chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Lost strength on his arm. Started to get a lot worse after getting the booster shot; Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot). At the time of the report, MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) had not resolved.            No Concomitant information was reported. No Treatment information was reported.  It was reported that arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone and it's been months. The pain is constantly there during the day and it becomes more intense during night time when he is resting.  Started a couple of days after the 2nd dose and it started to get a lot worse after getting the booster shot.   This case was linked to MOD-2022-474346 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was accidentally given a Moderna booster (3rd dose, 0.25ml) shot that was 12 hours past its use by time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was accidentally given a Moderna booster (3rd dose, 0.25ml) shot that was 12 hours past its use by time) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was accidentally given a Moderna booster (3rd dose, 0.25ml) shot that was 12 hours past its use by time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Was accidentally given a Moderna booster (3rd dose, 0.25ml) shot that was 12 hours past its use by time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter. It was reported that the patient was accidentally received a Moderna booster shot that was 12 hours past its use by time, total 24 hours since it was first punctured.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chest pain, Cough, Dizziness, Pulmonary pain
Clinical narrative: cough that will not go away; pain in her heart; she lost her voice for 3 weeks; pain in her lung; feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068(H or 4)21(7)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy). At the time of the report, COUGH (cough that will not go away), CHEST PAIN (pain in her heart), APHASIA (she lost her voice for 3 weeks), PULMONARY PAIN (pain in her lung) and DIZZINESS (feels dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not overweight. Patient do exercises and was taking care of herself. No concomitant medications were reported.  Treatment information was not provided. Symptoms started the next day of vaccination and had not resolved.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: general fatigue for 12 hours; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (general fatigue for 12 hours) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 004M10A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (general fatigue for 12 hours). In August 2021, FATIGUE (general fatigue for 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was provided. In addition it was stated that the patient was having trouble receiving his booster (fourth dose) dose because the Pharmacies that the physician was going to have not heard of a 4th booster dose for Immunocompromised patients.   This case was linked to MOD-2022-474206 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore right arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore right arm after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Pulmonary issue), Asthma (Pulmonary issue), Dust allergy, Allergy to molds, Grass allergy, Allergy to chemicals (sulfites), Drug allergy (Tylenol), Drug allergy (Sulfar), Drug allergy (Codeine), Allergy to antibiotic (Erythromycin), Allergy to antibiotic (Vancomycin), Allergy to antibiotic (Doxycycline), Drug allergy (very sensitive to Epinephrine), Allergy (Allergic to trees) and Thyroid disorder NOS. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Lung disorder NOS, LEVOTHYROXINE for Thyroid disorder, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), FLUTICASONE PROPIONATE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore right arm after 1st dose). On 20-Feb-2021, PAIN IN EXTREMITY (Very sore right arm after 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient drug allergy include Catfcan.  It was reported that the patient never had COVID positive test or diagnosis. The patient did not receive other vaccines within 1 month prior to Moderna. No treatment medications were taken by patient.   This case was linked to MOD-2022-474566, MOD-2022-474731 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females. It was reported that 10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F.   HCP mentioned that they always had the freezer between this range. Two vials were used to administered HCP's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  No concomitant medication reported No treatment medication reported
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Sore right arm, but not too much, after 2nd dose; Patient felt so tired , like she could not function,like was drunk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose) and FATIGUE (Patient felt so tired , like she could not function,like was drunk) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M70A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma, Dust allergy, Grass allergy, Allergy to molds, Allergy to plants, Drug allergy (to Catfcan, sulfites, Tylenol, Sulfar, Codeine, Erythromycin, Vancomycin, Doxycycline, and very sensitive to Epinephrine.) and Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLOVENT), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), FLUTICASONE PROPIONATE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose). 19-Mar-2021, the patient experienced FATIGUE (Patient felt so tired , like she could not function,like was drunk). On 20-Mar-2021, VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose) and FATIGUE (Patient felt so tired , like she could not function,like was drunk) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) but her antibodies were incredibly low, on 11 instead of hundreds..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided   This case was linked to MOD-2022-474541, MOD-2022-474731 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Skin test, Urticaria
