chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, Injection site reaction, Rash erythematous
Clinical narrative: Arexvy that was given via subcutaneous route; developed a big, red, oval shaped rash at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3X32F, expiry date 05-MAY-2025) for prophylaxis.   Concomitant products included COVID-19 vaccine inact (Vero) CZ02 (Covid-19 vaccine (vero cell), inactivated).   On 19-NOV-2023, the patient received Arexvy (subcutaneous, right arm). In NOV-2023, 2 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: developed a big, red, oval shaped rash at injection site). On 19-NOV-2023, the patient experienced intramuscular formulation administered by other route (Verbatim: Arexvy that was given via subcutaneous route). The outcome of the injection site rash was resolved (duration 1 week) and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site rash to be related to Arexvy.     It was unknown if the company considered the injection site rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-DEC-2023 and 21-DEC-2023 A pharmacist reported that a male patient received a dose of Arexvy that was given via subcutaneous route which led to intramuscular formulation administered by other route. No symptoms were reported. The reporter consented to follow up via email. The reporter was the wife calling on behalf of her husband, that reported that his pharmacist told him a few days after receiving his Arexvy vaccine in his right arm, that the vaccine was given as a Subcutaneous injection instead of Intramuscularly. The patient reported that he developed a big, red, oval shaped rash at the injection site 2 to 4 days after the injection that lasted maybe a week (patient unsure about time frame). The patient was receiving a Covid vaccine (unknown product information) a few days after receiving the Arexvy vaccine when his pharmacist provided the information about the wrong route of administration for the Arexvy vaccine. The reporter provided an Arexvy Lot number 3X32F that did not come up in the search.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: 18 year old patient received their 3rd dose of Menveo.; 18 year old patient received their 2nd dose of Menveo.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (patient received first dose of menveo on an unknown date).   On 18-DEC-2023, the patient received the 3rd dose of Menveo. On 12-MAY-2023, the patient received the 2nd dose of Menveo. On 12-MAY-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 18 year old patient received their 2nd dose of Menveo.). On 18-DEC-2023, the patient experienced extra dose administered (Verbatim: 18 year old patient received their 3rd dose of Menveo.). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 The pharmacist reported that a 17-year-old patient received their 3rd dose of Menveo. According to the reporter, the 2nd dose was administered on 12 May 2023 and the 1st dose date was unknown. The patient received second and third dose of Menveo which led to extra dose administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: received only the diluent component of Menveo; received only the diluent component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-month-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included kidney disorder (would need a kidney transplant in the future.).   On 13-OCT-2023, the patient received Menveo. On 13-OCT-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: received only the diluent component of Menveo) and inappropriate preparation of medication (Verbatim: received only the diluent component of Menveo). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 A nurse reported that a patient received only the diluent component of Menveo. A healthcare professional did not have the lot number or expiry date of the diluent portion. The reporter consented to follow up. Patient had a history of unspecified kidney issues (prior to vaccine) and would need a kidney transplant in the future.
Sex: F
Vaccine: TDAP
Symptoms: Product container seal issue
Clinical narrative: seal on Boostrix prefilled syringe was broken on 15Dec2023 and the product was not used, so it was placed back into the fridge; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 55-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 35S2S, expiry date 06-FEB-2026) for prophylaxis.   On 18-DEC-2023, the patient received Boostrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: seal on Boostrix prefilled syringe was broken on 15Dec2023 and the product was not used, so it was placed back into the fridge). The outcome of the incorrect storage of drug 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: 20-DEC-2023 The reporter stated that the seal of Boostrix prefilled syringe was broken on 15th December 2023 and the product was not used, so it was placed back into the fridge, which led to incorrect storage of drug. The vaccine was administered to a patient. Reporter was going to follow-up with patient, but stated that she did not believe the patient had any issues since the patient had not called in to report any issues. Reporter plans to follow-up with CDC to inquire about necessity of re-dosing this patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Immunisation, Product preparation issue
Clinical narrative: a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day; a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day; a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 45-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA944A, expiry date 31-JUL-2024) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA944A, expiry date 31-JUL-2024) for prophylaxis.   On 20-DEC-2023, the patient received Menveo and Menveo. On 20-DEC-2023, an unknown time after receiving Menveo and not applicable after receiving Menveo, the patient experienced overdose (Verbatim: a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day), inappropriate preparation of medication (Verbatim: a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day) and inappropriate dose of vaccine administered (Verbatim: a male patient received the diluent only of Menveo on 20Dec2023, followed by a correctly reconstituted dose on the same day). The outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-DEC-2023 The pharmacist reported that a patient received the diluent only of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, followed by a correctly reconstituted dose on the same day, which led to overdose of MenCYW-135 liquid conjugate component. The no symptoms reported. The reporter consented to follow up via email.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: reconstitution error/patient inadvertently received only the adjuvant component of Arexvy; reconstitution error/patient inadvertently received only the adjuvant component of Arexvy; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: reconstitution error/patient inadvertently received only the adjuvant component of Arexvy) and inappropriate dose of vaccine administered (Verbatim: reconstitution error/patient inadvertently received only the adjuvant component of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:20-DEC-2023 The sales representative called to state that a nurse him and reported that a inadvertently received only the adjuvant component of Arexvy. No other information was provided. The patient received only adjuvant part of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Headache, Pain, Poor quality sleep
