chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Sleep disorder
Clinical narrative: headache; pain at the injection site; redness and swelling at injection site; redness and swelling at injection site; had pain from waist all the way down both legs; had pain from waist all the way down both legs; fever; chills; nausea; red rash all over body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 1st June 2022, less than an hour after receiving Shingrix, the patient experienced headache, injection site pain, injection site erythema, injection site swelling, pain localized and leg pain. In June 2022, the patient experienced fever, chills, nausea and red rash. The patient was treated with steroids nos (Steroids) and paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain localized were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, leg pain, fever, chills and nausea were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling, pain localized, leg pain, fever, chills, nausea and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient reports that she received dose 1 of Shingrix in left arm on 1st June 2022. She stated that within minutes she had a headache pain, redness and swelling at injection site. Hours later she had pain from waist all the way down both legs. In the middle of the night, less than a day after receiving Shigrix she woke up with fever, chills and nausea. She mentioned that less than 2 weeks after vaccination, she had a red rash all over body. She stated that she had to go to the emergency room where they did a Computerised tomogram scan and gave her steroids and Tylenol. The patient was still experiencing headaches without relief for the past 12 days. The patient would not get second dose of Shingrix within 2-6 months. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea
Clinical narrative: nausea; lethargy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2022, 24 hrs after receiving Shingrix, the patient experienced nausea and lethargy. In May 2022, the outcome of the nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the nausea and lethargy to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix vaccine into right arm and about 24 hours post vaccination, on 14th May 2022, the patient experienced nausea and lethargy that lasted for about four days. The patient did not have any further information about the vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient  received a dose of only the liquid vial without reconstitution with the lyophilized powder; Patient  received a dose of only the liquid vial without reconstitution with the lyophilized powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient safety specialist reported that one of 43 possible patients might have received a dose of only the liquid vial of Menveo without reconstitution with the lyophilized powder. The consent to follow up could not be gathered, the HCP (Health Care Professional) mentioned not caring if we followed up with them or not and just wanting to receive medical information. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo without reconstitution with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 14-JUN-2022 Reporter's Comments: The licensed vocational nurse inquired regarding how to proceed and when to revaccinate.   The licensed vocational nurse (LVN) reported that they inadvertently administered an expired dose of Kinrix vaccine to patient. The reporter did not consent to follow up. Additional Supportive Information: The use of Kinrix dose which was already expired on 4th June 2022, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid diluent only portion; administered liquid diluent only portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 13th June 2022, the patient received Menveo. On 13th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that 16 year old male patient who was administered the liquid diluent only portion of the Menveo vaccine.  The diluent was not reconstituted with the lyophilized MenA component.   The reporter did not have the lot number / expiration date information available at the time of call, nor the patient's initials. At the time of reporting, the patient has not been redosed. The reporter gave consent to follow up. Additional supportive information: The diluent was not reconstituted with the lyophilized MenA component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Dry nostrils; Headache; Chills; Slight fever; Upset stomach; Tiredness; Did not get a good nights sleep last night; Pain at the injection site after the shot.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th June 2022, the patient experienced poor quality sleep. On 14th June 2022, the patient experienced headache, chills, fever, upset stomach and tiredness. On an unknown date, the patient experienced nasal dryness. On an unknown date, the outcome of the injection site pain, headache, chills, fever, upset stomach, tiredness and poor quality sleep were recovering/resolving and the outcome of the nasal dryness was unknown.   It was unknown if the reporter considered the injection site pain, headache, chills, fever, upset stomach, tiredness, poor quality sleep and nasal dryness to be related to Shingrix.     Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment: The reporter was patient. The patient stated that experienced pain at the injection site after the shot of Shingrix. On 14th June 2022, 26 days after receiving Shingrix the patient began experiencing headache, chills, slight fever ((99.9), upset stomach, and tiredness. He admitted that he did not get a good night sleep last night from the date of reporting. The patient said he started to feel better.  The patient also stated during the call that he had dry nostrils.  The patient provided limited information, declined to provide date of birth, but gave age. patient gave. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal dryness, Poor quality sleep, Pyrexia
