chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of meningitis in a adolescent male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant) and fever (serious criteria hospitalization). On an unknown date, the outcome of the meningitis and fever were recovered/resolved. The reporter considered the meningitis and fever to be almost certainly related to BEXSERO. Additional details were provided as follows: The office manager reported this case. The patient was high school aged. The patient's mother who was a nurse practitioner administered the vaccine. The patient had meningitis like symptoms, spiked a high fever and could not touch his chin to his chest. The patient's mother (nurse practitioner) took patient to the emergency room (ER) and hospitalized for a couple of days. At that point, the patient got better and the symptoms were resolved. It was unknown if any other vaccines were administered.
No reaction at all first week except tiny spot at injection site. Then fingers were getting very stiff. Painful and quite difficult to make a fist, especially at night for 3 weeks.  No redness or swelling of joints. Felt like I had sprained all my fingers. Very similar to an unknown problem in 1991 later called chronic fatigue/fibromyalgia that took several YEARS to clear. Scary! After 3 weeks, I can generally make a fist in the daytime but it still hurts in the evening or in the night. My gut feeling is that it's autoimmune problem, re-peat of 1991 but it seems like it's resolving faster this time. Also, some minor bruising on legs, arms. I don't remember smacking anything, but I am fairly oblivious when I move. I have a small painful lump by my ankle but I dropped 2x4 on my ankle two months ago; probably a bone chip.
Patient states that arm started hurting, then redness developed.  The area was warm to touch. body aches and fever also started.  He then started feeling nauseated and lost appetite.  He said diarrhea then developed.  He was not feeling well all weekend.  The rash on the arm has spread around arm and down to elbow.
On night of vaccine shot (4/20) had a racing heartbeat that would not slow but fortunately I fell asleep. Woke up at 5 am with massive neck pain. Could not lift my head off of the pillow without severe shooting pains in my neck and shoulders. Severe neck pain lasted until 2 pm on 4/21 and  fortunately was gone by 5 pm.
5 year old school immunization given 12/2/04 10:30am. Right arm swelling and redness started at 12:30pm same day continued x 3 days. Mom states redness, swelling now resolved.
Immediately felt like an insect bite. I had a very itchy red arm for longer than a week. I took an antihistamine for a couple of days, but I did not see a doctor. It took about 2 weeks 2 stop itching. It hurt a slight amount for a total of 3 weeks. I have since completely recovered from these symptoms.
Flu vaccine given at 6pm on 11/30/2001. She developed shakiness and chills, pain both legs along with tingliness which lasted for 4 hours. Symptoms went away on 12/01/2001 am.
chills, fever, upset stomach, h/a, tired; had chills & fever until next morning; the other sx approx 3 days; took APAP for 3 or 4 days;
Flares of Rheumatoid Arthriti on 4/20/2021, 4/25/2021, 4/29/2021, 4/30/2021  and after 2nd Covid-19 dose on 5/5/2021 lot EW0167 on: 5/9/2021, 5/12/2021, 5/25/2021, 5/28/2021, 5/31/2021, 6/2/2021, 6/10/2021, 6/18/2021, 6/22/2021, 6/23/2021, 6/24/2021, 6/30/2021 These flares included finger, knuckle, wrist and toe joints, also SI joints and shoulder inpingement inflamation. Fever of less than 100 degrees after 2nd dose.  Fever lasted less than 24 hours. Photos available upon request. Flares defined as: joints swelled, turned red, were warm to touch, stiff, difficult to use, usually lasted 2-3 days. Unable to walk when toe joints involved.
