chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, which was improperly stored and involved in a temperature excursion (Product storage error). The patient received 1 unspecified dose, lot # W006595, with an expiration date on 10-OCT-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  The dose of b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 57.49 degrees Fahrenheit (°F) during a time frame of for 1 hour 45 minutes. No adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: being diagnosed with autism; This spontaneous report was received from a consumer via vendor, referring to her nephew, a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unknown date in 1998 (reported as 24 years ago), the patient vas vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was diagnosed with autism. The outcome of the event was not provided.   The causal relationship between event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown. The reporter acknowledged the events may not have been related.  Upon internal review, being diagnosed with autism was determined to be medically significant.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller is an HCP reporting a patient missed her 2nd dose of GARDASIL 9 that was due in July and came in today to receive it. The patient, however, is now 46 years old. No additional clarifying statements or details were provided. HCP declined permiss; No additional AE; This spontaneous report was received from another reporter and refers to a 46-year-old female. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date (when the patient was 46-year-old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (inappropriate age at vaccine administration). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; An HCP is reporting an AE on behalf of a patient. The caller reports that a patient was administered a dose of PROQUAD after its labeled expiry date. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 13-DEC-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 mL (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U017140, with an expiration date of 28-NOV-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine, still got it/suspected vaccination failure; Still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and still got them. The patient stated that not as bad. The patient stated that get the vaccine or it will be worse. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, still got shingles/Suspected vaccination failure; Shingles/ Still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Hands were pink, no blisters, no pain; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpetic whitlow (got this on her hands from a manicure 25 years before date of reporting.), blister and erythema. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX) and acyclovir.   In November 2022, the patient received the 2nd dose of Shingrix. In December 2022, unknown after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   Linked case(s) involving the same patient:  US2022AMR183513   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Patient said she got herpes whitlow on her hands from a manicure 25 years ago.  Patient was taking acyclovir for the herpes whitlow for the past 25 years and she had not changed the amount of acyclovir she takes.  The patient said, about 3 times a year, her hands breaks out in blisters from the herpes whitlow infection and turns dark red with blisters and was painful for several weeks.  She said the blister cycle from the herpes whitlow was caused from great stress.  She said the blisters usually takes about a month to go away.  Patient reports getting the first shingrix shot in September 2022 and getting the second shingrix shot two weeks ago in November 2022.  Patient said that in the last 48 hours, she felt a change in her blisters on her hands.  On 5th December 2022, her hands were a light pink color instead of the dark blisters.  On 6th December 2022, that her hands were pink and had no blisters with no pain.  Patient did not know the lot number or the expiration date of the shingrix shots she received. No further information was reported to the agent by the patient.  Consented to follow up. No further information was reported to the agent by the patient.  Patient declined to provide consent for hcp follow-up.; Sender's Comments:  US-GSK-US2022AMR183513:same patient
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: reaction/faint grey dot (still present); This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 95552X, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number 242A7, expiry date unknown) for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) (batch number 242A7, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) (batch number FX0078, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix (received first dose on 10th June 2022, for tolerance case refer US2022AMR148962), Pediarix (received second dose on 17th August 2022 for tolerance case refer US2022AMR149551), Hiberix (received first dose on 10th June 2022, for tolerance case refer US2022AMR148962) and Hiberix (received second dose on 17th August 2022 for tolerance case refer US2022AMR149551).   On 1st November 2022, the patient received the 3rd dose of Pediarix (intramuscular), Pediarix Pre-Filled Syringe Device, the 3rd dose of Hiberix, the 3rd dose of ACTHIB (intramuscular) and the 3rd dose of PREVNAR. On an unknown date, less than 3 weeks after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. Rechallenge with ACTHIB was positive. Rechallenge with PREVNAR was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved.   The reporter considered the skin discoloration to be probably related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR148962, US2022AMR149551   Additional Information: GSK Receipt Date: 16-Nov-2022 Reporter's comment: The patient had reaction/faint grey dot which was still present. The reporter considered the skin discoloration to be probably related to Acthib and Prevnar. The consent to follow-up was granted.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171056:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles Vaccine  (about 15 years ago).   On 20th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 6th December 2022. Reporter's Comment:The patient got a Shingles Vaccine about 15 years ago. The got the first of the 2 Shingrix Shots. The reporter stated that he/she found it very unusually coincidental that by the end of the week, had shingles.  The reporter asked if there was any data on people who have contracted shingles from the vaccine.  The reporter know it was not the norm but stuff happens. The reporter could be contacted at this email address. Additional supportive information: The case has been linked with case US2022AMR183219 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR183219:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Mobility decreased, Vaccine positive rechallenge, Vomiting
Clinical narrative: Dizziness; Diarrhea; Vomiting; Prevented to move head, get out of bed; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dizziness (On an unknown date in 2020, received 1st dose, case US2022182824 and experienced diarrhea, vomiting and mobility decreased). Concurrent medical conditions included asthma.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 days after receiving Shingrix, the patient experienced dizziness, diarrhea, vomiting and mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the dizziness, diarrhea, vomiting and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the dizziness, diarrhea, vomiting and mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022182824   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: On an unknown date in 2020, the patient received his first and second Shingrix doses six months apart. About 6 days after each dose of Shingrix the patient experienced dizziness, diarrhea and vomiting (adverse events recovered). The dizziness prevented him from moving his head or getting out of bed for 3 or 4 days. The dizziness gradually improved then resolved after 7 to 14 days. The vomiting and diarrhea lasted for 3 or 4 days. The patient had nothing else to report. The patient did not want to be contacted. Declined to provide his mailing address. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022182824:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 1 year ago, 2nd shot 4 weeks ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's wife had shingles 5 weeks ago). Previously administered products included Shingles shot (received 1st shot 1 year ago).   In November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Dec-2022 Reporter's comment: The reporter did not provided patient's initials and date of birth. The reporter also asked that she got shingles 5 weeks ago and how long should she wait to get the shingles shot as she was on antiviral within 8 hours of discovering shingles. The reporter also stated that she had shingles so did not had really bad. The reporter did not consent to follow-up. Additional supportive information: The patient received the 2nd shot later than the recommended schedule, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Contracted covid 2 days later; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received the 2nd dose of Shingrix and 2 days later patient contacted covid and was put on pavlova. The reporter wanted to know was did the pavlova interfere with his/her second shot of Shingrix. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper
Clinical narrative: Stomach pain a few minutes of eating or drinking anything.; This case was reported by a consumer and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2022 11:15, the patient received the 1st dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the stomach pain to be related to Shingrix.     Additional Information: GSK receipt date: 08-DEC-2022 Reporter's comment: The patient had the first dose of Shingrix on Sunday at 11.15 am.  The patient said on the day of reporting as thursday, 6 am and he/she was still having stomach pain within a few minutes of eating or drinking anything.  The patient asked was this normal. When should he/she get it checked out.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen arm; Red arm; This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: After vaccination patient developed a swollen and red arm for 10 days.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: COVID-19; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 16th November 2022, 2 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The reporter stated that the patient had 2nd dose of Shingrix vaccine on 14th November 2022. Then on 16th November 2022 the patient had covid 19. The caller confirms that on 14th November 2022 2nd dose of Shingrix was taken.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia, Sensitive skin
Clinical narrative: Skin sensitivity, could I shed to him the virus?; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sensitive skin, fever and fatigue. On an unknown date, the outcome of the sensitive skin, fever and fatigue were unknown.   It was unknown if the reporter considered the sensitive skin, fever and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The reporter stated that her boyfriend had skin sensitivity on his back and side with fever, and fatigue. The reporter also mentioned patient was already been vaccinated against shingles Additional Supportive Information: The case had been linked to US2022AMR184538, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR184538:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error, Product preparation error
Clinical narrative: adjuvant used w/Covid vx, error caught on time; This case was reported by a pharmacist and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 6-Dec-2022 and 8-Dec-2022 Reporter's comment: The reporter reported that Shingrix diluent was missing and replacement was needed. On 8th December 2022, upon callback to clarified with health care professional, pharmacy manger provided clarification that the adjuvant vial was actually used to reconstitute a dose of Covid vaccine.  The error was caught during reconstitution and no medication was administered to patient.  No further details provided during callback. Emailed to safety as the case was locked and specialist realized the lot and expiration date were inadvertently left out of the narrative. The reporter only had limited details available at time of callback.  The reporter stated that she will provide medical information phone number to pharmacist and had pharmacist follow up with further details if available.  The reporter granted permission for safety to follow up. The reporter consented to follow-up. Additional supportive information: The Shingrix adjuvant vial used to reconstitute with a dose of Covid vaccine and it was caught during reconstitution, which led to intercepted product preparation error.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Vaccine positive rechallenge
Clinical narrative: Not comfortable, like having covid symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of discomfort (1st dose received on an unknown date, refer case US2022AMR185054).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR185054   Additional Information: GSK receipt date: 08-DEC2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd shot and stated that same as the 1st shot it was not comfortable. It was like a Covid symptoms once again. But he/she glad to he/she was protected. Additional Supportive information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR185054:Same reporter
