chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got extremely hot.  I undressed quickly and got into my bed.  My head moved from side to side with out my control.  I was swallowing rapidly.  I was awake and knew what was happening.  I don?t know how long it lasted. When the episode was over, I went to sleep.  I awakened in about 3 hours, went to the rest room, and returned to bed.  I was uneasy  and thought I might fall.  I slept another three hours and went to the bathroom again. I felt a little better. I got up in about two more hours and felt a little better. Didn?t feel good all day and my arm was really sore.
Information has been received from a pharmacist referring to 2 newborns (numbered 71 and 72). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 04-AUG-2015 patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/5.0 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported. There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
After 8 days, intense itching and swelling, red , warm circular 3 inch diameter
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The reported stated that on 23-DEC-2013 the patient was administered with the third dose of GARDASIL intramuscular (dose: 0.5 ml, lot # 670049/1171AA, expiration date: 11-NOV-2013) strength and site of administration not reported), which had expired on 11-NOV-2013. No adverse event reported. Additional information has been requested.
Lightheaded & dizzy; 14DEC94 f/u chills w/sl temp inc & SOB; given Epi; monitored v/s for 1hr; fever dec & BP returned to nl;
During administration, the syringe and needle separated and the patient did not get the full dose. Upon the first puncture it was estimated that the patient received 0.1 mL. In an effort to ensure the patient received full benefit of vaccination, she was given a second injection of 0.4 mL to make up a full dose.
Post vaccination, while patient seated in monitoring area, patient fell out of chair and hit right side and reportedly caught himself and did not hit his head. EMT witnessed event, patient did not loose consciousness. EMT evaluated Vitals HR 45, RR 24, BP 90/57, temp 98.1, +diaphoretic, AAOx3, blood sugar 132. Pt was given orange juice. Vitals remained unchanged for 10-15 minutes. Vitals measured q4 min, patient remained AAOX3 and answered all questions appropriately. At 12:22 Vitals HR 70, RR 20, BP 138/95, Temp 98, no longer diaphoretic. Pt stood without dizziness. Patient denied transfer to ER and was escorted to car at 12:30 reporting to EMT he feels back to baseline.
Respiratory distress, tachycardia, rapid a-fib, fever, severe inflammatory response, pleural effusions.
At the 48 hour mark after vaccination, flu like symptoms for the following 36 hours. No fever, but severe body aches and malaise with congestion, headache, fatigue. After 36 hours all went away except for fatigue and body aches. OTC taken Advil, Tylenol, Benadryl which made it worse in terms of pain. Talked with PCP who advised OTC and rest. No prescriptions.
Felt dizzy, weak. Vagal response; sat in recliner, given juice and crackers. Responded well.
I95.9 HYPOTENSION 10/10/2022 ABDOMINAL PAIN I95.9 HYPOTENSION 10/10/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 10/10/2022 DIARRHEA I95.9 HYPOTENSION 10/10/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. On 13-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L026602 with expiration date 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tongue heaviness and lightheadedness, given Benadryl 25 mg PO.
This spontaneous report as received from a Licensed Vocational Nurse refers to multiple unspecified patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route and lot number were not provided) which were stored improperly. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Tingling in face; headache; sneezing; itching; light headness and dizzy; lips swelling; eye swelling; like an allergies; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0173 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 10:45 (at the age of 66 years old) as first dose, single for COVID-19 immunization in a hospital. Medical history included stage 3 kidney disease, systemic lupus erythematosus, high blood pressure and thyroidectomy. The patient's known allergies: penicillin. The patient previously took dilaudid and prednisone; and experienced drug allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL); metoprolol; famotidine and alprazolam (ALPRAZ). The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced tingling in face, headache, sneezing, itching, light headedness/dizzy, lips swelling, eye swelling and had like an allergies on 19May2021 at 09:00. This case was considered non-serious and no treatment was given for these events. The outcome of these events was not recovered at the time of report.
Intense shoulder pain 3 days post vaccination  Herpes Simplex,  right upper lip, for 2 weeks post vaccination  Flu-like symptoms persisted 2 weeks post vaccination
Pt sat down after vaccination and within about 5 minutes she alerted the observer that she felt like she was "floating," dizzy, hot, racing pulse, light headed. EMS and paramedic alerted. took pt's VS. HR 80 BP 111/65 96% RR 18 . EMS arrived, they did their evaluation. Pt reported she was feeling better, wanted a coca cola. Pt waited in observation for an addition 30 minutes with no other symptoms noted. Pt signed refusal with EMS to be transported to the ED. Pt's daughter was present and suspects the pt had not felt well due to wearing a mask. Pt was given precautions to return to the ED by EMS.
PT RECEIVED ANTHRAX #1 AND PPD. PT RETURNED TO HER UNIT. WITHIN 1 HOUR OF RECEIVING (APPROX 1000)THE VACCINE, SHE BEGAN TO REACT. SHE TOOK AN OVER THE COUNTER BENEDRYL. PT  STATES SHE HAD RED SPOTS ON HER NECK, HER TONGUE AND LEFT EYE, LEFT HAND AND WRIST WAS SWOLLEN. THE FEFT SIDE OF HER FACE WAS SWOLLEN. SHE FELT TINGLING SENSATION IN HER LEFT PALM.  DENIES DIFFICULTY BREATHING. AT 1600 THAT DAY, THE REACTION CONTINUED TO WORSEN. SHE SPENT THE NIGHT IN HER LIVING QUARTERS. SHE AWOKE AT 0230, THE REACTION CONTINUED TO WORSEN. THE FOLLOWING MORNING, AT 0730 ON 16 OCT 07 SHE RETURNED TO KACC FHP, LTC BOATWRIGHT TOOK HER TO THE WARRIOR CLINIC, SHE RECEIVED SOLUMEDROL IM. SHE STATES ALL ADVERSE REACTIONS CEASED WITHIN 10 MINUTES OF RECEIVING THE SHOT. SHE RETURNED TO A NORMAL CONDITION. SHE WAS RELEASED WITH 3 TABLETS OF SOLUMED TO TAKE 1 PER DAY FOR 3 DAYS.
2 days after getting the second dose I started having some joint pain and then it got to lots and lots of pain along my spine to where it felt like my spine was on fire. Then I went to urgent care around the 26th or 27th (Northwest Urgent Care) and they prescribed steroids to help with the inflammatory response.
Arm swollen; Arm hurts; Face red; Fever; Body aches; Tired after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever) and MYALGIA (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was not provided.     This case was linked to MOD-2021-226244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received on 17 JUN 2021 and had significant information. Added patient demographics, concomitant medication, Batch number , event body ache.
Patient came to the ED because of headache and body pains.  Patient admitted with covid and treated with remdesivir.
Wife claims that patient was coughing up blood after they received the shot and passed away, not much else was described
Day 1 felt poorly, runny nose, and watery eyes. Day 2 began having congestion, worsening runny nose, and temp of 100. Took Covid-19 test and it was negative. Day three fever worsened and tested positive for COVID-19. Night of day 3 fever worsened up to 103 and began coughing up thick gelatinous mucus. Day 4 reached out to PCP and was offered PAXLOVID but declined. Took TYLENOL for fever and it was highly effective. Cough lasted for six weeks.
This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 03-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1610USA004609: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Patient was walking around the store after receiving his vaccine. About 7 minutes after receiving the vaccine the patient began feeling dizzy and the proceeded to faint.  He returned to consciousness right after falling to the ground.  He sat on the ground for a few minutes and was provided a bottle of water.  Once he stated he felt fine enough to get up he sat in a chair for 15 minutes.  He stated he felt find so we had him walk around the store for a few minutes before allowing him to leave.  He stated he did not need emergency care.
Severe stomach pain and diarrhea. Mild stomach pain started around 10 pm and got progressively worst.  Pain did not subside until about 10 a.m the next day.  A milder stomach pain was constant but a SEVERE stomach pain would come in waves. This was accompanied by nausea, I threw up one time. Pepto was taken but did not help. Also had chills and sweat spells.
Pt was given Tripedia U2397BA instead of Td with pertussis. No adverse reaction. Adverse reporting notified. States that re-vaccination was not required.
Patient reported headache, tingling in her hands and feet, chest pressure, and lightheadedness 25 minutes after receiving her first dose of the Pfizer vaccine. Blood pressure and pulse were was slightly elevated (140/90, 80), and patient was encouraged to lie down. Juice and a snack were provided, and 10 min later reported feeling better. Blood pressure had lowered as well (125/90). Allergy history includes seasonal allergies and Tylenol. No history of anaphylaxis.
3 cm area of redness, tenderness to injection site. Pt reports this site is tender and itchy. Also reports new 1 cm patch of rash/redness to RLQ abd.
101.4 degree fever and a little bruise during the night of the same day he got his shots.
She experiences like a heart attack, I put her in a heart monitor with my watch. (240 bits per minute). We went to the doctor and referred us to the hospital and was put in a heart Monitor and they diagnosed her with PSDP. After that there is not treatment. She can handle by now. If it gets worst she will get treatment with medicines.
Patient reported that he the injection in the right upper arm (though documented as given in left arm). Patient reported that 6 hours after getting the vaccine he developed chills, headache, body aches, then the next day his arm became red and is now warm. States that it been painful and swollen and area of swelling got progressively bigger.
Patient had syncopal episode and fainted. Was subsequently woozy for the next 15 minutes, experienced dizziness and headache.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 19Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 24Apr2022, outcome "recovered" (24Apr2022), described as "my right eye went half blind/The right side of my right eye was dark/black". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter reported that, I received my 1st Booster on 19Apr2022 five days after my right eye went half blind. The right side of my right eye was dark/black. This lasted about 1.5 hours. I told my doctor he ran blood work, Magnetic resonance imaging (MRI) on my brain, I wore a heart monitor for 3 days, electrocardiogram(EKG) and I had to see an ophthalmologist. The only negative was my cholesterol all other tests showed nothing. Ophthalmologist ran tests too with everything ok. I talked with many people regarding this incident many have had some the similar reaction. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On July 15, 2015, during a wellness checkup, I received the Pneumovax vaccine. 2 days later I started experiencing a sore throat. It got worse each day and I saw a physician on 7-22. He prescribed a 6 day treatment of Azithromycin. On 7-24, I returned to my physician & was refered to the local ER for a CAT scan. At this point, I could not talk or swallow. The CAT diagnosis was Acute Pharyngitis, unspecified pharyngitis type, and Anterior Lymphadenopathy. This was the most painful sore throat I ever experienced. I'm 73 and never smoked. Could not swallow fluids, or eat food for almost 3 days! I am reporting this as a possible complication from the this Vaccine.
Patients received an off EUA approval use. Patient's age group was was not a part of the Moderna study.
This spontaneous report was received from a pharmacist referring to a 72 year old female patient allergic to sulfa. The patient's medical history and concomitant therapies were not reported. On 16-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 lot # M041686, expiration date 28-MAY-2018; intramuscularly (anatomical location unknown) for prevention of pneumonia. On 17-MAY-2017, the patient experienced erythema to the left of the injection site and presented at the pharmacy with several red bumps around the injection site. No treatment was given for the adverse events and no laboratory tests were performed. At the time of the report, the patient was not recovered from the adverse events. No product quality complaint was involved. The causal relationship between the adverse events and PNEUMOVAX23 was not reported. Additional information has been requested.
A patient was dead the next day after receiving the flu shot; Initial information was received on 25-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a female patient (age unspecified) who was dead the next day after receiving the INFLUENZA VACCINE (death).  Medical treatments, vaccinations, concomitant medications and family history were not provided.  At the time of death, the patient had ongoing medical problems with her legs (leg discomfort).  On an unknown date, the patient was in the hospital due to problems with her legs and received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died the next day after receiving INFLUENZA VACCINE (death). This event was also assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment before death.  It was unknown if an autopsy was done.   The cause of death was not specified.  The information on batch number was requested for this case.   Sender's Comments:  This poorly documented social media case involves a female patient who died (death NOS) the next day after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. At the time of death, she had ongoing problems with her legs. Additional information regarding medical history, concomitant medications, lab investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Persistent soreness in triceps area of left arm. and in lymph node area in armpit of left arm.  Muscular contractions in hamstrings of both legs. Prickly sensation in fingers, especially in left hand.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX. On 7th March 2018, the patient received SHINGRIX (intramuscular). On 7th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received an injection of SHINGRIX by a pharmacist later that evening, the patient noticed swelling at the injection site about the size of a silver dollar. The patient had denied permission to contact their physician.
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the second 0.5 mL dose of GARDASIL (route and LOT# not reported). The patient experienced immediate pain with the insertion of needle and a dome shaped swelling at the injection site. The swelling went down after 10 minutes, however later the patient developed a bruise at the site. No laboratory or diagnostic studies were performed. Unspecified medical attention was sought. No further information is available at this time of reporting. Follow-up information has been received from the nurse practitioner. The nurse practitioner told that the patient was vaccinated at public health clinic/hospital. And she had no additional information to share. No further information is available.
Irregular menstrual cycle.; period extremely heavy; bad cramping; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 10:00 (Lot number: Fd8448) at the age of 34 years as dose 2,single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT; ORTHO-TRI-CYCLEN LO. Vaccination history included: Bnt162b2 (Dose: 1, Lot: Ew0176,, Time: 10:00 AM, vaccine location=Left arm), administration date: 28Jul2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 03Sep2021, outcome "recovering", described as "Irregular menstrual cycle."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Sep2021, outcome "recovering", described as "period extremely heavy"; DYSMENORRHOEA (non-serious) with onset 03Sep2021, outcome "recovering", described as "bad cramping". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea.  Additional Information: Irregular menstrual cycle, which is very unusual for me, especially considering I am on birth control. Began period almost two weeks early, and period extremely heavy with bad cramping. Hospitalization Prolonged was reported as no. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Device Date : 04Sep2021  Follow-up attempts are completed. No further information is expected.