Clinical narrative: She started to develop hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (She started to develop hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (She started to develop hives). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (She started to develop hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Skin test: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient after receiving the second shot started to develop hives that have continued up until today, at the time of report. These occur all over their body, which were itchy, red, raised, and occur with swelling. The patient had spoken to their primary care doctor, and an allergist who conducted blood and skin testing for allergies. Reportedly, the patient had been taking over the counter Xyzal, Benadryl, and Allegra.   This case was linked to MOD-2022-474640 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: She can't raise her arm , Difficulty to move her arm; difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076621A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Thyroid disorder and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, CARVEDILOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, LEVOTHYROXINE for Thyroid disorder, PANTOPRAZOLE and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient had no fever and no chills. Also the patient is still experiencing the side-effect for about 4months until now. Patient did not take any pain killers.the events are still ongoing since 26-Oct-2021.   This case was linked to MOD-2022-474637 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Dose was administered in deltoid muscle.  No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Inadvertently administered improperly stored vaccine; This spontaneous report was received from a medical student referring to a patient of unreported age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were no reported.   On 14-DEC-2021, the patient was Inadvertently administered improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, route of administration, frequency were not reported) for prophylaxis (Product storage error). "Lot number T034980 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Lot number T034980 does not match any Company product as confirmed by Lot Verification team.  The vaccine underwent a temperature excursion of 66.66 Fahrenheit for a time period of 13 hours. There was multiple previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Sensation you get before breakout; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had the first shot of Shingles vaccine and had the sensation before breakout. The patient could not get the second shot until it was clear. The follow-up could not be possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: unbearable itch, three times; unbearable pain, three times; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient 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 pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   The reporter considered the pruritus and pain to be possibly related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingle vaccine and it was an unbearable itch and an unbearable pain. The patient yet managed to survive it three times after his/her wonderful vaccination. The patient believed that the vaccination triggered it. The follow-up would not possible as no contact details were available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: part of vaccine running down arm; part of vaccine running down arm; part of vaccine running down arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J9T5, expiry date 17th April 2023) for prophylaxis.   On 30th January 2022, the patient received the 1st dose of Shingrix (intramuscular). On 30th January 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were reported as follows: The vaccine was administered on patient's left deltoid. The patient received a dose of Shingrix and noticed small part of vaccine running down the arm which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. Consent to follow up was granted.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Nausea
Clinical narrative: Experienced nausea again; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 16-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2021-2022 season) (batch number 292R2, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included nausea (it went away for a week prior to receiving Flulaval).   On 25th January 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 25th January 2022, less than a day after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient's parent. The patient received dose of FluLaval Quadrivalent vaccine and experienced nausea. The nausea was ongoing. The reporter did not have the expiration date. The reporter consented to follow up via email only and requested that subject line say something that will reference the AE.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeding disorder, Induration, Influenza like illness, Pyrexia, Rash erythematous
