chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PFIZER COVID VACCINE #3 GIVEN 11/9/21, LOT #FE3590; pt had a positive COVID home test on 2/15/22; hospital stay at Medical Center from 2/20/22 - 3/10/22 with respiratory failure secondary to COVID; was treated with Remdesivir, Decadron, ABX; pt had worsening renal failure; began dialysis; on Vapotherm; 3/10/22 pt admitted to Hospital for PT, OT, O2 weaning; no progress in O2 weaning; suffered probable acute cholecystitis with gallstones; not a surgical candidate; family chose to not pursue interventions for gallbladder; transitioned to comfort care, and pt died in the hospital
general flu feeling; General malaise; clammy not feverish; chest congestion; coughing; I can't get a full deep breath; tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 06Apr2021 13:45 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypertension. The patient concomitant medication was not reported. Patient experience general malaise and clammy feeling on 07Apr2021 which stopped in Apr2021 on an unspecified date (Thursday or Friday). It was relayed when asking about the general malaise, the clamminess and on an unknown date patient had general flu feeling which was gone and all the other symptoms were gone, on 07Apr2021, patient had chest congestion the only thing still which was ongoing. She noticed the coughing in Apr2021 on an unknown date (on Thursday or Friday). She had not been able to get a full deep breath since last in Apr2021 on an unspecified date (Thursday or Friday). She'd like this feeling to go away. The patient goes on to clarify she was still tired but was tired because she could not get a full breath, so she had been taken Mucinex twice a day and it seems to be helping and breaking up phlegmy crap. The coughing was also ongoing and was related to the chest congestion. She didn't see coughing and chest congesting as part of the side effects after the vaccine. Therapeutic measures were taken as a result of events. The clinical outcome of the event general malaise, clammy not feverish was reported as recovered on Apr2021 and general flu feeling was recovered on an unknown date. The clinical outcome of the events chest congestion, coughing, can't get a full deep breath, tired was reported as not recovered.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient seen 8/14 for left arm pain after recieving Pneumovax 23 vaccine 8/13/2015.
Pain and swelling under left arm toward breast; pain and swelling above left elbow with compromised mobility
pt recv vax 25SEP97 & pt exp alopecia & hair is falling out inclumps;pt alopecia persisted;
pt recv vax 23MAY96 & pt stopped by clinic to show inj site large local rxn w/redness, puffiness measuring approx 5" x 5";small knot @ inj site;
My COVID-19 symptoms started on 02/13/2023 in the morning. I had a mild head cold. I had nasal congestions and slight headaches. I tested for COVID-19 infection with a home test on 02/15/2023. I called my doctor on the same day and he prescribe me Paxlovid for 5 days. On 02/19/2023 I did 3 COVID-19 test which were negative. As of today I completely recovered.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with chest pain. Vaccination took place on 09.22.2008. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.
Day after administration of seasonal influenza vaccine, employee reported to Employee Health Nurse with red and inflamed skin running from right side of neck to right elbow. Employee reported it started approximately 5-6 hours after vaccination. When she presented to Employee Health, it was no longer spreading per employee. Recommended anti-histamine. Resolved within a few days.
Received H1N1 vaccine at school after N 15 min observation went to bathroom was rash, lethargic, vomiting, pale, awake but not alert. N/V, SOB with shock like symptoms. 911 called, to hospital via ambulance. Rash-slightly splotching, anxious. Returned to ER @ 5:48 pm w c/o seizure x 1hr- "flopping in bed, shaking all over" evaluated by ER MD - Hyperventilation - Tx with IV ATIVAN x 2. Referred to mental health and evaluated in ER. D/C 1:20 a.m. 11/05/09 Dx Psychogenic Resp Syndrome" 12/7/2009 ED records for 11/4/2009, patient admitted with ?seizure activity, hyperventilating and shaking all over. Tx IV Ativan, Solu-Medrol and Phenergan, DC DX Hyperventilation syndrome
This spontaneous report was received from a nurse via a company representative and refers to a 18 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 11-DEC-2014, the patient was vaccinated with the first dose of VAQTA, (strength, dose, route, anatomical location, lot number and expiration date were not reported), and the second dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not reported) was administered on 29-MAY-2015 which was 13 days early, by error. The patient had not demonstrated any adverse effects. Additional information has been requested.
Arm soreness and mild nausea set in that evening. The next day, also had muscle aches, joint aches, mild headache, chills, and very low grade fever. Took 2 ibuprofen and slept for 2.5 hrs that evening. All symptoms but arm soreness were gone in 24 hrs. No effects from 1st vaccine.
Bright red rash around injection site. Rash formed a circle around injection. Itchy and mildly sore. Referred to as ?Covid arm.?
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.
This patient under went a total knee arthroplasty 12/06/00. Prior to receiving the vaccine on 12/07/00 his temperature was 101F. Two hours after the vaccine his temperature was 102F. Two and a  half (2 1/2) hours after the vaccine his temperature was 105F. The patient was confused and experienced nausea and vomiting. Preadmission testing done prior to surgery revealed normal CBC and urinalysis, blood cultures done at 6:50 PM were positive for E.coli. The patient was treated with IV Rocephin and was released to home 12/09/00.
