chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 month later had covid/last booster Nov2022; 1 month later had covid/last booster Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249), on 30Jan2021 as dose 2, single (Lot number: EN5318), on 01Sep2021 as dose 3 (booster), single (Lot number: FC3183) and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "1 month later had covid/last booster Nov2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300075639 same patient, different vaccine dose/event (Dose 2);
Localized redness with swelling after vaccine (Typhoid, 0.5 cc IM) administered. Vital signs were HR 58, 149/93, RR 16, 100% O2 sat, at 11:28am, 11:40am 158/90 with HR at 61, 15cc, 11:45 am 146/92, 61, 16 with 99% O2 sat, 12:00pm 150/93, 17, 100% O2 sat, HR 58, 1210 pm 138/82 at 1205. no dyspnea nor discomfort per client, ice pack held at site intermittently. Client remained seated quietly x 45 min. Dr advised , last VS at 12:15 60, 130/83, 16 100% O2 sat. Dr checked client cleared ho to leave our clinic after she listened to lungs, examined site of patient and interviewed re history.
Patient tolerated well on date of injections 10/11/2012 at 9:10 AM. Saw Urgent Care 2 days later on 10/12/12 at 12:45 with complaints of arm pain at injection site. (No signs, redness or fever or rash.)
Patient developed hemolytic anemia, admitted to hospital, started on high dose steroids. Hematologist believes this is from the covid vaccine
Client was sitting on exam table and he leaned back, became unresponsive for approx 20 sec, opened eyes and immediately gave correct responses.  Mother in room entire time, juice box given to individual, he had not had anything to eat this afternoon.  Client sat up and talked, after approx 15 minutes individual walked to car with mother, he was not going to drive.
major seizure within minutes of receiving shot; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at 14:00 (at the age of 78 years), in left arm, for COVID-19 immunization. The first dose of BNT162B2 was given on 12Feb2021 at 12:00 PM in left arm (at the age of 78 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified statin drug and blood pressure medicine. On 05Mar2021 the patient experienced major seizure within minutes of receiving shot. The event required Emergency room/department or urgent care and ended up on ventilator in ICU. Treatment received included lorazepam (ATIVAN), intubation, ventilator, CT scan, MRI, EEG. The event was reported as serious as required hospitalization for 6 days and was life-threatening. Event outcome was unknown.  Information on the lot/batch number has been requested.
Patient states pain and inability to lift arm or sleep due to soreness.  She was going to physician to see if any treatment necessary.
Information has been received from a physician concerning a 4 month old female who on approximately 06-NOV-2007 was vaccinated PO with the second 2.0 ml dose of Rotateq (no lot number provided). Concomitant drug therapy included "antimicrobial (unspecified)." On 20-NOV-2007 two and a half weeks after being vaccinated, the patient experienced intussusception characterized by an abnormal stool and was hospitalized for a total of 3 days. A barium enema test was performed and the patient underwent surgery to repair the intussusception." On 23-NOV-2007 the patient was released from the hospital. Subsequently, the patient recovered. There was no product quality complaint. The physician also considered intussusception to be an other important medical event (surgery). Additional information has been requested.  1/11/08 Reviewed hospital medical records which reveal patient experienced irritability, black stools & bilious emesis x 12 hours which progressed to bloody stools.  Went to outlying ER where gastrograffin enema reveals IS that could not be reduced despite 3 attemps.  Transferred to higher level of care for surgical management.  Admitted 11/20-11/23/2007.  On admit, lethargic, distended abdomen w/epigastric mass palpablel.  To OR for exp lap, no bowel resection needed.  Did well post op & d/c to home. Final DX: intussusception, surgically reduced. 1/22/08 Reviewed vax record.
While in observation area following Vaccine developed headache with nausea, mild photosensitivity  BP: 200/110-180/100.  Monitored patient for 2 1/2 hours with BP checks every 15 minutes, patient in medical area resting.   She felt better upon discharge She was instructed to contact her family physician for follow-up.  Site manager made contact with her later in the same day -she still had a slight headache -again she was encouraged to call her physician for follow-up
swollen, red arm/Local site reaction 10cm x 10 cm; swollen, red arm/Local site reaction 10cm x 10 cm; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (medically significant), VACCINATION SITE ERYTHEMA (medically significant), outcome "unknown" and all described as "swollen, red arm/Local site reaction 10cm x 10 cm" after administration for 5 days. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of PREVNAR 20 and the onset of both events swollen, red arm/Local site reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect 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.