Clinical narrative: having trouble getting comfortable; Terrible headache; Achy/she felt achy; patient did not sleep well last night; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Toradol (received a dose of injectable Toradol, and the headache went away).   On 20-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Terrible headache), pain (Verbatim: Achy/she felt achy) and sleep disturbance (Verbatim: patient did not sleep well last night). On 21-DEC-2023, the patient experienced discomfort (Verbatim: having trouble getting comfortable). The outcome of the headache and discomfort were not resolved and the outcome of the pain was unknown and the outcome of the sleep disturbance was not reported.   It was unknown if the reporter considered the headache, pain, sleep disturbance and discomfort to be related to Arexvy.     It was unknown if the company considered the headache, pain, sleep disturbance and discomfort to be related to Arexvy.   Additional Information: GSK Receipt date: 21-DEC-2023 The patient was self-reported. The patient states that the other day (day not specified, but before receiving Arexvy), she went to an urgent care center because she had a bad headache. She received Arexvy one day prior to the reporting and she complained of a terrible headache, and she also stated that she felt achy. The patient did not sleep well last night, and on the day of reporting, she had trouble getting comfortable.  The patient did not wish to provide address and did not wish to consent to follow up with health care professional at this time.  The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site rash, Nausea
Clinical narrative: PINK AROUND INJECTION SITE; SORENESS AT INJECTION SITE; RASH AROUND INJECTION SITE; Dizziness; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-DEC-2023, the patient received Arexvy (intramuscular, right deltoid). On 19-DEC-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizziness) and nausea (Verbatim: Nausea). On 20-DEC-2023, the patient experienced injection site erythema (Verbatim: PINK AROUND INJECTION SITE), injection site pain (Verbatim: SORENESS AT INJECTION SITE) and injection site rash (Verbatim: RASH AROUND INJECTION SITE). On 20-DEC-2023, the outcome of the dizziness and nausea were resolved (duration 1 day). The outcome of the injection site erythema, injection site pain and injection site rash were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash, dizziness and nausea to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site pain, injection site rash, dizziness and nausea to be related to Arexvy.   Additional Information: GSK receipt Date: 21-DEC-2023 The patient reported this case for herself. The patient received arexvy vaccine in her right deltoid. 24 hrs after vaccination patient experienced pink around injection site, soreness at injection site and rash around injection site. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: inflammation; redness; swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inflammation in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 03-JAN-2026) for prophylaxis.   In DEC-2023, the patient received Bexsero. In DEC-2023, less than a week after receiving Bexsero, the patient experienced inflammation (Verbatim: inflammation), redness (Verbatim: redness) and swelling (Verbatim: swelling). The patient was treated with antibiotics. The outcome of the inflammation, redness and swelling were unknown.   It was unknown if the reporter considered the inflammation, redness and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the inflammation, redness and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter reported that a 16 year old female received a dose of Bexsero on Monday or Tuesday of this week and came in today with inflammation, redness, swelling to the point where the doctor prescribed antibiotics. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Needle issue, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Inappropriate age at vaccine administration; some of the vaccine leaked out of the needle; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received Men B NVS (Bexsero) (batch number J52HN, expiry date 31-MAR-2024) for prophylaxis.   On 21-DEC-2023, the patient received Bexsero. On 21-DEC-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and incomplete dose administered (Verbatim: some of the vaccine leaked out of the needle). The outcome of the inappropriate age at vaccine administration and incomplete dose administered were 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: 21-DEC-2023 A nurse reported that, a female patient received a dose of Bexsero where some of the vaccine leaked out of the needle which led to incomplete dose of vaccine administered. The patient received the dose of Bexsero at the age of 30 years which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early dose/received a dose of Havrix on 7-AUG-2023 and 20-NOV-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old male patient who received HAV (Havrix) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 20-NOV-2023, the patient received the 2nd dose of Havrix. On 20-NOV-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: early dose/received a dose of Havrix on 7-AUG-2023 and 20-NOV-2023). The outcome of the drug dose administration interval too short 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: 21-DEC-2023 The reporter stated patient was transferred from another facility inadvertently who received a dose of Havrix on 7th August 2023 and 20th November 2023.  The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule. The permission for follow-up was not asked.
