chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced tingling in her arm immediately after the vaccine.  Minutes later, the tingling moved into her entire body and she passed out in the store.  She was out for approximately 30 seconds.  Her right arm was very warm compared to the rest of her body.  She also reported ringing in both of her ears immediately after the vaccine was administered.
Chickenpox shot was given on 1/12/05.  She also received the HIB and PCV vaccine on this same day.  All were given in her legs. On the evening 1/21/05 I found a red bump on the back of my daughters neck.  When she woke up on 1/22/05, she had 2 more bumps, one on the front of her neck and one on her stomach but no temp. at this time.  I called the Dr. office and they paged a nurse to call me.  She felt it probably was not chickenpox because they had no blisters and suggested it may be contact dermatitis.  Around noon on 1/22/05, she started running a temp. ranging from 101 to 102 and the bump on the front of her neck began to get a small blister in the middle of it.  I began giving her tylenol for the fever.  Her temp remained around 101 to 102 the remainder of the day and throughout the night.  On 1/23/05, she still had a fever and it went up to 104.5 around 10 am at which point I called the Dr. office again and a nurse called back and then had a nurse practioner call me.  She said even if this was chickenpox the fever usually doesn't run that high and suggested that I take her to the ER or to the clinic.  I took my daughter to the clinic on 1/23/05 and her temp. was 103.5 at the Dr. office and was diagnosed with a mild case of chickenpox from receiveing the chickenpox vaccine.  She continued to run a temp. the rest of the day around 101 to 102 going up to 103.5 around 1:30 am on 1/24/05.  The fever finally broke about 4:30 am on 1/24/05 and she has not had a fever since.
Woke up to rash & outbreak spots on both arms & both legs (have photos). About 4 more came out during the day. No more outvreak after that
Patient reports, "After being given the H1N1 vaccine I went to a meeting. The meeting was short and about 30 minutes I started feeling my mouth getting full and my tongue swelling.  I took Benadryl at that point.  Then about 15 minutes later, the left side of my mouth and cheek became numb and felt like it does after a visit to the dentist. This lasted about an hour. Then about 3 hours later, after eating, I got dizzy, shaky and sweaty and as my roommate is diabetic we checked my blood sugar and it was 48.  Treated with sugar and protein and this resolved."
1-2 weeks following quadravalent Flu shot, pain developed in shoulder.  Pain remains 4.5 weeks later.  It is especially painful when pressure is applied at the site of the injection, leading me to think it may be related to flu shot.  This was my first year receiving the flu shot.
A case was received from a health professional on 15 June 2007. An 18-year-old female patient with a medical history of "cequor", vocal cord dysfunction, and ADD (attention deficit disorder) had received an intramuscular left deltoid injection of Adacel (lot number C2644AA) and an intramuscular right deltoid injection of Menactra (lot number U2234AA) on 08 June 2007. Beginning one day after vaccination, on 09 June 2007, she developed a stiff neck, photophobia, severe headache, loss of appetite, and difficulty sleeping. She presented to an emergent care facility where diagnostic testing, including CT scan and hematology, were within normal limits. She was treated with intravenous steroids and Valium. Concomitant medications included Singulair and Allegra. The events remained ongoing.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. Concomitant products included Hepatitis A vaccine. On 13th June 2018, the patient received BEXSERO .5 ml. In June 2018, less than a month after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details reported as follows: On 13th June 2018, the patient received Hepatitis A vaccine in a different arm. The patient's mom was called on 26th June 2018 and said the patient was having the pain in her arm till the time of reporting. There were no other side effects besides pain (no redness or swelling). She did think it was related to the BEXSERO.
I was fine ,but then it felt like I had an peanut allergy and felt woozy( suddenly it stopped for five minutes and was sort of hot and then my temperature went normal but it stopped and then I was fine and just stay hydrated. But today I got where my back was itchy and the bottom of.my rib cage was sore but I'm okay now cause I took benedryl.
Vomiting, diarrhea, temperature of 100.1. Could definitely be coincidence and not related to vaccine. No other family member is/has been I'll and I am a nurse. Around sick people all the time.
After 1 day, headache, low grade fever, and fatigue. Day 2 aspirin taken and symptoms improved. Monday started with cold sore on lip and sores on hands.  Sores then spread up arms, legs, and on buttocks. Went to Urgent care and received prednisone which improved sores.
Injection site sore and swollen -- started after injection and still continues today.  Eighteen hours after injection the following side effects came almost simultaneously--nausea, headache, sore throat, swollen glands, chills and very cold feet (these were the two worst side effects),  flushed face, body aches and pains, very fatigued.
This case was reported by a physician and described the occurrence of injection site itching in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. On 23rd February 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain. On 23rd February 2018, the outcome of the injection site itching was recovered/resolved. On an unknown date, the outcome of the arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hour after vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather weird dream in which he had developed an egg-sized tender mass at the injection site which he had named, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395 and US2018GSK036922, reported by the same reporter.
