chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On 1-31-22 the patient called to notify the pharmacy that she developed a mild rash with redness and itchiness at the injection site after receiving her third dose of Covid Pfizer vaccine on 1/27/22. She was unsure if there were any lymph node involvement under her arm. She asked about what she could take temporarily to relieve the mild itching. She said she was not allergic to Benadryl. I recommended Benadryl 25 mg 1 or 2 capsules or tablets by mouth, warned her about sedation, not driving and not to take any alcoholic beverages. I advised her to seek for medical attention ASAP.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Mobility decreased, Muscle fatigue
Clinical narrative: On 1-31-22 the patient called to notify the pharmacy that she developed a mild rash with redness and itchiness at the injection site after receiving her third dose of Covid Pfizer vaccine on 1/27/22. She was unsure if there were any lymph node involvement under her arm. She asked about what she could take temporarily to relieve the mild itching. She said she was not allergic to Benadryl. I recommended Benadryl 25 mg 1 or 2 capsules or tablets by mouth, warned her about sedation, not driving and not to take any alcoholic beverages. I advised her to seek for medical attention ASAP.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: On 1-31-22 the patient called to notify the pharmacy that she developed a mild rash with redness and itchiness at the injection site after receiving her third dose of Covid Pfizer vaccine on 1/27/22. She was unsure if there were any lymph node involvement under her arm. She asked about what she could take temporarily to relieve the mild itching. She said she was not allergic to Benadryl. I recommended Benadryl 25 mg 1 or 2 capsules or tablets by mouth, warned her about sedation, not driving and not to take any alcoholic beverages. I advised her to seek for medical attention ASAP.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature 8.2F/ Time frame: 1 hours and 30 minutes; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 23-DEC-2021, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U020238, expiration date: 28-JUN-2023, strength, dose and route were unknown) for prophylaxis (product storage error). The vaccine was stored at 8.2 degrees Fahrenheit (F) for one hour and 30 minutes. There was no previous excursion.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No aditional adverse event reported; RECOMBIVAX HB administered while improperly stored; This spontaneous report as received from a other health professional referring  to a male infant patient . Information regarding the patient medical history, concomitant medications, drug allergies or reaction was not provided.     On 19-JAN-2022, the patient was vaccinated with improperly stored dose  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # T021327expiration date 14-NOV-2022, 0.5 milliliter for prophylaxis (strength and administration route were not provided)(product storage error).  The vaccine was exposed to 49.9 Fahrenheit degrees for 2 hours and 30 minutes. No previous excursions were reported. No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, between 5 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown. The reporter reported that a patient needs to receive his second Shingrix shot by 8th February 2022 (6 months since first shot) as reported.  The reporter developed shingles 4 days prior to this report.  The patient currently had an active case of shingles. The lot number or expiry data available as the first dose was not administered at their pharmacy and the reporter did not know the exact date of the first dose.  The reporter stated that she needed to give a shot and not to log her out but then disconnected the chat.  The patient was unable to obtain permission for follow up due to this but an email was provided. The mailing address was listed in the reporter details section of the adverse event form but he/she was not able to confirm that this was the current address. Case US2022012215 was identified as a follow up of case US2022012210. Case US2022012215 was deleted due to being created in error. All future correspondence would be submitted to case US2022012210 (case of record). The case has been linked to US2018024303,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018024303:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Weight, Weight decreased
Clinical narrative: HAS LOSS WEIGHT FROM 215LB TO 160LB; FELT MORE ENERGY, LOVE, POSITIVE, OVERWHELMED, HAPPY, LIKE ALL SYSTEMS WERE FIRING, HORMONAL PROBLEM GONE, BETTER MEMORY, LEARNING URGE, LIGHT, MORE PREDICTABLE MENSIS, MENOPAUSE SYMPTOMS GOT BETTER; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 215 pounds, and height was not reported. The patient's past medical history included: ovarian tube removal surgery, tubal pregnancy, nursing, post procedural complication, and hormone replacement therapy, and concurrent conditions included: hormonal problem, and non-functional ovary, and other pre-existing medical conditions included: patient had no known drug allergies. 10 to 15 years ago had to remove an ovarian tube, believes due to that surgery one of her ovaries was non functional. She stated that she was not taking any medications at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced felt more energy, love, positive, overwhelmed, happy, like all systems were firing, hormonal problem gone, better memory, learning urge, light, more predictable mensis, menopause symptoms got better. On an unspecified date, the patient experienced has loss weight from 215lb to 160lb. Laboratory data (dates unspecified) included: Weight 215 pounds, 160 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt more energy, love, positive, overwhelmed, happy, like all systems were firing, hormonal problem gone, better memory, learning urge, light, more predictable mensis, menopause symptoms got better and has loss weight from 215lb to 160lb was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Illness