Since August 6, 2021, I have been having constant ear ringing or tinnitus in my left ear.  Sometimes it gets so bad that I cannot hear out of my left ear.  Almost 2 years later, and it has not gone away for even one day.  At some point I know I am going to need to get a hearing aid for my left ear just to be able to hear better.
a 64 year old patient receivced a dose of Fluzone HD, no AE; a 64 year old patient receivced a dose of Fluzone HD, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (other).  This case involves a 64 years old patient who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting the patient had no 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 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.  Information on the batch number was requested.
Headache & Myalgia Narrative: dose 1 day 1-pain at inj site;chill/ha; day 2-chill/ha;day 3-5 numbness dose 3 day 1 pain at inj site/ha; chills flu s/s
Localized erythem right arm after DTAP # 5 given.  No respiratory symptoms.  Symptoms subsided 3-4 days after vaccination.
This spontaneous report was received from a 66 year old female consumer refers to herself. No concomitant medication and pertinent medical history were reported. Drug reactions/allergies to penicillin and sulfa drugs, unspecified reaction to "a smallpox vaccine booster dose sometime in the 1960's". On 23-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) subcutaneous injection at her right arm. After vaccination, she first developed a bad headache. The next day, on 24-AUG-2013 she developed a lump on her arm at the injection site and began to get very achy with a lot of joint and muscle pain that was mostly on her right side (her injection site). She reported pain also in her hips and back. She first spoke with an unspecified pharmacist about her reaction. On 25-AUG-2013, she had "facial edema" and her face "felt tight",. She saw an unspecified doctor on 26-AUG-2013, and the  doctor told her to continue treatment with ice and BENADRYL. The patient could not confirm whether or not the redness on her skin was a rash, but she stated that the redness was itchy and "a little like a rash". No lab diagnostics studies were performed. At the time of report, the outcome of the events was recovering. Additional information has been requested.
Extremely swelling to the site. Mother states approx. 5X5". Red, hot to the touch. C/o itchy. Painful.
I took the vacacine Merdena.mabout one 1/2 hour in Time I started to get  tightness of the chest AND palpitaciones..AND also a sensation of an electricista.
Ithchiness at injection site 7-5cm erythema. Advised using heat/Benadryl cream for symtoms
I felt very fatigue; Terrible headache / Symptoms are back again and terrible heavy headache; Very little dizzy; Chills; Stuffed nose; Discomfort; discomforted throat; Little cough; muscle pain / muscle back pain; runny nose; Stomach acid influx; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 (at the age of 63 year old) as dose 1, singe for COVID-19 immunisation. The patient medical history included runny nose: allergy to cold. The patient's concomitant medications were not reported. After received the vaccine on 13Mar2021, on next day evening she felt very fatigue and terrible headache and sometimes very little dizzy, had chills, stuffed nose, discomfort, discomforted throat and a little cough, but no fever. She also had back muscle pain. The next day evening all this symptoms were gone except discomfort and stuffed nose. But two days later all this symptoms are back again. She specified the headaches were her most severe symptom while the other ones were mild. Next day she started to take Tylenol for pain relief. She continued to take pain relievers /Tylenols 500 mg for 5 days for headache. And after the fifth day of medication the headache was better, where she stop taking the medicine. It was reported that she was a person who easily gets cold and has to take medicine for 1-2 week before she can recover. She mentioned that she also had a runny nose, which was the allergy to cold and thus had a runny nose everyday in this past winter. Also, had stomach acid influx that hurts her throat, therefore she always had an unclear throat. Until the time of report, she still has headache and back muscle pain. The outcome of the events headache and back muscle pain was not recovered and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, sore throat Narrative: Per nursing report; " took vaccine on Wednesday 7-28-21. Thursday morning [7/29] after vaccine had headache and Friday morning [7/30] felt achy and states not feeling good. C/o this morning [8/5] c/o sore throat. Afebrile. "
Pt states that he had a rash that started on the day of administration (1/10/22) and lasted for a few days.  The rash spread from the injection site in the left arm to his elbow and abdomen.  He states that he took zyrtec and the rash started disappearing on 1/13/22.
