outcome was unknown.      Company comment: This spontaneous case concerns a 47-year-old female patient who experienced serious (due to medically significant) unexpected event of Deafness. The event is assessed as related to vaccination due to close temporal association. The patient also experienced non  serious event of COVID-19. The benefit-risk relationship of product is not affected by this report.       Patient degenerative Inner ear hearing loss got worsen in 2024. No concomitant and treatment medication were provided.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of FLUZONE HD was inadvertently administered  with no reported adverse event; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 79 years old and unknown gender patient who received an extra dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] was inadvertently administered  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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation.  On an unknown date, the patient received a  dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) Frequency: Once, lot UT84548A, Expiry date, strength was unknown via intramuscular route in the left deltoid for Immunization and an extra dose of fluzone hd was inadvertently administered  with no reported adverse event (extra dose administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to use of the product twice during the flu season."  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: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: given expired dose of DAPTACEL, with no adverse event reported; Initial information received on 21-Nov-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case was linked with US-SA-2024SA349831.  This case involves a 5 years old female patient who was given expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel], with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Nov-2024, the patient received 0.5 ml expired dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength- standard) Suspension for injection (lot- 2CA28C1 and expiry date- 04-NOV-2024) via intramuscular route in the right thigh for Immunisation with no adverse event reported (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.; Sender's Comments:  US-SA-2024SA349831:
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous has been downloaded from Regulatory Authority and referred to a male patient aged 15-19 years old. Vaccination history: Vaccine/s given. The patient's concurrent conditions, concomitant therapies and historical conditions were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, total vaccinations:1, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13),  total vaccinations:3, administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date in 2023, the patient experienced Pneumococcal infection. On an unknown date in 2023, Streptococcus pneumoniae serotyping not available. At the time of reporting, the outcome of Pneumococcal infection was not known. The action taken with suspect vaccines was not applicable. The causal relationship of Pneumococcal infection regarding pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event of Pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from Regulatory Authority on 25-NOV-2024, and referred to a 70-74-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, total 1 dose administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced Streptococcus pneumoniae pneumonia. Streptococcus pneumoniae serotyping was Not available. The outcome of the event was not reported.  The causal relationship was not reported.  Upon internal review, the event Pneumonia pneumococcal was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Eye infection, Herpes zoster, Pain, Pruritus, Shoulder operation
Clinical narrative: eye infection; Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced eye infection (Verbatim: eye infection). The outcome of the shingles and eye infection were not reported.   It was unknown if the reporter considered the shingles and eye infection to be related to Shingles vaccine.     It was unknown if the company considered the shingles and eye infection to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-NOV-2024 This case was reported by a patient via interactive digital media.  Patient had a right shoulder surgery three weeks ago and finally went to his/her primary doctor a week ago from the time of reporting and found out the itching and stabbing pain was shingles and also had the vaccine. The medication was helping but also developed a eye infection in the middle of all this but the shingles were not in my eye luckily. Patients doctor said that he/she was fortunately having a lighter case of it.  Consumer mentioned he/she will get the second vaccine. Surgery's can cause this he was told.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Blood glucose, Blood glucose decreased, Blood pressure measurement, Dizziness
Clinical narrative: Balance disorder; blood glucose decreased; Dizziness; wheelchair user; Lethargy; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious Courtesy case received from a consumer/non-health care professional.  This case involves a 78 years old male patient who had balance disorder, blood glucose decreased, dizziness, lethargy and wheelchair user after receiving Novavax COVID-19 Vaccine(COVID-19 vaccine prot. subunit (NVX CoV 2373)) and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe)  lot LM2211, strength was unknown via intramuscular route in unknown administration site for Prophylactic vaccination (Immunization) and also received a  dose of suspect Novavax COVID-19 Vaccine Injection of strength 0.5 ml not produced by Sanofi Pasteur lot T8470DA via intramuscular route in unknown administration site for COVID-19 Immunization (expiry date was unknown for both the suspects).  On 04-OCT-2024 the patient developed balance disorder, dizziness, lethargy and wheelchair user (latency : same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Novavax COVID-19 Vaccine. Relevant laboratory test results included: Blood glucose - On 04-Oct-2024:  [136 (units unknown)] Blood pressure measurement - On 04-Oct-2024:  [BP dropped to 56/41]  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (Balance disorder, Lethargy, wheelchair user, blood glucose decreased, Dizziness).  At time of reporting, the outcome was Unknown for all the events.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Lethargy, Wheelchair user
