chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FF2908) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Nov2022 as dose 5 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure (controlled with medication; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol (controlled with medication and exercise). The patient took concomitant medications. Other medical history: diabetes, narcolepsy, high blood pressure (controlled with medication, high cholesterol (controlled with medication and exercise). Past drug history included: Prozac, reaction(s): "Known allergies: Prozac", notes: Known allergies: Prozac; Trazadone, reaction(s): "Known allergies: Trazadone", notes: Known allergies: Trazadone.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that the patient received treatment of Paxlovid from 21Dec2022 to 26Dec2022, for treatment of COVID-19.
Pregnant; Slight Soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Slight Soreness at injection site) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J-20A) for COVID-19 vaccination.     The patient's past medical history included UTI. Concurrent medical conditions included Depression, Anxiety, Eating disorder and Asthma. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE for Pregnancy, OMEPRAZOLE, BUPROPION, LAMOTRIGINE and IRON for an unknown indication.    On 05-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight Soreness at injection site). On 05-Jan-2021 at 9:15 AM, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 05-Jan-2021 at 9:15 AM, EXPOSURE DURING PREGNANCY (Pregnant) had not resolved. At the time of the report, VACCINATION SITE PAIN (Slight Soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Prenatal screening test: results not provided. In 2020, Prenatal screening test: results not provided. On 04-Jul-2020, Pregnancy test: Positive. On 25-Nov-2020, Glucose tolerance test: results not provided. On 21-Dec-2020, Ultrasound scan: results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the vaccination site pain, a causal relationship cannot be excluded. This case also involves the product exposure during pregnancy with no additional  AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
fever (highest 103.4; average 102.1, 100.7 lowest) for 6 days, body aches 5 days, shortness of breath 2 days,  still dizzy on day 7 ; tired/fatigued still as of day 7,  had to stay home from work 3 1/2 days, 6 days swollen under arm (l) lymph node very painful (6).. Treatments: tylenol, advil, sleeping a lot, hot compress on under arm, hand cupping under arm and some gentle lymph drainage massage at home.  I am on day 7 as of the writing of this.
Redness and swelling at vaccination site; started to swell about 1 hour after vaccination, then continued to get more red and swollen until 2 days later his entire upper arm was red and swollen with extension to upper back.
Mom stated that injection site became red and swollen. It has a lump under where the shot was given.
Patient experienced syncope and fell on the floor shortly after vaccination. His face appeared pale in color. He was placed in a supine position with his feet elevated for 10-15 mintues and then in a sitting position for another 15 mintues. He sustained no injuries from the fall and fully recovered. Patient's blood pressure was measured twice, once in a supine position and once in a sitting position. Both blood pressure measurements were within normal range. Patient was advised to follow up with primary care physician.
Case number PHEH2014US022370 is an initial spontaneous report received from a medical assistant on 05 Nov 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14056) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered reached 50 F for 30 minutes on 03 Nov 2014. No adverse events were reported following the medication error.
Difficulty breathing, felt nauseous, went back to MD who did an ECG and then needed a stress test. .First stress test was inconclusive,  Second stress test was normal.
swelling, soreness and a lump at the injection site; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case was cross-referenced with case 2019SA098659 (same reporter).  This case involves 42-year-old patient who experienced redness and swelling at site of injection, while they received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6128AA, Exp. Date: 15-Dec-2020) in the left deltoid.  On an unknown date, the patient developed non-serious swelling, soreness and a lump at the injection site(injection site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was redness and swelling at site of injection.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported.
1st dose. About 5 mins I could taste vaccine.  30 mins later  my palette and roof of my mouth becoming tingly /numb. It then proceeded to my tongue . A few mins later proceeded to my lips. That  all lasted about an hour.  Later last night, same evening as receiving 1st dose. Around 11 hours later. My gums where tingling . Not as strong as earlier right after receiving the Moderna vaccine. That lasted about 45 mins.
Treatment of COVID-19/ Covid -19 test positive; Treatment of COVID-19/ Covid -19 test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cervical" (unspecified if ongoing); "lumbar spondylitis" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing). Concomitant medication(s) included: CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE], start date: 11Oct2022, stop date: 17Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19/ Covid -19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (17Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
while driving home from clinic felt arm itchy & was swollen & red; aprpox 3" diameter area around inject site; arm red & hard from shoulder to elbow by next AM; ssen by MD; cellulitis;
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On 27-Oct-2021 at 10:41 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 32.96.  No concomitant medication was reported by reporter.  On 27-OCT-2021, Excursion time was 9 AM, temp was 29, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on  29-SEP-2021, vial was moved to clinic on  27-OCT-2021. Vaccine BUD date was  29-OCT-2021.Number of vials sent to clinic was 2.  On 27-OCT-2021, Excursion time was 10 AM, temp was 32, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on  05-OCT-2021, vial was moved to clinic on  27-OCT-2021. Vaccine BUD date was 04-NOV-2021.Number of vials sent to clinic was 4.   It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Initial misuse report received from a healthcare professional on 10 July 2014. A patient had received a dose of FLUZONE on 10 July 2014. It was reported that the patient was administered vaccine that had expired on 30 June 2014, thus, an expired vaccine was used. No adverse event was reported. List of documents held by sender: none.
Biopsy diagnosis was follicititus; Seccond biopsy diagnosis was contact contact dermatitis; Discoloration on the outer side of both calves / circular / brownish, reddish purple and almost black; On his arm / had white pimples; scratched; It left a big red circle / Red mark on his left leg / Fingers on both hands were red; Blisters appeared on his left / right knee; Injection site was sore; This case was reported by a consumer via call center representative and described the occurrence of folliculitis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 11th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced folliculitis, contact dermatitis, skin discoloration, milia, scratch, erythema, blister and injection site pain. The patient was treated with triamcinolone acetonide. On an unknown date, the outcome of the folliculitis, contact dermatitis and erythema were recovering/resolving and the outcome of the skin discoloration, milia and injection site pain were recovered/resolved and the outcome of the scratch and blister were unknown.   It was unknown if the reporter considered the folliculitis, contact dermatitis, skin discoloration, milia, scratch, erythema, blister and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had the first and area of discoloration presented on the outer side of both calves. It was circular and looked brownish, reddish purple and almost black.   There was also an area on his arm that had white pimples.   The patient scratched one of the pimples and it left a big red circle. He did not scratch again. The patient visited the dermatology office and a biopsy diagnosis was follicititus.   The patient was prescribed Triamcinolone acetonide 0.1%. Soon after that the patient was working in his rock garden and was on both knees. That same day, blisters appeared on his left knee and then his right knee.   The patient again visited the dermatology office and a second biopsy diagnosis was showed contact dermatitis. The patient had also visited his endocrinologist for his diabetes and he had crossed his right leg over his leg one and the doctor noticed an aggressive red mark where on his left leg where the right leg had been sitting. The red mark lasted 20 minutes before resolving. He also mentioned that his fingers on both hands were red from areas where a ring would sit. From the area that bends on each finger up to the knuckles. Not the thumbs. The injection site was sore after the first dose for 2-3 days.   The reporter consented to follow up. For tolerance of 2nd dose refer case US2020AMR255569.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255569:Same reporter
blood clots; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient died one week after receiving Pfizer COVID vaccine, autopsy confirmed blood clots. Event took place after use of product.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect drug to the reported event  "blood clots" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: blood clots
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK198909). On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 19th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills and fever. On 20th October 2018, the patient experienced injection site rash and painful rash. On 21st October 2018, the patient experienced vomiting. The patient was treated with BENADRYL and meloxicam. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site rash, chills, vomiting, fever and painful rash were unknown. It was unknown if the reporter considered the injection site rash, chills, vomiting, fever and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. About 24 hours after receiving SHINGRIX, the patient experienced 2 by 3 inches rash around the injection site. The rash was inflamed and painful to the touch. The rash seems to be expanding and getting worse. The patient also had fever and chills the night he received SHINGRIX. Two days after receiving SHINGRIX, the patient experienced vomiting. This case has been linked with case US2018GSK198909, reported by same reporter for same patient.
The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.      Medical history was not provided. .     On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 11-Jun-2021, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.
flu-like symptoms; This is a spontaneous report from a Regulatory Authority. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 20Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer Covid-19 vaccine on 20Jun2021 and was scheduled to get the second dose on 12Jul2021 but did not push through because she developed flu-like symptoms. (Withheld) would like to know if his wife can make another appointment for getting the second dose or if she can just walk-in at the pharmacy. Patient mentioned he needed a interpreter. On an unspecified date in 2021, the patient experienced flu-like symptoms. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Jynneos vaccine was drawn up into the syringe 20 minutes before it was administrated to the patient.; Jynneos vaccine was drawn up into the syringe 20 minutes before it was administrated to the patient.; Case reference number US-BN-2022-002246 is a spontaneous case report initially received on 01-Sep-2022 from a pharmacist (reference number: USBAV22-1249), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient received the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox (explicitly coded as ' Product storage error', 'Product administration error ').  At the time of this report, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos.  Additional information received on 05-Sep-2022 from Bavarian Nordic included local case ID.  This case is linked with US-BN-2022-002245 and US-BN-2022-002247 concerning the same reporter; Reporter's Comments: A patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox, which is considered as product storage error and product administration error. No associated adverse events have been reported with the reported medication error. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe 20 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/ monkeypox, which is considered as product storage error and product administration error. No associated adverse events have been reported with the reported medication error. Product storage error and product administration error are considered as listed per company. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.