chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Back pain
Clinical narrative: Customer started experiencing intense back pain after receiving the VARIVAX vaccine; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      On 07-OCT-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, frequency, lot#, and expiration date were not reported) for prophylaxis.         On 19-OCT-2024, the patient experienced intense back pain after receiving the varicella virus vaccine live (oka/merck) (VARIVAX) vaccine.  The outcome of back pain was reported as not recovered. The causality was not provided.      Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Labelled drug-drug interaction issue
Clinical narrative: red bump; red patches; Labeled drug-drug interaction issue; miscommunication from prescribers; This spontaneous report was received from a patient's mother via another company and refers to an 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2024, the patient was vaccinated with 1st dose of varicella virus vaccine live (oka/merck) (VARICELLA VIRUS VACCINE LIVE (OKA/MERCK)) injection, administered for immunisation (strength, lot #, expiry date, and route of administration were not provided); 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MEASLES, MUMPS, AND RUBELLA (WISTAR RA 27-3) VIRUS VACC, LIVE) injection, administered for immunisation (strength, lot #, expiry date, and route of administration were not provided); and 1st dose of dupilumab via Dupixent single dose prefilled pen, 175 milligram per millilitre solution for injection, 200 milligram, every 4 weeks administered subcutaneously for eczema infantile (lot #, and expiry date were not provided) (Labelled drug-drug interaction issue). There has been miscommunication from prescribers, the patient had received live vaccines and doses were adjusted due to that incidence (Product communication issue). The patient only received 3 doses so far.  On an unknown date in September 2024, the patient experienced red bump and red patches after injection last time (approximately 1 month latency) (Skin mass, Rash erythematous). The patient did not have itchiness, no bleeding, but still some red patches. The patient was using topical cream daily still. The mother reported the patient's condition improved a bit. On an unknown date in 2024, the patient recovered from the event of red bump (reported that disappeared after two days). At the time of reporting, the patient was recovering from the event of red patches.   The action taken with varicella virus vaccine live (oka/merck) (VARICELLA VIRUS VACCINE LIVE (OKA/MERCK)) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MEASLES, MUMPS, AND RUBELLA (WISTAR RA 27-3) VIRUS VACC, LIVE) regarding skin mass and rash erythematous was not applicable. The action taken with dupilumab regarding both events was unknown.  The causal relationship between skin mass and rash erythematous and suspect drug and suspect vaccines was not provided.  Lot# is being requested and will be submitted if received.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP notified that a 15-month-old child was given PROQUAD and VARIVAX together/the HCP administered the 2 vaccines together on accident; This spontaneous report was received from a company representative and refers to a 15-month-old child of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-OCT-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, lot #, expiry date, route of administration and vaccination site were not provided), and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, lot #, expiry date, route of administration and vaccination site were not provided), both administered for prophylaxis. Therefore, on that day, the health care professional (HCP) administered the two vaccines together on accident (accidental overdose). No adverse side effects were reported. No additional information was available at this time. No additional adverse event (AE)and no product quality complaint (PQC) was noted (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 0.75
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; inadvertent administration of PNEUMOVAX 23 to a 9-month-old infant; This spontaneous report was received from a registered nurse and refers to a 9-month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 13-JUN-2024, the patient was inadvertent vaccinated with a dose of pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23), (dose, route, anatomical location, lot number and expiration  date were not reported) for prophylaxis (accidental exposure to product). No additional adverse events were reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptomatic adverse events were reported; the patient received their second dose of VAQTA before the required six month interval; This spontaneous report was received from a Registered Nurse (R.N) concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.        On 06-MAY-2024 the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route, lot#, and expiration date were not reported) for prophylaxis.      On 08-OCT-2024, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA)syringe injection, Lot# X025163, expiration date: 12-MAY-2025 (dose and route were not reported) for prophylaxis.   The patient received their second dose of hepatitis a vaccine, inactivated (VAQTA) before the required six-month interval (inappropriate schedule of product administration). No symptomatic adverse events were reported (no adverse event).
