chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt weak and dizzy and had syncopal episode. Patient received vaccine, walked out to sit in observation area and had syncopal episode after sitting down. Lasted about 1-2 minutes. Mother provided water and held patient up to prevent from falling over. Declined requesting ambulance. Patient became responsive after 1-2 minutes and continued to feel weak and dizzy. The patient was instructed to stay for at least 30 minutes. Mother left with patient after 45 minutes and were instructed to go to urgent care or emergency room if condition of weakness/dizziness does not improve.
Pt recvd vax 12MAR92 & dad phoned 13MAR92 & stated that site of DTP was red & painful 5" in diameter around site; no fever, moving hand but not arm (painful) not acting any different;
I was diagnosed with shingles approximately 2 weeks after shot. Reoccurence one month after that.(very mild in both cases) I have had a Shingrex vaccine and booster. Wondering if possibly related.
At first I felt like my heart was beating out of my chest. That lasted for several hours. Around 5:30 PM I got a bloody nose that was pretty bad. I decided that that was more than my body could take so I went to a urgent care clinic. They took my blood pressure and said I needed more care then what they could provide so I went to the ER at Medical Center and my blood pressure was 231 over 109. They did an EKG that came back okay. They admitted me for observation and gave me nitro under my tongue to bring my blood pressure down. They kept me overnight and since then my blood pressure has been high but not that high at it was at first. I have been extremely tired. My heart rate is still fast. Last night I started feeling like I could function normally for about two hours. Yesterday and today I could stay awake. I feel about 80% good. My blood pressure today was 125 over 80. I keep pushing fluids, sleeping, and waiting for things to go back to normal. Also last night I had woke up because I had horrible pains in legs.
Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021.  The patient experienced the following reaction(s) during the immediate   of observation: "Feeling funny" "Cold feet"  Patient was treated/managed as follows:   Vital Signs: 1240pm -BP: 140/76 HR: 94 RR:18 1250pm-BP: 133/88 HR: 82 RR: 18  Pt reports feeling better   Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.  Pt escorted out to car by Site Lead
pt recvd 2nd dose of measles vax 4JUN92; w/in 2 hrs of vax pt exp nausea & lightheadedness; w/in 4 hrs felt tired & lethargic; w/in 6 hrs exp vomiting; 5JUN92 became pallor & devel pruritic areas; n,v & fatigue persisted 1 wk;
POSITIVE FOR COVID 4/8/2021, HOME ISOLATION, SUPPORTIVE CARE
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium.
stomach upset; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0170) via intramuscular route administered in left arm on 18Apr2021 at 17:30 as single dose for COVID-19 immunization.  There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included COVID-19 from Feb2021 to an unknown date. The patient's concomitant medications were not reported. The patient experienced stomach upset, nausea, and vomiting; all non-serious in Apr2021 after the first dose. Outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021626225 same reporter/patient/drug (second dose), different events
loss of appatite  for4 days, nausea for 4 days, headache for 4 days, general malaise
feel sick; Initial information was received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves a patient of unknown demographic details who felt sick (malaise), after being vaccinated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.    On an unknown date, the patient received INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date were not reported) via unknown route, at an unknown dose at unknown vaccination site for prophylactic vaccination.  On an unknown date, (latency: unknown) after receiving INFLUENZA VACCINE, the patient felt sick for 2 days (malaise). The patient reported that the patient did not get the flu but every time after receiving the vaccine, felt sick for 2 days.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was resolved on an unknown date.  There will be no information available regarding batch number in this case.
Had diarrhea for 7 days worried that her second shot would cause the same problems, also her mom died from COVID
Injection site severely throbbing. Ague like syptoms - all over body aching and chills.  The symptoms lasted for 30 hours.
Patient received Hep. B vaccine (Glaxo-Smith-Kline Engerix-B) on 6/18/08 which had an expiration date of 6/15/08.
Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.
pt recvd 1st dose of vax & 15 mins following vax devel severe pain in lt shoulder which spread down the lt arm & lt chest wall; next day devel frontal h/a, fever, nausea, sweating & felt weak all over;
Patient received routine varicella vaccine, intramuscularly in the left deltoid, at a Pharmacy.  Shortly afterwards, the patient noticed a rash that developed near the injection site.  There was about a 6-9 inch diameter of a rash that resulted in some itchiness and discomfort.  The patient also developed chills.  The patient self treated with Tylenol and Benadryl and recovered after several days.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 03-Jan-2012, the patient inadvertently received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: No adverse events were experienced by the patient.
1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 at 11:00 as dose 1, single (Lot number: EN6206), in right arm, on 03Apr2021 at 11:00 as dose 2, single (Lot number: ER8734), in right arm and on 24Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) positive, notes: Test positive for covid on 17Nov2022; (21Nov2022) Negative, notes: test negative on 21Nov2022; (26Nov2022) positive, notes: repeat the test 26Nov morning getting a positive; (29Nov2022) positive, notes: Today is 29Nov still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Per clinical course, patient tested positive for covid on 17Nov2022 and started paxlovid lowdose (renal patient) on 18Nov2022 then tested negative on 21Nov2022. Last day of treatment was on 22Nov2022. Symptoms came back on 25Nov night: runny & stuffy nose, fatigue, sore throat and repeated the test on 26Nov morning and getting a positive. Today was 29Nov and still testing positive with fatigue and headache.
felt fatigued; nauseous; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose, (She didn't feel well after her second, dose either but only for 1 day).), for Covid-19 immunization, reaction(s): "Did not feel well". The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovering", described as "felt fatigued"; NAUSEA (non-serious) with onset Oct2021, outcome "recovering", described as "nauseous"; HEADACHE (non-serious) with onset Oct2021, outcome "recovering", described as "headache".  Additional information: Clinical course: About 12 hours post injection, age felt fatigued, nauseous and had a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives/rash all over body. Uncontrollable with Benadryl after 4 days.
Site sore to touch, warm, redness extending from 2 in below shoulder to 2 in above elbow in the arm injection was given.
Arm is sore; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired). At the time of the report, VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-023993 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023993:Crosslinked (MOD21-022232)
Patient received injection following work related injury. Now has severe deep muscle aching all through left back and left arm, elbow, wrist. No visible swelling, no infection. Persistant aching and pain through arm.
This spontaneous report was received from a nurse practitioner and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unspecified dates, improperly stored doses of ZOSTAVAX (dosage and route administration were not provided; lot # M009773 with expiry date 17-MAY-2017 and lot # M036296 with expiry date 14-NOV-2017) were administered to the patients. The vaccines were stored in the temperature 8 degrees Fahrenheit for 1 hour and 15 minutes. There were previous temperature excursions over 6 degrees Fahrenheit but under 14 degrees Fahrenheit for 2 hours and 25 minutes and over 15 degrees Fahrenheit but under 46 degrees Fahrenheit for 17 hours and 50 minutes on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1703USA013637.
Increased dyspnea and wheezing 3 days after vaccine administration, required ED visit and prednisone course
RAISED RED BUMP, VERY TENDER AND ITCHY. MOM TREATED WITH BENADRYL AND TYLENOL
Nausea, vomiting, dizziness after 1.5 hours, after 3rd shot HBV vaccine. No prior reaction to other shots. Also, complaining of hives. Denied shortness of breath.
Numbing of left leg/Numbing of left side of face; This is a spontaneous report received from a contactable pharmacist (patient herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: EL3247 and expiry date: May2021) via an unspecified route of administration to left arm on 17Jan2021 12:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. She was administered vaccine about 12:30 on 17Jan2021 she sat there monitored for about 15 minutes. She reported the Numbing of left leg started while she was walking out, about 13:00 from her left leg down to her foot; her left arm was fine, there was no Numbing there or other areas of body or left side of body other than onset of Numbing of left side of face a little bit after onset of Numbing of left leg. She thought at first maybe it was from the way she had been sitting, but she had been sitting normal. The Numbing of left leg and Numbing of left side of face lasted for a couple of hours on 17Jan2021; resolved and she recovered completely as far as she is aware by 17Jan2021. She reported not serious for both events because it went away. She is due for her second dose on Sunday and is afraid to get second dose. Both events were recovered on 17Jan2021.  No follow-up attempts are possible. No further information was provided.
Right arm pain at injection site, right arm numbness. on 2/8/16 rash, short of breath, tightness in throat, treated with oral steroid burst and taper. burning, numbness, pain in neck, upper back, and shoulders. headaches. bilateral leg and left arm weakness.