Pain and redness at injection sites "knot on left deltoid that went down overnight" (per pt.) Hard raised area noted to right deltoid approx 3 inches x 3 inches at injection site.
mom states pt began screaming shortly p/got home & screamed until went to bed approx 10PM;leg was sore to touch next day otherwise fine;notified MD day of screaming & told not to give DTP again;cont w/APAP;
Td 21MAY lt deltoid, appears red, raised & swollen 8 1/2 cm x 9 1/2 cm upper deltoid & smaller area distal to 1st area 4cm x 4 1/2 cm; hot to touch & pt relates tender & itchy; referred to own MD;
two red spots appeared on her neck (like rash) and they disappeared the same day; This is a spontaneous report received from a contactable consumer. This 45-Year old female consumer reported for herself (patient) that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Apr2021 single dose at left arm for COVID-19 immunization.  Medical history included breast cancer. Concomitant drugs were not provided. The patient reported that after the injection on 03Apr2021, two red spots appeared on her neck (like rash) and they disappeared the same day. She did not have a fever or anything else, she would like to know if it was an allergic reaction. The outcome of the event was recovered on 03Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within 6 hours of receiving vaccine pt developed pain, swelling from (R) shoulder to elbow - skin warm, red. No fever. Used BENADRYL. Seen by PCP - tx for cellulitis, given pain meds as well. Follow up planned.
SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy  Elevated troponin Acute renal failure (ARF)  Death
feel lightheaded; I have a bright red, itchy, raised and warm welt at the injection site as well; Pain and itching at the injections site immediately; Pain and itching at the injections site immediately; Throat tightness across the front; Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes; Swallowing feels like a "lump" in my throat, but does feel obstructed; I have a bright red, itchy, raised and warm welt at the injection site as well; This is a spontaneous report from a contactable Nurse who reported for herself.  A 51-years-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in the left arm at hospital on 17Dec2020 09:45 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin zinc, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced rash. The patient experienced pain and itching at the injections site on 17Dec2020 at 09:45 (reported as immediately), lasted approximately 3 hours (as reported), the final outcome was recovering (as reported). Throat tightness across the front, but not "inside." Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes. Swallowing felt like a "lump" in her throat, but did feel obstructed. Ate lunch without difficulty. Drinking without difficulty. The front of her throat, distal from jawline, to top of breast-line felt like she had a very light weight resting on it, even 8 hours post injection. Approximately 30 minutes after injection, the patient began to feel lightheaded. Lightheadedness became more intermittent for the next 4 hours and resolved. She had a bright red, itchy, raised and warm welt at the injection site as well, 8 hours later, on 17Dec2020. The patient did not receive any treatment for the events. The outcome for the event lightheaded was recovered, for the other events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
Seizure, convulsive movement lasting a few seconds. No color change. DC Summary received for DOS 9/16-9/18/06. DC DX: Seizure. Presented to ER after seizure activity noted at home. Mom states she was sleeping with patient and awakened to find her eyes dilated and rolled back in her head, arms and legs flexed and she reports three jerks. Patient then started crying. No color changed associated with that, no HX of any fever, no HX of previous seizures. Mom states she had mild upper respiratory symptoms for 3 days prior to visit also received 12 month well child vaccinations 6 1/2 hours prior to episode. Medication for vesicoureteral reflux had changed from Bactrim to nitrofurantoin which she received 2 hours prior to episode. Also received cold medication including active ingredients of acetaminophen , dextromethorphan and phenylephrine 1 1/2 hours prior to seizure. Mom denied any postictal symptoms.  PE unremarkable, afebrile.  DC on Keflex changed from nitrofurantoin due to possible adverse reaction of elevated liver enzymes. Follow up with neurologist.
