chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm pain which she is unable to move and that her arms keep hurting; left arm pain which she is unable to move and that her arms keep hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (COMIRNATY), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 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: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset May2021, outcome "not recovered" and all described as "left arm pain which she is unable to move and that her arms keep hurting". The events "left arm pain which she is unable to move and that her arms keep hurting" required physician office visit.  Additional information: The reporter is female and was 49 years when she received the vaccine and is now 50 years. she had her 1st dose of Comirnaty on 23Apr2021 and the 2nd dose on 14May2021. she said that starting around May2021, she experienced left arm pain she is unable to move and that her arms keep hurting. she asked if this should be lasting long as it's been a year now. she wanted information on that side effect. she took her first shot last year at the end of April and it is still aching from that long ago and it is hard to bend it and it won't go away. Her sister also has the same problem, and it was still hurting and she can't bend her left arm. Treatment: she stated her doctor sent her over to the hospital to get her arm checked out and they gave her a shot to help with the pain, but it didn't help at all. she didn't know what the name of the medication was. she doesn't think she was seen in the Emergency Room. she asked, should this be lasting this long. she states no one knows what is wrong with her arm. Her Sister's arm was hurting too, she has the same problem. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A week after the shot, I experienced stomach pain including diarrhea that subsided in a few days. Then, I felt pain in my side area, left side kidney area and I thought it was just a muscle strain. After 2 weeks I first started feeling the pain, I was concerned and checked in with my doctor. I met with the nurse practitioner and was examined. It was determined that the painful area was coming from the kidney. They did urine tests to check for infection, but found no infection, and recommended an ultrasound to further examine the kidney. The ultrasound happened a week later and it came back clear and the left kidney appeared healthy. They referred me to a urologist if I was still having pain. I am still having pain. Unfortunately, the earliest appointment was available July 29th. I contacted my doctor again because of the pain yesterday and they are scheduling blood tests soon.
pt recv vax 29OCT98 & returned to clinic 30OCT98 to report site of inj left deltoid, swollen area, hard to touch measures 7cm x 9cm;pt also c/o itching @ site of inj;
Patient described 'trouble swallowing and  shortness of breath' that started after receiving the vaccine and progressively got worse 3 hours after administration.  Patient also had 'hoarse voice' and 'diaphragmatic hiccups'
Approximately 9 days after injection, I developed a delayed onset rash near my injection site.  One small red lesion (dime size) and then a larger red area near the injection site approximately 1-2 inches in length.  The rash is not itchy and not painful.  I had been reporting my side effects via VSAFE, but the daily check-ins stopped after day 7. Thankfully, I did see a news report from a hospital talking about this delayed onset rash in approximately 30 patients thus far and as a result, I knew it was a possibility.
legs are weak, shaking and trembling; legs are weak, shaking and trembling; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on an unspecified date in Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced legs are weak, shaking and trembling. Caller stated he already spoke to the safety department and was transferred to us. Caller disconnected the call before agent could finish the call or get additional information about the AE. Caller wanted to know what she can do to stop it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Itching at site of injection within 1 min of injection. Gave 25mg diphenhydramine. Itching not getting worse. Mild redness about a quarter size at injection site.
On March 3, five days after the second Pfizer Covid shot, I developed Shingles.  I am being treated for that, and it persists. In the past week, I have developed an extreme severe head cold, with congestion, heavy mucus, coughing/choking, and muscle aches. I have always been a very healthy person.
vagina bleeding before menstruation; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, into left arm on 04May2021 (at the age of 23-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included pumpkin allergy. Patient was not pregnant. Concomitant medication includes generic oral contraceptives. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) into left arm on 15Apr2021 (at the age of 23-year-old) for COVID-19 immunization and experienced random episodes of dizziness about once per week. On an unspecified date after the administration of the 2nd dose, patient experienced vagina bleeding before menstruation. The patient did not receive treatment for the event reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): negative on 19Apr2021, negative on 26Apr2021 and negative on 03May2021. Outcome of event was not recovered.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother presented in clinic on 2/5/18 c/o itchy bumps on pt's legs, arm, and back since 1/29/18. Mother applied Vaseline with no relief. Pt's mother reported subjective fever when bumps first appeared, pt was afebrile in clinic today. Treatment:  Benadryl.
2 weeks after MMR, developed total body rash and joint swelling in hands and conjunctival injection B.
Pruritic, erythematous, raised, scaly rash on trunk and arms developed about 2 weeks after first dose of COVID-19 mRNA vaccine (Moderna). Patient reported he does not know what may have caused the rash aside from the COVID-19 vaccine, denies other recent changes to medications, soaps, detergents prior to onset of the rash. Rash is still present on trunk, arms, and legs about 2 weeks later on 2/26/21 and patient reports he has seen Dermatology and been prescribed a topical treatment.
Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and stat date of the event, a causal relationship cannot be excluded.
Patient here for bivalent booster.  During administration, vaccinator report that more than 50% of the vacicne leaked out. Vax site leads notified. Patient was revaccinated with no issues reported.
My vision is impared/ unable to see well at all; My vision is impared, very blurry/ everything is blurry especially print or screen images, signs; have constant watering of the eyes; have constant watering of the eyes and itching; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302), via an unspecified route of administration, administered in left arm on 18Feb2021 14:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included allergies: penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 20Feb2021 his vision was impared, very blurry. He also had constant watering of the eyes and itching. He was unable to see well at all and everything was blurry, especially print or screen images, signs. It's unknown if patient received treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
pt seen in ER 9AUG98 for c/o pain & swelling in lt upper arm was started on ATB;had no improvement in sx;adm to hosp 17AUG98;had fever >101 associated w/chills, n/v, loose stools;dx lt upper extremity cellulitis w/crepitus;
been a year from 2nd shot; No additional AE reported; The spontaneous report has been received from a pharmacist, concerning a patient with unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, drug reaction/allergies and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot number, expiration date, route and anatomical location was not provided) for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot number, expiration date, route and anatomical location was not provided) for prophylaxis. The patient had not yet been vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had been a year from the second dose (inappropriate schedule of product administration). No additional adverse event (AE) reported (no adverse event).
pt recvd vax & 10AM mom called 9DEC93 AM to say pt had t103 R during th noc & was fussy; seen by MD  who felt was viral infect; t104;
Day 2 Rt leg swollen and red splotchy rash above knee that goes from inter-leg to outer-leg.  Day 3 Rt leg swelled up more, red solid rash goes from upper knee to groin area, warm to touch.
No ADR Resident received the Pfizer bivalent dose but had not yet previously received the primary series
mom work full time pt was home w/sitter on 11FEB92 & suddenly went limp & eyes rolled back-episode lasted only few seconds then regained consciousness; no fever; is fine today; order obtained for ped DT;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 and concomitant medications were not reported. It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID 19 Treatment, Treatment start date- 08May2022, Treatment stop date-13May2022. Reported Event: Covid rebound - tested positive on 20Jun2022. If patient recovered was recovering. If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Pt began feeling ill (headache and feverish) on night after receiving vaccine. Symptoms worsened the following day and arm swelled with increased redness and temperature at sight of ZOSTAVAX injection.
Migraine; Body aches; Stomach cramps; Nausea; Diarrhea; Chills; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 25Jun2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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: EW0180) via an unspecified route of administration in the right arm on 04Jun2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 26Jun2021 at 04:00, the patient experienced second dose effects which included migraine, nausea, diarrhea, chills, body aches, stomach cramps, sore arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea, diarrhea, chills, body aches, stomach cramps, sore arm was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt fell out of chair at school three days post vax, with body wide tremors for two minutes. Per mother, pt had been seizure free for several years and previously had focal seizures with minimal tremors. Pt taken to ER but not seen. Mother called neurologist who prescribed Tegretol but has not seen pt as of 03/09/2000.
Patient reported numbness around mouth, chin and neck area within 30 minutes of receiving their 2nd dose of COVID-19 vaccine. RN monitored patient for additional 15 minutes, patient reported feeling better with numbness being isolated to neck area only, and able to drink water without difficulty. Patient continued to improve with reduced area of numbness, and was subsequently released to home at 0952. Vitals:  0930 ( BP 188/112 HR 90 O2 Sat 98%, RR 18 ) 0945 (BP 178/112 HR 81 O2 Sat 96% RR 18).  Lot# EW0196
Patient is 26 weeks pregnant, reports injection site pain, fatigue, and light headedness.
Information has been received from a consumer who was the relative of a male patient who "about 50 or 60 years ago" was vaccinated with a dose of MMR II (approved 15-SEP-1978). It was reported that the patient had a high fever and seizures after receiving MMR II. It was reported that the patient is now 45 years old and was functional but has learning disabilities. Upon internal review, seizure was considered to be an other important medical event and learning disability was considered to be a disabling event. This is one of two cases from the same source. No further information is available.
vasovagal response, passed out with pulse in the 30's; Patient placed on floor, 911 called, ER doc responded, patient transported to ED
Information has been received from a physician concerning her 11 year old son who on 01/26/1996 was vaccinated with the first dose of varicella vaccine in the right arm. Concomitant therapy on that day included the third dose of hep B vaccine in the left deltoid. On 04/15/2001, the pt was exposed to varicella. The physician reported that on 04/28/2001, her son developed a fever of 102 deg. F., malaise, and chills. On 04/29/2001, the pt developed 20-30 lesions characteristic of varicella. The pt subsequently recovered from the malaise, fever, chills, and varicella-like lesions. Additional info is not expected.
Four hours after taking pill # 1 - back & stomach cramps & diarrhea.  @ two hours later, client went to hospital E.R. with "severe "stomach pain (ULQ).  Client stated pain was intermittent from mild to severe.  E.R. nurse stated M.D. was assessing client for pancreatitis but all tests were negative.  E.R. stated client was feeling better.  Client has not returned phone calls as to her outcome.  7-21-09 - client called back she as recovered.  States all blood work & X-rays were normal in E.R.
This spontaneous report was received from a licensed practical nurse and refers to three patients of unknown demographics. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On unspecified dates, two patients were vaccinated with improperly stored GARDASIL 9 from lot # R011628, expiry date: 11-DEC-2020 (expiry date also reported as 02-OCT-2018) and one different patient was vaccinated with improperly stored VAQTA from lot # R010954, expiry date: 27-MAY-2019 (expiry date also reported as 02-OCT-2018 for prophylaxis (dosing details not reported) (Product storage error). No adverse effects were reported. The vaccines were exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This case is considered as non-valid due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from nurse on 12-OCT-2018 refers to a 13 year old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored second dose of GARDASIL 9 (dose and frequency were not reported) (lot # R011628, expiry date: 11-DEC-2020) intramuscularly in the left arm for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 02-OCT-2018. The outcome of event, vaccination site pain was reported as recovered/resolved. The relationship between the event, vaccination site pain and GARDASIL 9 was not provided. This is one of several reports received from the same reporter.
Approx 15 min after flu shot given pt returned to clinic. He was flushed B/P 158/08 No SOB or chest pain. Sent to ER.
Fever, severe migraine, nausea, diarrhea, fatigue, treated with Reglan and fluids at ER, on 09/16/2013.
Pt presented with redness, bruising, and tenderness on inside of elbow of arm where vaccine was administered.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 35-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 9K7E4, expiry date APRIL 2017). Concomitant products included Tetanus vaccine. On 17th OCTOBER 2016, the patient received FLULAVAL QUADRIVALENT, .5ml. On 17th OCTOBER 2016 4 hrs after receiving FLULAVAL QUADRIVSALENT, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved. The reporter considered the pruritus to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 30th SEPTEMBER 2016, the patient received tetanus vaccine. The patient received FLULAVAL QUADRIVALENT in his left deltoid. After receiving FLULAVAL vaccination, the patient experienced itching on scalp and head.
Syncope after injection of HPV, was fine afterward. Had had no breakfast, food or drink this AM.
strong chills; shaking; cold; feverish irritated; hurt to pee; feverish irritated; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 10:00 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; TIZANIDINE; ZOMIG; EXCEDRIN ASPIRIN FREE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 12Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 22Mar2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 10:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "strong chills"; TREMOR (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "shaking"; FEELING COLD (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "cold"; PYREXIA (non-serious), IRRITABILITY (non-serious) all with onset 17Dec2021 01:00, outcome "recovered" (Dec2021) and all described as "feverish irritated"; DYSURIA (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "hurt to pee". Therapeutic measures were not taken as a result of chills, tremor, feeling cold, pyrexia, dysuria, irritability.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.