chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Tdap in (L) arm, MENACTRA in (R) arm. Approximately 5min later while waiting in exam room pt stood up to walk towards father and briefly lost consciousness. Father lowered him to the floor. Immediately alert and coherent afterward.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no known allergies. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "s/p AVR" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; TAMSULOSIN. The following information was reported: DRUG INEFFECTIVE (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: Unknown Results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.   Clinical course: From 20May2022 to 25May2022, the patient was treated with Paxlovid for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
menstruation prolonged; headache; her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.; her heart was racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.), HEART RATE INCREASED (her heart was racing), HEAVY MENSTRUAL BLEEDING (menstruation prolonged) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LARISSIA) for Birth control.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.) and HEART RATE INCREASED (her heart was racing). On 29-Apr-2021, the patient experienced HEADACHE (headache). On 01-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstruation prolonged). The patient was treated with ACETAMINOPHEN on 29-Apr-2021 at an unspecified dose and frequency. At the time of the report, PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.), HEART RATE INCREASED (her heart was racing), HEAVY MENSTRUAL BLEEDING (menstruation prolonged) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: ADR form added
No additional AEs; Received 3rd dose of vaccine too early; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent condition, medical history, or concomitant therapy was reported.    On 03-AUG-2021, and 16-SEP-2021, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.  On 26-OCT-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 (unit was not provided), lot # T039466 with expiration date 20-MAY-2023) intramuscularly for prophylaxis (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Itchy red oval Rash about two inches long. Looks like a red circle around the injection site. Skin feels rough and itchy
Swelling and  erythema on the injection site > 25 mm.  I took antihistamine  for 2 days. The area was clear after 7 days.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Shingrix (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of Shingrix. On 20th July 2018, 38 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The healthcare professional reported that after receipt of 1st dose of Shingrix a patient developed shingles the following month.
Numb lips about 45min later, lasted about an hour.  injection site pain and swelling late afternoon, night and next day.  Upset stomach/naseua throughout night and morning.
felt light headed after vaccine. Patient was attended by medical monitors. Pt had a syncopal episode last greater than 10 seconds until patient was laid down.   standing B/P: 98/66, pulse 60, resp -16 laying B/P: 100/66, pulse 60, resp-16
Per parents she had a blank look less than 1 hr after shots, was not making any noises. "Mentally not there" would not say words. Lethargic x 10-12 days after the shots. She would eat but would not cry for a bottle. No fever. Lasted about 2 weeks. No treatment parent just said something today about it.
No other adverse event (AE) was reported; The patient received one dose of Pneumovax 23 in error; This spontaneous report has been received form a physician referring to a 14-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 25-AUG-2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, via intramuscular route, as immunization (lot number reported and validated as S029542, expiration date not reported but upon internal validation established as 10-JUN-2021;  strength, dosage, anatomical site of vaccination and vaccination scheme frequency were not reported).   It was reported that the patient received this vaccine in error (product administration error) however, no adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
seemed out of it, immed p/vax; went to sleep, became pale & white for 2hrs during sleep; temp to 101, slept x 5-6 hrs; seen in office nl; (?hyporesponsive episode secondary DTP?);
12/11/09 Fever T=102 and chest pain - Diagnosed = pneumonia - Treatment - Amoxicillin.
pt states her arm is very tender but no rash around the injection site but she woke up during the night w/ extreme joint pain in lower back, hip, knees and ankles.  Pt states she will probably not contact her PCP since she was advised that she may have some of these symptoms.  Pt stated she started taking ibuprofen before covid vax and is still taking it.
Got stressed out and felt like someone was sitting on my chest, began to have irregular heartbeats, wore heart monitor for 2 weeks.
Patient presented to ED with progressive shortness of breath with exertion.  Patient has a history of vaping nicotine for 2 years with increasing respiratory symptoms, shortness of breath for several months.  Patient received  first dose of Pfizer on 5/7/21 symptoms of shortness of breath predated vaccine but due to ongoing symptoms presented to ED 5/14/21 where he was found to have myocarditis.  Patient was hospitalized for 2 days treated with colchicine with improvement in symptoms.  Patient readmitted 5/21/21 with recurrent myopericarditis with newly reduced ejection fraction from 60% to 40-45%.  Remains in the hospital at this time
Mom called 7/15/04 states child's broke out with fluid filled blisters 2 days ago, on face, head, hairline, arms, afeb
Pt received first dose of Moderna covid vaccine and during observation period of 3 minutes, pt stated "I feel funny in my chest and a little shortness of breath."  VS taken= P-102,  BP- 149/98,  RR- 20.  Skin warm and dry.  No n/v noted.  No c/o AP or numbness to hands or legs.  Mother with pt.  Notified lead RN,  LVN of situation and wheeled downstairs to facilities urgent care.
1:26p c/o dizziness, nausea, blurred vision BP 119/84 P 97, 1:37p  repeat VS, BP 104/72 P 92 c/o dizziness, 1:42 ambulated with Staff to car, no c/o upon arrival to car.
Muscle pain in arm injection was given in occurring same day starting approximately 1 hour later, and lasting 4 days. 8 days after injection a  hard red bump at injection site developed along with itchiness. Redness extends about an inch around injection site.
Dizzy, light headed, facial flushing, cool/clammy, fever, severe body aches/ joint pain/ muscle pain/ migraines/ nausea/ abdominal pain  Home care with rest/fluids/meds  Today 10/1 is the first back to normal day
Since my second dose i have had 7 different episode where I get flu like symptoms. I can not regualte my tempature even with tylenol and motrin. I have flu like symptoms. My tempature will go from hot to cold in seconds. Im sick and I can not eat. After 24-30 hours of that I spend the next 3 days still feeling sick. I have zero energy. I cant really eat. Nothing I do fixes it except just going through it
Menstrual Cycle - have been having a period for over a month now; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 16Jul2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Jan2021, the patient underwent nasal swab test and the result was unknown. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 15Aug2021, the patient was having a period for over a month. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19 (also reported as yes). The clinical outcome of the event having a period for over a month was not resolved at the time of this report.
The usual pain on 12/19 exp soreness of arm, fatigue and  intermittent need to take a breath. Then I went running as usual I wasn't able. On 12/20 I tried again to go running very slow, breathless. When I came home took shower I noticed a  rash above abdomen dint itch. I  noticed that evening felt breathless .When I came in on 12/21 I contacted my team about the rash. I developed a cough every couple hrs.I went to see PCP on 12/22 took Covid test results negative, still exp with cough, rash symptoms expressed concerns of being possible asymptomatic. The cough wasn't as frequent and the rash went away on 12/23.
pt recv vax 31DEC96 & 2JAN97 pt exp inj site soreness of approx 4-5cm;8 days post vax pt had 0.5cm scabbed area @ the inj site;
Around 7:00 PM, on the day I received the 2nd vaccine, I developed a fever that lasted for 24 hours. I took advil to combat it, which helped, but it always came back until around 7:00 PM the following day. Along with this, my body ached making it tough to move. Once these two side effects went away, the next two days consisted of a severe migraine when bending down and standing up. This particular side effect did not affect my daily life, though.
Feeling fine in morning. Had cup of tea, went for vaccine at 10AM. Did fine with injection, sat down for observation, 8-10 minutes later started feeling sweaty, then passed out. Woke up on the floor with nurses around me feeling tightness in chest, numbness in fingers, body shaking off and on, started to feel like tongue was swelling. Nurses gave IV fluids,  oxygen and 2 Epi-Pens. Transported by ambulance to Buffalo General Hospital. Symptoms resolved not long after arrival at hospital. Remained in EMT bay hallway for observation., seen there by ER doctor. Another EGK done, additional half bag of IV fluids, released after 4 hours observation.
Patient called pharmacy 3 days post vaccination and reported symptoms of dizziness, leg pain (more clearly described as pins and needles type pain), low grade fever and general malaise. She indicated that it wasn't severe enough for a doctor visit.
SHINGLES, RASH UNILATERAL IN 1 DERMATOME, VOMITING, HEADACHE. TREATED WITH ACYCLOVIR ON 03/23/2016.
Patient presented to the pharmacy in the evening to show me a rash that had developed around the injection site.  It looked like a hive.  He said it was not painful, but did occasionally itch.  I recommended Claritin for the itch and IBU if it became painful.  He was instructed to contact his doctor if it worsened or he had any difficulty breathing.  I followed up with the patient today and he said the rash was getting smaller.
patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster.
Underdose due to vaccine leakage; dose dripped over the patients arm; Inadvertent exposure to vaccine; This case was reported by a nurseand described the occurrence of accidental underdose in a 39-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 34yn4, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 4th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided as follows: Nurse reported that the patient received underdose of the vaccine due to vaccine leakage, which led to accidental underdose. The reporter claimed that the needle was not properly attached to the prefilled syringe. They were not sure how much of the vaccine was administrated but claimed most of the dose dripped to the floor and the patients arm, which led to exposure via skin contact and inadvertent exposure to vaccine. No further events were reported. The reporter consent to follow up.
I started to have aches, fever, sore throat, and nasal congestion. I went to my PCP, who tested me for various flu strains, RSV, and COVID-19, I tested positive for COVID-19 and negative for everything else. My PCP prescribed me Paxlovid. I took the medicine and had to wait for about five days before I could return to work. It was about day seven or day eight that I finally got a negative result on a home antigen test.
restless legs; coughing; Nausea; I'm having arm soreness/muscle aches; I'm having trouble walking aching; I'm having memory issues; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I'm having trouble walking aching), MEMORY IMPAIRMENT (I'm having memory issues), RESTLESS LEGS SYNDROME (restless legs), COUGH (coughing) and NAUSEA (Nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 011J20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO), ARMODAFINIL (NUVIGIL), PREDNISONE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced GAIT DISTURBANCE (I'm having trouble walking aching), MEMORY IMPAIRMENT (I'm having memory issues) and MYALGIA (I'm having arm soreness/muscle aches). On an unknown date, the patient experienced RESTLESS LEGS SYNDROME (restless legs), COUGH (coughing) and NAUSEA (Nausea). At the time of the report, GAIT DISTURBANCE (I'm having trouble walking aching), MEMORY IMPAIRMENT (I'm having memory issues), RESTLESS LEGS SYNDROME (restless legs), COUGH (coughing), NAUSEA (Nausea) and MYALGIA (I'm having arm soreness/muscle aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on 02-Sep-2021 and case seriousness was upgraded from non-serious to serious and Detail's about patient hospitalization was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Pt takes Benadryl every 2 hours via picc line daily. Pt took Benedryl at 5am and again post vaccine at 08:14am via PICC line and done by pt administered as instructed by her immunologist. reviewed with provider 08:24am pt took an additional 25mg via PICC line via pt administration. NO signs of anaphlaytic reaction does have mild shaking of hands. Denies any difficulty breathing. Has been instructed can take up to 100mg. Pt started having angioedema 20minutes post vaccine.  Pt has angio edema reaction post vaccine at 20 minute mark 08:45 1st Dose EPI via pt to right thigh 08:49 2nd Dose EPI via pt to left thigh 08:50 140HR, 97% RA 08:53 132HR, 97% RA improved angio edema and decreased HR. Was in no respiratory distress.  08:55 EMS arrival and transported per guerney to ER per pt request.   Nurse was present and involved throughout.
This pharmacy is a hybrid store that have both Pfizer and Moderna.  All the paperwork was processed for Pfizer, however the pharmacist grabbed the wrong vaccine (Moderna) by mistake and administered to the patient instead of Pfizer. Moderna and Pfizer manufacturers were contacted to get further instruction. Patient was monitored for 15-20mins with no adverse reactions.
Received H1N1 vaccine 01/13/2010. On 1/15/10 in early AM began having tachycardia, irregular heart beat, chills, and sweating, chest pain and fullness. Lasting about 2 hrs and gradually resolving. See in ER. Was told undiagnosed chest wall pain. EKG, all labs, stress test all normal. No abnormalities found. Wt. loss 10lbs. Loss energy, stamina. Client has had approximately 25 episodes chest pain and tachycardia ect. Prior to H1N1 vaccine had been very athletic - playing basketball, working out gym - riding bicycle. Can only work about 3-4 hrs per day non-strenuous work.
Patient receieved the Flu Mist around 4:45 PM approximately 15 minutes later stated that her head and face were hot and started tp break out in hives and voice became Raspy. Hotness on head and face was coming and going along with hives. Approximately 9:30 Pm was starting to have difficulty with swalling and was light head and seek medical attention at ER. Patient was treated with Benadryl 50 mg and a injection of Solu-Medrol. Then sent home to rest. Patient was able to return to work on 10/22/09.  10/26/09:  Emergency Department Records received for date of service 10/22/09. Assessment:  Developed throat tightness and hives after nasal H1N1 flu vaccine.  Presented to the ED with c/o fever, headache and hives as well as some residual throat tightness.  Medicated with Solumedrol IM.  Discharged to home feeling better, will take Benadryl PRN.
Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain extended into the armpit/lymph area of my left arm and the pain remained steadily severe until Friday 1/15- 3 days after the initial injection. At 1pm on day of shot (1/12/21) had feelings of chills, sweaty and whole body aches. This lasted until Thursday morning 1/14 around 7am. During that time, took Tylenol for the aches and feverish feelings.    Arm soreness finally subsided Friday. migraines started Thursday evening into Saturday morning. With little relief from Imitrex (prescription medication for chronic migraines). Went to the emergency room Saturday for a shot of Torodal for the migraine to subside.
Case number PHEH2013US011442 is an initial spontaneous report received from a nurse on 21 may 2013 with a follow up information received on 11 Jun 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. Her concomitant vaccinations included VARIVAX (batch number: H016760) on to left arm and ADACEL (batch number: CA365AA) on to right arm; both vaccine at a dose of 0.5 ml administered on 21 May 2013. She was vaccinated only with 0.5 ml  MENVEO (batch number: M12028) intramuscularly on to right arm without being reconstituted with MenA powder component, on 21 May 2013. No adverse event was reported following this drug administration error. It was reported that her mother was advised of the missing component and was offered to revaccinate in 2 months which she declined. No other information was available. Follow up information received on 11 Jun 2013: Reporter details, patient demographics (height and weight), site of vaccine administration, concomitant vaccine details updated.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent or historical conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (lot # K021547 exp. date 06-MAY-2016) (dose, frequency and route). Concomitant therapies were not reported. No adverse effects were reported. This is one of two reports from the same source (MARRS linked report 1504USA004594). Additional information has been requested.
fever, chills, fatigue, weakness, joint pain, muscle pain, headache, nausea, diarrhea,horrible nerve pain