chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 07-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Patient received Influenza shot. Fifteen minutes later patient became nauseated. Patient remained seated, blood pressure was taken (117/90). After 10 more minutes patient went back to work. No temp or fever. Called pt am 9/24/09- she said ok and went back to work yesterday 9/23.09. P.S. Talked with patient next a.m. (9/24/09). Patient ok and stated she returned to work evening after shot. Patient appreciated call.
2:53 P.M. 18 y.o w/m administered a Tdap IM:(lt)Deltoid (Boostrix)Glaxo-Smith-Kline:lot Number AC52B039BA Immediately after injection pt. became dizzy, diaphoretic,(sweating profusely)and breathing slow and shallow as to be holding his breath. 2:54: RN BSN summoned RN MSN Nurse Manager to come to clinic room next door. Upon arrival pt. was sweating profusely head to toe: (soaking wet.) Pt. visually assessed.2:55 p.m. B/P 92/42 left arm pulse 44- reg. resp: 16. Pt. still sitting in chair. 911 EMS called.  3:00 P.M Pt. placed in trendelenburg position on the floor, B/p 112/70, pulse 45- reg. resp. 24.
Feel weak/was worse; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak/was worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feel weak/was worse). At the time of the report, ASTHENIA (Feel weak/was worse) had resolved. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2022-441836, MOD-2022-441961 (Patient Link).
Member was given Polio and MMR vaccinations in each arm. Member states he started feeling pain in L arm when he woke up this morning after receiving vaccines. No bruising, No swelling in local area, No fever, No n/v/d. Tender to touch. Member states he did have a few alcoholic beverages
Patient reports morning following injection a quarter size reaction manifested below injection site. Reaction site described as hot to touch and painful, with no change in mobility or arm function. Patient indicated following day reaction site was raised, patient was seen by urgent care facility and prescribed an antibiotic for possible cellulitis. Patient reports improvement in redness and pain.
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection.  All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
Approximately 12 hours after the vaccine was given I developed severe itching & hives on my arms, legs & torso. This lasted for 4 days.
I have been experiencing body ache throughout my whole body, pain if stay in one position to long on right hip or lower; headaches; I experienced dizziness, felt giddy/light headed; Then at night my whole body felt sore, ached on lower back and right side of my hip; Then at night my whole body felt sore, ached on lower back and right side of my hip; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm) on 29Dec2020 at 07:30 AM, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. Patient did not receive other vaccine four weeks prior COVID vaccination. The patient did not have COVID prior vaccination. The vaccine was administered in the hospital. Same day of shot, the patient experienced dizziness, felt giddy, then at night her whole body felt sore, ached on lower back and right side of her hip. In the morning of 30Dec2020, patient experienced body ache throughout my whole body, pain if stay in one position to long on right hip or lower back and legs, light headed and headaches. The patient did not receive treatment for the events. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number has been requested.
2 weeks after 1st dose, aches; dizziness; weakness; lethargy; tinnitus on overtime.
Within 10 minutes of vaccination I started to feel very dizzy, then collapsed in the doctor's office and needed to be revived. I was sick for several months following vaccination with chronic fatigue, bouts of diarhhea, constant joint and muscle pain. I also lost a considerable amount of body weight within 1 month of vaccination, for no explainable reason.
Pt. received his flu vaccine on 3/14/19. On 3/15/19 pt. noticed swelling, redness and heat bellow injection site. Treated site with ice to reduce swelling. Pt. mother brought pt. in on 3/18/19, no irritation at injection site. Mild swelling, redness below site. Per NP continue to monitor site and use ice to reduce swelling.
MILDLY SICKNESS; This spontaneous report received from a consumer via a company representative concerned multiple patients of unspecified age and sex. The patient's height, and weight were not reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced mildly sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sickness. This report was non-serious.
