chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 12 hours headache started and pain in left arm (injection site), 17 hours 100 degree fever and fatigue, 22 hours 5:30pm 6/2/21 extreme chills and fatigue went to bed 3 covers and 2 shirts, still could not get warm. 9:30 pm chills stopped went back to sleep. Woke up at 1:30am 6/3/21 called off work as total body aches and fatigue set in, stayed in bed until noon 6/3/21 ate some food and noticed redness on most of upper left arm. 4pm 6/3/21most symptoms returned to normal and I was able to get up and take a shower.  6/4/21 Feeling much better but all of upper left arm is now red and swollen, so much so that it appears to be retaining fluid. Have been using cold pack and taking Ibuprofen.
Narrative:  1st moderna vaccine: 2/3/21 2nd moderna vaccine: 3/3/21 3rd moderna vaccine: 10/16/21 covid positive: 1/18/2022 emergency room visit due to covid related ilness: 1/25/22 hospital admission due to covid related illness: 1/31/22 (today)
Abnormal periods.  Skipped one full period.  Each period since (July to Oct 2021) has included 5 to 10 days spotting.  Never had skipped or spotting prior to vaccine.
Patient experienced itching in mouth and lips. He had already taken two 25 mg BENADRYL and 10 ml BENADRYL Elixir before returning to pharmacy.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), on 20Oct2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 27Nov2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Treatment of COVID-19; (17Mar2023) Negative; (18Mar2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At approx 1130 am 2/11/15 I passed out at the abuse shelter. Staff unable to wake me. Taken to ER-heart monitored and IV fluids administered. Discharged between 2-3 pm.
No adverse events noted. Patient receive expired vaccine. Vaccine expired 3/7/15. Was given today 3/13/15.
Tongue swelling Rapid heartbeat  Couldn?t swallow well   - injection of methylprednisolone -Claritin
Within first five minutes sudden ringing in ears, nausea, dizziness, sweating. An urge to pass out/faint. Symptoms subsided after 10 minutes.
Had HPV #1 4/10/08 Merck 1758U left DEL; No problems. HPV #2 9/16/08. On 8/7/08 went to focus med, left arm swollen x 2days, had to cut ring off, sensitive to touch. Saw Pediatrician on 8/11 - given Medrol dose pack Rx. Saw ped 8/15 still swollen - mom filled Rx; saw Dr 8/18 neurologist.
Developed severe abdominal pain 3/22/2021. Hospitalized and dx w ISCHEMIC COLITIS, MESSENTERIC ISCHEMIA, TYPE II NSTEMI,  ANEMIA and THROMBOCYTOSIS. Hospitalized 9 days
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (lot number 731504/17, NDC number: 0005-0100-10), intramuscularly on the left deltoid on 16Mar2016 at 11:00 at 0.5 ml, single. Relevant medical history and concomitant medications were none. The patient experienced fever and arm was very painful and fatigued the day after vaccination on 17Mar2016. The events did not require emergency room or doctor visit and the patient was not hospitalized for the events. The patient recovered from the events. The physician stated that the patient provided to him/her information regarding the reported events with the use of the vaccine. The physician considered the vaccine had a causal effect to the adverse event. Follow-up (03May2016): New information reported from a contactable physician includes: patient's gender, lot number, site and time of vaccination, none medical history, onset date, no hospitalization, emergency room or doctor visit for the events, confirmation from the physician that the patient provided to him/her information regarding events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
Within 30 min. of receiving GARDASIL #3 patient became flushed, generalized itching. Hives on chest, headache, nausea taken to ER - required IV meds including steroids/antihistamines.
Patient stated that 10 to 12 hours after receiving the vaccine he experienced chills, a fever, light nausea and chest pain. The chest pain was so severe that he took a nitroglycerin tablet. Within 3 minutes of taking the nitroglycerin, the pain subsided. He then got a severe headache and went to his doctor for an office visit.
2 minutes after vaccine was administered, noticed swelling back of tongue, progressed to posterior 2/3 of tongue,  tachycardia, elevated BP. Progressive angioedema involving larynx, cough, shortness of breath. No wheezing. Physical exam did do show any obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered. some improvement in symptoms. In 30mins, reoccurrence of  angioedema and second epinephrine vaccine administered. Monitored for 2 hours without reoccurrence of symptoms and discharged from ER.
cough.  I had the first shot and the second shot of moderna and everything was fine. when I had the booster after two or three day days I started coughing. It has been 4 months now and I'm still coughing. MY coughs are dry and and often, no fever and no other symptoms.
