chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a minute patient became pale, cool and dripping sweat (pea size) from entire body.  He stated "I don't feel well".  He remained alert and oriented during the time period.  Blood pressure 54/40 within 3 minutes; administered contents of Epi-pen 0.3 mg IM in left lateral thigh at 2:22pm and Benadryl 50mg IM in Right lateral thigh.   At 2:27 blood pressure 104/54 Heart rate 89; His color was a little pinker and stop forming the balls of sweat.  EMS arrived at 2:32 pm and took over.  Patient express to EMS attendant that he did this once before when the lab tech had to draw blood. EMS took him to the local Hospital
Just after recieving vaccine, child couldn't breathe, turned purple, then began choking, gagging. Took several minutes to recover. No treatment.
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that they accidentally gave expired FLUMIST Quadrivalent to two patients which started on 31-DEC-2014. The outcome of the event of accidentally gave expired FLUMIST Quadrivalent to two patients is unknown. The report was considere3d to be non-serious.
Patient was due to receive Meningococcal and got MMR instead and was not due for it at this time. patient was up to date on MMR
Ten days after immunization, patient stated she had generalized aching for 2 days & thought it was due to fibromyalgia. Had light rash on neck and chest and sore glands at base of neck 2 to 4 days later (14-16 days after injection). Next day (day 17 after injection) knee was swollen and painful for a few hours, then pain resolved. Next day (day 18 after injection) both hands were painful for a few hours, then pain resolved. Approximately a week later, she had mild "pins and needles" tingling. Tingling is much less now, but still exists off and on (has been 33 days since injection).  Stated she got a cortisone injection 1-2 days after pain in knee for tendonitis.
Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot; I am not feeling well; I am feeling bad; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Had a little red place like a site reaction and then it got bigger and bigger; It is red and hot"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I am feeling bad"; IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster".  Additional information:  QR Comment: Reporter type was not available over the call as the consumer was unwilling to answer further questions hence, reporter type captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
These symptoms occurred after both treatments with the second dose feelings just as severe as the first.   Extreme fatigue, wide spread muscle soreness especially in my back, nausea, fever, chills (can?t get warm but have a slight fever of 99.9 degrees). My symptoms are flu like and prevent me from functioning through normal activities such as walking beyond short distances and standing for short periods of time.
Standard soreness at injection site within first 24 hours. I itch so much I can?t tell you exactly what day or time the redness, itching and hardness started. I think around day 7 or 8. I have a picture I took on March 22, 2021, which I can upload if it asks later during this report or I can e-mail the picture if you contact me and ask for it.
Spoke with patient; went to Pharmacy to get covid booster Tuesday, 48HRS later her vaccine site is red, swollen and warm to touch. She states it is a baseball size lump on her arm.
Narrative:  10/7/21: Pt w/ onset of rash on L forehead yesterday, somewhat worse today. Had admission x2 6 months ago for shingles c/b metabolic encephalopathy and hyponatremia. He states that the shingles developed after he received his first Covid vaccines and now, 3 days after his booster, he is getting the same sx. Denies any eye sx. Feels well now. Did have chills 2 nights ago. After his first vaccine and symptoms, valacyclovir was started but pt admitted when rash did not resolve and lesions increased and vision became blurry. Hence pt came to ED today for eval. Discharged from ED with valacyclovir.
No additional AEs; PROQUAD which was administered to a 37 year; PROQUAD which was administered to a 37 year The nurse states she does not know why PROQUAD was administered as the adult patient was needing the varicella vaccinations for graduate school; This spontaneous report was received from a registered nurse and refers to a 37 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 12-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T010651, expiration date 22-SEP-2021 1.5 milliliter, for prophylaxis. The nurse states she did not know why measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)was administered as the adult patient was needing the varicella vaccinations for graduate school
Flu-like symptoms, no cough, no fever, no treatment, resolved in about 2 days.
This spontaneous report was as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-MAR-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok W Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Injection site pain; Tierdness; joint pain; Headache; Chills; Swollen lymph node; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 52-year-old), at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included chronic knee pain. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Meloxicam, Rosuvastatin, empagliflozin (JARDIANCE), Valsartan, Fenofibrate, Amlodipine, Paroxetine and Hydrocodone (reported as hydrocidine). On 13Mar2021, the patient experienced favor chills, headache, joint pain, tiredness, swollen lymph nodes, feeling unwell, injection site pain/soreness. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Service member received her 3rd anthrax injection 20 Dec 06 and had a positive serum HCG on 19 Jan. Swelling start 12/20/06 end 12/23/2006 at injection site. Tenderness start 12/20/2006 end 12/23/2006, nodule subcutaneous start 12/20/2006 end 01/02/2007.
