chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: DTPPVHBHPB, HEP
Symptoms: No adverse event
Clinical narrative: No additional AE reported.; Customer called and reported that at a 2 month well baby checkup, a 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine. No additional AE reported. No PQC reported. No additional information; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-Apr-2025, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y004552, expiration date: 14-Oct-2026) (dose, route of administration and vaccination site were not reported) for prophylaxis; and with a dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered from prophylaxis.  On that day, a 1 month and 30-day old consumer inadvertently received the Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) concomitantly with the Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (overdose). No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided.  Lot # is being requested and will be submitted if received.; Reporter's Comments:
Vaccine: FLUN3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report has been received from a physician. The report concerns a female patient of (redacted) ethnic origin born in 1980 (age 44 years, height 160 cm, weight 58.966 kg).  The patient's past and current medical history included diarrhea (ongoing).  No concomitant products were reported.  The patient received Flumist (batch number(s) Unknown), via unspecified route, on 19-OCT-2024. The patient received 1 dose(s).    On 19-OCT-2024, the patient experienced diarrhea (preferred term: Diarrhoea).      The patient recovered from the event(s) diarrhea after 1 day on 19-OCT-2024.       The event was considered non-serious.      Device Information:  Combination Product Report: Yes  Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No  Non-Significant correction on 06-Jan-2025: Vaccine Facility Information added. Narrative amended. DCR-008762-A
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea, Pyrexia
Clinical narrative: Chest Tightness; Difficulty Breathing; Feverish; Initial report received on 13-Mar-2025.    A nurse reported that a 33-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced chest tightness, difficulty breathing, and felt feverish.   No medical history or concomitant medications were reported.     On 05-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 945659, 31-Jan-2025, NDC # 43528-003-05)] intramuscularly in the right deltoid. Concomitant vaccines administered included an unknown dose of a typhoid vaccine (Lot #, expiration date, NDC #, route not reported)] in the right deltoid, and an unknown dose of a hepatitis A vaccine (Lot #, expiration date, NDC #, route not reported) in the left deltoid.  The vaccines were given in preparation for travel.  On 07-Mar-2025, the patient called and reported that he went to the ER with chest tightness and difficult breathing.  The patient also reported feeling  feverish.  The patient had "testing" completed at the ER which ruled out any potential issues.  The patient was discharged home.   No other information was reported.      Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Eye swelling, Swelling face, Urticaria
Clinical narrative: Face Swelling, 2-3 Times Larger; Eye Swelling; Redness All Over; 1st Injection in July 2024 and Never Returned; Hives All Over; Initial report received on 18-Mar-2025.   A reporter reported that a 22-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced incomplete course of vaccination, facial swelling, eye swelling, hives all over, and redness all over.   No medical history or concomitant medications were reported.   In Jul-2024, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)].  The patient never returned for the next dose.  On 18-Feb-2025, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)] to begin a new series.   On 18-Mar-2025, 28 days after the first dose, dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945663, expiration date 31-Jan-2027, NDC # not reported) was administered intramuscularly in the right deltoid.     On 18-Mar-2025, two hours after injection, the patient came back to the clinic with facial swelling (described as 2-3 times larger), eye swelling, hives all over, and redness all over. The patient was treated with 50 mg of BENADRYL (diphenhydramine) intramuscularly.  The patient left the facility with a parent.   No other information was reported.      Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Had the first dose of Heplisav-B on 24JAN2025, and has not had the second dose yet; Initial report received on 19-Mar-2025.    A consumer reported that she, a female (race, age, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.    No medical history or concomitant vaccines were reported.     