chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 06-NOV-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as 1002873, expiration date: 27-JAN-2017, route and dose were unknown) which was improperly stored. There was no previous temperature excursion. No adverse reaction was reported. Lot number 100287 has been verified to be a non-valid lot number for MMR vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Pt coming in as 2-3 weeks ago she was in to get the new shingles shot. Her (R) arm turned red. She came in to be seen in office and was given pred. A week or so after that she dev red sores on her chest and base of her neck. She stayed in bed. At that time she had been off of the pred for 36 hr and dev diarrhea. She has new sores in her scalp. Pain has moved down into her arms and posterior rib cage and into her hips. States they all are tender to touch- but not like when it started and was like it was on fire. She states it is not the joints that hurt- just her skin.
Patient received FLUZONE HIGH DOSE 2018-19 vaccine on 10/17/18. Over the following weekend 10/20-21/18 she developed a rash/hives. She received medication to treat the reaction and reported the reaction on 10/24/18.
10/10/07 Received Pneumovax right arm c/o redness, swelling and tenderness to right upper arm 10/16 Seen client- only slight swelling noted
Mother states infant woke up at 10:00 am on 08/12/21 the day after immunizations w/ R side face swelling and watery R eye.  States no redness, no breathing difficulty, and no noted fever.  States infant smiling and appears to be in no distress.  Referred infant to ER.
Cough, congestion, fever, wheezing, crackling sound in lungs. 5 weeks, ongoing. Sudogest 60 mg.
This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583947A, and A0583948A
syncope; vomiting; Information has been received from a registered nurse referring to a 13-year-old male patient via the field employee. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not reported.      On 07-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. It was unknown which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series was administered.        After administered the vaccine, on the same day, the patient had syncope which lasted longer than usual. The patient also had vomiting and was treated with crackers and water. These events occurred during office visits and the patient sought for medical attention. The syncope and vomiting were resolved on the same day.   The reporter did not provide causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review, the event syncope was considered as medically significant.
NauseaVomitting chills, fatigue, foggy, swelling and welt to left arm at injection site  Narrative:
7 hours, post vax, the pt's left upper arm had large edema, redness and warmth lasting during the night. In the AM, she still had edema, redness and warmth continuing through 2 days. Temperature was 98.2F.
24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours.; 24 hours post injection chills, low grade temp 100.5, generalized achiness lasting 8-10 hours; Injection site red, swollen and warm to touch extending 4"x2"; Injection site red, swollen and warm to touch extending 4"x2; Injection site red, swollen and warm to touch extending 4"x2; This is a spontaneous report from a contactable nurse reporting for herself. A 52-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL0142, via intramuscular route in left arm on 19Jan2021 at 11:45 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Vaccination history included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EJ1685, via intramuscular route in left arm on 29Dec2020 at 12:00 PM, administered in Hospital. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID-19 post vaccination. Unspecified concomitant medications were administered. On 20Jan2021 at 03:00 the patient experienced injection site red, swollen and warm to touch extending 4"x2". Twenty-four hours after vaccination the patient experienced chills, low grade temperature at 100.5 and generalized achiness lasting 8-10 hours. No treatment was administered for the reported events. The event "Generalized achiness" resolved on 19Jan2021, whereas the other reported events were resolving at the time of the report.
nausea; This is a spontaneous report from a non-contactable consumer An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced nausea. The patient recovered from the event on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an 8 yr old male who on 04Nov99 was vaccinated with a dose of varicella virus vaccine live (lot631476/1004J). There was no concomitant therapy. The physician reported that on 02Nov05, the pt developed a case of breakthrough varicella. On 04Nov05, the pt presented to the physician's office with about 20-25 lesions. At that time, the pt was noted to be afebrile. No treatment or lab/diagnostic tests were required. At the time of this report, the pt was recovering from the breakthrough varicella. Additional information has been requested.