Sex: M
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Rotarix vaccine reconstituted with sterile water instead of the approved Rotarix diluent; 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 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 20-DEC-2023, the patient received Rotarix lyophilized formulation. On 20-DEC-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: Rotarix vaccine reconstituted with sterile water instead of the approved Rotarix diluent). The outcome of the wrong solution used in drug reconstitution 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: 21-DEC-2023 A pediatrician reported that a patient received the Rotarix vaccine reconstituted with sterile water instead of the approved Rotarix diluent (Calcium carbonate), which led to wrong solution used in drug reconstitution. The health care professional (HCP) asked for guidance on this situation.  The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received a dose of Havrix that had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old male patient who received HAV (Havrix) (batch number 4F2A9, expiry date 12-DEC-2023) for prophylaxis.   On 20-DEC-2023, the patient received Havrix. On 20-DEC-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received a dose of Havrix that had expired). 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: 21-DEC-2023 A nurse reported that a patient inadvertently received a dose of Havrix that had expired on 12 December 2023 which led to expired vaccine used. The case US2023178665 was identified as duplicate of case US2023178724. All future correspondence would be added in case US2023178724, which stands as case of record for this patient and the case US2023178665 would be deleted. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant patient was given dose of Boostrix  (26 weeks pregnant); pregnant patient was given an extra dose of Boostrix (28 weeks pregnant); pregnant patient was given an extra dose of Boostrix; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M7YY5, expiry date 06-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number M7YY5, expiry date 28-FEB-2025) for prophylaxis.   On 21-DEC-2023, the patient received the 2nd dose of Boostrix (intramuscular, unknown deltoid). On 01-DEC-2023, the patient received the 1st dose of Boostrix (intramuscular, unknown deltoid). On 21-DEC-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: pregnant patient was given an extra dose of Boostrix). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was given dose of Boostrix  (26 weeks pregnant)) and vaccine exposure during pregnancy (Verbatim: pregnant patient was given an extra dose of Boostrix (28 weeks pregnant)). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Boostrix): 26 Weeks Pregnancy Exposure (Boostrix): To mother in second trimester Last Menstrual Period Date: 02-JUN-2023 Estimated Delivery/Due date: 08-MAR-2024 Pregnancy Outcome: Pregnancy was ongoing   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-DEC-2023 The reporter was an obstetrics or gynecology physician. The reporter reported that a pregnant patient was given an extra dose of Boostrux, which led to extra dose administered and vaccine exposure during pregnancy. The pregnant patient was given a dose of Boostrix in 26 weeks of pregnancy, which led to vaccine exposure during pregnancy. Patient received extra dose of Boostrix in 28 weeks of pregnancy 20 days after 1st dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle disorder
Clinical narrative: muscle concaved inward; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of muscle disorder in a female patient who received Herpes zoster (Shingrix) (batch number DN75X, expiry date 15-SEP-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (On 13th July 2023, received first dose intramuscular with batch number M9F2T and expiry date 6th August 2024).   On 24-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). In NOV-2023, 1 month after receiving Shingrix, the patient experienced muscle disorder (Verbatim: muscle concaved inward). The outcome of the muscle disorder was unknown.   It was unknown if the reporter considered the muscle disorder to be related to Shingrix.     It was unknown if the company considered the muscle disorder to be related to Shingrix.   Additional Information: GSK Receipt date: 22-DEC-2023 The reporter called to report that a patient received both doses of Shingrix. After first dose patient had no problems, but 1 month after taking the second dose, patient reported the muscle concaved inward. The reporter was not sure which arm this issue occurred in but thought that the patient's left arm. The location of administration was not provided in the report for either dose of Shingrix. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Intercepted product storage error
Clinical narrative: vaccine stored for 3 to 4 days at room temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product storage error in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: vaccine stored for 3 to 4 days at room temperature). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-DEC-2023 The consumer was the reporter. The reporter stated that Arexvy was delivered to his home by the pharmacy for a nurse to administer. The consumer did not store the vaccine in the refrigerator (product storage error). The vaccine was stored on the countertop for 3 to 4 days at room temperature and vaccine was not administered which led to intercepted product storage error.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: swelling; redness; numbness at the site.; received Shingrix subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) (batch number 557PZ, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling), injection site erythema (Verbatim: redness), injection site numbness (Verbatim: numbness at the site.) and intramuscular formulation administered by other route (Verbatim: received Shingrix subcutaneously). The outcome of the injection site swelling, injection site erythema, injection site numbness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site numbness to be related to Shingrix.  It was unknown if the company considered the injection site swelling, injection site erythema and injection site numbness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-DEC-2023 A pharmacist reported a patient who received Shingrix subcutaneously and developed swelling, redness and numbness at the site. The reporter consented to follow up. The patient received shingrix subcutaneously, which led to intramuscular formulation administered by other route. This case was linked to US2023AMR179885, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR179885:Same reporter/different patients
