chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Posture abnormal, Presyncope, Vomiting
Clinical narrative: Patient wasn't feeling well the evening of the vaccine (10/07/2023) so went to bed early and didn't sleep well.  The next day (10/08/2023) she felt sick to stomach, felt overheated, head rolled back, eyes rolled back in head, white as paper, excessive sweating, other people said the patient passed out, and when they came to they threw up. She lives at a retirement community and the nurse checked her out and recommended she go to the hospital, but she decided to wait.  She saw her doctor on 10/09/2023 for a full work up and everything came back normal. She had physical therapy later in the day and still felt unwell, but the physical therapist occasionally took her pulse and blood pressure and it was normal. Doctor believes it was a vasovagal response.  She felt back to normal by the third day 10/10/2023.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pancreatic failure
Clinical narrative: She got her vaccine, nothing to speak of other than sore arm and fatigue.  She cannot pinpoint the direct date, she started with having frequency of deficating.  This persisted for months, which happened every day and every other day after eating, usually in the middle of the day.  She was not running around to the doctor as we were on lockdown, thought it was related to stress.  Towards her October of that year she went to her doctor, sent her for testing and showd that her pancreatic enzymes that were not good.  She takes pancreatic vitamins now that she will have to take the rest of her life.  Over the course of the last 2 years and things improved and tried to see what was different in her life, and decided it  was the vaccine.  She also does have a small cyst on her pancrease that is being monitored and it is not growing at this point.    She has had the other vaccines.  She now has to take the enzymes as if she does not then it may cause death.  She must take them with every meal and make sure that she has them with her at all times.    Diagnosis is Exocrine pancreatic insufficiency.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Frequent bowel movements, Magnetic resonance imaging abdominal, Pain in extremity
Clinical narrative: She got her vaccine, nothing to speak of other than sore arm and fatigue.  She cannot pinpoint the direct date, she started with having frequency of deficating.  This persisted for months, which happened every day and every other day after eating, usually in the middle of the day.  She was not running around to the doctor as we were on lockdown, thought it was related to stress.  Towards her October of that year she went to her doctor, sent her for testing and showd that her pancreatic enzymes that were not good.  She takes pancreatic vitamins now that she will have to take the rest of her life.  Over the course of the last 2 years and things improved and tried to see what was different in her life, and decided it  was the vaccine.  She also does have a small cyst on her pancrease that is being monitored and it is not growing at this point.    She has had the other vaccines.  She now has to take the enzymes as if she does not then it may cause death.  She must take them with every meal and make sure that she has them with her at all times.    Diagnosis is Exocrine pancreatic insufficiency.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatic cyst, Pancreatic enzyme replacement therapy, Pancreatic enzymes abnormal, Pancreatic failure, Stress
Clinical narrative: She got her vaccine, nothing to speak of other than sore arm and fatigue.  She cannot pinpoint the direct date, she started with having frequency of deficating.  This persisted for months, which happened every day and every other day after eating, usually in the middle of the day.  She was not running around to the doctor as we were on lockdown, thought it was related to stress.  Towards her October of that year she went to her doctor, sent her for testing and showd that her pancreatic enzymes that were not good.  She takes pancreatic vitamins now that she will have to take the rest of her life.  Over the course of the last 2 years and things improved and tried to see what was different in her life, and decided it  was the vaccine.  She also does have a small cyst on her pancrease that is being monitored and it is not growing at this point.    She has had the other vaccines.  She now has to take the enzymes as if she does not then it may cause death.  She must take them with every meal and make sure that she has them with her at all times.    Diagnosis is Exocrine pancreatic insufficiency.
