chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; blister; bumps itch; 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), shingles (Verbatim: got shingles), blister (Verbatim: blister) and itchy rash (Verbatim: bumps itch).  The outcome of the vaccination failure was unknown and the outcome of the shingles, blister and itchy rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and itchy rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, blister and itchy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient had shot and got shingles with no pain but blister bumps and itch. The reporter asked if anybody had this reaction. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up was not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: still red; hard; painful; This non-serious case was reported by a consumer and described the occurrence of erythema in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-SEP-2023, the patient received Shingles vaccine. On 14-SEP-2023, less than a day after receiving Shingles vaccine, the patient experienced erythema (Verbatim: still red), induration (Verbatim: hard) and pain (Verbatim: painful).  The outcome of the erythema, induration and pain were not resolved.   It was unknown if the reporter considered the erythema, induration and pain to be related to Shingles vaccine.     It was unknown if the company considered the erythema, induration and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Sept-2023 The patient received a dose of Shingles vaccine and still had red, hard painful. The symptoms were not treated. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: loss of power in the pharmacy and several products compromised; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not received Shingrix. On 17-SEP-2023, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: loss of power in the pharmacy and several products compromised).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 It was reported that there was loss of power in the pharmacy and that several products may had been compromised which led to intercepted product storage error. He was being transferred to GSK Customer Response Center for questions about shelf stability.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Headache, Pain
Clinical narrative: Horrible headache; Body hurt; Chills; upset stomachupset stomach; Fever; appetite went away for three horrible days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: Horrible headache), general body pain (Verbatim: Body hurt), chills (Verbatim: Chills), upset stomach (Verbatim: upset stomachupset stomach), fever (Verbatim: Fever) and decreased appetite (Verbatim: appetite went away for three horrible days). The outcome of the headache, general body pain, chills, upset stomach, fever and decreased appetite were resolved (duration 3 days).   It was unknown if the reporter considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   It was unknown if the company considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The case was received from the patient interactive digital media. The reporter stated that the symptoms when they gave you the vaccine were horrible.  The patient had 3 terrible days with a horrible headache and his/her whole body hurt. The patient had horrible chills, upset stomach and fever and my appetite was gone for three days, that vaccine felt horrible. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Horrible headache; Body hurt; Chills; upset stomachupset stomach; Fever; appetite went away for three horrible days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: Horrible headache), general body pain (Verbatim: Body hurt), chills (Verbatim: Chills), upset stomach (Verbatim: upset stomachupset stomach), fever (Verbatim: Fever) and decreased appetite (Verbatim: appetite went away for three horrible days). The outcome of the headache, general body pain, chills, upset stomach, fever and decreased appetite were resolved (duration 3 days).   It was unknown if the reporter considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   It was unknown if the company considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The case was received from the patient interactive digital media. The reporter stated that the symptoms when they gave you the vaccine were horrible.  The patient had 3 terrible days with a horrible headache and his/her whole body hurt. The patient had horrible chills, upset stomach and fever and my appetite was gone for three days, that vaccine felt horrible. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Bone pain
Clinical narrative: every bone in my both hurt so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bone pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On 16-SEP-2023, the patient received RSV vaccine. On an unknown date, the patient received FLU VACCINE (NAME UNKNOWN). In SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced bone pain (Verbatim: every bone in my both hurt so bad). The outcome of the bone pain was not reported.   It was unknown if the reporter considered the bone pain to be related to RSV vaccine.   It was unknown if the company considered the bone pain to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 and 18-SEP-2023 The case was received from the patient interactive digital media. The patient went to Sunday (from the day of reporting) and got his/her flu shot and RSV shot and when he/she woke up 3 hours later every bone in his/her both hurt so bad but Medicaid did paid for it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 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 pain in arm (Verbatim: arm was a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.   It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 and 18-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that had mine, no side effects, his/her arm was a little sore.  The patient was following physician's recommendation.  The patient stated that one more boaster and a flu shot.  It did not became a zoomie so it must be safe. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Feeling abnormal, Illness
