chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seven days after first dose, I got a raised, hot, itchy swelling on my left arm, approx. 5  1/2" x 3. "  It took about a week to lighten, although still left shadow for a couple weeks.  In addition, the lymph nodes in my underarm and up my neck enlarged.  The ones on my underarrm are no longer apparent, however, I still have some swelling in my neck --- after more than 2 months.    On the advice of my doctor, I took Allerclear just prior to and for a week after my second dose on 2/20/2021 (which I got in my right arm, not the left one as with initial dose).  After 11 days, I got a hot, raised swelling on the cheek on the right side of my face and a smaller on on the left side.  They took about 5-7 days to lighten.     I also got flu light symptoms, including fatigue, chills and significant sweating during the night, beginning 12 hours after the second dose.  These symptoms resolved after approximately 3 days.
Started with alternating chills and sweating at 10pm day of vaccine which lasted through the night. Never had a fever. Woke up the next day with a headache and significant muscle/body aches that lasted the day and into the night. On the 2nd day post vaccine still fatigued and new sore throat.
Information has been received from a physician concerning a 6 month old male with no medical history and no allergies who on 03-JUN-2006 was vaccinated with a first 2 ml oral dose of Rotateq (Lot #653915/0389F). Subsequently, on 03-JUN-2006 the patient experienced cramping, but no vomiting for diarrhea. It was reported that the patient recovered within 5 days. On 25-JUL-2006 the patient was vaccinated with a second 2 ml dose of rotavirus G1 G2 G3 G4 P1 reassorted vaccine live (human bovine) (Lot # 653915/0389F). Concomitant vaccines administered on 24-JUL-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified)  (+) tetanus toxoid, a dose of poliovirus vaccine, a dose of pneumococcal 5 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) and a dose of HIB conj-hepatitis B vaccine (MSD). Subsequently on 25-JUL-2006 the patient experienced cramping but had no vomiting or diarrhea. It was reported that the patient recovered within 5 days. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that the patient's mother reporter at her son's & month check up that after the second dose of ROTATEQ at the patient's 4 month check-up that he acted "not quite right", and he seemed like he had a stomach ache for a few days.Additional information has been requested.
Skin on hands and feet are peeling, both fingers and toes are red, raw and sensitive to the touch
My husband was sick the week before and we both tested negative for COVID-19. On Saturday evening after the vaccine, I had fatigue, slight fever. Sunday, I woke up with a very runny nose and sneezing. I took a home COVID-19 test, and it came back positive for COVID-19. Since then, I followed up with a physician with Monday and my husband tested positive that day, as well. I believe I got it from him. I have had all the symptoms almost - but was just a little feverish on Sunday and that's it for fever. I have had congestion, sneezing, coughing and fatigue. I do have an appt on Friday for the monoclonal antibodies. I have just taken OTC medicine to help manage some of the symptoms.
welts and rashes; welts and rashes; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 1st of the two reports.   A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The nurse reported that the patient received the second dose of the vaccine on Monday (11Jan2021) and broke out in welts and rashes in Jan2021. The patient went to the ER and was given steroid treatments. The patient did not report respiratory distress. The outcome of the events was unknown   Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026638 Same reporter/drug; different patient/event.
Patient came in for a booster shot from Pfizer. Patient already had 1st COVID-19 Pfizer shot on 10/21/21 with 2nd shot administered on 11/11/2021. Gave COVID-19 Pfizer booster shot on 3/15/22. Administered booster shot 1 month early. Patient had no adverse reaction to receiving booster shot one month early. Patient told about early dosage administration. Doctor notified of incident.
Chronic Rash a lot all over legs, some on arms, some on back, butt, chest; Chronic Rash(hives) a lot all overlegs, some on arms, some on back,butt, chest; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208), via an unspecified route of administration in the left arm on 12Mar2021(at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included stage 3 kidney disease. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN) tablet 50 mg from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced chronic rash (hives) a lot all over legs, some on arms, some on back, butt, chest. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with hydroxyzine hcl 25 mg and triamcinolone acetonide. The clinical outcome of the event chronic rash(hives) a lot all over legs, some on arms, some on back, butt, chest was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
In February 2001 the patient developed a mild case of chicken pox. The patient had one day of fever and a few eruptions. The patient was not seen in the physician's office for symptoms. Unspecified medical attention was sought. Additional information has been requested.