On 24-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available).   At the time of the report, 54 days after receiving dose 1 of HEPLISAV-B, the patient had not received the second dose yet.   The reporter declined to provide further information.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received Heplisav-B As First Dose, and Second Dose was Engerix-B; Initial report received on 19-Mar-2025.    A nurse reported that a 21-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENGERIX-B as the second dose.   No medical history or concomitant medications were reported.    On 13-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943191, expiration date 21-Feb-2026, NDC # not reported)] intramuscularly in left deltoid.   On an unknown date, the patient received ENGERIX-B (no details provided) as the second dose. There were no other side effects.   No other information was available.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 1st Dose on 04NOV2023 and now She is Here for the Second Dose; Initial report received on 21-Mar-2025.    A pharmacist reported that a 53-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 04-Nov-2023 and returned to receive the second dose on 21-Nov-2025.   No medical history or concomitant medications were reported.     On 04-Nov-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, site not reported)].    On 21-Mar-2025, 503 days after having been vaccinated with HEPLISAV-B, the patient presented to the pharmacy to receive the second dose.    No additional information was reported.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Viral titre decreased
Clinical narrative: Titer Drawn and it was Low; Initial report received on 21-Mar-2025.    A pharmacist reported that a 57-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer drawn and it was low.   Medical history and concomitant medications at the time of vaccination were not reported.    On 28-Jul-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)].   29-Aug-2023, 32 days after having been vaccinated with first dose of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)].  On an unknown date, the patient had a titer drawn and it was low. Her physician recommended to get another dose of HEPLISAV-B.   No additional information was reported.      Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Shortness of Breath; Tongue Swelling; This serious case was reported by a pharmacist via sales rep and described the occurrence of shortness of breath in a female patient who received Herpes zoster (Shingrix) (batch number 3BD9E) for prophylaxis.   On 22-NOV-2021, the patient received the 1st dose of Shingrix. On 22-NOV-2021, less than a day after receiving Shingrix, the patient experienced shortness of breath (Verbatim: Shortness of Breath) (serious criteria hospitalization) and swollen tongue (Verbatim: Tongue Swelling) (serious criteria hospitalization). The outcome of the shortness of breath and swollen tongue were resolved.   The reporter considered the shortness of breath and swollen tongue to be related to Shingrix.     The company considered the shortness of breath and swollen tongue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 The patient accepted the first dose of Shingrix. She waited 15 minutes in office after.  The patient drove home and had tongue swelling and shortness of breath. Immediately she drove back to the hospital because of reaction.; Sender's Comments: Dyspnoea is an unlisted event, due to the following criteria (strong temporal association) is considered related to GSK vaccine Shingrix Swollen tongue is a  listed event which is considered related to a GSK vaccine Shingrix
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac dysfunction, Echocardiogram abnormal, Ejection fraction, Hypotension
Clinical narrative: reduced cardiac function; elevated cardiac enzymes; low blood pressure; weakness; low grade fever; elevated pro-BNP; This serious case was reported by a physician via sales rep and described the occurrence of cardiac function decreased in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (Patient undergone Heart transplant 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac function decreased (Verbatim: reduced cardiac function) (serious criteria GSK medically significant), cardiac enzymes increased (Verbatim: elevated cardiac enzymes) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: low blood pressure), weakness (Verbatim: weakness), low grade fever (Verbatim: low grade fever) and nt-probnp increased (Verbatim: elevated pro-BNP). The outcome of the cardiac function decreased was not reported and the outcome of the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased were resolved.   