Clinical narrative: Balance disorder; blood glucose decreased; Dizziness; wheelchair user; Lethargy; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious Courtesy case received from a consumer/non-health care professional.  This case involves a 78 years old male patient who had balance disorder, blood glucose decreased, dizziness, lethargy and wheelchair user after receiving Novavax COVID-19 Vaccine(COVID-19 vaccine prot. subunit (NVX CoV 2373)) and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe)  lot LM2211, strength was unknown via intramuscular route in unknown administration site for Prophylactic vaccination (Immunization) and also received a  dose of suspect Novavax COVID-19 Vaccine Injection of strength 0.5 ml not produced by Sanofi Pasteur lot T8470DA via intramuscular route in unknown administration site for COVID-19 Immunization (expiry date was unknown for both the suspects).  On 04-OCT-2024 the patient developed balance disorder, dizziness, lethargy and wheelchair user (latency : same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Novavax COVID-19 Vaccine. Relevant laboratory test results included: Blood glucose - On 04-Oct-2024:  [136 (units unknown)] Blood pressure measurement - On 04-Oct-2024:  [BP dropped to 56/41]  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (Balance disorder, Lethargy, wheelchair user, blood glucose decreased, Dizziness).  At time of reporting, the outcome was Unknown for all the events.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Started itching after about 15minutes and hives noted to face. They took Benadryl and Pepcid at home and symptoms resolved after about 2hours
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Mother reported in phone call related to pending lab testing that 3 months previously when patient received Menveo vaccine she developed severe swelling at the vaccination site that took several days to resolve with no medical intervention/visit (Picture attached)
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Aphasia, Asthenia, Blood test, Cerebrovascular accident, Cluster headache
Clinical narrative: on 10/25/24 I had a Covid and a flu shot at the same time, at pharmacy. I woke the next morning feeling fine, but within an hour (10:00 AM) I began to feel very ill and weak. I did not loose consciousness, but did collapse. Within a few minutes I lost the ability to speak an write, followed by a difficult understanding spoken language.  I texted gibberish to a friend who understood that I was in trouble. She called 911 and I was quickly taken to the hospital. The likely cause was a stroke. All the appropriate testing was done, but there was no conclusive evidence. I went home on the 27th, only to return in the same way. I told this happened 4 times. The last two were dealt with at home. I saw my PCP, Neurologist & Cardiologist. All of whom are unaware what caused these events. Either a TIA or a cluster migraine. I've had several TIA's in past years, but never like this. I've never had a migraine before. I have had the flu shot many times, and I've had all the Covid vaccines available, but this was the first time together.  I was advised by the pharmacist to contact you.  Admitted 2 x to hospital.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Computerised tomogram, Dysgraphia, Echocardiogram, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: on 10/25/24 I had a Covid and a flu shot at the same time, at pharmacy. I woke the next morning feeling fine, but within an hour (10:00 AM) I began to feel very ill and weak. I did not loose consciousness, but did collapse. Within a few minutes I lost the ability to speak an write, followed by a difficult understanding spoken language.  I texted gibberish to a friend who understood that I was in trouble. She called 911 and I was quickly taken to the hospital. The likely cause was a stroke. All the appropriate testing was done, but there was no conclusive evidence. I went home on the 27th, only to return in the same way. I told this happened 4 times. The last two were dealt with at home. I saw my PCP, Neurologist & Cardiologist. All of whom are unaware what caused these events. Either a TIA or a cluster migraine. I've had several TIA's in past years, but never like this. I've never had a migraine before. I have had the flu shot many times, and I've had all the Covid vaccines available, but this was the first time together.  I was advised by the pharmacist to contact you.  Admitted 2 x to hospital.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise, Retinogram, Syncope, Transient ischaemic attack
Clinical narrative: on 10/25/24 I had a Covid and a flu shot at the same time, at pharmacy. I woke the next morning feeling fine, but within an hour (10:00 AM) I began to feel very ill and weak. I did not loose consciousness, but did collapse. Within a few minutes I lost the ability to speak an write, followed by a difficult understanding spoken language.  I texted gibberish to a friend who understood that I was in trouble. She called 911 and I was quickly taken to the hospital. The likely cause was a stroke. All the appropriate testing was done, but there was no conclusive evidence. I went home on the 27th, only to return in the same way. I told this happened 4 times. The last two were dealt with at home. I saw my PCP, Neurologist & Cardiologist. All of whom are unaware what caused these events. Either a TIA or a cluster migraine. I've had several TIA's in past years, but never like this. I've never had a migraine before. I have had the flu shot many times, and I've had all the Covid vaccines available, but this was the first time together.  I was advised by the pharmacist to contact you.  Admitted 2 x to hospital.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Large local inflammation reaction present measuring 2in x 3in at site of Flucelvax injection 48hrs prior. Area is warm, pink, itchy, but not tender. Area outlined to monitor for spread. Benadryl 37.5 mg given.
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness
Clinical narrative: The patient felt dizzy and lightheaded after receiving the flu and covid shots. The patient was advised to lie down in a supine position. She felt better after a few minutes. I contacted her father the next day and everything was progressing normally. B. Pressure - average - 100/79 HR normal 11/15/24.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority referring to a female (age: 35-39) patient. The patient's medical history, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with 1 dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) (formulation, indication, strength, dose, route of administration, lot#, and expiration date were not reported).  On an unknown date in 2023, the patient developed Pneumonia (Pneumonia pneumococcal). On an unknown date in 2023, the patient's streptococcus pneumoniae serotyping was reported as not available. At the time of reporting, the outcome of the event was unknown. The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.   Upon internal review, the event of Pneumonia pneumococcal was determined to be medically significant.  Additional information is not expected.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Infectious pleural effusion; This spontaneous report has been downloaded from regulatory authority.  This report concerns a male child patient aged 5 to 9 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates , the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided) and with 3 doses of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  In 2023, the patient experienced Streptococcus pneumoniae pneumonia, and Infectious pleural effusion. Streptococcus pneumoniae serotyping was Not available. At the time of reporting, the outcome of the events was unknown. No causality assessment was provided    Upon internal review, the events Infectious pleural effusion and Streptococcus pneumoniae pneumonia were determined to be medically significant.