chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. On 01-AUG-2017, the patient was inadvertently administered an expired dose of dose of VARIVAX injection (lot # L028278 with expiration date at 28-JUL-2017, for prophylaxis; exact dose, route of administration and anatomical location were not reported) reconstituted with sterile diluent (lot # reported as N014021 with expiration date at 04-AUG-2019; strength and dose were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
it was rpt from MD concerning pt who 2 months p/vax devel diarrhea;
BODY PAIN/BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body pain/body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body pain/body aches was not reported. This report was non-serious.
I had serve headache, running nose, wet cough, and fatigue. These lasted for about 4 days. I tested positive for Covid-19 on Dec 27th.
pt started screaming, would not stop leg began swelling from below knee to groin about 2x nl size; no temp;
Severe uncontrollable chills and shivering; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 03Apr2021 at 16:45 (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient was allergic to shellfish. Concomitant medications in two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN) and mirtazapine (REMERON) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 04:15, the patient experienced pain at injection site and 12 hours later, the patient experienced uncontrollable chills and shivering. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain at injection site, uncontrollable chills and shivering was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Covid; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Covid) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CORONAVIRUS INFECTION (Covid). At the time of the report, CORONAVIRUS INFECTION (Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 24-JUL-2021 included no new information.
pt recv vax 25JUN97 & 26jUN97 pt devel redness @ the inj site;29JUN97 pt devel diffuse swelling @ the inj site;
For my Dose 1 - I had some  tiredness and it only lasted couple days.  Dose 2 - A week of being achy, slight fever, tiredness, dizziness and I had a little bit of nausea - I was really bad the second day (the symptoms). The nausea and fever was gone in a couple of days. The achiness lasted about a week.  Tylenol - 600 mg (double strength) - I probably took two of those all together.
On 6/28/07, received report of infant death from Coroner's Office.  7/17/07 T/C to coroner to request prelim COD: stated as Undetermined.  Patient was sleeping in bassinet using pillows & blankets as mattress & was found face down.  8/24/07 Received vax record which confirms RO dose & lot # as reported.  11/6/07 Received death certificate & autopsy report which state COD as undetermined in setting of non-standard (home made mattress) bedding in which patient was placed face down.
The first time I was seen was on 11/23/2022. My symptoms were headaches, runny nose, chills, and that was it. I tested because I thought I just had a cold. When I tested, I tested positive for COVID-19 and I was shocked. I went to urgent care and they gave me PAXLOVID 300mg. By the next day, I didn't have the headache anymore but I was exhausted. I still had congestion. I stayed home for 5 days and after the 5th day, I could go out and wear a mask. After that, I started feeling like I had a cold again on 12/03/2022 and I tested again and tested positive. I went back to the urgent care, and the doctor said that it's uncommon but it can happen for a rebound case. He prescribed a Z-PAK and said it use it if I really needed to, but I ended up not using it. 8-9 days later, my eyes were blood shot and red, and I went back to urgent care again and they said it seemed as though the COVID-19 infection went to my eyes. They gave me eye drops and told me to quarantine for another 5 days and that seemed to be the last of the COVID-19 infection. On 12/06/2022 was when I went back to urgent care for my eyes. On 12/09/2022, I went to another care facility and they noted I also had a UTI and prescribed some medication. The medication they gave me was resistant to the UTI. So I went back on 12/13/2022 and they did some tests and gave me medication that actually worked. They noted that my immune system must have been ran down because they said I could have fought it off without medication, but my body couldn't do it at that time. I always wore a mask and I was fully vaccinated, so I was a bit shocked when I did get COVID-19.
Discussed with patient that he was getting Tdap vaccine, gave VIS. Patient stated he had no allergies and was not on any meds. 15-20 minutes later, patient came back and stated that mother told him he had allergic reaction to pertussis as a child. Notified physician in building and took vital signs. Dr advised patient to go to ER and notify them of event. Patient stated that he felt "alright" and did not need to go to ER.
Patient experienced a migraine (both sides of the head) headache, nausea, and chills about 3 hours after the shot.  She went to bed early with the headache and didn't start feeling better until 30 hours after the shot.
The pt received Varivax on 4/8/02. On 4/14/02, vesicular lesions appeared on trunk, face and scalp. She was dx'd with varicella zoster on 4/15/02 by MD. It was noted by the MD, at this visit, that the pt's father had an active course of shingles. Still with active disease.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient died under hospice care on 3/6/21. Cause of death unknown as care was not being provided by the facility. PMH not current in system.
Headache, light sensitivity, chills, feeling feverish, muscle cramps/aches, nausea
The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient was not tested positive or was not diagnosed with COVID-19.     On 16-May-2022 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-May-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  Administered vaccine after the BUD from 08-Mar-2022 to 2-Jun-2022.   Number of Vials where 6 vials, the vial was initially stored in refrigerator was 08-MAr- 2022. The vial did not undergo the temperature excursion. Patient had no reported symptoms. No treatment medications were provided.