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: The patient then developed rotavirus; This spontaneous report was received from a vaccine coordinator register nurse (RN) via a company representative, referring to a 3-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2024, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #2032347, expiration date: 22-OCT-2025, administered orally for prophylaxis (strength was not provided).   Then on that day, the patient developed rotavirus (rotavirus infection). On an unknown date, the patient was admitted to the hospital due to the event (pending clarification). It was unclear why the patient was initially in the hospital. At the time of reporting, the patient was recovering from the event. The action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding the event was not applicable.   The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD may have been inadvertently administered to multiple patients after the TE occurred. Nurse reports TE occurred on 08/26/24 and could have been administered from 08/26/24 until today 9/17/24; Product administration error (Indicate at which point in the process the medication error ocurred: administration); This spontaneous report was received from a Nurse and refers to a 5-year-old White hispanic or latino female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 26-AUG-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) vaccines, experienced a temperature excursion (TE) of -12.7 degrees Celsius (C) during a time frame of 30 minutes.   On 05-SEP-2024, the patient was inadvertently vaccinated with improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y008885, expiration date: 03-NOV-2025, administered intramuscularly at public health clinic/ hospital purchased with public funds as prophylaxis (strength, exact dose and anatomical locations were not provided) (Product storage error). The point in the process the medication error occurred was reported as administration (Product administration error). No treatment was prescribed for the adverse events. Operator of vaccine /device was a trained healthcare professional. The outcome of Product storage error and Product administration error was reported as recovered.  No additional adverse event (AE) was reported.  It was reported that from 26-AUG-2024 until 17-SEP-2024, 5 measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), lot #Y008885, expiration date: 03-NOV-2025, were administered. Temperature excursion checked with the company; vaccines were still viable.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA013461:Original Case : 2409USA006137 US-009507513-2409USA006137:Original Case : 2409USA006137 US-009507513-2410USA013459:Original Case : 2409USA006137 US-009507513-2410USA013460:Original Case : 2409USA006137
Age: 28.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Contraindication to vaccination, Exposure during pregnancy, Wrong product administered
Clinical narrative: Consumer calling on behalf of his wife who is 35 weeks pregnant. She was supposed to received the TDAP vaccine but was accidentally given the Gardasil 9; She is not currently experiencing any side effects. No additional AE; Consumer calling on behalf of his wife who is 35 weeks pregnant. She was supposed to received the TDAP vaccine but was accidentally given the GARDASIL 9 at 1:20PM today, which is not indicated for pregnant women. She is not currently experiencing; Patient was accidentally given the GARDASIL 9 at 1:20PM today, which is not indicated for pregnant women; This spontaneous report was received from a Consumer (patient's husband) regarding a pregnant 28-years-old female patient.   Concomitant medications included minerals nos (+) vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient did not have any pertinent medical history or concurrent conditions. Her past drug reactions and allergies were not provided.   On 30-OCT-2024, at 13:20, while the patient was 35 weeks pregnant, she was accidentally vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided) (Exposure during pregnancy), which is not indicated for pregnant women (Contraindicated product administered), when she was supposed to receive the "TDAP" vaccine (Wrong product administered). Pregnancy outcome was pending, and fetal outcome was unknown. It was reported that the patient had not experienced any side effects and no additional adverse event were reported for her.
Age: 28.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Consumer calling on behalf of his wife who is 35 weeks pregnant. She was supposed to received the TDAP vaccine but was accidentally given the Gardasil 9; She is not currently experiencing any side effects. No additional AE; Consumer calling on behalf of his wife who is 35 weeks pregnant. She was supposed to received the TDAP vaccine but was accidentally given the GARDASIL 9 at 1:20PM today, which is not indicated for pregnant women. She is not currently experiencing; Patient was accidentally given the GARDASIL 9 at 1:20PM today, which is not indicated for pregnant women; This spontaneous report was received from a Consumer (patient's husband) regarding a pregnant 28-years-old female patient.   Concomitant medications included minerals nos (+) vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient did not have any pertinent medical history or concurrent conditions. Her past drug reactions and allergies were not provided.   On 30-OCT-2024, at 13:20, while the patient was 35 weeks pregnant, she was accidentally vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided) (Exposure during pregnancy), which is not indicated for pregnant women (Contraindicated product administered), when she was supposed to receive the "TDAP" vaccine (Wrong product administered). Pregnancy outcome was pending, and fetal outcome was unknown. It was reported that the patient had not experienced any side effects and no additional adverse event were reported for her.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant Patient 21 Weeks Gestation Received HEPLISAV-B; Initial report received on 30-Sep-2024.  The report was initially received from the Registry.  A nurse the reported that a 19-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant at 21 weeks gestation.  No medical history or concomitant medications were reported.  On 26-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 944942, expiration date 03-Jan-2027; NDC #, route, and site not available)].  The patient was 21 weeks gestation at the time of vaccination. No adverse reactions were reported.   No additional information was reported.   The Registry was closed and not accepting any new subjects at the time of reporting.   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: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong Product Administered; 12 Month Old Received Dose; Initial report received on 02-Oct-2024.  A medical assistant in the reported that a 1-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications were not reported.  On 01-Oct-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot # 943008, expiration date 30-Sep-2025, NDC # 43528-003-05)] intramuscularly in the left thigh.  This was an accidental administration instead of the HIB vaccine, which was ordered.  No adverse reactions were reported.   No additional 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: Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Received 2 Doses of HEPLISAV-B 7 months Apart; Non-reactive Hepatitis-B Surface Antibody; Initial report received on 10-Oct-2024.  A nurse in the reported that a female (age race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received 2 doses of HEPLISAV-B 7 months apart and had a hepatitis B surface antibody test that was non-reactive.  Medical history and concomitant medications at the time of vaccination were not reported.   On an unknown date, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, injection site, and route unknown)] from a nurse.   On an unknown date, 7 months after receiving the first dose,  the patient received the second dose of HEPLISAV-B (lot #, expiration date, injection site, and route unknown).   On an unknown date, the patient was non-reactive for the hepatitis B surface antibody. the reported noted that the patient did not follow instructions on the recommended timing for vaccination.   The reporter stated that the patient will be recommended to receive another dose of HEPLISAV-B and titers will be re-drawn.  No additional information was reported.    Company Comment: The company assessed the events as non-serious and not immunologically confirmed for vaccination failure. The doses of HEPLISAV-B were administered 7 months apart and the timing of the hepatitis B surface antibody was not specified.; Sender's Comments: The company assessed the events as non-serious and not immunologically confirmed for vaccination failure. The doses of HEPLISAV-B were administered 7 months apart and the timing of the hepatitis B surface antibody was not specified.
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives On My Groin, Arms, Chest, Back, Inner Thighs, and Around My Waist; Initial report received on 22-Oct-2024.  A consumer in the reported that he, a 39-year-old male, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced hives on his groin, both arms, chest, back, inner thighs, and around his waist.  No medical history or concomitant medications were reported.   On 22-Oct-2024, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date not reported)] intramuscularly in the left deltoid.    On 22-Oct-2024, the same day after having been vaccinated with HEPLISAV-B, the patient experienced hives on his groin, both arms, chest, back inner thighs, and around his waist.  No other side effects were reported  The reporter stated that 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: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling; This serious case was reported by a pharmacist via sales rep and described the occurrence of swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: Swelling) (serious criteria other: serious as per reporter). The outcome of the swelling was unknown.   The reporter considered the swelling to be related to Shingrix.     The company considered the swelling to be unrelated to Shingrix.   Additional Information: GSK receipt date: 28-OCT-2024 Patient took 1st dose of Shingrix vaccine and experienced swelling.; Sender's Comments: Swelling is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: with a sore arm; flu like symptoms; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: with a sore arm) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the pain in arm and influenza-like symptoms were resolved.   The reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     The company considered the pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 10-OCT-2024 Medical receptionist was talked about her husband who had received Shingrix and complained for several days with a sore arm and flu like symptoms.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle Pain; Joint pain; headache; fever; This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, 1 day after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle Pain), joint pain (Verbatim: Joint pain), headache (Verbatim: headache) and fever (Verbatim: fever). The outcome of the muscle pain, joint pain, headache and fever were not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, headache and fever to be related to Shingrix.     It was unknown if the company considered the muscle pain, joint pain, headache and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 After receiving second shot of Shingrix the following day involved muscle and joint pain, headache and fever for the duration of the day and into the night, similar yet milder symptoms, existed the second day following the shot.