Clinical narrative: Dry nostrils; Headache; Chills; Slight fever; Upset stomach; Tiredness; Did not get a good nights sleep last night; Pain at the injection site after the shot.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th June 2022, the patient experienced poor quality sleep. On 14th June 2022, the patient experienced headache, chills, fever, upset stomach and tiredness. On an unknown date, the patient experienced nasal dryness. On an unknown date, the outcome of the injection site pain, headache, chills, fever, upset stomach, tiredness and poor quality sleep were recovering/resolving and the outcome of the nasal dryness was unknown.   It was unknown if the reporter considered the injection site pain, headache, chills, fever, upset stomach, tiredness, poor quality sleep and nasal dryness to be related to Shingrix.     Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment: The reporter was patient. The patient stated that experienced pain at the injection site after the shot of Shingrix. On 14th June 2022, 26 days after receiving Shingrix the patient began experiencing headache, chills, slight fever ((99.9), upset stomach, and tiredness. He admitted that he did not get a good night sleep last night from the date of reporting. The patient said he started to feel better.  The patient also stated during the call that he had dry nostrils.  The patient provided limited information, declined to provide date of birth, but gave age. patient gave. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: arm at the injection site was painful, still tender; arm at the injection site was red; hives on her face and collar bone; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and GARDASIL for prophylaxis.   On 31st May 2022, the patient received the 1st dose of Bexsero .5 ml, Bexsero Pre-Filled Syringe Device and GARDASIL. On 1st June 2022, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain and injection site erythema. In June 2022, the patient experienced hives. On an unknown date, the outcome of the injection site pain, injection site erythema and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and hives 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: 14-June-2022 Reporter's comment: The patient received Bexsero on right arm and Gardasil on left arm. The patient's mother stated that the day after her daughter got the 1st dose of Bexsero, her daughter's arm at the injection site was painful and red. The injection site was still tender and slightly red but was improving.   On 2nd June 2022, about 36 hours after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Gardasil, the patient started to get hives on her face and collar bone. The hives would fade and then come back. The patient currently had some hives on her face.  The reporter didn't have the lot number or expiration date for the Bexsero.  It was unknown if the reporter considered the injection site pain, injection site erythema and hives to be related to Gardasil. Consented to follow up was granted.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had dose 1 on September 2020; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in September 2020).   On an unknown date, the patient did not receive the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2022  Reporter's comment: Nurse practitioner (NP) reported a patient inquired about restarting the series or not Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Bexsero, which led to incomplete course of vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Vaccine reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: Nurse was unable to confirm if a patient was involved, she reported that there was a potential that Hiberix was reconstituted with sterile water from another manufacturer. Follow up request was not asked during conversation. Additional Supportive Information: Hiberix was reconstituted with sterile water from another manufacturer which led to wrong solution used in drug reconstitution.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Some patients received the vaccines without the powder portion.; Some patients received the vaccines without the powder portion.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a n unknown number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMXA440A, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that some patients received Menveo vaccines without the powder portion. They believe that there were three patients that received a partial dose of Menveo but they were not sure. The reporter consented to follow up by email. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in sep 2020 never got the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020 (batch number erv5zb and expiry date 9th June 2021)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: HCP (Health Care Professional) reported that the patient received first dose of Shingrix in September 2020, never got the 2nd dose. The patient was immunocompetent. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first dose 1.5 months ago, has developed Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 15th June 2022, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Reporter was the health care professional (HCP) who stated that a patient received her first dose of Shingrix 1.5 months ago from the date of reporting. On the day of reporting, the patient had developed Shingles. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix and Engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 2573G, expiry date 28th May 2022) for prophylaxis.   On 15th June 2022, the patient received Havrix and Engerix B. On 15th June 2022, unknown after receiving Havrix and Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist reported that expired havrix and engerix-b administered. The reporter consented to follow up. Additional Supportive Information: The patient received expired havrix and engerix-b which led to expired vaccine used. The case been linked with case US2022093622 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093622:Same reporter