Clinical narrative: started feeling bad; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 10-SEP-2023, the patient received RSV vaccine. On 11-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick). On 15-SEP-2023, the patient experienced feeling bad (Verbatim: started feeling bad).  The outcome of the sickness was resolving and the outcome of the feeling bad was not reported.   It was unknown if the reporter considered the sickness and feeling bad to be related to RSV vaccine.   It was unknown if the company considered the sickness and feeling bad to be related to RSV vaccine.   Additional Information: GSK Receipt date: 15-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got this shot last Sunday, sick Monday and Tuesday, felt great Wednesday and Thursday, started feeling bad today (Friday) they said it had to be a reaction to this shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Vomiting; Pounding headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 fever (Verbatim: Fever), chills (Verbatim: Chills), vomiting (Verbatim: Vomiting) and pounding in head (Verbatim: Pounding headache).  The outcome of the fever, chills, vomiting and pounding in head were resolved (duration 2 days).   It was unknown if the reporter considered the fever, chills, vomiting and pounding in head to be related to Shingles vaccine.   It was unknown if the company considered the fever, chills, vomiting and pounding in head to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR130616   Additional Information: GSK Receipt Date: 18-SEP-2023 The case was received from the patient via interactive digital media. The patient stated he/she was vaccinated with shngles vaccine and was scared of shingles. The patient also stated vaccine was no picnic either, but at least was for only two days not months. The patient experienced fever, chills, vomiting and pounding headaches with both doses. This case is linked with US2023AMR130616, 2nd dose. The follow-up would not required per process.; Sender's Comments:  US-GSK-US2023AMR130616:For second dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Fever; Chills; Vomiting; Pounding headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2023AMR130599).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), vomiting (Verbatim: Vomiting) and pounding in head (Verbatim: Pounding headache).  Rechallenge with Shingles vaccine was positive. The outcome of the fever, chills, vomiting and pounding in head were resolved (duration 2 days).   It was unknown if the reporter considered the fever, chills, vomiting and pounding in head to be related to Shingles vaccine.   It was unknown if the company considered the fever, chills, vomiting and pounding in head to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR130599   Additional Information: GSK Receipt Date: 18-SEP-2023 The case was received from the patient via interactive digital media. The patient stated he/she was vaccinated with shngles vaccine and was scared of shingles. The patient also stated vaccine was no picnic either, but at least was for only two days not months. The patient experienced fever, chills, vomiting and pounding headaches with both doses. This case is linked with US2023AMR130599, first dose. The follow-up would not required per process.; Sender's Comments:  US-GSK-US2023AMR130599:For first dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In SEP-2023, the patient received Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm still hurt).The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's husband via interactive digital media. The patient got shingles vaccine 3 days ago and arm still arm hurts. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR129925, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR129925:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: I have had the vaccine and I still keep getting this chickenpox virus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox 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 chickenpox (Verbatim: I have had the vaccine and I still keep getting this chickenpox virus).  The outcome of the chickenpox was not reported.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.   It was unknown if the company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that it's been almost two years, he/she had the vaccine and still keep getting this chickenpox virus. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: COVID19, FLUX, RVX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On 19-SEP-2023, the patient received RSV vaccine, COVID 19 VACCINE and INFLUENZA VACCINE. On 19-SEP-2023, less than a day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 19-SEP-2023 The case was received from the patient via interactive digital media. On the day of reporting patient received 3 shots of RSV, Influenza flu and Covid-19 vaccine. The patients arm was little sore. It was unknown if the reporter considered the pain in arm to be related to Influenza flu and Covid-19 vaccine.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: they hurt a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2023AMR129957).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: they hurt a lot). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR129957   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient already took both doses and they hurt a lot. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient forgot to get the second dose of twinrix in the vaccine series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 28th February 2023, with batch no. 2KE55 and expiry date 22nd September 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient forgot to get the second dose of twinrix in the vaccine series).  The outcome of the incomplete course of vaccination 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: 18-SEP-2023 The pharmacist reported a patient forgot to get the second dose of Twinrix in the vaccine series, which led to incomplete course of vaccination.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: How long after first shot if they forgot get second shot is it still ok to get Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on unknown date received 1st dose).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: How long after first shot if they forgot get second shot is it still ok to get Shingrix).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-SEP-2023 The sales representative submitted the following via database for a physician:  The reporter asked how long after 1st shot if they forgot to received 2nd shot was it still ok to got the Shingrix  The patient forgot to receive the 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 A pharmacist asked for information about a patient who received the first dose of Shingrix back in 2020. The pharmacist enquired did the series needed to be re started. The reporter did not provide information about first Shingrix. Due to the nature of the call permission to follow up was not requested. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: powder component of Menveo was mixed with Menactra and administered to patient; powder component of Menveo was mixed with Menactra and administered to patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA928A) for prophylaxis.   Concomitant products included MENACTRA.   On 14-SEP-2023, the patient received Menveo. On 14-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder component of Menveo was mixed with Menactra and administered to patient) and inappropriate dose of vaccine administered (Verbatim: powder component of Menveo was mixed with Menactra and administered to patient).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 A Medical Doctor called to inform that the powder component of Menveo was mixed with Menactra, and then administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Hypersensitivity, Urticaria