It was unknown if the reporter considered the cardiac function decreased to be related to Shingrix. The reporter considered the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be related to Shingrix.     The company considered the cardiac function decreased, cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2025 Reporter stated that patient who is about 22-year-old and 2 years post-heart transplant on IC who received second dose of Shingrix vaccine and within 12 hours started having symptoms low BP, weakness and low-grade fever.  He was seen at ED, ECHO performed showed reduced cardiac function no values provided for LVEF.  Lab work showed elevated pro-BNP and cardiac enzymes.  The patient did not require hospitalization and was only seen for follow-up at the clinic.; Sender's Comments: Cardiac dysfunction and Myocardial necrosis marker increased are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Myocardial necrosis marker increased, N-terminal prohormone brain natriuretic peptide increased, Pyrexia
Clinical narrative: reduced cardiac function; elevated cardiac enzymes; low blood pressure; weakness; low grade fever; elevated pro-BNP; This serious case was reported by a physician via sales rep and described the occurrence of cardiac function decreased in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (Patient undergone Heart transplant 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac function decreased (Verbatim: reduced cardiac function) (serious criteria GSK medically significant), cardiac enzymes increased (Verbatim: elevated cardiac enzymes) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: low blood pressure), weakness (Verbatim: weakness), low grade fever (Verbatim: low grade fever) and nt-probnp increased (Verbatim: elevated pro-BNP). The outcome of the cardiac function decreased was not reported and the outcome of the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased were resolved.   It was unknown if the reporter considered the cardiac function decreased to be related to Shingrix. The reporter considered the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be related to Shingrix.     The company considered the cardiac function decreased, cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2025 Reporter stated that patient who is about 22-year-old and 2 years post-heart transplant on IC who received second dose of Shingrix vaccine and within 12 hours started having symptoms low BP, weakness and low-grade fever.  He was seen at ED, ECHO performed showed reduced cardiac function no values provided for LVEF.  Lab work showed elevated pro-BNP and cardiac enzymes.  The patient did not require hospitalization and was only seen for follow-up at the clinic.; Sender's Comments: Cardiac dysfunction and Myocardial necrosis marker increased are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: peripheral neuropathy in feet and leg.; This serious case was reported by a consumer via interactive digital media and described the occurrence of peripheral neuropathy in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: peripheral neuropathy in feet and leg.) (serious criteria disability and GSK medically significant). The outcome of the peripheral neuropathy was not resolved.   The reporter considered the peripheral neuropathy to be related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient wished she would have never taken the Shingles vaccine.  She reported that she had been dealing with the effects for several years. Almost like having inner shingles.  The patient experienced burning tingling and loss of feeling in feet and legs. She continued to have peripheral neuropathy in feet and legs.  She stated that the physician just treated symptoms with every drug imaginable.; Sender's Comments: Neuropathy peripheral  is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Sex: F
Vaccine: RVX
Symptoms: Gait inability
Clinical narrative: next day could not walk still can not; This serious case was reported by a consumer via interactive digital media and described the occurrence of unable to walk in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In OCT-2023, the patient received RSV vaccine. In OCT-2023, 1 day after receiving RSV vaccine, the patient experienced unable to walk (Verbatim: next day could not walk still can not) (serious criteria disability). The outcome of the unable to walk was not resolved.   It was unknown if the reporter considered the unable to walk to be related to RSV vaccine.     The company considered the unable to walk to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his wife got the shot in October 2023 next day could not walk still could not. The doctor said nothing could do help, be very careful of this shot.; Sender's Comments: Gait inability is an unlisted event which is considered unrelated to GSK RSV vaccine.