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 15th June 2022, the patient received Havrix. On 15th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist reported that expired dose of Havrix administered. The reporter consented to follow up. Additional Supportive Information: The patient received expired havrix which led to expired vaccine used. The case has been linked with case US2022093621 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093621:Same reporter
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 15-June-2022 Reporter's comment: Nurse reported that the patient received a 2 days expired dose of twinrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired twinrix which led to expired vaccine used.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 15-June-2022 Reporter's comment: The patient received an expired Havrix vaccine. This was patient´s first dose. The reporter consented to follow up. The Vaccine Administration Facility was same as Primary Reporter. Additional Supportive Information: The patient received expired havrix which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Bexsero; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 15-June-2022 Reporter's comment: The physician reported that a patient received an expired dose of Bexsero. The vaccine expired in February, but the expiration date and lot number were not available. Consented to follow up via postal mail. Additional Supportive Information: The patient received expired Bexsero which led to expired vaccine used.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose of Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 15-June-2022 Reporter's comment: The clinic Supervisor stated that an expired dose of Havrix was administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: could not get dose two within six months from dose one; This case was reported by a other health professional via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 15-June-2022 Reporter's Comments: Pharmacy Operations Manager reported that a couple years ago (as reported) the patient could not get dose two of Shingrix within six months from dose one.  The patient could not get the vaccine because it was not available. The reporter consented to follow-up. Additional Supportive Information: The patient could not get the 2nd dose of Shingrix vaccine because it was not available, which led to product supply issue. This case has been linked with cases US2022093601 and US2022AMR094050, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093601:Same reporter. US-GLAXOSMITHKLINE-US2022AMR094050:Same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chondropathy, Joint swelling, Magnetic resonance imaging, Trigger finger, X-ray
Clinical narrative: TRIGGER FINGER OF RIGHT MIDDLE FINGER.LEFT MIDDLE FINGER AND RIGHT POINTER FINGER; RIGHT MENISCUS WAS NOT OK; SWELLING IN THE KNEES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, at left arm administered on OCT-2021 for prophylactic vaccination. The batch no was not reported and has been requested No concomitant medications were reported.  On an unspecified date, since he received the shot in OCT-2021, the patient experienced swelling in his knees. The patient underwent MRI and X-Ray knees and his doctor mentioned that his right meniscus was not ok, and may need surgery too. On an unspecified date in early in NOV-2021, the patient experienced his tendon getting tight, trigger on the middle finger of the right hand and started to have difficulty with the mobility of the middle finger of his right hand. His finger would get stuck in a bent position from time. He received cortisone as a treatment to help with his condition. On an unspecified date, a few months after, in MAR-2022, The patient also experienced trigger in the middle finger of the left hand. On an unspecified date, in APR-2022, he had to do surgery as cortisone treatment was not really effective. His doctor had to make an incision in both of his fingers and cut a sleeve of his tendon to help to recover the mobility of his fingers. On an unspecified date, in the beginning of May-2022, the patient experienced trigger in the pointer finger of the right hand. Laboratory data (dates unspecified) included: MRI (Magnetic resonance imaging) and X-ray shows right meniscus was not ok. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trigger finger of right middle finger, left middle finger and right pointer finger, right meniscus was not ok and swelling in the knees was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220627447 -Covid-19 vaccine ad26.cov2.-Trigger finger of right middle finger, left middle finger and right pointer finger. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ADHD (Attention deficit hyperactivity disorder) and allergy and other pre-existing medical conditions included: Patient was not hospitalized. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) 0.5 ml, 1 total administered on 16-MAR-2021 at 13:30 on left arm for prophylactic vaccination. Age at time of vaccination 58 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate 20 mg within 2 weeks of Covid-19 treatment. It was unknown if the patient experienced any adverse reactions following the administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine Moderna (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 003F214 expiry: unknown) dose was not reported, administered on 27-OCT-2021 at 18:30 on left arm for prophylactic vaccination.  On 31-MAY-2022, the patient tested positive for asymptomatic covid-19 (dose number in series 2).  On 01-JUN-2022, the patient was prescribed by the physician Paxlovid (nirmatrelvir/ritonavir) (route of admin not reported, lot number FY9909, expiry: unknown) 3 tablets, twice daily for 5 days for Covid-19 treatment. The patient took Paxlovid as prescribed till 06-JUN-2022.  On 07-Jun-2022, the patient retested for Covid-19 using home antigen rapid test which was positive. The patient do not have any symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from asymptomatic covid-19. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 on left arm for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms which included headache, and body aches (suspected covid-19 infection). In early MAY-2022, the patient underwent Laboratory data included: COVID-19 rapid POC (Point-of-care) test which was positive which indicates suspected clinical vaccination failure. The patient was confirmed to be covid positive by second rapid test at doctor's office Laboratory data (dates unspecified) included: COVID-19 rapid POC test Positive. The patient was prescribed paxlovid by his doctor and his symptoms lasted for about 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235807.; Sender's Comments: 20220630544-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical vaccination failure- The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 52 year old female of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 16-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: patient was not pregnant at the time of vaccination and patient was not taking any other medications within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered in right arm on 10-APR-2021 13:00 for prophylactic vaccination. Age at time of vaccination was 51 years. No concomitant medications were reported. The patient additionally received non-company suspect vaccine spikevax (elasomeran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 027H21B, expiry: unknown) dose was not reported, administered in left arm on 28-NOV-2021 15:00 for prophylactic vaccination. Age at time of vaccination was 51 years. The patient took Paxlovid for treatment of Covid-19 from 12-MAY-2022 to 16-MAY-2022. The patient tested negative for Covid-19 for several days and then on 22-MAY-2022, the patient started feeling ill. On 22-MAY-2022 and 23-MAY-2022, the patient tested positive for Covid-19 (confirmed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). On 23-MAY-2022, the patient had severe nausea and vomiting and on 24-MAY-2022 was able to drink liquids. Laboratory data included: COVID-19 virus test Positive. On 23-MAY-2022, Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235986.; Sender's Comments: V0:20220630545 -covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 51 year old female. Initial information was processed along with the additional information received on 16-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, poly-cystic ovarian syndrome, latex allergy, and beef allergy. The patient was not pregnant at the time of report. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 to right arm for prophylactic vaccination. Age at time of vaccination 50 years old. No concomitant medications were reported. The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 039F21A, expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 to right arm for prophylactic vaccination. The patient was treated with Paxlovid for the treatment of covid-19 infection with the start date of 27-MAY-2022 and end date of 31-MAY-2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 05-JUN-2022, the patient was rebounded with positive PCR (Polymerase Chain reaction) test five days after finishing treatment, coded as confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccine failure (Dose number in series 1).  On same day, the laboratory data included: COVID-19 PCR test Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection and confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235983.; Sender's Comments: V0-20220630549-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Helicobacter pylori, non-alcoholic fatty liver (NAFL), penicillin allergy, and drug allergy (Sudafed, Ceftin). The patient was not pregnant at the time of vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 25-SEP-2021 12:00 to right arm for prophylactic vaccination. Age at time of vaccination 52 years old. 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) (suspension for injection, route of administration, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 08-JAN-2022 12:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 53 years old. Concomitant medications included ramipril for drug used for unknown indication. The patient was prescribed with non-company drug Paxlovid (form of admin, route of administration, batch number: unknown and expiry: unknown) dose was not reported, administered first dose on 31-MAY-2022 and last dose on 04-JUN-2022 for covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 2). On 08-JUN-2022 at 06:30, symptoms of covid-19 returned on day 9 following treatment with Paxlovid. The symptoms include congestion, runny nose, fatigue and muscle aches (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and has been requested.; Sender's Comments: V0:20220631599-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.; Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 27May2022, 1 vial was placed in the refrigerator from which 2 doses (0.25mL booster doses) were administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-589616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2022: Significant follow-up received: Patient details (age) added.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criteria death and medically significant). The reported cause of death was Seizures. It is unknown if an autopsy was performed.   Concomitant medication was not provided.  Reporters dad and cousin died from vaccine. Reporters dad ended with strokes after Pfizer shot, and cousin died from seizures from moderna. Don't even. Reporters dad died days before fathers day last year. Treatment medication information was not provided by the reporter.  Company comment: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Seizures