chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Pfizer COVID-19 vaccination. She was asked all the appropriate questions prior to administration. She had no past experiences or allergies that would be a cause for concern. After administration she expressed confidence that she felt fine. She went to the waiting area to wait 15 minutes prior to exiting the pharmacy. Within 5 minutes her mother notified the pharmacist that she passed out. Upon examination, she indeed fainted while sitting in a chair. The pharmacist called 911 while an intern when to check her vitals. Within 30 seconds, the patient awoke and was a little confused but felt better. Paramedics came and she was checked out and sent home with her mother.
Information has been received from a physician concerning a female who was already being treated for vulvar Condyloma (genital wart) and was vaccinated with GARDASIL.  Several weeks later, the patient came back to the office because her genital warts got significantly more prevalent and worse.  Additional information has been requested.
Information has been received from a nurse practitioner referring to 50 patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. The nurse practitioner was reporting that the 50 patients were administered with VARIVAX (Merck) (lot # K007980, expiration date 03-JUN-2016, dose and route not reported) on unspecified dates, that had been improperly stored (incorrect product storage). No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was not reported. Additional information is not expected as there was no consent for follow up contact.
pt stated within 10 minutes after receiving vax she became flushed, had chills, cold sweats and palpitations.  Pt stated her vitals were taken and her BP was 215/104.  After about and hour it came down to 160/?.  Pt stated that 2 weeks after the vax she developed a 6" red, warm, swollen, itchy area around injection site.  Pt stated her symptoms have subsided but she has contacted her PCP about getting second dose and was advised not to take it.
Headache; dizziness; tiredness; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no allergies to medications, food, or other products. Concomitant medications included blood pressure pill (MANUFACTURER UNKNOWN), from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced headache, dizziness and tiredness. 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 events headache, dizziness and tiredness were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had second COVID vaccine in the allergy department in case of reaction. Both Pfizer COVID vaccine intradermals were negative. We then proceeded with administration of the full Pfizer COVID vaccine. She was observed here for 60 minutes. She had no change in her physical exam, her vital signs, or her overall demeanor. At this time, patient is fully vaccinated. She does not demonstrate any evidence of allergic reaction to her 2nd vaccine. She can receive her booster without any additional precautions. Refill of Epi pen on same day.
SORENESS IN ARM; This spontaneous report received from a consumer concerned a male of unspecified age. 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, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness in arm was not reported. This report was non-serious.
Liver Failure, Swelling in Feet, Bed ridden, loss of awareness, total disability for several days. VA Neurology Clinic. Spoke with nurse she indicated that patient did not receive a vaccine but experienced an adverse event to an injection that was exacerbated by his oral medications. She will fax a copy of the office note for the DOS 08/03/2006 to validate medication administered. krk 09/13/06-office notes received from Biloxi VAMC for DOS 08/03/2006- office visit regarding prostate needle biopsy, results adenocarcinoma Gleason's score 6. Plan: RX Zoladex 10.8 mg given. Prescription for Flutamide 250 mg TID times 90 days, Zoladex. Later same day patient's wife contacted clinic stating patient began the Flutamide, he can hardly walk and his urine is real dark (no burning/discomfort). Wife state he is deteriorating and feels it's caused by the medication. Clinic instructed patient to discontinue Flutamide, increase fluid intake and if condition fails to improve within 24-48 hours or worsen to F/U with his PCP or ER. 01/1/2010 It has left him disabled, unable to walk real good, unable to have sex, unable to think. 02/09/10 Still in recovery, needs care almost died of liner failure, in hospital for four days.
Sharp shooting pain which seemed like an implosion in arm;  numbness occurred & is still present, initially in entire arm, now from elbow-wrist area;
PATIENT HAD COVID-19 PFIZER VACCINE Dose 1 date: 12/22/2020,  Dose 2 date: 01/12/2021, AND TESTED POSITIVE TO COVID.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a currently 19 year old female patient. The patient's concurrent conditions and medical history were none. There was no history of drug allergies and reactions. On 02-OCT-2015, the patient was vaccinated with VARIVAX (Merck) (lot # 013825; and expiry date of 21-APR-2017) unknown strength, dose and route while she was pregnant. Concomitant medications were none. The patient was unaware that at the time of administration, that she was pregnant. The last month period date is approximately 20-AUG-2015 and estimated date of delivery is 26-MAY-2016. The patient's gestation age was reported to be 14 weeks and 6 days. The patient underwent a routine prenatal lab work on an unknown date in 2015. No treatment was received in response to the event. The patient sought medical attention and spoke to a doctor. Additional information has been requested.