At noon on 08/31/2021 patient felt like there was something in his eye and then progressed to drooping. Then started to affect his mouth and side of face. Went to the ER the next day and it was determined that he had Bell's Palsy. The only thing different in his life was that he had gotten his second dose of the Shingrix.
exhaustion; arm pain; over all not feeling well; feverish; flush; chills; got cold; extreme fatigue; arm felt hot, burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish) and FLUSHING (flush) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site). At the time of the report, FATIGUE (exhaustion), PAIN IN EXTREMITY (arm pain), MALAISE (over all not feeling well), PYREXIA (feverish), FLUSHING (flush), CHILLS (chills), BODY TEMPERATURE DECREASED (got cold), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm felt hot, burning at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient reported the next day he had numbness in his arms like he had been laying on them. The initial site does not hurt when hurts when patient makes a fist.  Patient advised to take rotate tylenol and ibuprofen, warm/cold compresses and to f/u in clinic if symptoms do not improve or worsen  Patient communicated this information through patient portal
This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown) on unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
products were not good and needed to be returned with no reported adverse event; poor quality vaccine administered/excursion vaccine was administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious events of  "products were not good and needed to be returned with no reported adverse event (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the event products.  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.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: paint in the armpit of same arm that was injected-Medium, Systemic: Headache-Medium
Fever of 103.8 lasting for 3 days. Moderate-severe rash covering front & back of torso, face & neck beginning 10/22/2011-present. Decreased appetite 10/21/2011-present. Gave Tylenol & ibuprofen to lower fever.
Headache, fever, nausea, light headed, fatigue, back pain, restlessness, difficulty sleeping
felling dizziness; nausea; not feeling strong; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization and lubiprostone (AMITIZA) , via an unspecified route of administration from Dec2020 to an unspecified date at 1 DF, 2x/day as laxative..Medical history included:TIA started in Dec2020, bowel problem, fell (she fell about 3 weeks before she got the Pfizer COVID-19 shot) and some memory loss ( not serious).She wanted to know if she should receive her second dose of the COVID-19 vaccine if she was presenting the following side effects: felling dizziness, nausea and not feeling strong. She was currently taking Amitiza as a laxative. She believed these side effects were not related to the administration of the first dose of the vaccine and were rather common conditions for her age , she also stated that she did not have any "negative feelings" with the first shot of the vaccine.   Consumer said she had an appointment today for her second shot of the Pfizer COVID-19 vaccine and got a letter yesterday that said she could get it at 03:00PM today at the center where she got the first vaccination. She said that they gave the shot in her left arm for her first vaccination. She said it was very common at this age that she very often didn't feel well, and she was on a new laxative that might be causing some upset. She said she had no fever, she was not nauseated, she had no headache, there was nothing wrong. However the outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness, nausea and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Further details about the patient's medical history, concomitant conditions and the events would be helpful. The contributory role of the concomitant laxative also cannot be excluded. This case will be reassessed once 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 identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This is a literature report. An adolescent female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHABDOMYOLYSIS (medically significant), outcome "unknown", described as "Recurrent, non-traumatic, non-exertional rhabdomyolysis"; MYALGIA (non-serious), outcome "unknown"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "dysferlinopathies". Sender's Comments: As there is limited information in the case provided, the causal association between the events RHABDOMYOLYSIS and the vaccine (BNT162B2) cannot be excluded. "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 identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate".
Starting 11/22/2021, I was having sinus/cold symptoms. So, a week later it was still present but coming and going. I went to Urgent Care 11/30/2021 for a PCR test and 2 days later on 12/02/2021 I got the results back that I was positive. Then, 12/5/2021 I was having chest pains and pressure over a day and I got nervous. I went to the ER and got an EKG, CT scan, X-Ray and bloodwork. Chest X-ray was fine but did find that the left side of my thyroid was slightly larger than the right. So, I was informed to get that looked at as soon as I was better. A few weeks later, I went to an ENT for the thyroid issue. They ordered and ultrasound and bloodwork to be done. Then the ultrasound came back suspicious for a nodule and they ordered a biopsy to be done of it. So, a couple of weeks later I had the biopsy done and the results showed it was pre-cancerous and that, based on a genetic mutation, it was around a 70% chance it was cancerous. So they recommended the left side of the thyroid to be removed. So, I was referred for surgery and it was done last week (04/14/2022).
