chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: affecting her at work; arm of injection site swelled up to the size of a tennis ball; could still feel a hardness underneath; pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes). The patient was treated with Manual therapy (acupuncture, chiropractor, massage therapy, and stretch therapy) for Vaccination site pain. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes) had not resolved.            No concomitant medications were reported.  On 29-Nov-2021, the patient received the booster dose of Moderna COVID-19 vaccine. Patient still had a side effect that could be debilitating at tim es. Patient went to her doctors but there was no relief. Patient reported that a week and a half later, swelling at injection site went down, but she could still feel a hardness underneath. It has been like this for almost a year. Patient had ultrasounds, nerve testing, X-rays, acupuncture, chiropractor, massage therapy, stretch therapy. Patient would have physical therapy next week.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022; No adverse event; given bivalent booster dose which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination. No Medical History information was reported.    On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022). No concomitant information provided. The vial did not undergo any temperature excursions.  The patient took previously fist dose on 30-Jun-2021,sencod dose on 02-Aug-2021 of unknown brand. No treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. This case is reported for 14th patient out of 20 patients. No treatment information was provided.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Initial information received from RA on 19-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced stroke, after receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) and COVID-19 VACCINE (not produced by Sanofi Pasteur)  lot number not reported at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date(latency: unknown), the patient developed a serious stroke (cerebrovascular accident) .   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (stroke). At time of reporting, the outcome was Unknown for the event stroke.  Seriousness criteria: medically significant for the stroke; Sender's Comments: Sanofi company comment dated 28-Oct-2022: This case involves an unknown age female patient who was vaccinated with Influenza vaccine( produced by unknown  manufacturer ) and covid 19 vaccine (not manufactured by Sanofi) and experienced stroke. The time to onset is not reported with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup, would be needed for a complete assessment of the case. The case is confounded by multiple vaccines administered. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction, Influenza like illness
Clinical narrative: got weird reactions for many days, as if I had the flu; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp. RA number: 01331257  This case involves an unknown age female patient who experienced got weird reactions for many days, as if i had the flu while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date 8 to 10 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, route, lot number, administration site) for flu vaccination.  On an unknown date, the patient developed a non-serious got weird reactions for many days, as if i had the flu (influenza like illness) at unknown latency following the administration of INFLUENZA VACCINE.  It was reported that She has not received a flu shot in 8 to 10 years due to her reactions the last time she received a flu shot. It was 8 to 10 years ago, and she received influenza vaccine. She does not know the manufacturers "senior" vaccine that she received. She stated that she "got weird reactions for many days, as if I had the flu". Another year she received an influenza vaccine that was egg-free. She does not know the particular manufacturer of the egg-free flu vaccine that she received; and has no way to find out since it was in a different state at least 10 years ago. She had a "bad reaction" to that flu vaccine without egg."     Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event got weird reactions for many days, as if i had the flu.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: was given MENQUADFI on 08Sep2022 and 18Oct2022 with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who was given meningococcal A-C-Y-W135 (T Conj) vaccine [Menquadfi] on 08-sep-2022 and 18-oct-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2022, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE  0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0. 5ml o Strength: standard except for Fluzone HD (High dose) (lot U7299AC, expiry: 04-AUG-2024) via intramuscular route in the left deltoid. On 18-Oct-2022 she also received a dose 2 of the same vaccine  (lot U7299AC, expiry date: 04-Aug-202 (Year unspecified) via unknown route in unknown administration site as immunization (extra dose administered; Latency: 1 month 10 days)   Still using product : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired Fluzone quad vaccine with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2022SA442254 and 2022SA443067(CLUSTER).  This case involves a 15 years old male patient who administered an expired fluzone quad vaccine with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a total dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) (strength: standard) via intramuscular route in the left deltoid for immunization.  On 20-OCT-2022 the patient administered an expired fluzone quad vaccine with no reported adverse event (expired product administered) (Latency: same day)  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received the expired fluzone dose with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2022SA442254 and 2022SA443423(CLUSTER).  This case involves a 17years old female patient to whom expired fluzone dose with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a total dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) (strength: standard) via intramuscular route in the left deltoid for immunization.  