Age: 78.0
Sex: F
Vaccine: RVX
Symptoms: Arthralgia, Deformity, Pain in extremity, Peripheral swelling
Clinical narrative: Right hand is still slightly swollen; Painful hands; painful knees and ankles; her right hand was disfigured again; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in hand in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included osteoarthritis, occipital neuralgia and trigeminal neuralgia. Concomitant products included COVID-19 vaccine and Influenza vaccine.   On 02-NOV-2023, the patient received RSV vaccine. On 03-NOV-2023, 1 days after receiving RSV vaccine, the patient experienced pain in hand (Verbatim: Painful hands), pain ankle (Verbatim: painful knees and ankles) and arthritis (Verbatim: her right hand was disfigured again). On an unknown date, the patient experienced hand swelling (Verbatim: Right hand is still slightly swollen). The outcome of the pain in hand, arthritis and hand swelling were not resolved and the outcome of the pain ankle was resolved.   It was unknown if the reporter considered the pain in hand, pain ankle, arthritis and hand swelling to be related to RSV vaccine.     It was unknown if the company considered the pain in hand, pain ankle, arthritis and hand swelling to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-Dec-2023 The patient was self-reported this case. The patient stated that she was unsure whether this was GSK or Pfizer RSV vaccine.   The patient received her RSV vaccine and on the morning of 3rd November 2023, she awoke with painful hands, knees, and ankles.   The patient stated that her right hand was particularly bad.  She stated that she had been to see her rheumatologist the week before the vaccine and her hands were in good shape at that time.  The physician was surprised to see that her right hand was disfigured again. The patient stated that all other pain has passed, but that her right hand was still painful and slightly swollen.   She also stated that she had covid and flu vaccines two to three weeks before receiving her RSV shot.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Shingles infection which was painful/suspected vacciation failure; Shingles infection which was painful; Inappropriate age at vaccine administration; a 42-year-old patient called to inform the 2nd dose of the series of Shingrix was administered April 2023; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 42-year-old patient called to inform the 2nd dose of the series of Shingrix was administered April 2023). On an unknown date, the patient experienced vaccination failure (Verbatim: Shingles infection which was painful/suspected vacciation failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles infection which was painful) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the vaccination failure, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-DEC-2023 The patient informed she received the 2nd dose of the series of Shingrix in April 2023.  The patient was currently going through a shingles infection, which was painful.  The patient received 2 doses of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow up by safety team in phone number.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Impaired work ability, Poor quality product administered
Clinical narrative: serious health problems; greatly limit my ability to work; three batches might contaminate.; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (serious health problems) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30033603, 30004895 and 300042698) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (three batches might contaminate.). On an unknown date, the patient experienced IMMUNISATION REACTION (serious health problems) (seriousness criterion medically significant) and IMPAIRED WORK ABILITY (greatly limit my ability to work). At the time of the report, IMMUNISATION REACTION (serious health problems), IMPAIRED WORK ABILITY (greatly limit my ability to work) and POOR QUALITY PRODUCT ADMINISTERED (three batches might contaminate.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient had serious health problems since my vaccinations, which affect him severely and restricted work as a physician. Patient suspected that his three batches might be contaminate.  Treatment information was not provided.  Treatment information was not provided. Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) event of Immunization reaction (reported as serious health problems) which occurred in context of mRNA-1273 vaccinations; the patient has been vaccinated 3 times with mRNA-1273. Latency cannot be assessed as the event onset date is not known. Impaired work ability and Poor quality product administered (reported as inquiry if three batches might contaminate) were also reported in the case. No further clinical information or details about course of the event was provided for medical review. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation reaction, Rash, Rash pruritic
Clinical narrative: developed an itchy rash on neck and chest 3 days after injection so went to the doctor who said it was a reaction to the injection but not shingles