elevated temp @ 8PM; 130M pt awoke w/temp of 104, raised welts & blisters over back & rt arm; seen by PP who felt it was a allergic react to vax prescribed DPH; rash went away but 4PM rash on face again;
The day I got it I had wired feeling. Then I went home took Tylenol and went to sleep. Around 5 am I wake  up itching and left side of my eyelids swollen. Them hives all over my body. Later afternoon I start having swollen on my left hand. Around night time Tingling in the mouth, dizziness, lightheaded ness, chest tightness, swollen lips,  went to emergency room at HOSPITAL . That gave me  IV medications. Methylprednisolone, diphenhydramine, famotidine and 1 bag is NS.  The swelling went down about after one hour. Itching went away after a few min.  Got discharge home with prednisone, famotidine, diphenhydramine for 4 days. I still have dizziness and  weakness
This spontaneous report was received from a 65 years old male patient, who was reporting on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX 1 shot/one time (lot # and route of administration were not provided). On 10-NOV-2015, within 24 hours of vaccination, the patient experienced terrible rash of shingles. The event was treated with unspecified antiviral medication on the same day. The outcome of the event was reported as not recovered. The patient sought unspecified medical attention. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Presented to ED w/SOB; admitted for COVID-19 infection and acute resp failure; tx w/O2 therapy, abx, remdesivir, steroids, zinc; weaned to RA; dc'd home
- I had a severe headache within 4 hours of receiving the vaccine. Behind my eyes.
No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to CDC's recommendation of revaccinating this individual.
Headache; sore arm; felt fatigued; mental cloudy; body aches 3 on 10 scale/extreme body ache 8 on 10 scale; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0171), via an unspecified route of administration on 23Apr2021 09:00 as dose number unknown, single for covid-19 immunisation. Medical history included Migraine periodically, not chronic. The patient had no known allergies.  The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (lot number: Er8737) as dose 1 on 02Apr2021 for Covid-19 immunization (at the age of 62-years-old). On 23Apr2021 at 12:00, the patient experienced headache, sore arm, felt fatigued, mental cloudy, body aches 3 on 10 scale/extreme body ache 8 on 10 scale. The patient underwent lab tests and procedures which included investigation: 3 on 10 scale, and 8 on 10 scale. Therapeutic measures were taken as a result of the events. Treatment drug included ibuprofen self-treated. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Approx 4 hrs post jab, the patient had Headache sore arm. As day continued felt fatigued, mental cloudy, body aches 3 on 10 scale, ibuprophen helped some but still felt off. In morning extreme body ache 8 on 10 scale, headache, fatigue. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Admit for COVID. Fully vaccinated 3/2021. Steroids, O2, remdesivir, merrem, zithromax, rocephin, singulair, Vit-D. Discharged home on baseline O2.  Patient was admitted to the medical floor and ID consult requested from Dr. He was continued on IV decadran and IV remdesivir. His symptoms rapidly improved and oxygen requirements also improved to 2 L nasal canula. Blood sugars uncontrolled, patient requested discharge .He was discharged with po decadron.
Pain in injection site and arm, swelling / redness, pain in left leg (hip and knee), acute high fever (104+, lasting about 10 hours)
My right ear started to feel strage a couple of weeks after and it persisted. I went and got my ears cleaned but they couldnt find anything wrong , just felt funny like something wasnt right. on Nov. 18 it felt worse, there was numbness arout the inner part of my ear and ringing. Then on Nov, 19 half of my face was paralyzed. I went to the ER and was diagnosed with Bells Palsy.
Left arm swelled up two to three times the size from shoulder all the way down to wrist. Arm was a light red color. Injection site was a large bump size of half golf ball, very red and warm to touch. I became very pale in complexion and very lightheaded and dizzy. This continued for 4 days.
About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting ready for bed. This happened while standing up. The shaking was so bad that I could not use my phone to search the side effects. The shaking started to subside after I laid down. Other symptoms after this event: unable to fall asleep for about 4 hours; feeling warm at times, with some minor chills; thirsty during this 4 hour period.
Pounding heart pain and dizziness. Lasted about 10 seconds, but happened on multiple occasions, sometimes multiple times a day.
Sever chills, fever, feeling of being cold, headache, exhaustion and terrible body aches