chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received dose on April 11th 2022, expired on April 6th 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-week-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th April 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th April 2022, unknown after receiving Engerix B and Engerix B 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: 13-APR-2022 Reporter's Comments:  Clinic administrator reported patient received a dose of Engerix B that was already  expired on 6th April 2022.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Havrix and Engerix to adult pt; Pediatric Havrix and Engerix to adult pt; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 61-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On 11th April 2022, the patient received Havrix pediatric and Engerix B pediatric. On 11th April 2022, unknown after receiving Havrix pediatric and Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 13-Apr-2022 Reporter's Comments: Pharmacist reported an adult patient (61 years old) had been vaccinated with a pediatric dose of Havrix and one of Engerix on Monday ( 11th April 2022). The Healthcare professional had no information about lot numbers of the vaccines. The reporter consented to follow up. Additional Supportive Information: The adult patient received pediatric dose of Havrix and Engerix B, which led to underdose and adult use of a child product. Note: The formulation of suspect products was captured as solution for injection, as the reporter had no information regarding the formulation.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 13th April 2022, the patient received Engerix B. On 13th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-Apr-2022 Reporter's Comments: Nurse reported that a female patient received on13th April 2022, an expired dose of Engerix-B by error. The reporter consented to follow up via email please. The Healthcare professional did not allow to create an account in database. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.       Additional Information: GSK Receipt Date: 13th Apr 2022 Reporter's Comments: The reporter was medical assistant. The reporter stated that adult patient was accidentally administered pediatric dose of Engerix B. The patient was unaware of the mix up, but had not reported any reactions. The reporter consented to follow up. Additional Supportive Information: The adult patient was accidentally administered pediatric dose of Engerix B which led to accidental underdose and inappropriate age at vaccination.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 12th April 2022, unknown after receiving Boostrix and Boostrix 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: GSK Receipt Date: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product, Vision blurred
Clinical narrative: Temporarily experienced blurring; Unspecified amount ended up in patient's eye; Unspecified amount ended up in patient's eye; This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blurred vision, occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the blurred vision, occupational exposure while administering product and exposure via eye contact were unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.     Additional Information: GSK Receipt Date: 14th Apr 2022 Reporter's Comments: The pharmacist reported case for herself. The pharmacist reported that when they were drawing up Shingrix adjuvant, an unspecified amount ended up in their eye. The pharmacist was wearing contacts and temporarily experienced blurring. The pharmacist rinsed both their eyes and contacts. The vaccine was not administered to the patient. The reporter declined to provide additional information.  The reporter did not consent to follow-up. Additional Supportive Information: While drawing up Shingrix adjuvant, an unspecified amount ended up in the reporter's eye, which led to blurred vision, occupational exposure while administering product and exposure via eye contact.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Death, Illness
Clinical narrative: Sick, went to hospital 3 times before passing; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included solitary kidney (the patient had an extensive medical history including having only one kidney).   On 9th October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. In October 2020, between 1 and 2 weeks after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness (serious criteria death and hospitalization). On 15th April 2021, the outcome of the sickness was fatal. The patient died on 15th April 2021. The reported cause of death was sickness.   It was unknown if the reporter considered the sickness to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comment: The case was reported by patient's husband.  The reporter did not provide specific details about the event or vaccine.  He stated that, the patient received the Flulaval Quadrivalent vaccine and about 1.5 weeks later she was sick and had to go to the hospital. The patient went to the hospital, she spent several days. The reporter could not describe patient's sickness or give a diagnosis.  He stated, she was in the hospital 2 more times before passing on 15th April 2021.  The reporter did not consent to follow-up. No further information was to report.; Reported Cause(s) of Death: Sickness
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an 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 almost 3 months ago to the reported date 25-JUN-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 reported that IGA antibody test was completely negative (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 IgA antibody test: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000224730 The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220408605-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Pyrexia
Clinical narrative: STOMACH ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: HTN (hypertension), thyroid, cholesterol, asthma, COPD (chronic obstructive pulmonary disease), seasonal allergies, ex-smoker (The patient stated she smoked for 30 years but quit 18 years ago) and no alcohol use, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had nausea when treated with codeine. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination.  On 06-APR-2021, the patient experienced fever, chills, headache, stomach hurt (Dose number in series 1). The patient stated that she had initially fever with body temperature 102.4 F and after 5 hours post vaccination fever came down to 99.9 F. The patient recovered from fever, chills, headache, stomach hurt on 06-APR-2021(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: 213D21A expiry: UNKNOWN) dose was not reported, 1 total administered on 15-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-NOV-2021, the patient experienced fever which reached to 99.9 F, headache, and stomach ache but with less severity than with the initial vaccination (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and stomach ache on 15-NOV-2021 after 10 hours of post vaccination. This report was non-serious. This case, involving the same patient is linked to 20220431821 (Dose number in series 1).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Thrombosis
Clinical narrative: BLOOD CLOT; JOINT PAIN; This spontaneous report received from a patient concerned a 63 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pseudo gout, moderate to severe chronic plaque psoriasis and arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total (first dose) administered on 11-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. Non-company suspect drugs included: risankizumab (form of admin not reported, subcutaneous, and batch number were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.  On an unspecified date, the patient experienced blood clot, and was hospitalized (date unspecified). Number of days of hospitalization was not known. She also had joint pain (dose number in series 1). The patient additionally received Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, administered on JAN-2022 for covid-19 vaccination. It was unknown whether patient had any adverse events following administration of Pfizer vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and the outcome of blood clot was not reported (dose number in series 1). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220424655 -COVID-19 VACCINE AD26.COV2.S- blood clot.The event(s) has a 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.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex smoker (smoker for 30 years and had quit 18 years ago), and concurrent conditions included: hypertension, thyroid disorder, asthma, cholesterol, COPD, and seasonal allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Age at time of vaccination 71 years old. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4, 99.9. On 06-APR-2021, the patient experienced stomach hurt, chills, fever, and headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach hurt, chills, and headache on 06-APR-2021, and fever on 10-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20220421138.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 12-Apr-2022 was initially stored in refrigerator on 13-Apr-2022; A patient was administered an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose) and PRODUCT STORAGE ERROR (Vaccine expired on 12-Apr-2022 was initially stored in refrigerator on 13-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 12-Apr-2022 was initially stored in refrigerator on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose) and PRODUCT STORAGE ERROR (Vaccine expired on 12-Apr-2022 was initially stored in refrigerator on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient was administered with the 2nd booster dose on 13-Apr-2022. Date the vial was initially stored in the refrigerator was on 13-Apr-2022. The vial did not undergo any temperature excursions. Patient did not experience any symptoms.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up document received includes no new information.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Erythema, Oedema peripheral, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs) and ASTHMA (Asthma after booster) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028C20A and 025J2019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aortic valve replacement in 1993 and Pacemaker insertion (cardiac) in 2016. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included ALOPURINOL, LOSARTAN, WARFARIN, LEVOCETIRIZINE and GLIPIZIDE for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Nov-2021, the patient experienced RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash). At the time of the report, RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash) outcome was unknown. No concomitant medication information was provided. Patient received half dose of booster shot. Patient visited the dermatologist and was prescribed with expensive topical ointments and asthma medications. The reporter stated that they can not afford the copays and the deductibles. Reporter asked whether there were lot of reactions to Booster shot and also what they should do with the next shot and asked whether patient should receive a different COVID-19 vaccine. This case was linked to MOD-2022-539502 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs) and ASTHMA (Asthma after booster) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028C20A and 025J2019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aortic valve replacement in 1993 and Pacemaker insertion (cardiac) in 2016. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included ALOPURINOL, LOSARTAN, WARFARIN, LEVOCETIRIZINE and GLIPIZIDE for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Nov-2021, the patient experienced RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash). At the time of the report, RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash) outcome was unknown. No concomitant medication information was provided. Patient received half dose of booster shot. Patient visited the dermatologist and was prescribed with expensive topical ointments and asthma medications. The reporter stated that they can not afford the copays and the deductibles. Reporter asked whether there were lot of reactions to Booster shot and also what they should do with the next shot and asked whether patient should receive a different COVID-19 vaccine. This case was linked to MOD-2022-539502 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine from a vial that was punctured more than 12 hours; Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours) and PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours) in a 91-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022 at 12:30 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours) and PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 24-Mar-2022. The vaccine was punctured on 11-Apr-2022 at 12:54 pm. Post puncture the vail was stored in refrigerator. The vial did not undergo any temperature excursions.   No Treatment medications were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Psoriatic arthritis (Started 40 years ago and Stable.), Interstitial lung fibrosis (Idiopathic Interstitial fibrosis of lungs. Stable) since 2021, Cholesterol and Thyroid disorder. Concomitant products included GUSELKUMAB (TREMFYA) for Psoriatic arthritis. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 05-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. It was also reported that patient took antacid and some medication for Cholesterol and Thyroid. Patient did not have any allergies from medications, food and other products. Patient is taking Tremfya for about an year. Patient was sick with fever and chills for 2-3 days after receiving the 2nd dose. Patient has experienced the similar event fever in the past. The patient was not tested positive or diagnosed with COVID. Treatment medication was not reported. This case was linked to MOD-2022-539509 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given past the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vaccine was stored at within range standard freezer temperatures (Min/Max = -13.0 F to -9.0 F) between 19-Jan-2021 through 25-Mar-2021. The vaccine was moved to a within range refrigerator (35.6 F to 46.4 F) on 25-Mar-2021 at 1200 hours. Booster dose (0.25 ml) was given to a patient past the expiration date of 28-Mar-2022 on 29-Mar-2022 at 1300 hours.  No treatment medications was reported.   This case was linked to MOD-2022-539512 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Head discomfort, Headache, Influenza like illness
Clinical narrative: a heavy head; feel dizzy; headache; joint pain; felt like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (a heavy head), INFLUENZA LIKE ILLNESS (felt like she had the flu), DIZZINESS (feel dizzy), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), HEADACHE (headache) and ARTHRALGIA (joint pain). On 13-Apr-2022, the patient experienced HEAD DISCOMFORT (a heavy head) and DIZZINESS (feel dizzy). At the time of the report, HEAD DISCOMFORT (a heavy head), DIZZINESS (feel dizzy) and HEADACHE (headache) had not resolved and INFLUENZA LIKE ILLNESS (felt like she had the flu) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant drug was reported. The reporter stated that his wife took her fourth booster dose on Friday 08-Apr-2022 and still had a headache so the reporter queried was that normal. The reporter refused to provide any additional information regarding Moderna Covid-19 vaccine. No information was provided on the patient's second primary vaccine or the patient's first Moderna Covid-19 booster dose. No treatment drug was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contain no new information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 :14 Mar 2022. Vial did not undergo any temperature excursion. No concomitant medication was reported.    No treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: vial was not shipped frozen; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 939906) for COVID-19 vaccination.     The patient's past medical history included Syncope on 21-Jan-2016, Testicular disorder on 20-May-2009, Esophageal reflux on 11-Feb-2008, Aortic valve replacement on 17-Feb-2016 and Anticoagulant therapy on 11-Aug-2016. Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Blood pressure high on 28-Jun-2016, Hypercholesteremia on 28-Jun-2016, Morbid obesity on 28-Jun-2016 and Type 2 diabetes mellitus on 26-Jun-2020.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Delivery of Moderna vial at refrigerator temp. on 16-Jun-2021. Office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived morning of 16-Jun-2021. Transport temperature between 2-8C for a couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. The dose was then administered. Per Moderna one re-freeze was ok, but can not be given beyond 30 days that time. Patient had no signs and symptoms of any adverse reaction to the injection given.   No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022.  The vial did not undergo any temperature excursions.  No concomitant medication reported.  No treatment medication details reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypocholesteremia since 27-Jul-2018.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days).    It was unknown whether patient was ever diagnosed with COVID-19. It was unknown whether the patient had acute illness at the time of vaccination and up to 1 month before.  No concomitant medication information was provided.  On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature. The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 23-Aug-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 23-Aug-2021. Per Moderna one re-freeze was ok but could not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given.  No treatment medication were provided. Patient did not seek medical care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fall, Gait disturbance, Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: Could hardly walk; Almost falling backwards like someone who has cerebral palsy; His back hurt bad/back pain is ongoing/back pain is improving; His neck really hurt; Out of work for the week so far/missed 3 days of work; His neck has weak spots; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Administered on Fall 2021.Route of administration- Intramuscular) in 2021 and J&J (First dose). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII and J&J. Concurrent medical conditions included Hypercholesterolemia (No change in status such as improvement or worsening recently.). Concomitant products included SIMVASTATIN for an unknown indication.   On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced NECK PAIN (His neck really hurt). On 11-Apr-2022, the patient experienced GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving). In April 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (His neck has weak spots) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work). At the time of the report, MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), FALL (Almost falling backwards like someone who has cerebral palsy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) outcome was unknown, GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) was resolving and NECK PAIN (His neck really hurt) had resolved.            Patient received second booster dose on 09-Apr-2022 afternoon. The manufacturer of the second dose patient received was unknown. No treatment medications were reported.   This case was linked to MOD-2022-539764.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Could hardly walk; Almost falling backwards like someone who has cerebral palsy; His back hurt bad/back pain is ongoing/back pain is improving; His neck really hurt; Out of work for the week so far/missed 3 days of work; His neck has weak spots; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Administered on Fall 2021.Route of administration- Intramuscular) in 2021 and J&J (First dose). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII and J&J. Concurrent medical conditions included Hypercholesterolemia (No change in status such as improvement or worsening recently.). Concomitant products included SIMVASTATIN for an unknown indication.   On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced NECK PAIN (His neck really hurt). On 11-Apr-2022, the patient experienced GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving). In April 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (His neck has weak spots) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work). At the time of the report, MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), FALL (Almost falling backwards like someone who has cerebral palsy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) outcome was unknown, GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) was resolving and NECK PAIN (His neck really hurt) had resolved.            Patient received second booster dose on 09-Apr-2022 afternoon. The manufacturer of the second dose patient received was unknown. No treatment medications were reported.   This case was linked to MOD-2022-539764.