Age: 35.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy
Clinical narrative: 36 weeks pregnant patient receive Arexvy; went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead; 35 year patient received Axexvy vaccine; she is experiencing a low grade fever; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Arexvy (right arm). On 10-OCT-2023, less than a day after receiving Arexvy, the patient experienced low grade fever (Verbatim: she is experiencing a low grade fever), wrong vaccine administered (Verbatim: went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead) and inappropriate age at vaccine administration (Verbatim: 35 year patient received Axexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 weeks pregnant patient receive Arexvy).  The outcome of the low grade fever was not resolved and the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the low grade fever to be related to Arexvy.     It was unknown if the company considered the low grade fever to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was a patient. The patient was 36 weeks pregnant. The patient went to the pharmacy on reporting day to received the Abrysvo vaccine since it was FDA approved for 32 to 36 weeks pregnant. The pharmacist gave her Arexvy instead. The reporter completed the consented forms for the Abrysvo and then after the pharmacist had given patient the vaccine, patient noticed that the box next to him said Arexvy. The patient was experiencing a low grade fever 99.8 degree Fahrenheit. The pharmacist was convinced it was the same thing and did not made a big deal of it. The patient was very concerned since Arexvy had not been FDA approved for pregnant women on the effects on her or her baby. The reporter consented to follow up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration.
Age: 35.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: 36 weeks pregnant patient receive Arexvy; went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead; 35 year patient received Axexvy vaccine; she is experiencing a low grade fever; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Arexvy (right arm). On 10-OCT-2023, less than a day after receiving Arexvy, the patient experienced low grade fever (Verbatim: she is experiencing a low grade fever), wrong vaccine administered (Verbatim: went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead) and inappropriate age at vaccine administration (Verbatim: 35 year patient received Axexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 weeks pregnant patient receive Arexvy).  The outcome of the low grade fever was not resolved and the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the low grade fever to be related to Arexvy.     It was unknown if the company considered the low grade fever to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was a patient. The patient was 36 weeks pregnant. The patient went to the pharmacy on reporting day to received the Abrysvo vaccine since it was FDA approved for 32 to 36 weeks pregnant. The pharmacist gave her Arexvy instead. The reporter completed the consented forms for the Abrysvo and then after the pharmacist had given patient the vaccine, patient noticed that the box next to him said Arexvy. The patient was experiencing a low grade fever 99.8 degree Fahrenheit. The pharmacist was convinced it was the same thing and did not made a big deal of it. The patient was very concerned since Arexvy had not been FDA approved for pregnant women on the effects on her or her baby. The reporter consented to follow up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration.
Age: 35.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: 36 weeks pregnant patient receive Arexvy; went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead; 35 year patient received Axexvy vaccine; she is experiencing a low grade fever; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Arexvy (right arm). On 10-OCT-2023, less than a day after receiving Arexvy, the patient experienced low grade fever (Verbatim: she is experiencing a low grade fever), wrong vaccine administered (Verbatim: went to receive Abrysvo vaccine,the pharmacist gave me Arexvy instead) and inappropriate age at vaccine administration (Verbatim: 35 year patient received Axexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 weeks pregnant patient receive Arexvy).  The outcome of the low grade fever was not resolved and the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the low grade fever to be related to Arexvy.     It was unknown if the company considered the low grade fever to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was a patient. The patient was 36 weeks pregnant. The patient went to the pharmacy on reporting day to received the Abrysvo vaccine since it was FDA approved for 32 to 36 weeks pregnant. The pharmacist gave her Arexvy instead. The reporter completed the consented forms for the Abrysvo and then after the pharmacist had given patient the vaccine, patient noticed that the box next to him said Arexvy. The patient was experiencing a low grade fever 99.8 degree Fahrenheit. The pharmacist was convinced it was the same thing and did not made a big deal of it. The patient was very concerned since Arexvy had not been FDA approved for pregnant women on the effects on her or her baby. The reporter consented to follow up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy
Clinical narrative: administration of Arexvy to a pregnant woman; 35 years old patient recieved Arexvy; administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO); This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old patient recieved Arexvy) and wrong vaccine administered (Verbatim: administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO)). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Arexvy to a pregnant woman).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-OCT-2023 The nurse reported that the administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO). The healthcare professional asked for information regarding this situation. The patient was in her 37th week of pregnancy. The reporter did not provide information about the Arexvy dose given (lot number, expiration date) nor patient initials. The 35 years old patient received Arexvy instead of the RSV vaccine from Pfizer (ABRYSVO), which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: administration of Arexvy to a pregnant woman; 35 years old patient recieved Arexvy; administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO); This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old patient recieved Arexvy) and wrong vaccine administered (Verbatim: administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO)). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Arexvy to a pregnant woman).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-OCT-2023 The nurse reported that the administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO). The healthcare professional asked for information regarding this situation. The patient was in her 37th week of pregnancy. The reporter did not provide information about the Arexvy dose given (lot number, expiration date) nor patient initials. The 35 years old patient received Arexvy instead of the RSV vaccine from Pfizer (ABRYSVO), which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: administration of Arexvy to a pregnant woman; 35 years old patient recieved Arexvy; administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO); This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old patient recieved Arexvy) and wrong vaccine administered (Verbatim: administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO)). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Arexvy to a pregnant woman).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-OCT-2023 The nurse reported that the administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO). The healthcare professional asked for information regarding this situation. The patient was in her 37th week of pregnancy. The reporter did not provide information about the Arexvy dose given (lot number, expiration date) nor patient initials. The 35 years old patient received Arexvy instead of the RSV vaccine from Pfizer (ABRYSVO), which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Have long covid since 2022 with figure and brain fog; Have long covid since 2022 with figure and brain fog;This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 31Mar2022 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; lot number EN6200), administration date: 28Feb2021, when the patient was 67-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE; lot number EP7534), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), BRAIN FOG (non-serious) all with onset 2022, outcome "not recovered" and all described as "Have long covid since 2022 with figure and brain fog".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331279 same patient, different drug, different event;
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Post-acute COVID-19 syndrome
Clinical narrative: Have long covid since 2022 with figure and brain fog; Have long covid since 2022 with figure and brain fog;This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 31Mar2022 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; lot number EN6200), administration date: 28Feb2021, when the patient was 67-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE; lot number EP7534), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), BRAIN FOG (non-serious) all with onset 2022, outcome "not recovered" and all described as "Have long covid since 2022 with figure and brain fog".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331279 same patient, different drug, different event;
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Nurse called to report VAXNEUVANCE that expired 9/30/2023 was administered today, 10/5/2023. Operator of device is an HCP/ Outbound call placed to Customer. Confirmed it was PNEUMOVAX23 not VAXNEUVANCE that was administered.; This spontaneous report was received from a nurse and refers to a 77-year-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-OCT-2023, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W019533, has been verified to be a valid lot number, expiration date was reported as 30-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used). No side effects or symptoms reported, no temperature excursion history. No additional AE/no PQC.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE case where product was administered.  10.3C for 0 hours 26 minutes 0 seconds  prior: 19.6C for 5 hours 52 minut; This spontaneous report was received from a registered nurse referring to a 3-year-old female patient. The patient's medical history historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-OCT-2023, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 5/0.5 mcrg/ml, lot#: W030076, expiration date: 11-APR-2024; dose and route of administration were not reported) administered by a health professional for prophylaxis. The vaccine administered experienced temperature excursion (TE) at 10.3C for 26 minutes (product storage error). Besides, this vaccine also had prior TE experience at 19.6C for 5 hours 52 minutes. No additional adverse events (AE) were reported (no adverse event).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraplegia
Clinical narrative: paraplegic; This spontaneous case was reported by a patient and describes the occurrence of PARAPLEGIA (paraplegic) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAPLEGIA (paraplegic) (seriousness criterion medically significant). The patient was treated with OXYGEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAPLEGIA (paraplegic) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient was a paraplegic and was on Oxygen. After vaccination the patient had a lot of problems and the doctors reported it to Moderna. No treatment medication was reported. Company comment: This spontaneous case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of PARAPLEGIA. The event was reported with no onset date; hence latency could not be properly assessed to the first or the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). She reported having had problems after vaccination and that she was on oxygen. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic failure syndrome, Injected limb mobility decreased, Local reaction, Nausea, Nervous system disorder
Clinical narrative: About 1 hour after Nausea, vomiting.  Days later a large local reaction.  Then inability to move left arm.  Progressive decline in her autonomic nervous system and now she is in a wheel chair.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheelchair user
Clinical narrative: About 1 hour after Nausea, vomiting.  Days later a large local reaction.  Then inability to move left arm.  Progressive decline in her autonomic nervous system and now she is in a wheel chair.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Partial seizures, Petit mal epilepsy
Clinical narrative: Tonic clonic seizures absence and partial onset
Age: 67.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Fatigue, Pain
Clinical narrative: fatigue, aches and pain, dizziness, but only about every other day for about two weeks now.  I had the flu shot with it.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker is reporting that unknown number of patients received improperly stored vaccines.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX ( x010534   4/11/2025); This spontaneous report was received from a health professional and referred to unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies or drug reactions/allergies were not reported.  On an unknown date, the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010534, expiration date: 11-APR-2025, lot #W022293, expiration date: 13-JUL-2024 administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). Temperature excursion occurred and it showed 11.4 degree Fahrenheit for 1 hour (product storage error). No additional adverse events were reported (no adverse event).  This case is non-valid due to unidentifiable and unquantifiable patients.  Follow-up information has been received on 17-OCT-2023. The patient's identifiers were updated. On 10-SEP-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# was reported as X012248, but upon internal validation indicated as an invalid number) administered subcutaneously (SQ) on the left thigh by a trained healthcare professional. The vaccine administered was stored in a freezer. The excursion was not reported until the following day until the staff noticed it.