On 20-Oct-2022 the patient developed a non-serious patient received the expired fluzone dose with no reported adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Developed shingles on S2 dermatone approximately two weeks after vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient developed shingles on October 26, 2022 after administration of the moderna and shingrix vaccines on 10/24/2022. The patient was treated with gabapentin and valacyclovir on 10/27/2022.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date; No adverse event; Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported. On 24-Oct-2022 at 9:33 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Doses were administered >12 hours post puncture. Dose administered after 30-day Use By Date).    No concomitant medications were reported. The doses were administered post 12 hours of puncture. Visuals were first thawed on 20-Sep-2022. The vial size was 2.5 mL The vial was initially stored in the refrigerator on 20-Sep-2022. The vial was first punctured on 17-Oct-2022 at 9AM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for less than a minute. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665349 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665349:Patient 1
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patients were administered the vaccine after the 30-day beyond use date; No adverse event; administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date).    No concomitant medications were reported. The vial size was 2.5mL. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was administered vaccine after the 30 day beyond use date; No adverse event; Patient was administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date). No concomitant medications were reported.  Individual vials or unbroken cartons was opened individual vials. Vial size was 2.5ml. The vial was initially stored in the refrigerator was 20-Sep-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Chest pain, Chills, Dyspepsia, Hyperhidrosis
Clinical narrative: 10/13- sharp back pain, mucus build up in left nostril  10/14-10/16- sharp back pain, heavy mucus, fever & chiles, sweats, sleeplessness  10/17-10/19- developed rash (behind knees, upper back thigh, triceps area, around arm pits to upper back), heavy mucus, sleeplessness  10/20-10/27 - on and off chest pain, rash, light mucus,  sleeplessness 10/28- rash begins to fade, chest pain, heart burn throughout the night, sleeplessness  10/29-10/31- rash still fading, heartburn, chest pain, sleeplessness
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Pyrexia, Rash, Secretion discharge
Clinical narrative: 10/13- sharp back pain, mucus build up in left nostril  10/14-10/16- sharp back pain, heavy mucus, fever & chiles, sweats, sleeplessness  10/17-10/19- developed rash (behind knees, upper back thigh, triceps area, around arm pits to upper back), heavy mucus, sleeplessness  10/20-10/27 - on and off chest pain, rash, light mucus,  sleeplessness 10/28- rash begins to fade, chest pain, heart burn throughout the night, sleeplessness  10/29-10/31- rash still fading, heartburn, chest pain, sleeplessness
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion, some administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Boostrix, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Boostrix, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The nursing director reported that temperature excursion for some GSK vaccines.  Over a month, from September to October 2022, Pediarix, Infanrix, Kinrix, Engerix-B, Boostrix and Bexsero vaccines was exposed to a lowest temperature of minus 3 degree C and some of these vaccines had been administered. The patient had received some of these vaccines.  The reporter consented to follow up by email. Additional supportive information: The patients had received the Pediarix, Infanrix, Kinrix, Engerix-B, Boostrix and Bexsero vaccines which were exposed to a lowest temperature, which led to incorrect storage of drug. This case was considered conservatively for multiple patients as number of patient involved was not clear.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Patient had a very sore left arm; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     The patient had no history of myocarditis or pericarditis. They had no history of Covid-19 infection.  Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills) outcome was unknown.            Patient had previous doses of Moderna covid-19 vaccine -1st dose on 10-Mar-2021 (lot number and expiration date was unknown), 2nd dose on 02-Apr-2021 (lot number and expiration date was unknown) and 1st booster dose on 29-Oct-2021 (lot number and expiration date was unknown).  No treatment medication was reported.   This case was linked to MOD-2022-664796, MOD-2022-664801, MOD-2022-664802 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Flushing
Clinical narrative: Achy all over; achy all over and joints; Very tired / felt tired, had to lay down; chills; headaches; Flushed; irritated; felt like dead weight / felt like an orgasm; 3 hours after short and through the night I urinated every 20 minutes; vaginal twitches, pulses, felt like an orgasm; sore arm / pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F221B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy (Penicillin).    On 25-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills) and HEADACHE (headaches). On 26-Oct-2022, the patient experienced PAIN (Achy all over) and ARTHRALGIA (achy all over and joints). At the time of the report, FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), PAIN (Achy all over), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills), HEADACHE (headaches) and ARTHRALGIA (achy all over and joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-1 test: (Positive) Positive.         No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-665347 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Irritability, Muscle twitching, Pain, Pain in extremity
