chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; I felt some body aches; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration, administered in arm left on 03Feb2021 at 14:30 (at the age of 51-years-old) as unknown, single for COVID-19 immunisation. Medical history included COVID-19 (if Covid prior vaccination: Yes). The patient had no known allergies. Concomitant medication(s) included zinc, vitamin C [ascorbic acid], vitamin D3 and multivitamins. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 04Feb2021 at 03:00, the patient experienced chills but he felt none by the next morning. The next day the patient felt some body aches which only lasted that day. The outcome of the events was recovered on 04Feb2021.  Follow-up attempts completed. No further information expected.
Hives to chest and arms, Swollen left neck lymph node, diarrhea, injection site warm
The patient Has cellulitis 30 by 45 mm induration and erythema at the injection site; also increased warmth. Treated with Keflex for 7 days.
Allergic reaction; Red rash all over her body; Itchy rash all over her body; Hot rash all over her body; Hands are swollen; Hives, almost sun burn appearance, on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body) and PERIPHERAL SWELLING (Hands are swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LOSARTAN and METOPROLOL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.
Mom states face and eye swelled--mom called covering MD--did not tell pmd until 6/26/13.  Had no pictures.
Per OSDH: Regarding COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Very strong flu like symptoms; Fatigue; Sore throat; Runny nose; Little bit of tightening of the throat; Sneezing; Persistent cough; Postnasal drip; Inflammation of lymph nodes in the throat; This is a spontaneous report from a contactable consumer (patient's parent). A 39-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration unspecified, on 07Jun2019 at a single dose for immunization.  Medical history included ongoing type 1 diabetes. Concomitant medication included ongoing insulin for type 1 diabetes. On 08Jun2019, the patient had very strong flu-like symptoms; fatigue; sore throat; runny nose; and a little bit of tightening of the throat. In Jun2019, the patient was sneezing; had persistent cough; postnasal drip; and inflammation of lymph nodes in the throat. The outcome of the events, very strong flu-like symptoms, fatigue, sore throat, runny nose, a little bit of tightening of the throat, sneezing, persistent cough, postnasal drip and inflammation of lymph nodes in the throat, was unknown.   Information on the batch/lot number has been requested.
Arthritis type symptoms in joints of arms and legs-worse in hands and wrist painful. Swelling occurred overnight, unable to use hands in Am until swelling went down. Symptoms started around 10-9-08, tested for parvovirus, RA, CBC, ANA, led rate- all normal/ negative. Hand X-ray normal. Referred to Rheumatologist, but he didn't go because it was obvious it was vaccine. Homeopathic anti vaccine helped as did energy healing session. Its slowly improving and is almost gone.
Seen 11DEC91 @ clinic w/1 day hx of losing balance when walks, excessive sleeping; dec fluid intake & t102 R; PE-stood up to walk & walks w/wide based stiff gait; BOM, throat red;
Around 7:45 pm on Saturday, I began to feel unwell.  Around 8:30 pm, my heart rate was racing,  I had a terrible headache, I was shivering and unable to get warm, my hands and feet were like ice, my upper left arm (site of injection) was hot, swollen, and painful.  I felt feverish. My heart raced the entire night and did not return to a normal beat until early in the morning.    Today, on Tuesday, the injection site has an angry rash that extends down to my elbow.  It is hot and swollen and painful.  My history:  I got shingles while undergoing chemotherapy in 2014.  I received the shingles vaccine in 11/2015.  I also received the flu shot at the same time as the shingles vaccine on Saturday, 9/28/2019.
Headache; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patient).   A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 02Mar2021 at 09:45 am (Batch/Lot Number: en6205) as First dose, single for covid-19 immunisation. Medical history included colitis ulcerative and took ampicillin for hypersensitivity experienced rash. Concomitant medications included mesalazine, and citalopram. The patient has not taken any vaccine in four weeks. The patient has taken lialda and citalopram in two weeks. The patient has not experienced covid prior to vaccination. The patient has not tested for covid post vaccination. The patient experienced headache, and fatigue on 02Mar2021 at 19:00 pm. The patient has not taken any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Delayed second dose/  received vaccine in march and did not get second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment drugs were not provided.
had a "titer" test done and the test results showed that she was "no longer immune to chicken-pox"; This spontaneous report was received from a 40-years-old female consumer, referring to herself. It was reported that she did not have any pertinent medical history, drug reactions or allergies; concomitant medications were not reported.   On 12-JUN-1995 and 01-AUG-1995, the patient was vaccinated with 0.5 milliliters (ml) as the first and second doses, of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot numbers reported as "040313" and "041613", which have been verified as invalid) respectively, in her left deltoid, as chicken-pox virus prevention (concentrations, vaccinations scheme frequency, routes of administration and expiration dates were not reported).  In April 2019 (reported as "recently, around April or May of this year") the patient had a titer test done by her physician, and the results showed that "she was no longer immune to chicken pox" (viral titre decreased). Therefore, her physician was recommending her to get a third shot of varicella virus vaccine live (Oka/Merck) (VARIVAX).   The relatedness between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the reported event was not provided by the reporter.
I took a PCR test on April 29th with a negative result. I became symptomatic over the weekend and tested positive on May 2nd, 2022. My symptoms are similar to a bad cold. I developed bad cough, sore throat, some congestion, headache, fatigue, restlessness, and some fogginess. I do resistance training and have a usual pain in my clavicle bone area.
Patient received dose at younger than recommended age. Patient reported that she was fine. She had no side effects out of the ordinary from those that were common with the vaccine
Pfizer-BioNTech pediatric-  0.2 ml of pediatric vaccine was administered with  no diluent.
Rash (almost looked like hives) on arms, shoulders, upper back, chest, abdomen and upper legs. Lasted almost 2 weeks. 7 small swollen "lumps" on arms, upper butt and abdomen.
Left upper arm became very swollen and bright red. Developed a fever of 100.1. Fever gone next morning. Swelling and redness at injection site continues
6-28 hours after injection experienced high fatigue, injection site soreness, dizziness, headaches. Seven weeks after the injection I am tiring very quickly with a fast heart rate. I am more fatigued many afternoons than I was before the getting the vaccine. I have had maybe 6-10 bad afternoon headaches since the vaccine. This has not been all too bad so I have not taken time off work to schedule a health checkup. I will bring it up in the new year when I get an annual wellness check from my work.
Tremor, alteration in levesl of consciousness, startle reaction, cyanosis of mouth & hands & t100.0 R; for about 1/2 hr to 45 mins;
Tdap, MENACTRA vaccines given. Finger prick done to check cholesterol. Approx 3-5 min. after procedures done, child had seizure lasting approx 30 seconds. Post ictal state, urinary incontinence, lips pale. Hungry prior to procedures. Referred to neuro. Result from neuro - Vaso-vagal. No primary seizure disorder.
Day 1: took Covid-19 Pfizer 2nd dose vaccine at 5 pm; low fever at night Day 2: fatigue, light headache; stomach pain; no fever Day 3: no fever; short breath, nausea and fast heart beats happened twice in between half an hour at 9:30 am-11 am.  the oxygen % was as slow as 45 % and heart beats was as fast as 145 beats/min by using sport oximeter (it works in normal function). the monitored numbers varies quite abnormal: oxygen % varied from 45% to 80, or 90%; heart beats varies from 145-45 beats/min.  Day 4: no observed adverse  side effects any more
This spontaneous report as received from a physician refers to a 17 years old female patient with irregular periods. None drug reactions or allergies were reported. on 13-MAR-2013 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot number were not reported). There were none concomitant medications. Patient reported to physician, that after receiving her 1st dose of GARDASIL, on 13-MAR-2013, she had "head and neck pain". Physician reported that patient suffered from a severe rash surrounding her neck and shoulders after receiving the first dose of GARDASIL. The following morning, on 14-MAR-2013, the patient had a rash on her leg that "looked like hives" and was itchy all over. The patient self medicated with BENADRYL (manufacturer unspecified) which did not help. The patient reported all her symptoms "went away within the week" in approximately March 2013. At the moment of the report, the 2nd dose of GARDASIL has not bee administered. None lab/diagnostic studies were performed. The patient did not seek medical attention. Additional information has been received from the physician concerning the patient with no illness at time of vaccination, and none pre-existing allergies or medical conditions, who on 13-MAR-2013 at 14:52, was vaccinated in her left arm with GARDASIL (lot # H020002, expiration date 08-AUG-2015). Reporter stated on 13-MAR-2013, patient experienced hives, Itching, and sore in neck and back. Physician reported no treatment was given for the events, the events resolved on own on 21-MAR-2013. None relevant diagnostics test or laboratory data were performed. Patient was not seen for symptoms. Additional information is not expected.
Day after vaccine..feet and hands have* tingling sensations* Every day since then.. Went to  local Fast Pace clinic  because of this and had blood work done...and have another appt with family doctor on May 17th.  Symptom or side effect.continues 24/7
Baseball sized lump hot and red at injection site. Dr said give Benadryl and Benadryl cream but it's just getting bigger.
vasovagal syncope with suspected seizure (tonic-clonic jerks observed by staff as well as loss of bladder control)
Extreme unusual fatigue, nausea, headache, muscle aches that started the evening of the vaccine, still experiencing unusual fatigue and sleeping a lot more than normal.   The fatigue and the time frame it has lasted is what concerns me, that it is 3/29 and still happening.  I had my annual blood work just weeks ago and everything was in normal range except my cholesterol was elevated.
Strong headache, paleness, general malaise, pain on the legs. BP 80/40 HR 120/min Temp: 38.1.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA317816 same reporter. This case involves a 57 years male patient who experienced rash all over, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported. On an unknown date, the patient developed a non-serious rash all over (rash) few days later following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests included no lab data. Final diagnosis was rash all over. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
expired dose of ACTHIB with an expired diluent were administered with no reported adverse event; Initial information received on 15-Mar-2023 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 15 months old female patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received an expired Booster dose of 0.5 mL of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Strength: standard) (lot: UJ649AAA; expiry date: 05-Mar-2023 ) via intramuscular route in the right thigh with an expired diluent with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib with an expired diluent were administered with no reported 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 the 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.; Sender's Comments:  US-SA-2023SA085856:01533896
Swelling IN Bicep of Injection ARM. Redness in large area of upper ARM. Started Next Day IN morning.
9/14/09 - sore arm, achy feeling. 9/15/09 -  nausea, sore arm, achy feeling; 100 temp. 9/16/09 - nausea, sore arm, achy, cough, chest congestion, went home sick. - P.A.C. dx adverse reaction & adeno virus systems persisted through 9/20/09 - chest congestion & cough remains.
General arm soreness on day one. By 2 days post-shot the pain had radiated down my left arm to a dull ache which at times was moderately severe pain. On day 3 post-shot I experienced intense back pain in my left shoulder blade area. This area of my back has caused pain before due to old sport injuries. I visited my physician on day 5 and he performed range of motion tests for shoulder injury. None of the tests were positive for shoulder injury. I took acetaminophen and a muscle relaxer for pain relief.  The pain was gone by 10 days post-shot.  My feeling is that my reaction to shot #1 was intense due to the fact that I had tested positive for covid-19 just 6 weeks prior to receiving the first dose.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: rash/hives from fingertips to shoulder of left arm
Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer, macular degeneration, type 2 diabetes, atrial fibrillation. No known allergies. Concomitant medications included glipizide, warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. 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.; Reported Cause(s) of Death: Death 2 days later
This spontaneous report as received from a medical assistant (Immunization coordinator) refers to a child patient of unknown age. It was reported that the child was supposed to receive VARIVAX (Merck), however, PROQUAD (Merck) (0.5 ml, subcutaneous, lot# unspecified) was administered inadvertently, instead of M-M-R II on 23-APR-2014, and the child received PROQUAD (Merck) and VARIVAX (Merck) (J008652, exp date as 10-JUL-2015, 0.5 ml, subcutaneous) on a same day (23-APR-2014) inadvertently. No adverse effects reported. Additional information has been requested.
Information has been received from a RN concerning children who were vaccinated with varicella virus vaccine live. It was reported that there was an outbreak of chickenpox at a school. It was reported that a 5 year old child with epidermolysis bullosa attends the school and was exposed to the children with chicken pox, however never developed chickenpox. Unspecified medical attetion was sought. No further information is available.
unable to curl the finger down; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0271; Expiration Date: Sep2021) intramuscular, administered in Arm Left on 10Aug2021 11:50 (at age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not any history or other products. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, her husband (patient) got COVID shot yesterday. On his left hand, index finger, it was red, swollen, inflamed and painful on 10Aug2021. On an unspecified date he was unable to curl the finger down because of the inflammation. He got the shot before lunch at 11:50 AM yesterday. The index finger being red, swollen, inflamed, and painful started a couple of hours after the shot. He mentioned it started to bother him in the afternoon. When he woke up this morning it was much worse on an unspecified date. They were not sure where it would progress from here. He never had an issue with his hand before. Adverse event did not require to visit emergency room or physician office; but caller told him to that she recommended that he follow up with his doctor. She was calling because she was required to report it within 24 hours. The outcome of events unable to curl the finger down and it is red and swollen and inflamed and painful (Condition aggravated) was unknown while it was not recovered for all other events.  Information on the lot/batch number has been requested.
A few hours after I received the second dose of the Pfizer Corona Virus vaccine I experienced rapid heartbeat, faster than normal. I also was not able to sleep at all, I was awake. The next day there were minor body aches that went away after I took acetaminophen, but the rapid heartbeat did not stop. A week after I got the second dose I still have rapid heart beat, I feel a slight tension around my chest, but no pain, no heart pounding. I am concerned about doing physical activity, that it will cause heart damage or even a heart attack. I do not smoke, am not diabetic, don't drink alcohol, do not have health problems, am not overweight.