chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccine given 10/21/2002. Noticed rash this am 10/25/2002. Rash on hand, face, chest, arms, and hands. Rash was red and not well defined. States rash itches, but does not burn and is not painful. Denies dyspnea, blurred vision or change in mortal status or fever/chills.
Patient had severe myalgias, widespread drug rash on her body, and fever with nausea and vomiting for two days.
Sore wrists and forearms.; Sore wrists and forearms.; Tight and stiff shoulders and lower back, fatigue, restlessness, depression.; Tight and stiff shoulders and lower back, fatigue, restlessness, depression.; Tight and stiff shoulders and lower back, fatigue, restlessness, depression.; Tight and stiff shoulders and lower back, fatigue, restlessness, depression.; Tight and stiff shoulders and lower back, fatigue, restlessness, depression.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jun2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included vitamin d deficiency and depression. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride 300 milligram daily (WELLBUTRIN) and escitalopram oxalate 20 milligram daily (LEXAPRO). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jun2021, the patient experienced sore wrists and forearms. The patient also experienced tight and stiff shoulders and lower back, fatigue, restlessness, depression. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore wrists and forearms, tight and stiff shoulders and lower back, fatigue, restlessness, depression was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt tingling on neck, shoulder and head; This is a spontaneous report from a non-contactable consumer (patient's mother) via Pfizer sales representative. An adult female patient (unknown if patient was pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Vaccine facility type was unknown. The patient's medical history and concomitant medications were unknown. Known allergies reported as unknown. Other vaccine in four weeks was Unknown. It was unknown if covid tested prior or post vaccination. On 07Mar2021, two days after getting injection, patient felt tingling on neck, shoulder and head, was not sure if it had anything to do with the vaccine. Patient was not treated for the event. The event did not result in emergency room/ physician office visit. The outcome of the event was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.; This spontaneous case was reported by a patient and describes the occurrence of FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Lot 013L20A) on 19-Jan-2021, MODERNA COVID-19 VACCINE (Lot 012M20A) on 16-Feb-2021, MODERNA COVID-19 VACCINE on 10-Sep-2021 and MODERNA COVID-19 VACCINE (lot 048L21A) on 19-Mar-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Asthma since 2017, Hypogammaglobulinemia, Brain tumor since 2016 and Meningioma.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.). At the time of the report, FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: bloodwork, fine.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.   Patient had a facial injury August 11, 2023. She had dermal fillers in both eye troughs and nasolabial and chin area.   This case was linked to US-MODERNATX, INC.-MOD-2023-747593 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747593:Case for SPIKEVAX 2023-2024 PFS
2/7/2021 - Myocardial Infarction 2/8/2021 - Cardiac Arrest/ Ischemia/Blockage of OM2 Artery treated with emergency PCI
slight pink blotch 2 inches down and an inch over the vaccination site; itchy; felt like a knot; tenderness over vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (slight pink blotch 2 inches down and an inch over the vaccination site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (felt like a knot) and VACCINATION SITE PAIN (tenderness over vaccination site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced RASH MACULAR (slight pink blotch 2 inches down and an inch over the vaccination site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (felt like a knot) and VACCINATION SITE PAIN (tenderness over vaccination site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at a dose of 1 dosage form. On 16-Feb-2021, RASH MACULAR (slight pink blotch 2 inches down and an inch over the vaccination site) outcome was unknown and VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (felt like a knot) and VACCINATION SITE PAIN (tenderness over vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment details provided as Benadryl tablets and calamine lotion.   This case was linked to MOD-2021-021171 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: follow up received on 24-06-21 with NNI
His daycare  is saying he should have gotten one dose after he turned 12 months old/no AE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 32 months old male patient who should have gotten one dose of HIB (PRP/T) VACCINE [ACT-HIB] after he turned 12 months old (drug dose administration interval too long, PT: Inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to inappropriate schedule of product administration.  At the time of this report, 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.  Information on the batch number was requested.
July 3, 2021 - Admitted to ER for Chest Pains on Right side of Chest/Pelvis/Upper Legs at 2AM,  Performed blood test and scans, diagnosed blood clots in both lungs by 4AM, origin from where blood clot came from are still not determined.
A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was sore and tender to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On an unknown date, patient experienced injection site was sore and tender to touch. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of events injection site was sore and tender to touch was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
PT RECEIVED VACCINES FOR TRAVEL AT 9:30AM. AT APPROX. 2:00PM, PT CALLED THE HEALTH DEPT. AND SPOKE WITH IMMUNIZATION NURSE. PT C/O SWELLING TO ENTIRE RIGHT ARM DOWN INTO HAND AND FINGERS. PT STATED HIS ARM WAS CHANGING COLORS. STATED IT LOOKED PURPLE IN COLOR. PT C/O NUMBNESS. PT DENIED ANY OTHER S&S. PT WAS REFERRED TO ED. NO TREATMENT GIVEN PER PT. INSTRUCTED TO MONITOR FOR FURTHER SWELLING OR PROBLEMS.
