chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax on 10AUG92 & on 10AUG92 hives erupted over entire body w/extreme itching; Pt seen by MD;
37yr old female around 30 weeks pregnant- received my covid booster on 6/12/2022. Developed tinnitus 2 weeks after. Went to ENT and completed audiograms, there is no hearing loss. Improved but not resolved in about 6 months. But then 1/22/2023 (post pardum 3.5months), I received by bivalent pfizer booster and 1 week later the tinnitus worsened greatly, which is why I now know it's from the vaccine which I did not initially know. This is why i'm reporting so late.
Information has been received from a registered nurse concerning a 5 year old male with no pertinent medical history, and a drug hypersensitivity to ranitidine hydrochloride (ZANTAC) who on 01-APR-2004 was vaccinated subcutaneously into the right arm with a booster dose, 0.5 ml, of varicella virus vaccine live (Oka/Merck) (Lot # 658373/1116U). There was no concomitant medication. Subsequently the patient developed a 3-4 cm raised wheel and erythematous. At the time of reporting the patient was recovering, and "the reaction was beginning to fade". Medical attention was sought. The patient was seen in the office on 08 OCT 2007. There was no product quality complaint. There were no lab diagnostic studies performed. A lot check has been requested by the reporter. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Bruise approximately 1.5? in diameter at injection site & swelling, very sore shoulder muscle for next 2-3 days; Pulsating tinnitus  in right ear started 3/29/21; dizziness started 3/31/21 or 4/1/21;  headaches  and construction of facial muscles around right eye began 4-5 days after injection;  4/4/21 dizziness was accompanied by feeling of nausea and loss of appetite  Visited ENT on 4/5/21.  Audiologist assessed loss of hearing in both ears
Besides being sick in bed for 24 hours the entire next day after vaccination, there is something much more interesting that I want to report. My childhood chickenpox inoculation scar (the circular looking skin scar) has all swollen up and is read all around and hurts all around it. It looks like red bracelet on my arm . It is about 4 inches below my moderna shots, that are barely swollen or red and hurt little.
No Adverse Reactions. Moderna was administered to patient while under the age. of 18. No adverse Side effects noted.
Febrile 48 hours after injection 100.4 left arm extremely sore-16-18 hours after injection.  11/19/2003-enlarged lymph node right side of neck, decreased hip pain.  Pain with wacking.  11/20/2003.  Body aches generalized with increased right hip pain.  Body aches unable to ambulate.  Patient sore.  Called next after month, used strain for nourishment.
Fever, still has 100.5 temperature; Headache; Chills; This is a spontaneous report from a contactable consumer (patient; Nursing assistant). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 24Dec2020 09:00 at single dose for COVID-19 immunization Patient's medical history included hypertensive, cholesterol abnormal, chronic insomnia, and Covid-19 (last March). The patient's concomitant medications were not reported. The patient mentioned that he had Covid-19 last March. So, he stayed in hospital more than 2 weeks. The patient stated the hospital is giving vaccine to the hospital workers, he received the vaccine in their Institution. The patient reported that last night (Dec2020), he developed some fever, headache and chills until now he still has 100.5 temperature. He added that last two days ago he got the swab test and its negative and positive with the immunity. The patient stated he was just taking some acetaminophen 500mg, it is just like Tylenol. The outcome of events was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: results not reported Results not reported. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event Bell´s palsy, approximately 2 days after an unspecified dose of mRNA-1273.  MR imaging was performed without reported results. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event Bell´s palsy, approximately 2 days after an unspecified dose of mRNA-1273. MR imaging was performed without reported results. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Maculopapular eryth. rash diffuse head to toe. Fever for 3 days before rash, likely oral examination.
Woke up with pounding headache, vomiting, blood pressure 220/135 unable to take blood pressure medications due to vomiting, went to emergency room due to increased blood pressure, negative findings vomiting stopped took blood pressure medications that evening, blood pressure within normal limits says feels fine today states not like usual migraines, thought due to yellow fever vaccine.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Severe, Systemic: Nausea-Severe
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient started therapy with ZOSTAVAX (route, dose, frequency and lot # not reported). It was reported that the patient received 2 doses of ZOSTAVAX 1 month apart (dates unspecified). No known adverse effects. Additional information has been requested.
Sleeping non stop; she has had constant fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue). At the time of the report, SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue) outcome was unknown.            Concomitant medications also included antidepressant medications and Ids medications. No treatment information provided.
Felt flushed and dizzy within minutes after receiving vaccine, and started convulsing. Later that evening  on 5/1 started convulsing again and then twice more. Went to ER to get evaluated by a neurologist who believed he had vasovagal convulsions. Has not had a convulsion since but has had feelings that he might and has steady HA's and feeling faint.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported.   On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route, lot#, expiration date were not provided) for prophylaxis. The patient's concomitant medications were not reported. On an unspecified date, the patient was ordered on Prednisone, 20mg, 2 tablets once daily for inflammation (unspecified). At the time of this report, the outcome of inflammation was unknown. The causality between ZOSTAVAX and inflammation was not reported. Additional information has been requested.
Within hours of vaccine heat began racing.  Sustained pulse of approximately 128 for over 12 hours, measured via pulse/ox on finger.  Didn't go higher so no add'l treatment retained.
PATIENT NOTICED REACTION THAT NIGHT. RASH ON ARM AT INJECTION SITE, WARM TO TOUCH, SWOLLEN AND PAINFUL TO LIFT.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours on 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
My left leg, arm, and side of my face went numb; Felt like pins and needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 18:00 (Lot number: Ew0161) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 03May2021, outcome "recovered with sequelae", described as "My left leg, arm, and side of my face went numb"; PARAESTHESIA (non-serious) with onset 03May2021, outcome "recovered with sequelae", described as "Felt like pins and needles". The events "my left leg, arm, and side of my face went numb" and "felt like pins and needles" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: The events lasted constantly for a couple weeks, then slowly tapered off. Still feel it from time to time. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store.  No follow-up attempts are possible. No further information is expected.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Agency Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
ON 4/1/2021 PATIENT WENT HOME FELT A BIT TIRED FELL ASLEEP WOKE UP AROUND 9PM WITH ARM PAIN AND HEADACHE, ATE A LITTLE AND TOOK TYLENOL 500MG AND WENT BACK TO SLEEP  WOKE UP THE NEXT DAY WITH EXTREME ARM PAIN CONGESTION AND HEADACHE. SHE TOOK TYLENOL EVERY 6 HOURS AROUND THE CLOCK. PATIENT ARM PAIN BECAME LESS PAINFUL HOWEVER THE HEADACHE LINGERED. PATIENT WENT TO URGENT CARE ON 4/29 MD PRESCRIBED NAPROXEN 500MG BID AND SUGGESTED TO SEE PCP IN A WEEK.
gotten progressively worse; rash; redness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itchy), CONDITION AGGRAVATED (gotten progressively worse) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy) and RASH (rash). On 27-Feb-2021, the patient experienced CONDITION AGGRAVATED (gotten progressively worse). At the time of the report, ERYTHEMA (redness), PRURITUS (itchy), CONDITION AGGRAVATED (gotten progressively worse) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt recvd Td vax & the next day presented to ER c/o fever, chills, myalgias; routine dip-stick exam was pos for blood in the urine; 2 days later pt returned to the clinic had macroscopic hematuria & trace protein in urine;
Initial misuse report received from a healthcare professional on 16 December 2014. A patient of unknown age and gender received YELLOW FEVER VACCINE (batch number, expiry date 06 February 2014, route, dose and anatomical site of administration not reported) on 18 February 2014. The patient received an expired vaccine. No adverse event was reported. The list of documents held by sender: none.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 18-year-old male patient who received MENVEO (batch number M16133, expiry date 31st July 2018). On 3rd August 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 3rd August 2017, less than a day after receiving MENVEO, the patient experienced fever, vomiting, chills, weakness and headache. On an unknown date, the outcome of the fever, vomiting, chills, weakness and headache were not recovered/not resolved. The reporter considered the fever, vomiting, chills, weakness and headache to be almost certainly related to MENVEO. Additional details were provided as follows: The case was reported by the Physician's Assistant (PA). The patient received MENVEO in the right deltoid. The patient's fever ranged from 102 to 103 degrees C.
Mo related the events of 9/12/08 on 11/6/08 at next check-up.  Sl cranky on the afternoon of shot but afebrile.  Around 6 PM became v. cranky, then extreme pallor w/ sl. blueness around lips.  Then just became limp and unconscious.  Mother estimated unconscious for about 1 min.  Then opens eyes and takes about 10 min to fully wake up and regain consciousness.
BLOOD PRESSURE LOWERED/SHOT LOWERED BLOOD PRESSURE; TIRED; This spontaneous report received from a parent concerned a 38 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced blood pressure lowered, and tired. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) low Blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and blood pressure lowered was not reported. This report was non-serious. This case from the same reporter is linked to 20210540039.
On Tuesday, May 20th, about two and half weeks after the first dose, my mom felt listless, tired, run down. She developed a cough, a lot of throat pain, headache, back pain, body aches.  About a week after she began to feel sick, she developed shingles on Thursday, May 29th. She knew what it was immediately because she had shingles previously. She started anti-viral medication on Friday, May 30th.