Vaccine: VARZOS
Symptoms: Gait inability, Vertigo
Clinical narrative: worst case of vertigo (hospital stay); Over a month before I could walk carefully again never had before; This serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a 74-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles is bad).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vertigo (Verbatim: worst case of vertigo (hospital stay)) (serious criteria hospitalization) and unable to walk (Verbatim: Over a month before I could walk carefully again never had before) (serious criteria hospitalization). The outcome of the vertigo was not reported and the outcome of the unable to walk was resolving.   It was unknown if the reporter considered the vertigo and unable to walk to be related to Shingles vaccine.     The company considered the vertigo and unable to walk to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated that shingles was bad and did got one shot of Shingles vaccine (after years of suffering) when it was basically over.  The patient got something from shot and his/her doctor told him/her to hold back on second and nobody came up with an answer, but after shot the patient got the worst case of vertigo and had a hospital stay.  Over a month before I could walk carefully again never had before, otherwise in good health.; Sender's Comments: Vertigo and Gait inability  are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: the pediatric dose of haverix instead of the adult dose; received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 21-year-old female patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   Previously administered products included Hepatitis A vaccine (got a previous Hepatitis A pediatric dose on 6 March 2009).   On 07-MAR-2025, the patient received Havrix 720 (intramuscular, left deltoid) .5 ml. On 07-MAR-2025, an unknown time after receiving Havrix 720, the patient experienced adult use of a child product (Verbatim: the pediatric dose of haverix instead of the adult dose) and underdose (Verbatim: received a pediatric dose of Havrix). The outcome of the adult use of a child product and underdose were not applicable.   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: 17-MAR-2025 The reporter was a Medical Assistant for a medical office.  An adult patient received the pediatric dose of HAVRIX (0.5ml) instead of the adult dose which led to adult use of a child product and underdose. Further, when the call was transferred to Medical Information line, the Medical Assistant explained that it was not the first Hepatitis A dose as mentioned to the prior agent but patient got a previous Hepatitis A pediatric dose on March 6th 2009.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Pain, Pain in extremity, Rash, Rash vesicular
Clinical narrative: pregnant patient received Shingrix; vesicular rash on both arms, neck and chest; burning pain similar to sunburn/painful arm; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2026) for prophylaxis.   On 03-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 14-MAR-2025, 11 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: vesicular rash on both arms, neck and chest) and pain burning (Verbatim: burning pain similar to sunburn/painful arm). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Shingrix). The outcome of the vesicular rash and pain burning were unknown and the outcome of the vaccine exposure during pregnancy was not applicable.   It was unknown if the reporter considered the vesicular rash and pain burning to be related to Shingrix.     It was unknown if the company considered the vesicular rash and pain burning to be related to Shingrix.    Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter stated that the patient received her first Shingrix injection in her left deltoid on 3-Mar-2025.  On 14-Mar-2025 she presented with a vesicular rash on both arms, neck and chest and the rash was giving her burning pain similar to sunburn. Pregnant patient received Shingrix, which led to vaccine exposure during  pregnancy.
Sex: F
Vaccine: TDAP
Symptoms: Breast cancer female, Chest pain, Dyspnoea, Muscle spasms, Tetanus
Clinical narrative: Tetanus-like; Lockjaw; Clot blood; Muscle spasms; Chest pain; Shortness of breath; Breast cancer in 2024; This serious case was reported by a consumer via call center representative and described the occurrence of tetanus-like in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   Concurrent medical conditions included hyperlipidemia and type ii diabetes mellitus (NIDDM). Concomitant products included rosuvastatin, ezetimibe (Zetia), fenofibrate and tirzepatide (Mounjaro).   In APR-2023, the patient received Boostrix (intramuscular, left deltoid). On 05-MAR-2025, between 1 and 2 years after receiving Boostrix, the patient experienced tetanus-like (Verbatim: Tetanus-like) (serious criteria hospitalization and GSK medically significant), lockjaw (Verbatim: Lockjaw) (serious criteria hospitalization), clot blood (Verbatim: Clot blood) (serious criteria hospitalization and GSK medically significant), muscle spasm (Verbatim: Muscle spasms) (serious criteria hospitalization), chest pain (Verbatim: Chest pain) (serious criteria hospitalization) and shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization). On an unknown date, the patient experienced breast cancer (Verbatim: Breast cancer in 2024) (serious criteria GSK medically significant). On 12-MAR-2025, the outcome of the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain and shortness of breath were unknown (duration 7 days). The outcome of the breast cancer was resolved.   It was unknown if the reporter considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be related to Boostrix.     The company considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be unrelated to Boostrix.   Additional Information: GSK Receipt Date: 19-MAR-2025 The patient self-reported this case. The patient reported that she received a Boostrix injection in April 2023.  On 5-Mar-2025, she was admitted to the hospital with tetanus-like symptoms. She was not officially diagnosed with tetanus but suffered with lockjaw, blood clots, muscle spasms, chest pain and shortness of breath.; Sender's Comments: Tetanus, Trismus, Thrombosis, Muscle spasms, Chest pain, Dyspnoea and Breast cancer are unlisted events which are considered unrelated to GSK vaccine Boostrix.
