chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Axillary pain, COVID-19, Chest pain, Cough, Decreased appetite
Clinical narrative: Probably within five minutes of getting the vaccine, I went to go sit down and wait. I immediately had a headache and it felt like my deltoid where they had given me the shot was really sore, like something had hit it. Then I felt it spread down towards my left hand and a neuropathy. I went to tell the nurse. I also felt some pain under my armpit and part of my chest. She enrolled me in VSafe and told me to get some BENADRYL. When I went home about 20 mins later I started to have numbness and tingling in my other hand and that night I had the same feeling in my feet. I spent most of the day Tuesday in bed, I took some BENADRYL and had a low grade fever of 99. The next day, I think it was Wednesday. I had a fever of 100.6, and then that broke and I haven't had any fever since then. I lost my appetite and had muscle aches and pain, sneezing and coughing, and a lot of mucus. I called the doctor's office for an upcoming procedure to tell them and they told me to test for COVID-19. I did and tested positive on Thursday. I called my PCP and they set up a tele-health appt. They recommended I take PAXLOVID and discussed underlying conditions. I started that last night. My heart rate has been a little high, doctor told me to monitor it, but it has come down since the appt.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: Probably within five minutes of getting the vaccine, I went to go sit down and wait. I immediately had a headache and it felt like my deltoid where they had given me the shot was really sore, like something had hit it. Then I felt it spread down towards my left hand and a neuropathy. I went to tell the nurse. I also felt some pain under my armpit and part of my chest. She enrolled me in VSafe and told me to get some BENADRYL. When I went home about 20 mins later I started to have numbness and tingling in my other hand and that night I had the same feeling in my feet. I spent most of the day Tuesday in bed, I took some BENADRYL and had a low grade fever of 99. The next day, I think it was Wednesday. I had a fever of 100.6, and then that broke and I haven't had any fever since then. I lost my appetite and had muscle aches and pain, sneezing and coughing, and a lot of mucus. I called the doctor's office for an upcoming procedure to tell them and they told me to test for COVID-19. I did and tested positive on Thursday. I called my PCP and they set up a tele-health appt. They recommended I take PAXLOVID and discussed underlying conditions. I started that last night. My heart rate has been a little high, doctor told me to monitor it, but it has come down since the appt.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Neuropathy peripheral, Paraesthesia, Pyrexia, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: Probably within five minutes of getting the vaccine, I went to go sit down and wait. I immediately had a headache and it felt like my deltoid where they had given me the shot was really sore, like something had hit it. Then I felt it spread down towards my left hand and a neuropathy. I went to tell the nurse. I also felt some pain under my armpit and part of my chest. She enrolled me in VSafe and told me to get some BENADRYL. When I went home about 20 mins later I started to have numbness and tingling in my other hand and that night I had the same feeling in my feet. I spent most of the day Tuesday in bed, I took some BENADRYL and had a low grade fever of 99. The next day, I think it was Wednesday. I had a fever of 100.6, and then that broke and I haven't had any fever since then. I lost my appetite and had muscle aches and pain, sneezing and coughing, and a lot of mucus. I called the doctor's office for an upcoming procedure to tell them and they told me to test for COVID-19. I did and tested positive on Thursday. I called my PCP and they set up a tele-health appt. They recommended I take PAXLOVID and discussed underlying conditions. I started that last night. My heart rate has been a little high, doctor told me to monitor it, but it has come down since the appt.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Sneezing
Clinical narrative: Probably within five minutes of getting the vaccine, I went to go sit down and wait. I immediately had a headache and it felt like my deltoid where they had given me the shot was really sore, like something had hit it. Then I felt it spread down towards my left hand and a neuropathy. I went to tell the nurse. I also felt some pain under my armpit and part of my chest. She enrolled me in VSafe and told me to get some BENADRYL. When I went home about 20 mins later I started to have numbness and tingling in my other hand and that night I had the same feeling in my feet. I spent most of the day Tuesday in bed, I took some BENADRYL and had a low grade fever of 99. The next day, I think it was Wednesday. I had a fever of 100.6, and then that broke and I haven't had any fever since then. I lost my appetite and had muscle aches and pain, sneezing and coughing, and a lot of mucus. I called the doctor's office for an upcoming procedure to tell them and they told me to test for COVID-19. I did and tested positive on Thursday. I called my PCP and they set up a tele-health appt. They recommended I take PAXLOVID and discussed underlying conditions. I started that last night. My heart rate has been a little high, doctor told me to monitor it, but it has come down since the appt.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; Pharmacy intern reported patient received their first dose of VARIVAX at 1 year old and recently received their second dose of VARIVAX at 19 years old.; This spontaneous report was received from a pharmacy intern referring to a 19-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On an unknown date (reported as " the patient at 1 year old"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided). On 11-AUG-2022 (also reported as "the patient at 19 year old"), the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (lot # T041686, expiration date: 10-DEC-2022, dose, strength and route of administration were not provided) (inappropriate schedule of product administration). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HEP, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was given RECOMBIVAX HB and PROQUAd that expired; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent with lot number W026513 and expiration date 15-APR-2025.  On 19-DEC-2022, the patient was vaccinated with expired vaccines including hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) lot number U008328 with expiration date 16-DEC-2022 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) with lot number U019285 and expiration date 15-DEC-2022.  The administered vaccines had not experienced temperature excursions prior to the date of administration and no adverse events or product quality complaints were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; HCP states that VARIVAX was administered to a patient on 12/19/2022 after a supported temperature excursion that took place on 12/1/2022. No additional AE information provided. No PQC.         ?    Names of vaccines involved (including lot/exp) VAR; This spontaneous report has been 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 19-DEC-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W021741 verified as valid, expiration date reported and upon internal review stablished as 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) after supported temperature excursion that happened on 01-DEC-2022 at a temperature of 19.4 Fahrenheit degrees (F) for 50 minutes (product storage error). No additional adverse event information provided.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; Caller reports a 2 year old male patient received PNEUMOVAX 23 instead of PREVNAR 13; This spontaneous report was received from a medical assistant referring to a 2-year-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 05-JUL-2022, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# U034712, expiration date upon internal review was established as 30-JUL-2023, strength and route were not reported) for prophylaxis instead of pneumococcal conjugate vaccine (13-valent) (PREVNAR 13) (wrong product administered). No previous doses were vaccinated. No additional adverse event (AE) details available. No additional AE reported (no adverse event).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibromyalgia, Herpes zoster, Post herpetic neuralgia
Clinical narrative: fibromyalgia; post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximately 75-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-FEB-2014, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, post-herpetic neuralgia and fibromyalgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster, post herpetic neuralgia and fibromyalgia to be related to zoster vaccine live (ZOSTAVAX).
Age: 41.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age, Viral titre decreased
Clinical narrative: titers tested low for mumps and varicella; a 41-year-old female patient was given PROQUAD; This spontaneous report was received from a registered nurse concerning a 41-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-DEC-2013, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #J003705, expiration date: 27-MAR-2015 (strength, and route of administration were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #J002502, expiration date: 28-FEB-2015 (strength, and route of administration were not provided), both administered as prophylaxis.  On 14-DEC-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012741, expiration date: 16-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age), because her recent titers tested low for mumps and varicella (Viral titre decreased). The patient needed to make sure her immunizations were up to date for upcoming nursing school, which is why they drew the titers. The outcome of the event of viral titre decreased was not reported.   The causal relationship between the event of viral titre decreased and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), varicella virus vaccine live (oka/merck) (VARIVAX), or  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was not reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Caller reports that an expired MMR II was administered to a patient on 27Oct2022; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concurrent condition and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 27-OCT-2022, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (1 dose, lot #T029550, expiration date upon internal review was established as 01-SEP-2022, strength and route were not reported) for prophylaxis (expired product administered).  The reporter confirmed that the dose was properly stored up through administration. The reporter was unable to provide sterile diluent lot/expiration date used with dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) but confirmed that it was not expired. No other adverse events reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # W009829 confirmed to be valid for formulation syringe with expiration date 19-OCT-2024 (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion of 32.7 Fahrenheit degrees for 118 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Age: 0.17
Sex: F
Vaccine: PNC15
Symptoms: Crying, Injection site pain
Clinical narrative: Cried; Injection site pain; This spontaneous report has been received from a physician, concerning a 2-month-old female patient, via Company representative.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis.  On an unknown date, after receiving pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the patient experienced injection site pain (Vaccination site pain) and she cried (Crying).  At the time of reporting, the outcome of both events was unknown.   The causal relationship between the vaccination site pain and crying with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported. No further information provided.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: Suspected vaccination faliure; Still got the flu.; Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a child female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 04-Jan-2023 Reporter's Comments:  The consumer reported about the babies by posting a PSA and encouraged all of us to vaccinate our kids.  The consumer reported that the 13 year kid and had only received the flu shot once as toddlers.  The patient got sick that year and never had the flu or shot since.  As a family, decided that it would be better to opt out of the flu shot.  The consumer stated that kids rarely get sick and we tried to refrain from prescription meds as much as possible. The CDC and FDA are money makers.  These people could not be encouraging anyone to vaccinate their children.  They should be encouraging people to do what would best for their family. This case had been linked with US2023AMR001611 same reporter. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2023AMR001611:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-Jan-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient did not experienced chickenpox. The patient received the Shingles vaccine and 1 month later the patient got shingles. The patient was asking someone to explain. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Not been to sleep since the shot; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th January 2023 15:00, the patient received Shingles vaccine. In January 2023, less than a day after receiving Shingles vaccine, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was not recovered/not resolved.   It was unknown if the reporter considered the insomnia to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 05-Jan-2023. Reporter's Comment:The case was reported by patient. The patient took the shingles shot yesterday at 3:00 and the patient not been able to sleep since. The patient had been up so what he/she could do. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine right about a year ago, but have not gotten the second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022, right about a year ago on left arm from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The reporter was the patient and did not want to give any further demographics. The patient did not get the second dose yet (till the time of reporting). The patient had planned on getting the second vaccine. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site pruritus
Clinical narrative: injection site is a little itchy; Upset stomach; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2022, the patient received Shingrix (intramuscular). On 30th December 2022, 1 days after receiving Shingrix, the patient experienced injection site itching, upset stomach and headache. On an unknown date, the outcome of the injection site itching, upset stomach and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, upset stomach and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jan-2023  Reporter's Comments: The patient would contacted to healthcare professional.  The reporter did not consent to follow up. Note: As per clarification the route of administration was considered as intramuscular.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   On 30th November 2022, the patient received the 2nd dose of Engerix B pediatric. On 30th November 2022, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's comments: A healthcare professional (HCP) had called to report that a pediatric dose of Engerix-B was given to an adult. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The adult patient had received the Engerix-B pediatric dose, which had led to adult use of a child product and underdose.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to a 18 years-old  Inappropriate age at vaccine administration; Adult dose given to a 18 years-old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml. On an unknown date, unknown after receiving Engerix B adult, the patient experienced inappropriate age at vaccine administration and overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and overdose were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comment: The pharmacist called to ask for information about the administration of adult dose 1 mL (20 mcg) Engerix-B to a patient.  The reporter mentioned that this was the first dose and asked if the patient had to complete the schedule of 2 more doses with the adult dose (20 mcg) or if the vaccination had to start over with the 0.5 mL (10 mcg) dose. The reporter consent to follow up. Additional supportive information: The 18 years old patient received 1 ml Engerix-B 20, which led to inappropriate age at vaccine administration and overdose.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Serology negative
Clinical narrative: Expired Engerix B administered; 1st dose on 18Sep2021, 2nd on 03Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Previously administered products included Engerix B (On 18th September 2021, received 1st dose).   On 3rd January 2023, the patient received the 2nd dose of Engerix B. On 3rd January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.    Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The patient never went back for second dose.  Titers were collected which were negative, so the patient was restarting the series today (on the day of reporting). At the time of reporting, a repeat dose had not been given following the expired dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow- up. Additional Supportive Information: Patient received dose of Engerix-B of expired date, which led to expired vaccine used. Patient received 2nd dose of Engerix-B late, which led to drug dose administration interval too long.
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Overdose
Clinical narrative: Kinrix and Daptacel received the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a child female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (DAPTACEL) for prophylaxis.   Previously administered products included Daptacel (On 16th August 2022, received 1st dose of Daptacel).   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device and the 2nd dose of DAPTACEL. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 03-Jan-2023. Reporter's Comment: The reporter called to report that a patient had received a dose of Kinrix the same day that the 2nd dose of Daptacel vaccine was received. The reporter did not specify the date of vaccination when Kinrix and Daptacel were given at the same time. The reporter consented to Follow-up. Additional Supportive Information: Patient received Kinrix and Daptacel the same day, which led to overdose of DTP component.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Dizziness; Weakness; Headache; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2023, the patient received the 1st dose of Shingrix. On 3rd January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th January 2023, the patient experienced dizziness, weakness and headache. On an unknown date, the outcome of the injection site pain, dizziness, weakness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness, weakness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jan-2023  Reporter's Comments: The case was reported by patient's husband. The reporter stated that the patient received first Shingrix vaccine day before the reporting. 24 hours later, the patient experienced dizziness, weakness, and headache.  The patient had soreness at the site of injection, immediately after getting the vaccine. The patient was still experiencing all of these symptoms.  The reporter did not have any further information regarding lot or expiration of the vaccine.  The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Skin warm, Vomiting
Clinical narrative: Vomiting/vomiting 6 times within 4 hours/The vomiting has resolved; Headache; Warm to touch; This case was reported by a nurse via call center representative and described the occurrence of skin warm in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5p2t7, expiry date 31st January 2026) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2023, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd January 2023, 1 hr after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vomiting and headache. In January 2023, the patient experienced skin warm. On an unknown date, the outcome of the skin warm was unknown and the outcome of the vomiting was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the skin warm, vomiting and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's comments: The nurse had reported that a 16 year old patient who had received her second dose of Bexsero a day before reporting.  Within one hour, the patient had experienced a headache and vomiting (vomiting 6 times within 4 hours). The patient was also warm to touch and according to the patient mother who was also an MD. No temperature was available. At the time of reporting the vomiting has resolved but not the headache. The reporter had consented to follow-up. Additional supportive information:  Less than an week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced skin warm.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 13months ago, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comment: The HCP (Health care professional) called to ask for information about a patient who received the first dose of Shingrix 13 months ago. The reporter asked about safety information regarding the administration of the second dose. The reporter did not provide the lot number and expiration date of the first Shingrx dose administered.  During this call the HCP was asking how to proceed with the administration of the 2nd dose of Shingrix. The second dose was not yet administered at the time of the call. The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Wrong technique in product usage process
Clinical narrative: received Shingrix and Pneumococcal shot in left arm; pain in (Left) arm/pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 4th January 2023, the patient received Shingrix and PNEUMOCOCCAL VACCINE (intramuscular). On 4th January 2023, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. In January 2023, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: The patient stated that she received Shingrix and Pneumococcal shot in left arm. She stated that she was having pain now and was concerned. Spoke per FAQ content. Referred to healthcare professional. Adverse event filed with limited information, patient did not want to provide and further information and disconnected the call. The adverse event was filed and did not consent to follow up. Additional Supportive Information: The patient Shingrix and Pneumococcal shot in left arm, which led to wrong technique in product usage process. It was unknown if the reporter considered the injection site pain to be related to Pneumococcal vaccine.
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st had Trumenba and then Bexsero; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In June 2022, the patient received the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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-JAN-2023 Reporter's Comments: The reporter was the mother (nurse) of the patient.  The reporter wanted to remain completely anonymous and would not provide any demographic information.  She did not even want an adverse event report filed. The patient just got her vaccination for Meningococcal B, but they actually gave her the wrong one.  She had a Trumenba vaccination in and was supposed to get her second dose in December (2022).  The patient went and the pharmacist gave her the Bexsero. The reporter stated that she had the lot number for Bexsero but refused to provide it. The reporter provided limited information The reporter did not consent to follow-up. Additional Supportive Information: The patient received Bexsero instead of Trumenba, which led to Interchange of vaccine products.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Got a little bit of the vaccine, some went out; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 397b5, expiry date 30th November 2024) for prophylaxis.   On 5th January 2023, the patient received Boostrix. On 5th January 2023, unknown after receiving Boostrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The pharmacist reported an intern while administering Boostrix, the patient jerked the arm, he was able to get a little bit of the vaccine in but then the patient jerked the arm and some went out The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received little bit of the Boostrix vaccine, which led to incomplete dose administered.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA748A, expiry date 13th September 2024) for prophylaxis.   On 28th November 2022, the patient received Menveo. On 28th November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: A pharmacy manager called to ask for information about the administration of only the liquid component of Menveo.  The pharmacy manager asked for safety information and if patients had to be revaccinated. The reporter consented to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient only received the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023002251:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS/ISSUES; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects/issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects/issues was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever. This report was non-serious. This case, involving the same patient is linked.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional via another pharmaceutical company (Pfizer) concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The patient experienced body aches, chills and fever (Dose number in series 1). The patient recovered from body aches, chills, and fever. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was ill and was feeling sick and experienced body aches, chills, and fever for 10-12 hours following vaccine administration (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever. This report was non-serious. This case, involving the same patient is linked.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized for an unknown number of days and died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120832 and 20230120898.; Sender's Comments: V0: 20230120818-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 99.7; This case was reported by a consumer and described the occurrence of fever in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol), gabapentin and hydrocodone.   On 4th January 2023, the patient received Shingrix. On 4th January 2023, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comments: This report was submitted via the customer via reporting system. The patient stated that she had fever 99.7 degree Farhenit from: 4 Jan 2023 to ongoing Shingrix vaccine manufacturer, unspecified expiry date of Shingrix vaccine was unknown. The reporter had consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Severe headache; Severe chills; Shaking; Terrible body aches; This case was reported by a consumer and described the occurrence of headache in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times in life, did not had them for several years).   On 28th December 2022, the patient received Shingles vaccine. On 28th December 2022, less than a day after receiving Shingles vaccine, the patient experienced headache, chills, tremor and general body pain. On 30th December 2022, the outcome of the headache, chills, tremor and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache, chills, tremor and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-Jan-2023. Reporter's Comments: The patient self-reported this case. The reporter mentioned this shot was terrible.  The reporter never had to have another one and severe headache, severe chills, shaking and terrible body aches and stated that the symptoms were treated.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: woman who passed away after receiving the Moderna bivalent booster dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (woman who passed away after receiving the Moderna bivalent booster dose) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided.  Company comment: This is a spontaneous case female patient of unknown gender, with no medical history, who experienced unexpected fatal serious (medically significant) event of death (reported as woman who passed away after receiving the Moderna bivalent booster dose), which occurred unspecified days after booster dose of mRNA-1273 bivalent BA.1 vaccine. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 bivalent BA.1 vaccine is not affected by this report.; Reported Cause(s) of Death: woman who passed away after receiving the Moderna bivalent booster dose