chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction (skin) in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX. One to two days after vaccination with KINRIX, the subject developed a red wheel-like skin reaction at the injection site (skin). The physician who examined the site also note that it felt warm. There was no medical intervention and the subject was sent home and told to keep an eye on it. At the time of reporting the outcome of the events was unspecified. It was reported that a total of three subject experienced similar reactions following administration with KINRIX. It was reported that one subject may have been male, and another taking an antibiotic, but it was not known which patient's specifically. The subject that was taking the unknown antibiotic also received an unknown vaccine, other than KINRIX, on the same date. The dates of vaccination and events were not known. Linked cased include: A0978765A and A0978766A.
Got the shot on Sunday.  On Friday later that week, left foot (specifically the big toe and two toes next to it) got chilblains like sore, which I think is Covid toes.
Migraines with aura lasting 4 hours each on 3/18/21, 3/22/21, and 3/25/21 .
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a Healthcare professional. This case involves 15 months old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: U6302AA, expiration date: 30-Jun-2019, route was not reported in left thigh) on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
After 3 days of Pfizer-BioNTech, my son started to experience chest pain with every heart beat. He did not want to get this vaccination to begin with but did so in order to cross into the border to see his grandma.  He felt like his chest near his heart was constricted and he reported an irregular heartbeat. I asked him if he wanted to go to the hospital but he said no due to his fear of more needles. This pain and restriction lasted for approximately 24 hrs. He is otherwise completely healthy.
Very high fever with multiple generalized tonic clonic seizures.  Some seizures assoc. with high fever and some not.  Also dx with otitis media.
Within a week of the shot I began to develop a rash on the thighs that became intensely itchy and has spread to the whole body by about 5 weeks later.  This may be the third year in a row that this has happened to me, and this year I noticed the temporal relationship and realized that this might be a reaction to the flu shot I received in early December 2007.
Shingrix vaccine August 2018 / 2nd dosage 19-Mar-2021; Her arm gets a rash / big red rash; Her arm gets / white  spots around the rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash erythematous (received 1st dose in August 2018, refer case US2021AMR068257).   On 19th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced red rash and skin discoloration. On 19th March 2021, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the red rash, skin discoloration and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced red rash and skin discoloration. The patient received received 2nd dose late, which led to lengthening of vaccinations schedule. The caller did not know if it was because of the length of the dosages were too far apart and had question towards if the patient had to take vaccine again.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR068257:Same reporter. US-GLAXOSMITHKLINE-US2021067596:FU1 deleted
RECEIVED VACCINE DOSE THAT WAS IN A TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 26-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 26-JUL-2022, the patient experienced received vaccine dose that was in a temperature excursion, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine dose that was in a temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220758989. This report was associated with a product quality complaint: 90000244073.
High fever 102.9 F, chills, headache, pounding heart, red swollen left arm  started 12 hours after the vaccine.  Tylenol did not stop the headache.  Fever remained over 100.4  F for 24 hours.  Headache for 2 days.  Arm is still red and swollen 3 days later?m feeling ugh better.
Time - approximately 5 hours. Symptoms - Difficulty breathing. Went to the emergency room about 1700. Was told if it persisted or got worse to come back.
Fever, chills, shortness of breath, weakness, fatigue, uncontrollable shaking, headache for 12 hours
Immediate headache during the 15 minute wait times and took Tylenol immediately. When I took off the bandaid 2 hours later the injection site was red, swollen and itchy. The later the day went the injection site reaction got worse and was the size of a golf ball. I took Advil and Tylenol every 4 to 6 hours alternating and iced the injection site. I was also fatigued the day after the injection. Swelling, redness, itching continued for a week after
pt recvd vax; redness, pain, swelling, itching at site, ha, dizziness, n, abdo pain, lethargy p/ dose 1; pre tx w/ dph for dose 2 & 3; no rxn;
Information has been received from a registered medical assistant concerning a 46 month old female with no past medical history who on 11/15/00 was vaccinated with a varicella virus vaccine live (lot # 636357/0532K). There was no illness or concomitant medication at the time of vaccination. On 8/30/03 the patient had spots. On 9/3/03 the patient reportedly had breakthrough chicken pox. The patient's mother reported that there were a total of 16 chicken pox spots. The patient complained of itching but no fever. It was noted that the mother called the doctor's office with the total amount of spots on 9/12/03. It was noted that there were no relevant diagnostic tests or laboratory data. It was also noted that the patient had not experienced any adverse events following previous vaccinations. The patient's pustules were treated with bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate. It was reported that the patient recovered. No further information is expected.