Clinical narrative: Achy all over; achy all over and joints; Very tired / felt tired, had to lay down; chills; headaches; Flushed; irritated; felt like dead weight / felt like an orgasm; 3 hours after short and through the night I urinated every 20 minutes; vaginal twitches, pulses, felt like an orgasm; sore arm / pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F221B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy (Penicillin).    On 25-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills) and HEADACHE (headaches). On 26-Oct-2022, the patient experienced PAIN (Achy all over) and ARTHRALGIA (achy all over and joints). At the time of the report, FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), PAIN (Achy all over), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills), HEADACHE (headaches) and ARTHRALGIA (achy all over and joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-1 test: (Positive) Positive.         No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-665347 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, SARS-CoV-1 test
Clinical narrative: Achy all over; achy all over and joints; Very tired / felt tired, had to lay down; chills; headaches; Flushed; irritated; felt like dead weight / felt like an orgasm; 3 hours after short and through the night I urinated every 20 minutes; vaginal twitches, pulses, felt like an orgasm; sore arm / pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F221B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy (Penicillin).    On 25-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills) and HEADACHE (headaches). On 26-Oct-2022, the patient experienced PAIN (Achy all over) and ARTHRALGIA (achy all over and joints). At the time of the report, FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), PAIN (Achy all over), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills), HEADACHE (headaches) and ARTHRALGIA (achy all over and joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-1 test: (Positive) Positive.         No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-665347 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Fatigue, Feeling abnormal
Clinical narrative: Flushed; Irritated; Felt like dead weight  3 hours after short and through the night I urinated every 20 minutes;Achy all over; Sore arm / pain in left arm; Very tired / felt tired, had to lay down; Chills; Headaches; Achy all over and joints; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (Irritated), FEELING ABNORMAL (Felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (Vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 001A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided. Adverse event caused patient to seek medical care. Patient was not hospitalized. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Irritability, Muscle twitching, Pain
Clinical narrative: Flushed; Irritated; Felt like dead weight  3 hours after short and through the night I urinated every 20 minutes;Achy all over; Sore arm / pain in left arm; Very tired / felt tired, had to lay down; Chills; Headaches; Achy all over and joints; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (Irritated), FEELING ABNORMAL (Felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (Vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 001A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided. Adverse event caused patient to seek medical care. Patient was not hospitalized. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pollakiuria, SARS-CoV-2 test
Clinical narrative: Flushed; Irritated; Felt like dead weight  3 hours after short and through the night I urinated every 20 minutes;Achy all over; Sore arm / pain in left arm; Very tired / felt tired, had to lay down; Chills; Headaches; Achy all over and joints; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (Irritated), FEELING ABNORMAL (Felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (Vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 001A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided. Adverse event caused patient to seek medical care. Patient was not hospitalized. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml).    No concomitant medications were reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment drug details were reported. This case is reported for 4th patient out of 20 patients.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient had sore arm after every mRNA shots; Patient had headaches after every mRNA shots; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots). At the time of the report, PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665512, US-MODERNATX, INC.-MOD-2022-665518 (Linked Report). This case was linked to MOD-2022-665505 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665512:Husband cases- (MOD-2022-665512-1st dose and MOD-2022-665518-Bivalent dose) US-MODERNATX, INC.-MOD-2022-665518:Husband cases- (MOD-2022-665512-1st dose and MOD-2022-665518-Bivalent dose)
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from registered nirse and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039726, expiration date: 15-DEC-2023, administered for prophylaxis (dose, route of administration and anatomical location were not provided) was administered to the patient.  The vaccine experienced a temperature excursion of minus 11.8 degree Celsius for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA000872: US-009507513-2210USA001538: US-009507513-2210USA001524: US-009507513-2210USA001062: US-009507513-2210USA001278: US-009507513-2210USA000999: US-009507513-2210USA001209: US-009507513-2210USA001904:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: Got the vaccine, 4 months later shingles/suspected vaccination failure; worst case of shingles ever.; Sick for a month.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-OCT-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received Shingle vaccine and had the worst case of shingles ever and was sick for a month. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.