chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous administration of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date 11th June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details reported were as follows: The patient received Shingrix subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. The reporter did not consent to follow up.
Age: 0.33
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: given Bexsero to a 3 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, 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 8th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The health care professional given Bexsero to a 3 month old by mistake , which led to inappropriate age at vaccine administration. The patient was fine, had no adverse reaction. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Oedema peripheral, Swelling
Clinical narrative: Redness at the site of injection; Swelling at the site of injection; Pain in triceps; Swollen armpit; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2022, the patient received the 2nd dose of Shingrix. On 19th February 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, muscle pain and local swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the muscle pain and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain and local swelling to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported The patient received 2nd dose of Shingrix vaccine and day after the dose, experienced redness and swelling at the site of injection.  The patient also experienced pain in his triceps and swollen armpit.  Redness and swelling at the site of injection had resolved but pain in triceps and swollen armpit had not. The reporter did not consent to follow-up. This case has been linked with case US2022046179, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046179:same reporter
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Soreness at the injection site/spread from the injection site and down to the patient's elbow; Injection site itchy/symptoms spread from the injection site and down to the patient's elbow; Rash at the injection site/symptoms spread from the injection site and down to the patient's elbow; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number E99e7, expiry date 11th May 2023) for prophylaxis.   On 10th December 2021, the patient received the 1st dose of Shingrix. On 11th December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, itchy upper limbs and rash. On an unknown date, the outcome of the pain in arm, itchy upper limbs and rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs and rash to be related to Shingrix.  Additional details reported were as follows: The patient received Shingrix in left deltoid. A day after receiving Shingrix, the patient experienced soreness, itchiness, and a rash on the same side as the injection. The symptoms spread from the injection site and down to the patient's elbow. The symptoms were 4 to 5 days in duration. There were no breathing issues noted. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, several days after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received Shingrix into his left arm. Several days after receiving Shingrix, the patient experienced swollen lymph nodes but stated that he was not sure if it was due to the vaccine. The reporter did not have the lot number or expiration date of the vaccine administered The reporter gave consent to contact health care professional (HCP) but could not provide the HCP demographics requested. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Some patients received SQ instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter stated that, some patients received doses of Shingrix subcutaneously (SQ) instead of intramuscularly (IM), which led to intramuscular formulation administered by other route. No further details provided. The reporter submitted all information per web form received.No additional details available. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2017, hasn't gotten the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 96-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2017, Dose:0.5 ml, Route of administration: intramuscular, Anatomical location:Unknown).   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 details were provided as follows: The case was reported by the patient's daughter. The age at vaccination was not applicable for this report. The patient got her first Shingrix vaccine in 2017 and had not gotten the second, which led to incomplete course of vaccination.  The patient did intend to get the second, but wanted to know how to proceed and spoke per content and referred to healthcare professional . The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix instead of Infanrix; 15-month-old received Boostrix.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29th May 2023) for prophylaxis.   On 24th January 2022, the patient received Boostrix. On 24th January 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient inadvertently received dose of Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The patient was fine, had no side effects. No further information reported. The reporter consented to follow-up. Notes:as reported dose 4 can't be kept as we don't know about previous doses were boostrix or infanrix.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: pain at injection site; redness at injection site; swelling at injection site; pain that radiates down arm; decreased range of motion in arm; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site swelling was unknown and the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient who received Shingrix at the end of November 2021 and she developed pain, redness and swelling at the injection site.  The pain and redness had since resolved, but she continued to have pain that radiated down her arm and she had decreased range of motion in the arm. The physician did not have lot or expiry date. The reporter consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received first dose, developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number t333te, expiry date 15th April 2023) for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Shingrix. On 10th January 2022, 39 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 2nd dose given in 2020 and 3rd dose in march 15th 2022; 2nd dose given in 2020 and 3rd dose in march 15th 2022; gave to a patient Menveo instead of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA642A, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2018).   On 15th March 2022, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 15th March 2022, unknown after receiving Menveo and not applicable after receiving Menveo, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, wrong vaccine administered and extra dose administered were unknown.  Additional information were received as follows: It was reported that the patient received 2nd dose of Menveo in 2020, which led to extra dose administered.  The medical assistant reported that on the day of reporting he/she gave to a patient 3rd dose of Menveo instead of Bexsero, which led to wrong vaccine administered and extra dose administered.  The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: was exposed to temperatures outside the refrigerator and administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information were received as follows: It was reported that Flulaval QIV was exposed to temperatures outside the refrigerator for 7days. It was stored in the refrigerator afterwards for 1 month and then administered to the patient, which led to incorrect storage of drug. No reactions reported. The reporter consented to follow up via email.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: BROKE OUT WITH COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced broke out with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000221663. The suspected product quality complaint has been confirmed to be this report indicates medical adverse event for the patient "my son" ("broke out with covid"). there is no product quality issue described. while the reporter states they were vaccinated, there is no report of symptoms, tests performed or statement indicating the vaccine did not work. therefore, this case is being sent for void approval. based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220327336 and 20220327382.; Sender's Comments: : Medical assessment comments not required as per standard procedure as the case is considered non serious
