chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022; No adverse event; Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose,Lot#: FEA092681) on 19-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Dose,Lot#: ER8734) on 09-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (1st Booster dose andLot#: FH8028) on 18-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 17-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive 2 months ago.     For mRNA-1273 (Moderna COVID-19 Vaccine) (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 with a booster dose of the Moderna Covid 19, after its expiration date.) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022).    No concomitant medications were reported. The expiration date of vial was 13-Aug-2022. The vial was initially placed in the refrigerator on 14-Jul-2022. The vial did not undergo temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Follow-up received included vaccine refrigeration date was updated.
Felt unwell; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th March 2022, 1 days after receiving Shingrix, the patient experienced unwell and pain in arm. On an unknown date, the outcome of the unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the unwell and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The reporter was the patient's wife stating that her husband got his first Shingrix vaccine. The reporter stated that on the following day patient had a sore arm and felt unwell in general for a few days.  The patient had recovered from these symptoms.  The reporter did not consent to follow-up.  This was report of 2nd patient out of 2 patients. Additional Supportive Information:  This case was linked with US2022114895 reported by same reporter.; Sender's Comments:  US-GSK-US2022114895:Same reporter. Patient 1
INJ GIVEN 04/25/07 AT HEALTH DEPT., NO REDNESS OR SWELLING FOR 3 DAYS, SEEN IN OUR OFFICE ON 5/1/07 RT ARM RED AND SLIGHTLY SWOLLEN FROM ELBOW TO FINGERS, SLIGHT REDNESS AT INJECTION SITE. PT STATES VERY PAINFUL. TEMP ON 5/1/07 100.2 ORALLY. INSTRUCTED TO TAKE TYLENOL FOR PAIN, ICE ARM AND REST IT UNTIL BETTER.
Hives-like appearance on both arms within 10 minutes of administering vaccine. Resolved by itself in 30-40 minutes.
PATIENT CAME TO THE PHARMACY ON 11/22/17 COMPLAINING THAT SHE HAS NOT BEEN ABLE TO LIFT HER LEFT ARM ABOVE SHOULDER LEVEL SINCE SHE RECEIVED HER FLU SHOT ON 10/25/17.  I ASKED IF SHE HAD SEEN ANYONE OR HER DOCTOR TO EVALUATE IT AND SHE SAID NO.  I RECOMMENDED SHE BE EVALUATED TO DETERMINE WHAT THE ISSUE IS.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 28-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T042012, expiration date 22-JUL-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000788: US-009507513-2112USA000785: US-009507513-2112USA000789: US-009507513-2112USA000792: US-009507513-2112USA000791.
After she received Hep. A she had a 5 second seizure-eyes became fixed, started shaking-Before this happened, she said she was dizzy.
p/vax pt devel fever, chills, nausea, erythema @ site & tenderness;
Got vaccine on Tuesday and following Sunday feel bad and had chest pain; Got vaccine on Tuesday and following Sunday feel bad and had chest pain; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Jun2021 13:00 (Batch/Lot number was not reported), age at vaccination of 64-years-old, as single dose, for covid-19 immunisation.  Medical history was none.  The patient was not pregnant and was not pregnant at the time of vaccination   The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced got vaccine on Tuesday and following Sunday on 04Jul2021 14:00 she felt bad and had chest pain. The events resulted in Emergency room/department or urgent care, Hospitalization (2 Days Hospitalization). It was unknown if treatments were given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 10-JAN-2020,  the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Tested positive for COVID 5 days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Expired Vaccine Used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used).    No concomitant medication were reported. A total of 35 doses were given from 4 vials.  The vial was initially stored in refrigerator on 07-Jun-2022.  The dates in which vaccination were given are on 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. The vial didn't undergo any temperature excursion. No treatment information were provided.
As I got the vaccine, I noticed ringing in my ear and I thought it would be a temporary thing. It didn't go away and it's been almost 3 years now. A year in, I went to see an audiologist. I also went to get hearing aids because I couldn't hear what people were saying in the background. The audiologist did notice some hearing loss. Some days are a lot worse than others. It's pretty constant and I can't avoid it. I did notice it got worse every time I took a Moderna vaccination. I did take a Pfizer vaccine in between these Moderna doses and there didn't seem to be a change. I just know that prior to these vaccinations, I did not have any ringing in my ears.
feeling something on shoulder pushing down; corner of her mouth feels numb; heat where the lump is; She is not dizzy or nauseous, it is just weird; bells ringing in her ear; swimmy headed; part of left side of her face numb; pinching at the wrist; swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird) and TINNITUS (bells ringing in her ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 078C21A and 052B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm). At the time of the report, MUSCULOSKELETAL DISCOMFORT (feeling something on shoulder pushing down), HYPOAESTHESIA ORAL (corner of her mouth feels numb), VACCINATION SITE WARMTH (heat where the lump is), FEELING ABNORMAL (She is not dizzy or nauseous, it is just weird), TINNITUS (bells ringing in her ear), DIZZINESS (swimmy headed), HYPOAESTHESIA (part of left side of her face numb), ARTHRALGIA (pinching at the wrist) and VACCINATION SITE SWELLING (swelling on the injection site upper arm,, the swelling is an inch and a half lower from injection site, more on inside of arm) outcome was unknown.            No concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2022-524037 (Patient Link).
Symptoms: Fatigue, body aches, body temperature changes, coughing, sneezing, headaches, minor sore throat  Signs: soreness, low energy Treatment: ibuprofen  Time course: 48 hours
Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
patient says has shortness of breath at times since he has been on the Brilinta and states he recently had open heart surgery and was allowed to return to work today for the first time . patient got a covid vaccine on friday 10/08 and today at work he was having shortness of breath on exertion as he has since he has been on the brilinta but it was more frequent and wondered if it could be from the vaccine. I told him to follow up with his dr since he just had open heart surgery and make sure the dr did not think there could be issues stemming from his surgery with his breathing . I told him I would report the adverse reaction.
Approximately 2 by 2 inch rash developed at site left deltoid 24 hours after injection. Site was red, warm and hard.
Fever. Was only to 101. However malaise and fatigue seemed excessive compared to the fever.
This spontaneous report was received from a medical assistant regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 72 hours from 19-APR-2016 to 22-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter.  Additional information has been requested.
Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit; Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: New event added vaccination site used some vaccine this morning 09-MAR-2021, to vaccinate people
Pt here for f/u on her pneumococcal vaccination. On 12/1619 pt received prevnar 13 in the R deltoid. Since then she has experienced swelling, pain, and redness at the site of the injection. Pt notes that she had a swollen lymph node on the R side of her neck a few days ago which has since gone away. She has been taking tylenol for pain which has helped but has been taking up to 2000mg at a time. Pt is still taking doxycycline for sinusitis as of last week. Did have a low grade fever after vaccination Will do ibuprofen for pain and swelling and advised pt to ice regularly. She will contact us with an update in approximately 7 days. Advised to notify us sooner if worsening.
States that a 41 year old received a pediatric dose of ENGERIX-B; States that a 41 year old received a pediatric dose of ENGERIX-B.; received Engerix-B by intercostal route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 30-OCT-2023, the patient received Engerix B pediatric (intercostal, left deltoid). On 30-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: States that a 41 year old received a pediatric dose of ENGERIX-B), adult use of a child product (Verbatim: States that a 41 year old received a pediatric dose of ENGERIX-B) and intramuscular formulation administered by other route (Verbatim: received Engerix-B by intercostal route). The outcome of the underdose, adult use of a child product and intramuscular formulation administered by other route were unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The reporter reported that 41 year old patient received a pediatric dose of Engerix-B by intercostal route, which led to underdose, adult use of a child product and intramuscular formulation administered by other route.   The reporter consented to follow up.
I am just reporting that I contracted COVID-19 after receiving the Pfizer vaccination. I never had a fever or cough. The only symptoms I had were congestion, headache, mild shortness of breath. It almost felt like a sinus infection. I also loss my taste/smell about 4 to 5 days after testing positive.
chronic urticaria (hives); This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (chronic urticaria (hives)) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced URTICARIA CHRONIC (chronic urticaria (hives)). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC SUMITOMO) at a dose of 40 milligram once a day; FAMOTIDINE (PEPCID AC) at a dose of 40 milligram once a day and HYDROXYZINE at a dose of 10 milligram once a day. At the time of the report, URTICARIA CHRONIC (chronic urticaria (hives)) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered URTICARIA CHRONIC (chronic urticaria (hives)) to be related.    Concomitant medication was not reported.  Patient had severe extended long-term reaction to the bivalent booster (4th shot total) and was wondering if they were studying fold like (hives and dermatographia starting almost 2 weeks after the shot). So far, the only treatment patient had been able to get steroids and antihistamine but there seems to be no end in sight to the symptoms. Patient went to the doctor, the allergist said patient had chronic urticaria (hives) from immune response to the vaccine. Patient had additional blood work done at this time but will most likely have to go in a once-a-month injection to battle the symptoms for 6 months to a year. Blood work results are not available. Patient had never got COVID. Just his immune system was in overdrive. Patient had to take 4/10 mg Zyrtec, 2/20mg Pepsid ac and 1/10mg Hydroxyzine a day to keep the symptoms at bay.
Moderna vaccine use for COVID-19 under Emergency Use Authorization (EUA): patient had both doses 04/29 and 05/27. Patient proceeded to have venous clot leading to ischemic stroke 07/18 by way of patent foramen ovale.