had a sore arm; This is a spontaneous report from a contactable nurse.   A male patient of an unspecified age received the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as 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 on an unspecified date and experienced had a sore arm and felt more uncomfortable after the first. The patient had a sore arm on an unspecified date.  The patient underwent lab tests and procedures which included antibody test: 64 in 2021. The outcome of  had a sore arm was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M033096 with expiration date 31-MAY-2018, lot # M001579 with expiration date 05-OCT-2018, lot # M000442 with expiration date 31-MAR-2018, lot # M023718 with expiration date 09-AUG-2018, lot # M029233 with expiration date 09-AUG-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & the next day mom noted inject site red, tender, swollen w/dec movement, t101; t98.6 when seen @ clinic on 22APR94;
redness around injection site; for the last 2-3 days she had itching at the COVID-19 Vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EN6208, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 16Mar2021, administered between 1:30PM-2:00PM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunisation at pharmacy/drug store. The patient's medical history included multiple sclerosis from 2018 and unknown if was ongoing. The patient's concomitant medications were not reported. There were no other products. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. There were no prior vaccinations (within 4 weeks). On the day before reporting (on 24Mar2021), the patient realized she had redness at the place where she was injected with the COVID-19 Vaccine. She said that she now remembered that for the last 2-3 days, she had itching at the COVID-19 Vaccine injection site, as well. She said she had not done anything to the COVID-19 Vaccine injection site. Reported she had multiple sclerosis, and her doctor told her it was safe for her to get the COVID-19 Vaccine. Reported she had a virtual appointment with her doctor yesterday (24Mar2021) and forgot to mention the injection site itching and redness to her doctor at that time. On the day of reporting, the day was 9 from the first dose. It was like a circle around that area that is red. Reported she did not look for injection site redness since she got her COVID-19 Vaccine. She said she just happened to look in the mirror, and saw the COVID-19 Vaccine injection site was red. She clarified the injection site was itching, and she had not touched the injection site, but looked in the mirror, and saw the injection site was red. She stated that she got her COVID-19 Vaccine in her right arm because she was lefthanded. The patient with Multiple Sclerosis since 2018 who received the first dose of the Pfizer Covid-19 vaccine on 16Mar2021. She has noticed itching for the past 2-3 days and yesterday redness around injection site. Is this normal? Her doctor said it was ok to get the vaccine.  Today is day 9 from the first dose. It was like a circle around that area that is red. She asked, what should I do? asked if what she was experiencing was a normal reaction to the COVID-19 Vaccine. She did not visit emergency room or physician room. Relevant tests were none. The outcome of both the events were not resolved.  The follow-up attempts were made. Follow-up attempts had been completed and no further information was expected.
Two positive home Covid tests 17Apr2022; Two positive home Covid tests 17Apr2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EW 0170) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Recently diagnosed with asthma and some improvement with Advair and Singular take.; "COVID", start date: Mar2020 (unspecified if ongoing), notes: Best I've felt in two years following my initial bout with COVID and hospitalization in Mar2020. Concomitant medication(s) included: ADVAIR, start date: 30Mar2022, stop date: 29Apr2022; MONTELUKAST, start date: 30Mar2022, stop date: 29Apr2022. Vaccination history included: Covid-19 vaccine (Primary vaccination Details was Unk since Dose Number Unk also considered [Did you/the patient previously receive a COVID-19 Vaccine? Yes]), for covid-19 immunisation.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "not recovered" and all described as "Two positive home Covid tests 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Two positive, home COVID tests; (17Apr2022) Positive, notes: Two positive, home COVID tests; (30Apr2022) Positive, notes: Once again tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course COVID 19 Treatment with Paxlovid, treatment start date: 17ap2022, treatment stop date: 21apr2022. Other medication in 2weeks lot number: 57422002A3. The patient started Paxlovid after two positive home COVID tests 17Apr2022. he was significantly improved within 24 hours and completely normal within 48 hours of starting Paxlovid. he completed the 5-day course and felt great perhaps the best he has felt in two years following his initial bout with COVID and hospitalization in Mar2020. On Tuesday 26Apr2022 he started feeling sick again with similar Covid symptoms of headache though much more mild, sore neck, chest tightness, cough, and sore throat. His symptoms persisted until 30Apr2022, and he couldn't sleep so he just got up in the middle of the night and have once again tested positive for COVID. Recently diagnosed with asthma and some improvement with Advair and Singular take. For three weeks before developing COVID which was diagnosed after worsening of my asthma symptoms. The patient had no known allergies. The AE did not result in physician office visit or emergency room.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient experienced severe headache followed by chills, body aches, body shakes and nausea.  Symptoms dissipated 4 hours after onset after taking Tylenol+codeine.  Symptoms restarted at 2:30 AM 7/11/2013 and pt took Tylenol.  Symptoms stopped at 7:00 AM.