Sex: F
Vaccine: RVX
Symptoms: Rash, Rash macular, Skin discolouration
Clinical narrative: red spot on the inside of my right arm/right breast/dark spot on stomach; dark spot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of red spotty rash in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced red spotty rash (Verbatim: red spot on the inside of my right arm/right breast/dark spot on stomach) and skin discoloration (Verbatim: dark spot). The outcome of the red spotty rash and skin discoloration were not reported.   It was unknown if the reporter considered the red spotty rash and skin discoloration to be related to RSV vaccine.     It was unknown if the company considered the red spotty rash and skin discoloration to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 19-OCT-2024 This case was reported by a patient via interactive digital media. The patient reported that she had been vaccinated all the time but strangely enough past year she had a reaction. She stated that after vaccination (pneumonia), she got a red spot on the inside of right arm and she was already worried about it. She had a right spot under the right breast and another one on the same side but further back and another dark spot on stomach on the left side. She did not know what to do at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles really terrible; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles really terrible). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-OCT-2024 This case was reported by a patient via interactive digital media. The reported that patient got the shingle shot and still got shingle and really terrible. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got Shingles again./ suspected vaccination failure; I got Shingles again; shingles right under bust, hurt so bad and it felt like rib was cracked; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got Shingles again./ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got Shingles again) and pain (Verbatim: shingles right under bust, hurt so bad and it felt like rib was cracked). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-OCT-2024 The patient got shots of Shingles vaccine and got Shingles again.  It was right under bust.  It hurt so bad and it felt like rib was cracked. It was so important to try to reduce stress from life. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(dose 1 and 2) .
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Flulaval trivalent vaccine was administered to this patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 70-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 4SF79, expiry date 29-JUN-2025) for prophylaxis.   Co-suspect products included Influenza vaccine (Influenza trivalent vaccine) for prophylaxis.   On 09-SEP-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, the patient did not receive Influenza trivalent vaccine. On 09-SEP-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced wrong vaccine administered (Verbatim: Flulaval trivalent vaccine was administered to this patient). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2024 The nurse reported that she advised since a patient had to receive an Influenza high dose trivalent instead of a Flulaval vaccine. The reported that dose of Flulaval trivalent vaccine was administered to this patient which led to wrong vaccine administered.  No further detail was given from the licensed practical nurse in this call. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles after Shingrix; Incomplete course of vaccination/ did not receive 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Additional patient notes included did not have underlying immunocompromised conditions.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination/ did not receive 2nd dose). The outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-OCT-2024 The health care provider reported that patient took the first dose of Shingrix 2-3 years ago.  The reporter wanted to know did the GlaxoSmithKline recommend the second Shingrix now or did recommend restarting a series of two doses. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: really made me sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced sleepiness (Verbatim: really made me sleepy). The outcome of the sleepiness was resolved.   The reporter considered the sleepiness to be related to Shingrix.     The company considered the sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2024 The reporter reported shingles shot really made sleepy. The patient was in bed most of monday and all day tuesday until had to drive. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received her second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26-AUG-2020).   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: has not received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-OCT-2024  The patient had not received her second dose of Shingrix. The reporter did not have any information about the first dose, other than the date administered, such as lot/expiry/route/location of administration. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Arthropathy, Dizziness, Heart rate irregular, Hyperhidrosis, Inflammation
