chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Generalised oedema, Pyrexia, Suicidal ideation, Vomiting
Clinical narrative: Suicidal thoughts, felt like hurting myself; swallen all over body; I have trouble peeing; fever; fatigue; vomiting; Anxiety; really scared; crying and very upset, many bad reactions; upset; This case was reported by a consumer via call center representative and described the occurrence of suicidal ideation in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetic.   On 21st July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress. On 28th July 2022, the patient experienced suicidal ideation (serious criteria GSK medically significant). The patient was treated with diclofenac. On an unknown date, the outcome of the suicidal ideation, generalized swelling, urination difficulty, fatigue and anxiety were not recovered/not resolved and the outcome of the pyrexia, vomiting, fear, crying and emotional distress were unknown.   It was unknown if the reporter considered the suicidal ideation, generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporters comment:  The reporter was a Spanish-speaking patient. Her call was transferred to me by a non Spanish speaking agent. She was crying and very upset. The patient stated she received Shingrix dose 1 ( on left arm) on 21st July,22. Had many bad reactions to it. swollen all over her body and hands, troubled peeing, fever, fatigue, vomiting, anxiety. She went to the physician on 28 July 2022 and he given to her shot and a pill diclofenac. she did not know what else to do. she was really scared because had suicidal thoughts, she stated she was alone and has nobody that could help her.  The reporter did not consent to follow-up.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: if by accident administered only the diluent; if by accident administered only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On 27th July 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: 1-Aug-2022 Reporter's comment: The reporter asked how to proceed if by accident they administered only the diluent portion of Menveo. This was on 27th July 2022. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the diluent portion of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: received by error a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received HBV (Engerix B) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 1st August 2022, the patient received the 4th dose of Engerix B. On 1st August 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: HCP had patient that, on 1st August 2022, received by error a 4th dose of Engerix-B. The reporter did not want the information stored in their database but agreed to follow up by safety. the reporter consented to follow up. Additional Supportive Information: The patient was administered with 4th dose of Engerix B vaccine, which led to extra dose administered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered an expired Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 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 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 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: 01-AUG-2022 Reporter's Comments: The medical Assistant called into inquire, how to proceed and did the patient need to be revaccinated. The reporter reported that they inadvertently administered an expired Bexsero dose to a patient. No other details provided.  The reporter did not consent to follow-up.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose (30Jun2022) today (01Jul2022); This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXb27aa, expiry date 30th June 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 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 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: 01-Aug-2022 Reporter's comment: The nurse reported that a patient was inadvertently administered an expired dose of Bexsero on the day of reporting. The reporter declined follow-up from Safety. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; Patient recived a pediatric dose of engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   It was unknown if the reporter considered the underdose to be related to Engerix B 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: 01-Aug-2022 Reporter comment: The pharmacist reported that a patient received a pediatric dose of Engerix-b. The reporter consented to follow up. Additional Supportive Information: The patient 55-year-old received Engerix-b pediatric, which led to underdose and adult use of a child product.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Gotten shingles three times/ Suspected vaccination Failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comment: The patient was a reporter. The reporter stated that the patient received Shingrix vaccine. Patient had both the vaccine shot on deltoid muscle of the upper arm. Patient does not recall for sure which arm she got vaccine but stated she usually uses her left arm for vaccination because she was right handed. Patient got shingles three times and currently had an outbreak right now. Patient stated shingles was not pleasant and she had to go to the urgent care to had it diagnosed treated.  Patient was not at her home at the time of report so she did not had access to the medical records . Patient may had lot numbers at home. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Age: 17.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received Engerix-B 4th dose; third dose 7/14/2020, first and second Oct 2002 and Dic 2002 respectively; third dose 7/14/2020, first and second Oct 2002 and Dic 2002 respectively; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received HBV (Engerix B) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose in October 2002).   On 30th June 2022, the patient received the 4th dose of Engerix B. On 14th July 2020, the patient received the 3rd dose of Engerix B. In December 2002, the patient received the 2nd dose of Engerix B. In December 2002, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 14th July 2020, the patient experienced drug dose administration interval too long. On 30th June 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The nurse reported that they had two patients received Engerix-B extra dose by error. The reporter consented to follow-up via email. The case is for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received the 2nd and 3rd dose of Engerix-B later than the recommended interval, which led to lengthening of vaccine schedule. The patient also received 4th dose of Engerix-B, which led to extra dose administered. As the patient received an extra dose of Engerix-B and it was clear that the dose was given by error and intention behind the dose giving was unknown therefore extra dose administered event was coded.; Sender's Comments:  US-GSK-US2022113816:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration, Inflammation
Clinical narrative: dose #2 02AUG22, #1 given MAR2020; headache; fatigue; brain fog, believed it was COVID; inflammation; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Shingrix. In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 8 days after receiving Shingrix, the patient experienced headache, fatigue, foggy feeling in head and inflammation. On 2nd August 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, fatigue, foggy feeling in head, inflammation and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, fatigue, foggy feeling in head and inflammation to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter's comment: The patient stated that on the day of reporting, he received 2nd dose of Shingrix in left arm.  8 days after the 1st dose of Shingrix, the patient experienced headache, fatigue, brain fog and inflammation.  The patient believed it was Covid but he tested negative.   Spoken as per content and was sending package insert.  Referred to health care professional. Did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: dose #2 02AUG22, #1 given MAR2020; headache; fatigue; brain fog, believed it was COVID; inflammation; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Shingrix. In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 8 days after receiving Shingrix, the patient experienced headache, fatigue, foggy feeling in head and inflammation. On 2nd August 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, fatigue, foggy feeling in head, inflammation and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, fatigue, foggy feeling in head and inflammation to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter's comment: The patient stated that on the day of reporting, he received 2nd dose of Shingrix in left arm.  8 days after the 1st dose of Shingrix, the patient experienced headache, fatigue, brain fog and inflammation.  The patient believed it was Covid but he tested negative.   Spoken as per content and was sending package insert.  Referred to health care professional. Did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 yo patient received Engerix-B 1 ml dose; 18 yo patient received Engerix-B 1 ml dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B 1 ml. On an unknown date, unknown after receiving Engerix B, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The nurse reported that they had a patient that received 1ml of Engerix-B dose but the insurance rejected because of the age. The reporter did not consent to follow-up. The case was linked with case US2022AMR114586, reported by same reporter. Additional supportive information: The patient received 1ml dose of Engerix-B, which led to overdose and adult product administered to child. As per local schedule, 1ml dose was administered to adult patient and if check it out the patient was 18 years old and above 19 years patient was considered for adult dose as per schedule, therefore adult product administered to child was coded as event.; Sender's Comments:  US-GSK-US2022AMR114586:Same reporter
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose 01Aug2022, had an expiration date of 18Jun2022; received one dose as a child, did not receive second dose until 01AUG22; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Previously administered products included Havrix (received one dose of Havrix as a child ).   On 1st August 2022, the patient received the 2nd dose of Havrix. On 1st August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Havrix one day before the reporting day, which had an expiration date of 18th June 2022.  The reporter stated they were trying to get this patient caught up on her vaccines.   The patient had received one dose of Havrix as a child but did not receive second dose until one day before the reporting day (yesterday).   At the time of reporting, dose has not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Havrix which was already expired in past, later than the recommended interval, which led to expired vaccine used and lengthening of vaccine schedule.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: REBOUND COVID-19; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: low body temperature, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 53 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 2022, the patient experienced rebound covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rebound covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Grip strength decreased, Pain in extremity
Clinical narrative: GRIP STRENGTH DECREASED/CANT GRAB THINGS; COVID-19; PAINFUL HAND; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 6 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced grip strength decreased/cant grab things, covid-19, and painful hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The outcome of the painful hand, grip strength decreased/cant grab things and covid-19 was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: Ehlers-Danlos, myasthenia gravis, Hashimotos, and sulfonamide allergy. The patient had previously received two doses covid-19 vaccine (Unspecified manufacturer) (Dose number in series 1) (form of admin, rout of admin, Batch number and expiry date were not reported) dose and start therapy dates were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following two doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 18555835 expiry: unknown) dose was not reported, 1 total administered to left arm on 06-DEC-2021 at 13:00 for covid-19 prophylaxis. Age at time of vaccination 57 years old. Concomitant medications included levothyroxine, and methadone.  On an unspecified date, the patient experienced covid-19 (coded to suspected covid-19 infection) (Dose number in series 2). The patient received non-company suspect drug Paxlovid (form of admin, rout of admin, Batch number and expiry date were not reported) dose and frequency were not reported from 15-JUL-2022 to 20-JUL-2022 for covid-19 treatment. On 22-JUL-2022, the patient reported as sore throat, and headache were remained post treatment with Paxlovid. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in May/2022 (Three months ago), the patient died from an unknown cause of death and it was reported as "My brother died on Johnson and Johnson shot 3 month ago". It was unknown if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220806378-covid-19 vaccine ad26.cov2.s- Died. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 31 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Not reported), and other pre-existing medical conditions included: Patient had no relevant medical history and concurrent condition.  The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 30 years old. Concomitant medications included cetirizine hydrochloride, dextromethorphan hydrobromide/ guaifenesin/ paracetamol/ pseudoephedrine hydrochloride, and paracetamol.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (tozinameran, dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 06-NOV-2021 in left arm for covid-19 prophylaxis.  On an unspecified date in 2022, patient had COVID-19 for which patient was prescribed with non-company suspect drug Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose not reported, administered on 13-JUL-2022 till 18-JUL-2022 for treatment of covid-19.  On 22-JUL-2022, patient had patient had rebound 3 days after first negative test (suspected covid-19 infection, dose number in series 2). On an unspecified date in JUL-2022, Laboratory data included: COVID-19 virus test Negative  The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was discontinued.  The patient had not recovered from suspected covid-19 infection.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident
Clinical narrative: Stroke; No vision on one eye; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (No vision on one eye) 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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (No vision on one eye) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (No vision on one eye) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Caller stated that she talked with someone who also received the Moderna Covid 19 vaccine who also had this problem No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Cerebrovascular accident and unexpected, serious (medically significant) event of Blindness unilateral that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of the mRNA 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Cerebrovascular accident and unexpected, serious (medically significant) event of Blindness unilateral that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of the mRNA 1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry). No concomitant medications were reported. It was reported that the date of the patient vaccine administration was not known, and it was also unknown whether patient took first, second or first and or second booster doses. The vaccine was expired on 01-Apr-2022 and vials were initially stored in the refrigerator on 07-Jun-2022, they had not undergone any temperature excursions. It was reported that the dates of vaccine administration were 01-Apr-2022, 05-Apr-2022,06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine). Concomitant product use was not provided by the reporter. The date of vaccine administration by patient was not known. It was unknown whether patient took first, second, first booster and or second booster dose. The date the vial was initially stored in the refrigerator was 07-Jun-2022. Number of doses/vials were 35 doses and 4 vials. The vial did not undergo any temperature excursions. The dates of administration of the vaccines were reported as 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2022-589423 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-589423: Master case.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 7-Jun-2022.  The vial did not undergo any temperature excursions.  It was reported that a total of 35 doses were given from 4 vials for approximately 40 patients.  The dates of administration of the vaccines was reported as 1-Apr-2022, 5-Apr-2022, 6-Apr2-022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced a headache. At the time of the report, headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. The patient wanted to know if she could take ibuprofen for a headache.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident
Clinical narrative: had a stroke on 4/22/2021 that left her blind; Received dose 2 of primary series and had stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Received dose 2 of primary series and had stroke) and BLINDNESS (had a stroke on 4/22/2021 that left her blind) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Received dose 2 of primary series and had stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS (had a stroke on 4/22/2021 that left her blind) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Received dose 2 of primary series and had stroke) and BLINDNESS (had a stroke on 4/22/2021 that left her blind) outcome was unknown.       No concomitant drug was reported. The reporter stated that a friend experienced a stroke following the receipt of Moderna vaccine. No treatment drug was reported.  Company comment-This spontaneous case concerns an elderly female patient aged 67 years with no medical history reported, who experienced the unexpected serious (medically significant) events of Cerebrovascular accident (AESI) and Blindness after second dose of mRNA-1273 vaccination. The event Cerebrovascular accident occurred 25 days after vaccination and Blindness on an unknown date. It was reported that patient had a stroke that left her blind after vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the previous doses was available in the report. Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly female patient aged 67 years with no medical history reported, who experienced the unexpected serious (medically significant) events of Cerebrovascular accident (AESI) and Blindness after second dose of mRNA-1273 vaccination. The event Cerebrovascular accident occurred 25 days after vaccination and Blindness on an unknown date. It was reported that patient had a stroke that left her blind after vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the previous doses was available in the report. Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The vaccine was given 1 day past beyond use date of 23-Jun-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given 1 day past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given 1 day past beyond use date of 23-Jun-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given 1 day past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given 1 day past beyond use date of 23-Jun-2022).    No concomitant medications were reported. It was reported that vaccine was given 1 day past beyond use date of 23-Jun-2022. The moderna was contacted and the lot was analyzed. It was stated that as per moderna this lot was still active and patient was not needed to be revaccinated. No treatment medications were reported.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Hot flush, Joint swelling, Pain
Clinical narrative: Swollen joints; Pain; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen joints), PAIN (Pain) and HOT FLUSH (Hot flashes) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (Swollen joints), PAIN (Pain) and HOT FLUSH (Hot flashes). At the time of the report, JOINT SWELLING (Swollen joints) and PAIN (Pain) outcome was unknown and HOT FLUSH (Hot flashes) had resolved.            No concomitant medication were provided  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  For Humira, causality as per reporter for events pain and swollen joints was not reported and for event hot flashes it was reported as no reasonable possibility.  For Janssen COVID-19 vaccine, causality as per reporter for events pain and swollen joints was not reported and for event hot flashes it was reported as possible.  No treatment details were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In July 2022, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  The patient received booster dose of Moderna COVID-19 vaccine.  Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of rheumatoid arthritis flare up with Moderna COVID-19 vaccine was reported as possible. The reporter's causality for the event of rheumatoid arthritis flare up with Humira (adalimumab) was no reasonable possibility (Not Related).  Treatment information was not provided.  Company comment: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (rheumatoid arthritis flare up) which occurred after receiving a booster dose of the mRNA-1273 vaccine in the COVID-19 vaccination series and Co-suspect product of non-company product ADALIMUMAB (HUMIRA). Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (rheumatoid arthritis flare up) which occurred after receiving a booster dose of the mRNA-1273 vaccine in the COVID-19 vaccination series and Co-suspect product of non-company product ADALIMUMAB (HUMIRA). Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.