Tired; Could not keep my eyes open; Rash; Allergy; This is a spontaneous report from a contactable consumer (Patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was tired, could not keep my eyes open, rash and allergy. It was reported that, patient had a reaction to the Covid Vaccination. Patient had the vaccination, Wednesday the 3rd (unspecified) at 1:30. And patient was fine, just very tired. About 8 O'clock, patient could not keep eyes open. So, patient said now was just going to go to bed. Patient went to bed, slept till at around a little, past 10 O'clock, and woke up and patient was covered with a rash and so had allergies to dust and stuff like that. So, patient took an allergy pill that has the Benadryl (treatment) in it and went back to bed and then in the morning 3 quarters of the rash was gone, just had a little bit, a few on patient's face and little bit on neck. Patient inquired and was concerning about second vaccination coming up the 24th, is it okay to have the vaccination. Therapeutic measures were taken as a result of allergy. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Dizziness, vertigo, nausea- onset 30 minutes after recdiving shot, on day 5 and still feeling it  Chills, sweats, aches- days 2-3
face iitchy; Rash in his face and whole body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in his face and whole body) and PRURITUS (face iitchy ) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient had no known allergies before.     On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Rash in his face and whole body) and PRURITUS (face iitchy ). At the time of the report, RASH (Rash in his face and whole body) and PRURITUS (face iitchy ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
79 year old male here for evaluation of possible allergic reaction to Moderna COVID-19 vaccine. 1.Allergic reaction, Urticaria  Pt received hist first dose of the Moderna vaccine on Tuesday, March 9th at 11am in his left arm. On Wednesday he began experiencing chills, felt cold and developed a fever of 101.9. Today his symptoms from yesterday resolved however he developed a pruritic urticarial rash on his upper thighs bilaterally, upper arms bilaterally, lower back and abdomen. He took one tablet of Benadryl this morning which did not improve his symptoms. He is not experiencing any shortness of breath, cough, sore throat, difficulty swallowing or wheezing. He has not tried applying any topical creams or ointments. No new medications, laundry detergents, body wash, perfumes or bedding. No history of allergies to food, environment or medications. He has a history of COVID-19 and was hospitalized 2nd to COVID-19 pneumonia for 25 days in 12/2020.  - Take OTC Claritin during the day and OTC Benadryl at night for one week  - Take 20 mg Pepcid once daily  - Start medrol pack  - Increase fluid intake  - Apply moderate strength triamcinolone ointment to rash  - Labs drawn today will call with results  - Will report allergic reaction to public health department - VAERS - Reviewed previous labs, HGB low  - ER/red flag precautions given.   Followed up with patient today 3/12/2020 over the phone: Called pt to follow up. He reports the rash worsening this morning and spreading behind his knees, behind his thighs and behind his calves mostly on his left leg. He applied the steroid cream this morning and he reports the rash greatly improved afterward reducing to about 10-15% remaining. States his rash is almost gone. Patient has been taking all of his medications as prescribed: Medrol dose pack, steroid cream, Claritin, Benadryl, Pepcid. Advised pt to continue to finish full course of medications as prescribed. PT denies any wheezing, cough, SOB. Advised pt that if symptoms worsen or do not improve over the weekend to go to urgent care or ER if life threatening. Red flag signs and symptoms provided. Pt verbalized understanding.
TDAP was given instead of Kinrix.  There was no adverse effect. and pt was able to get Kinrix same day while still in clinic
Received pneumonia shot as usual - 1st time it really stung for days and big golf ball size knot on arm.
Drain; Nausea; She received the first two doses two weeks apart in March 2021.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Drain), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FATIGUE (Drain), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received the first two doses two weeks apart in March 2021.) had resolved. At the time of the report, FATIGUE (Drain) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-396661 (Patient Link).
grand mal seizure/he was having a seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/he was having a seizure) outcome was unknown.            Patient doesn't have family history of seizures.  No concomitant medications were reported.   It was reported that patient was fine after the first two doses, but he had a grand mal seizure after the booster and never had seizures before. Patient went to work at the office, and the next thing he know, was he was having a seizure. The emergency personnel came to check on the patient and patient said that he doesn't know if the Moderna booster was the one that caused it.  No treatment details were reported.  Company comment: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Generalised tonic-clonic seizure that occurred in the context to third dose of mRNA-1273.222vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional details of Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to US-MODERNATX, INC.-MOD-2022-645580 (Linked Report).; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Generalised tonic-clonic seizure that occurred in the context to third dose of mRNA-1273.222vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional details of Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-645580:case
9:30 AM vaccines administered, 9:40 Hives developed at Varicella vaccine site, 9:45-,Dr administered Benadryl
Muscle stiffness, pain, slight swelling. Reported having difficulty moving the arm.  Patient called on 10/25/2013 to report the incident and said the condition had gotten better and could bend at the elbow, but still had trouble lifting the arm from the shoulder.
