chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a 8cm round erythematous and raised mark at the site of the injection, which lasted two days and resolved completely.   It is now 8 days later, and she woke up today with a 6-7cm round erythematous, indurated mark at the same site, AS WELL AS an extreme fatigue so that she could not wake up this morning, and continued to fall asleep throughout the morning.  Since this afternoon she has been feeling herself.  The recurred erythematous mark at the injection site remains.
12/28/2021:   Event occurred after 2nd vaccine.  64-year-old gentleman presents the emergency department for evaluation of shortness of breath.  Patient denies any productive cough, fevers, chills, nausea vomiting. He did have some mild left-sided chest pain associated with this.  Symptoms resolved.  Patient also notes that he had cramping in his left calf today which is atypical for him.
Pt recvd vax approx 4PM & @ 6PM parent noted fussy, began trembling & turned blue; pt taken to hosp by ambulance; t101; dx otitis @ ER visit; parents report pt teething;
Itching all over; runny nose. Doctor gave me Prednisone 20mg.
pt had brief palpations 20 minutes after vaccine, pain in left arm spreading across the chest to right side 5 hrs later. Felt like someone had punched him repeatedly in the chest the next day and that night he was profoundly fatigued and couldn't take a deep breath, was winded with simple physical tasks ie walking across the room. The next day 1/24/21 the pain resolved but was easily winded. Improving since then
Pt. stated that she began to run fever and experienced chills all day on Friday 04/20/2018. She wore 2 shirts all day and went to an outing later that night and wrapped herself up in a jacket then in addition to the 2 shirts. She also stated that Friday she could not lift her arm. She stated she never looked at the injection area on her arm until Saturday and when she did, she had a bruise at the injection site and had a large 3 inch knot on her arm around the injection site. She tried to come to our pharmacy to get consultation but we were closed. She then went to another pharmacy to purchase Benadryl and she consulted the pharmacist there. They informed her that what she experienced is normal for that vaccination. Today when she reported it to us, the swelling had gone down significantly. She did say that she felt slightly short winded today, but may not have anything to do with the injection.
Severe nausea, vomiting, blood pressure changes, heart rate changes, dizziness, slurred speech. Sent to ER for monitoring and fluids.
Patient had a local reaction to his right arm (site where vaccine was administered) developed redness, rash and pain.
Information has been received from a health professional concerning a 32 year old female who on 03-FEB-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant medication was not reported. On an unspecified date within 24 hours after the vaccination, the patient experienced sweet taste on the surface of tongue which did not last very long. Subsequently, the patient recovered from sweet taste on the surface of tongue. Additional information is not expected.
LEFT TIBIAL PLATEAU FRACTURE WITH NO INCITING TRAUMA/EVENT.  HEMARTHROSIS
Per ED Note: Patient is a 56-year-old woman with past medical history significant for diabetes, hypertension, diagnosed with COVID-19 approximately 3 days ago that presents emergency department with worsening shortness of breath.  Patient denies any outright chest pain palpitations, unilateral weakness or sensory changes.  Patient states that she has had worsening shortness of breath since diagnosis.  Patient states everyone in her house has Covid.  Patient reports that she was immunized by the fibroids are vaccine completely in April.
After first pfizer booster shot, 13 days later my shoulder and knee joints swelled up and I had extreme pain to the point I could barely walk. Had MRI on shoulders and nothing showed up that would cause this kind of pain and swelling. I have been put on prednisone 3 or 4 times now. it is the only thing that helps. I am now on 5 mg prednisone once a day and hydroxychloroquine 200 MG tablet twice a day
Syncope and collapse episode on 4/22/22. I had Afib in a parking lot.  I was provided CPR and reported shock with AED.   Since episode, I have had no reoccurrant syncope.  I had a S-ICD implanted in October 2022 just as a precaution.  Unclear what happened on 4/22/22 (syncope verses cardiac arrest versus other).