Clinical narrative: Sweat; Dizzy; Erratic Heartbeat; Inflammation; so knocked him down; unable to use arm/Problem with left shoulder/Problem with left wrist/Problem with left elbow/Problem with Left shoulder blade; This non-serious case was reported by a consumer via call center representative and described the occurrence of sweating in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced sweating (Verbatim: Sweat), dizziness (Verbatim: Dizzy), heartbeats irregular (Verbatim: Erratic Heartbeat), inflammation (Verbatim: Inflammation), unwell (Verbatim: so knocked him down) and mobility decreased (Verbatim: unable to use arm/Problem with left shoulder/Problem with left wrist/Problem with left elbow/Problem with Left shoulder blade). The outcome of the sweating, heartbeats irregular, inflammation and mobility decreased were not resolved and the outcome of the dizziness and unwell were unknown.   It was unknown if the reporter considered the sweating, dizziness, heartbeats irregular, inflammation, unwell and mobility decreased to be related to Shingrix.     It was unknown if the company considered the sweating, dizziness, heartbeats irregular, inflammation, unwell and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2024 The reporter was a patient that received his first dose of Shingrix in his left arm, in July 2023, and reported that it was so knocked him down, that he lay down, and it was a week before he got up for more than food and to use the restroom. The patient reported that he had all but lost use of his left arm. The patient reported that right after receiving the Shingrix vaccine, he had problems with his left shoulder, not pain. The patient reported ongoing over time since receiving the vaccine, these problems had gone down his left arm to his left elbow first, and was now affecting his left wrist. The patient reported that this problem had moved over his left shoulder blade to his backbone. The overall problem was the loss of use of his left arm, which the patient states has never been regained. The patient reported this problem was steadily going downhill, and now he could not extend his left arm straight forward. The patient reported this problem with his left arm was affecting everything, he had a reaction to most everything now, had an ongoing erratic heartbeat, and was dizzy. The patient reported when he moved around, after a couple of hours he broke out in a sweat like a fever. The patient reported he did have a MRI of his left shoulder (no date provided), and inflammation was found. The patient reported that he had received 3 cortisone shots (unknown product information), one every three months, over the last year after receiving Shingrix, for this inflammation. The patient reported all that was provided about these adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Malaise, Mobility decreased
Clinical narrative: Sweat; Dizzy; Erratic Heartbeat; Inflammation; so knocked him down; unable to use arm/Problem with left shoulder/Problem with left wrist/Problem with left elbow/Problem with Left shoulder blade; This non-serious case was reported by a consumer via call center representative and described the occurrence of sweating in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced sweating (Verbatim: Sweat), dizziness (Verbatim: Dizzy), heartbeats irregular (Verbatim: Erratic Heartbeat), inflammation (Verbatim: Inflammation), unwell (Verbatim: so knocked him down) and mobility decreased (Verbatim: unable to use arm/Problem with left shoulder/Problem with left wrist/Problem with left elbow/Problem with Left shoulder blade). The outcome of the sweating, heartbeats irregular, inflammation and mobility decreased were not resolved and the outcome of the dizziness and unwell were unknown.   It was unknown if the reporter considered the sweating, dizziness, heartbeats irregular, inflammation, unwell and mobility decreased to be related to Shingrix.     It was unknown if the company considered the sweating, dizziness, heartbeats irregular, inflammation, unwell and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2024 The reporter was a patient that received his first dose of Shingrix in his left arm, in July 2023, and reported that it was so knocked him down, that he lay down, and it was a week before he got up for more than food and to use the restroom. The patient reported that he had all but lost use of his left arm. The patient reported that right after receiving the Shingrix vaccine, he had problems with his left shoulder, not pain. The patient reported ongoing over time since receiving the vaccine, these problems had gone down his left arm to his left elbow first, and was now affecting his left wrist. The patient reported that this problem had moved over his left shoulder blade to his backbone. The overall problem was the loss of use of his left arm, which the patient states has never been regained. The patient reported this problem was steadily going downhill, and now he could not extend his left arm straight forward. The patient reported this problem with his left arm was affecting everything, he had a reaction to most everything now, had an ongoing erratic heartbeat, and was dizzy. The patient reported when he moved around, after a couple of hours he broke out in a sweat like a fever. The patient reported he did have a MRI of his left shoulder (no date provided), and inflammation was found. The patient reported that he had received 3 cortisone shots (unknown product information), one every three months, over the last year after receiving Shingrix, for this inflammation. The patient reported all that was provided about these adverse events.
