chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 61-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.   The  concomitant medications on use were not provided. No treatment information was provided.  No adverse event reported.   This case was linked to MOD-2021-395985 (Patient Link).
This case was reported by a nurse and described the occurrence of bilateral knee pain in an adult male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. On 10/20/2005 the subject received 1st dose of Engerix B (lot AHBVB004BA. On 10/20/2005, less than one day after vaccination with Engerix B, the subject experienced bilateral knee pain. The outcome of the bilateral knee pain was not reported.
October 2nd (Days after administration date 9/26/2020) patient woke up with welps on right arm along with redness and itching.  October 3rd. Welps are gone but large red circle with circumference of 2 and 1/2 inches + itching.  October 4th. Still red but feels better as time goes on.
Per mom, the pt was first noticed to have an itchy right earlobe 3 days after the vaccines were administered.  This went away and then her cheek got red and itchy.  After that disappeared she has had small welts appear on her right, upper arm and thigh surrounded by red tissue.  The welts and redness are spread in an area of about a dollar bill on her the lateral aspect of her right thigh and the area on her arm was not visible at the time of assessment.  Mom states the pt did have a fever of 101 the night after the imms were given.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and the second episode of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:58 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced the first episode of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and the second episode of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, last episode of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 65.41 on 13-Feb-2021 and 65.51 on 20-Mar-2021. Concomitant products were not provided. For Lot no : 031L20A on 13-Feb-2021, excursion time was 9 AM and temperature was 34 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021 and was moved to clinic on  13-Jan-2021. 30 vials was sent to clinic. Vaccine BUD date was 10-Mar-2021. For Lot no : 031A21A on 20-Mar-2021, excursion time was 9 AM and 10 Am and temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021 and was moved to clinic on  20-Mar-2021. 19 vials was sent to clinic. Vaccine BUD date was 08-Apr-2021. For Lot no : 031A21A vial was stored on cooler 1 , on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44, 5 PM: 43 . The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines 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. Treatment medications were not reported.
On 9/23/02 mother brought in child with mild pink rash with diffused macular papular areas on anterior trunk and legs. Temp 96.8 ax. MD notified advised parent to see MD or ER.
muscle pain; joint pain; puffy eyes; feels bad; bad headache; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date in Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia. The patient's concomitant medications were not reported. The patient previously took methotrexate for rheumatoid arthritis and experienced shingles. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation and experienced pain, was nauseated, and ended up vomiting. The patient reported that she has been a mess and had Rheumatoid Arthritis and Fibromyalgia. She ended up getting Shingles 3 months ago and stopped Methotrexate prior to getting vaccine. She has not started it back, so she was pretty inflamed with Rheumatoid. The patient stated prior to the first dose of the vaccine she had gotten shingles and stopped her methotrexate for rheumatoid arthritis and fibromyalgia. On an unspecified date in Jun2021, the patient had muscle pain, joint pain, and stuff and it took a day to hit her after second vaccination. The pxatient stated the symptoms were not that bad a day before (yesterday) and she was able to work. Sunday it was the same thing. Day before she still had muscle pain and joint pain, but it was not that bad, and she ended up working. "Last night" all of a sudden "bam" the pain intensified. "Today" (15Jun2021) patient woke up with puffy eyes, feels bad, and has a bad headache. Patient would like to know did Pfizer heard of it going in sections like that, where symptoms developed on the 5th or 6th day. In between she had chills. She would have a chill and then a couple of hours later another chill. The patient stated she was used to the muscle pain and joint pain due to her fibromyalgia and rheumatoid arthritis, but she was not expecting the symptoms to hit her like a ton of bricks. She just wanted to make sure it was normal for the side effects to appear after so long since she had received the vaccine. Patient informed she does not feel good at this time. The outcome of event feels bad was not resolved and rest all events was unknown.  Information about batch/lot number has been requested
FELT LIKE KICKED IN THE HEAD BY A MULE (MASSIVE HEADACHE); This spontaneous report received from a patient concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously vaccinated with Covid-19 vaccine ad26.cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D2114, and expiry: Unknown) dose was not reported, (dose number in series 2) 01 total administered in left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, after receiving the booster, the patient felt like she had covid-19, all over again and had a massive headache, felt like she was kicked in the head by a mule (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like kicked in the head by a mule (massive headache) was not reported. This report was non-serious.
Extremely weak, high fever, chills, nauseous, confused.  Right arm & face flushed. Right arm became very hot & sore, &has  still red rash.  Symptoms suddenly started around 10 am next morning (Tuesday) & lasted until mid day Thursday. Could not function at all. Once chills subsided on Thurssday, was extremely week until Saturday morning (11/13/2021).  Arm still has red rash today, but I am starting to function again, finally. Wonder if I got full dose instead of booster. Also had increased heart rate according to my watch for Tues- Thurs,
patient called pharmacy reporting red bumps, similar to chicken pox lesions, on her left arm, left leg, and back
Throat became dry and irritated lips became numb started to cough was wheezing eyes became very very red the next day had a red rash over my neck and trunk.
Swelling in lymph node on left side under arm; injection was given in left arm.  It is still swollen 8 months after the injection.  I will be seeing a physician recommended by my primary doctor soon to perform any needed tests.
Significant higher heart rate, been monitoring heart rate daily.  Average before vaccine about 70 BPM, now 2 weeks later 89 BPM daily average  Chest pain, tight feeling in my throat, anxiety feeling on edge, terrible sleep  Late menstrual cycle, I am always on a schedule period was 9 days late.
Dizziness, Nausea, chills, heat flashes, heart beat surged, felt like I was going to pass out. Constant coughing, and weak in the body.
This spontaneous report was received from a licensed vocational nurse regarding a patient of unknown demographics. There was no -24-MAY-2018, information about concurrent condition, concomitant medication and historical medication. On 29-NOV-2016, the patient was vaccinated with improperly stored VARIVAX lot # M025867/expiration date-24-MAY-2018, subcutaneous. The vaccine was drawn into a syringe from the vial and stored in the syringe for 24 hours before administration (at an unspecified temperature) which is outside of the prescribing information recommendation. No adverse effects reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
spider bite few days before getting the first dose (21Jan2021) of the vaccine and she started; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (spider bite few days before getting the first dose (21Jan2021) of the vaccine and she started) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (spider bite few days before getting the first dose (21Jan2021) of the vaccine and she started). At the time of the report, ADVERSE EVENT (spider bite few days before getting the first dose (21Jan2021) of the vaccine and she started) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a spider bite few days before getting the first dose of the vaccine and she started experiencing adverse effect and she called her doctor who said she shouldn't have gotten the vaccine knowing that she had just gotten spider bite. Concomitant medications were not provided. Treatment information was not reported.
Less than 5 minutes, patient began to feel light-headed.  She stood up to find husband and blacked out/husband caught her.  Patient woke up with in seconds.  25mg Benadryl given per mouth with water.  Husband took her to ER per MD request.
Really bad reflux all day two days later (I don't get reflux unless I am pregnant, and it's been close to 4 years).  Then the next day I had a really bad pain in my chest which occurred every time I swallowed. Was told this was probably an ulcer (I've never had one of these before).
he lost sense of taste and smell; he lost sense of taste and smell; legs feeling heavy and hard to move; restless sleep; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation.  Medical history included Patient has recently had a pacemaker implanted. Concomitant medication included potassium Once a day, hydrochlorothiazide (DIURETIC), 20 mg Twice a day, dutasteride (AVODART), Once a day, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg Once a day and a multivitamin QD (Once a day). The patient had the COVID-19 vaccine administered on 14Jan2021. That evening he began waking up several times after a restless sleep approximately six times on 14Jan2021. This lasted approximately two more evenings. On 19Jan2021 he lost sense of taste and smell for approximately three days. As of 20Jan2021 he has regained some sense of taste. The patient's temperature has been normal with no fever and pulse oximetry has been approximately 96%. Lastly on 17Jan2021 patient reported his legs feeling heavy and hard to move which lasted approximately three days. The outcome was recovering.  Information on the lot/batch number has been requested.
On 7/9/07-Gardasil administered. Pt had reported LMP-7/1/07. After immunization administered, patient states-"I was wrong-my period wasn't 7/1/07-it was 6/1/07. Pregnancy Test Positive. No adverse event noted.
experienced a sick stomach; she did not feel well; her arm hurts; chills; feels tired; slight headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 29Jan2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced a sick stomach, she did not feel well, her arm hurt, chills, felt tired, slight headache on an unspecified date in 2021. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
I just had a sore arm; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included severe Fibromyalgia. The patient's concomitant medications were not reported. The patient had received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation. The patient experienced i just had a sore arm on an unspecified date (the patient was concerned that the second vaccine would lead to a flare). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea.  Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.
Sudden onset of decline. Audible, course crackles upper airways. O2 sats 88% on 4L O2, BP 112/70, P90, R24, T98.6. Elevated HOB, nebulizer given. MD immediately informed w/orders, if no improvement w/PRN neb tx or worsening sx's, transfers to ER for eval. Guardian notified & in agreement w/MD orders. During neb tx, O2 sats decreased to 84% w/audible course crackles, BP 102/78, P89, R34. Ambulance called, arrived & during assessment per ambulance crew, rt. expired at 2145. Ambulance crew informed Co. Sheriff of death. No concerns re: death. Guardian & MD informed of rt.'s passing. Funeral home notified.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 31-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Patient reports she began hallucinating "brilliant colors" (neon) for about 4 hours. She was dizzy for about 24 hours. She developed a "big goose egg" at injection site and then one above it and one below it for a total of 3 "goose eggs". She then developed a rash.  She reports as of 03/05/2021 the 2 goose eggs above and below the injection site have resolved and the one at he injection site has "gone down".
Janssen COVID-19 Vaccine EUA Body aches and pains (specifically on left side of body and in lower back), lasted for ~14 hours.  Migraine-like headache, currently ongoing but started 11 hours ago.  Unable to sleep due to these moderate-severe amounts of pain (woke up at 3am unable to go back to sleep).
Tingling in feet, hands, head. Weakness in legs. Pounding heartbeat, paleness, malaise. Symptoms have improved but continue off and on.
Had few heart palpitations after the 1st dose Sporadic; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic). At the time of the report, PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-355784 (Patient Link).
TINNITUS; UNABLE TO EAT; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A01A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced unable to eat. On 08-APR-2021, the subject experienced unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, unable to eat, and unable to sleep. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non serious.
Flu shot this year, sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine (receiving every year).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a flu shot every year and the flu shot this year, the patient felt sick. The patient stated would be thinking twice next year.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 25-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.