Patient experienced tightness in her throat and difficulty breathing. She was still able to breath just expressed that it felt more difficult and the feeling was increasing. We administered diphenhydramine 50mg IM and monitored patient for more than 1 hour afterwards. Patient reported breathing became easier within 10 minutes and the tightness had eased. She was a staff member at a long term care facility. Family picked her up and she took the rest of the day off. Tried to contact for follow up but was unable to reach patient.
On Sunday, the same day as the vaccine, my face felt like it was burning. I took my temperature and it was only 99.4 F. From there it went down. By Tuesday morning my tongue was hurting and so was the back of my throat. It was not a sore throat. When I got off work I took a look at the back of my throat and under the backside of my tongue and I had what looked to me as blisters. I went to Urgent care and the doctor told me that they were ulcers and there was nothing I could do about them. He did not associate them with the vaccine. The next day I felt worse. I had some gastro problems. Not diarrhea but  more like pain and discomfort. I have not been able to make a doctor's appointment with my family doctor and that is why I went to Urgent Care. I guess it is hard to know if this is a reaction from the vaccine but I normally don't get ulcers in my mouth and I haven't felt this bad in a long time. It might be worth noting that facility had my name wrong in the system
Pt presented with hyphema and platelet count of 2K on 9/7/21.  He received pfizer Covid vaccine on 7/30/21 and 8/20/21.  Platelet count was normal (208K) on 8/31/2021.  PF4 was negative.  No thrombosis.  Pt was felt to have ITP, and was treated with platelet transfusion, steroids, and IVIG.  Platelet count on 9/27 was 133K
Called patient and explained the error. She hasn't experienced any adverse reactions. She is aware that she needs to wait 60 days to receive the bivalent Covid vaccine booster.
Seven hours after shot, while lying in bed, had pounding and racing heart for 2.5 hours.  Did not call doctor because it was in the middle of the night and racing did stop.   Now, continue to feel weak and fatigued, 70 hours after shot.  Spoke to doctor's office this morning.  Advised me to keep hydrated and take Tylenol if needed.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "developed ringing in my left ear"; OSTEITIS (non-serious), outcome "unknown", described as "I developed inflammation in my jaw"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "jaws stiff". Additional information: The caller stated that the patient had the vaccine, a year before that was the Pfizer BioNTech COVID19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case was fully vaccinated and boosted, and was hospitalized for Covid and died of Covid.   The patient is a 81 y.o. female with a hx of diastolic CHF, breast cancer, COVID, OSA, afib, COPD on 2L oxygen, and PE/DVT on xarelto was found down upon a wellness check. She was found down on the ground, unresponsive and EMS was summoned. Imaging showed a large L sided midbrain hemorrhage. ICH score of 4 which has >97% mortality. She subsequently became more obtunded and developed sustained V-tach. After discussion between the son,the Intensivist, the EP Cardiologist, and the Neurologist, the decision was made to transition to Comfort Care on 12/25. She was started on a morphine infusion and transferred out of the ICU. She passed away at 2335  CAUSE OF DEATH: 1.        Intracranial hemorrhage  2.        Ventricular tachycardia    SECONDARY DIAGNOSES: Principal Problem: Nontraumatic subcortical hemorrhage of left cerebral hemisphere  Active Problems: AF (paroxysmal atrial fibrillation)  Chronic respiratory failure with hypoxia  OSA (obstructive sleep apnea) History of pulmonary embolism Chronic diastolic heart failure  DM type 2 (diabetes mellitus, type 2)  COVID-19
Left eyeball swelling x 3 days, increased tinnitus sounds-both ears?ongoing, nausea, increased diarrhea, unable to drink fluids and loss of appetite x 10 days that caused acute renal failure (by labs)
Post vax, the pt was very tired. On 9/15/00, the pt developed itchy small blisters on left thumb and forefinger. He also had reddish dots on neck, trunk, buttocks, groin down legs.
This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash) and HEADACHE (headachy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, AZELASTINE for Rhinitis, METOPROLOL for an unknown indication. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash). On an unknown date, the patient experienced VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), HEADACHE (headachy) and FATIGUE (extremely tired). At the time of the report, VASCULAR INJURY (second one was definitely worse she thinks because the woman that gave her the shot hit a blood vessel), VACCINATION SITE PRURITUS (rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash. It is also very itchy), VACCINATION SITE PAIN (achy where she got the shot/burns a little), VACCINATION SITE RASH (rash near where she got the shot/rash after the second shot started the day after the shot and it is way more of a rash, half of her upper arm has a rash), HEADACHE (headachy) and FATIGUE (extremely tired) outcome was unknown. No treatment medication were reported. This case was linked to MOD-2021-291193.
