chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches a lot; I had my vaccine; I have a concern about my face, I feel my face numb; feeling very tired; cough; have a cold; cough with phlegm; 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 48 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 48 years 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: HYPOAESTHESIA (non-serious) with onset 08Feb2022, outcome "unknown", described as "I had my vaccine; I have a concern about my face, I feel my face numb"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "feeling very tired"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "have a cold"; PRODUCTIVE COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough with phlegm"; PAIN (non-serious), outcome "unknown", described as "body aches a lot".  Additional information: The patient stated that he had a question, he had his vaccine the 27th last month the 27 and he had a concern about his face. he felt his face numb so, he wants to make sure, if this is like a symptom for the vaccine. he asked if his symptoms are related to vaccination and to make sure if he should go to the doctor, he stated since Friday he have been feeling very tired, he had some cough and cold, a cough with phlegm and body aches a lot, yesterday he felt on his face like it was kind of going numb and it felt like that throughout the day, but this morning he woke up and felt it a little better, I no longer feel that same symptom on his face.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA003156.
Patient had body aches, chills, vomiting, feeling faint, feeling tired and a headache. These symptoms set on in the evening of the day she got the shot. It happened with both her first and second doses. It was worse with the second dose.
Fever of 102.8; Headache; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 10:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included the patient was allergic to a sulfa drug. The patient did not take any concomitant medications within 2 weeks prior to vaccination. The patient previously received codeine and had an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Mar2021 at 15:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. 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 at 22:30, the patient experienced a fever of 102.8, headache and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 102.8, headache and loss of appetite were recovered with sequelae at the time of the report.  No follow-up attempts are needed. No further information is expected.
Immediate severe pain after shot administered. Pain has continued to present day from April 22, 2016 until now. Many weeks of physical therapy and steroid injection.
Patient said he got woozy, light headed, felt like fainting.   Gave him some water and observed him for 15 more minutes He called back and said it happened two more times.  Today he is feeling fine.
A non-serious spontaneous report of administration of FLUMIST to individual over 49 years of age was received from a registered nurse involving a 73-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Information has been received from a health professional concerning a 4 year old female who on 09-FEB2002 was vaccinated with a dose of varicella virus vaccine live. On 24FEB2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Her arm got very itchy at the injection site; Have big red oval shape at the injection site; injection site felt warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site), VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) and VACCINATION SITE WARMTH (injection site felt warm to the touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN and VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site), VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) and VACCINATION SITE WARMTH (injection site felt warm to the touch). On 19-Jan-2021, VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site) had not resolved and VACCINATION SITE WARMTH (injection site felt warm to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were nor ptovided by reporter.
It was red; It was warm; Got shingles shot, it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On 19th October 2022, the patient experienced erythema and skin warm. On an unknown date, the outcome of the pain, erythema and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her shingles shot this past Monday. It hurt for a few days, then 3 days ago it was red and warm. On day of reporting (morning) the patient woke up and it hurts again.  The patient asked should be worried. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
OBSTRUCTIVE SLEEP APNEA  8/11/2022,  9/15/2022,  9/16/2022, 12/21/2022 -- RECURRENCE OF SAME SYMPTOMS
Vaccinated arm was inflamed, painful, warm, red, swelling, hard to raise.
alleges onset suddenly of fever, chills, & nasal congestion;24hr later nasal sx but fever & chills subsided;
Day following injection: sore throat, runny nose. Two days following coughing with congestion in chest lasting approximately 2 weeks, chills, headache, also congested sinuses. Prescribe Cephalexin 500 mg; GPN/Phenylep 600, Benzonatate 200 mg.
pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;
Soreness in arm for 2 days Tingling lips and tongue 2 hours after vaccination for 2 minutes  Body fatigue 8 hours after shot, lasting until next morning around 7 am
Muscle weakness in legs and arms after fall on night of 02/14/2021 @11.00pm following the vaccination @ 9.00am on 02/13/2021 . Contacted PCP the next day she told me to rest and drink plenty of fluids take 2 Tylenol.  I regain strength in your legs and arms so I could life myself up.
blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment for the event was not provided.  Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
2cm x 2cm eryth. hardened area with warmth over entire upper arm. Good ROM.
