chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncope; pleurisy; difficulty breathing; Flu-like symptoms; fever; chills; muscle and joint aches; muscle and joint aches; persistent headache; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176) in the hospital, via intramuscular route on 10Feb2021 at 10:30 at a single dose on the right arm for COVID-19 immunization.  Medical history included Non-Hodgkin's lymphoma from 2010 to 2011 and allergies to penicillin on an unknown date and unknown if ongoing. Prior to vaccination, was the patient not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: H9899) in the hospital, via intramuscular route at 01:15 PM on the left arm for COVID-19 immunization. Since the vaccination the patient has not been tested for COVID-19. It was reported that on 12Feb2021 at 08:00 PM (also reported as '3 days after injection') the patient experienced flu-like symptoms that included fever, chills, muscle and joint aches, and a persistent headache. On 13Feb2021 (also reported as 'on the 4th day', the patient developed pleurisy and difficulty breathing and had 2 syncope events the morning of 14Feb2021 (also reported as 'on the 5th day'). The patient was taken by ambulance and admitted to ER for further testing. It was determined that all symptoms likely related to the second dose of the COVID-19 vaccine recently received. Pleurisy persists one week following vaccine dose. The patient went to the emergency room/department or urgent care due to the events. As treatment for the event, the patient was monitored and given IV fluids over 12 hour stay in CDU. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects). The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship and current known drug safety profile.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Nausea; vomiting; Fever with chills; Myalgias; Upper respiratory tract congestion; Injection site pain; patient received the second dose of BNT162B2 on 05Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via intramuscular on 05Jan2021 13:00 in left arm at single dose for covid-19 immunization.  Medical history included none. Allergies to medications, food, or other products was no. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 10:00 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered was in hospital. The patient experienced nausea, vomiting, fever with chills, myalgias, upper respiratory tract congestion and injection site pain, all on 06Jan2021 03:00 with outcome of not recovered. Treatment of paracetamol (TYLENOL) was received for the events. All events were reported as non-serious.
after recv vax pt scratching head, 104 fever, head to toe hives. gave meds & went into asthma
23JUL macular papular rash on chest, neck, back & face, pruritic mild, dull h/a occipital region to ER 24JUL;tx atarax from ER & sent home;25JUL AM maculopapular rash extended to legs, less pruritic;
Wife found husband dead two days after2nd dose.  This Health Department was made aware of the death by the  the Kidney Center.  The patient failed to show up for a scheduled dialysis appointment on 03/24/2022. The clinic obtained information of the passing from the wife. The patient received his SECOND dose of COVID-19 vaccine on 3/22/21, reported feeling ill 3/23/21 and then passing on 3/24/21. The clinic called  the health department to report the death of the patient on 3/24/2021.
pt recv vax 20FEB97 mom called & reported child cold & shakey;mom urged to take pt to MD;nurse @ MD office reported pt sent home was pale & listless w/t102;
I have a horrible headache like I?ve never had before and my chest on my left side feels really tight and I have a watery pain sensation right under.
Post vax, the pt experienced an unspecified adverse event. The reporter indicated that 5 pts experienced an adverse event following receipt of flu vax, however they were not identifiable. No further information was provided.
Headache and nausea starting 5:30am 15 Jan with exertion. Same symptoms on 16 Jan, 17, and 21 Jan with sexual activity. BP started to be in 150-160/110 range (used home BP cuff) on 19 Jan. No neurological deficits. Presented to ER on 21 Jan with c/o headache an d nausea. BP was  160+/110+. CT scan showed SAH. Transferred to hospital for eval. Was in neurosciences ICU x 1 night and neuro ward x 2 nights. Discharged  on 24 Jan. DSA and MRA showed no AVM or aneurysm. LP showed no inflammatory or infectious process. CBC WNL. PT/PTT WNL. Lipids showed hyperlipidemia. Working diagnosis is Reversible Cerebral Vasoconstriction Syndrome.
Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated)
Fever of 101-103 developed 10 days after immunizations while a generalized rash developed 1 day later. Pt seen 2 days later at office on 10/6/01. PE positive for generalized maculo-papular rash on thorax, few on extremities. Positive petechie upper palate. History of subsequent desquamation. Tylenol rx'd for fever.
Dizziness to the point of not being able to stand. HA start an 1 hr after vaccination, extreme nausea and vomiting from 1000 pm - 2:30 am. Dry mouth and disoriented starting at 9:30 p.m.
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation.  Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing.  Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea.  The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
patient passed out in a chair for a few seconds and was pallor. she did not hit her head. she had not eaten breakfast or drank anything all day. we called 911 and the ambulance was dispatched. she drank some water and began feeling better and color returned to her face almost immediately. ambulance emts evaluated patient and determined no need to send her to the hospital. she felt fine and left with emts.
Headache, Arthralgia, Diarrhea, Site pain/discomfort, fatigue, Flu-like symptoms Narrative:
This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ lot # M019708 with expiry date 25-OCT-2017 (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Headache, Myalgia, NauseaVomiting, injection site reaction Narrative: Pt received 3rd (booster) dose of Moderna vaccine on 10/24/21 from pharmacy. Reported injection site pain/discomfort, redness, and swelling, as well as chills, headaches, body aches, fatigue, upset stomach, and sore throat. Did not take any medications for symptoms, and was feeling somewhat better by the following day. No other information provided.
No adverse effects reported; a dose of PROQUAD was given to a 17yr old patient, which is outside the indication of 12 months old to 12 years old listed in the prescribing information.; This spontaneous report was received a 17-year-old patient of unknown gender referring to itself.   The patient's pertinent medical history, drug reactions/allergies, and concomitant therapies were not reported. Historical vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella zoster vaccine live (VARIVAX).   On 21-MAR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and which was outside the indication of 12 months old to 12 years old listed in the prescribing information (Product administered to patient of inappropriate age). This was a 2nd dose given on a catch-up schedule (first dose administered was measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live [M-M-R II] and varicella zoster vaccine live [VARIVAX]). No adverse effects reported.
I was admitted to the emergency room with stroke like symptoms. Discordination of the mouth and right side of my face, w/ tongue involvement. Slurred speech, inability to blink or close my right eye. I was diagnossed with Bell's Palsy. No prior problems with paralysis or viral infections.
Received varicella vaccine on 4/17/03. 4/30/03 mom reported local erythema (3cm) with 1 single vesicular on R leg. No other rash or illness. 5/1/03 mom reported many pox, clearly full out break. Routine course.
Arm hurt up to shoulder, swollen at site, red and purple at site. Child very sleepy
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapies included sterile diluent. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX vial 19400PFU (dose, units and frequency were unknown), (Lot# N025704 and expiration date 16-DEC-2018) (Lot# N025701 and expiration date 16-DEC-2018) for prophylaxis. The temperature excursion details were provided. The temperature was 6 F to 14 F (7 F). The previous temperature excursion was at 14 hours. The call was because of a digital data logger. On 21-FEB-2018, it was reported that the product was difficult to reconstitute (product reconstitution quality issue). The Pharmacist reports that it was not noticed that the previous ZOSTAVAX from those lots were difficult to reconstitute. No adverse effects were reported.
DIZZINESS/CHEST PAIN - 12LEAD EKG - 325MG ASA - IV PLACED AND TRANSPORTED TO MEDICAL CENTER EMERGENCY DEPTARTMENT.
Pt was given vaccine at 1125 and was moved to observation area, following he had a syncopal episode and fell from his chai. he was moved to the EMS room and vitals were stable.
After RN administered tdap vaccination client fainted. Client had been sitting on examination table and was laid down. RN obtained pulse oximeter and placed it on clients finger, but pulse oximeter was not functioning. RN called for secretary who contacted director who came in to examination room. Client came to and began vomiting. Client was sat up and provided with garbage can. Cool paper towels were placed on clients forehead and neck and client was provided with orange juice which he took sips of. Client was AAOx3 after incident. Client remained sitting on exam table, sipping orange juice with cool towels for approximately 10 minutes. Client was then assisted in to sitting, and then standing position and stated that he felt "fine". Client and MOC deny questions or concerns, client was walked out to waiting room and left the facility with his mother at approximately 0930.
Late in the evening on May 12, my mother started having pain on her right side.  She also could not take a deep breath without having a stabbing-like pain.  The pain level was severe and kept her awake all night.  On May 13, she went to the urgent care department at the medical center.   An xray of her chest cavity was taken.  It showed fluid in her right lung, but the results were inconclusive because of her limited able to take a deep breath.  Extensive blood work was also performed.  The urgent care doctor suspected that she has a blood clot in her lung, and she was sent to the hospital for further testing.  She is still in the ER of the Medical Center. They are still doing tests and have not officially confirmed that she has a blood clot yet.
On 8/19/2022, I had a fever of 101 and I had a lot of body aches, chills, and a lot of upper respiratory congestion, swollen glands and sore throat. On 8/20/2022, I went to the urgent care, and they did a PCR COVID-19 test and a quick COVID-19 test and the result was negative. The PCR test came back on 8/21/2022 as positive. The doctor told me to quarantine and to take acetaminophen, and prescribed me a cough medicine, BROMPHEN-PSE-DM. My symptoms resolved in about 6 to 7 days and we quarantined for 10 days.
Information regarding PREVNAR was received from a consumer regarding a 9-month-old female patient who received a second and third dose of PREVNAR on 22-Jun-2007.  On the same day, she experienced irritability and her right thigh was red, swollen and a hard lump formed at the injection site on her right thigh.  The patient's concurrent illness includes premature baby (one month premature).  No previous adverse event occurred with the patient's first injection of PREVNAR administered on 19-Dec-2006.  Concomitant medications were not reported.  On 22-Jun-2007, the patient's mother reported that PREVNAR was administered to her daughter twice in one day.  She received one dose in her left thigh with no reaction reported, and one injection in her right thigh.  On the same day the patient's right thigh was red, swollen and a hard lump formed at the injection site.  She also experienced irritability.  The patient's outcome is unknown.  No additional information was available at the time of this report.
2/27 About 45 min after getting the shot I started to feel unwell. I felt exhausted, clammy, and had a headache.  Felt better the next day and did not noticed until late in the afternoon that I had a swollen, warm, hard, sore,  red circle around injection site. about 2 inches across.  Called doctor  on 2/28 and did not get a call until 3/3 to go and see doctor. It had dissipated by then.  decided not to see doctor unless it got worse.  On 3/6 around 4pm noticed that where the injection site was on my arm felt warm to the touch and somewhat itchy. The red circle was back, swollen, hard and warm to the touch. No other symptoms. Called nurse on 3/7 made an apt. with doctor on 3/9.Told to fill out VAERS.
10 seconds after vaccination, pt's body tensed, he became pale and unresponsive. Arms and body became flexed and stiff. He was placed on floor, 911 called, Ammonia inhalant used with immediate response. VS stable, pt continued to be responsive. Skin was pale and diaphoretic. Denied headache, chest pain, SOB, nausea.  No rash noted on skin, lungs clear, no wheezing. Pt improved, took sips of water and ate a snack. Tolerated well, no emesis. Medics arrived, assessed pt, offered transport to hospital but pt refused. Medics provided instruction to seek medical attention if symptoms return or worsen. Pt monitored for 30 minutes post event, no further symptoms. Ambulated without assist, steady gait to car.
Systemic: dvt-Severe, Additional Details: diagnosed with DVT and prescribed enoxaparin
Coughing bouts early on lasting as long as 10-15 min.  On and off for a few hours then a few hours of quiet time then all of a sudden it would start up all over again.  When I would lay down for bed  my breathing would be fine till a few hours after I get up and the coughing would start all over again.
This spontaneous report as received from a 54 year old male patient who was a Merck employee with no pertinent medical history and drug reactions/allergies. On 31-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX vial lot # J013450, Exp date: 24-JAN-2015, (0.65 ml, as per prescribing information, dose# and strength unspecified), subcutaneous. No concomitant medication was taken. On 01-AUG-2014 the patient experienced rash. The patient did not seek medical attention and no treatment was given for the event. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information is not expected as the physician did not want to be contacted.
Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; No additional AE.; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # 1780867  confirmed to be valid for formulation syringe with expiration date 08-AUG-2023 (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion. Data regarding temperature excursion was not available. No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA003157:MSD US-009507513-2301USA003129:MSD US-009507513-2301USA003155:MSD US-009507513-2301USA003156:MSD
Pain started a week after about two inches below injection site. Red, hot, swollen. The pain started going away but the heat and itchiness stayed. Disappeared for 1-2 days. Rash is back and splotchy.
Started having what I believe is being called Covid Arm.  A late reaction to the shot with a hard, large, red welt that is tender to the touch and itches. Will begin taking antihistamines as was suggested.
Pt is on apnea monitor since birth because sibling died of SIDS episode; @ 9AM pt started w/alarms going off would arouse pt; cont w/apnea lasting longer, untill 1AM lips were cyanotic & mom had to shake pt to arouse him;
Patient reported that after the 2nd dose she wasn't able to sleep... the symptoms haven't gotten any better....and she has a lump under her left arm pit that hasn't gone away
REAL BAD HOT FLASHES; BOOBS HURT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced real bad hot flashes, and boobs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from real bad hot flashes, and the outcome of boobs hurt was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot#, total dose and route unknown). Concomitant therapies included methotrexate. The pharmacist reported that the patient was vaccinated with (Oka/Merck) VARIVAX while on maintenance dose of methotrexate 7.5 mg every other day for unspecified immunocompromised condition. The pharmacist was not aware of any adverse effect to the patient. No further information was provided. Additional information is not expected.
Major Seizure(s) requiring extensive stay with testing/treatment in Hospital. Seizure(s) happened day after the COVID-19 booster shot was given.  The seizures aggravated my spinal cord issue resulting in severe pain in several parts of my body. This requiring me to take additional pain meds and going to Physical Therapy 2x per week.
p/vax pt exp headache; shaky; intermittent nausea; felt hot; tx: ibuprophen
This is a spontaneous report received from contactable other HCP and consumer or other non-HCP, for a Pfizer sponsored program (143231). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had chills (experienced chills after first COVID-19 vaccine), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient said she was having trouble breathing soon after she went to the post dose waiting area.  An epi pen was administered as her breathing was labored.  She was helped to the floor as she stopped responding  and went limp.  Her breathing was shallow until the EMTs arrived.  She started to convulse around the time the EMTs arrived.  She came to shortly after and the EMTs had taken over care at that point.  Patient had a history of seizures.  EMTs arrived within 5 minutes of the patient's symptoms starting.
Began medication (follitropin 200 units) for assisted reproductive technology on evening of 01/02/21. Added ganirelix injections on 01/06/21. Trigger injection with leuprolide administered at 20:00 on 01/11/21. Immediately prior to oocyte retrieval on 01/13/21, given 1L IVF and ampicillin (dose unknown) at approx. 07:30am. Retrieval at 08:00am was uneventful, but notable for 17 oocytes retrieved and only 10 were mature. Post-procedure vitals were WNL. Discharged home from facility (Family Health Center) at approx. 09:30am. At approx. 12:00pm, noted increasing abdominal girth. At approx. 14:00, noted mild shortness of breath. Abdominal distention and shortness of breath continued to worsen. Unable to recline even moderately due to difficulty breathing.