2nd booster administered at 1pm on 4/16/22.  At 3am on 4/17, experienced dizziness upon getting out of bed to go to the bathroom.  By 7am on Sunday morning, 4/17, patient was debilitated by the injection.  for 36 hours, he was dizzy, had severe vertigo, could not lift his head off the pillow.   Could  not eat or get out of bed all day Sunday, and slept most of the day.  Monday, 4/18,  very dizzy and weak. most of the day. Mostly slept.  Tuesday, feeling better; expected to leave for a 6 hour drive @ 10am Tuesday.  Exercised in the early morning, on the recumbant bike, and after 20 minutes, could do no more.  Most of Tuesday, feeling dizzy.  Did not sleep at all Tuesday night but felt better Wednesday, 4/20, and drove 6 hours.    For 5 days, mostly stayed in hotel because he felt dizzy and "off".  Today, 4/27,  11 days after getting the booster, he is still dizzy and tired, and unsteady on his feet walking.  Depressed appetite.  Very disconcerting.   This does not seem to be getting better.
No advese event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No advese event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 05-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (No advese event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No advese event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No advese event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
She had a red knot with a bumpy rash and it was painful at the site where she received Varivax in her right arm on 6/5/07.
Within two minutes of administering the last of four vaccines (in order: PROQUAD, VAQTA, IPOL, and DAPTACEL), and shortly after leaving the exam room, the patient returned with her mother with a complaint of "feeling like vomiting". The patient then regurgitated approximately two tablespoonfuls of orange colored vomit. Once the vomiting ended, the patient was placed upright into a chair and assessed for any hives, itching, breathing difficulty / shortness of breath, cyanosis, or lightheadedness. Patient was given a box of apple juice to drink, which she began drinking without difficulty. She then began to talk with her mom. Her speech consisted of full, age-appropriate words with no slurring or stuttering of speech. Pulse was assessed at 109 BPM and breathing sounds were clear throughout and regular bilaterally. Patient was monitored for an additional 20 minutes with no further vomiting episodes or complaints.
Shoulder swelling with vesicular itchy red rash surrounding site.  Site hot to touch.  Advised to ice for swelling, Benadryl for itching, Motrin or Tylenol for pain.
On 09/15/2000 at 4:45 PM, the patient developed a local rash at the injection site. It was reported to be 3 little bumps at the site of injection and was reported to be itchy. Subsequently, the patient recovered. On 11/03/2000 the patient was vaccinated SC in the left arm at 8:40 am with the second dose of varicella virus vaccine live and it was reported that the patient experienced an injection site reaction. On 11/05/2000 the patient experienced redness and swelling with a hard lump at the site. It was reported that the redness and edema radiates down the arm. The patient sought unspecified medical attention. On follow up it was reported that the patient was treated with Valtrex. Subsequently, the patient recovered 11/04/2000. No further information is expected.
tested positive for Covid; tested positive for Covid; light congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (005570). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Lot number: BNT162B2) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "tested positive for Covid"; NASAL CONGESTION (non-serious), outcome "unknown", described as "light congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for Covid illness between doses; negative, notes: had a negative covid test.  Additional Information: Caller was consumer who called on behalf of her son (11 y/o male) who received the pediatric formulation of the Pfizer-Biontech Covid19 vaccine, then tested positive for Covid illness between doses.  She stated he has since quarantined for 10 days, had a negative covid test, and only light congestion as a symptom, and has returned to school.  Caller would like to know when she can take him for a second dose.She was getting conflicting recommendations from her pediatrician who was telling her to rely on natural immunity and wait 2 months before receiving another dose, and her pharmacist stated to get the dose now. As the company who makes the product what were our recommendations.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.