Clinical narrative: Slight fever; didn't feel real good; man-flu/flu-like symptoms (didn't feel good, had a fever); a rash consisting of 5-6 "fired-up red spots" on his right arm but not at the injection site, closer to his elbow/super rash; itchy; kind of hard; This case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 6th February 2022, less than a day after receiving Shingrix, the patient experienced red spotty rash, itchy rash and induration. On 7th February 2022, the patient experienced fever, feeling bad and influenza-like symptoms. In February 2022, the outcome of the fever, feeling bad and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the red spotty rash, itchy rash and induration were not recovered/not resolved.   The reporter considered the red spotty rash, itchy rash, induration, fever, feeling bad and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received a dose of Shingrix in right deltoid intramuscularly on Sunday around 03:00 pm in the afternoon. On same day of vaccination, in night around 7:00 or 7:30 pm, the patient had a rash consisting of 5 to 6 fired-up red spots on his right arm but not at the injection site, closer to his elbow.  These spots were not blistery but were super-red, itchy and kind of hard and they were not resolved. 1 day after receiving vaccination, the patient had a slight fever and did not felt real good.  The reporter joked that he had the man-flu and was resolved. The patient received the shot at a pharmacy. The pharmacy paperwork did not have the lot number or expiration date listed but the reporter provide the pharmacy's name and phone number since the pharmacy should had the lot number on file. The reporter consented to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Slight fever; didn't feel real good; man-flu/flu-like symptoms (didn't feel good, had a fever); a rash consisting of 5-6 "fired-up red spots" on his right arm but not at the injection site, closer to his elbow/super rash; itchy; kind of hard; This case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 6th February 2022, less than a day after receiving Shingrix, the patient experienced red spotty rash, itchy rash and induration. On 7th February 2022, the patient experienced fever, feeling bad and influenza-like symptoms. In February 2022, the outcome of the fever, feeling bad and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the red spotty rash, itchy rash and induration were not recovered/not resolved.   The reporter considered the red spotty rash, itchy rash, induration, fever, feeling bad and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received a dose of Shingrix in right deltoid intramuscularly on Sunday around 03:00 pm in the afternoon. On same day of vaccination, in night around 7:00 or 7:30 pm, the patient had a rash consisting of 5 to 6 fired-up red spots on his right arm but not at the injection site, closer to his elbow.  These spots were not blistery but were super-red, itchy and kind of hard and they were not resolved. 1 day after receiving vaccination, the patient had a slight fever and did not felt real good.  The reporter joked that he had the man-flu and was resolved. The patient received the shot at a pharmacy. The pharmacy paperwork did not have the lot number or expiration date listed but the reporter provide the pharmacy's name and phone number since the pharmacy should had the lot number on file. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Cerebrovascular accident, Tremor
Clinical narrative: STROKE; THICK BLOOD; REALLY BAD SHAKES; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient reported, "probably had a stroke from blood being thick. My blood got so thick that I could not check my blood sugar. Johnson & Johnson my blood got so thick I could not check my blood sugar, and now I have the shakes really bad. Sometimes I can hardly eat for shaking food off my fork." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, thick blood and really bad shakes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20220221056-COVID-19 VACCINE AD26.COV2.S- stroke. 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).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having severe reaction) in a female 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 VACCINATION COMPLICATION (Having severe reaction). At the time of the report, VACCINATION COMPLICATION (Having severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose: 02Feb2021 ,  2nd dose: 22Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076621A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for Blood pressure high, CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE, PANTOPRAZOLE and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided   This case was linked to MOD-2022-474595 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Pruritus, Skin test, Swelling
Clinical narrative: itchy; red; swelling/raised; Since receiving the booster dose of the vaccine, this has been worse/Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In January 2022, the patient experienced URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives). On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not provided results not provided. On an unknown date, Skin test: results not provided results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has no history of prior allergies. The patient reported that after receiving the first 2 shots started to develop hives that have continued up until today (07-Feb-2022). In addition those occurred all over body, itchy, red, raised, and occur with swelling. The  primary care doctor, and an allergist who conducted blood, and skin testing for allergies. Since receiving the booster dose of the vaccine, that had been worse and occurring every day despite the OTC medications which helped. The patient went to the emergency room for her symptoms on Saturday where they gave prednisone. The patient had an upcoming appointment with an allergist on 07-MAR-2022. No concomitant medications were reported.   