chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received first dose with Heplisav-B, and second dose with Engerix; Initial Report Received on 11-OCT-2022  This is a spontaneous report, received from a pharmacist regarding a male patient, aged 42 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 25-AUG-2022, dose 1 of HEPLISAV B (Lot #937781, expiration date 20-SEP-2023, NDC #43528-003-05), route not specified, was administered in the left deltoid for hepatitis B immunisation.  No concomitant medications at the time of vaccination were reported.    On 28-SEP-2022, 35 days after having been vaccinated with HEPLISAV B, the patient was vaccinated with Engerix-B. The patient has not   The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 14-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported.  Concomitant medications were not reported.  On 11-Oct-2022, dose 1 of HEPLISAV B (Lot #935843, expiration date 08-Oct-2022, NDC # unknown), intramuscular in the right deltoid for hepatitis B immunisation.   The dose was 3 days past the expiration date. No adverse reactions were reported by the patient.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received A Third Dose of Heplisav-B; Initial Report Received on 17-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a 53-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported.  Concomitant medications were not reported.  On 19-Feb-2022, dose 1 of HEPLISAV B (Lot #935842, expiration date 29-Oct-2022, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation. On 27-Mar-2022, dose 2 of HEPLISAV B (Lot #935842, expiration date 29-Oct-2022, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation. On 09-Oct-2022, dose 3 of HEPLISAV B (Lot #938793, expiration date 07-Oct-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received First Dose With Heplisav-B, and Second Dose With Engerix; Initial Report Received on 18-Oct-2022  This is a spontaneous report, received from a clinic manager regarding a 29-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported.  Concomitant medications were not reported.  On 07-Jun-2022, dose 1 of HEPLISAV-B (Lot #937229, expiration date 13-Sep-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.  On an unspecified, the second dose of a hepatitis B vaccine administered was Engerix-B.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: got a flu shot, then got the flu/suspected vaccination failure; flu; was down for 2 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) (batch number 2750055, expiry date 28th February 2025) for product used for unknown indication.   Concurrent medical conditions included penicillin allergy and sulfonamide allergy. Concomitant products included ibuprofen (Motrin Ib), olmesartan medoxomil and paracetamol (Tylenol).   On an unknown date, the patient received Flu vaccine and Lenvima (oral) 14 mg once daily (14 mg daily). On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. The action taken with Lenvima was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine.     Additional Information: GSK receipt date:23-Nov-2022 Reporter's comment: The patient was advised that she got a flu shot them after getting the flu and was down for 2 weeks. The patient also received Lenvima. The patient was good now. The physician was aware. No further information was provided. Additional supportive information: It was unknown if the reporter considered the influenza and sickness to be related to Lenvima.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Breast pain, Burning sensation, Herpes zoster, Pain, Rash pruritic
Clinical narrative: had both vaccines, months later shingles/Suspected vaccination failure; looks like shingles; rash on  left breast/left breast itches really bad; left breast burn; awful shooting pain in  breast; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, burning sensation and breast pain. On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, burning sensation and breast pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, burning sensation and breast pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that had this rash on my left breast itches really bad and burn and the patient sometimes got this awful shooting pain in my breast went. The patient's physician stated that it looks like shingles and had both vaccines a few months prior to the reporting was this possible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: had both vaccines, months later shingles/Suspected vaccination failure; looks like shingles; rash on  left breast/left breast itches really bad; left breast burn; awful shooting pain in  breast; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, burning sensation and breast pain. On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, burning sensation and breast pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, burning sensation and breast pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that had this rash on my left breast itches really bad and burn and the patient sometimes got this awful shooting pain in my breast went. The patient's physician stated that it looks like shingles and had both vaccines a few months prior to the reporting was this possible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Inappropriate schedule of product administration, Muscle atrophy, Neuropathy peripheral, Pain
Clinical narrative: Neuropathy in feet & hands; Walk with a walker; Lost weight; Lost muscle mass; In pain 24/7; 1st dose on Oct2021, 2nd on Sep2022; This case was reported by a consumer via other and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of guillain-barre syndrome (received 1st dose in October 2021 kindly refer case US2022AMR176659 for 1st dose.).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), walking difficulty, weight loss, muscle atrophy and pain. On an unknown date, the outcome of the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176659   Additional Information: GSK Receipt Date: 23 NOV 2022 Reporter's comment:The patient had good health before takign vaccine. The patient received 2nd dose in September 2022,  The patient was walk with the walker, had lost weight and muscle mass. The patient also suffered from neuropathy in feets and hands. The patient still persisted with the pain 24x7. Less than 3 months after vaccination the patient experienced peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain.  The reporter consented to follow up. Additional supportive information: As patient received 2nd dose of Shingrix more than recommended scheduled which led to drug dose administration too long. This case is linked with case US2022AMR176659 same patient.; Sender's Comments:  US-GSK-US2022AMR176659:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Walking aid user, Weight decreased