Client received 3 vaccines, immediately following vaccine #3, client lost consciousness and began to seize. Reaction lasted approximately 30 seconds. Client then regained consciousness and began feeling nauseated and appeared pale. Client provided with juice, and nausea dissipated and client regained normal coloring. Client instructed to wait in waiting room for 15 minutes before leaving clinic. Instructed to call with recurring side effects or questions.
Anxiety, hyperventilation, headache, hip girdle pain within 1-2 hours of vaccine administration.
Redness, swelling, raised welt. Weeping blisters, weakness, fatigue, by 12/22/2013. Started to get better 11/23/2013 AM.
pt recvd vax & failed to seroconvert; 3DEC92 pt recvd 4th dose of vax & 10 days later devel a transient, pruritic urticaria on face, neck & forearm & a rash above rt eye;
After my husband got the flu shot, he went home and fell asleep and slept til bedtime, then got up and slept til 9:30 am. next day.  When he got up, he had trouble getting his breath when he went up stairs or just going into the bathroom.  Just the day before shot he was walking around fine breathing with no problem.  I took him to license branch and lab and he had to do a lot of walking and it didn't bother him.  The day after the flu shot, he said he must have iron poor tired blood because everything he did wore him out.  He got the shot on Wednesday and this kept happening.  He was fine if he was just sitting still.   On Sunday night, when he got up to go to bed, he really couldn't get a good breath at all.  He yelled help me and just barely got sit down.  He had me call 911 and they came in with oxygen.  They told him to slow down, he was hyperventilating.  They made him walk to the stretcher outside and told me he would be okay.  Then, I called the hospital to see if I could come see him and they said right away.  When I got down there they said his heart stopped as soon as he got there and they tried CPR.  They could not revive him and he passed away a little after midnight.  This was a man whos oxygen normally ran around 98% and after the flu shot his oxygen was only running around 89-90% and dropped to 72 % right before ambulance got there.  I'm not sure if they took oxygen off him or not because they asked me for a mask for him.  That didn't make sense.
Vaccines were given on August 24. Patient called pharmacy on August 27 to report her left arm was still in pain and impacting her normal function. On August 28, patient reported her right arm was still in pain but her left arm was ok.
Vaccine dose administered to be patient pertained to a vial that had been opened for over 6 hours.
Nausea 4-6 hours later Rash on arms (non injection site) and face (2 days - present)
Multiple active problems. Recurrent depressive disorder, Type 1 diabetes, generalized weakness, Sneddon syndrome, idiopathic livedo reticularis with thrombotic CVAs, Autoimmune thrombocytopenia ,Antiphospholipid syndrome, Seizure disorder, Hemiparesis affecting the right side secondary to her CVAs, Essential hypertension, Ongoing cognitive impairment status post acute infusion. ED visit on 11/19; Hospitalized on 11/19 (5 days), 11/24 (8 days), 12/4 (11 days), and 12/15-current (14 days). These visits are within 6 weeks of receiving COVID vaccine.
Fever, Aches, Sore Throat. By 8:00 PM fever was 102 F. Took Tylenol. Felt much better next morning, but not 100% well.
Painful rash, swelling and irritation on face and lips 2 days after vaccine.
On 11/18/2000 the patient presented to the physician's office with "4 lesions with crusting, all on her right side". The lesions did not cross the patient's midline. The physician stated that she did not actually see the patient, but that another physician saw the patient and diagnosed herpes zoster. As of 12/12/2000 the patient recovered from her herpes zoster lesions/scabs. Additional information has been requested.
Severe nausea, vomiting, and chills for 5+ hours, NO FEVER
Swollen rash that is warm and red from elbow to collarbone. Skin was peeling, itching, burning, painful to touch. Today, Day 4, not as painful but still red and tender and rash still from elbow to collarbone.