Modern a COVID-19 vaccine EUA.     Temp. 102.  Pulse ox 88, chest pains, muscle aches, chills, sore throat
Hospitalization: 10/1/2022 - 10/4/2022 Presentation to the ED: BLEEDING RECTUM AND COFFEE GROUND EMESIS.  COVID-19 + date: 10/1/22. Treatment: NO SPECIFIC TREATMENT FOR COVID. Discharge to: PATIENT IS DECEASED. DATE OF EXPIRATION: 10/4/22.
Injection administered too high in left shoulder area, resulting in pain and loss of range of motion in shoulder.
Patient was receiving the flu vaccine and became very agitated. Patient stated that the vaccine hurt and started to swing her arm around. Patient started screaming asking to remove the vaccine from her arm. The vaccine was removed, but the full dose of the vaccine was not given.
Fever to 100.2 with chills lasting all day very sore arm, fatigue
Got the shingles shot, then got shingles/ Suspected vaccination failure; Shingles; Pain; Visual symptoms were vague; nightmare; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, visual impairment and nightmare. On an unknown date, the outcome of the vaccination failure, visual impairment and nightmare were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, visual impairment and nightmare to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced shingles and the visual symptoms were vague, pain made him want to end it all, because no one could figure it out. it was a nightmare. The patient was ok at the time of reporting. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M028552, expiration date 07-JUN-2018 and lot # M003440, expiration date 20-JAN-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit grades (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA001224: US-009507513-1612USA010151.
first dose on 29Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 12-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 29th March 2021 at 11 years of age).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: pharmacist reported that a patient received the first dose of Engerix-B. The patient had not received any other doses of hepatitis B vaccinations as per the moment of this report. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Arm pain/Arm pain felt like needle pricks; injection site feels tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks) and VACCINATION SITE PAIN (injection site feels tender) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks). In January 2021, the patient experienced VACCINATION SITE PAIN (injection site feels tender). At the time of the report, PAIN IN EXTREMITY (Arm pain/Arm pain felt like needle pricks) and VACCINATION SITE PAIN (injection site feels tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Ever since I have been vaccinated I have bruising that won?t go away, memory loss, difficulty falling asleep and I forget how to spell, I can?t afford to go to the doctor to get checked
Severe headache, vomiting, chills within one hour of vaccine, full body rash and itching 12/29 through ongoing, swollen feet resulting in inability to walk 1/4/2021 (PCP suggests erthyema nodosum); treated with Claritin
COVID-19 positive; COVID-19 positive; weak; tired; cough; gout worsend; psoriasis break out on left side of stomach; felt like truck hit and ran over again; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240023-00 (AbbVie).  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single, intramuscular, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) and second regimen subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19 positive"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; COUGH (non-serious), outcome "unknown", described as "cough"; GOUT (non-serious), outcome "not recovered", described as "gout worsend"; PSORIASIS (non-serious), outcome "recovering", described as "psoriasis break out on left side of stomach"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "felt like truck hit and ran over again". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter causality for all events with BNT162B2 was not reported.  The reporter causality for the events of covid-19 positive, weak, tired, cough, psoriasis break out on left side of stomach and felt like truck hit and ran over again, gout worsened with Humira (adalimumab) was a reasonable possibility.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
p/vax arthralgia & myalgia starting in spine, migrating large upper legs muscles, knees, shoulders, wrists & hands;?nerve connection;pain has been somewhat managed by Ibuprofen, now Celebrex currently in shoulders-hands;
Large swelling (local reaction) on thighs bilaterally post DTaP and Prevnar.
Pt broke out in a rash that itched and lasted 7 days. Initially on shoulders and progressed down her torso to legs over next two days. Pt was fine after one week.
Systemic: Hypotension-Mild, Systemic: Tachycardia-Mild, Additional Details: pt had dizziness upon standing immediately after receiving vaccine. pt may have stood up to fast causing dizziness and then had some anxiety with the dizziness. Blood pressure was slightly elevated
headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Biliateral Pulmonary Emboli, Rt leg DVT up to iliac vein.            Treated with Eliquis po. -- sent to hospital for further treatment Remains in hospital at this time Symptoms were swelling of Rt foot, normally SOB, no increase in baseline
Less than 50% of the vaccine dose was administered and a full dose was immediately given in the opposite arm according to CDC Medication Error and Deviation Guidelines.
