chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number j95h7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 13-Jul-2022 Reporter's comment: Medical assistance reported that a patient was administrated with an expired dose of Havrix on the day of reporting. The Vaccine Administration Facility was the same as Primary Reporter. No adverse event was reported. No patient's identifiers were provided. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 41-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number EB7J7, expiry date unknown) for prophylaxis. Previously administered products included FLUARIX QUADRIVALENT vaccine with an associated reaction of rash (dose received in 2017, refer case US2018GSK211225). On 26th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). In October 2018, less than a month after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced rash. On 29th October 2018, the patient experienced injection site itching. Rechallenge with FLUARIX QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the rash and injection site itching to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced itching at the injection site, which further progressed to the rash under her arm, around the back, behind the knees and all the way down to the left side of the body. The rash was progressive. The patient had an appointment scheduled with her physician at afternoon on the reporting day. Emergency room visit required. No further details were provided. The reporter gave consent to follow up.
The sore arm commenced about 7.5-8 hours after injection (just like previous 2 vaccines, which were also Pfizer), however the upper & under upper arm areas from my left shoulder to my left elbow became extremely sore with tingling in left thumb. The very significant pain in the left underarm pit commenced about 0130 hours then spread down the left side of my chest to the left breast area but didn't go into the breast. This is also when the swelling of that whole area started. The swelling was about 6"long x about 3" wide x about 2.5-3" high. The pain in this area required me to live around the clock on acetominophen for 3 days and I couldn't wear my usual bras. I looked like a water balloon had been inserted under my skin in this swollen area - the area was very tender, sore.  I also slept 14 hrs/day for the 1st 2 days of the vaccine, which is what also happened with the 1st 2 vaccines. The usual achy/sore back lasted the usual 2-3 days, and the decrease in appetite lasted the usual 2-3 days. The swelling is still present but is gradually subsiding; wearing my normal bras is still not feasible. I was able to stop taking the acetominophen on day 4. I'm VERY concerned about this swelling as a side effect, and hope no further Covid vaccines/boosters are recommended for me.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg) and GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting). The patient was treated with POTASSIUM CHLORIDE (KLOR-CON M20) at a dose of 1 dosage form and FUROSEMIDE at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
fever; body pain; shivering; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 10:00 (Lot number: EL3302) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Name of Drug as Reported: Pfizer, DOSE 1, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Jan2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Jan2021, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 30Jan2021, outcome "not recovered", described as "body pain"; CHILLS (non-serious) with onset 30Jan2021, outcome "not recovered", described as "shivering". The events "fever", "body pain" and "shivering" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pyrexia, pain, chills. Additional Information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Device Date was 22Nov2021 Facility type was vaccine Nursing Home Senior Living Facility. Patient had not suffered from Covid prior vaccination. Patient gone through Covid tested after post vaccination. There was no known allergies and other medical history. Privacy policy consent was available.  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B; 1st & 2nd dates are not know, 3rd dose given on 24JAN91 & pt did not respond;
At first the area around the injection site felt a little sore, and might have been swollen, but didn't bother me, until a 3 or 4 hours later when I noticed my arm was noticeably swollen, and the swelling had gone down to my elbow; he said as long as it doesn't go down my arm he didn't think it was serious and told me what to watch out for. But it did go down my arm, was a light red, and a little itchy. the next day I went to urgent care and was told to take Benadryl, which only helped slightly. On tues. Went to my doctor & was told to ice it, and keep it uplifted which I did, and she prescribe 3 prednisone pills to take by Fri. if it got worse or not better. After 6 days the swelling subsided.
On the evening of May 28 into The morning of May 29 started vomiting and had diarrhea. Then into the early morning started getting extreme pain in my abdomen. Went to ER
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985.
8 patients received expired vaccine with no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via call center via  Medical Information  (Reference number- 00829571) in a specific country.  This case involves an 87-year-old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ515AA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  At the time of reporting, no adverse event was reported.  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 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.
Fever 100*F, chills, fatigue, diarrhea, muscle aches, headache, joint pain.
Patient alerted her father that her tummy hurts, he asked for something in case she vomited. I gave him a trash can and she proceeded to vomit in the trash can. She looked very pale, but said she didn't feel dizzy or have any blurred vision. She had not eaten much breakfast, or drank much water all morning. I gave her a bottle of water and asked her to take a little sip. She started to have more color in her face and said she felt better. She sat around for about 20 minutes and said she was ready to go.
Fatigue; Shaking; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 29-Jan-2021, the patient experienced FATIGUE (Fatigue). On 28-Jan-2021, TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 29-Jan-2021, FATIGUE (Fatigue) had resolved.       This case was linked to MOD21-017077 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient took second dose and stated no need for further follow up
Received injection and went home.  Was feeling  a little sluggish that evening, but I didn?t think anything about it.  The morning of January 19, 2022 at approximately  9:15 a.m., I had just left my house on foot to walk my 16 year old.  I had walked approximately 80 meters and almost immediately felt light headed and dizzy.  I immediately returned to home, took my blood pressure and my heart rate was 40.  I monitored my heart rate for approximately 45 minutes, using two separate heart rate monitors;  with only slightly different readings.  I called for my husband to come inside the house and he took me to the hospital.  Once at the hospital,  I was taken by wheelchair to an exam room where the nursing staff immediately executed a 12 lead ECG and I was diagnosed to a ?TOTAL AV BLOCK? and  was being sent to the Cardiac unit at Medical Center.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was provided. On 27-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route, lot # and expiration date were not reported). On 06-OCT-2015, the patient accidentally received a dose of GARDASIL (exact dose, route, lot # and expiration date were not reported) instead of GARDASIL 9 as the second dose of the series. No adverse effects were reported. Additional information has been requested.
Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022; reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed; reaction to the second booster Covid-19/felt stabbing pain in chest and feet; reaction to the second booster Covid-19/felt stabbing pain in chest and feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed), CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet), PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily Dose. In May 2022, the patient experienced CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet). On 22-May-2022, the patient experienced VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022). In May 2022, CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022) outcome was unknown.      No concomitant medication was reported. No treatment medication was reported.
No adverse event; Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-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 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:original case US-MODERNATX, INC.-MOD-2022-687786:
expired Bexsero administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 05-AUG-2022 Reporter's Comments: The reporter was the patient's mother stating that the patient got his first Bexsero vaccine which was 5 days expired. The patient received Bexsero in left arm. The reporter did not report any side effects from the patient getting the expired vaccine. The reporter consented follow up. Health care professional for follow up. Additional Supportive Information: The patient received 5 days expired vaccine, which led to expired vaccine used.
Fever for 3 days, achy/weak for 3 days, severe migraines for 7 days (worst migraines patient has ever experienced), then patient was 3 weeks late on her cycle (should have started June 6 based on her normal 28 day cycle, but started June 27).
Tiredness; Achy; Had chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills). At the time of the report, FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.