Normal vaccine administration, that afternoon patient became very fussy and irritable. Irritability and frequent crying every day since vaccine. Not eating well, listless. Fever up to 101.6. Some loose stools. Measles-like rash on trunk, neck, and face. Will continue acetaminophen or ibuprofen and watch.
Patient reports that her right upper arm hurt the first day, then less so the following day. By the third day it started to hurt more again and by day 4 she was in tears with the discomfort- felt a lot of arm " heaviness"- even dropped a cup she was holding bc she could not hold it. denied any numbness or tingling. No local redness or swelling. Taking Advil with fairly good relief. Today she is having less discomfort but still reporting 3/10 pain. No recent illnesses. No known injury.
patient got the first dose on 8/3/21 with no issues but called pharmacy on 8/23/21 and reported that she was having some pain and swelling in the arm that she recieved the vaccine in that started with in the last several days, patient was advised to take analgesics and antihistamines and use cold compress on area and if symptoms didnt resolve or worsen to seek medical attention
Client states that the day after she received injection, she started to feel pain in the left shoulder which has progressively worsened and now radiates up to the neck and back of neck when she moves. States there is no pain at injection site and no swelling. Informed to see MD if pain continues to worsen.
Presented to ER with SOB and received diagnosis of COVID PNA. Admitted to floor where abx and steroids were given. Also given remdesivir. Completed remdesivr course ans still struggling with O2 saturation. Pt listed as DNR and wished to not be intubated. Remains hospitalzied with poor overall prognosis. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 12 days later.
Fever; chills; headache; sweating; fatigue; This is a spontaneous report from a consumer or other non hcp. A 28-year-old male patient started to receive bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration from 18Feb2021 09:45 to 18Feb2021 09:45 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. On 18Feb2021 22:00, the patient experienced fever, chills, headache, sweating, fatigue. The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
c/o dizziness, loss of sight but cont ambulating; laid in floor-no loss of consciousness pale?; BP 106/64 lying; no nausea or vomiting; no localized site reaction; given Ammonia inhalant;
The first days after the vaccine I felt weak, on the fourth day after receiving the vaccine I collapsed, I couldn't see anything and I passed out, I was unconscious, I was shaking when I was on the floor and when I woke up I was disoriented for a few minutes. This has happened to me two times already in 11 days after I took the vaccine, the other day (04/09/22)  the same thing described above happened to me and I vomited. I feel like I am fighting for my life every day after getting vaccinated. This had never happened to me before, I am a healthy person, I exercise and take care of my diet.
Pt recvd MMR vax on 01NOV90; Approx 10 days to 2 wks following vax pt devel rash over chest & groin, which was dx as pityriasis rosea; MD did not attribute pt's exp to vax w/MMR;
Mom called 08/05/2002 reporting MD visit because left arm of pt; increased redness circling arm with hard raised knot. Treated with Benadryl.
Felt cold -- chills and shivers / shakes.  Turn the heat / thermostat up to 80° and threw on a couple extra blankets and a sweater.  Lasted about 5 hours.   The next day I had aches and felt a little weaken... The following day, I was back to normal...
44yo F with PMH of anaphylaxis on multiple medications who developed subjective symptoms of her throat becoming tight, dry, and scratchy. Pt became tachypnic and tachycardia to 110s, 100% saturation. Pt was evaluated by medical staff and ems, given oral hydration and 60mg fexofenadine. Pt was monitored with symptomatic improvement after 45min. She was cleared and discharged with instruction to not recieve second pfizer dose.
Patient broke out in a rash on 7/15/2010 of freckle like spots that formed in a line of about 50 spots per arm. Also rash on left side of head and face. Patient also noted pruritis. Patient said the rash and pruritis is resolving. Patient counseled to seek medical attention if exacerbation or persistence of symptoms.
Ongoing fever from date of vaccine until 6/24/22.  Temp up to 102.
flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Feb2021 17:00 (Lot number: EN6203) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson Disease" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose Exp.: 31May2021, lot #EN5318, received: 05Feb2021, Anatomical Site of injection- Shoulder, Route of administration-Intramuscular), administration date: 05Feb2021, when the patient was 73 years old, for Covid-19 immunization, reaction(s): "flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. No follow-up attempts are possible. No further information is expected.
Pt clinically well, received routine 2 month vaccines at 10:00 on 5/25/01. Pt returned with mom with history of: went limp, at mall, ? stopped breathing, no resuscitation required at mall. Mom shook pt and she was well after about 30 seconds. Repeat exam at 12:30 was WNL. Referred to ER for further evaluation.