On 6/17, pt developed redness and swelling of L thigh, worse on 6/18// approximately 20cm with central clearing.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna). At the time of the report, IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna) outcome was unknown.         No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
I had vaccination on 10/06/2022. On 10/07/2022 started coughing and I had a sore throat. I tested COVID-19 negative 10/08/2022 10/09/2022 and 10/10/2022. I tested positive 10/09/2022 from PCR test at doctors office. I took PAXLOVID for 5 days. I tested COVID negative every day until 10/22/2022 in which I started to test COVID-19 positive again. I am now in isolation again.
Full body rash, itching within 20 minutes of Fluarix flu prefilled vaccine. Airway patent. No known latex or egg allergy.
pt recvd vax OCT91 & w/in 24 hrs devel fever of 100.4, abdominal cramps, malaise & arm was tender; pt took APAP;
Hives, rash, breathing abnormality. Treated at home with 5mL of generic BENADRYL at 4:30pm. Treated at local urgent care facility at 5pm, held in observation until 8pm. Was given steroid and BENADRYL. Prescribed steroid for home administration and epinephrine pen for use at home as needed.
Hives on upper torso, legs and ankle.  Hives occurred after both shots.  Hives appeared 3 days after first dose and again 7 days after 2nd dose.   First dose given on 4/30/21 and 2nd dose given on 5/24/21.
itching red welts worse in mouning wake up  itch all mourning 04/18/2021-4/22/2021 itching skin
The first indication was I had a lot of itching in the middle of my back. A couple days later I noticed a rash under my left breast and then I noticed on my left breast. And I thought maybe it was heat rash but it never got any better. And I tried over the counter medication and it was not getting better. I then went to the doctor 06/01/2022 and she looked at it and told me it was Shingles. And I think it was a normal produce with Shingles they turned into to blisters and I did not get a lot of scabbing but it took 5 weeks for the rash to go away. It was painful but not a constant pain but a shooting pain. There were times it was extremely painful.
9cm, rough rash, warm to the touch. Patient reports throbbing ache. Used ice as treatment but rash has not resolved for the last 8 days. Recommended that patient see PCP.
Blurred vision, fainting episode, followed by severe sweating. I called my pcp who instructed I go to ER. This occurring 2/14/2021. This was the day after my second dose, in the morning. Upon arrival in ER my heart rate was elevated and blood pressure was high.  ER determined I maybe had a vasovagal syncope.
Covid-19; Covid-19; This is a solicited report received from a contactable consumer (patient herself) from the marketing program facilitated collect based on information received by Pfizer (Manufacturer Control Number#: 21K-163-4091835-00). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, also reported as: Tozinameran), dose 1 intramuscular on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and then dose 2 intramuscular on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot Number: 1141472) to an unspecified date, at unknown dose, (Citrate Free) for psoriatic arthritis. Relevant medical history includes ongoing psoriatic arthritis. The patient's concomitant medications were not reported. On 21Sep2021, the patient experienced COVID-19. It was also reported that in 2021, the patient experienced developed bizarre rash followed the second COVID vaccine/raised bumps. In 2021, the patient developed bizarre rash followed the second COVID vaccine/raised bumps resolved. The action taken for adalimumab was unknown. The outcome of the event was unknown.   Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), for COVID-19 it was not reported; while for Vaccination site rash and Vaccination site papule, it was possible. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of developed bizarre rash followed the second COVID vaccine/raised bumps onset in 2021, developed bizarre rash followed the second COVID vaccine/raised bumps onset in 2021 and COVID-19 was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Efficacy of the vaccine varies from patient to patient. However, a contributory role of the usage of the vaccine BNT162B2 to the reported events cannot be excluded.
patient received an expired dose of VAQTA; This spontaneous report was received from an office manager, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 12-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 ml (injection site, route of administration were not provided, lot # S009562 was confirmed to be valid, expiration date was reported as 26-JUL-2020, but upon internal validation, it was established as 05-MAY-2019) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After my fourth dose, on Saturday morning, I had a rash on the right side of my face, scalp, forehead and eye. I went to the doctor on that Sunday May15th. They put me on Valtrex and gabapentin. I saw a corneal specialist, he gave me a antiviral to go in my eye. I am continued on a dose of Valtrex twice a day. I still take gabapentin cause the pain is continuing now. I am being monitored now so the rash does not come back in my eye. I also have a very stiff neck. The rash is beginning to resolve but the pain is still there.
