chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: EN6198) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: arthritis; "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Batch/lot number: EN6198, left arm), administration date: 01Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "Ringing in ears". The event "ringing in ears" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: No prior vaccinations. Everything good except the arthritis. Has high blood pressure, which he takes medicine for. No relevant family medical history. Patient has had 4 total doses Covid shots. Third shot (LOT: FF8839) on 29Oct2021 and fourth shot (Moderna) on 24May2022. Ringing in ears was reported as worsened. Started about 6 months after getting Covid shot. Reported this to his arthritis doctor. Heard Covid shot causes that ringing in ears. At time of report, was still ringing, has gotten louder. Bought over the counter stuff, that ain't helping him. Told rheumatologist about it, was asking him about it, the ringing in the ears. Doctor told him, at his age, would probably get it. Then, caller heard the vaccine was causing it. Figured, while he was on the phone with Pfizer, would talk about it. Patient just talked to his rheumatologist about it, probably a year ago. It has gotten worse, since it started. For the treatment, other than the over counter stuff, has had no other treatments.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300169105 same reporter/patient, similar event, different dose;
Eczema; contact dermatitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol; "hearing loss" (unspecified if ongoing), notes: Other medical history: hearing loss; "eczema" (unspecified if ongoing), notes: Other medical history: eczema. Concomitant medication(s) included: CRESTOR; OMEGA 3 [FISH OIL]; VITAMIN D [COLECALCIFEROL]; TRANEXAMIC ACID. The following information was reported: ECZEMA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Eczema"; DERMATITIS CONTACT (non-serious) with onset 09Mar2021, outcome "not recovered", described as "contact dermatitis". The events "eczema" and "contact dermatitis" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, dermatitis contact.   Additional information: Eczema and contact dermatitis that was under control flared up approx 2-3 days after 1st shot. Got it cleared up and flared up again after 2nd shot. Still cant get it under control since then. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event with Creams to treat skin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies: Methyldibromo Glutaronitrile.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt dizziness and giddiness. Onsite EMS was called vitals BP 90/50  100%O2 HR 65. Patient treated, released against medical advise.
Signs/Symptoms: sweaty, clammy, nauseas, tunnel vision. Patient was in classroom when she felt the symptoms. She went out to the hallway and blacked out. Ice was applied to her head. She was given Benadryl and Tylenol. Patient felt pain at injection site. She sat out in the hallway for 20-30 min, felt better, and went back inside the classroom. Patient felt symptoms again, went back out to hallway to rest, and then went back inside. Patient still felt sick on Thursday (day after vaccination) when she woke up and her arm was still hurting. Patient went to see a doctor on Thursday and was told that she was likely experiencing nerve pain due to vaccine possibly given at a higher injection site near the shoulder.
Staff called medical for a pt. Upon arrival PT unconscious GCS-3 w/ snoring respirations.  More resources were called for.  Airway was maintained. Pt regained consciousness and brought to medical for further evaluation.  PT shocky w/ low B/P.  911 was called .  PT was conscious but not alert.  PT started vomitting.  PT lose consciousness briefly.  Ambulance arrived & care transferred.  Time from 20 min from shot to ambulance.
hospitalization (non-ICU) Only one dose documented.   Lot number/site not documented.
Mother states child started having swollen, tender, sherry right arm.  Shot site problem 08/28/2002 am-Stated history similiar problem. 03/15/99-after receiving DTAP at Doctors office.  After next and compression-resolved.
COVID positive after testing after second dose; COVID positive after testing after second dose; This is a spontaneous report from Pfizer, received from a contactable consumer (patient). A female patient of an unspecified age received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified dates (Batch/Lot number was not reported) as single doses for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After the second dose, patient was COVID positive after testing after second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Vaccination failure; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), on 09Feb2021 as dose 2, single (Lot number: EM9809) and on 21Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Vaccination failure "; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: diagnosed with Covid; (unspecified date) Positive, notes: I had Covid rebound and tested positive 9 day after being diagnosed with Covid; (22Jul2022) Negative, notes: I tested negative 6 days after starting paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had no taken other medications in 2 weeks and known allergies was no.  No follow-up attempts are possible. No further information is expected.
staff member reported to night supervisor that she had experienced delusions and delirium after first dose, lasting approximately 6 hours then slept it off. Stated that the next day she felt like she had been "hit by a train," exhausted, and body aches.