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: RIGHT ARM AND SHOULDER PAIN-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PATIENT STATES RIGHT ARM PAIN UP INTO NECK AND NUMBNESS DOWN TO HAND
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: RIGHT ARM AND SHOULDER PAIN-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PATIENT STATES RIGHT ARM PAIN UP INTO NECK AND NUMBNESS DOWN TO HAND
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 63.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Pt came in for a TDAP because he has a new grandchild coming soon and the staff pulled a DTAP instead of TDAP and it was expired..  Pt has had no problems and the provider was made aware and said we could have him come back in 2 weeks for the correct medication.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case, Pfizer 4/21/21 EW0150, 5/13/21 EW0179, and boosted 12/27/21 FL3198
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue and achy joints
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th December 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 5th December 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-DEC-2022 Reporters comment: The nurse reported that 4 month old child was inadvertently administered Boostrix into left thigh. The HCP did not deny consent or provide consent for follow up. Additional Supportive information: The patient was inadvertently administered Boostrix, which led to inappropriate age at vaccine administration
Age: 24.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient arrived to the vaccine clinic, received both the Pfizer Bivalent vaccine and the Flucelvax Quadrivalent Influenza Vaccine.   Patient vaccinated at 0625 Patient complained of itchiness all over the arms, torso, legs, and back. Patient did not complain of swelling of the tongue, dysphagia, or trouble breathing. Medic, EMT, and RN verified symptoms and patient assessment.  0630 Assessed patient with vaccination team, no shortness of breath or swelling noted, lung sounds clear. Hive started to appear.   0635 Assessed vitals. Administer IM Benadryl, assessed patient and called medical team on site to assess patient. Hive started to dissipate.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by parents. Patient to be boosted per CDC guidelines.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Child inadvertently given vaccine dose for age 6 -11.  Child is  large for age.  Child tolerated the vaccine well.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Burning sensation, Feeling hot, Pruritus, Skin swelling
Clinical narrative: States she has itching and raised skin as well as a hot burning sensation. Started feeling symptoms 5-6 hours after vaccination and reported symptoms to nurse following morning as symptoms are still present.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: States she has itching and raised skin as well as a hot burning sensation. Started feeling symptoms 5-6 hours after vaccination and reported symptoms to nurse following morning as symptoms are still present.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Burning sensation, Feeling hot, Pruritus, Skin swelling
Clinical narrative: Employee stated she has burning and itching to the injection site at onset. Continues to complain of tenderness and itching, nodule formation noted to site.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Employee stated she has burning and itching to the injection site at onset. Continues to complain of tenderness and itching, nodule formation noted to site.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling abnormal, Headache, Malaise, Varicella
Clinical narrative: My son actually got/contracted chickenpox and became ill with the virus. He had a splitting headache, broke out in about 75 pox, and felt  "really weird" every time he moved his head (turning, looking down, etc.).
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to a pediatric patient; Adult dose given to a pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 1st December 2022) for prophylaxis.   On 1st December 2022, the patient received Havrix adult. On 1st December 2022, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Medical assistant reports an adult dose of Havrix was inadvertently administered to a pediatric patient. The reporter consented to follow up. Additional Supportive Information: The pediatric patient received adult dose of Havrix inadvertently, which led to accidental overdose and adult product administered to child.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient woke up this morning with red rash all over both arms.  She stated it is starting to itch.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Malaise, Oropharyngeal pain
Clinical narrative: 12/04/2022 I was not feeling well and my husband had tested positive for COVID. I took a home COVID test and it was positive. My symptoms were mild. I had a slight cough and sore throat. I called my doctor that day. He prescribed molnupiravir which I had filled on 12/7/22 and I started taking it that day. My symptoms stayed the same for about a week and then went away and now they have come back. I have not taken another COVID test.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/04/2022 I was not feeling well and my husband had tested positive for COVID. I took a home COVID test and it was positive. My symptoms were mild. I had a slight cough and sore throat. I called my doctor that day. He prescribed molnupiravir which I had filled on 12/7/22 and I started taking it that day. My symptoms stayed the same for about a week and then went away and now they have come back. I have not taken another COVID test.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alopecia, Asthenia, Astigmatism, Condition aggravated, Eye disorder
Clinical narrative: Hair loss, Eye Problems and no energy.    Tried hair treatment, had side effects and had to stop using.   Went to eye doctors, had my reading glasses changes (Stigmatism got worse.)  And still having problems with my eyes.    Note about the hair loss.  I had been noticing hair loss, didn't realize it was a side effect until talking to my son.  He had hair loss  after having Covid and was asking me about it.  And I decided to search hair loss and found out that there was a study referencing this. And people that didn't have covid. Then I searched hair loss after vaccines, for those that didn't have covid. And there was  a number of people that had hair loss and when I read about their problems, then I realized I had the same thing.