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: The patient presented to the pharmacy today to report a large, swollen, tender pink to reddish lump on her vaccinated left deltoid muscle, 2 days after receiving the Arexvy vaccine.  She also reported  a severe headache on the second day after the vaccine and feeling very tired.  It was important to her that these adverse events be reported, for the purpose of data collection.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: The patient presented to the pharmacy today to report a large, swollen, tender pink to reddish lump on her vaccinated left deltoid muscle, 2 days after receiving the Arexvy vaccine.  She also reported  a severe headache on the second day after the vaccine and feeling very tired.  It was important to her that these adverse events be reported, for the purpose of data collection.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pt reports pain and swelling at injection side - a bump the size of half an egg - pain to touch - improving slowly. said she also felt run down and had a fever the day after the injection
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: injection site reaction, redness, swelling, soreness in arm
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pt reports pain and swelling at injection side
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Patient came to pharmacy on 12/29/23 in the morning  two days after vaccination presenting  with redness of arm, cup size welt and warm to touch.  Pharmacist on duty told her to take some benadryl by mouth and could apply  some hydrocortisone cream if arm is itchy. Also told the patient to go to doctor if symptoms did not improve.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: patient's husband called and reported hallucinations starting 1 day after vaccinations. pt has a history of abilify 2 mg on file 10-31-23, but never picked up. assuming history of some psychosis so unsure if psychosis is related to vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain has persisted to my left deltoid and upper arm unrelieved by heating pad, tylenol or ibuprofen.  The pain is mild to moderate and has at times limited raising my arm above my head.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Visual impairment, Vomiting
Clinical narrative: body aches; fever; throwed up; her vision is too bad and she couldn't even see the pharmacist telephone number to call her/had a problem on her eyesight; This is a spontaneous report received from a Pharmacist from medical information team, Program ID:.  An 87-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "throwed up"; VISUAL IMPAIRMENT (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "her vision is too bad and she couldn't even see the pharmacist telephone number to call her/had a problem on her eyesight". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: FH80228) at the age of 51 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound day 10, test positive day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid treatment from 15Dec2023 to 19Dec2023. No Known allergies.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective, COVID-19 cannot be excluded
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 27 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Anaphylaxis to tree nuts" (unspecified if ongoing); "known allergies: seasonal allergies" (unspecified if ongoing); "known allergies: Anaphylaxis to tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment from 13Dec2023 to 18Dec2023.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Cardiomegaly, Dizziness
Clinical narrative: Blood Pressure 180; Feeling Faint; heart is enlarged on the left side; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE SYSTOLIC INCREASED (medically significant), outcome "unknown", described as "Blood Pressure 180"; DIZZINESS (non-serious), outcome "unknown", described as "Feeling Faint"; CARDIOMEGALY (non-serious), outcome "unknown", described as "heart is enlarged on the left side". The events "blood pressure 180" and "feeling faint" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 180/something. Therapeutic measures were taken as a result of blood pressure systolic increased.  Clinical course: Caller states he is calling about the Pfizer Covid Vaccine from 2020. Caller states he got the vaccine because he was working on a project that required him to get it and right after that he had to go to the hospital because he was feeling faint and everything and his blood pressure was 180/something and he has been on Blood Pressure Medication ever since. The caller states he was also told his heart is enlarged on the left side. Caller states he has (healthcare name) and he looked at his history and for the last 2 years and he never had high blood pressure until he got that vaccine and that really worries him. The caller states he is wondering if there is any compensation or compensation in case, he had to have medical emergencies or whatever or compensation for his side effects? The caller states maybe the Legal Department can give him some tips or advice on how to deal with this, caller states from what he has been reading other people have similar problems too and he is getting older.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hay fever" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 17Dec2023 to 21Dec2023 for treatment of COVID-19. No known allergies. Seriousness reported by reporter as non-serious and not resulted in death, no life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, and no congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient Anti viral covid treatment Paxlovid started on 18Dec2023 till 22Dec2023. No known allergies reported.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162b2 omi xbb.1.5 to the reported events, vaccination failure, covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual.