chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 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 medical history and concomitant medications were not reported. Patient reported with the first dose of the Pfizer Covid 19 vaccine he initially thought he had bruising but then clarified he did not experience bruising and only just a sore arm. Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drunk caffeinated beverage or a energy drink. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated. This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. Patient questioned, Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? "Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine." In closing call, consumer stated to agent, "Thanks a lot (Withheld) I had to say you did a great job in helping us and giving us info and Kudos to you and Pfizer what you were doing, I really appreciate that." The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vasovagal syncope within 10 minutes of vaccine being given when walking out of office
APPROXIMATELY 2 DAYS AFTER VACCINE ADMINISTRATION PATIENT DEVELOPED A RASH ON ENTIRE BODY DESCRIBED BY MD AS VIRAL EXANTHUM,
I felt fine immediately after and the days following.  I had slight soreness in my arm but nothing terrible until a week later. I woke up with my arm red and swollen and hot to the touch. It got worse over the next two days. The swelling started to become hard and started traveling down my arm almost to my elbow.  At this point, I was becoming more concerned because of adverse reactions similar to mine. On 1/21/21 I made an appointment to video conference with a doctor. This doctor recommended I take Benadryl and ice my arm. I was informed if it got worse, I should contact my PCP or go to an urgent care. I did ice my arm several times a day, applied a topical Benadryl and I took Benadryl before going to bed. Today, 1/22/21, I can see a lot of improvement.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 45 year old female. 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210913164, 20210915731 and 20210915748.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician refers to his 27 year old female daughter. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX first dose (dose, strength and lot number were not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient received a second dose of (Oka/Merck) VARIVAX and was tested and did not seroconvert, after that the patient received either one or two more doses of (Oka/Merck) VARIVAX and she still did not seroconvert. Therefore, the reporting physician was figuring out whether to vaccinate her again. Patient sought medical attention through a healthcare provider visit and patient did not received treatment for the events. At the time of the report, the outcome of the events seroconversion test negative and no therapeutic response was not recovered. The causal relationship between the events and vaccination with (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
PATIENT REPORTED FEELING "JITTERY" AND HAD MILD BILATERAL HAND TREMORS. NO DIZZINESS, SHORTNESS OF BREATH, ITCHING OR OTHER SERIOUS SYMPTOMS REPORTED.
Same month post vax, this pt experienced fever and stiffness of the neck. There were no adverse events following the first vax. No further information is available.
Initial report was received from a consumer, who was also the patient's parent on 15 February 2012. A two-month-old female patient had received an intramuscular injection of DTAP (manufacturer, lot number and site of administration unknown) on 19 February 2010 and cried for 12 hours straight and developed a fever. The patient had no known allergies (NKA), denied any illness at the time of vaccination, denied any other vaccinations within 4 weeks of DTaP and weighed 5 pounds 4 ounces at birth. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None. Follow up information received on 7 May 2012. The patient had no illness at the time of vaccination. On an unknown date the patient had recovered from the events.
Cellulitis; Four redness with purplish lesions to the upper arm almost to antecubital; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), dose 1 via an unspecified route of administration on 26Feb2021 as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed on day four (unknown date in 2021) redness with purplish lesions to the upper arm almost to antecubital. He was put on Levaquin by primary physician, the evaluation in his case was a cellulitis (unknown date in 2021). The reporter asked if the patient should get the second dose. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded.  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.
very fussy w/t106 in PM of inject day; taken to hosp given APAP & told to defer future pertussis injects; did recover;
Extreme fussiness, diarrhea.  IV fluids, abdominal U/S. 1/16/08-records received for DOS 12/2/07-Seen in ED for C/O fussy, frequent small stools since 11/28/07 however on 12/2/07 only 1 stool moderate mucous yellow accompanied by screaming unconsolably. Five day HX of colicky abdominal pain. Straining with stools, constipated. Hellow like stools no heatochezia. Hyper active bowel sounds. Admitted overnight for observation
vaccine was used for doses after expired date/ 1 week after expired date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was used for doses after expired date/ 1 week after expired date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  It was reported that there were no side effects has been experienced by patient, the vial did not undergo any temperature excursions. Number of doses/vials: 13 doses total from 3 vials The vial was initially stored in the refrigerator on 10-Sep-2021,  Dates of administration of vaccine: 3 different dates that is on 12Oct2021, 16Oct2021 and 19Oct2021.  7 doses were administered on 19-Oct-2021   This case was linked to MOD-2021-359475 (Patient Link).
Passed out two weeks after the second shots; Heart racing; Dizziness; Diagnosed with POTS; Migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 22-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "Passed out two weeks after the second shots"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; DIZZINESS (non-serious), outcome "unknown"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "Diagnosed with POTS"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines". The event "diagnosed with pots" required emergency room visit. Clinical course: Passed out two weeks after the second shots. Had heart racing, dizziness. Then diagnosed with POTS in the ER at the same time. Also reported that she had migraines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
redness/swelling/knot/warmth at tetanus injection site.  treated with antibiotics.
Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Within minutes of shot, my son had a seizure. He complained of tingling in left arm, then he couldn?t hear anything and had blurred vision, and said he had an extreme headache. Within moments he began convulsions that became stronger and his whole body was shaking. This lasted for about 45 seconds. He stopped shaking and began to wake up. He was groggy and confused and said he didn?t remember anything, but the pain in his head subsided. 911 was called and they took him to the hospital to check his vitals. They could not be sure what brought on Seizure. Suggested Vagol Response. We went home. That evening he felt tingles and needles in body, we thought side affect of vaccine. Today, he was in extreme pain from pins and needles sensations throughout his body.
As soon as the vaccine was injected into my body, I started to experience joint pain. The pain is now in my hands (sharp, burning sensation like my hands are on fire) and bilateral knees radiating to my feet (achy, sharp pains).
taste has been altered; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (taste has been altered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste has been altered). At the time of the report, TASTE DISORDER (taste has been altered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Headache; Left eye swelling; I didn't feel well for my eye; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0175, expiry date: unknown), via an unspecified route of administration on 28Apr2021 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication reported as none. The patient has not been for any lab test and have not been to the Hospital. On an unspecified date, the patient experienced headache and left eye swelling; I didn't feel well for my eye. Patient reported, he received that dose on April 28th and the details he provided that he experienced the headache, he did take Tylenol (treatment) for the headache. The reason for his call is he noticed yesterday that his left eye started to have swelling and he called us for medical advice on what to do. I am just doing it because I mean before the vaccine. I just doing it I didn't feel well for my eye comes again swelling up, I never had it. I got the vaccine and first person (Medical Information Department) told me that it was the part of the possible symptoms. I want to know whether I can go and buy over the counter medication for my eye, that's the reason I was calling, I was not calling for any other reason. I want to know if it was ok for me to go and get an eye medication, but she was telling me that maybe I can go to walk in clinic but then you know walk in clinic wants insurance, they to cost lot of money, so that's the reason I am not going to a clinic. Therapeutic measures were taken as a result of headache (Tylenol). The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Fatigue; Chills; Body Aches; Fever; Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Oct2021 08:30 (Lot number: EN0217) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2 at 15:30 PM, Batch/Lot No: ER5734, Intramuscular in Arm Left), administration date: 07Apr2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1 at 16:30 PM, Batch/Lot No: EN6207, Intramuscular in Arm Left), administration date: 17Mar2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Fatigue"; CHILLS (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Chills"; PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Body Aches"; PYREXIA (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Injection site pain". Therapeutic measures were not taken as a result of fatigue, chills, pain, pyrexia, vaccination site pain.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. Concomitant drugs reported as None, Relevant test were None.   Follow-up attempts are completed. No further information is expected.
Around 5:00 pm, my arm started hurting. Around 6:30 I got a fever, then chills and body aches. During the night around 2:00 development extreme vomiting and diarrhea.
Tired 4 hours post vaccination but went away by the next day. Feeling on and off lightheaded for the last 3 days post vaccination.
the evening of the second injection I started bleeding and it wasn't my period cycle and it didn't stop also followed migraine headaches and bouts of high blood pressure 190/100 or better, still occurring
Information has been received from a medical assistant concerning a 11 year old female who in 1995 was vaccinated with varicella virus vaccine live (Oka/Merck). In 1995 the patient experienced developed 10-20 lesions after administration of her first dose. The medical assistant was unaware of the details of the rash or if any treatment was required at the time. The patient recovered from the rash and was not administered the second dose. No further information is available.
This spontaneous report was received from a pharmacist regarding two patient's of unknown age and gender with no pertinent medical history. On an unknown date, the patient's were vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneous injection (lot number not reported). No concomitant medications were reported. Subsequently the patient's received ZOSTAVAX and broke out with shingles within 2 months. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
Nasal conjestion on 12/14. On 12/15 felt feverish, more congestion from the neck up. On 12/16 fever cont. & tx w/Alka-Seltzer Cold Tabs. Congestion now in chest w/cough & wheezing. No relief of symptoms. Sugar level elevated, less/excercise
SYNCOPE IN SEATED POSITION 1 MINUTE AFTER SECOND VACCINE GIVEN. PT WAS EASED TO A LAYING POSITION.  SHE REGAINED FULL CONCIOUSNESS IN 1 MINUTE, SHE EXPLAINED SHE HAD NOT EATEN ALL DAY AND HAD JUST RETURNED FROM GYM AFTER A MODERATE WORKOUT. SHE WAS GIVEN A BOTTLE OF WATER TO DRINK AND REMAINED IN CLINIC FOR 30 MINUTES.  DURING THIS TIME, SHE HAD NO RASHES, COUGHING, HIVES, SOA, NOR DID SHE GET NAUSEAUS. SHE WAS LAUGHING AND STATED SHE FELT FINE IN ALL RESPECTS . AFTER 10 MINUTES I GAVE HER A CANDY BAR WHICH SHE SAID MADE HER FEEL BETTER STILL . SHE LEFT WITH A FRIEND WHO WAS PRESENT WHO DROVE
My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I had swollen glands under my jaw.  1)The morning after the shot I awoke to severe nausea and vomiting and had to get prescription anti-nausea meds.  2) A few days later my bowels went wild with lots of rumbling and gas and frequent bowel movements.   3) The swollen glands in my jaw cycled between getting better and then worse, and I had and bouts of feeling unwell and fatigued. I went from sleeping 7-8 hours per night before the vaccine to sleeping 9-10 hours a night.  Some days I was fine. Then I would have a bad day. One day I was fine in the morning then crashed after noon -- like when I had mononucleosis at 17.