Sex: F
Vaccine: TDAP
Symptoms: Thrombosis, Trismus
Clinical narrative: Tetanus-like; Lockjaw; Clot blood; Muscle spasms; Chest pain; Shortness of breath; Breast cancer in 2024; This serious case was reported by a consumer via call center representative and described the occurrence of tetanus-like in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   Concurrent medical conditions included hyperlipidemia and type ii diabetes mellitus (NIDDM). Concomitant products included rosuvastatin, ezetimibe (Zetia), fenofibrate and tirzepatide (Mounjaro).   In APR-2023, the patient received Boostrix (intramuscular, left deltoid). On 05-MAR-2025, between 1 and 2 years after receiving Boostrix, the patient experienced tetanus-like (Verbatim: Tetanus-like) (serious criteria hospitalization and GSK medically significant), lockjaw (Verbatim: Lockjaw) (serious criteria hospitalization), clot blood (Verbatim: Clot blood) (serious criteria hospitalization and GSK medically significant), muscle spasm (Verbatim: Muscle spasms) (serious criteria hospitalization), chest pain (Verbatim: Chest pain) (serious criteria hospitalization) and shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization). On an unknown date, the patient experienced breast cancer (Verbatim: Breast cancer in 2024) (serious criteria GSK medically significant). On 12-MAR-2025, the outcome of the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain and shortness of breath were unknown (duration 7 days). The outcome of the breast cancer was resolved.   It was unknown if the reporter considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be related to Boostrix.     The company considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be unrelated to Boostrix.   Additional Information: GSK Receipt Date: 19-MAR-2025 The patient self-reported this case. The patient reported that she received a Boostrix injection in April 2023.  On 5-Mar-2025, she was admitted to the hospital with tetanus-like symptoms. She was not officially diagnosed with tetanus but suffered with lockjaw, blood clots, muscle spasms, chest pain and shortness of breath.; Sender's Comments: Tetanus, Trismus, Thrombosis, Muscle spasms, Chest pain, Dyspnoea and Breast cancer are unlisted events which are considered unrelated to GSK vaccine Boostrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypohidrosis, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; not sweating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and valaciclovir hydrochloride (Valtrex) cream for shingles.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Valtrex. On an unknown date, less than a year after receiving Shingrix and Shingrix and not applicable after starting Valtrex, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and sweating decreased (Verbatim: not sweating). The action taken with Valtrex was unknown. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the sweating decreased was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the reporter considered the sweating decreased to be related to Valtrex.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the company considered the sweating decreased to be related to Valtrex.   Additional Information: GSK Receipt Date: 19-MAR-2025 The patient received 1st and 2nd dose of Shingrix vaccine in 2024 and was feeling fine.  In 2024, the patient experienced Shingles. In 2025, the patient was not sweating. The reporter reported sweating as usual.  Patient stated the health care professional prescribed her Valtrex for her Shingles, and she noticed after starting the Valtrex in 2025 that her body stopped sweating as usual.  She had gone to 4 health care professional and wondered why this was happening and no one seems to answer.  The reporter did not to release any health care professional name and numbers. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and dose 2)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: she noticed tingling and numbness in her fingertips on both arms; she noticed tingling and numbness in her fingertips on both arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-MAR-2025, the patient received the 2nd dose of Shingrix (left arm). In MAR-2025, less than 2 weeks after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: she noticed tingling and numbness in her fingertips on both arms) and numbness of upper arm (Verbatim: she noticed tingling and numbness in her fingertips on both arms). The outcome of the tingling of extremity and numbness of upper arm were unknown.   It was unknown if the reporter considered the tingling of extremity and numbness of upper arm to be related to Shingrix.     It was unknown if the company considered the tingling of extremity and numbness of upper arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2025: Reporter was the patient who states that she received her second dose of Shingrix on 7 March 2025 on her left arm. This past week, she noticed tingling and numbness in her fingertips on both arms.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 01-SEP-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that the patient received the first dose of Shingrix on September 1, 2024.  The patient had not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 month old given Menveo (pink cap) in her left leg quad; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis.   On 20-MAR-2025, the patient received Menveo .5 ml. On 20-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 12 month old given Menveo (pink cap) in her left leg quad). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter called to speak to medical information department. The reporter stated that they gave a 12 month old a dose of Menveo (pink cap) in her left leg quad which led to inappropriate age at vaccine administration. This presentation was for use in individuals 10 through 55 years of age. Parents of minor child were not notified as of the time of call.