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: localized reaction (rash) at and around the injection site on the upper lateral arm; This spontaneous report has been received from a nurse prescriber and refers to a female patient of unknown age.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml), administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced localized reaction (rash) at and around the injection site on the upper lateral arm (vaccination site rash).  At the time of reporting, the outcome of the event localized reaction (rash) at and around the injection site on the upper lateral arm was not provided.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a temperature excursion; no additional adverse events were reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W039294, expiration date: 11-DEC-2024; strength, dose, and route of administration were not provided) by a health professional for prophylaxis. The vaccine administered experienced temperature excursion before, which was improperly stored at 17.4F for 2 hours (product storage error). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was accidently administered an expired dose of PNEUMOVAX 23 on Oct 18, 2023. Product expired on Jul 30, 2023.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-OCT-2023, the patient was accidently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (lot#: U034712, expiration date: 30-JUL-2023, once; strength, dose, and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: pregnant patient (unknown gestation) received GSK's RSVPreF3; received GSK's RSVPreF3, adjuvanted OA vaccine rather than Abrysvo; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient (unknown gestation) received GSK's RSVPreF3 ) and wrong vaccine administered (Verbatim: received GSK's RSVPreF3, adjuvanted OA vaccine rather than Abrysvo).  The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 12-Oct-2023 Patient information was unknown.  This was reported to VAERS (unknown when).  The reporter was reporting this after learning of the error during a presentation and speaking with CDC speaker who shared that it was reported to VAERS (but not informed of specific details). The reporter did not consent to follow-up. Pregnant patient received Arexvy (GSK's RSVPreF3, adjuvanted OA vaccine) rather than Abrysvo (maternal RSV vaccine), which led to vaccine exposure during pregnancy and wrong vaccine administered.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Bladder spasm, Diarrhoea, Headache, Injection site pain, Pain
Clinical narrative: bladder spasms; one episode of diarrhea; headache; body aches; low grade fever/ fever of 101.6; injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-OCT-2023, the patient received Arexvy. On 07-OCT-2023, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site soreness) and fever (Verbatim: low grade fever/ fever of 101.6). On 08-OCT-2023, the patient experienced bladder spasm (Verbatim: bladder spasms), diarrhea (Verbatim: one episode of diarrhea), headache (Verbatim: headache) and general body pain (Verbatim: body aches).On 09-OCT-2023, the outcome of the injection site pain and fever were resolved (duration 2 days) and the outcome of the diarrhea, headache and general body pain were resolved (duration 1 day).The outcome of the bladder spasm was not resolved.   It was unknown if the reporter considered the injection site pain, bladder spasm, diarrhea, headache, general body pain and fever to be related to Arexvy.   It was unknown if the company considered the injection site pain, bladder spasm, diarrhea, headache, general body pain and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was the patient.  She received Arexvy the morning and had injection site soreness.  That evening she had a low grade fever.  The next day, she had a fever of 101.6, body aches, headache, one episode of diarrhea and bladder spasms.  All of these effects (except the bladder spasms) resolved in the morning of 9th October 2023.  The patient spoke with her doctor on 9th October 2023.  The doctor did not believe the bladder spasms were related to Arexvy.  A urinalysis was done and results were pending.  The bladder spasms continued.  Nothing else was reported. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: bladder spasms; one episode of diarrhea; headache; body aches; low grade fever/ fever of 101.6; injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-OCT-2023, the patient received Arexvy. On 07-OCT-2023, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site soreness) and fever (Verbatim: low grade fever/ fever of 101.6). On 08-OCT-2023, the patient experienced bladder spasm (Verbatim: bladder spasms), diarrhea (Verbatim: one episode of diarrhea), headache (Verbatim: headache) and general body pain (Verbatim: body aches).On 09-OCT-2023, the outcome of the injection site pain and fever were resolved (duration 2 days) and the outcome of the diarrhea, headache and general body pain were resolved (duration 1 day).The outcome of the bladder spasm was not resolved.   It was unknown if the reporter considered the injection site pain, bladder spasm, diarrhea, headache, general body pain and fever to be related to Arexvy.   It was unknown if the company considered the injection site pain, bladder spasm, diarrhea, headache, general body pain and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was the patient.  She received Arexvy the morning and had injection site soreness.  That evening she had a low grade fever.  The next day, she had a fever of 101.6, body aches, headache, one episode of diarrhea and bladder spasms.  All of these effects (except the bladder spasms) resolved in the morning of 9th October 2023.  The patient spoke with her doctor on 9th October 2023.  The doctor did not believe the bladder spasms were related to Arexvy.  A urinalysis was done and results were pending.  The bladder spasms continued.  Nothing else was reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: a patient was given an expired dose of Twinrix today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Twinrix adult. On 10-OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: a patient was given an expired dose of Twinrix today).  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: 10-Oct-2023 Pharmacist declined to provide patient's demographics because of privacy concerns. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received an expired dose of Twinrix adult, which led to expired vaccine used.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Product administered at inappropriate site, Skin warm
Clinical narrative: Patient says that she received Spikevax in the incorrect site; arm was swollen; She felt heat in the arm; there was a red mark; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), INJECTION SITE WARMTH (She felt heat in the arm), INJECTION SITE ERYTHEMA (there was a red mark) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient says that she received Spikevax in the incorrect site) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced PERIPHERAL SWELLING (arm was swollen), INJECTION SITE WARMTH (She felt heat in the arm) and INJECTION SITE ERYTHEMA (there was a red mark). On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient says that she received Spikevax in the incorrect site). In September 2023, PERIPHERAL SWELLING (arm was swollen), INJECTION SITE WARMTH (She felt heat in the arm) and INJECTION SITE ERYTHEMA (there was a red mark) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient says that she received Spikevax in the incorrect site) outcome was unknown.            Concomitant medication not reported.  Patient received Spikevax in the incorrect site. She received it in the "fatty" part of her triceps. This was her 4th or 5th dose. Her arm was swollen, hot, and there was a red mark. She felt heat in the arm. This lasted for about 5 days. With her past doses she experienced headaches and was tired.  Treatment medication not reported.   Reporter did not allow further contact
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administering an expired vaccine to a patient with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and administering an expired Hib (PRP/T) Vaccine [ACT-HIB] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received a expired dose of 0.5 ml of suspect  Hib (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 05-Oct-2023 and lot UJ801AA) via unknown route in unknown administration site as immunization (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component; patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter inquired what to do and asked if the patient should be revaccinated. The reporter reported that a patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the Arexvy adjuvant; patient received the Arexvy adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient received the Arexvy adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient received the Arexvy adjuvant).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter reported that the patient received the Arexvy adjuvant without it being reconstituted with the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any patient demographics, lot number, or expiration date to provide. The reporter consented to follow up.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administering an expired pentacel to a patient with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender, reporter reported that the an expired diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] administering  to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2023, the patient received a expired dose of 0.5 ml of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 08-Oct-2023 and lot UJ794AB) via unknown route in unknown administration site as immunization (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.  No additional information available at time of call; caller declined to respond to questions and refuses future follow-up.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. The vaccine expired on 08/07/2023 and was administered on 09/21/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 21-SEP-2023, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (valid lot #U026216 with reported expiration date: 07-AUG-2023), administered for prophylaxis (strength, dose description and route of administration were not provided) (Expired product administered). There was no additional adverse event (No adverse event).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore arm/Pain in left upper arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 02-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: sore arm/Pain in left upper arm).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that patient's upper arm was still hurting after receiving the Shingrix vaccine. The reporter consented to follow up.