The person developed extreme aches and pains; As well as a severe headache; This is a spontaneous report from a contactable consumer. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jun2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Jun2021, the patient developed extreme aches and pains as well as a severe headache and was unable to go to school for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events, the person developed extreme aches and pains as well as a severe headache and was unable to go to school for 2 days was resolved on an unknown date in Jun2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Vaccine administered 6/17. Arm turned pink immediately following, then cleared. Several hours later arm turned red and slightly swollen in a 3" diameter. Area is very itchy and burns. Patient had difficulty sleeping for 2 nights. Rash has still not cleared. Patient will now begin hydrocortisone cream.
Pt scheduled and appt for J&J  vaccine and it was administered by LPN  in his left arm. Pt waited in observation for 5 minutes and reported he felt dizzy. Pt loss consciousness while sitting in his chair. Nurse repeatedly  called patients name with no response . Charge Nurse was called for assistance . Charge Nurse administered a sternal rub and patient woke up . Pt was able to state his name , DOB and location . Pt reported that he lost his vision , with a headache and everything was black. Laid patient in first aid area on a cot and took patients vitals which were WNL. After lying down for 15 min patients vision returned.  Pt stated he walked 25 min in the sun to the vaccination clinic and only had 1 meal for the whole day. Pt was monitored for an additional  30 minutes ,  drank water and was provided some crackers. Pt refused EMS services and just wanted to lie down . medial director was notified immediately of the incident and felt comfortable releasing the patient to walk back home on his own .  Patients Vitals were rechecked and within normal limits . Pt left after 45 minutes
She felt extreme soreness after 1st dose; This is a spontaneous report from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she felt extreme soreness after 1st dose. She is taking antibiotics and is scheduled to get 2nd dose of covid vaccine today and on the antibiotic bottle it says not to get any vaccines while taking. Wanted to know if she should reschedule- provided number for as they are not open yet. Caller then mentioned that she didn't want to take any chances. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt devel dizziness, nausea & vomiting, flu-like sx & flushing p/recvd 1st dose of Engerix-B; addtl doses have not yet been administered;
She got her vaccine, very painful arm.  Last night she broke out with shingles on her back side, blisters, painful.  She has been having a lot of pain, muscle pain in her legs over the last couple of weeks that she did not have before.  It hurts to get up.  She has not gone to the doctor again.
Starting 4/28 with significant symptoms similar to those she had with COVID virus; significant brain fog which progress to dizziness, headache and nausea to the point she went to the ED, the only finding was elevated neutrophils and granulocytes. She was treated with palliative care; symptoms persisted w/o significant reduction until week of June 8, 2021 gradually subsiding yet still present with less severity.
Severe left shoulder joint pain which has lasted for over two weeks and is on going after receiving the Tetanus vaccine. I am unable to lift my left arm over my head and it is very painful at the shoulder joint when I move my left arm. I received the injection near my left shoulder.
No Adverse effect, vaccine was given post expiry date which is 9/30/22, but per communication from Pfizer, per stability data vaccine is stable until 10/19/2022
No adverse effect.  Pentacel vaccine was not reconstituted thus the patient ended up getting only the Dtap-IPV portion of the vaccine
Information has been received from a registered respiratory therapist concerning a 56 year old male with no drug reactions or allergies who in 2002 was vaccinated with a first dose of PNEUMOVAX (lot # not reported) with no problems.  On an unspecified date, (approximately August 2008) the patient was vaccinated with a second dose of PNEUMOVAX (lot # 658673/0990U).  No other vaccinations were given at the same visit.  24 hours after vaccination the patient developed an injection site reaction.  The patient developed a fever of 103 degrees F, injection site pain with significant injection site swelling and redness.  At the time of the report, the patient's injection site reaction, fever or 103 degrees F, injection pain, significant swelling and redness persisted.  At the time of the report the patient was to be seen in the physician's office and was to be treated with PREDNISONE.  Additional information has been requested.
The patient suffered a brief grand mal type seizure within 24 hours of administration of the immunization.
Woke up in morning with extreme fatigue, bad headache, and muscle soreness.  Symptoms lasted roughly 24 hours. Onset of symptoms were approximately 18 hrs after vaccination.  Did not visit a doctor.
Woke up around 2 AM on Saturday morning after the Friday morning shot --- fever/sweating, headache, felt like every bone and muscle in my body hurt. Felt like I had been hit by that truck everybody gets hit by. Fever broke some time during the night.  Pain subsided. Was able to eat breakfast about 9AM.  Very weak. Dozed on and off the rest of the morning.  Low grade fever most of the rest of the day. By Sunday morning felt pretty much normal, but still weak. By Monday morning pretty much back to normal.
Patient develops syncope with bilateral symmetrical pupil dilation.  Duration aprox. 1 minute with return to consciousness in supine position.  Patient states no memory of adverse event.  Patient AO for place, time, name, and reason for medical encounter, but not oriented for period during loss of consciousness.  Patient instructed to stay in supine during medical assessment and assessment of vitals signs.  Patient examined by medical provider without any significant or adverse findings.  Patient left the facility without assistance once post medical observation period ended for adverse event.  Patient instructed by provider to follow-up with PCM for further evaluation.
Patient developed a sore throat day after the vaccines.  Lasted few days & went away.  Then started low grade headaches & felt chilly.  No fever.  No swelling or redness of the injection site.
seizure; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of recovered. It was reported that when the patient got his first vaccine, he did not wait the 15 minutes after the vaccine, he just left without knowing he was supposed to do this. He got into his vehicle and then started having a seizure but commented that he was okay now. He wanted to know if it was common or if it was something he should be concerned about. He got it at (name withheld) and they didn't tell him he needed to wait. He added that everyone he has talked to said that he was supposed to wait. He just wanted to know he was not trying to make a big deal out of it or nothing. Should he be concerned about it or was it a quick weird reaction. Should he be concerned and talk to his doctor. He just wanted to check and see if this has been happening.  Follow up attempts are needed. Information on the lot/batch number has been requested.
Adverse event is that the vaccine was given to an Unauthorized age group today; age was 17 years old; observed at clinic for required 15 min. Parent was there with children and will be notified by staff of event; DOH notified; CDC and Jannsen contacted for further clinical guidance.
PFIZER COVID VACCINE #3 GIVEN 11/18/22, LOT #32030BD; 1/12/22 pt had a positive COVID test ordered. 1/16/22 pt had a second positive COVID test at Medical Center, dc'd from hospital to another Hospital on 1/19/22; COVID PNA for dyspnea; pt passed away in the hospice facility on 1/23/22
2 year old with warm, red and indurated area at site of injections (DTAP and Hep-A).
After the first administration of the Pfizer dose I have symptoms of sweating, dizziness, and nervousness.
lethargy & temp onset 4JUL94; rash occuring 5JUL94 w/temp aprpox 100; temp inc to 103 7JUL94;
Patient was given vaccine on 1/25/10 on 1/26/2010 he had no fever but had a rash on leg, joints ached and heels hurt and he was nauseated for 2 days then on 1/27/2010 all symptoms were gone.
Narrative: At 2nd dose Covid vaccine appointment pt reported having headaches on day 2 of the first vaccine, then a rash on day 5-7 that looked like chigger bites on legs. He was seen in the ER at the hospital for these side effects. He wants to continue to get his second shot despite these side effects from the first shot. Per hospital ER records on 2/25/2021 MD progress note: "The patient is a 73-year-old who started having an itchy red rash on the 12th, 6 days after he got his first Covid 19 shot. He was seen by dermatology and given a steroid shot but he has continued  to have severe itching. He has tried ointment that dermatology prescribed which she did not helped and cortisone cream as well as Benadryl cream neither of which have helped much either. In the meantime he got an infection in his left arm where he had a shave biopsy which is been treated with clindamycin." ER MD prescribed new RX for Clobetasol cream thin layer to affected area twice daily as needed. Rash resolved by 3/4/21 date of Covid vaccine dose #2.
anaphylaxis-pt was @ hosp later in afternoon & felt ill, nauseous, had rash & dyspnea;went to ER & was treated by their MD for 4hr w/complete recovery;
injection site and arm pain; tiredness; muscle pain; joint pain; feeling unwell; metallic taste in mouth
Acute hearing loss in right ear. Muffled, ringing sound one day after vaccine administered. Was sleeping and heard a high pitched sound from right ear. Waited several weeks for it to clear up. Finally went to my PCP and was started on steroids. That did not help. Saw an ENT specialist and restarted on another round of steroids.
He walked out to the waiting room to wait for his mother, and he vomited x 1 and became diaphoretic. He had a winter jacket on and a long sleeve knit top. The waiting room was very warm as was the room where he had his vaccines. I immediately sat him down, and helped him take his jacket off. He immediately began to feel better. I offered water which he drank and had him sit for about 15 minutes. At no time, did he lose consciousness or fall. 13:30 I called his mother to ask how he was doing and mother stated he was doing fine. He has had no emesis episodes, breathing okay and maybe a little rash on his neck, but barely can see it. I told her to call her primary physician or call 911 if there was a medical emergency.
Topical reaction from the first COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Topical reaction from the first COVID vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Topical reaction from the first COVID vaccine). At the time of the report, SKIN REACTION (Topical reaction from the first COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
1 1/2 wk /p immun pt developed T 105 & slight rash. Taken to ER 9Nov90 where lumbar puncture performed (nl). Mom called Hlth Ctr 20Nov90 to report this, pt recovered.