COVID positive; COVID positive; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's Wife) reported for a 48-year-old male patient (reporter's husband). A 48-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 17May2021 (48-years-old at the time of vaccination), as dose 1, single, dose 2 via an unspecified route of administration, administered in arm left on 07jun2021 (batch/lot number: er8729) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Consumer stated there are six people in her house, and they all got COVID. Her and her husband both got COVID and were both vaccinated, on 29Jul2021 her husband (patient) experienced covid positive. He did not have a prescribing doctor. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 29Jul2021.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
rt upper extremity paresthesias/pain  down to fingertips;(however does have +neck sx-?pre-existing problem);referred for ortho eval;
01/03/22 presents to ED for "malaise and diffuse weakness" "slurred speech for 2 weeks". PMHx of "hepatitis B"
does not know if this is considered a anaphylactic reaction; her heart rate rapidly increased, and it got up to 160; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history included food allergy. Concomitant medications were not reported. On 19Apr2021, shortly after the vaccination, the patient's heart rate rapidly increased, up to 160. Her heartbeat also increased in intensity. The patient did not have any skipped heart beats. The patient's baseline heart rate was 65-72. The reporter did not know if it was considered an anaphylactic reaction and queried whether this was a full anaphylactic reaction. Within half an hour, the patient's heart rate was down to 95 to 100. The rest of the day, the patient rested, drank fluids, and had no stimulants. Today (20Apr2021), the patient's heart rate was back to her baseline at 65 to 70. The reporter preformed an electrocardiogram on the patient on an unspecified date, and it showed normal sinus rhythm. The reporter asked if the patient should get the second dose of the vaccine. The clinical outcome of anaphylactic reaction was unknown, while of "her heart rate rapidly increased, and it got up to 160" was resolved on 20Apr2021.   Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylactic reaction cannot be excluded.  The case will be reassessed if additional information becomes available.
Pt cAlled today 6/18. C/O HeAdAche Approx. 1 hour After receiving Bexsero no fever no vomiting. 1 episode of diarrheA. HAd virtuAl visit with Dr todAy.
No additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ on 5/22/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot # S013890, expiration date 14-FEB-2021 (exact dose, strength, frequency, route of administration and indication were not reported). The vaccine was stored at the temperature of 12.1 (C) for 16 hours 11 minutes which was registered by the data logger. There was no previous temperature excursion occurred. No additional adverse event information was provided.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out after administration and was cold and clammy blood pressure checked 112/84 patient regained consciousness after a couple of minutes and said she felt light headed
Pt came in for a booster.  He had J&J as a initial dose.  He wanted J&J again.  Dose was administered and he was waiting 15 min of observation.  About 13 min into that wait, he c/o not feeling well, hot, hard to breath, wanted a glass of water.  One nurse stayed with him and another went for the water.  Upon return with the water, the patient has lowered himself to the ground.  He complained again of not feeling well, hard to breathe and chest hurt.  B/P was 160/104 and HR was 160 and pulse ox was 98%.  Rapid breathing.  We attempted to get him to slow down breathing and take deeper breaths.  He continued to complain of blurred vision and chest hurting.  BP remained elevated and HR was 160's and pulse ox remained at 98%.  He was much more anxious and c/o mouth dryness and throat dry.  We administered The Auvi-Q epi dose and we were able to get him to take 50mg of benedryl.  He continued to be extremely anxious and c/o of being cold, hands tingling and difficulty breathing.  At that time we called 9-1-1.  The ambulance arrived and parmedics evaluated.  He was then transferred to Hospital.
Information has been received from a Registered pharmacist concerning an 83 year old female patient with "heart condition", quinolones allergy, penicillin allergy, MACROBID allergy and sulfonamide allergy who on 30-JUN-2010 was vaccinated SQ in the right arm with a dose of ZOSTAVAX (Merck) (Lot# 665516/1271Y) (Expiration date: 03-MAR-2010). Concomitant therapy included sotalol hydrochloride, potassium (unspecified), warfarin, furosemide and carvedilol (reported as carbadiol). The pharmacist reported that on 07-JUL-2010, the patient developed a reaction and presented to her physician with a rash all over her body especially her face and arms. She was prescribed Hydroxyzine for treatment and took one dose. The symptoms had now resolved in full, but she still had a residual itch between her fingers. Follow up information was received from the physician indicating that he did not remember any one adverse reaction and that they were not aware of any ill effects to ZOSTAVAX (Merck) for this patient. No further information is available.