Arthritis; Gout; pain had affected his ankle, knees, hand; Can't hardly walk; he was still sick; joints and knees were hurting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk) and ILLNESS (he was still sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS, Diabetes and Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever). The patient was treated with CELECOXIB (CELEBREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication includes Diabetes Medication, Blood Pressure Medication, Cholesterol Medication and Thyroid Medication.   This case was linked to MOD-2021-101730, MOD-2021-101589 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated reporter contact information, suspect product information, events
In the 2 months since the flu shot was administered, my right arm has been sore with tingling and muscle weakness.  It is painful to do certain motions, such as grabbing and lifting.  Note, I am a normally healthy woman.
COVID-19 breakthrough infection. Pt received Pfizer on 6/3/2021 and 6/22/2021
Chest pain, dizzy, light headed, leg and arm pain, short of breath, tired, spaced out mentally/unable to focus. No treatment at this time.
Mother of child called on 07/28/2003 to report that for the past 4 days child has had a sore neck and sore muscles, headache and chills.  For the past 3 days (starting 07/26), has had temperature of 104.  She has notified their family physician.
Approximately 5 minuets after receiving Moderna, COVID-19 vaccine, while talking with writer, client became unresponsive and slumped over in chair. Client's extremities became stiff and his eyes rolled to the back of his head. Client was lowered to the floor with assistance and remained unresponsive for a minuet more. EMTs on site responded to event and monitored client for approximately 40 minuets before discharging client home in stable condition. During the monitoring period, client did have emesis x 1. His skin was also clammy after initially becoming unresponsive.
Pt was administered 0.5ml Moderna COVID vaccination, no adverse reactions noted or reported.
I've had the first vaccination AND the second vaccination /had /suspected vaccination failure; I had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st vaccination and the 2nd vaccination with the booster and still had shingles twice this year.  The patient kept the oral medicine on hand so that, the patient could start taking it as soon as feel an outbreak coming on. If the patient catch it early, it would not get out of control or last as long.  The patient was disappointed that the vaccinations had not kept the patient from an outbreak. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. No contact details were available.
Rash, hematoma on right thigh at area of injection. Left thigh which also received vaccination had no reaction.
Patient had BEXSERO vaccine, two day later patient stated arm was red, swollen and warm to touch.
A little soreness; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little soreness) and HEADACHE (Mild headache) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (A little soreness) and HEADACHE (Mild headache). At the time of the report, PAIN (A little soreness) and HEADACHE (Mild headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  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.
Patient started to experience numbness in immediate area of injection site. She reports that approx 5 minutes after injection, numbness began to spread out from injection site, but was contained mostly to upper arm. She denies weakness, pain, numbness of mouth, difficulty breathing. BP 152/100. Pt reports she is very anxious.   pt given ice pack and asked to stay in obs area for an extra 30 minutes. No sequelae after initial numbness
Rash 2-3days. started on stomach and spread all over. vaccines 4 days ago. no new food/meds. not otherwise ill. had tick bite a week ago, improving. no target rash noted. many diffuse small isolated papulovesicular red lesions over entire body. few on palms/soles. none in mouth/scalp. 1cm drying papule on center of chest at site of tick bite. no annular rash.
Soreness in left arm pit. Currently pregnant with due date of September 8, 2022
Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Patient received second dose in series at 10 AM.  At around 11:30 he came back to the pharmacy complaining of pain in his back upon breathing, and a "fuzzy" feeling in his tongue.  I had an associate call 911, then I  administered a 0.3 mg Epinephrine IM, and 50 mg of oral liquid diphenhydramine. The ambulance service arrived and transported him to the local hospital while he remained alert and oriented.
Soreness of muscle, left leg, from mid-calf to behind the knee. Soreness caused limping. Subsequently within 3 days, pain lessened, no longer limping.