tested positive for A influenza one month after the vaccine; tested positive for A influenza one month after the vaccine; Initial information received on 12-Dec-2019 regarding an unsolicited valid serious case received from a physician.  This case is linked with case 2019SA348219 (same patient)  This case involves a elderly old female patient who experienced Influenza A virus infection (influenza) one month after the vaccine (Influenza A virus test positive), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Patients Family history were not provided. At the time of the event, the patient had ongoing Hypothyroidism and Familial hypercholesterolemia.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, patient developed a serious Influenza A virus infection (influenza) as she was tested positive with  influenza A virus test, one month following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  It is also a case of vaccination failure.  Relevant laboratory test results included: On an unknown date: tested positive for A influenza.  Final diagnosis was Influenza A virus infection.  It was not reported if the patient received a corrective treatment.  The patient event outcome is not reported.  Information on the batch number was requested.; Sender's Comments: This case involves an elderly female patient who tested positive for influenza A one month after and despite vaccination with FLUZONE HIGH DOSE. The time to onset is compatible with the role of the vaccine. However, there is no information regarding patient's condition at time of vaccination, immune status, and predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
This spontaneous report as received from a pharmacy student refers to an unspecified number of patients (gender and age unknown). On an unknown date the patients were vaccinated with a dose of COMVAX (lot number, route and dose were not reported). The pharmacy student reported that an unknown number of dose of COMVAX that were exposed to temperatures of -9 degrees Celcius for 72 hours, may have been administered. No adverse effects were reported. This case is related to case MARRS # 1212USA004592 (same reporter link). Additional information has been requested.
Aching  at site, 1am.      4 on a scale of 1-10 vomiting             7am aching and fever 100.2  sweating  (10) drank water had chicken soup.  took 2 tylenol (500 mg)  Thursday continued, , 1am -mid afternoon, woke up, then slept 20 hours  Friday Jan 22, 2021 Not as much sleeping aching  (7) fever down.  Called the Clinic, my doctor 1x,  NW Specialty Hosp 3 x Normal doses of insulin.  14 units, 7pm, Tresiba, Wed. Thurs and Friday.
fatigued for appx 24 hours after injection and headache. Left arm swelled and has bump/knot at site of injection. Swelling down a bit but bump/knot still present and sensitive to touch. Also arm and shoulder pain. Have not been able to lift arm all the way w/out experiencing pain in my shoulder. No full range of motion. Still hurts to lay on left arm, or put any pressure.
FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
PARTIAL DOSE GIVEN FLUID LEAKED FROM ARM; INJECTION NEEDLE WAS INSERTED  THROUGH A SPECIAL BAND AID, PRESSED DOWN ON THE SYRINGE, THE NEEDLE POPPED BACK IN.; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced partial dose given fluid leaked from arm. On 08-APR-2021, the subject experienced injection needle was inserted through a special band aid, pressed down on the syringe, the needle popped back in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose given fluid leaked from arm and injection needle was inserted through a special band aid, pressed down on the syringe, the needle popped back in. was not reported. This report was non-serious.
Pt immediately developed arm pain at site of inj and then a HA, then she fainted. Was still on exam table. VSS +/0. Kept for 30 min. BS = 81.
Tested positive for Covid after experiencing mild flu-like symptoms; Tested positive for Covid after experiencing mild flu-like symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "recovering" and all described as "Tested positive for Covid after experiencing mild flu-like symptoms". Prior to vaccination, no Covid-19 was reported. Post vaccination, Covid-19 was tested positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sore arm after 2nd shot; Tired after 2nd shot; Chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported.On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot). On 21-Feb-2021, PAIN IN EXTREMITY (Sore arm after 2nd shot), FATIGUE (Tired after 2nd shot) and CHILLS (Chills after 2nd shot) had resolved. No Concomitant medications were reported.No Treatment information was reported.This case was linked to MOD-2021-405051, MOD-2021-405921 (Patient Link).
achy; tired; nauseated/  felt like throwing up; dizzy; watery mouth; This case was reported by a physician via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 24th July 2021, 1 days after receiving Shingrix, the patient experienced pain, tiredness, nausea, dizziness and salivation. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the pain, tiredness, nausea, dizziness and salivation were unknown.   It was unknown if the reporter considered the pain, tiredness, nausea, dizziness and salivation to be related to Shingrix.  Additional details were provided as follows: The physician reported that the patient received a dose of Shingrix and 1 day after the vaccination patient experienced feeling achy,tired,nauseated,dizzy,watery mouth and felt like throwing up. The physician prescribed Zofran as measure. The Physician said a patient was waiting and did not answer any more questions. The case was linked with US2020153384 and US2019104391 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153384:Same reporter US-GLAXOSMITHKLINE-US2019104391:Same reporter
loss of hearing in rt ear, vertigo, tinnitus, nausea, emesis;
Patient was vaccinated with two parents during end of day waste avoidance protocols, on the 8th day of dispensing Moderna; patient returned for dose 2 with parents, where it was discovered he was not 18 years of age; Moderna Dr. was contacted and indicated he may be able to receive dose 2, if parents agreed to enter son into a Moderna clinical trial for adolescents; parents sais, "No" to the clinical trial and all departed without dose 2
I came down with shingles for about two months. Still have some residual nerve issues but very manageable.
Patient was unintentionally administered Shingrix instead of flu vaccine. Symptoms and outcomes are unknown.
Pain at injection site.; Reddness at injection site.; Swelling at injection site; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pruritus, injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the pruritus, injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the pruritus, injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient had itching, pain, swelling, and redness. The batch number of Shingrix was reported as GZ24L, which was corrected to GZ29L as per sales data sheet.