Clinical narrative: she experienced hives on her lower back; allergic to an ingredient in the Shingles vaccine; have COPD; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: she experienced hives on her lower back), allergic reaction (Verbatim: allergic to an ingredient in the Shingles vaccine) and chronic obstructive pulmonary disease (Verbatim: have COPD).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the hives was resolved and the outcome of the allergic reaction and chronic obstructive pulmonary disease were not reported.   It was unknown if the reporter considered the hives, allergic reaction and chronic obstructive pulmonary disease to be related to Shingrix.     It was unknown if the company considered the hives, allergic reaction and chronic obstructive pulmonary disease to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2023 and 18-SEP-2023 The patient self-reported this case. After receiving her first dose, the patient experienced hives on her lower back. Hives resolved after taking Benadryl. The patient stated that she was allergic to an ingredient in the Shingles vaccine that was given to her in 2021 and at pharmacy when she tried to get the RSW Pfizer vaccine Abrysvo the computer told the pharmacist she might had an allergic reaction as the component of the Shingles vaccine was in the RSV vaccine. They did not know the ingredient that was in the question. Pharmacy stated they did not know that there were 2 types of vaccines for RSV so the patient was wondering if the Arexvy vaccine might not had that component. The patient had COPD and the patient really need to take one of these vaccines. The patient asked for the ingredient of the Arexvy vaccine. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero administered as 2nd dose of Trumenba.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 15-SEP-2023, the patient received Bexsero. On an unknown date, the patient received TRUMENBA. On 15-SEP-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Bexsero administered as 2nd dose of Trumenba.).  The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Sep-2023 The pharmacist called to inform that a patient received a dose of Bexsero, but such patient had already received a dose of Trumenba which led to interchange of vaccine products. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received HAB (Twinrix) (batch number P9LT9, expiry date 01-JAN-2023) for prophylaxis.   On 18-SEP-2023, the patient received Twinrix. On 18-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Twinrix).  The outcome of the expired vaccine used 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 19 Sep 2023 The pharmacist reported that a patient received an expired dose of Twinrix the day before reporting. The reporter consented to follow up. The patient received an expired dose, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came for his 2nd 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 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th October 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: never came for his 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The pharmacist reported that the patient never came for his second dose. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix on October 2021 and 2nd dose on 20th September 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on October 2021 ).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Shingrix on October 2021 and 2nd dose on 20th September 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: legs that were pink and red/ both leg was red; experienced swollen legs/ Both legs were swollen; This serious case was reported by a consumer via call center representative and described the occurrence of redness of legs in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 11-SEP-2023, the patient received Arexvy (unknown arm) and Flu vaccine (unknown arm). In SEP-2023, an unknown time after receiving Arexvy and Flu vaccine, the patient experienced redness of legs (Verbatim: legs that were pink and red/ both leg was red) (serious criteria hospitalization) and swelling of legs (Verbatim: experienced swollen legs/ Both legs were swollen) (serious criteria hospitalization).  The patient was treated with antibiotics nos (Iv Antibiotics (Nos)). The outcome of the redness of legs and swelling of legs were unknown.   It was unknown if the reporter considered the redness of legs and swelling of legs to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the redness of legs and swelling of legs to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 The consumer reported received the Arexvy in one arm and flu shot in the other arm (did not remember flu vccine name or which arm). Afterwards experienced swollen in both legs that were pink and red, was referred to emergency room who admitted her for 2 days with Intravenous antibiotics and they wanted to make sure it was not a blood clot. The patient's husband also received the same vaccine on the same day with no adverse event. Consumer stated would provide additional details to reporting Agent. Consumer declined to provide any further  details or self details. The reporter did not consent to follow-up.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: circle on arm is warm; Red arm red circle around injection site; Circle part is hard; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 21-Mar-2021, Pfizer (Dose 1) on 21-Mar-2021, Pfizer (Dose 1) on 21-Mar-2021 and Pfizer (Dose 2) on 22-Apr-2021; for COVID-19 prophylaxis: Moderna (Dose 3) on 10-Nov-2021, Moderna (Dose 3) on 10-Nov-2021, Moderna (Dose 3) on 10-Nov-2021 and Moderna (Dose 4) on 19-Jun-2022; for Covid-19 Prophylaxis: Moderna Bivalent (Dose 5) on 03-Oct-2022. Past adverse reactions to the above products included Chills with Moderna and Pfizer; Muscle soreness with Moderna and Pfizer; No adverse event with Moderna, Moderna Bivalent and Pfizer; and Pain in arm with Moderna and Pfizer.    On 18-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard). At the time of the report, INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741386 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741386:Same patient, monovalent moderna vaccine
