chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fairly severe right leg pain while walking; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 03Aug2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 13Jul2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 03Aug2021 at 17:20, about 20 minutes after her second dose, the patient experienced fairly severe right leg pain while walking. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event fairly severe right leg pain while walking was unknown at the time of the report.
pt recv vax 11JUN97 2PM & rash redden area noticed 8PM, warm to touch, tender to palpation;circle shape redden inj site induration, lump sl harder area 1.3 x 1.3cm;
The morning following vaccination, pt lost all feeling and movement in left arm for approx. 30 minutes. Experienced slow recovery over following hour. Pt has submitted this due to resistance from Navy doctor's to document and submit this adverse report.
No symptoms prior to the shot.  Developed mild symptoms shortly thereafter that got worse over the next 24 hours. Tested positive for Covid in the evening of 10/12/2023.  I know of 2 other people who had exactly the same experience.
This 74  year old female received the Covid shot on 2/20/21    and went to the ED and was admitted on  3/22/21  with the following diagnoses listed below. I63.9 - Cerebral infarction, unspecified I63.9 - Ischemic stroke
fatigued; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:45 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021 13:00, outcome "recovered" (2021), described as "fatigued". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt was vaxed in nurse's area & 10 mins later was leaving building & almost passed out-was seated on chair-found to be pale, diaphoretic c/o unable to see well; BP 90/60 strong;
Information has been received from a physician and L.P.N. concerning an 84 year old female who on 12-DEC-2006 was inadvertently vaccinated with a 0.5 ml dose of Varivax (lot 3 654813/1088F) instead of Zostavax. Unspecified medical attention was sought. This was reported to be staff error and not product confusion. The administering L.P.N. stated that the office stopped carrying Varivax on an earlier date and she did not realize that they started carrying it again. The L.P.N. said that she grabbed the vaccine out of the freezer, saw varicella on the bottle and thought it was Zostavax. After administering the vaccine the L.P.N. saw the brand name of the vaccine on the bottle. The patient has not had any adverse experiences. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Started unusual menstrual cycle after receiving shot. I have regular cycles at about 27 to 28 days apart and last about 6 days. I started 9 days early with prolonged spotting and light bleeding that lasted 12 days and extremely heavy bleeding with blood clots about 2 inches in diameter at day 13. The cycle has not stopped as of yet.  Did not start having menstrual cramps until day 13 when the heavy bleeding started.
This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with the first and the second dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.  It was stated that if the patients began the human papillomavirus (HPV) series with GARDASIL then, on an unknown date, they received GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis in order to finish the human papillomavirus (HPV) series. No adverse effects were reported.  Additional information has been requested.
Information has been received from a consumer concerning her 19 weeks old daughter with gastrooesophageal reflux and milk allergy who was vaccinated orally with the first dose of ROTATEQ (dose and lot# were unspecified) on 07-OCT-2011. Concomitant therapy included MIRALAX and ZANTAC. On 13-DEC-2011, the patient was taken to clinic for her second dose of ROTATEQ; while the technician as administering ROTATEQ to the patient, the patient was spitting some of the medication out. Five seconds after the administration of ROTATEQ was completed, the patient vomited. No lab diagnostics studies were performed and no treatment was given for adverse events. On 14-DEC-2011, the patient felt good and recovered from vomit. Follow up information has been received from a doctor requested no more letters from this report. No further information is available.
8 seizure like episodes which began 1 day following vaccinations and lasted 1 day, no episodes since (currently 3 days post last episode) sent to hospital and pt referred to neurology.
This spontaneous report as received from an unknown reporter, via company representative, refers to a two patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of ZOSTAVAX (dose, strength, route and sire of administration not reported). On an unknown date the patients developed rash after receiving the ZOSTAVAX. The outcome was unknown. The relatedness between ZOSTAVAX and rash was not reported. Additional information has been requested.
patient got her 1st shot, few minutes later, she felt throwing up, stomach issues, sweating , dizziness, called 911 , they came checked her bp, and virtals, looked all good, did not take her to hospital
Chills; a small fever; Stomach ache; very tired; Very sore arm; breath was short; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0171, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization, reaction(s): "had a sore arm"; Bnt162b2 (dose 2, single), for COVID-19 immunization, reaction(s): "very tired", "big bump on the arm", "sore arm". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "a small fever"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stomach ache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "very tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very sore arm"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "breath was short"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "couldn't walk".  Additional Information: Patient is a Vet (further clarification unknown), who took the booster vaccine (Further not clarified, hence captured as Unspecified Vaccine) and experienced events for three days. Patient went to withheld with his/her dad who was 85 years old and they told patient that they took it (booster), they said him/her to take it too, If patient have more than six months. Patient had card in the wallet and was eight months out .So patient took the booster vaccine so, eight months from second vaccine, patient would like Pfizer to know that was patient was healthy, never sick, when patient got the other two shots, two vaccines and had a sore arm. The second vaccine, one very tired day with the sore arm, a big bump on the arm but that was the side effects that was it was one sore arm and one tired day. Patient took the booster vaccine and that has every symptoms which are described. Patient don't regret that patient took the booster not calling to complain. Patient just wanted to inform this happened because may be it helps in future to understand the reactions on it. It is helpful to the vaccine to the Pfizer company in general.   Follow-up attempts are completed. No further information is expected.
On 11/30,99, the pt developed chickenpox. The pt sought unspecified medical attention. It was indicated  that two of the pt's siblings and other children in the school developed chicken pox following vax.
Day after and second day after experienced spiking fever of 103.5; treated with tylenol.  Ten days after, swollen neck glands and fever; diagnosed with strep and treated with antibiotics.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called on 9/21/21 regarding long term hives and itching after vaccine. Patient was advised to take a benadryl to help with hives and itching (she has not done so due to concer that it might affect the efficacy). patient cancelled appointment for second dose until resolution of symptoms
Noticed a red, oval shaped, firm mass below injection site 8 days post vaccine.   Area is hot to the touch and extremely itchy. Has continued to increase in size throughout the day.  Itchiness has also worsened.
sore arm (2 days) fever (1 day) chills (1 day) headache (2 days) fatigue (3 days) nausea (2 days) 1st day after, in bed all day 2nd day, in bed quite a bit 3rd day, worked from home with breaks and a nap 4th day, felt great
COVID-19 Pfizer BioNTech was administered as a booster instead of COVID-19 Pfizer BioNTech Bivalent. No adverse reaction reported.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. Date of refrigeration was reported as 07-MAY-2021   This case was linked to MOD-2021-364944 (Patient Link).
redness @ site of inject w/ a long red knot extending downward for about 1-1 1/2" from inject site; no pain, fever, or edema of surrounding tissue; advised warm water bath 11JAN95; pt improved;
Narrative: Body aches, headache, productive cough, malaise, chills, shortness of breath
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 88 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported. Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. CUS245) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot no: EN6208 ) on 04-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot no: EW0151 ) on 09-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster and Lot no: SJ5683 ) on 08-Mar-2022.   On 24-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DEPRESSED MOOD (feeling depressed) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) had resolved and VACCINATION COMPLICATION (had problems) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. In the afternoon patient started experiencing adverse events.
Initial 2 days of flu like symptoms but today is day 4 post vaccine and the patient is reporting continued headaches into today.
Fever 101.4; Fatigue; Chills; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on 13May2021 04:45 (at the age of 75-years-old), as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR [ATORVASTATIN]); unspecified multivitamin; and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101.4, fatigue, chills, nausea, vomiting, and feeling unwell on 14May2021 12:30. The patient underwent lab tests and procedures which included body temperature: 101.4 (fever) on 14May2021. It was unknown if treatment was given as a result of the events. Patient seek consult with her physician. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Unsure if this is connected, but in light of recent studies I thought I should report.  I had been taking Lupron and an aromatase inhibitor to prevent breast cancer recurrence.  15 months before the vaccine I discontinued Lupron expecting that I was in full menopause and need not continue it.  Around the time of my second shot I had what appeared to be a full menstrual period, which required me to stop the AI, bridge with Tamoxifen, and have a hysterectomy after consultation with my oncologist and a gynecologic oncologist.  I did have fibroids which may have contributed, but in case this is a pattern I wanted to alert you to this.