One week after second injection  started itching in upper torso.back of neck shoulders and both arms up to wrist. the itching is more violent at night scratching myself almost to bleeding. Tacking Tylenol almost nightly  and using ointment for calming effect.it is almost three weeks and no let up.
Red arm from shoulder to elbow and down the side of his left ribs. The redness lasted about 4 hours. Patient was given Benadryl 12.5 mg tablets every 4-6 hours. Patient was better the next day.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: immediately after receiving vaccine, pt passed out, turned red, then had a mild convulsion. the event lasted less than a minute. Pt reported having fear of shots and that this happens sometimes due to extreme anxiety after receiving any type of injection.
Patient received Menactra on 07/21/2006-were not aware. Patient had received same vaccine year before.  Patient received another Menactra on 07/24/2006 due to an office staff error.
irritable,cried constantly,devel low grade T,rash;lack of speech devel noticed 2 mo later,use of previous vocabulary discontinued;stitches&tooth extraction for lip injury but no rxn to pain but mild sz;staring;severe autism;MILD SZ
Patient is fully vaccinated for COVID-19. Patient was hospitalized due to COVID-19.  She stated she began to have what she believed to be a sinus headache on 7/24/2021. Over a few days it developed into bronchitis. Her doctor was out of town so she took over the counter meds. On 7/29/21 she went to Urgent Care and they did a COVID test which was positive. She was given some pills by the physician at Urgent Care which she was told is usually given to dogs. She was to take 5 pills one day and another 5 the next day. After the first dose of the medicine she developed severe diarrhea. By Sunday 8/1/21 she went to the  Hospital ER because of shortness of breath where she was kept in their ER until 8/3/21 when they found a room for her. She was admitted to a room and then discharged 8/4/21 to home. She stated she had been vaccinated in January with the Pfizer vaccine.
Initial unsolicited report received from a physician on 17 Nov 2016. This case involves a 32-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI673AA, expiry date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 06 Oct 2016. Illness at the time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions airborne allergies. Concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had asthma attack with worsening systems and was hospitalized. On an unknown date, following the vaccination the patient was positive for flu virus (detected in nasal swab test). The patient other laboratory data and corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none. Sender's Comments: This concerns a 32 year old female patient who experienced severe asthma attack with worsening symptoms and nasal swab for flu was done and it was positive for flu virus, one week after receiving a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. As with any other vaccine influenza vaccine may not protect 100% of individuals. However, more information regarding medical history of the patient, previous vaccination and infectious work-up results (details of specific influenza strain identified in PCR) are needed to further assess this case.
Tinnitus in both ears, muffled hearing in right ear,  clogging/congestion of the right ear
experiencing severe soreness and aching on the entire right side of her body; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 24Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient on an unspecified date in Jun2021, experienced severe soreness and aching on the entire right side of her body. The patient would like to know whether she could take ADVIL for pain. The clinical outcome for the event was unknown.  Information about Lot/Batch number requested.
4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
One day after Pfizer COVID bivalent booster, patient experienced a sudden, fatal cardiac arrest while exercising at the gym. Resuscitation efforts were unsuccessful. His 3 prior COVID vaccines were Moderna.
Within 24 hrs had raised, red 7cm area at injection site, itching - over next 24 hrs flattened, ~10cm macular erythema.  Resolved by 72 hrs.  Rx diphenhyd. 25mg po q 6 h, ice, TYLENOL.
This spontaneous report as received from an unspecified reporter, refers to a female patient in her 50's with no medical conditions or allergies. In approximately 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # J011714, expiration date: 20-FEB-2015). It was reported that the recommended dose was given to the patient. On an unknown date in approximately 2014 the patient experienced reactions on her left arm: redness, swelling, warm to touch. She caller her doctor on 15-OCT-2014 and the doctor prescribed her antibiotics (unspecified). The outcome of the events was reported as recovering/resolving (reported as "she is OK now".) Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Employee received his 2nd dose of COVID vaccine on 1/26/2021 and tested positive for COVID on 3/15/2021 without symptoms.
Pt developed a persistent temperature to 102F X 5 days. No treatment except ibuprofen and Tylenol.
As of the morning of the day after vaccine was administered pt was with some 2cm indurated areas with superficial erythema over both thighs (antero lateral areas where imm were place yesterday). No fever. Mother to massage areas with cool compresses and administer TYLENOL PRN for pain.
Becomes a little itchy, but not all the time, swollen, soreness, mild pain, redness, heat radiating off injection site with swelling...redness around 7 inches long.  Had a low grade fever for only a day on Sunday 2/21/21. Pain all started on 2/20/21, a week later after receiving the Moderna vaccination.  I have taken Ibuprofen and Benadryl and it has helped a little.  Seeing primary doctor today on 2/22/21 for him to look at my arm.
neuropathic pain; bilateral feet burning, burning in both calves and slight extent to both hands; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient [unknown age of vaccination] received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was experiencing neuropathic pain, bilateral feet burning, burning in both calves and slight extent to both hands on an unspecified date. She inquired if there were other reports like this. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Severe, uncontrollable open-wound eczema on the face and body that did not respond to pharmaceuticals. Months of prescription ointments, specialists, and poor quality of life for baby. Skin irritation began the morning after vaccine. He was only supposed to get the Dtap (which he had a moderate skin reaction to at 4 months, resolved after 2 months) his doctor called me after we got home and said the wrong vaccine was given: combo  Pediarix
Information has been received from a camp physician concerning a 10 years old patient who on 16-MAY-2002 was vaccinated with a dose of VARICELLA (Merck) (lot# 643078/0471M). On 17-JUL-2009 the patient had a chickenpox outbreak. The patient had seen the camp physician for medical attention. The reporter was concerned that the lot number of VARIVAX (Merck) that was given tot his child may have been ineffective. The patient is currently recovering. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Headache, nausea,  muscle aches, bilateral arm pain. Fatigue, loss of appetite  Approximately 14 hours after vaccine adverse events started still feeling some of the adverse reactions.
I have had aching and increasing discomfort to my left breast, very tender to touch and swollen since day 1 of receiving the 2nd Moderna vaccine. I have also been feeling intermittently nauseous. My eczema has been flaring up daily since getting the vaccine.
Went to the dermatologist because he has a problem with psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Went to the dermatologist because he has a problem with psoriasis) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Went to the dermatologist because he has a problem with psoriasis). The patient was treated with SALICYLIC ACID, TRIAMCINOLONE ACETONIDE (KENALOG [SALICYLIC ACID;TRIAMCINOLONE ACETONIDE]) for Psoriasis, at a dose of 2.5 mg CC. At the time of the report, PSORIASIS (Went to the dermatologist because he has a problem with psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
2 wks p/vax, pt had cold chills, fever, h/a; to MD; dx:bronchitis; in bed 1 wk; to ER; suspected spinal meningitis; pt isolated; spinal tap inconclusive; return to hosp 2 wks later; dx: possible rxn to Td or decongestant, viral meningitis..
Headache, Chills, Vomiting, Coughing, Stuffy Nose
Syncope after receiving immunization.  Sat in chair for about a minutes.  Then passed out.  Head hit wall by the chair bruise/abrasion on left temple.  Reported nothing eaten since lunch.  Alert talking, pupils equal & react to light.  B/P at 5:20 100/70 P 92.