Patient recieved his first 3 vaccinations on 4/20/07, friday at 4:45 pm.  Friday night he had a fever of 103 at the highest.  Saturday the fever was between 102-103, he was fussy, sensitive to touch and movement, and didn't open his eyes very often.  Saturday night he was still fussy, fever between 101-102, didn't sleep well, and his body seemed to hurt.  Sunday morning his temp.was 102 and then it went down to around 100 and stayed that way for the rest of the day.  Seemed like he was starting to feel better.  Then that afternoon he started getting fussy again and he kept flinching.  Around 8 pm I noticed red streaks over his knuckles on both hands and big toes.  He started crying more and more.  Didn't sleep well, fussy, tense and uncomfortable, unable to soothe him for long.  Monday his hands were worse, red over the knuckles, looked swollen, red over big toes and now red over ankle bones.  Acting as if he is in alot of pain. Crying out in his sleep, screaming suddenly when awake.  Doesn't want to be moved at all.  Took him to the ER Monday morning.  After blood work, research, and observation we were discharged with the following diagnosis.  Non-specific post vaccination arthritis/arthralgias.  I was instructed to do a follow up visit with his primary physician, which I did the following day (4/24/07).  I have tried to get further follow up care, to figure out what went wrong or how to prevent such a reaction from happening again, but have been unable to get any referals to anyone who can give me more answers.
body twitching; nerve damage; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient (reporter's husband) received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included atrophy from an unknown date and unknown if ongoing, prostate infection from an unknown date and unknown if ongoing. The patient previous received first dose of bnt162b2(Batch/Lot number was not reported) for COVID-19 immunization and developed got sick. The patient's concomitant drug was not reported. The patient experienced body twitching, nerve damage on an unspecified date. She and her husband aged 78 received the second dose of the Pfizer BioNTech Covid 19 vaccine. Her husband, aged 78, nine days after the second dose developed body twitching and nerve damage which he is still experiencing. His primary doctor says to get the booster dose but his neurologist says to hold off. When probed about adverse events related to husband: Reporter stated, her husband he is not here and she didn't have his card. She was going to say 9 days after he had his second Pfizer. With the first one he got sick. With the second one about 9 days, 2 weeks later (as reported) he came down with muscle twitches, so he has been to every doctor and he has nerve damage now. He is about 5 (foot) 8 (inches) and about 185-186 (pounds). Other Medical conditions: Reporter stated, he has atrophic, now it's prostate and like other things that has come with him older. There are two labs test down the last one was the prostate and so the other one was and so one in his regard quest (further clarifications unknown). The patient underwent lab tests and procedures which included Lab test: unknown results, prostate: unknown results both on an unspecified date. The outcome of events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101450679 same patient, different event, different dose of vaccine
No additional AE; Inbound call from office manager calling to report administration of VARIVAX that experienced a temperature excursion; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 21-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL once, lot # W039689 with expiration date 13-DEC-2024, for prophylaxis (strength, route of administration and anatomical location were not reported). It was stated that the vaccine experienced previously a temperature excursion with a duration of 52 minutes and a temperature of -13.3°C. No additional adverse event (AE) was reported. A previous temperature excursion was reported. A digital data logger was not involved.; Sender's Comments:  US-009507513-2306USA011426:
Body aches and chills (8 hours after) fever, nausea, chills, body aches, dizziness, and chest pain (12 hours after)
Intense flu-like symptoms (intense headache, fatigue, dizzy, nausea, body aches) for 36 hours.  Tylenol for pain, little benefit. Very sore right arm at injection site.
LEFT THIGH AREA 10X8 LOCALIZIED REACTION, RED SWOLLEN AND WARM TX BENADRYL, WENT TO ER 10/15, IM BENADRYL 20MG., SENT HOME P.O. BACTRIM QID X 10 DAYS. SEEN AT FACILITY 10/18/10. AREA PINK SLIGHTLY DECREASED IN SIZE, DECREASED SWELLING, NO PAIN, NO FEVER.
Lightheadedness, dizziness (when standing) shortness of breath (while doing any activity) started while at spin class at 5:45  on 4/8/21 and continues into 4/9/21. No treatment needed.
Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative:  12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.
Small patch on the leg/small patch became a rash and spread to stomach, lower back, upper legs, Chest and under arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small patch on the leg/small patch became a rash and spread to stomach, lower back, upper legs, Chest and under arms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced RASH (Small patch on the leg/small patch became a rash and spread to stomach, lower back, upper legs, Chest and under arms). At the time of the report, RASH (Small patch on the leg/small patch became a rash and spread to stomach, lower back, upper legs, Chest and under arms) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment information was provided.
Rigidity and spasming of muscles at injection site and in chest wall, abdomen and thoracic spine resulting in restricted labored breathing, pulse ox down to 85.  Inflammation in soft tissue around muscles. Loss of mobility requiring intervention and assistance from physical therapy
Narrative:  Inpatient died during MICU car with consulting palliative care inpatient visit at hospital. Patient died on Nov 23,2022@02:00 while inpatient. Death was caused by: Multiorgan failure due to metastatic cancer Reporting this since pt had received an EUA vaccine for covid-19 vaccine EUA (J&J) on 5/12/2021. THIS DEATH IS NOT RELATED TO THE COVID VACCINE.