This is a spontaneous report from a contactable consumer (reporting for her mother) and a contactable physician. A 68-year-old female patient of unspecified ethnicity, received PREVNAR 13 (previously reported as PREVNAR 7)), via an unspecified route of administration on 03Apr2014. Medical history and concomitant medications were not reported. The patient received the vaccine on 03Apr2014, and experienced high fever for three days, cough and cold symptoms; onset date in Apr2014. The outcome of high fever for three days, cough and cold symptoms was unknown. Follow-up (22May2014): New information reported from a contactable consumer includes: suspect product data (suspect product was updated to PREVNAR 13). Follow-up (26Jun2014): New information received from the contactable physician includes: This physician confirmed the occurrence of the events. Follow-up attempts completed. No further information expected.
tingling sensation side of jaw; tingling sensation inside the mouth; tingling sensation inside toungue; blood pressure went up; pulse went up; A spontaneous report was received from a nurse who was also a 72 years old, female patient who experienced the serious events of a tingling sensation in the side of her jaw, inside her mouth, and tongue, and also had an increase in blood pressure and pulse rate.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 26 Dec 2020, approximately 5 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The patient reported she received the Moderna vaccine on 26 Dec 2020 and after 5 minutes, she experienced tingling in the side of her jaw, inside of her mouth, and tongue. She described it as "like getting a Novocain injection." She was rushed to the ER and then suddenly her blood pressure and pulse went up. A CT scan of the brain was performed, and per the patient, symptoms were somehow resolved. She was advised by her primary care physician that she cannot get the second dose of the vaccine based on her reactions. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, tingling sensation in the side of her jaw, inside her mouth, and tongue, and had an increase in blood pressure and pulse rate were considered resolved on 26 Dec 2020.; Reporter's Comments: This case concerns a 72 years old, female subject, who experienced a serious unexpected event of jaw disorder, paraesthesia, paraesthesia oral, and non-serious unexpected event of blood pressure increased and heart rate increased. All the events occurred after 5 mins of mRNA-1273 (Lot# 039K20A) vaccine administration. The subject was treated in ER (details not provided). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore Lt Shoulder with redness and slight swelling then very tender Left arm with swollen lymph nodes and ache with arm movement.
pt recv vax 10NOV98 & dizziness 15NOV98;?URI 11NOV98 pseudolphedine;UTI 10NOV98 sulfamethoxatzote/trimethze x 5 days;
Pt received vaccine 3/2000 in other office. Varicella - illness with >100 lesions and fever to 102. Mother and uncle with varicella at same time.
Fainted very briefly but she asked where she was and heard loud music while out. Nauseated and dizzy. Headache too.  She stayed at the doctor office for at least 15 minutes afterwords. Nurse walked us to the car.
Sore; This is a spontaneous report from a received from Pfizer colleagues Immediate Family and household Vaccination program. A contactable nurse reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore on unknown date. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arthralgia L hip pain, R arm lymph node swelling, fatigue, stiff neck Emp reported previous L hip steroid injection 15 days prior to #1 covid vacc on 12/30/20. s/p #1 vacc day 1 noticed increased pain in L hip w no relief until 10 days after. noted on day 5 R underarm lmyph swelling, fatigue, and stiff neck.
Patient experienced loss of voice due to dry cough. ER visit. Was told to quarantine for a week.  Negative for Covid. Cold/Flu symptoms.
Patient to office on 10/11/11 c/o fatigue, nausea, vomiting, numbness in bilateral hands, syncope at work. Received flu vaccine on 10/10/11 at a separate facility.
Left leg became red, swollen and inflamed on 3/26 and gradually became hotter, more swollen and larger to softball size area. SXs are ongoing.
Site of injection: redness, swelling, warm to touch, tender to touch and rough patch of skin. Redness is scpreading. Doctor assessed and prescribed antibiotic cephalexin 250 mg/5mL oral suspension.
Am guessing on the flu sho:. I have Flu Quadrivalent 0.5ml PF age 6 (IMM400A). Felt weird around 9:45 and went to bed. Awoke at 11:45 P.M. to pee and started whole body tremors, everything shaking and extremely  cold. Went back to bed and awoke at 3:45 to pee and almost fell  but landed hard on the toilet seat, not yet recovered from shaking. Went back to bed and was only a little tremorous the next day.