Patient went in for a well-check on 1-21-08, we did not know he had a Temp of 100.1 at the time of the Varicella shot. Facility said his temp was normal. We got the records from the office and that is when we saw he had temp of 100.1. After he got the shot we left and went to get a pair of shoes. He said he did not feel good and did not want to get a movie. So we came home that was around 3:30 he went to his room and laid down. I asked him if he wanted to watch a movie and he said no. He fell asleep and I checked on him he felt warm. I got him up to take his temperature and he threw up and he had a temp of 102.3 so I gave him Tylenol and he fell back to sleep. I checked on him at 8:30 he was burning up his temp was 104.8 I called the ER and she told me to put him in a tepid bath and give him Tylenol and Motrin alternate every 4 hours. I got his Temp down to 102 and it stated at 102 and 101.6 I could not get a an appointment with Dr. he was booked so I took him to the ER on 1-24-08 Dr. saw him, I told her that he had a chickenpox Vaccine on the 1-21-08 she was not concerned about that she said he had Acute Bronchitis. She gave him a Z-Pack 200mg. We gave him the pills crushed up in applesauce. He seemed ok for a few days and then he started jerking his head and he had neck pain. On 2-7-08 he got up around 7:30 and he was jerking out of his skin he could not talk to me and he was staring out into space. I ran him To The ER and Dr. could not find the reason for the Seizure he took a Video of patient, I don't know what he did with it. I told him patient had a chickenpox shot on 1-21-08 he was concerned about that, and he ran all kinds of tests on him. He finally said patient needed to go to Hospital he was taken by ambulance, Dr. gave him a dose of penicillin before he left. It took 3 1/2 hours to get to hospital in another city when he got there the jerking and twitching had slowed down. The neurologist did no tests no EEG on patient. We were there 22 hours we did not see a Doctor until 8am 2-8-08 when he did come in he looked at patient and said he has a TIC. He gave him Topmaz 25mg and told us to go home and try to live with it. Patient has seen 3 neurologist he has been in 3 hospitals. We found a neurologist in another city he has put patient on Penicillin 250mg and Clonidine 0.1mg. Patient went into Dr. office a happy little boy on 1-21-08 he is now suffering and jerking all over his body he is having severe neurological problems. One 1-20-08 he made the HONOR ROLL at school, that is why he was going to get a new pair of SHOES.
Chills / Shivers; This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingix in the end of February 2020 and experienced chills and shivers in the evening of the day the patient received the vacine. The reporter was not consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (Arm sore) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
redness on the left thigh; used an expired dose on a patient of poliovirus; Initial information received on 18-Mar-2022 and then on 21-Mar-2022 regarding an unsolicited valid non-serious case received by a health professional via call center.  This case involves a 2 years old unknown gender patient who experienced redness on the left thigh while receiving vaccine Poliomyelitis Vaccine (Inactivated) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation; Hib Vaccine (HIB) for Immunisation; Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation; and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 18-Mar-2022, the patient received 0.5 mL of Poliomyelitis Vaccine (Inactivated) suspension for injection (strength: unknown; lot R1F973M and expiry date:03-Oct-2021) via intramuscular route in the left thigh for immunization.  On 18-MAR-2022 (Latency: same day), the patient developed redness on the left thigh (vaccination site erythema) after the HCP used an expired dose on a patient of poliovirus (expired product administered).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Event outcome: Not Recovered / Not Resolved for the event redness on the left thigh.  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 the 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.
Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure  VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING
I had a headache. I felt wiped out. I was exhausted and I hadn't done anything. I think I started having a fever. Not a high one but one that got my attention. I basically slept. I took Tylenol and went to bed and stayed there for awhile. Then the symptoms went away. Went to ER on May 13th at midnight (so Friday morning). I never had thrown up as much in my life as I had that Thursday night - it was black liquid - they think it was liver bile. They put a nasal to gastric tube in me for 12 days. Admitted to hospital on 14th - They were initially removing all the liquid in the stomach which was really distended. They were pulling more than a liter every 12 hours of liquid - that's what I saw next to my bed. It was black for three or 4 days and then it turned to gastric juices which were gold colored. They operated on me on 5/16/2021 and they pulled out. (I had had an operation in 2007 for an umbilical hernia) - that scar tissue from that 2007 operation incarcerated the small intestine - 19 inches of it - so they removed those 19 inches. It took awhile for my gastric tract to reset after that.  I have severe sleep apnea - the last time I was tested I stopped breathing 68 times every hour - for 12 nights I couldn't take my CPAP mask because of the nasal/gastric tube. I didn't sleep those 12 nights. I got the point I was having delusions.
Arm pain: approx. 30 hours Diarrhea and gas: 12 hours Fatigue: 24 hours
FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient previously received covid-19 vaccine ad26. cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, 1 total, administered on 09-MAR-2021 on left arm for prophylactic vaccination. On 10-MAR-2021, the patient experienced flu-like symptoms and recovered on 13-MAR-2021 (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced flu-like symptoms (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-NOV-2021. This report was non-serious. This case, involving the same patient is linked to 20211258945 (Dose number in series 1 case). This case, from the same reporter is linked to 20211258107 and 20211258204.
Dizziness, headache, ammonia inhalants, TYLENOL taken (acetaminophen).
From mailed correspondence received at manufacturer on 3/4/02 from a research group, it was reported that a male received Ipol on 12/17/01. It was reported that PT was "rolling his head side to side and has a goofy look in his eyes". He was cranky and screaming. "The inject site reaction described as hot to touch, swollen and very tender."
Headache, chills , body aches, lethargy, low grade fever, diarrhea, and nausea