chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION COMPLICATION (Covid arm). At the time of the report, VACCINATION COMPLICATION (Covid arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-405602 (Patient Link).
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: Feeling sick; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced MALAISE (Feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 31-May-2021, MALAISE (Feeling sick) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.    This case was linked to MOD-2021-405546 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021 at 11:33 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Pain stopped hurting; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Pain stopped hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-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 THERAPEUTIC RESPONSE UNEXPECTED (Pain stopped hurting). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Pain stopped hurting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication reported included blood pressure medication.   No treatment medication details was reported.   This case was linked to MOD-2021-405067, MOD-2021-405734 (Patient Link).
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 11:05 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first dose on the 1Apr2021 and the second dose on the 21Apr2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  .   This case was linked to MOD-2021-404133 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash, Tremor
Clinical narrative: Shaking all the time like having a seizure; Rash all over body; This spontaneous case was reported by a non-health professional and describes the occurrence of TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body). At the time of the report, TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided.  No concomitant medication was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm after 2nd shot; Tired after 2nd shot; Chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported.On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot). On 21-Feb-2021, PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot) had resolved. No Concomitant medications were reported.No Treatment information was reported.This case was linked to MOD-2021-405051, MOD-2021-405921 (Patient Link).
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021 at 11:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 11:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021 at 11:20 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Drug hypersensitivity
Clinical narrative: On thurs. Nov. 25 I discovered a tick in my shoulder.  The hotel where I was staying helped rmove it, and the ite was very red and irritated.  I texted. Dr. andspoke with him on fri. Nov 26.  He sent a prescription for 100 mg tabs of Doxycycline Hyclate which I began taking that day., to be taken 2x day on empty stomach.  The medicine made me nauseous and caused vomiting.  I kept trying to take it, but it kept making me sick.  By Sunday eve. it caused vomiting again, and I called Dr. to prescribe a different antibiotic.  I have never reacted to an antibiotic this way before.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm soreness with swelling (size of lemon) and higher temperature under arm for 2 days
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cyst rupture, Pain, Vaginal discharge
Clinical narrative: Painful aches in body,  burning sensation in bones, and a cyst popped and felt like a menstrual period had started, however it was just brown and slightly green fluid excreting from the reproductive organs. No fever. It took about a day of aches and pains before it finally stopped.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test negative
Clinical narrative: Absence of periods ( amenorrhea) during 3 cycles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's friends. The age at vaccination was not reported. The reporter stated the patient's got shingles from the Shingles shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (got singles for four time). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the two shingles shots last year (2020) and two weeks ago from reporting date he/she had shingles now again for fifth time, this time on his/her face near his/her eye. The doctor said it would be worse if he/she had not had shot and would be mild because he/she had the shots and patient stated so far it had been. The follow up would not possible as no contact information was available. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine, the physician told to patient 2 days ago of reporting date, could get shingles. It was possible had shingles on left side of head and neck. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the 11 year old pediatric patient inadvertently received Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identify the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248441 and US2021AMR250027 reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248441:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identity the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248437 and US2021AMR250027 reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021248437:Same reporter: US-GLAXOSMITHKLINE-US2021AMR250027:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose a couple of years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable. The patient does not remember if she received a second dose, which led to incomplete course of vaccination. The patient contacted her pharmacy but they were unable to retrieve her records. The patient did not wish to provide any additional information. The consent to follow-up was denied.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis. On 3rd December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The reporter called to report that she administered the second dose of Shingrix to a patient before the recommended 2-6 month window of time (second dose was given early), which led to drug dose administration interval too short. Patients personal healthcare professionals information was not known by the reporter. The consent to follow up was denied.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: REACTION TO VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a female patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination (Dose series 1). 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 died from reaction to vaccine. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20211212807- COVID-19 VACCINE AD26.COV2.S-Reaction to vaccine. 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).; Reported Cause(s) of Death: REACTION TO VACCINE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SHARP SHOOTING PAIN IN ARMS AND LEGS; This spontaneous report received from a parent concerned a 50 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, route of admin, and batch number were not reported) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-AUG-2021, the patient experienced sharp shooting pain in arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in arms and legs on 30-AUG-2021. This report was non-serious.  This case, from the same reporter is linked to 20211212162 and 20211212813.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis
Clinical narrative: PSORIASIS FLARE UP/PSORIASIS HAD BEEN VERY BAD AND SHEDDING; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. 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 psoriasis flare up/psoriasis had been very bad and shedding, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and had not recovered from psoriasis flare up/psoriasis had been very bad and shedding. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Mobility decreased, Rash morbilliform, Urticaria
Clinical narrative: Hives on the right leg after booster; Measles like rash on the right leg after booster; Weakness after booster; Could not get off the chair after booster; Severe Dizziness after booster,Dizziness on & off; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness after booster), MOBILITY DECREASED (Could not get off the chair after booster), DIZZINESS (Severe Dizziness after booster,Dizziness on & off), URTICARIA (Hives on the right leg after booster) and RASH MORBILLIFORM (Measles like rash on the right leg after booster) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 028L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement and Hip replacement. Concurrent medical conditions included Blood pressure high (HBP controlled by medications). Concomitant products included IRBESARTAN (IRBESARTAN OD) and VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLOIRDE) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced ASTHENIA (Weakness after booster), MOBILITY DECREASED (Could not get off the chair after booster) and DIZZINESS (Severe Dizziness after booster,Dizziness on & off). On 15-Nov-2021, the patient experienced URTICARIA (Hives on the right leg after booster) and RASH MORBILLIFORM (Measles like rash on the right leg after booster). The patient was treated with DIMENHYDRINATE (DRAMAMINE) (oral) for Adverse event, at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) for Measles-like rash, at a dose of around the clock; FAMOTIDINE (PEPCID AC) (oral) for Measles-like rash, at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) for Measles-like rash, at an unspecified dose and frequency. On 18-Nov-2021, ASTHENIA (Weakness after booster), MOBILITY DECREASED (Could not get off the chair after booster), URTICARIA (Hives on the right leg after booster) and RASH MORBILLIFORM (Measles like rash on the right leg after booster) had resolved. At the time of the report, DIZZINESS (Severe Dizziness after booster,Dizziness on & off) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the patient has a Pace Maker and BP at time of Dizziness was fine.   This case was linked to MOD-2021-031141 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:04 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pyrexia
Clinical narrative: she felt like she got hit by a mac truck; body aches; FEVER/She had a fever between 101-104 throughout it; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt like she got hit by a mac truck), PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it). On 16-Apr-2021 at 11:00 PM, the patient experienced FEELING ABNORMAL (she felt like she got hit by a mac truck). On 17-Apr-2021, FEELING ABNORMAL (she felt like she got hit by a mac truck), PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 101-104 (High) fever between 101-104 throughout.         No concomitant medication information was provided.  It was reported that patient got the second shot around 1 PM in the afternoon.   No treatment information was provided.   This case was linked to MOD-2021-404296, MOD-2021-405023 (Patient Link).
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 12:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 28-Oct-2021 at 12:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Oct-2021 at 12:11 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  The vaccine facility placed the vaccines into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: my blood pressure rose to over 180; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (my blood pressure rose to over 180) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (my blood pressure rose to over 180). At the time of the report, BLOOD PRESSURE INCREASED (my blood pressure rose to over 180) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180 (High) Rose to over 180.         No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-403137 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm after first shot; Tired after first shot; Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-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 PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot). At the time of the report, PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2021-405853, MOD-2021-405921 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Headache, Hyperhidrosis, Night sweats
Clinical narrative: sweating,feet is sweating,sweating profusely,hands always sweating; underarm is awful; night sweats; stomach aches; headaches; puking; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0213c1a and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included FISH OIL for an unknown indication.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking). At the time of the report, HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking) had not resolved.            Concomitant product included supplements. Treatment medication was not provided. Patient reported that she was looking for receiving surgical treatment.  8 hours after vaccination with the second dose patient experienced puking, headaches, stomach aches. Immediately after vaccination with the 2nd dose patient had sweating, underarm  was awful,night sweats. The symptoms were ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: No new information. On 06-Dec-2021: Updated Patient initials.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sweating,feet is sweating,sweating profusely,hands always sweating; underarm is awful; night sweats; stomach aches; headaches; puking; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0213c1a and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included FISH OIL for an unknown indication.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking). At the time of the report, HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking) had not resolved.            Concomitant product included supplements. Treatment medication was not provided. Patient reported that she was looking for receiving surgical treatment.  8 hours after vaccination with the second dose patient experienced puking, headaches, stomach aches. Immediately after vaccination with the 2nd dose patient had sweating, underarm  was awful,night sweats. The symptoms were ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: No new information. On 06-Dec-2021: Updated Patient initials.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (Received 0.25 ml for 2nd dose of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: very ill,didn't do well, very sick; very tired; left arm hurting all of the time for 21 days now; left shoulder hurting all of the time for 21 days now; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill,didn't do well, very sick), FATIGUE (very tired), VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001F21A, 011A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Acute bronchitis, Diabetic neuropathy, Chronic pain and Stroke (4 strokes). Concurrent medical conditions included Asthma and Arthritis. Concomitant products included HYDROCODONE, LIDOCAINE, METHOCARBAMOL, ALBUTEROL [SALBUTAMOL], LACTULOSE, DILTIAZEM HYDROCHLORIDE (DILTIAZEM XR), PRAVASTATIN, FLUTICASONE, TERAZOSIN, MONTELUKAST SODIUM and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now). On an unknown date, the patient experienced ILLNESS (very ill,didn't do well, very sick) and FATIGUE (very tired). At the time of the report, ILLNESS (very ill,didn't do well, very sick) outcome was unknown and FATIGUE (very tired), VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.  It was reported that, Doctor told to take antihistamines and forget about it.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL). At the time of the report, ACCIDENTAL OVERDOSE (3rd dose given instead of booster dose,  gave a Moderna COVID-19 booster dose of 0.5 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Folliculitis
Clinical narrative: folliculitis of hair follicles on legs arms and back after receiving both Moderna doses; This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses). At the time of the report, FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses) outcome was unknown.            No concomitant medication reported. No treatment information was provided. The patient had folliculitis of hair follicles on legs arms and back after receiving both Moderna .   This case was linked to MOD-2021-405053 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient was tired after his first vaccine/lasted for one day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient was tired after his first vaccine/lasted for one day) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced FATIGUE (Patient was tired after his first vaccine/lasted for one day). On 05-Jun-2021, FATIGUE (Patient was tired after his first vaccine/lasted for one day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.