This case was linked to MOD-2022-474585 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy; red; swelling/raised; Since receiving the booster dose of the vaccine, this has been worse/Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In January 2022, the patient experienced URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives). On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not provided results not provided. On an unknown date, Skin test: results not provided results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has no history of prior allergies. The patient reported that after receiving the first 2 shots started to develop hives that have continued up until today (07-Feb-2022). In addition those occurred all over body, itchy, red, raised, and occur with swelling. The  primary care doctor, and an allergist who conducted blood, and skin testing for allergies. Since receiving the booster dose of the vaccine, that had been worse and occurring every day despite the OTC medications which helped. The patient went to the emergency room for her symptoms on Saturday where they gave prednisone. The patient had an upcoming appointment with an allergist on 07-MAR-2022. No concomitant medications were reported.   This case was linked to MOD-2022-474585 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: sweat; Fever; body aches; Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweat), PYREXIA (Fever), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours). On an unknown date, the patient experienced HYPERHIDROSIS (sweat), PYREXIA (Fever) and MYALGIA (body aches). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours) had resolved. At the time of the report, HYPERHIDROSIS (sweat), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        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 concomitant medications reported by reporter No treatment medications provided by the reporter.  Vial was punctured on 31-Jan-2022 around 4:30pm.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: non-significant follow up appended: No new information
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: very sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very sore right arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma, Dust allergy, Allergy to molds, Grass allergy, Allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Drug allergy (very sensitive to Epinephrine.). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Lung disorder NOS, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (very sore right arm). On 20-Feb-2021, MYALGIA (very sore right arm) had resolved.        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.   Concomitant medication include Flonase which was mentioned the indication as Inhaler and for Albuterol the indication was mentioned as Inhaler only for rescue. No Treatment medication was reported.   This case was linked to MOD-2022-474566 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was mistakenly administered booster dose of the Moderna Covid 19 vaccine when it had already expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was mistakenly administered booster dose of the Moderna Covid 19 vaccine when it had already expired) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021 at 1:46 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was mistakenly administered booster dose of the Moderna Covid 19 vaccine when it had already expired). On 11-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient was mistakenly administered booster dose of the Moderna Covid 19 vaccine when it had already expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   2 vials removed from -20C freezer at 12:30pm. On 11 Dec 21, thawed for 30 min at room temp, drawn up and placed in fridge (3.8C) for duration of clinic, from 1pm-4pm on 11 Dec 21. No temperature excursions were noted at any time during the administration of the vaccine.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Illness
Clinical narrative: head congestion; sick all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), ILLNESS (sick all over) and HEADACHE (headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 HEAD DISCOMFORT (head congestion), ILLNESS (sick all over) and HEADACHE (headache). At the time of the report, HEAD DISCOMFORT (head congestion) and ILLNESS (sick all over) outcome was unknown and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on concomitant medication, but does not specify which ones. From first dose, the patient had a pretty strong reaction to it, such as headache, head congestion, sick all over. The patient reports no fever. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-474799, MOD-2022-474811 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: first dose of Astra Zeneca/first dose > 35 days before second dose; second dose was 0.25 ml of Moderna; They came in for a second dose, and she received a Moderna booster; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Astra Zeneca/first dose > 35 days before second dose), ACCIDENTAL UNDERDOSE (second dose was 0.25 ml of Moderna) and INCORRECT DOSE ADMINISTERED (They came in for a second dose, and she received a Moderna booster) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Astra Zeneca (she had one dose of Astra Zeneca in Mexico on 21Jul2021.) on 21-Jul-2021. Past adverse reactions to the above products included No adverse effect with Astra Zeneca.    On 03-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Astra Zeneca/first dose > 35 days before second dose), ACCIDENTAL UNDERDOSE (second dose was 0.25 ml of Moderna) and INCORRECT DOSE ADMINISTERED (They came in for a second dose, and she received a Moderna booster). On 03-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Astra Zeneca/first dose > 35 days before second dose), ACCIDENTAL UNDERDOSE (second dose was 0.25 ml of Moderna) and INCORRECT DOSE ADMINISTERED (They came in for a second dose, and she received a Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. The patient has no known allergies. It is unknown whether she ever tested positive for COVID or if she had other vaccines one month prior to her Moderna dose. She has no other medical conditions.   Reporter did not allow further contact