Beginning in April, my menstrual cycle has been extremely heavy. It has never been this heavy before in my life. There are numerous things that could have caused it (age) but I did notice it more so after the vaccination.
soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient mentioned that previously she already received 4 shots of Pfizer COVID -19 Vaccine, 2 doses of the primary series (captured as Pfizer COVID 19 Vaccine) and 2 booster shots (captured as COVID 19 vaccine booster). Consumer stated, it was between elbow and wrist, so the forearm and that was 3 days after the vaccination. So, patient had a typical reaction that had for the prior 4 Pfizer Vaccination for the symptoms, soreness of the upper arm where the injection site occurred. Height about 5 ft. 3.5 and weight about 105 pounds and weight is about 105 up to 110 but you can say 105. Other Medical Conditions and Other Medications: Consumer stated, Yes, but nothing neurological and nothing having to do with heart let back on you and talking about other medical condition, nothing having to do with heart or anything like that, only numbness in hand or fever anything like that. Consumer stated no treatment was received. No Investigations was conducted.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296272 same patient, different vaccine dose/event;US-PFIZER INC-202201296759 same patient/ event, different vaccine doses;US-PFIZER INC-202201296760 same patient/ event, different vaccine doses;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN.), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300336312 same reporter/patient; different drug/events;
Mother denied child having any problems following vaccine - mother stated she called pediatrician, to inform her H1N1 nasal mist given in error - stated Dr did not recommend antivirals - states was told to call office if child started having flu-like symptoms.
Patient came in 8/22/15 Red swelling on upper arm wasn't' hot to touch. Told her to ice down overnight. Patient came in Sunday 8/23, swelling and redness went down.
no Problems reported.   Patient vaccine was given a dose that was  in the refrigerator for 37 days.
Sore Throat, swollen tonsils, T 100.2, body aches and cough, Txed with PREDNISONE and TAMIFLU.
Soreness at injection site on arm immediately and increasing for next 2 days.  Body aches, shivering and fever began about 24 hours after vaccination with fever up to 100.3. Fever lowered within 3 hours to normal range with NSAIDs. Continued use of NSAIDs for 24 hours. By next morning, no fever, but continued NSAIDs to manage body aches. Body aches resolved by morning of 3rd day. Still soreness on arm (less than previously.)
This infant had DTaP given 03/29/01. 10 x 8 cm local reaction, redness, and induration on the leg leg.
9dats following injection upper arm bright red swollen itchy and painful deep into muscle. Has lessened but still sore now
Client received first dose of vaccine @2:52pm.  At 3:16pm  client alerted EMT he was not feeling well, stated he "felt like he was shutting down".  Client lost consciousness while EMTs supported him upright in chair.  Client had convulsions for 5 seconds and was unconscious for approximately 20 seconds.  Once client regained consciousness he was assisted to zero-gravity chair, alert and oriented.  Client was pale and diaphoretic, no trouble breathing, able to talk and answer questions.  Client denies having any seizure activity in past, denies medical conditions, not taking medication, no allergies.  EMS was called by lead RN @ 3:30pm, arrived on scene @ 3:40pm.  EMS completed assessment, made client aware everything appeared normal, offered to take patient to hospital, client declined.  Client made aware to follow up with his primary care and when to call 911.  Client's girlfriend and family present, client able to walk out with steady gait.  Client left @ 3:50pm.
Severe diarrhea, Lips tingling and swelling, rapid heart rate, sweaty, feeling hot (pt didn't check for fever).
Information has been received from a physician and a healthcare worker concerning a 44 year old male with who on 17Aug05 was vaccinated SC in the left arm with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot650453/0791P).  It was noted that the lot number was also reported as unk, although the physician believed it was lot 650453/0791P.  The pt presented to the physician's office on 18Aug05 with a swollen left arm pt was treated with a methylprednisolone (Medrol) dose pack and diphenhydramine hydrochloride (Benadryl). No diagnostic lab tests were performed. The physician requested a lot check. Results are pending. Swollen left arm was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Spotting and Blood from Rectum; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (manufacturer control number 21K-163-4081234-00).   Solicited report by a consumer of an adult female with an event of non-serious spotting and blood from rectum with HUMIRA (adalimumab). There was no reported medical history. On an unknown date in 2021, the patient experienced spotting and blood from rectum. PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown; 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. Reaction(s): Rectal bleeding - (Rectal haemorrhage) with outcome of not recovered/not resolved. Reaction: Rectal bleeding - (Rectal haemorrhage) with start date unknown in 2021 and stop date unknown. Suspect drug(s): HUMIRA (solution for injection in pre-filled pen) (adalimumab), unknown; daily dose reported as citrate free; route of administration was subcutaneous; indications for use was moderate to severe ulcerative colitis; therapy dates were unknown; product-reaction level: drug: HUMIRA (solution for injection in pre-filled pen) (adalimumab), unknown; action(s) taken with drug was unknown. Suspect drug(s): PFIZER BIONTECH COVID-19 VACCINE (tozinameran); daily dose was 1 in 1 once; route of administration for 1st and 2nd dose was intramuscular; therapy dates/duration of 1st dose was on 13Sep2021 to 13Sep2021; indications for use was covid-vaccination; product-reaction: drug: PFIZER BIONTECH COVID-19 VACCINE (tozinameran), unknown; action(s) taken with drug was unknown. Other relevant history was not reported. Concomitant drugs and dates of administration were not reported. Causality for HUMIRA (adalimumab): The reporter's causality for the event spotting and blood from rectum was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event rectal bleeding-rectal haemorrhage was reported as probable.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. 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.