itching; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious) with onset Jan2021, outcome "unknown", described as "itching".  Additional Information: The patient stated she already did a report with her first one because she had itching. The patient stated that to get the booster, but it is coming from the same vial as the first or second. She got things from Pfizer as a share holder that they are looking into the booster that will be for Delta and other strands. They are now saying to get the booster, but it is coming from the same vial as the first or second. The reporter states she is just asking a general question and not speaking of a specific lot number. She already got the first and second and they are only giving the booster at certain places. She asked the pharmacist who said it was not a booster it is a third shot because it is coming from the same vial as if getting the first or second. If this is saying it is only going to last 8 months, what will make the third last eight months if the first and second together only lasted 8 months. She doesn't want to put stuff in her body if it is not needed, but she doesn't not want to do if it is needed. This was back in Jan2021. Reporter clarified product as COVID vaccine.received second dose of bnt162b2 (BNT162B2), administration date on an unspecified date (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-386799, MOD-2021-387476 (Patient Link).
1 hour after receiving the vaccine, strong headache, lethargy, sweating overnight, insomnia, muscular pain, and pain in the injection arm. On the next morning the same symptoms but with uncontrollable nausea. Around 10 am of February the 12, the same symptoms but also with a very strong headache even after taking Ibuprofen 600 mg. The nauseas were more pronounced too. 1 hour later experienced chest pressure, and breathing fast, I rest in bed with some breathing control techniques. These symptoms lasted around 2 hours. The headache improved a little but stayed all day and night, accompanied with nausea on the next day until February 14.
Narrative:  Other Relevant Hx:  Wife reports that approximately 2 hours after receiving the vaccine the patient lost control of his bladder and urinated on himself and had difficulty speaking. Hospitalized at Hospital where he received MRI of head and found no signs of TIA/CVA. Patient then transferred to another hospital on 2/03/21 to further assess anemia potentially secondary to GIB.  Symptoms:  Confusion & aphasia
I started feeling exhausted struggled to eat and was Lethargic couldn't eat Sunday the 15th went to urgent care I was diagnosed with an inflammatory reaction I was prescribed 800 mg ibuprofen after taking first dose started to recover from event.
pt recv vax 30AUG96 & 19MAY97 pt devel a shingles rash;
After receiving the vaccine, pt felt lightheaded, dizzy, and slightly nauseaous. He did not have an irregular H/R or breaths and did not eat today.
noted hives in arm pits & blotches on knees p/vax; appeared to go away last noc; this am hives on back of hands & elbows;no other sxs;advised to contact MD
Pt. called and reports red patchy outbreak at injection site with itching. Now he has the same patchy red area on chest.
Started with a numb tongue and eventually could not close Right eye. Was admitted on 17 OCT to rule out other possible conditions only.  DX of Bells Palsy on Right and 5th nerve palsy on the left side of his face.
Fatigue; Left arm, breast and back pain; Breast and back pain; Back pain; Some swelling; Migraine; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Sep2021, the patient experienced fatigue, also left arm, breast and back pain as well as some swelling for two weeks and migraine for three days. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine was resolved on 17Sep2021, after a duration of three days, while that of some swelling was resolved on an unknown date in 2021 after a duration of two weeks. The clinical outcome of the events fatigue and left arm, breast and back pain was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Oct2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient fainted approximately 3 minutes following vaccination and regained consciousness immediately. He was observed to have pale skin tone with normal pulse and respirations. He was responsive to questions and was oriented to time and place. EMS was called and arrived within 8 minutes. Patient was evaluated and the parents elected not to take ambulance. The father followed up with me after the ER visit. The patient had normal testing results including EKG and was doing well. Vasovagal syncope adjacent to vaccination was the diagnosis.
C/O SOB with walking within observation room Assessment:  Vitals: B/P: 162/100 HR: 57 Resp.: 16 O2Sat: 95% Skin Signs: Warm and Dry, pre existing dermatitis skin rash on arm, les to chest Circulation: Cap Refill <2sec Resp.: Other- diminished with few rals at base  Treatment: Observation Repeat Assessment: 13:43 Vitals: B/P: 168/98 HR:55 Resp.: 16 O2Sat: 93% Skin Signs: warm and dry Circulation: Cap refill <2sec Treatment: Pt monitored, states feels better, no SOB, no wheezing, pt stable, pt d/c'd home with instructions to call 911 for and exacerbated symptoms
Symptoms started 7 hours after injection: Fatigue Chills Body Aches Fever Soreness at injection site
Sore arm; Headache felt as if head was coming off; Lingering Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lingering Dizziness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache felt as if head was coming off) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (said she had vertigo in august) in August 2020. Previously administered products included for Vertigo: Dramamine.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Lingering Dizziness) and HEADACHE (Headache felt as if head was coming off). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, DIZZINESS (Lingering Dizziness) and HEADACHE (Headache felt as if head was coming off) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Suspected vaccination failure; Reported a case of shingles in her groin area; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was in her 60s at the time of reporting. The age at vaccination was not reported. The patient received new Shingles vaccine, a year ago from the date of reporting. After receiving Shingles vaccine, the patient got shingles in her groin area. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. The reporter consented to follow up. This case has been linked with the case US2021AMR161208 (Nucala case), reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161208:Same reporter.
Localized tenderness along with "string/cord" in armpit when stretches his arm, has a tight/stretched feeling. It is uncomfortable but not painful and he has used Tylenol with some relief. He got vaccination 5 days ago and is still feeling this.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old female patient who experienced localized reaction, flushing and redness in her face, felt warm but no fever, feels sluggish and achiness in her legs, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Herpes zoster (shingles twice this year in on unspecified date at May and July). The patient's past medical treatment included Acyclovir for shingles, BENADRYL and Prednisone for 4 days for another problem but is not sure which year she took the medication. The patient's past vaccination(s) included FLUZONE QUADRIVALENT past every year. The patient's past family history was not provided. On an unknown date at 05:00 PM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction, four hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date (reported as next AM), the patient developed a non-serious flushing in her face, redness in her face and felt warm but no fever following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious feels sluggish and achiness in her legs, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was achiness in her legs, feels sluggish, felt warm but no fever, flushing and redness in her face and localized reaction. The patient received BENADRYL but did not help her. The outcome of the events was not reported. Documents held by sender: none.
My left arm was s still extremely painful after my second Pfizer Shot after 6 months? I reported to my doctor but he said it will stop hurting but it is still hurting after six months ;(,
Arm that shot was given in was sore for a few days, now arm is sore from elbow to wrist
Information has been received from a registered nurse and a licensed practical nurse from patient's report and emergency room (ER) records concerning a 16 year old female with CECLOR allergy who was vaccinated with the 1st and 2nd doses of GARDASIL (1st lot #661764/0650X, 2nd lot #661531/1311X) on 15-DEC-2008 and 16-FEB-2009, respectively. She did not have problems on the first dose of GARDASIL. There was no concomitant medication. No other vaccines were given on 16-APR-2009. Additional information received from a nurse indicated that on 16-FEB-2009, the patient experienced an episode of syncope and fell down and got hurt on her head after getting GARDASIL. The patient went to ER on 16-FEB-2009 at 19:45 where a CT of the head was normal. She was given TYLENOL, MOTRIN for pain and released. Event was not disabling or life threatening and did not require in-patient hospitalization. The patient had recovered by the time of the 20-FEB-2009 office visit. Additional information has been requested.
Got Covid-19 headache , sore throat, diarrhea, cough, fatigue
Injection site was warm; Left arm began hurting; Injection site was red; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE PAIN (Left arm began hurting), VACCINATION SITE ERYTHEMA (Injection site was red), CHILLS (Chills) and FATIGUE (Fatigue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-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) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE PAIN (Left arm began hurting), VACCINATION SITE ERYTHEMA (Injection site was red), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE PAIN (Left arm began hurting), VACCINATION SITE ERYTHEMA (Injection site was red), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events were Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up document was attached on 12-May-2021 which contains updated outcome of the events as recovered.
FAST HEARTBEAT; This spontaneous report received from a patient concerned a male of unspecified age. 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, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fast heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat on APR-2021. This report was non-serious.
(Bilateral) Sx - watering eyes, burning eyes on 4-28-14. On 5-5-14 progressively worse then given ABX with steroid, on 5-9-14 saw a corneal specialist and was given steroid eye drop and to d/c the ABX. Return to clinic 5-13-14, was currently diagnosed with dry eye.
pt recv vax 12JUN97 & 15JUN97 pt devel diarrhea, fever of 103 & was hosp;pt given IV ATB but did not seem to work;fever came down a couple of days but now returned;lab eval of pt WBC count was detected as high;