Information has been received from a physician concerning a 45 year old white asplenic female with a history of splenectomy in 1993 for hemolytic anemia who on 1/15/02 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid. Concomitant therapy included sulfasalazine and folate. On 1/15/02, hours after administration, the patient developed pain, swelling, redness, and tennis ball sized induration at the injection site. The patient had a fever to 103 F for 3 days with increased inflammation at the injection site. The patient was treated for possible pyrogenic infection with cephalexin for 7 days with good results. No additional information is expected.
Shot location of the DTap vaccine is really red around it as well as a hard lump under where the redness is.  She is running a 100.1 degree temperature so I have to keep giving Pediacare fever reducer every 4 hours.
Shaking arms, throat irritation, nausea and vomiting, aching back, chills.
Shingles - Headache, fatigue started 11/7, tingling 11/9, shingles blisters 11/12/15.
Mom states baby has been fussy since receiving vaccines.  Will sleep at night and eat ok but more fussy during the day and wanting to be held, no fever.
Nausea. Vomiting. Headache. Fever. Lethargy
Body aches; chills; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy nonsteroidal anti inflammatory drugs (NSAIDS). Concomitant medications included vitamin d NOS (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 as a single dose for COVID-19 immunisation. The patient previously also received paracetamol (APAP) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 06:00, the patient experienced body aches, chills and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the body aches, chills and headache was resolving.   No follow-up attempts are possible. No further information is expected.
c/o mid-day fever, yellow exudate out of sinus', sore throat, ears hurt "By Saturday night, c/o 'it was into my chest', and I was down."
Mom brought patient in for vaccines, mom said patient ate a good meal before this appointment. Medical assistant gave the vaccine ordered for patient, to the patient on August 27, 2021, at 5:30 p.m. Before giving the vaccine, I instructed medical assistant, to make sure patient wait in the exam room for fifteen minutes after receiving the vaccine. She did not instruct patient to wait for 15 minutes. Mom left with patient after vaccine was given, shortly after vaccine was given medical assistant told me patient is not feeling well, she told me he was in one of the exam rooms, I went in quickly to see patient he was lying on the exam table, mom said he is feeling dizzy, patient did not fall, no loss of consciousness.  Patient looks slightly weak, but he was alert but looks tired and talking, he told me he was feeling dizzy, his pulse rate was good and strong, but his skin felt clammy. His vitals revealed a blood pressure decreased to 61/41, blood sugar was ordered his oxygen saturation was 98% on room air. Patient was not in any form of respiratory distress, he was given some oral fluid, and some juice which he tolerated well. His blood sugar was 95. His temperature was 97.3 degrees. Patient was monitored closely his pulse rate remained strong and good. Patient gradually improved. A follow-up blood pressure was 77/51, patient was more alert, and communicating well. He denied any headache no abdominal pain, he improved, and a repeat blood pressure was 107/72.  Patient said he was feeling fine was no longer dizzy, said he was back to his usual self.  discussed with mom, patient left with  mom feeling fine and was instructed to bring patient back on Monday August 30, 2021 for follow up  at 9:30 a.m.
very fatigued a few hours after the vaccination; He had a very large abnormal headache; He thinks he had a fever; His arm hurt; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. After his second dose of the Pfizer vaccine, the patient became very fatigued a few hours after the vaccination. He had a very large abnormal headache. He thinks he had a fever. His arm hurt. The start date of events was on an unspecified date in Jan2021. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Jan2021. Facility type vaccine was Workplace clinic. Unknown if other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Unknown if COVID tested post vaccination.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained.
C/O lip tingling/ swelling, chest tightness,  tongue tingling and burning  1:12 133/85, P 94, 02-98% R18 Epi O.3 IM, experienced immediate relief 1:16 114/88 p-110  Transported by EMS to ED
Child had 3 minute febrile sz approximately 10 hours after shots given. Child's fever probably from fifth dz. Had apnea/dusty spell became child and choked on a baby aspirin mom gave child for her fever. T104 by EMS. I don't feel this is vaccine related. Tx- Motrin only
14 days after COVID shot number 2 I developed what i think a new food allergy to Sunflower seed oil which is in many foods. This was sudden onset after eating my normal foods that had contained sunflower seed oil.  It caused whole body rash/hives, itching/burning, lips numb, somewhat swollen, require ED visit for IV steroids and IV benadryl.   Awaiting appt for allergist. Only common ingredient in all three reactions I had from Post vaccine days 14,15, and 16 was sunflower seed oil.