Age: 1.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was due to receive DtaP #2 and separate IPV #2, instead the combined DTaP/IPV (Quadracel) was given
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bradycardia
Clinical narrative: bradycardia
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Family came in to be vaccinated for flu during a flu clinic. signed consents and administered.  Upon updating system records, was noted that patient received flu vaccine from clinic on 9/12/2022
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Sepsis
Clinical narrative: Hospitalization for Sepsis due to pneumonia from COVID-19 on dates 12/5/2022- 12/8/2022. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Leakage during administration; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 1-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 5th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 6th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Registered nurse called in to report that the first dose of Havrix was administered but during the process, a leakage was witnessed, and the liquid fell on the table.  The incident took place on 6th December 2022  They inquired about how to proceed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administering with  1st dose of Havrix but during the process, a leakage was witnessed, and the liquid fell on the table, which led to incomplete dose administered. expiry date was captured as 5th May 2023 and due to lack of information administration error was not captured, as per conservative approach and clarification was raised for same.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test normal, Cardiac monitoring normal, Dizziness, Echocardiogram normal
Clinical narrative: She got her vaccine, spent the afternoon with family visiting.  They had dinner together at around 6-6:30, and was sitting at the table when she felt super dizzy like she was going to pass out.  She tried to get her head down between her legs and her husband caught her before she hit the floor.  She tried to get to the bathroom to vomit, which continued with the dizziness and vomiting.  She was taken to the ER at Hospital.  They took her and laid her down, did an EKG and put her on a heart monitor for about 3 hours.  They did blood work, and they also gave her an IV of saline and something for her nausea.  She was diagnosed with nausea and light headedness.  They told her that all of her tests were fine, but she felt weak but otherwise OK.  Ever since then she had some more blood work, an echocardiogram and a Holter monitor and everything came back fine.   The next day she slept a lot but otherwise has been fine.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram ambulatory normal, Electrocardiogram normal, Hypersomnia, Nausea, Vomiting
Clinical narrative: She got her vaccine, spent the afternoon with family visiting.  They had dinner together at around 6-6:30, and was sitting at the table when she felt super dizzy like she was going to pass out.  She tried to get her head down between her legs and her husband caught her before she hit the floor.  She tried to get to the bathroom to vomit, which continued with the dizziness and vomiting.  She was taken to the ER at Hospital.  They took her and laid her down, did an EKG and put her on a heart monitor for about 3 hours.  They did blood work, and they also gave her an IV of saline and something for her nausea.  She was diagnosed with nausea and light headedness.  They told her that all of her tests were fine, but she felt weak but otherwise OK.  Ever since then she had some more blood work, an echocardiogram and a Holter monitor and everything came back fine.   The next day she slept a lot but otherwise has been fine.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Hospitalization for pneumonia due to COVID-19 on dates  12/7/22- 12/12/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED THE BOOSTER BIVALENT MODERNA COVID VACCINE AS FIRST DOSE OF SERIES
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Mother and Father brought children in for flu vaccine during flu clinic.  flu vaccine administered without difficulty. upon registering it was noted that patient received flu vaccine 9/12/2022
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Hospitalization for COVID-19 symptoms on dates 12/7/22- 12/12/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath reported as ADR from COVID vaccine. No other information available in regards to when the vaccine was given, time of onset, or other course of events.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Inflammation, Pain
Clinical narrative: Pain in right shoulder around rotator cuff due to vaccination inflammation - not any better after 12 months of pain.  Since receiving the 2nd dose (11/22/2021) patient has maintained a journal of "spike headaches" if heart rate is above 150 bpm for more than 5 minutes.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Diarrhoea, Discharge, Ear pain
Clinical narrative: Cough, sneezing, sniffling, body aches, drainage, congestion, throat pain, ear pain, LOOSE bowels/diarrhea(continued for 3 weeks; controlled by BRAT diet, Imodium, Pepto-Bismol), rhinorrhea, nausea, myalgias, meddle ear effusion both ears, Prescribed Molnupiravir, Isolated 10 days (no work for 15 days), mostly resolved by 12/12/2022
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Influenza A virus test negative, Influenza B virus test, Middle ear effusion, Myalgia, Nausea
Clinical narrative: Cough, sneezing, sniffling, body aches, drainage, congestion, throat pain, ear pain, LOOSE bowels/diarrhea(continued for 3 weeks; controlled by BRAT diet, Imodium, Pepto-Bismol), rhinorrhea, nausea, myalgias, meddle ear effusion both ears, Prescribed Molnupiravir, Isolated 10 days (no work for 15 days), mostly resolved by 12/12/2022
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Cough, sneezing, sniffling, body aches, drainage, congestion, throat pain, ear pain, LOOSE bowels/diarrhea(continued for 3 weeks; controlled by BRAT diet, Imodium, Pepto-Bismol), rhinorrhea, nausea, myalgias, meddle ear effusion both ears, Prescribed Molnupiravir, Isolated 10 days (no work for 15 days), mostly resolved by 12/12/2022
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Sneezing
Clinical narrative: Cough, sneezing, sniffling, body aches, drainage, congestion, throat pain, ear pain, LOOSE bowels/diarrhea(continued for 3 weeks; controlled by BRAT diet, Imodium, Pepto-Bismol), rhinorrhea, nausea, myalgias, meddle ear effusion both ears, Prescribed Molnupiravir, Isolated 10 days (no work for 15 days), mostly resolved by 12/12/2022
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 11/02/22 presents to ED for "shortness of breath and cough". PMHx of "HLD"
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted on 12/11 with a PMH of CHF, CVA, COPD, type 2 diabetes mellitus for intractable headache. On 12/15 pt developed a fever and had difficulty breathing. Tested positive for COVID-19.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Sore throat, sneezing, fever, fatigue, body aches, headache. Onset 5 days after household exposure. Positive Binex results day of first symptoms. Paxlovid prescribed.  Currently on Day 3 of treatment with symptomatic relief.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Sore throat, sneezing, fever, fatigue, body aches, headache. Onset 5 days after household exposure. Positive Binex results day of first symptoms. Paxlovid prescribed.  Currently on Day 3 of treatment with symptomatic relief.
Age: 64.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Facial pain, Headache, Pain in jaw, Trigeminal neuralgia
Clinical narrative: Patient had Tdap and Covid booster on 12/12/22. He noted facial pain, jaw pain and headache starting 12/15/22. I suspect trigeminal neuralgia.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Mobility decreased, Vaccine positive rechallenge, Vomiting
Clinical narrative: Dizziness; Diarrhea; Vomiting; Prevented to move head, get out of bed; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 6 days after receiving Shingrix, the patient experienced dizziness, diarrhea, vomiting and mobility decreased. On an unknown date, the outcome of the dizziness, diarrhea, vomiting and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the dizziness, diarrhea, vomiting and mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR183381   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: On an unknown date in 2020, the patient received his first and second Shingrix doses six months apart.  About 6 days after each dose of Shingrix the patient experienced dizziness, diarrhea and vomiting (adverse events recovered). The dizziness prevented him from moving his head or getting out of bed for 3 or 4 days. The dizziness gradually improved then resolved after 7 to 14 days. The vomiting and diarrhea lasted for 3 or 4 days. The patient had nothing else to report. The patient did not want to be contacted. Declined to provide his mailing address. The reporter did not consent to follow-up. For tolerance to the 2nd dose refer case US2022AMR183381.; Sender's Comments:  US-GSK-US2022AMR183381:Same reporter
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyskinesia, Pyrexia, Tension
Clinical narrative: PATIENT RECEIVED MODERNA BIVALENT COVID VACCINE.  FACILITY NURSE REPORTED THE PATIENT DEVELOPED SYMPTOMS OF FEVER, BODY TENSION, CLINCHING, AND JERKING MOVEMENTS.  PRESCRIBER WAS CONTACTED AND PATIENT WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION. PATIENT HAS BEEN ADMITTED AND IS CURRENTLY IN THE HOSPTIAL.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt had a positive COVID test on 6/9/22; pt passed away at home on 7/6/22; no medical records received on this patient
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Erythema, Pruritus, Urticaria
Clinical narrative: Shortly after 2nd dose of Pzifer COVID vaccine, I started experiencing urticaria all over my skin. Large spaces of hives would flare up in no predictable areas, would be present for 10 minutes or so, then usually go away. This still happens to present day several times a day. Associated itching and redness. Still no specific area, but is usually on the arms, legs, and back.