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220327300 and 20220327382.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 admin not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death (dose number in series 2). The reporter stated that, "My ex and his brother both died from getting the jnj booster". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220327268.; Sender's Comments: V0:20220327356-COVID-19 VACCINE AD26.COV2.S-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSEBLEED TWO WEEKS AFTER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced nosebleed two weeks after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nosebleed two weeks after. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: QUITE FEW SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced quite few symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of quite few symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Death, Rash macular, Thrombosis
Clinical narrative: LOOKED LIKE BLOOD CLOTS; BRAIN BLEED; BIG BLOTCH ON INNER THIGH; DEATH; This spontaneous report received from a consumer via a company representative concerned a female 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 patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient got shot and within 5 days, she had big blotch on inner thigh that was black and blue, her daughter took her to the clinic (physician office) and they said it wasn't blood clots but looked like little blood clots, she also had a brain bleed.  On OCT-2021, The patient was died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on OCT-2021, and the outcome of looked like blood clots, big blotch on inner thigh and brain bleed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220332164-COVID-19 VACCINE AD26.COV2.S-Death,looked like blood clots, Brain bleed. 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
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: VERY MILD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate for rheumatoid arthritis. On MAR-2021, the patient experienced very mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious. This case, involving the same patient is linked to 20220250779.
Age: 35.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tooth extraction
Clinical narrative: TOOTH EXTRACTION; This spontaneous report received from a patient concerned a 36 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-MAR-2022, the patient experienced tooth extraction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of tooth extraction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ENDED WITH THE DISEASE THAT CAUSED ON BRAKES IN THE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 and expiry were not reported) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, a month after receiving the vaccine, patient ended up with the disease which caused on brakes in the syndrome, and was hospitalized on an unspecified date for unspecified days. The patient visited to the emergency room. On an unspecified date, the patient got discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ended with the disease that caused on brakes in the syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220336274-COVID-19 VACCINE AD26.COV2.S-Ended with the disease causes on brakes in the syndrome. 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.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Libido increased, Paraesthesia
Clinical narrative: INCREASED LIBIDO DUE TO HORMONE CHANGES; BURNING OF LEGS AND RIGHT TOE; TINGLING LEGS; NUMBING LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disease, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. 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 APR-2021 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 increased libido due to hormone changes, burning of legs and right toe, tingling legs, and numbing legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbing legs, increased libido due to hormone changes, tingling legs, and burning of legs and right toe. This report was non-serious
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEGATIVE REACTION TO VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced negative reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction to vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022; Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Pharmacist does not know which arm the patient received the Moderna COVID-19 vaccine in. The Pharmacist does not have any other adverse events or side effects to report. The Pharmacist wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022.The Moderna COVID-19 vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022. No concomitant and treatment medication were reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacist had written an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. It was reported that the vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and the vial did not undergo any temperature excursions. It was unknown on which arm the patient had received the vaccine. No other adverse events or side effects were reported.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date; Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment information was reported.  The pharmacist did not know which dose the patient received and on which arm it was administered. The pharmacist did not have any other adverse events or side effects to report. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022; Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, vial was transferred from the Freezer to the Refrigerator and initially stored in it. The vial did not undergo temperature excursion.  No information on treatment medication was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date; Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 24-JAN-2022. The vial did not undergone any temperature excursions. The Pharmacist does not know which dose this patient received the invalid dose on and wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022.  No Concomitant information was reported. No Treatment information was reported.  The Pharmacist did not have any other adverse events or side effects to report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial did not undergo any temperature excursions. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. The Pharmacist does not have any other adverse events or side effects to report. No treatment medication information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.  It was reported that the patient received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. No other adverse events or side effects were reported. Vial did not undergo any temperature excursion.  Treatment medications were not reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022; Patient received vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given.  The Reporter reported that the pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients and the pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022.   The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022; The pharmacy gave Moderna COVID-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. The Moderna COVID-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022. The vial did not undergo any temperature excursions. The reporter did not know which dose the patient was received. The reporter did not have any other adverse events or side effects to report for the patient.  No treatment information was provided by the reporter.