chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 8 days after vaccination, patient experienced redness, swelling, hematoma, and erythema at injection site. Patient was evaluated in the ER by facility hospitalist and prescribed Bactrim DS twice daily for 7 days with follow-up per MD instructions
Chills, 102 fever, back pain lasted about 15 hours Then over the next week or two bumps the size of a mosquito bite on various parts of the body-gone after another week
1/17/2021 08:30 a.m. noticed red area on left arm at injection site. 1/18/2021 the red area on left upper arm is approximately 11 cm long. Red area not raised, not warm to touch or itchy.   1/19/2021 area remains similar in size but is less red at 7:05p.m.
After 10-15min of receiving the second booster I experienced numbness, tingling and muscle weakness in my hands, fingers and arms.  This lasted about an hour then subsided.  The very next morning I woke up with a bad migraine and a headache that lasted consistently for 10 days.  I had intense chills and shaking for three days that started within 24 hours of receiving it.  I also experienced muscle aches and pains, fatigue, nausea and tummy aches lasting about 10 days.
12:30pm day after shot starting getting major headache ,achy, chills, fever.  Hard to sleep over night but fever broke around 12:30am. Today, 2 days after, woke up ok, but as the day goes on: headahe, chills, fever  100.6, and feeling like crap. Have taken tylenol, pushed fluids, rested-but too frozen to sleep, ibuprofin. Injection site is red, hard, hot & itchy
Following the vaccine, I was perfectly fine and was able to go about my day as normal. However, while doing dishes at 11:30 at night (about 10 hours after I received my second dose of the Moderna vaccine) exhaustion and dizziness suddenly hit me, and my vaccine went black and my ears started ringing. I managed to lie down but I fainted and blacked out for a minute. After I regained consciousness, I had these muscle contractions/shivers (although I took my temperature and had no fever). I felt really exhausted, and went to sleep after that. However, other than that I had no other vaccine side effects. I was told by my doctor to report this though since they had not heard of anyone else fainting, and I have no history of fainting (other than once following blood donation). I also was not thinking about anything remotely related to the vaccine at the time of fainting, and I had no qualms with being vaccinated so I highly doubt it was psychological, especially considering I have no history of fainting, and I had an injectable medication so I have no issues with injections.
This case was reported by a consumer and described the occurrence of not responding to therapy in a 69-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Relevant medical history was reported as "borderline". Concurrent medications included Vitamin, Calcium and PLAVIX. On 3 December 2009, 5 June 2009 and 6 May 2009 the subject received 3rd dose , 2nd dose and 1st dose of ENGERIX B (20 mcg, unknown, left arm). On 3 December 2009, less than one day after vaccination with dose 3 of ENGERIX B, 6 months after vaccination with dose 2 of ENGERIX B, 7 months after vaccination with dose 1 ENGERIX B, the subject experienced not responding to therapy. The subject stated that she received her 3rd ENGERIX B vaccine on 03 December 2009 after she was exposed to a dirty needle that same day. Because of the dirty needle exposure (from a normal blood draw from another person - subject was a phlebotomist), her blood was drawn to get a baseline of her level of immunity to the Hepatitis B virus. Subject was found to be not immune to Hepatitis B despite her having received those previous two ENGERIX B vaccines.
Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for B-cell lymphoma NOS.    Previously administered products included for Drug use for unknown indication: IODINE. Past adverse reactions to the above products included Iodine allergy with IODINE. Concurrent medical conditions included Iodine allergy and Penicillin allergy (penicillin v potassium allergy). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT), COLECALCIFEROL, FISH OIL (FISH OIL + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ALLOPURINOL and SIMVASTATIN for an unknown indication.   On 12-Oct-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 100 milligram four times per day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEART RATE INCREASED (Rapid heart beat). At the time of the report, HEART RATE INCREASED (Rapid heart beat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: Rapid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Bell's Palsy type Left Side Facial Numbness and Tingling Radiating to Left Arm, that Initiated 12-16 Minutes after the second injection lasting Approximately 24 Hours. Felt like I had been anesthetized for dental work,  I was Given Oral Benadryl and observed for other Side affects.  Numbness had resolved by the next afternoon.
Pt c/o lightheadedness, dizziness, flushing/sweating, nausea.  Pt vomited 200mL digested food.  Pt given PO fluids.  BP 93/42, HR 66, RR 20 -- > 105/57, 59, 18 -- > 108/60, 65, 16 -- > 109/68, 68, 16.  Pt was COVID positive Jan 2021 (s/sx body ach).  No h/o fainting with vaccines or blood draws. Pt's symptoms resolved after drinking water and laying down with knees bent. Advised taking 2nd dose supine.
Heart palpitations beginning 11 hours after shot and continuing for 14 hours (every few minutes; frequency declined after that). Fever and chills beginning 11 hours after shot, chills stopped after 3 hours.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot #, dose and route not reported) instead of ZOSTAVAX. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016) subcutaneously (strength, dosing details, anatomical location were unknown) (expired product administered). No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Extended interval between doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended interval between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 29-SEP-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Red swelling and hot to touch (roughly 4 inches in diameter)for 4 days following injection.  On 2nd day post shot I experienced major swelling in lymph node region under left arm. Extreme discomfort and itched and hurt like crazy.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0162), in right arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other medications in two weeks. Tested negative after 5 days of Paxlovid anit-viral. Then 10 days later tested positive again with cold-like symptoms.  No follow-up attempts are possible. No further information is expected.
Two and 1/2 days post vax, this pt developed significant swelling, redness and tenderness consistent with cellulitis at the site of vax. In addition, she had significant lip swelling that was progressive with urticarial rash. She was admitted on 09/14 and discharged on 09/16.
dx of celluitits lt upper arm hosp x 2 days w/IV ATB & warm moist heat;
pt recvd vax & was crying; pt cried for 5 hrs intermittent; meds given; induration Lt Leg & was swelling;
Drowsy for 3 days (sleeping -> 15 hrs/day a/onset of acute sx 16JAN91. Evening hrs face became swollen, temp 103.4, began moaning, stopped eating. Seen by MD 19JAN91 dx w/cervical adonitis treated w/Augmentin sx dissipating 21JAN91.
VARIVAX given 12-19-03; No known history wild type Varicella disease; sign of shingles about 2 weeks prior to today's exam (was out of town and I did not see active lesions although Dx is clear)
vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol.  Pt contacted and no adverse reaction, pt states no problems only sore arm
Difficulty breathing, swelling of face, red face, hives.  09/10/2007 MR received for ER visit 6/27/2007 for c/o facial swelling and trouble breathing s/p varicella vaccine. PE (+) for wheezing, hives, at the injection site and on back, facial redness and edema. Impression:  Allergic reaction.
Information has been received from a registered nurse concerning an 8 year old female with no known drug reactions/allergies who on 03-MAY-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 20-AUG-2007, the patient developed a chickenpox type rash that started with several spots. On 21-AUG-2007, the rash was all over the patient's body in different stages. The rash was very itchy. The patient sought unspecified medical attention. The patient was treated with Benadryl and Calamine Lotion. The patient's chickenpox type rash persisted. There was no product quality complaint involved. Follow-up information was received on 21-SEP-2007 from a registered nurse concerning an 8-year-old female with no pre-existing medical conditions or allergies, who on 03-MAY-2002 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 20-AUG-2007, the patient developed a chickenpox type rash that was described as many small papula/pustules on trunk, itchy (varicella). The patient was prescribed to take subs in the shower twice daily with soapy water along with Benadryl, Tylenol and Calamine Lotion. At the time of the report the patient's status was reported as "significantly better". Vaccination records indicated that the patient was vaccinated with 3 intramuscular does of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), 5 intramuscular doses of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), 4 intramuscular doses of Hib conj vaccine (unspecified carrier), 5 doses of poliovirus vaccine inactivated (unspecified), 2 subcutaneous doses of measles virus vaccine  live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), one dose of hepatitis a virus vaccine (unspecified), one dose of therapy unspecified "PV', one dose of therapy unspecified "BCG" and one does of therapy unspecified "montre". Information received on 21-SEP-2007 contained the following adverse events: massive ear pain (25-MAY-2007) and strep (Aug 2007). This is one of several reports from the same source. Additional information is not expected.
I had shingles 12/19/2021 I was given medication for the symptom it was Valacyclovir. So, I just had COVID-19 symptoms for I guess two weeks, sore throat, very congestion. The first couple of days I had an elevated temperature of about 99. I had a cough and it impacted taste and smell. I was achy and tired, I took Tylenol, night sweats. That continued on until the following weekend like 02/13/2022. It seems the duration of the symptoms were longer due to the pregnancy. Pregnancy Info Due 07/24/2022, normal pregnancy to this point, I followed up with OB and they told me what to look for and I will be doing an additional ultra sound in the third trimester.
Vaccine given 8/2/19, patient noted reaction the next day.  She has no insurance and no primary care provider so came back to the immunization clinic.  Stated her right arm was very swollen with a large bump near the injection site.  Her arm itched and she felt sick, achy with a slight fever.  On 8/5/19 arm is very red, swollen near the injection site and warm to the touch.  She has small bumps that appear to be hives, the bump is still there, but not as large as two days ago.  Patient reports redness and swelling have gone done with the use  of ice.  Patient also complained of pain with range of motion, but is able to raise arm.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 06-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2018 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
got dizzy, was close to passing out, and went back into the office; This spontaneous report was received from a Licensed Practical Nurse and refers to a female patient of unknown age. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 20-AUG-2019, the patient was vaccinated with the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), route of administration reported as injection (exact dose, lot # and expiration date were not reported) for cancer prevention. On 20-AUG-2019, the patient refused to wait in the office after receiving her dose of the vaccine and went outside to her car. She got dizzy, was close to passing out and went back into the office. The outcome of the event was reported as recovered on 20-AUG-2019. The reported stated that, the event was an adverse effect after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Therefore, the event was considered to be related to suspected vaccine.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA008206:
Injection site upper arm constantly in pain , especially upon movement .  Daily chores are difficult , exercise is difficult -  dressing and lifting/carrying  things is difficult  and all of the above are painful .  Scale of 1-10 , where 10 pain level is the worst , my daily pain is at a 7.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding her son who experienced autism. The child, who is currently 5 years of age, received the fourth dose of Prevnar on 7/30/2001, at 12 months of age. The patients concurrent illness includes trisomy 21 with a past history of ear tube insertion, surgery for cryptorchism and atrial septal defect PFO hole in heart, early 2001) which closed on its own. Indication for Prevnar was immunisation. Product was administered on 7/30/2001. Dose regimen was 1 dose 1 time per day intramuscular. there other vaccines unspecified are suspect and were administered on 10/5/2000, along with the first dose of Prevnar. Concomitant medications were not reported. According to the child's mother, her son was diagnosed with autism after receiving the series of Prevnar injections. The reporter noted that the diagnosis of autism occurred on 11/23/2003. The fourth and last dose of Prevnar was administered on 7/30/2001. The child is currently 5 years of age and is entering kindergarten. Since 2003, the child takes oral therapies, glycolax powder for constipation, melatonin for sleep disorder, calcium/magnesium/zinc as a dietary supplement. No additional information was available at the time of this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ampicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid Treatment start date: 04Jul2022, Treatment start date: 8Jul2022,Indication: Treatment of COVID-19.
High fever (~103 degrees) for approximately one day, chills, body aches, insomnia, moderate fatigue.
Nausea  Chills Low grade fever Muscle aches Exhausted Sudden muscle pain Headache  Brain fog
Woke up extremely dizzy and this lasted the entire day and was only able to get up at 6:30 at night. Patient was extremely nauseous the whole day as well and when she moved she vomited. Episode progressed slightly into the next day but symptoms improved and resolved.   Took Tylenol and Dramamine.
pt c/o chills, low grade temp, joint aches, h/a, nausea for 2-3 days following inj;pt reported these sx to provider on 10JUL97;
Redness/rash at injection site when he woke up on day 8 post shot.