Patient came to get her seasonal flu shot. Patient states she has no NKA and is the first time to get the Flu shot. Patient received the vaccine approx. 8:55 a.m. Patient states she started experiencing tingling in the throat and at the injection site approximately 15 minutes later (9:10 a.m).  after administration of vaccine. I contacted Medical Director for recommendations. Dr. recommends patient get 25 mg of Bendadryl. Patient received 25 mg(10 mls) liquid Benadryl with no complications noted. Vital Signs stable at B/P 102/70, pulse 77, SpO2 100%, Lungs clear to auscultation to all lobes. Re-checked symptoms 15 mins later (9:25 a.m.) patient states she still feels some swelling to back of neck. Dr. recommends to administer another 25mg (10mls) of Bendadryl. Patient took medication with no complications. At 9:45 a.m. patient states she feels better, but drowsy. Her husband was called to drive her to clinic to get checked by Dr. I instructed patient to go get checked  at the clinic. Patient verbalized understanding. Dr. aware patient was on her way. I placed a follow up call at 11:21 a.m. to see how patient was doing. She states she did not go the clinic to get checked and went home to rest. She states she is feeling better. She states she does not have no respiratory distress, no swelling, no wheezing  and no other s/s. Patient was instructed again to go to the ER if symptoms worsen. She verbalized understanding. Dr. was notified and aware of patient conversation.
Headache, Myalgia & Arthralgia Narrative:  Other Relevant History:
Joint pain and sensation of febrile.  I was an avid runner prior and now cannot due to bilateral ankle pain for past 3 months.  I am currently undergoing physical therapy and work up for possible autoimmune condition.
Received vaccine on 1/25/2021. Awoke on 1/27/2021 nauseated and took 1/2 promethazine 25mg tab, at 1630 that afternoon symptoms included vomiting, headache, aching and fever. These symptoms continued for 3 days. On third day patient started having diarrhea and feeling very  "jittery". Took Excedrin for aches and headache. Pt did not seek medical treatment.
swelling in lips; This is a spontaneous report from a contactable Other-HCP (Nurse).   A 12-years-old male patient received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EL0176) via an unspecified route of administration, administered in Arm Right on 21May2021 12:40 (Age at Vaccination 12-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing asthma the patient was very early on diagnosed with asthma when he was 1-2 years old. Concomitant medications were not reported.  The patient experienced swelling in lips on 22May2021 with outcome of not recovered.  Therapeutic measures were taken as a result of swelling in lips. It was reported that Per Caller, My son, age 12 developed swelling in lips after the first dose of the Pfizer covid vaccine. Patient was administered Benadryl and Zyrtec for swollen lips following the Pfizer Covid-19 vaccine.  Caller reported that the Benadryl and Zyrtec were ineffective for the patients lip swelling. Caller reported that the patient's second dose of the Covid-19 vaccine was scheduled for 11Jun2021.The outcome of the event was not recovered.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected
Headache; Chills; Nauseous; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 10Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, nauseous, and was not feeling well on 14Jan2021. The patient stated "I am curious I just had the vaccine on Sunday. It's Pfizer obviously and today I have been experiencing this side effects. Now, I had headache, chills, no fever, nauseous and just not feeling well. I missed like, I missed a week of work. Do you think I should be tested for Covid itself or it's just an allergic reaction and not worry about it?" The patient was informed about Pfizer Department. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Approximately 24 hours after vaccine On 11/-7/21, onset of debilitating headaches, extreme fatigue, dry non productive cough, sore throat, blood shot eyes, chest pain, lightheadedness, sensation of ?head feeling like it?s on fire?, mild confusion and decreased processing time, nausea, diarrhea, lethargy, back and neck pain , nasal confection? Irritability, Mottling and  swelling in bilateral lower extremities, decreased appetite sensitivity to light and noise, decreased balance.  Symptoms have progressively gotten worse.  Daily headaches have become debilitation, sleeping excessive amounts of time and very limited tolerance to activity.  Patient has been  home from school and had abstained from sports since 11/18/21.  14 day course prophylactic Amoxicillin started 11/30/21.  Referral to neurologist pending for imaging.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week 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 SHINRIX. Additional details were provided as follows: The patient received their 1st dose of SHINGRIX last Friday. The patient experienced symptoms of chills and shivers since the administration of the vaccine. The patient called because they are concerned about how long was expected that symptoms would be remain and what was the recommendation on receiving the 2nd dose in series. Remote disconnected from the patient during warm transfer, however the GSK360 request had been opened and placed in the patient call back folder for follow-up. The patient did not want to provide the health care professional name for follow up but could send her the letter. No further information was reported regarding the event.
No additional AE reported; the patient was administered PROQUAD and VARIVAX on the same day; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On 08-FEB-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection (0.5 ml, lot#: W024970, expiration date: 05-FEB-2024) subcutaneously for prophylaxis and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (0.5ml, lot#: W011625, expiration date: 06-APR-2024) subcutaneously for prophylaxis (overdose). No additional adverse events (AE) were reported (no adverse event).
Sharp shoulder pain for over a month after vaccine. Bumps behind ear and red spots on stomach area.
Feeling dizzy, drowsy and nauseous 3 days after the 1st shot
Pt called and reported experiencing ADR to the vaccine he received on 5/4/12. Pt reported redness all over his body, all body rash, itchy. Pt denied blisters fever, pain.
RASH ON THIGH AND UPPER CALF; DULL ACHING IN SAME LEG AS RASH; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left deltoid on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced rash on thigh and upper calf. On 14-MAR-2021, the subject experienced dull aching in same leg as rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on thigh and upper calf and dull aching in same leg as rash was not reported. This report was non-serious.
Child had a rash appear on right thigh on 3/23/2021 appearing as vesicular lesions. Child also had runny nose, congestion and fussiness at the onset of the rash. No fever. Rash spread to torso and left leg. Child revisited doctor's office that administered the vaccines on 3/31/2021 and received confirmation of adverse effect of vaccine. Rash continued to spread and child returned to doctor's office again on 4/15/2021. On 4/15/2021, rash was diagnosed as patchy maculopapular rash on arms, torso and legs. Vesicles had cleared and rash was now blanching.  Rash cleared up entirely on 4/23/2021.
Immediately p/immun of shot #2 pt became paper white, blue around mouth no sound or movement; resp even unlabor; eyes open staring; also noted small petechiae;
Fever started on 10/29/2012, peaked at 102.5 at 10:00PM.  Our son continued to have a low fever for two days, was very fussy and lost his appetite.  He continued to drink a lot of water.  He developed blisters on his fingers and toes over the next few days.  He developed a bad diaper rash.  By 11/2/2012, he had no fever and his appetite returned.  The blisters are now dried up.
Suspected pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Suspected pericarditis) 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 prophylaxis.     Previously administered products included for COVID-19 vaccination: BNT162B2 (previous 4 doses). Past adverse reactions to the above products included No adverse event with BNT162B2.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Suspected pericarditis) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Suspected pericarditis) had resolved.            Concomitant medication was not provided. After taking Aspirin, event pericarditis resolved within a couple of days.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the expected serious (medically significant) event of pericarditis. The event occurred on an unknown date after the fifth dose of Spikevax bivalent BA.4/BA.5. The patient received 4 doses of Pfizer vaccine previously. As reported, the patient had suspected pericarditis after fifth dose but after taking Aspirin, it resolved within a couple of days. No further information about the event was provided. The benefit-risk relationship of Spikevax bivalent BA.4/BA.5 is not affected by this report.
The first 48 hours I had a really bad headache, 7 days after I had increase symptoms and increased episodes of Supraventricular Tachycardia and chest pain. The following week was worse because the pain was up on my left arm and my neck, my heart rate was up 145bpm and yesterday I ended up going to the doctor to get tested and the results were positive for COVID.
The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (also reported as around 10 weeks ago) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID on an unspecified date (for clarification). The patient underwent Covid-19 test and became negative on an unspecified date (reported as 2 1/2 weeks ago). The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Weakness; Soreness in the arm at the injection site; Chills all night long; A little fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION SITE PAIN (Soreness in the arm at the injection site), CHILLS (Chills all night long) and PYREXIA (A little fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills all night long) and PYREXIA (A little fever). 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, CHILLS (Chills all night long) and PYREXIA (A little fever) had resolved. At the time of the report, ASTHENIA (Weakness) and VACCINATION SITE PAIN (Soreness in the arm at the injection site) outcome was unknown.
Had a TDaP vaccination. I went for my 6 month check-up at the Clinic on April 13th, 2017. The doctor's assistant ask me if I had ever received a Whooping Cough vaccination, I told her if I had I would have been so young that I couldn't remember! She told me Whooping Cough was going around and ask if I would like to have the vaccination? I thought about it and felt it might be better to be sure, so I received a Tdap Shot. My arm was sore after that, but I thought this was just normal. However, the pain kept getting worse and is almost unbearable at times. I called the Clinic about this, and a Nurse Practitioner had me come over to the clinic on May 9th, 2017. At that time they took an X-ray and told me to put ice pack and heat on my shoulder and gave me prescription for Diclofenac Gel, this did not help the pain. On May 16th, 2017 I went to our family doctor. She suggested heat pads and lined me up to start Re-hab. I am now doing Re-hab to see if that will help the pain, but as of today the pain is still as bad if not Worse!!!
After shot, I sat for 15 minutes, but when I got up to start walking around the store, I very suddenly got dizzy, light headed, weak, sweat was dripping off my face and neck even though it was normal temperature in the store on the frozen food aisle.  I had to immediately sit down, drink a bottle of water, and ate 2 oranges.  I was then able to walk to the car but was still very shaky.  I had eaten breakfast and snack and was well hydrated prior to the shot.  When I got home I barely got out of bed until Monday morning, and had a temperature of around 100.5 and body aches, even with Tylenol and ibuprofen.
Patient reported soreness and redness. She said that the soreness has improved some, but she is still experiencing some. She said the redness was larger than a quarter size. Patient was counseled to begin aspirin and benadryl regimen.