Urticaria on trunk, upper arms, lower extremities, groin area lasting approximately 10 days.
The day after her shot she got headache,severe body aches and fever. The symptoms lasted 3 days and went away on their own
Right arm where I rec'd injection, swollen, warm to the touch, itchy and has broken out into a rash.
PT C/O DIZZINESS, CANNOT SEE WELL. THE SAME THING HAPPENS WHENEVER SHE GIVES BLOOD. VITAL SIGNES CHECKED . VITALS STABLE. PT HYDRATED WITH GATORADE. AFTER 5 MIN, PT STATED THAT HE WAS FEELIJNG BETTER. THE PT WAS OBSERVED FOR 30 MIN BEFORE BEING SENT HOME.  O2 96% BP 126/69 HR 68
Cool compresses, juice and water given, graham crackers given. Vitals checked, doctor made aware.
Per mom, patient developed vesicles with clear fluid (varicella-type rash) on arms, back, and legs 3 days after vaccine administration. No fever. When I evaluated patient on 10/23/15 there was evidence of erythematous crusted over varicella type rash.
pt recvd vax 16JUN95 & 26JUN95 devel rubella characterized by swollen glands of ipsilateral axilla,confluent red dots,dry cotton mouth & throat;also had stiff joints & soreness behind ear & neck;pt recovered;no further details were provided
About 24 hours after receiving the second vaccination I developed chills followed by a fever that ranged from 99.7-101.6 during the next 10 hours.  Had a slight headache.  Took 2 advil around 2:00 pm and another 2 at about 7:30 pm. Went to bed at 9:30.  Had no adverse effects the next day.
Having allergic sensitivity issue/ allergic reaction; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection), via an unspecified route of administration on 04May2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization. The reporter stated that her daughters had the covid vaccine (second) on 04May2021, and they developed an allergic reaction. The reporter had a picture of their cards but did not have demographic information of the patient as the patient did not want to share the information. Limited information available over the call. On an unspecified date in May2021 (after receiving second dose of Pfizer Covid vaccine), the patient experienced having allergic sensitivity issue. The outcome of the event was unknown.   Information on lot/Batch number has been requested.
Patient received 1st dose of Pfizer vaccine and after sitting for about 10 mins, patient felt faint and passed out, falling off his chair and onto the floor.  Pharmacist rushed to the patient and assisted in comforting him and making sure he was ok.  He was able to get back up after a few mins and sit back in chair.  He was given water and paramedics arrived to check all vitals, which were normal.
Patient's first time getting Kinrix but this is his 4th dose of Dtap as well as IPV. Patient shows having the flu vaccine in previous seasons; this being the 3rd. Per mom called clinic back 4 days later (9/30/2022) stating that her son was complaining that his leg was "itchy" on his left thigh where the vaccine was administered. Per mom stated, he has a rash and feels hot just on that area." Mom reports the rash persisted for the past 4 days, slightly less erythema and swelling. No pain reported.  Diphenhydramine 7.5ml q 6 hours for itchiness and swelling . Cephalexin 3x/day for 10 days for suspected cellulitis. Mom stated she would like to watch the rash on diphenhydramine prior to starting the cephalexin. If redness and swelling improved then no need for Cephalexin. Resolved
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M047662 [expiration date 02-DEC-2018]) (dose and route unknown) for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002361 and 1708USA002363).; Sender's Comments: US-009507513-1708USA002363: US-009507513-1708USA002328: US-009507513-1708USA002361: