chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, General physical health deterioration, Glassy eyes, Head injury
Clinical narrative: He got his vaccine, he usually walks up to 3 miles a day and after 1 ½ miles he turned around, when he got back at the end of the walk he could see the end point and could not stop his legs, was glassy eyed and fell down to try and stop himself and he fell and bumped his head.  A couple of days later he called and saw his doctor, he had 2 MRI's, 2 EKG's and some other tests through a program he went through.  He was confirmed to have a light stroke.  He has slowly declined and used to be able to use a cane, but now has to use a walker.  He no longer drives as he cannot see, and he sold his truck.  He did call Pfizer and they sent him some papers to fille out, which he did and they continued to send him paperwork, which he did not fill out.  He continues to see a neurologist, and sees one every 6 months, and has slowly used the loss of his legs and has neuropathy really bad, and asked for something to ease his pain.  He had a bleeding ulcer in the past and is unable to take antiinflammatories but is going to prescribe Gabapentin.   He has fallen a couple of times and fallen and had to go to the ER.  He had a very light case of neuropathy prior to the vaccine, and it has now tripled since then.  He is no longer to walk very much.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Magnetic resonance imaging, Musculoskeletal disorder, Neuropathy peripheral, Pain
Clinical narrative: He got his vaccine, he usually walks up to 3 miles a day and after 1 ½ miles he turned around, when he got back at the end of the walk he could see the end point and could not stop his legs, was glassy eyed and fell down to try and stop himself and he fell and bumped his head.  A couple of days later he called and saw his doctor, he had 2 MRI's, 2 EKG's and some other tests through a program he went through.  He was confirmed to have a light stroke.  He has slowly declined and used to be able to use a cane, but now has to use a walker.  He no longer drives as he cannot see, and he sold his truck.  He did call Pfizer and they sent him some papers to fille out, which he did and they continued to send him paperwork, which he did not fill out.  He continues to see a neurologist, and sees one every 6 months, and has slowly used the loss of his legs and has neuropathy really bad, and asked for something to ease his pain.  He had a bleeding ulcer in the past and is unable to take antiinflammatories but is going to prescribe Gabapentin.   He has fallen a couple of times and fallen and had to go to the ER.  He had a very light case of neuropathy prior to the vaccine, and it has now tripled since then.  He is no longer to walk very much.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Walking aid user
Clinical narrative: He got his vaccine, he usually walks up to 3 miles a day and after 1 ½ miles he turned around, when he got back at the end of the walk he could see the end point and could not stop his legs, was glassy eyed and fell down to try and stop himself and he fell and bumped his head.  A couple of days later he called and saw his doctor, he had 2 MRI's, 2 EKG's and some other tests through a program he went through.  He was confirmed to have a light stroke.  He has slowly declined and used to be able to use a cane, but now has to use a walker.  He no longer drives as he cannot see, and he sold his truck.  He did call Pfizer and they sent him some papers to fille out, which he did and they continued to send him paperwork, which he did not fill out.  He continues to see a neurologist, and sees one every 6 months, and has slowly used the loss of his legs and has neuropathy really bad, and asked for something to ease his pain.  He had a bleeding ulcer in the past and is unable to take antiinflammatories but is going to prescribe Gabapentin.   He has fallen a couple of times and fallen and had to go to the ER.  He had a very light case of neuropathy prior to the vaccine, and it has now tripled since then.  He is no longer to walk very much.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MENB, RV5, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: It was not prescribed by a healthcare professional/It was in a vaccine error/Prevnar 20 was ordered, the provider ordered Prevnar 20; Trumenba given to a 4 month old; administered Trumenba has experienced a series of vomiting.; This is a spontaneous report received from an Other HCP and Consumer or other non HCPs from medical information team and a sales representative.  A 4-month-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 29Apr2024 at 09:30 as dose 1, 0.5 ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 4 months intramuscular for immunisation. The patient didn't receive pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), described as "It was not prescribed by a healthcare professional/It was in a vaccine error/Prevnar 20 was ordered, the provider ordered Prevnar 20"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), described as "Trumenba given to a 4 month old"; VOMITING (non-serious), described as "administered Trumenba has experienced a series of vomiting.". Additional information: The reporter called to find out any possible effects of Trumenba, which was administered to a 4-month-old (later clarified as 4 months 2 Days) and supposedly Trumenba should given to 10 years and up. It was then reported that Trumenba was not prescribed by a healthcare processional. It was a vaccine error. Prevnar 20 was ordered, the provider ordered Prevnar 20. On 01May2024, Caller reported that Trumenba was administered to a four month old baby and that the baby has experienced a series of vomiting.   Follow-up (01May2024): This is a spontaneous follow-up report received from a consumer. This consumer reported for a patient that: Updated information: added new reporters and series of vomiting was added as event; drug use for unapproved population was updated to Drug administered to patient of inappropriate age
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MENB, RV5, MENB
Symptoms: Product administered to patient of inappropriate age, Vomiting, Wrong product administered
Clinical narrative: It was not prescribed by a healthcare professional/It was in a vaccine error/Prevnar 20 was ordered, the provider ordered Prevnar 20; Trumenba given to a 4 month old; administered Trumenba has experienced a series of vomiting.; This is a spontaneous report received from an Other HCP and Consumer or other non HCPs from medical information team and a sales representative.  A 4-month-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 29Apr2024 at 09:30 as dose 1, 0.5 ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 4 months intramuscular for immunisation. The patient didn't receive pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), described as "It was not prescribed by a healthcare professional/It was in a vaccine error/Prevnar 20 was ordered, the provider ordered Prevnar 20"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), described as "Trumenba given to a 4 month old"; VOMITING (non-serious), described as "administered Trumenba has experienced a series of vomiting.". Additional information: The reporter called to find out any possible effects of Trumenba, which was administered to a 4-month-old (later clarified as 4 months 2 Days) and supposedly Trumenba should given to 10 years and up. It was then reported that Trumenba was not prescribed by a healthcare processional. It was a vaccine error. Prevnar 20 was ordered, the provider ordered Prevnar 20. On 01May2024, Caller reported that Trumenba was administered to a four month old baby and that the baby has experienced a series of vomiting.   Follow-up (01May2024): This is a spontaneous follow-up report received from a consumer. This consumer reported for a patient that: Updated information: added new reporters and series of vomiting was added as event; drug use for unapproved population was updated to Drug administered to patient of inappropriate age
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: started having trouble with the heart; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "trouble with heart". The following information was reported: CARDIAC DISORDER (medically significant) with onset Nov2023, outcome "unknown", described as "started having trouble with the heart". The event "started having trouble with the heart" required emergency room visit. The patient reported that in the last six months they have been at the emergency room more than seven times. Also reported taken the Pfizer Covid-19 vaccine twice.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400057903 same patient, drug and event, different dose;
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 4/30/2024; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history, and concomitant therapies were not provided.  On 30-APR-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml/dose, lot #X017490, expiration date: 25-JUN-2025, administered for prophylaxis (strength, frequency, route of administration, and anatomical location were not provided).  The vaccine was stored at a temperature of 14 degrees Fahrenheit up to 46 F (18.5 F) for a duration of 168 hours. There was no prior temperature excursion.  No additional adverse events.  This is one of several cases from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported ROTATEQ was administered after a temperature excursion to patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-APR-2024, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968392, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 24-MAY-2024 (strength and exact dose were not provided), administered orally for prophylaxis. The temperature excursion was reported as 32.9 grades Fahrenheit (°F), with a time frame of 3 hours 18 minutes (product storage error). No previous temperature excursion was reported. No further information provided and no additional adverse event (AE) reported (no adverse event)
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; ROTATEQ was administered after a temperature excursion to patient.; This spontaneous report has been received from a medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.    On 10-APR-2024, the patient was vaccinated with an improperly stored first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Oral liquid, lot number 1968392 with expiration date 24-MAY-2024, that has been verified to be valid, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   On an unknown date, the vaccine had a temperature excursion of 32.9 gradeds Farenheit, for a time frame of 3 hours 18 minutes. No additional adverse events or product quality complaint were reported. No previous temperature excursion reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ was administered after a temperature excursion to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-APR-2024, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dosage form, lot #1968386, expiration date: 23-MAY-2024, administered orally for prophylaxis (strength and vaccination scheme were not provided).  The storage characteristics were the following:  Temperature: 32.9 F Time frame: 3 hours 18 minutes Previous temperature excursion? No.  No additional adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pneumonia, Sinusitis, Tonsillitis, Toothache
Clinical narrative: a lung infection; tonsillitis; Sinusitis; bronchitis; mononucleosis; rhinopharyngitis; Covid; toothaches; tracheitis; sore throats; symptoms of exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (a lung infection) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (a lung infection) (seriousness criterion medically significant), TONSILLITIS (tonsillitis), SINUSITIS (Sinusitis), BRONCHITIS (bronchitis), INFECTIOUS MONONUCLEOSIS (mononucleosis), NASOPHARYNGITIS (rhinopharyngitis), COVID-19 (Covid), TOOTHACHE (toothaches), TRACHEITIS (tracheitis), OROPHARYNGEAL PAIN (sore throats) and FATIGUE (symptoms of exhaustion). At the time of the report, PNEUMONIA (a lung infection), TONSILLITIS (tonsillitis), SINUSITIS (Sinusitis), BRONCHITIS (bronchitis), INFECTIOUS MONONUCLEOSIS (mononucleosis), NASOPHARYNGITIS (rhinopharyngitis), COVID-19 (Covid), TOOTHACHE (toothaches), TRACHEITIS (tracheitis), OROPHARYNGEAL PAIN (sore throats) and FATIGUE (symptoms of exhaustion) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that, the patient received three doses of the Moderna vaccine and since then being constantly ill. Patient stated that before COVID, she was never sick and at the time of reporting she had 12 episodes of tonsillitis with sinusitis and sore throats, 8 tracheitis which turns into bronchitis, a lung infection, mononucleosis, 7 rhinopharyngitis, Covid, and 4 toothaches, she was exhausted.  Treatment medication was not reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Pneumonia, which occurred on an unknown date after the third dose of SPIKEVAX NOS vaccine. Since no vaccination, nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2024: Follow up received contains non-significant information: Reference number added.
Sex: F
Vaccine: COVID19
Symptoms: Tracheitis
Clinical narrative: a lung infection; tonsillitis; Sinusitis; bronchitis; mononucleosis; rhinopharyngitis; Covid; toothaches; tracheitis; sore throats; symptoms of exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (a lung infection) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (a lung infection) (seriousness criterion medically significant), TONSILLITIS (tonsillitis), SINUSITIS (Sinusitis), BRONCHITIS (bronchitis), INFECTIOUS MONONUCLEOSIS (mononucleosis), NASOPHARYNGITIS (rhinopharyngitis), COVID-19 (Covid), TOOTHACHE (toothaches), TRACHEITIS (tracheitis), OROPHARYNGEAL PAIN (sore throats) and FATIGUE (symptoms of exhaustion). At the time of the report, PNEUMONIA (a lung infection), TONSILLITIS (tonsillitis), SINUSITIS (Sinusitis), BRONCHITIS (bronchitis), INFECTIOUS MONONUCLEOSIS (mononucleosis), NASOPHARYNGITIS (rhinopharyngitis), COVID-19 (Covid), TOOTHACHE (toothaches), TRACHEITIS (tracheitis), OROPHARYNGEAL PAIN (sore throats) and FATIGUE (symptoms of exhaustion) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that, the patient received three doses of the Moderna vaccine and since then being constantly ill. Patient stated that before COVID, she was never sick and at the time of reporting she had 12 episodes of tonsillitis with sinusitis and sore throats, 8 tracheitis which turns into bronchitis, a lung infection, mononucleosis, 7 rhinopharyngitis, Covid, and 4 toothaches, she was exhausted.  Treatment medication was not reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Pneumonia, which occurred on an unknown date after the third dose of SPIKEVAX NOS vaccine. Since no vaccination, nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2024: Follow up received contains non-significant information: Reference number added.
Sex: U
Vaccine: HIBV
Symptoms: Injury associated with device, Product complaint, Syringe issue
Clinical narrative: Needle stuck on patient leg/it was hard to pull the needle from the baby it was almost stuck; Needle stuck on patient leg/it was hard to pull the needle from the baby it was almost stuck; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental needle stick in a infant patient who received Hib (Hiberix) (batch number 9E3BH) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: Needle stuck on patient leg/it was hard to pull the needle from the baby it was almost stuck), pharmaceutical product complaint (Verbatim: Product Complaint) and syringe issue (Verbatim: Needle stuck on patient leg/it was hard to pull the needle from the baby it was almost stuck). The outcome of the accidental needle stick, pharmaceutical product complaint and syringe issue were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt date: 17-APR-2024 Health care provider reported that a nurse was using hiberix and the plastic device on the tip of the syringe broke, after reconstitution and injecting a baby, when she withdrew the needle from the baby leg, the plastic piece disconnected from the syringe and it was hard to pull the needle from the baby it was almost stuck.  The reporter wanted to know if there was information on how to reconstitute and apply the vaccine correctly and to inform you on the situation so you are aware.  The suspect product administered. The HCP who was preparing the dose an experienced user. During administration the defect discovered and the needle and the Luer-Lock tip stayed (got stuck) in the patient leg. The vaccine administration facility was the same as primary reporter.
Age: 77.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect product administration duration
Clinical narrative: administration of Twinrix after the the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 77-year-old male patient who received HAB (Twinrix) for prophylaxis.   On 23-APR-2024, the patient received the 2nd dose of Twinrix. On 23-APR-2024, an unknown time after receiving Twinrix, the patient experienced drug administration duration too long (Verbatim: administration of Twinrix after the the recommended interval). The outcome of the drug administration duration too long 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: 23-APR-2024 The pharmacist requested data about the administration of Twinrix after the recommended interval which led to lengthening of vaccination schedule. During the call, the pharmacist handed the call over to their partner, who was also a pharmacist and continued the call.  No further information was collected as the pharmacist ended the call.  The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Mal administration may have occured/ possible liquid only used in up to 2 instances; Mal administration may have occured/ possible liquid only used in up to 2 instances; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate preparation of medication (Verbatim: Mal administration may have occured/ possible liquid only used in up to 2 instances) and inappropriate dose of vaccine administered (Verbatim: Mal administration may have occured/ possible liquid only used in up to 2 instances). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-APR-2024 The reporter do not know but it was reported maladministration might had occurred. There was no information given other than possible liquid only used in up to 2 instances, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patient outcomes reported or facts around when it occurred. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: her arm was sore for a day or two; This non-serious case was reported by a physician via other manufacturer and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included eltrombopag olamine (Promacta).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: her arm was sore for a day or two). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2024 The patient reported that she recently had a Shingles vaccine and her arm was sore for a day or two. The patient stated that she called her doctor before receiving the vaccine to make sure it was okay with being on Promacta.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Acne, Diarrhoea, Erythema, Pyrexia
Clinical narrative: fever, stomach pain, diarrhea, vomit, temporary red pimple.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: fever, stomach pain, diarrhea, vomit, temporary red pimple.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme pain left shoulder to hand.; swollen from left shoulder to hand.; lift my arm; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cholesterol. Concomitant products included pravastatin.   On 18-APR-2024, the patient received Shingrix. On 25-APR-2024, 7 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: Extreme pain left shoulder to hand.), hand swelling (Verbatim: swollen from left shoulder to hand.) and mobility decreased (Verbatim: lift my arm). The outcome of the pain in arm, hand swelling and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, hand swelling and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm, hand swelling and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 29-APR-2024 The patient had extreme pain and swollen from left shoulder to hand and could not close hand because of swollen nor lift arm due to extreme pain. At emergency room, administered anti-flammatory and pain medicine received via IV push and injection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: dizziness immediately after receiving GARDASIL 9 vaccine; near syncope episode immediately after receiving GARDASIL 9 vaccine; This spontaneous report was received from a nurse prescriber via a company representative and refers to a 12-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included procedural anxiety, and possible autism. Concomitant therapies were not reported.  On an unknown date (also reported as within past few months), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (also reported as within past few months), the patient experienced dizziness and had a near syncope episode immediately after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The causal relationship between dizziness and near syncope episode and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; Expired MMR II was given to 4-year-old patient; Expired MMR II was given to 4-year-old patient. / it was 4-year-old child receiving first dose of MMR II; This spontaneous report has been received from a physician, referring to a 4-year-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 16-APR-2024, the patient was vaccinated with the first dose of expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) injection, at a dose of 1 dosage form, lot# W028733, expiry date 12-APR-2024 (route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age, expired product administered). The vaccine had never experienced a temperature excursion. No side effects reported (no adverse event).
Age: 60.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered GARDASIL 9 to a 60 year old female patient on unspecified date; No side effects or symptoms reported/No additional AE; This spontaneous report has been received from a pharmacist and refers to a 60-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies provided.  On an unknown date (at the age of 60 years old), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, dose number, route of administration, anatomical location, lot #, and expiry date were not provided), for prophylaxis (Product administered to patient of inappropriate age). No side effects, symptoms or additional adverse events were reported.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling was noted around the injection site.; Redness and swelling was noted around the injection site.; This spontaneous report was received from a physician refers to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown exact day in April 2024 (estimated date, also reported as: within the last 2 weeks), the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), formulation: subcutaneous injection, administered subcutaneous (lot #, expiration date, exact dose and anatomical location were not provided) for prophylaxis.    On an unknown exact day in April 2024 (estimated date, also reported as: within the last 2 weeks), the patient experienced vaccination site erythema and vaccination site swelling (redness and swelling was noted around the injection site). Benadryl was administered to the patient and the redness and swelling resolved after about one day. The outcome of vaccination site erythema and vaccination site swelling was reported as recovered/resolved.   The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; 1 dose of VARIVAX was administered to a patient after being involved in a temperature excursion; This spontaneous report was received from the office manager referring to a 12-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 01-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported, valid lot number X026320 with an expiration date of 07-NOV-2025). The administered dose of the vaccine experienced temperature excursions of 14 to 46 (27.1) degrees Fahrenheit for 1 hour and 30 minutes and  from 6 to 14 degrees Fahrenheit for 2 hours and 30 minutes. It was reported if the information was obtained from the data logger or not. There was no adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; administered after a temperature excursion; This spontaneous report was received from medical assistant and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-APR-2024, the patient received one dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025482, expiration date: 12-APR-2025, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion of 39.2 degree F for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No addition adverse event reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; administered after a temperature excursion; This spontaneous report was received from medical assistant and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 29-APR-2024, the patient received one dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot # X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion of 39.2 degree F for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No addition adverse event reported (no adverse event).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began 3 months later.
Age: 65.0
Sex: F
Vaccine: ADEN_4_7, ADEN_4_7
Symptoms: Blister, Cerebral haemorrhage, Cerebrovascular accident, Communication disorder, Death
Clinical narrative: Patient died 09/30/2022, just over one year after receiving the vaccines. She died of a stroke (brain bleed) and also had a blood clot in her legs. Blood clots and strokes had been common among the vaccinated. She was hospitalized for 10 days before her death. Each day she progressively got worse. The first day I found her we could communicate. After that, it was very difficult to communicate.  However, as I report this, she did have issues with her legs which might have been a result of the vaccines. They had water blisters on them. She finally had to go to a wound doctor for help. They wrapped her legs to help the healing. And issued at home equipment which helped her blood circulate in her legs.
Age: 65.0
Sex: F
Vaccine: ADEN_4_7, ADEN_4_7
Symptoms: Musculoskeletal disorder, Peripheral vascular disorder, Thrombosis, Wound treatment
Clinical narrative: Patient died 09/30/2022, just over one year after receiving the vaccines. She died of a stroke (brain bleed) and also had a blood clot in her legs. Blood clots and strokes had been common among the vaccinated. She was hospitalized for 10 days before her death. Each day she progressively got worse. The first day I found her we could communicate. After that, it was very difficult to communicate.  However, as I report this, she did have issues with her legs which might have been a result of the vaccines. They had water blisters on them. She finally had to go to a wound doctor for help. They wrapped her legs to help the healing. And issued at home equipment which helped her blood circulate in her legs.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: with in a few hours a blotchy rash developed and spread to just above the elbow and lasted about 2 &1/2 days. Arm was slightly swollen, warm, and the muscle was sore.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction noted. This vaccine is only recommended for 12 months - 12 years old and this patient was 13 years old at the time of vaccination.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects needed
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: inject RSV to 35 weeks pregnant in February. called and talked to patient. She confirmed she is at 35 weeks pregnant and the doctor recommend her to get the RSV.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Hepatitis A administered on 03/18/2024 was the 3rd dose for this patient and was not needed. The patient was contacted on 05/07/2024 when error was discovered and had no adverse event to the "extra" dose and had no questions or concerns at this time for the nurse.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Acute kidney injury, Anaemia, Atypical haemolytic uraemic syndrome, Blood creatinine increased, Blood lactate dehydrogenase increased
Clinical narrative: Onset fever, emesis 4/20,  diarrhea 4/21 and dx with HUS.  hospitalized 4/21 - 5/2/24 at hospital.  admitted with HUS on 04/21/24 including anemia with evidence for hemolysis - schistocytes and elevated LDH, thrombocytopenia, and AKI  .Stool studies notable for rotavirus (S/P oral vaccination on 04/19/24) and STEC by 04/21/24 GI PCR.    04/22/24 = aHUS genetic panel positive for rare heterozygous missense variant CFHR5  .
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Cytogenetic analysis abnormal, Diarrhoea, Escherichia test positive, Haemolysis, Pyrexia
Clinical narrative: Onset fever, emesis 4/20,  diarrhea 4/21 and dx with HUS.  hospitalized 4/21 - 5/2/24 at hospital.  admitted with HUS on 04/21/24 including anemia with evidence for hemolysis - schistocytes and elevated LDH, thrombocytopenia, and AKI  .Stool studies notable for rotavirus (S/P oral vaccination on 04/19/24) and STEC by 04/21/24 GI PCR.    04/22/24 = aHUS genetic panel positive for rare heterozygous missense variant CFHR5  .
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Red blood cell schistocytes present, Rotavirus test positive, Thrombocytopenia, Transfusion, Vomiting
Clinical narrative: Onset fever, emesis 4/20,  diarrhea 4/21 and dx with HUS.  hospitalized 4/21 - 5/2/24 at hospital.  admitted with HUS on 04/21/24 including anemia with evidence for hemolysis - schistocytes and elevated LDH, thrombocytopenia, and AKI  .Stool studies notable for rotavirus (S/P oral vaccination on 04/19/24) and STEC by 04/21/24 GI PCR.    04/22/24 = aHUS genetic panel positive for rare heterozygous missense variant CFHR5  .
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Cytogenetic analysis, Haemolytic uraemic syndrome, Poor feeding infant, Pyrexia, Vomiting
Clinical narrative: Onset fever, emesis 4/20,  diarrhea 4/21 and dx with HUS.  hospitalized 4/21 - 5/2/24 at hospital.  admitted with HUS on 04/21/24 including anemia with evidence for hemolysis - schistocytes and elevated LDH, thrombocytopenia, and AKI  .Stool studies notable for rotavirus (S/P oral vaccination on 04/19/24) and STEC by 04/21/24 GI PCR.    04/22/24 = aHUS genetic panel positive for rare heterozygous missense variant CFHR5  .
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 4/11/2024.  Names of vaccines involved (including lot/exp): VAQTA (X023973 12/26/2024) Temperature: 32.9°F Time frame: 3 hours 18 min; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-APR-2024, the patient was vaccinated with hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, once for prophylaxis (lot # X023973, expiration date: 26-DEC-2024, strength, dose and route of administration were not provided), after a temperature excursion (temperature: 32.9 F, time frame: 3 hours 18 minutes) (product storage error). No additional adverse events were reported (no adverse event). Operator of device: health professional.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Supraventricular tachycardia
Clinical narrative: constant headache for a week . blood pressure 220/160.  now I a on constant blood pressure meds. I have also been diagnosis with SVTs
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Cardiac monitoring, Computerised tomogram, Concussion, Feeling hot
Clinical narrative: Initially started feeling hot (if I am in 80 degrees Fahrenheit my body acts like it is over 100 degrees). Within two months I started passing out and getting concussions in the process. I am diagnosed with Orthostatic Hypotension. One of my triggers is heat. I have seen to several doctors, many tests, had several concussions from passing out. I have tried multiple medications, but doing dietary things to keep up blood pressure, staying out of heat, and reducing stress help the most. I have had to ask foe accommodations at work, medical leave, and had to resign because of this.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Loss of consciousness, Orthostatic hypotension, Temperature intolerance
Clinical narrative: Initially started feeling hot (if I am in 80 degrees Fahrenheit my body acts like it is over 100 degrees). Within two months I started passing out and getting concussions in the process. I am diagnosed with Orthostatic Hypotension. One of my triggers is heat. I have seen to several doctors, many tests, had several concussions from passing out. I have tried multiple medications, but doing dietary things to keep up blood pressure, staying out of heat, and reducing stress help the most. I have had to ask foe accommodations at work, medical leave, and had to resign because of this.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given to the patient. Vaccine was given on 5/3/24, but vaccine expired on 4/7/24. New vaccine was ordered. Patient was informed and instructed to come back and repeat the dose.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to chemicals, Brain fog, Cardiac monitoring abnormal, Electroencephalogram abnormal, Exercise tolerance decreased
Clinical narrative: 1-2 weeks following vaccination, I started experiencing heart palpitations. Within a month of the vaccine, I also started experiencing brain fog and exercise intolerance (every time I tried to exercise all my symptoms were exacerbated) . 5 months after the vaccine, I started experiencing light sensitivity and eye floaters. A couple of months after that I started experiencing insomnia. 8 months after the vaccine, in college, began having panic attacks and extreme exacerbation of the previously listed symptoms. As of now, I have all the listed symptoms, in addition to extreme mold, chemical, and food sensitivity.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Food intolerance, Insomnia, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: 1-2 weeks following vaccination, I started experiencing heart palpitations. Within a month of the vaccine, I also started experiencing brain fog and exercise intolerance (every time I tried to exercise all my symptoms were exacerbated) . 5 months after the vaccine, I started experiencing light sensitivity and eye floaters. A couple of months after that I started experiencing insomnia. 8 months after the vaccine, in college, began having panic attacks and extreme exacerbation of the previously listed symptoms. As of now, I have all the listed symptoms, in addition to extreme mold, chemical, and food sensitivity.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Mycotic allergy, Palpitations, Panic attack, Photophobia, Vitreous floaters
Clinical narrative: 1-2 weeks following vaccination, I started experiencing heart palpitations. Within a month of the vaccine, I also started experiencing brain fog and exercise intolerance (every time I tried to exercise all my symptoms were exacerbated) . 5 months after the vaccine, I started experiencing light sensitivity and eye floaters. A couple of months after that I started experiencing insomnia. 8 months after the vaccine, in college, began having panic attacks and extreme exacerbation of the previously listed symptoms. As of now, I have all the listed symptoms, in addition to extreme mold, chemical, and food sensitivity.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Drooling, Dyskinesia, Musculoskeletal stiffness
Clinical narrative: Patient, age 7, has autism, intellectual disability and ADHD. he is in foster care.  At a pediatrics visit today in the clinic that is part of this foster agency, we administered his second dose of HepA vaccine, as above.  Approxmiately 80 - 90 minutes later, while driving home, his father called us to report that he'd stiffened, the arms were jerking, and that he was drooling.  I don't know the duration of the event. Afterwards, he fell asleep.  Out of concern that this may have represented a generalized tonic-clonic seizure, I am reporting this to VAERS. Patient will be seen in an ED shortly.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient is a 33y.o. G1P0, at the time of vaccine,  A+, type 2 diabetic with learning disabilities, hearing impaired,  adult female.  EDC of 05/23/24, delivered on 05/XX/24.  birth weight 7# 8oz.   The incident that occurred was on 03/05/24 and 03/18/24.  The TDAP was given on both dates, by two different  MA's.  No adverse reaction occurred to the patient, no reaction.  Patient was told of the mistake.  Each MA was counseled on the proper documenting of the vaccine so mistakes like this do not occur.  On 03/05/24 the MA did not accurately document in the patient's record, making it look like the TDAP was never given.
Age: 7.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave Dtap to 7 year old instead of Tdap.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING, ERYTHEMA, REDNESS ON LOCAL INJECTION SITE SINCE THE SHOT BUT SYMPTOMS IMPROVING