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated
Clinical narrative: worsening of arthritis; This non-serious case was reported by a consumer via call center representative and described the occurrence of arthritis aggravated in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included joint replacement (joint replacement surgeries on his knees bilaterally and his left hip) and shingles. Concurrent medical conditions included arthritis and hypertension. Concomitant products included meloxicam.   On 13-FEB-2025, the patient received Shingrix. On 01-MAR-2025, 16 days after receiving Shingrix, the patient experienced arthritis aggravated (Verbatim: worsening of arthritis). The outcome of the arthritis aggravated was not resolved.   It was unknown if the reporter considered the arthritis aggravated to be related to Shingrix.     It was unknown if the company considered the arthritis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2025 The patient called to inquire whether Shingrix can cause existing arthritis to worsen.  He reported a history of arthritis including joint replacement surgeries on his knees bilaterally and his left hip.  He stated that the arthritis pain in his left shoulder began to worsen around 1-Mar-2025 and gradually worsened since that date.  The patient also had a shingles infection before he received the Shingrix vaccine, and waited until the vesicles were healed to get the vaccine.  He refused to provide any additional information including his name, telephone and address and also refused to provide his initials and date of birth for this report.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first dose of Shingrix in November 2022 and the second dose in October 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2022).   In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received her first dose of Shingrix in November 2022 and the second dose in October 2024). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 21-MAR-2025 The patient is the reporter. The patient received her first dose of Shingrix in November 2022 and the second dose in October 2024 which led to lengthening of vaccinations schedule. (Drug dose administration interval too long).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient had first dose 18 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 21-MAR-2025 The patient received his first dose of Shingrix approximately 18 months ago and he has not yet had the 2nd dose. Till the time of reporting the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging abnormal, Muscle rupture, Pain in extremity
Clinical narrative: Torn muscle; Painful arm; This serious case was reported by a other health professional via call center representative and described the occurrence of torn muscle in a 47-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4s5YG, expiry date 30-JUN-2025) for prophylaxis.   On 16-DEC-2024, the patient received FluLaval 2024-2025 season (intramuscular). On 16-DEC-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced torn muscle (Verbatim: Torn muscle) (serious criteria GSK medically significant) and pain in arm (Verbatim: Painful arm). The outcome of the torn muscle and pain in arm were resolving.   The reporter considered the torn muscle and pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     The company considered the torn muscle to be unrelated to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval 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: 21-MAR-2025 The patient received Flulaval vaccine and experienced pain in the left arm and magnetic resonance imaging showing a torn muscle.; Sender's Comments: Muscle rupture is an unlisted event which is considered unrelated to GSK vaccine FluLaval 2024-2025 season and FluLaval PRE-FILLED SYRINGE DEVICE.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administration of Engerix B -Pediatric instead of Engerix B- Adult; received administration of Engerix B -Pediatric; This non-serious case was reported by a other health professional via sales rep and described the occurrence of adult use of a child product in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number k4JH7, expiry date 19-JUL-2026) for prophylaxis.   On 14-MAR-2025, the patient received the 1st dose of Engerix B pediatric (left arm). On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of Engerix B -Pediatric instead of Engerix B- Adult) and underdose (Verbatim: received administration of Engerix B -Pediatric). The outcome of the adult use of a child product and underdose were not applicable.   Additional Information: GSK Receipt Date: 24-MAR-2025 The reporter reported that the patient was an adult received administration of Engerix B -Pediatric instead of Engerix B- Adult, which led to adult use of a child product and underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Headache, Nausea