24 hours after Tdap vaccine employee ran fever, body aches & 70 x 70 cm local reaction - warm to touch & painful. Lasted 4 days after vaccine.
Brain fog; chills & shaking; skin feeling raw; headache; brain zaps; fatigue; sore muscle; slight bruising at injection site
Here for 12 mo WCC, rec'd VARIVAX & Hep A vaccine in (R) thigh approx 5 min after administration noted 1 hive adjacent to VARIVAX insertion site, no resp s/sx. BENADRYL po given observed 30 min in office. Discg home.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 15-JUL-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Severe swelling and pain in all joints. Feet, hands, ankles, knees, burning in back and shoulders, swelling in wrist and fingers.  Started after about a week after 1st dose.  2nd does I had to go to the Emergency Room at hosptial.
Heart felt swollen and painful on two occasions after taking the vaccine.  One time after first dose, another time after second dose.
For almost 10 mos. I have an egg-shaped lesion on my left deltoid.  Range of motion is pitiful, I am in pain everyday.  Had low-grade fever for over 40 days straight. 10/30/2008 PCP and vax records received. OV 12/17/07 with c/o L arm pain at TD injection site. Vax given 11/1/07. Reports nerve/muscle pain 8/10.  Initially at injection site but pain spread and worsened to include the whole arm. Bruising noted at base of deltoid. Decreased ROM L shoulder.
SLEPT MORE THAN USUAL; SLIGHT FEVER OF 99F; INCREASED TIREDNESS/FEELING DRAINED; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced slept more than usual, slight fever of 99f, and increased tiredness/feeling drained. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever of 99f, increased tiredness/feeling drained and slept more than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817805, 20210818021, 20210818107 and 20210818401.
This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No additional AE reported; the vaccine administered today (8/4/2021) was expired.; This spontaneous report has been received from a nurse prescriber, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 04-AUG-2021 (reported as today), the patient was vaccinated with an expired dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination and vaccine scheme was not reported; lot number S037574 has been verified to be a valid lot number, expiration date reported and established as 10-APR-2021) (expired product administered) as prophylaxis The caller reported no symptoms from injection. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's medical history included Multiple Sclerosis. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot # unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles within one month after they received ZOSTAVAX. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Redness and swelling in the right arm at injection site since this morning - 48 hours after the injection
Very sore , site area red in color and hard, slightly warm to touch, rash and itched a lot
pt c/o hoarseness, wheezing, coughing, SOB lasting only minutes;cont w/hoarseness;
Headache and fatigue started several hours after vaccine administration. Experienced headache, fatigue, chills the following day. Resolved the next day.
Pt tested positive for COVID on admission screening.  Was admitted for non COVID related reasons and asymptomatic for COVID
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received booster shot of Moderna COVID-19 vaccine.
Almost immediately patient broke out with a bubbly reddish rash on left trunk and arm. Rash is slightly itchy, patient denies egg allergy.
Bell's Palsy affecting the right side of the face. Began with a funny sensation and progressed to facial droop.
Suspected Vaccination failure; I am just getting over shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the 2 doses of Shingles vaccine 2 years ago and had shingles. The reporter stated that he/she was just getting over of shingles. The reporter stated that from what he/she heard from others, patient's case was not as bad as it could have been so might be the vaccination was helpful. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
runny nose; itchy watery eyes, like allergies; itchy watery eyes, like allergies; fluid in her ears; allergies; only had a sore arm for a day; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 14Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received her first Covid19 vaccine on the 14Jan2021 and everything has been great. She stated she only had a sore arm for a day, but now 5 days later (19Jan2021) she has a runny nose, itchy watery eyes, like allergies, and fluid in her ears. She stated she feels it was just allergies because she can take a Benadryl and it makes it quit. She stated Benadryl knocks her out though. She stated she would like to know if these side effects have been mentioned by others and being 5 days after given the dose. Therapeutic measures (Benadryl ) were taken as a result of runny nose, itchy watery eyes, like allergies and fluid in her ears. The outcome of the event sore arm for a day was recovered while other events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
30 min after dose felt like my tongue was getting thicker, neck and throat felt tight, tingling around upper gum line near front teeth. Slight numbness in skin around upper mouth.  Difficulty swallowing for five hrs post dose and I took 50mg of Benadryl at 730pm when I got to my car. Swelling in throat and back of mouth remained same from 530-730, gradually noticed improvement at 1015 pm