C/O Burning and soreness at injection site. Also, nausea since the day of the shot.
Woke up morning of 12/13/2009 with R sided facial weakness, typical of Bell's Palsy treated with Medrol dose pak and acyclovir 800 mg tid in the ER on 12/13 but switched to prednisone 80 mg po qd x 7days and Valtrex 1000 gm po tid x 7days.
I woke up this morning with pins and needles type of feeling in my left cheek (follows the cheekbone).  I can only compare it to the feeling of after having novocaine at a dentist visit when you've resumed the majority of your feeling back, but there's still some tingling.  I have feeling in my cheek if I touch it, but if I just let my face rest, it has a slight soreness and tingling.  I noticed it as soon as I woke up at 6am and it is currently 3:33pm and I still have the sensation.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored in June 2014 ZOSTAVAX (dose, units, route of administration, anatomical location, lot numbers were not reported). The reporter stated that the vaccine was evaluated by the Company and found to be viable and since then they were administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused to contact physician.
Patient had 3 seizures, 1 day after flu shot was administered, 1 at home, one at physician, 1 at hospital.    12/31/09:  Hospital records received for dates of service 10/14/09 to 10/16/09.  Dx:  New onset seizures.  Experienced eyes rolling to back of head, drooling, limbs went limp, lethargic but still breathing.  Tired and sleepy afterward for 5-10 minutes.  Repeated episode of seizure in peds. office, decision made to admit.  Admitted and experienced a third seizure on the same day, this time with tonic clonic activity. Oxygen desaturation to 60%, supplemental O2 given.  Started on fosphenytoin, and IV fluids.  Discharged home on Topamax.  01/04/10:  Primary care records and ED record received for dates of service 10/14/09 to 12/17/09.  No new information.
he had an erratic heartbeat/irregular heartbeat; a burning sensation in his chest, stomach, throat; dizziness; can't calm down; He was believed to be having an allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp.   A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 11:00 (at the age of 34-years-old) as DOSE 1, SINGLE for covid 19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken for hypertension from 2014 and ongoing; buspirone (BUSPIRONE) taken for an unspecified indication from Oct2020 and ongoing. On 09Feb2021, the patient experienced he was believed to be having an allergic reaction.  On 10Feb2021, the patient experienced he had an erratic heartbeat/irregular heartbeat, a burning sensation in his chest, stomach, throat, dizziness, can't calm down.  The patient underwent lab tests and procedures which included heart rate: erratic heartbeat on 09Feb2021 At 11:00, he had an erratic heartbeat all the way up to 100 while sitting, heart rate: irregular   on 10Feb2021 today 10Feb2021, he started to have an irregular heart beat.  The outcome of the event he was believed to be having an allergic reaction was unknown. The outcome of the events had an erratic heartbeat/irregular heartbeat, can't calm down was recovering. The outcome of the event burning sensation in his chest, stomach, throat, dizziness was not recovered.  Follow-up (11May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Blurry vision, has not tried anything yet - will continue to monitor and make appointment with eye doctor on Monday if not resolved.
Dental implantation; Infection; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL IMPLANTATION (Dental implantation), ILLNESS (Sickness) and INFECTION (Infection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 11-Nov-2021, the patient experienced ILLNESS (Sickness). On 27-Jan-2022, the patient experienced DENTAL IMPLANTATION (Dental implantation). In 2022, the patient experienced INFECTION (Infection). At the time of the report, DENTAL IMPLANTATION (Dental implantation) and ILLNESS (Sickness) had resolved and INFECTION (Infection) outcome was unknown.            No concomitant medications were reported.  In 2022, the patient experienced sick and infection. The sick was resolved.  She had dental implant on 27-Jan-2022 then she developed an infection and was sick for 6 weeks, took antibiotics.  She had to use intravenous, the intravenous was removed on 17-Apr-2022.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: pt blood pressure dropped to 88/54 after vaccine and was lightheaded, paramedics were called but bP had recovered to 111/62 by their arrival, pt  was monitored but did not go with the paramedics, refused too, ultimately went home with friend driving her
Patient called at 8:00 am on 9-29-16 stating her arm hurt so bad she could hardly move it. She decided to see PCP and called back at noon to say that PCP said the vaccine ruptured her bursa and would take about two weeks for recovery. Patient states she is in a lot of pain.