Clinical narrative: arm had huge red and hot circle 4 inches plus in size; Nausea; tiredness; pain in arm; Headache is intermittent; arm had huge red and hot circle 4 inches plus in size; dizziness; This non-serious case was reported by a consumer and described the occurrence of erythema in a 74-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (did not have any side effects with first Shingles shot). Concomitant products included tramadol hydrochloride (Tramadol), etodolac, lorazepam, estradiol benzoate (Estradiol) and Centrum Silver.   On 19-MAR-2025 10:52, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced dizziness (Verbatim: dizziness). On 20-MAR-2025, the patient experienced erythema (Verbatim: arm had huge red and hot circle 4 inches plus in size), nausea (Verbatim: Nausea), tiredness (Verbatim: tiredness), pain in arm (Verbatim: pain in arm), intermittent headache (Verbatim: Headache is intermittent) and extremities hot feeling of (Verbatim: arm had huge red and hot circle 4 inches plus in size). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the erythema, nausea, tiredness, pain in arm, intermittent headache and extremities hot feeling of were not resolved and the outcome of the dizziness was not reported.   It was unknown if the reporter considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2025 The patient was the reporter. The Shingles vaccine shot was administered at 10:52 Wednesday, 19th March 2025, symptoms became evident within a few hours, by Thursday 20th March 2025, the arm had very red, hot circle, which continued to grow throughout Thursday, Friday, Saturday, (it had grown to 4 inches from top to bottom) Sunday and today, Monday 24th March 2025. However it was getting lighter in color, it is growing to the underside of my arm, still painful. Headache was intermittent. Have been icing the site, alternating Advil and Tylenol for headache, and resting, also had dizziness. The patient also experienced the same thing with Covid shot. Did not have any side effects with first Shingles shot. The symptoms were not treated.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: arm had huge red and hot circle 4 inches plus in size; Nausea; tiredness; pain in arm; Headache is intermittent; arm had huge red and hot circle 4 inches plus in size; dizziness; This non-serious case was reported by a consumer and described the occurrence of erythema in a 74-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (did not have any side effects with first Shingles shot). Concomitant products included tramadol hydrochloride (Tramadol), etodolac, lorazepam, estradiol benzoate (Estradiol) and Centrum Silver.   On 19-MAR-2025 10:52, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced dizziness (Verbatim: dizziness). On 20-MAR-2025, the patient experienced erythema (Verbatim: arm had huge red and hot circle 4 inches plus in size), nausea (Verbatim: Nausea), tiredness (Verbatim: tiredness), pain in arm (Verbatim: pain in arm), intermittent headache (Verbatim: Headache is intermittent) and extremities hot feeling of (Verbatim: arm had huge red and hot circle 4 inches plus in size). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the erythema, nausea, tiredness, pain in arm, intermittent headache and extremities hot feeling of were not resolved and the outcome of the dizziness was not reported.   It was unknown if the reporter considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2025 The patient was the reporter. The Shingles vaccine shot was administered at 10:52 Wednesday, 19th March 2025, symptoms became evident within a few hours, by Thursday 20th March 2025, the arm had very red, hot circle, which continued to grow throughout Thursday, Friday, Saturday, (it had grown to 4 inches from top to bottom) Sunday and today, Monday 24th March 2025. However it was getting lighter in color, it is growing to the underside of my arm, still painful. Headache was intermittent. Have been icing the site, alternating Advil and Tylenol for headache, and resting, also had dizziness. The patient also experienced the same thing with Covid shot. Did not have any side effects with first Shingles shot. The symptoms were not treated.