Red swelling at vaccination site, intense itching, fever (100.9), severe joint and muscle pain, increases flare up of psoriasis.
This solicited report was received from a consumer and refers to a female patient of unknown age enrolled in a market research. the patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. It was stated that the patient was an extremely talented and dedicated dancer, who on an unknown date began to have major muscular issues and at the time of the report she was no longer able to dance. the outcome of the events was not reported. the relatedness between the events and GARDASIL was not reported. Additional information is not expected as the reporter refused additional contact.
Patient has an area of erythema and induration over right upper arm ascending from tip of shoulder to the lower third of upper arm. Patient was treated with Benadryl and Keflex.
DTaP-IPV (Kinrix;) was given to patient that was 1. This vaccine was documented to be for kids 4-6. Physician contacted patient's mother who said baby was doing well. Physician explained the patient will need a follow up appointment to repeat with correct immunization.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Helicobacter pylori, non-alcoholic fatty liver (NAFL), penicillin allergy, and drug allergy (Sudafed, Ceftin). The patient was not pregnant at the time of vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 25-SEP-2021 12:00 to right arm for prophylactic vaccination. Age at time of vaccination 52 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 08-JAN-2022 12:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 53 years old. Concomitant medications included ramipril for drug used for unknown indication. The patient was prescribed with non-company drug Paxlovid (form of admin, route of administration, batch number: unknown and expiry: unknown) dose was not reported, administered first dose on 31-MAY-2022 and last dose on 04-JUN-2022 for covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 2). On 08-JUN-2022 at 06:30, symptoms of covid-19 returned on day 9 following treatment with Paxlovid. The symptoms include congestion, runny nose, fatigue and muscle aches (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and has been requested.; Sender's Comments: V0:20220631599-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
1cm lump over left thigh.  Prescription: warm compress and massage 2 weeks.
(R) leg with red, itching rash (4 x 2" rash) with pain & bruising. Started with red & swollen leg, next AM had bumpy rash. No fever. Slightly warm to touch. Cried x 1 hour with pain. Took almost a week to clear rash red & pain. Cried x 1 hr solid.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. On or about 05-JAN-2017, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe tooth pain which radiated into his left cheekbone and eventually throughout the left side of his face.  On or about 18-FEB-2017, he presented to a hospital where he was ultimately diagnosed with trigeminal neuralgia.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. The lawyer considered trigeminal neuralgia, vaccination failure and herpes zoster to be disabling. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 07/28, Pfizer, dose #1 08/25, Pfizer, dose #2 12/29 COVID swab, result: detected 12/26 pt cc: low grade fevers, headache, body aches, sore throat, sinus congestion, cough productive of clear sputum, dyspnea; exposure: unknown; 12/29 Pt admit to ED cc: low grade fevers, headache, body aches, sore throat, sinus congestion, cough productive of clear sputum, dyspnea dx: COVID LOS: 1day 12/29 PT: 12.1 12/29 INR 1.08 12/29 DDIMER 0.53 12/29 TROPONIN 1: <0.016 12/29 CTA PE:. Negative study for pulmonary embolism. 2. No acute pulmonary disease. 3. Small to moderate-sized hiatal hernia. 12/29 CXR impression: No pleural effusion or pneumothorax. No pulmonary edema or focal consolidation. Normal cardiomediastinal silhouette.
on November 13 patient came down with symptoms of chills, headache, fatigue, loss of appetite, nausea, cough, and progressively worsening general weakness over the past several days.  Patient had an outpatient COVID19 test that was negative on November 18th but then went to see his PCP on November 20th and a chest x-ray at that time demonstrated ?pneumonia that look like COVID19? according to the patient's wife.  Patient is not currently on antibiotics.  Patient did not have a repeat COVID19 test on November 20th.  EMS noted that the patient was hypoxic with a pulse oximetry of 87% on room air at the home.  Admitted to hospital with COVID pneumonia on 11/22/2021, still hospitalized. Currently on 6 L of oxygen via nasal cannula.
Although I had virtually no reaction to my first three Pfizer vaccinations (some soreness in my arm and swelling of lymph node under armpit of injection site), this Moderna vaccine administered to me as a booster had a serious reaction. Addition to overall aches, pains and tiredness, I ran a fever of 101+ degrees all night of April 27. The fever broke the next morning. I also experienced a rash on the injection arm. I experienced the rash and swelling of the lymph node one week after the injection.
Yesterday got swelling of the left arm, started at 3 am it got swollen and red. She was given the PPSV 23 at the lower site of the arm. The area is warm and swollen and in a lot of pain. She is dizzy and fever of 102 extreme pain and swelling discoloration in and around injection site.