Itchy arm; Red arm; Raised oval shape on arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Mar-2021, the patient experienced PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm). On 26-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 07-Mar-2021, PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm) had resolved. Not Provided          No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25 May 2021 included: Reporter's email updated, patient demographics updated, second dose details updated and changed action taken from unknown to no change On 25-May-2021: Follow-up received on 25 May 2021: contain no new information
Patient reports increasing erythema and tenderness with axillary lymphadenopathy starting on Friday (day 9).  Patient reports a 7-10 Burning pain in arm and a dull ache in armpit.  She is self treated with ibuprofen 800mgs 4x per day.  She describes normal progression from papule, to  vesicle, to pustule and no scab. She states mild drainage noted when changing dressing, serous in nature. She describes continued low grade HA not relieved by ibuprofen, but otherwise feels well. She did have 4 loose BMs yesterday but no n/v.  The patient likely presenting with a robust take.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, a relative of a 3 year old female patient who received a fourth dose of Prevnar on 8/24/03. On 3/24/04, the child developed autism. The patient's concurrent illness includes ear infection (reported as ear tubes were inserted for chronic ear infections). Indication for Prevnar was immunization. Product was administered on 8/24/03. Dose regimen was 1 dose (IM). Additional suspect medication included Hib-Titer vaccine, Act-Hib, Infanrix, MMR II, Varivax, Engerix, Recombivax, and Polio vaccine. Concomitant medications were not reported. On 8/24/03, the patient received a fourth dose of Prevnar. On 3/24/04, the patient developed autism. As of 2/17/05, the patient had not recovered. No additional information was available at the time of this report.
Patient was fully vaccinated as of 3/31/21. patient is symptomatic as of 9/19 and lab confirmed as of 9/22
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild
Of note, patient was also exposed to siblings with fevers/myalgias (likely H1N1 disease). Patient had sudden onset of profuse sweating, lethargy, hypothermia (35'c), hypoglycemia (47). Taken to ER, given IV fluids, IV antibiotics, recovered rapidly. Monitored, no recurrence.
red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 79-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose of the vaccine she had side effects that included red blood bleeding during the 3-4 days that she had gastrointestinal upset, diarrhea, chills, and headache. The patient stated, the bleeding stopped, and she was doing better now but she was just upset and concerned with the bleeding. She did not know if she should receive the second dose. She would like to know should she receive the second dose after having this side effect. The Pfizer team responded as the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The Pfizer team referred patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events red blood bleeding was recovering, and the outcome of the events gastrointestinal upset, diarrhea, chills, and headache was unknown. Information on the lot/batch number has been requested.  Information on the lot/batch number has been requested.
I got the vaccine on Thurs and  worked the following day. On Sat morning I felt sick with fever, clammy and tired went to get tested results positive. I dint think this was a reaction to the vaccine. I have missed week of work.
Pt recvd 2nd dose of Hep B vax MAY1991 & following vax pt suddenly became weak & blood pressure shot up; this resolved over a period of hrs; pt also devel numbness & tingling in arm & pain;
On 10.14.04 - Patient received FLU, DTAP, COMVAX, MMR & PNEUM. conj after this did not talk, quiet, sick, tired, fever (HOT) 3-4 d. ibu. given did not eat with in 2 wks, eyes rolling (thought nl after vacc). Still does not eat well. Mom thought was regressing & mad abt being held down. In bed 3d. Mom lived with guilt for 10 mo, finally presented to Dr 9-7-05. Very severe delays/regression. Does not speak (did at 11 mo). Very restricted diet, refuses most foods.   5/8/09 Received vaccine & PCP medical records. FINAL DX: Autism spectrum disorder; mixed receptive-expressive language disorder; feeding difficulties; encopresis; constipation; dental caries Records reveal patient experienced runny nose s/p cold week prior to vaccination on 10/14/04.  Developed social withdrawal & speech loss.  2/24/05 dx w/RLL pneumonia; 12/05 bilat AOM & diaper rash; 4/06 viral URI; 10/06 viral pharyngitis. Loss of language, loss of eye contact, loss of reciprocal attention/joint attention. Parent remains adamently convinced that after these 5 injections her son was ill for a week (fever/lethargy) and never recovered his previous social nature. Language is slowly coming.