72 y/o with hx of HTN, Aortic valve replacement, venous stasis and venous insufficiency of both lower extremities, CAD, AAA, and s/p squamous cell carcinoma excision in 2019  Upon reviewing the history, here is what we found.   1. 2/27 -- Received send-out covid swabbing/testing- Patient did not disclose this information when screened for his covid vaccination at the clinic.   2. 3/2, 10:00 AM ? Presented to Covid Vaccination Clinic and received 1st dose of Moderna. Results of pending covid test were not back at this time, nor did he disclose this information when screened by nurse prior to vaccination.  3. 3/2, 10:30 PM ? Covid result came back to lab as positive SARS Co-V 2019  4. 3/3 ? patient called and notified of result per ED nurse   5. 3/3 ? Pharmacy recommended patient for mAB infusion (patient did not receive it)   6. 3/6 ? patient presents to ED in severe respiratory distress, DX of Covid-19 pneumonia & transferred to ICU  7. 3/21 ? patient dies after 15 day hospitalization in ICU (pt. had received convalescent plasma x 2 and remdesivir there)
As described by patient:  Muscle pain from top of legs to calves. Trouble walking, proceeded to difficulty moving legs.  Tests were done to r/o blood clots, arthritis.  MD and PT considering GBS.  Currently walking with a cane.  States symptoms began about 4 days after receiving flu shot. 3/6/08-records received-12/12/07-seen for cardiology consult with C/O chest discomfort in midsternal area occurs with activity and releived with rest. Shortness of breath with activity.12/17/07-C/O knees hurting and arm goes to sleep, Heartburn. Seen on 12/19/07-C/O left knee pain. Fell onto her knees after cataract surgery 3 weeks ago. Knee pain increased after flu vaccine. Pain and swelling of knee with difficulty bearing weight. Impression:blunt trauma left knee.
soreness over the injection arm; Redness over the injection arm; tingling, "pins and needles" sensation; black and blue bruising over the injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm). At the time of the report, PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  The patient was in line to get the second dose of the vaccine and reported side effects from the first dose. The patient experienced soreness, redness, tingling, "pins and needles", and black and blue bruising over the injection arm. These side effects persisted for up to two weeks after receiving the vaccine but were not longer present at this time.  Treatment information was not provided.
SARS-CoV-2 Infection; SARS-CoV-2 Infection; This is a literature report.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, booster dose, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 month after the suspect product(s) administration, outcome "recovered" and all described as "SARS-CoV-2 Infection". The patient underwent the following laboratory tests and procedures: diagnostic testing: Positive, notes: day 0; Polymerase chain reaction: Unknown results; SARS-CoV-2 test: Positive, notes: on days 9 through 15, remained positive for 2 to 7 days; Negative, notes: day 22; Unknown results; Negative, notes: day 0; Negative, notes: day 1; Positive, notes: day 2; Positive, notes: day 5; Positive, notes: day 6; Negative, notes: day 8; Negative, notes: day 9; Positive, notes: day 11; Positive, notes: day 12; Positive, notes: day 13; Positive, notes: day 14; Positive, notes: day 15; Positive, notes: day 16; Mild, notes: day 17; Negative, notes: day 18. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that all the patients had been fully vaccinated and had received at least one dose of a messenger RNA booster 0.5 to 7 months before diagnosis. None of the patients had any known immunocompromising conditions, and all recovered without additional antiviral treatment. It was reported that patient received second booster 1 month before diagnosis.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202200065235 Same article/ drug/event and different patient:;
Rash around injection site that is hot to the touch and red. Patient reports no itching just pain at injection site. Was instructed to take OTC anti-histamine
Rt deltoid with no swelling, mildly warm to touch, erythema shaped in a heart appearance with 3 in. spread of erythema.
This spontaneous report as received from a physician assistant refers to a 61 years old male patient. The patient was vaccinated with lot #/exp date (0240AE, 15-MAR-2013 date), 0.65 ml ZOSTAVAX on 07-AUG-2012. No other co-suspects were reported. Concomitant medications included: pravastatin sodium. On 09-AUG-2012, the patient experienced outbreak of shingles after getting ZOSTAVAX. The reaction was tender rash on the upper eyelid, right eyebrow, scalp and forehead. The patient outcome of outbreak of shingles after getting ZOSTAVAX was reported as not recovered/not resolved at the time of the report. Additional information has been requested.
Shot has painful (not the prick) but the process of the medicine being injected; Flu like symptoms; Felt very poorly; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, flu like symptoms and feels poorly. On an unknown date, the outcome of the injection site pain and flu like symptoms were unknown and the outcome of the feels poorly was recovered/resolved.   It was unknown if the reporter considered the injection site pain, flu like symptoms and feels poorly to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter described the actual shot had painful (not the prick) but the process of the medicine being injected. The patient felt very poorly for about 24 hours afterward. This case has been linked with US2019AMR190698, reported by the same reporter.
This spontaneous report as received from a back office lead refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JAN-2017, dose reported as 1 mg, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.