Clinical narrative: Neuropathy in feet & hands; Walk with a walker; Lost weight; Lost muscle mass; In pain 24/7; 1st dose on Oct2021, 2nd on Sep2022; This case was reported by a consumer via other and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of guillain-barre syndrome (received 1st dose in October 2021 kindly refer case US2022AMR176659 for 1st dose.).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), walking difficulty, weight loss, muscle atrophy and pain. On an unknown date, the outcome of the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176659   Additional Information: GSK Receipt Date: 23 NOV 2022 Reporter's comment:The patient had good health before takign vaccine. The patient received 2nd dose in September 2022,  The patient was walk with the walker, had lost weight and muscle mass. The patient also suffered from neuropathy in feets and hands. The patient still persisted with the pain 24x7. Less than 3 months after vaccination the patient experienced peripheral neuropathy, walking difficulty, weight loss, muscle atrophy and pain.  The reporter consented to follow up. Additional supportive information: As patient received 2nd dose of Shingrix more than recommended scheduled which led to drug dose administration too long. This case is linked with case US2022AMR176659 same patient.; Sender's Comments:  US-GSK-US2022AMR176659:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: GBS in Jul2022 (now in physical/home therapy); This case was reported by a consumer via other and described the occurrence of guillain barre syndrome in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In July 2022, between 8 and 10 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gamma Globulin) and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the guillain barre syndrome was recovering/resolving.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176636   Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: The patient had good health before takign vaccine. The patient received Shingrix vaccine in October of 2021.  The patient was came down with Gullian Barre in July of 2022.  The patient had been through 10 infusions of gamma globulin and now the doing outpatient physical therapy and home therapy. The reporter consented to follow up. Additional supportive information: For 2nd dose refer case US2022AMR176636.; Sender's Comments:  US-GSK-US2022AMR176636:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Syncope
Clinical narrative: rash on breast and tummy; I fainted; This case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2022, the patient received the 1st dose of Shingrix. On 26th November 2022, 1 days after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant). On 27th November 2022, the patient experienced rash. On an unknown date, the outcome of the fainting and rash were unknown.   It was unknown if the reporter considered the fainting and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27 NOV 2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that had first dose of Shingrix two days prior to the reporting. The patient fainted next morning. The patient was then detected rash on breast and tummy
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Feeling cold, Feeling hot
Clinical narrative: Still feel cold; Upset stomach; Chills, shivering; Stomach ache; Nausea; Fever; Achy; Hot 4 days after shot; This case was reported by a consumer and described the occurrence of feeling cold in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back surgery (3 months ago).   On 16th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot. On an unknown date, the outcome of the feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot were recovering/resolving.   It was unknown if the reporter considered the feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Nov-2022 Reporter's comment: The patient got her shot on Wednesday and still felt cold, upset stomach, achy, hot 4 days after her shot. The patient provided the above address, which was current.  The patient stated that she had acromioclavicular surgery months ago.  The patient received her Shingrix vaccine at her doctor's office.  The patient consented to follow up with health-care professional. The patient had experienced stomach ache, chills, nausea, fever, shivering ever since receiving her first dose of the Shingrix vaccine last week. The symptoms were subsiding.  The call back to the patient was done on 21st November 2022. The consent to follow-up was granted.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Still feel cold; Upset stomach; Chills, shivering; Stomach ache; Nausea; Fever; Achy; Hot 4 days after shot; This case was reported by a consumer and described the occurrence of feeling cold in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back surgery (3 months ago).   On 16th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot. On an unknown date, the outcome of the feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot were recovering/resolving.   It was unknown if the reporter considered the feeling cold, upset stomach, shivering, stomach pain, nausea, fever, pain and feeling hot to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Nov-2022 Reporter's comment: The patient got her shot on Wednesday and still felt cold, upset stomach, achy, hot 4 days after her shot. The patient provided the above address, which was current.  The patient stated that she had acromioclavicular surgery months ago.  The patient received her Shingrix vaccine at her doctor's office.  