chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness/it feels like arthtritis; sore arm / pain in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood cholesterol abnormal.    On 14-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking medication for thyroid and cholesterol concomitantly. Treatment information was not provided. Patient asked whether she can take tylenol or use any pain cream for the sore arm. Patient experienced a similar event in the past.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expiration date 25Mar2022, stored in the refrigerator 05Apr2022, Date administered 15Apr2022; 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) and PRODUCT STORAGE ERROR (Expiration date 25Mar2022, stored in the refrigerator 05Apr2022, Date administered 15Apr2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 076C21A, 027B21A and 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and URSODEOXYCHOLIC ACID (ACTIGALL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date 25Mar2022, stored in the refrigerator 05Apr2022, Date administered 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) and PRODUCT STORAGE ERROR (Expiration date 25Mar2022, stored in the refrigerator 05Apr2022, Date administered 15Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported The patients are not experiencing any symptoms after receiving the vaccine. Patient not ever had COVID + test or diagnosis. Patient not had allergies and Acute and Chronic illnesses at the time of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up received contains no new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022; Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 076C21A, 027B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergy to antibiotic (Clyndamycin). Concomitant products included PREDNISONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other vaccine was taken by the patient within 1 month prior to Moderna.  Vial was initially stored in refrigerator on 05-Apr-2022. Vial did not undergo any temperature excursion.  No treatment medication was reported by reporter.  The patient was not experiencing any symptoms after receiving the vaccine or any acute or chronic illness after vaccination.  Patient had never had COVID positive test or diagnosis.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up was received and included no significant information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia, Rash
Clinical narrative: felt different; broke out with rash; Running a chill; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt different), RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A, 046C21A, 026A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced FEELING ABNORMAL (felt different), RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt different) outcome was unknown and RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches) was resolving.            Concomitant medications were not provided by the reporter. Caller stated that she was a caregiver for her mom.   This case was linked to MOD-2022-541566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: injection site rash; small rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash) and RASH (small rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site rash) and RASH (small rash). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (injection site rash) and RASH (small rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided.   This case was linked to MOD-2022-541538 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up source document contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Sinus pressure/symptoms were slightly more severe than with previous doses; Sore arm/symptoms were slightly more severe than with previous doses; Fever/symptoms were slightly more severe than with previous doses; headache/symptoms were slightly more severe than with previous doses; Nausea/symptoms were slightly more severe than with previous doses; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Sinus pressure/symptoms were slightly more severe than with previous doses), PAIN IN EXTREMITY (Sore arm/symptoms were slightly more severe than with previous doses), PYREXIA (Fever/symptoms were slightly more severe than with previous doses), HEADACHE (headache/symptoms were slightly more severe than with previous doses) and NAUSEA (Nausea/symptoms were slightly more severe than with previous doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 018B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa), Blood pressure high, High cholesterol and Hypothyroidism. Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus pressure/symptoms were slightly more severe than with previous doses), PAIN IN EXTREMITY (Sore arm/symptoms were slightly more severe than with previous doses), PYREXIA (Fever/symptoms were slightly more severe than with previous doses), HEADACHE (headache/symptoms were slightly more severe than with previous doses) and NAUSEA (Nausea/symptoms were slightly more severe than with previous doses). At the time of the report, PARANASAL SINUS DISCOMFORT (Sinus pressure/symptoms were slightly more severe than with previous doses), PAIN IN EXTREMITY (Sore arm/symptoms were slightly more severe than with previous doses), PYREXIA (Fever/symptoms were slightly more severe than with previous doses), HEADACHE (headache/symptoms were slightly more severe than with previous doses) and NAUSEA (Nausea/symptoms were slightly more severe than with previous doses) had resolved.            Patient received the first booster dose. Symptoms lasted approximately 30 hours. No treatment medication was reported.   This case was linked to MOD-2022-541588, MOD-2022-541582, MOD-2022-538599 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Sinus pressure; headache; Nausea; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Sinus pressure), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa), Blood pressure high, High cholesterol and Hypothyroidism. Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2022, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 12-Apr-2022, the patient experienced HEADACHE (headache) and NAUSEA (Nausea). On 13-Apr-2022, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus pressure). On 12-Apr-2022, PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) had resolved. On 13-Apr-2022, PYREXIA (Fever) had resolved. At the time of the report, PARANASAL SINUS DISCOMFORT (Sinus pressure) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were provided  Patient had headache started on 12/04/2022 at 02.00 am and lasted for 4 hours. Patient symptoms lasted approx 30 hours.   This case was linked to MOD-2022-541582, MOD-2022-541581, MOD-2022-538599 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 17-Aug-2020, Type II diabetes mellitus since 17-Jul-2019 and Essential hypertension since 05-Dec-2019. Concomitant products included ATORVASTATIN, EZETIMIBA and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Jun-2021 at 11:04 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included lyumjev kwikpen 30 units injection TID. No treatment medications were reported.   This case was linked to MOD-2022-503289 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Not feeling well; swollen lymph nodes felt like carrying golf balls under my arm; feelings of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 009C21A and 044A21A) for COVID-19 vaccination.     Patient don't have allergies, no history of COVID.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm) outcome was unknown.  No concomitant products were reported.  Reported that feelings of sore arm and not feeling well with other doses but did not specify which dose resulted in which side effects.   This case was linked to MOD-2022-541985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up contains no new information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006M20A) for COVID-19 vaccination.     Patient had no allergies.  Concurrent medical conditions included Hypothyroidism (no recent change in condition status) since 28-Sep-2020. Concomitant products included LEVOTHYROXINE from 28-Sep-2020 to an unknown date for an unknown indication.   On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021 at 12:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Mar-2021 at 12:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) to be not related.    Patient did not experience any adverse event including signs and symptoms. clinical course and or treatment with dates/timelines. Patient did not experience any symptoms during  the temperature excursion.   This case was linked to MOD-2022-503346 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient was administered booster dose from a vial that had been open for 24 h.; Vial was open for more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered booster dose from a vial that had been open for 24 h.) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered booster dose from a vial that had been open for 24 h.). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered booster dose from a vial that had been open for 24 h.) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. There were 7 number of booster doses. The vial was initially stored in the refrigerator on 12-Apr-2022. The vial was first punctured on 13-Apr-2022 at 8:00 am and vaccine was administered on 14-Apr-2022 8:02 am. The vial was stored in refrigerator at 4-5 °C post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 min or less. The vial did not undergo any temperature excursions. The patient did not experience any symptoms.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was exposed to room temperature for 27 hours; Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 2:36 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2022 at 2:36 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 08-Mar-2022 and was first punctured on 12-Mar-2022 at 11:08 am and the Vial was stored in room temperature. Vial did not undergo any temperature excursions.  The vial was exposed to room temperature for range (8° to 25°C= 46° to 77°F) for 27 hours. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-511737 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Imaging procedure, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Less than 10 days after the vaccine, I had acute pain in my MCPs and MTPs. I saw my primary care doctor approximately 10 days after the pain started. Bloodwork was normal, but she referred me to a rheumatologist who diagnosed me with rheumatoid arthritis. Despite beginning medication, pain is ongoing. I know 3 other women in my age group who are experiencing the same symptoms and are awaiting to see a rheumatologist. I strongly suspect a vaccine-related AE, either from this years flu vaccine, the Covid booster, or receiving the two in close proximity.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Autoimmune disorder, Blood test, Computerised tomogram, Condition aggravated
Clinical narrative: Severe breathing issue, noted at ER:breathing treatments as far as 7 months out (present) Skin rash and hair loss, noted at dermatology : steroid shot, oral and cream  Vision issues and changes, noted with eye Dr: went a couple times a week for about 6 weeks. Ended up having to change script. Autoimmune diseases flared immediately and have continued
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary function test, Rash, Visual impairment, X-ray
Clinical narrative: Severe breathing issue, noted at ER:breathing treatments as far as 7 months out (present) Skin rash and hair loss, noted at dermatology : steroid shot, oral and cream  Vision issues and changes, noted with eye Dr: went a couple times a week for about 6 weeks. Ended up having to change script. Autoimmune diseases flared immediately and have continued
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: I think the vaccine messed with my immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "I think the vaccine messed with my immune system".  Additional information: The reporter stated that she wanted to know if there are doctors that are treating the side effects or know how to treat the side effects. Wanted to know if she should see her doctor, stated that she is having an adverse event, stated that she had every adverse event and then some and still has them, stated that everything she had problems with in her body has revved up again, stated that she thinks that it messed up her immune system who knows or does she have to wait. No further details provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: has the same feel 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "has the same feel 3 times". Additional information; No it won't work  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Interchange of vaccine products, Off label use
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (COMIRNATY), on 27Oct2021 as dose 2 (initial Pfizer dose), single (Lot number: FH8020) at the age of 54 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose 1), administration date: 15Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Oct2021, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for COVID-19 with an at home test"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (COMIRNATY), on 27Oct2021 as dose 2 (initial Pfizer dose), single (Lot number: FH8020) at the age of 54 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose 1), administration date: 15Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Oct2021, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for COVID-19 with an at home test"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Feeling hot, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness/Heaviness/Pain-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Within 2 minutes after administration patient alerted pharmacist she felt out-of-breath, chest tightness and an overall warm feeling. At 5 minutes, blood pressure and heart rate checked with arm blood pressure kit. All numbers were normal. At this time, patient felt a little better. At 10 minutes, I offered Benadryl and/or Zyrtec but patient declined. She stated she felt much better. She could go home with no issues.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness/Heaviness/Pain-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Within 2 minutes after administration patient alerted pharmacist she felt out-of-breath, chest tightness and an overall warm feeling. At 5 minutes, blood pressure and heart rate checked with arm blood pressure kit. All numbers were normal. At this time, patient felt a little better. At 10 minutes, I offered Benadryl and/or Zyrtec but patient declined. She stated she felt much better. She could go home with no issues.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Pruritus, Rash erythematous
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states after second dose (first dose was 12/8 and no adverse event) she had welts/rash/red bumps and lots of itching start from elbow of immunized arm all the way to her whole back could potentially be allergic reaction told her to go to her primary care provider to make sure it is nothing else
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states after second dose (first dose was 12/8 and no adverse event) she had welts/rash/red bumps and lots of itching start from elbow of immunized arm all the way to her whole back could potentially be allergic reaction told her to go to her primary care provider to make sure it is nothing else
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired product administered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: three fingers right hand/index, middle, ring, face/right side mouth
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Paraesthesia oral, Rash, Rash pruritic
Clinical narrative: After the normal aches/pains/chills, 48 hours after the injection I began to get an itchy rash on my forearms, stomach, chest with tingling on my lips. I was told to use benadryl and to go the ER if symptoms got worse or if I began to have difficulty breathing.  It is now Tuesday, April 19th and I still have the itchy rash. I have just taken my 3rd dose of Benadryl in less than 24 hrs.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Headache, Myalgia
Clinical narrative: Headache, muscle pain (throughout entire body), joint pain (throughout entire body), chills and chest pain.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient with 2 dose Moderna series admitted to hospital with COVID PCR pos 4/14/22
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Flushing, Pain in extremity, Paraesthesia
Clinical narrative: Anxiety-PAINAND HEAT IN ARM. HEAT PROGRESSED TO ENTIRE BODY. TINGLING IN FEET ON LEFT SIDE. 1222 STILL FEELING HOT/FLUSHED. 1232 FLUSING FONG Narrative:  1202 BP 151/101, HR 66, Temp 98.8, SPO2 98% RA. 1212 BP 176//117, HR 68, Temp 98.1, SPO2 98% RA. 1222 BP 151/100, HR 64, Temp 98.4, SPO2 98% RA. 1232 BP 153-101, HR 60, Temp 98.7, SP02 97% RA. Treated with Ice pack. Symptoms resolved.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Adverse event: mis-stored vaccine administered to patient. Result: revaccinated.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Adverse event: mis-stored vaccine administered to patient. Result: revaccinated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Adverse event: mis-stored vaccine administered to patient. Result: revaccinated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Adverse event: mis-stored vaccine administered to patient. Result: revaccinated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed and hospitalized with covid while up to date with vaccinations
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Erythema, Haemorrhage, Pruritus, Swelling
Clinical narrative: I started itching on my elbows and the blood flowed to my skin. My temperature dropped it happened in 5 different areas on my body. I knew it wasn't normal it caused me to be red, itchy and swollen. I was given an Epi-pen by my doctor.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Lymphadenopathy, Nausea, Pain
Clinical narrative: The second day after my vaccination I had all kinds of side effects, my arm got swollen, red and painful. I had swelling of the lymph node under my arm and on my neck. I was nauseous I had fever and this went on for at least 4 days. During this time I also had burning arms and had to be careful with what type of fabric I wore and where I placed my arm, I also had body aches.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The second day after my vaccination I had all kinds of side effects, my arm got swollen, red and painful. I had swelling of the lymph node under my arm and on my neck. I was nauseous I had fever and this went on for at least 4 days. During this time I also had burning arms and had to be careful with what type of fabric I wore and where I placed my arm, I also had body aches.
Age: 33.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Blood pressure increased, Cardiac arrest, Cardiac failure, Electrocardiogram
Clinical narrative: I started having issue with heart failure after Moderna, Dose 3: 10/25/2021 and lot 076C21A. 11/21/2021 noticed blood pressure extreme spike, then It was second week of February in 2022. Blood pressure was spiking 190/120 and after it blood pressure was checked and while it went down it was never normal the average range it would fall was between 130/90. Undiagnosed Omicron 2nd week of Jan. 2022. Mild cardiac arrest in 02/2022 ; down from 13 pills a day to 2. Stethoscope and Re-scheduled for EKG.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Headache, Limb discomfort
Clinical narrative: It started the second or third day, it lasted for about three days. It started as a slight headache and my left eye started twitching. My arm felt heavy on the left side and it lasted a couple days but went away.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Fatigue, Malaise
Clinical narrative: After the booster, I have been dizzy and I have been falling a lot. I also have vertigo often. I have also been having blurry vision today. I was sick for 3 1/2 days with a fever, chills, fatigue and a sore arm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vertigo, Vision blurred
Clinical narrative: After the booster, I have been dizzy and I have been falling a lot. I also have vertigo often. I have also been having blurry vision today. I was sick for 3 1/2 days with a fever, chills, fatigue and a sore arm.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received her second booster too soon. She was due 5/27 and was given the vaccine 4/19. About 42 days early. No known adverse events. Patient was made aware of the error and was directed to the app as well to keep an eye on adverse events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Swelling
Clinical narrative: I woke up late the following night after receiving the vaccine I felt something in my left arm that was different. I looked in the mirror and saw swelling above my clavicle at the base of my next going over to my shoulder. I went to see the doctor on Monday morning around 11AM to have his check this out. He advised me to wait a week or two see if the swelling would go down. Most of the swelling has come down.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus - ringing in my ears.  Developed slowly. Was unsure what it was initially. Seem to have progressively gotten worse.  Much louder and more frequent.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna  Covid  Booster instead Pfizer, pt too young for Moderna.. no adverse reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient came in Friday 4.15.22 to get her second dose of Shingrix.  She states that on Sunday a red bruise like circle appeared on her arm.  It was hot to the touch and sore.  It is several inches below the injection site.  The circle is getting larger, but the soreness has decreased.  She took benadryl yesterday but did not do anything.  Today it is larger, but not as hot to the touch. It is slightly sore but decreasing compared to Sunday. This did not occur to her after her first dose
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide increased, Respiratory viral panel, Respirovirus test positive, Substance use
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Cardiac monitoring, Chest pain, Drug use disorder, Echocardiogram abnormal
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Haemophilus test positive, Imprisonment, Intensive care, Malaise
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Parainfluenzae virus infection, Pericarditis, Prohormone brain natriuretic peptide increased, Troponin increased
Clinical narrative: Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide increased, Respiratory viral panel, Respirovirus test positive, Substance use
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Cardiac monitoring, Chest pain, Drug use disorder, Echocardiogram abnormal
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Haemophilus test positive, Imprisonment, Intensive care, Malaise
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Parainfluenzae virus infection, Pericarditis, Prohormone brain natriuretic peptide increased, Troponin increased
Clinical narrative: Patient received first dose of covid vaccine on 4/12/22 in Detention Center.  ATTENDING NOTE 04/18/22  I personally reviewed all the data, examined the patient myself, talked with the family. I agree with resident note with some remarks.  18 year old that has dropped school, uses meth daily when at home that got covid shot while in jail last Tuesday and by the end of the week was sick, weekend had some chest pain, not getting better and came to Hospital . EKG with ST changes , CK and troponin elevated, echo with mild dysfunction. Also found to be paraflu 3 positive