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: female patient received the Arexvy vaccine on 18-JAN-2024, and started having Guillain Barre Syndrome on 27-JAN-2024; This serious case was reported by a other health professional via sales rep and described the occurrence of guillain barre syndrome in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included guillain barre syndrome. Previously administered products included Flu vaccine (Guillain Barre Syndrome in 2009 after receiving a flu vaccine).   On 18-JAN-2024, the patient received Arexvy. On 27-JAN-2024, 9 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: female patient received the Arexvy vaccine on 18-JAN-2024, and started having Guillain Barre Syndrome on 27-JAN-2024) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK receipt date: 23-OCT-2024 and 24-OCT-2024 The patient received the Arexvy vaccine started having Guillain Barre Syndrome. No further patient demographics were provided.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: GI symptoms; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL DISORDER (GI symptoms) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine and Tdap. Past adverse reactions to the above products included No adverse effect with Flu vaccine; and Shoulder pain with Tdap. Concurrent medical conditions included Penicillin allergy.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GI symptoms). At the time of the report, GASTROINTESTINAL DISORDER (GI symptoms) outcome was unknown. Not Provided          No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-776040 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Vomiting
Clinical narrative: I get deathly ill for 18-16h without stopping; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I get deathly ill for 18-16h without stopping) and VOMITING (throwing up) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I get deathly ill for 18-16h without stopping) and VOMITING (throwing up). At the time of the report, ILLNESS (I get deathly ill for 18-16h without stopping) and VOMITING (throwing up) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient had been getting the Pfizer and Moderna vaccines and then got deathly ill for 16 to 18 hours without stopping and throwing up, so the patient would be trying the Novavax vaccine and wanted to see which variant it covered the side effect.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nodule
Clinical narrative: some symptoms including lymph nodes and nodules, I mean nodule issues and everything; some symptoms including lymph nodes and nodules, I mean nodule issues and everything; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (some symptoms including lymph nodes and nodules, I mean nodule issues and everything) and NODULE (some symptoms including lymph nodes and nodules, I mean nodule issues and everything) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (some symptoms including lymph nodes and nodules, I mean nodule issues and everything) and NODULE (some symptoms including lymph nodes and nodules, I mean nodule issues and everything). At the time of the report, LYMPHADENOPATHY (some symptoms including lymph nodes and nodules, I mean nodule issues and everything) and NODULE (some symptoms including lymph nodes and nodules, I mean nodule issues and everything) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774192 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2024: Live non-significant follow up received. Reporter details and reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774192:A woman case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: she has "slight headache and aches and pains, like having the flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (she has "slight headache and aches and pains, like having the flu) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included GI upset. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine and Moderna Covid-19 vaccine; for Product used for unknown indication: TDAP, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and flu vaccine. Past adverse reactions to the above products included Chills with Pfizer vaccine; Fever with Pfizer vaccine; Gastrointestinal discomfort with Pfizer vaccine; No adverse effect with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and flu vaccine; Shoulder pain with TDAP; and Vomiting with Pfizer vaccine. Concurrent medical conditions included Penicillin allergy.    On 27-Oct-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 28-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced INFLUENZA LIKE ILLNESS (she has "slight headache and aches and pains, like having the flu). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (she has "slight headache and aches and pains, like having the flu) was resolving.            The concomitant medication was not reported by reporter.  She received the Moderna COVID-19 vaccine on 27-OCT-2024 and was experienced a slight headache along with general aches and pains, resembling flu-like symptoms. She took Tylenol to alleviate these discomforts. This was her seventh COVID-19 vaccine dose, having received Moderna three times; she reported no symptoms after the first dose, mild gastrointestinal symptoms after the second, and felt pretty good following this latest dose. In contrast, her experienced with Pfizer vaccines included fever, chills, vomiting, and gastrointestinal issues. She inquired about the reasons for her varied reactions to COVID-19 vaccines compared to her positive response to other vaccines, such as Tdap, which only resulted in a sore shoulder.   This case was linked to MOD-2024-776049 (Patient Link).