The patient consented to follow up with health-care professional. The patient had experienced stomach ache, chills, nausea, fever, shivering ever since receiving her first dose of the Shingrix vaccine last week. The symptoms were subsiding.  The call back to the patient was done on 21st November 2022. The consent to follow-up was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling has been increasing; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he / she had received vaccine 48 hours ago.  The patient's area of swelling had been increasing. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Severe nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked was it common to have severe nerve pain following a shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Burning pain, very extreme; Numbness in upper back, pectoral and under arm/ bad side effect; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced pain burning and numbness. On an unknown date, the outcome of the pain burning and numbness were unknown.   It was unknown if the reporter considered the pain burning and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The patient self-reported this case. The patient stated that he/she experienced extreme side effect after receiving Shingrix vaccine. The patient received dose of Shingrix vaccine and experienced burning pain and numbness in upper back, pectoral and under arm. The patient also stated that it had been 5 days since vaccination from the date of vaccination. The patient asked was there anything he/she should do for relief, the pain was extreme. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Boostrix not shaken; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process 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: 22-NOV-2022 Reporter's comment: The reporter asked for prefilled syringes, what happened if the Boostrix vaccine not shaken. The reporter was unsure if there was a patient involved. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of Boostrix vaccine which was was not shaken, which led to Wrong technique in drug usage process.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Nerve block, Pain, Pruritus
Clinical narrative: Got shots years ago, shingles 6-7 months ago/suspected vaccination failure; Shingles; Rash; Redness; Itching; Severe pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, pruritus and pain. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, erythema, pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, pruritus and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176058   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The patient was over 70 years of age now.  The patient's husband reported that the patient got shingrix injections several years ago and 6 to 7 months ago the patient got shingles. The caller reported that the patient still had shingles and further described her shingles symptoms by saying she still had the rash, redness, itching and severe pain.  The caller said the patient received nerve block injections for the shingles which helped her a little bit.  The caller also reported that the patient received lidocaine for the pain from the shingles.  The caller said the lidocaine was not helping the patient. The caller did not knew the exact year when the patient received Shingrix. The caller declined to give the patient's date of birth. Did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR176058, reported by same reporter for different product.; Sender's Comments:  US-GSK-US2022AMR176058:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Got shots years ago, shingles 6-7 months ago/suspected vaccination failure; Shingles; Rash; Redness; Itching; Severe pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, pruritus and pain. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, erythema, pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, pruritus and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176058   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The patient was over 70 years of age now.  The patient's husband reported that the patient got shingrix injections several years ago and 6 to 7 months ago the patient got shingles. The caller reported that the patient still had shingles and further described her shingles symptoms by saying she still had the rash, redness, itching and severe pain.  The caller said the patient received nerve block injections for the shingles which helped her a little bit.  The caller also reported that the patient received lidocaine for the pain from the shingles.  The caller said the lidocaine was not helping the patient. The caller did not knew the exact year when the patient received Shingrix. The caller declined to give the patient's date of birth. Did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR176058, reported by same reporter for different product.; Sender's Comments:  US-GSK-US2022AMR176058:same patient
Sex: F
Vaccine: COVID19
Symptoms: Death, Pulmonary embolism
Clinical narrative: PASSED AWAY; PULMONARY EMBOLISM; This spontaneous report received from a consumer via a company representative through an media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "My sister in law unfortunately passed away a week or two after getting the J&J shot. I think it was a pulmonary embolism" On an unspecified date, the patient experienced pulmonary embolism. On an unspecified date, after a week or two weeks following vaccination, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date and the outcome of pulmonary embolism on an unspecified date. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220802964 and 20221156496.; Sender's Comments: V0: 20221157249- Passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221157249-pulmonary embolism. The event has a unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAINS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced chest pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pains was not reported. This report was non-serious. This case is a duplicate of 20221158489.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE TAKEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822812 expiry: 13-OCT-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 09-NOV-2022, the patient experienced expired vaccine taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine taken was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Chest discomfort, Dyspnoea, Malaise, Migraine