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Patient did slept the next day however not as much as with the Moderna vaccine; slight body aches; light chills; sore arm/sore right arm; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine), PAIN (slight body aches), CHILLS (light chills), PAIN IN EXTREMITY (sore arm/sore right arm) and FATIGUE (fatigue) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.   On 09-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine), PAIN (slight body aches), CHILLS (light chills), PAIN IN EXTREMITY (sore arm/sore right arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine) and HEADACHE (headache) outcome was unknown, PAIN (slight body aches) and CHILLS (light chills) had resolved and PAIN IN EXTREMITY (sore arm/sore right arm) and FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Fibromyalgia was diagnosed many years before the Moderna Covid-19 vaccine. Concomitant medication was not provided. Fatigue was not as severe. Light chills and slight body aches lasted for 2 or 3 hours. Fatigue starts about 6 to 7 hours after each of her Moderna Covid-19 vaccines. One time it took 10 hours for the Fatigue set in and then patient slept for 24 hours. After Moderna Covid-19 vaccine on 04-May-2023, the patient had a sore right arm and no other side effects. Treatment information was not reported.   This case was linked to MOD-2021-370218 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Somnolence
Clinical narrative: Patient did slept the next day however not as much as with the Moderna vaccine; slight body aches; light chills; sore arm/sore right arm; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine), PAIN (slight body aches), CHILLS (light chills), PAIN IN EXTREMITY (sore arm/sore right arm) and FATIGUE (fatigue) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.   On 09-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine), PAIN (slight body aches), CHILLS (light chills), PAIN IN EXTREMITY (sore arm/sore right arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, SOMNOLENCE (Patient did slept the next day however not as much as with the Moderna vaccine) and HEADACHE (headache) outcome was unknown, PAIN (slight body aches) and CHILLS (light chills) had resolved and PAIN IN EXTREMITY (sore arm/sore right arm) and FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Fibromyalgia was diagnosed many years before the Moderna Covid-19 vaccine. Concomitant medication was not provided. Fatigue was not as severe. Light chills and slight body aches lasted for 2 or 3 hours. Fatigue starts about 6 to 7 hours after each of her Moderna Covid-19 vaccines. One time it took 10 hours for the Fatigue set in and then patient slept for 24 hours. After Moderna Covid-19 vaccine on 04-May-2023, the patient had a sore right arm and no other side effects. Treatment information was not reported.   This case was linked to MOD-2021-370218 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Chills; sore muscles all over; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Mar-2021, Pfizer on 22-Apr-2021, Pfizer on 22-Apr-2021 and Pfizer on 22-Apr-2021. Past adverse reactions to the above products included Chills with Pfizer; Muscle pain with Pfizer; and Pain in extremity with Pfizer and Pfizer.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over) outcome was unknown.            No concomitant medication was reported. Suspect product dosage text was reported as unknown. Patient received Moderna 5th vaccine bivalent Moderna 03-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741945:Same patient, 6th dose moderna vaccine
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Vision blurred, Visual impairment
Clinical narrative: visual disturbances/blurry section in his visual field on both eyes; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (visual disturbances/blurry section in his visual field on both eyes) in a 65-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient was in good health.     On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VISUAL IMPAIRMENT (visual disturbances/blurry section in his visual field on both eyes). On 21-Sep-2023, VISUAL IMPAIRMENT (visual disturbances/blurry section in his visual field on both eyes) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered VISUAL IMPAIRMENT (visual disturbances/blurry section in his visual field on both eyes) to be related.    Concomitant product use was not provided by the reporter.  It was reported that patient go the new covid-19 vaccine yesterday.  This morning 21-Sep-2023 he had about 10 minutes of visual changes, which resolved on its own.it was blurry section in his visual field on both eyes. Reporter stated that patient received the new monovalent 2023-2024 Formula. He did not had the lot number. He confirms it's the Spikevax, the newest one.  Reporter also stated that there was talk about an increased risk of thrombosis or thrombotic events back in 2020. However, reporter was talking about Spikevax as a 2-dose series.  Treatment information was not provided.  The reporter states he was concerned that the visual disturbances might had been a transient ischemic attack that was caused by the vaccine.
Sex: M
Vaccine: UNK
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding from the left arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site) in a 49-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site). On 22-Sep-2023, VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient was bleeding a little in the arm. Not bleeding currently, He also received his flu shot today.  No treatment information was reported.   This case was linked to MOD-2022-693251, MOD-2021-066255 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Patient mentioned her husband received the same dose but only feel sore arms.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Walker user and Unable to walk.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.). At the time of the report, PAIN IN EXTREMITY (Patient mentioned her husband received the same dose but only feel sore arms.) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741624:Wife case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine on 24-Dec-2020 and Moderna Covid-19 vaccine on 21-Jan-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    In October 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 03-Sep-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2023, SARS-CoV-2 test: Positive. On 04-Sep-2023, SARS-CoV-2 test: Negative. On 05-Sep-2023, SARS-CoV-2 test: Negative.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication not reported.
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Sep-2023, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) had not resolved.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.