Information has been received from a pharmacist concerning a male who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). It was reported that the two vaccines were stored in the same freezer and the pharmacist "just pulled out" the wrong vaccine. The nurse then gave the vaccine though she "knew something wasn't right." The patient had no adverse event. There was no product quality complaint involved. On an unspecified date since this event the patient was correctly vaccinated with zoster vaccine live (Oka/Merck) (MSD). No further information was provided. Additional information has been requested. The patient's wife had the same experience with vaccination (WAES # 0706USA03508).
Patient presents for her second COVID-19 vaccination, she did not have her vaccine card with her at the time of her second dose and she did not remember what vaccine she received for her first dose. It was written on a sticky note that she was due for Pfizer dose today 09-14-2021. Medication removed from fridge, mixed per directions, and administered per standing orders. Writer did not check system prior to administration of vaccine. Patient monitored for 15 minutes after administration with no adverse reaction and was released back to work. After patient was released, I went to put vaccine in system it was figured out that she was administered Moderna on 08-17-2021 and Pfizer was administered today 09-14-2021. Pt notified at this time.
This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had every 4 times a year). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication, medical history and laboratory tests were not reported. After receiving SHINGRIX, the patient experienced Shingles and it was making it worst. The 2nd dose of SHINGRIX was still pending. Other needed information was not reported since when pharmacist heard that she was calling company, she said she got a wrong number. This was the only information received from the pharmacist regarding the adverse event.
hives, urticaria, redness and swelling (4cm x 8cm) at injection site.  diffuse
Patient became unresponsive immediately after injection, eyes rolled back. Patient then became flushed, and about 30 seconds after symptoms began the patient started being responsive again.  After about another 30 seconds the patient's flushing resolved. The patient also reported being extremely sweaty. I contacted the vaccination protocol physician, Dr., via phone. After Dr. took a history of the event and spoke with the patient, he came to the conclusion that the patient had a vasovagal reaction to the flu shot, and she should be fine as soon as she felt well enough to leave.
Eyes feel hot like she is about to get a fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eyes feel hot like she is about to get a fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Eyes feel hot like she is about to get a fever) and CHILLS (Chills). At the time of the report, OCULAR HYPERAEMIA (Eyes feel hot like she is about to get a fever) and CHILLS (Chills) outcome was unknown.            Reporter did not allow further contact
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 04-MAR-2016, the patient received the first dose of GARDASIL. The patient would like to receive the second dose of GARDASIL on 25-MAY-2016 (inappropriate schedule of drug administration). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
later in the day p/vax felt blah & achy w/sl runny nose;relieved sl by APAP but need to repeat each time it wore off;11 days later began w/h/a & atrial fibrillation;18NOV98 severe muscle aches all over;dx PMR;
21 cm x 23 cm redness and urticarial redness and warmth and pruritis.
Developed hypo-mania and irritability after both 1st and 2nd Dose. Including significant insomnia. Lasted about 3-4 days after each shot.   However, when I received the lower dose Moderna Booster 3rd shot, I did not experience the same problems as with the 1st and 2nd dose. Also, I didn't experience the same problems with the 4th shot, my second booster, which was Pfizer.
swollen injection site, diameter approximately 5-6 inches, round. redness, hardness, warmth, pain at site. Recommended cold compress, antihistamine, ibuprofen, cortizone cream, follow up with md if no improvement or worsen
I just started feeling crappy and achy with a fever, congestion, ear and neck pain, headache, and shortness of breath. I decided to take a COVID-19 on 01/03/2022, and it came back positive. The day before on the 2nd, the test was negative, but I knew that had to be a mistake. I notified my employer and my physician about my positive result; my doctor and I discussed prescribing me PAXLOVID, but didn't want to because of his previous patients catching rebound COVID-19 and informed me to let it run its course. As of now, it's a day by day thing; currently I still have a headache, congestion, and shortness of breath.
Patient reported swelling, redness, and a little sore in his left arm is the area adjacent to his he said the vaccine was given and that the symptoms started the next morning . He said that he exercised to relieve the soreness and the swelling went down as well, however the redness had not resolved.   When he came to the pharmacy, his arm did  have  bug-bite like red area (~2 inches diameter) with a faint target appearance. This was also closer to his left bicep, and the patient stated the this was not the injection site; he pointed to his deltoid region to indicated where his vaccine was given
10-15 mins after hep B and PPD given pt stated feeling dizzy and c/o upset stomach. Pt had nothing to eat or drink prior to imms.