Clinical narrative: CHEST TIGHTNESS; MIGRAINE HEADACHE THAT LASTED FOR COUPLE DAYS; VERY SHORT WINDED; SICK FOR A COUPLE DAYS; PAIN IN MY BACK & LEGS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease. The patient was previously received with three doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse event post primary vaccination with covid-19 vaccine (Dose number in series 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs. It was reported as "I got the vaccines, when I went & got the 4th, vaccine, I was sick for a couple days, and having pain in my back & legs, and chest tightness, and very short winded, and migraine headache that lasted for couple days. But if I hadn't of gotten the vaccines, I could of ended up in the hospital on a ventilator or even worse, could have died, due to having copd & being older." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: CHEST TIGHTNESS; MIGRAINE HEADACHE THAT LASTED FOR COUPLE DAYS; VERY SHORT WINDED; SICK FOR A COUPLE DAYS; PAIN IN MY BACK & LEGS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease. The patient was previously received with three doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse event post primary vaccination with covid-19 vaccine (Dose number in series 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs. It was reported as "I got the vaccines, when I went & got the 4th, vaccine, I was sick for a couple days, and having pain in my back & legs, and chest tightness, and very short winded, and migraine headache that lasted for couple days. But if I hadn't of gotten the vaccines, I could of ended up in the hospital on a ventilator or even worse, could have died, due to having copd & being older." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient via a company representative via social media (JNJ Corporate) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date 2 weeks after vaccination, the patient experienced heart attack. As per the patient, "Had a heart attack two weeks after receiving vaccine. Had just had a great physical wo any problems". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221161632- Heart attack. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Death, Intracranial aneurysm
Clinical narrative: DIED IN HIS SLEEP; BRAIN ANEURYSM; This spontaneous report received from a consumer via a company representative through media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced brain aneurysm and died in his sleep. It was unknown whether an autopsy was performed. It was reported as, "I personally know a young man, fully vaxxed died in his sleep...brain aneurysm....". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from an unknown cause of death and the outcome of brain aneurysm was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221161673-Died in his sleep. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221161673-Brain aneurysm . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221131374.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: WHOLE SIDE HURT; THE ARM GOT THE SHOT HURT REALLY BAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced whole side hurt, and the arm got the shot hurt really bad. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole side hurt, and the arm got the shot hurt really bad. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: ITCHING; CANNOT SLEEP; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker, and vitamin b12 down (B12 down since a long time), and other pre-existing medical conditions included: The patient had other health problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin for vitamin b12 down.  On an unspecified date, the patient experienced itching, and cannot sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching and cannot sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162412.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned an 80 year old of unspecified sex. Initial information was processed along with additional information on 29-NOV-2022. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got covid-19 infection (suspected covid-19 infection) and was sick about for two weeks (dose number in series 2). The reporter stated "I'm 80 years old and had all the pre shots. I got COVID, and was sicker than I've ever been for two weeks, but guess what?? I'm still here. I know I wouldn't have made it without the shots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000260986. The suspected product quality complaint has been confirmed to be void (there is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid, no brand of vaccination mentioned and no positive confirmatory test reported) based on the PQC evaluation/investigation performed.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Flushing, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; METAL TASTE IN MOUTH; FEELING FAINT; FLUSHING; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 62 year old White female of an unspecified ethnicity. The patient's height, and weight were not reported. Patient was not pregnant at time of vaccination. The patient's past medical history included: penicillin allergy. The patient had previously received first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 in total was administered on 03-Nov-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 in total was administered to left arm on 13-MAR-2022 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). On 21-NOV-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment. On 21-NOV-2022 19:45, the patient experienced metal taste in mouth, was feeling faint, and flushing (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was not reported. The outcome of the suspected covid-19 infection, metal taste in mouth, feeling faint and flushing was not reported.  This report was non-serious.