Clinical narrative: SICKNESS; TERRIBLE REACTION; This spontaneous report received from a consumer concerned an elderly female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination.  The patient had no any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient was sick, she had a terrible reaction for 24 hours and she was feeling bad (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible reaction, and the outcome of sickness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220123706.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 80 year old female of unspecified race and ethnic origin. 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 (dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 1). The reporter stated that the patient currently has COVID-19. It was reported that, the patient received an antibody infusion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. The patient received Pfizer vaccine (dose number in series 2), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination, for 12 years and older formulation (purple cap) one week before she got COVID-19. It was unknown whether patient had adverse event following Pfizer vaccine (dose number in series 2). This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000214016.; Sender's Comments: V0: 20220147651-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. 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 20220147651-COVID-19 VACCINE AD26.COV2.S-Suspected Covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 63 year old White, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's  concurrent conditions included: non alcohol user, non smoker, tinnitus from medication she was on, neuropathies, neuralgias, flu (every year), immunocompromised, upper respiratory issues with infusions, sulfa drugs don't do well, multiple drug allergies/ allergic to lot of rheumatoid drugs, and autoimmune rheumatoid inflammatory disease due to vaccine for lyme disease. The patient had a past medical history of covid-19 on DEC-2020 and was hospitalized for 10 days.On 18-JUN-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The patient had no adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1).On 02-NOV-2021, the patient was treated with covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered to left arm on 24-JAN-2022 for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered. (Dose number in series 2). Concomitant medications included abatacept (Orencia) 750 mg intravenous a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the off label use and inappropriate schedule of vaccine administered was not reported.This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed, Menstruation irregular
Clinical narrative: LATE MENSTRUAL CYCLE; CYCLE IS ABNORMAL; IRREGULAR MENSTRUAL CYCLE/PROGRESSIVELY WORSE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced late menstrual cycle, cycle is abnormal, and irregular menstrual cycle/progressively worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the late menstrual cycle, cycle is abnormal and irregular menstrual cycle/progressively worse was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAD A LOT OF TROUBLE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had a lot of trouble. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a lot of trouble was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED TO PATIENT FROM A VAIL OPENED FOR MORE THEN 6 HOURS; VACCINE VIAL OPENED FOR MORE THAN 6 HOURS STORED IN REFRIGERATOR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-JAN-2022 14:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine administered to patient from a vail opened for more then 6 hours, and vaccine vial opened for more than 6 hours stored in refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient from a vail opened for more then 6 hours and vaccine vial opened for more than 6 hours stored in refrigerator was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEEL LIKE RUNNING A 103 F FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported)  1 total dose, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient experienced any adverse event after following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects and feel like running a 103 F fever (event occurred in Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like running a 103 F fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Urticaria
Clinical narrative: Started getting hives on my arms and legs every few days/It has got worse after the second dose; It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose; Could not figure out what I was allergic to; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to). At the time of the report, URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter. Patient stated that events got worse after second dose.   This case was linked to MOD-2022-462023 (Patient Link).   Reporter did not allow further contact
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 12 year old patient was administered the Moderna COVID.19 vaccine as first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old patient was administered the Moderna COVID.19 vaccine as first dose.) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old patient was administered the Moderna COVID.19 vaccine as first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old patient was administered the Moderna COVID.19 vaccine as first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: smelling cigarette smoke; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelling cigarette smoke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (smelling cigarette smoke). At the time of the report, PAROSMIA (smelling cigarette smoke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  The vial was initially stored in the refrigerator on 1 Dec 2021 and the vaccine was administered on 03 JAN 2022(booster dose). The vial did not undergo any temperature excursions.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.). On 27-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.  This patient received 2 doses of the Moderna covid-19 vaccine by intramuscular injection to the deltoid. They have not reported any symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.  Date the vial was initially stored in the refrigerator on 01 Dec 2021. The use by date was 30 Dec 2021. The vial did not undergone any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator 1 Dec 2021. 7 booster doses of the Moderna Covid-19 Vaccine given on 3 Jan 2022 were past the 30-day Use By Date of 30 Dec 2021. Vial does not undergo any temperature excursions.  No concomitant product information was provided. No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Influenza like illness, Myalgia, Pain
Clinical narrative: arm hurt the first and second day, it was a small ache and not as hot to the touch; achy; flu-like symptoms; arm hurt the first and second day, it was a small ache and not as hot to the touch; tired; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer surgery (Thyroid cancer surgery) on 29-Apr-2021. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) from April 2021 to an unknown date for an unknown indication.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever). In 2021, PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first and second dose: arm hurt the first and second day, it was a small ache and not as hot to the touch. The day after the shots the patient experienced achy, tired, flu-like symptoms, body aches, low grade fever for a day or a day and a half.   The patient had second dose in mid-Jul.   This case was linked to MOD-2022-463116 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm hurt the first and second day, it was a small ache and not as hot to the touch; achy; flu-like symptoms; arm hurt the first and second day, it was a small ache and not as hot to the touch; tired; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer surgery (Thyroid cancer surgery) on 29-Apr-2021. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) from April 2021 to an unknown date for an unknown indication.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever). In 2021, PAIN IN EXTREMITY (arm hurt the first and second day, it was a small ache and not as hot to the touch), PAIN (achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (arm hurt the first and second day, it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first and second dose: arm hurt the first and second day, it was a small ache and not as hot to the touch. The day after the shots the patient experienced achy, tired, flu-like symptoms, body aches, low grade fever for a day or a day and a half.   The patient had second dose in mid-Jul.   This case was linked to MOD-2022-463116 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Brain Fog after booster; Lost Voice after booster; Chills after booster; Fatigue after booster/Too Tired after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 018B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster). At the time of the report, FEELING ABNORMAL (Brain Fog after booster), APHONIA (Lost Voice after booster), CHILLS (Chills after booster) and FATIGUE (Fatigue after booster/Too Tired after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was provided. No treatment medication was provided. Patient states that Every 7 to 10 days has recurring side effects. The doctor did a COVID test and result was Negative. She states that she also had a Flu shot in NOV-2021.   This case was linked to MOD-2021-358836, MOD-2021-358790 (Patient Link).
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash on her back, on her shoulders, on her feet, all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on her back, on her shoulders, on her feet, all over her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053h21a, 047b21a and 002c21a) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced RASH (a rash on her back, on her shoulders, on her feet, all over her body). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, RASH (a rash on her back, on her shoulders, on her feet, all over her body) outcome was unknown.            Reporter has provided  other treatments, like pain relief pill, rubbing alcohol, palmer's lotion, doctor pills, moisturizer. Patient date of birth was given as 1953.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm, chills, fatigue, headache lasting more than 72 hours.
Sex: U
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Feeling abnormal, Hand-eye coordination impaired, Pyrexia
Clinical narrative: Significant dizziness and disorientation, even when sitting still. Slight loss of hand-eye coordination; it was hard to  hold a pencil to write my symptoms down. Cloudy thoughts and giddiness. Mostly I just bumped into things a lot and had a hard time thinking straight. This was accompanied by a fever. Symptoms started about 4 hours after injection and subsided after 8 hours of sleep and resting the next day. I was only concerned because the dizziness and disorientation isn't listed under common symptoms. No headache, nausea, or pain.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood test normal, Cardiac monitoring abnormal, Electrocardiogram normal
Clinical narrative: Heart palpitations after several days of second Pfizer vaccine. It happened with the first dose too, but went away after a few days. This time, it seems to be sticking around and not getting any better. We took Pt to the ER on 1/27/2022 in the middle of the night because his heart rate was up to 135. They did an EKG and blood work. All came back normal. He is looking lethargic, not sleeping well. Having some bad dreams and nigh sweats. We are monitoring his heart with an oximeter and it is fluctuation constantly. While it mostly is staying with in the range of "normal for his age", it doesn't stay stable and then goes into a higher heart beat when lying down.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Heart rate increased, Lethargy, Night sweats, Nightmare
Clinical narrative: Heart palpitations after several days of second Pfizer vaccine. It happened with the first dose too, but went away after a few days. This time, it seems to be sticking around and not getting any better. We took Pt to the ER on 1/27/2022 in the middle of the night because his heart rate was up to 135. They did an EKG and blood work. All came back normal. He is looking lethargic, not sleeping well. Having some bad dreams and nigh sweats. We are monitoring his heart with an oximeter and it is fluctuation constantly. While it mostly is staying with in the range of "normal for his age", it doesn't stay stable and then goes into a higher heart beat when lying down.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Poor quality sleep, Thyroid function test normal
Clinical narrative: Heart palpitations after several days of second Pfizer vaccine. It happened with the first dose too, but went away after a few days. This time, it seems to be sticking around and not getting any better. We took Pt to the ER on 1/27/2022 in the middle of the night because his heart rate was up to 135. They did an EKG and blood work. All came back normal. He is looking lethargic, not sleeping well. Having some bad dreams and nigh sweats. We are monitoring his heart with an oximeter and it is fluctuation constantly. While it mostly is staying with in the range of "normal for his age", it doesn't stay stable and then goes into a higher heart beat when lying down.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: 2 hours and 25 minutes after the injection my tinnitus turned back on after a stoppage of just over one year. As noted earlier, the first attack lasted from November 2017 (after accidental aspirin overdose) to December 2019. I immediately reproduce this to the agency and tried to report via the Pfizer reporting system, but it kept crashing, so I gave up. Only today read about VAERS. This should be better advertised. Btw, below there should be a box for "possible permanent damage". I'm not checking the "permanent damage" box because that is unknown, but it may unfortunately turn out to be the case.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Sore arm with moderate pain Shivering, headache, muscle and joint pain, tiredness, stomach pain and nausea. Couldn?t do regular activities for two days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Nausea, Pain in extremity
Clinical narrative: Sore arm with moderate pain Shivering, headache, muscle and joint pain, tiredness, stomach pain and nausea. Couldn?t do regular activities for two days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Malaise, Pain in extremity
Clinical narrative: This adverse events report is filed for the Moderna COVID-19 booster vaccine. The patient had taken the Pfizer-BioNTech COVID-19 vaccine for the first two shots.  Symptoms - malaise (for 3 days), joint ache - left knee which aches when patient tried to put pressure on the leg (for 3 days), chills (first two days), and diarrhoea (started on the night of the third day)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: Missed menstrual cycle. Cycle was over 60 days late and abnormal.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Chills, Diarrhoea, Malaise
Clinical narrative: This adverse effect report is filed for the Moderna COVID-19 booster vaccine. The patient had received the Pfizer-BioNTech COVID-19 vaccine for the first 2 doses.  Symptoms: malaise (started on first day, persisted for 3 days), joint ache at the left knee - there is some pain when the patient puts pressure on the left leg (started on first day, persisted for 3 days), chills (started on first day, persisted for 2 days), diarrhoea (started on the night of the third day)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This adverse effect report is filed for the Moderna COVID-19 booster vaccine. The patient had received the Pfizer-BioNTech COVID-19 vaccine for the first 2 doses.  Symptoms: malaise (started on first day, persisted for 3 days), joint ache at the left knee - there is some pain when the patient puts pressure on the left leg (started on first day, persisted for 3 days), chills (started on first day, persisted for 2 days), diarrhoea (started on the night of the third day)
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Urticaria
Clinical narrative: Breaking out in hives, swollen eyes
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Gastrooesophageal reflux disease, Heart rate increased
Clinical narrative: Doubled heart rate for over 2.5 months, fever, chest pain, shortness of breath, acid reflux, insomnia, weight loss, extreme fatigue, left arm weakness, faint
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test normal, Muscular weakness, Pyrexia, Syncope
Clinical narrative: Doubled heart rate for over 2.5 months, fever, chest pain, shortness of breath, acid reflux, insomnia, weight loss, extreme fatigue, left arm weakness, faint
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, White blood cell count increased
Clinical narrative: Doubled heart rate for over 2.5 months, fever, chest pain, shortness of breath, acid reflux, insomnia, weight loss, extreme fatigue, left arm weakness, faint
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Dysstasia, Electromyogram abnormal, Fall, Gait disturbance
Clinical narrative: After my booster on August 27, 2021, on September 7, I started falling and it got progressively worse. I could not feel from my hip to right under my knees bilaterally. I couldn?t walk. I had several series of falls. I couldn?t balance. My gait was extremely abnormal and I was finally hospitalized at a local HCF on September 27-30 as being unambulatory.  My calves hurt horribly but I could still feel them and I had pins  and needles in my feet. It was highly painful whenever someone touched them. I couldn?t straighten my legs and I couldn?t stand up or get out of bed without assistance.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Loss of personal independence in daily activities, Lumbar puncture normal, Lumbar radiculopathy, Magnetic resonance imaging head normal
Clinical narrative: After my booster on August 27, 2021, on September 7, I started falling and it got progressively worse. I could not feel from my hip to right under my knees bilaterally. I couldn?t walk. I had several series of falls. I couldn?t balance. My gait was extremely abnormal and I was finally hospitalized at a local HCF on September 27-30 as being unambulatory.  My calves hurt horribly but I could still feel them and I had pins  and needles in my feet. It was highly painful whenever someone touched them. I couldn?t straighten my legs and I couldn?t stand up or get out of bed without assistance.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal normal, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: After my booster on August 27, 2021, on September 7, I started falling and it got progressively worse. I could not feel from my hip to right under my knees bilaterally. I couldn?t walk. I had several series of falls. I couldn?t balance. My gait was extremely abnormal and I was finally hospitalized at a local HCF on September 27-30 as being unambulatory.  My calves hurt horribly but I could still feel them and I had pins  and needles in my feet. It was highly painful whenever someone touched them. I couldn?t straighten my legs and I couldn?t stand up or get out of bed without assistance.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sensory loss, Tenderness
Clinical narrative: After my booster on August 27, 2021, on September 7, I started falling and it got progressively worse. I could not feel from my hip to right under my knees bilaterally. I couldn?t walk. I had several series of falls. I couldn?t balance. My gait was extremely abnormal and I was finally hospitalized at a local HCF on September 27-30 as being unambulatory.  My calves hurt horribly but I could still feel them and I had pins  and needles in my feet. It was highly painful whenever someone touched them. I couldn?t straighten my legs and I couldn?t stand up or get out of bed without assistance.