Donor called into the plasma center and reported gnawing, throbbing pain deep in right arm 2 weeks after Tdap immunization. Donor reports that a resting position alleviates pain minimally and movement/use increases pain. Donor states there is no bruising present  and initial muscle soreness from injection subsided about 3-4 days after the injection. Donor states he has used Advil and Pennsaid topical ointment (Diclofenac) for treatment of pain with little to no improvement. Donor states he is going to see his primary care doctor to follow up as soon as possible.
Flu like symptoms - fever muscle aches chills sweats lasting 12 hours.  Intestinal probs - diarrhea lasting 48 hours. Extreme arm pain and swelling. Unable to use left arm for 48 hours.
After taking the 3rd dose, my arm was sore and I was very tired. Then ten days after receiving the 3rd dose, I woke up and my whole body was covered in hives. I received prednisone from my rheumatologist. The hives still has not went away. The hives are itchy as well.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 16-MAY-2014, the patient was vaccinated with ROTATEQ inj, lot J015062, expiration date 13-OCT-2015 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful until 4/12. Continued to be tired until 4/15.
Severe muscle pain under injection site, requiring round the clock ice pack for 2 days and continual TYLENOL dosing. Deltoid muscle felt like there was 'acid' in the arm for 3 weeks. Visible inflamed muscle 'bump' for 3 weeks. Motion limited, could not sleep on that arm for at least two weeks, pain with stretching of muscle. Never experienced other adverse reactions to immunizations before, except the first dose of BEXSERO as well (6 months ago) which produces the same excruciating symptoms. Concerned that it causes muscle damage with very slow healing. Would not have returned for this booster shot if I was not asplenic and absolutely needed the series. PLEASE look into having this vaccine reevaluated and adjusted.
8x8 cm erythema and edema right upper arm. Seen on 4/14/04. DPT-A given. Shot given 4/13/04. No systemic reaction.
Mom called and reported that child had loss of appetite and irritable within a couple of hours after receiving the HIB vaccine 0n 9-11-18. Mom called today (9-20-18) because she had to pick up child at daycare with a fever of 102.4. Child was seen at Pediatrics and was tested negative for flu. Mom reports that fever has gone down after TYLENOL but child is lethargic. Mom also reports that child's urine has a strong odor. Mom told me that the Dr. she saw today at Peds told her that reactions usually occur with a couple of days but Mom is still concerned because she thought it was her first dose of HIB. I, told Mom that according to our records she had previously had a first dose of HIB. I instructed Mom to take child to ER if fever spikes again.
Low grade fever      4 Days Brain fog                  10 Days Body aches                4 Days Loss of taste            14 Days Minor loss of taste continuing Sore arm                    2 Days Head ache                14 Days Fatigue                      21 Days
Potential administration of only the diluent/ one vial of adjuvant missing; Potential administration of only the diluent/ one vial of adjuvant missing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number AS01B, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The pharmacist reported that a box of shingrix had at the moment of the conversation, five vials with lyophilized agent, and four vials with the diluent AS01B. The reporter called due to being short 1 diluent and stated that someone could have had gotten diluent only, but did not had any details about anyone specific. Additional supportive information: The patient might had received diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The follow-up could not be possible as no contact details were available.
Body ache; Headaches; Nausea; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Aug2021 at 14:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 16:00, the patient experienced body ache, headaches, nausea and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, headaches, nausea and swollen lymph nodes were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Nurse practitioner concerning a 25 year old female patient who on 18-APR-2008 was vaccinated with the first dose of GARDASIL. After receiving the first dose of GARDASIL the patient was diagnosed with right breast cancer (2008). In November 2008, the patient had a right segmental mastectomy and lymph node dissection. As per the oncologist the breast cancer is not related to the GARDASIL. The patient was continuing on HERCEPTIN chemotherapy treatments until May 2009. She was also currently receiving radiation therapy. Upon internal review, breast cancer was considered to be an Other Important Medical Event. Additional information has been requested.  1/19/09 Reviewed PCP medical records of 11/14/2008. FINAL DX: right breast cancer, clinical stage T1C N0 M0; ER-positive, HER-2-positive; neoadjuvant chemotherapy; BRCA1 & 2 gene negative; right segmental mastectomy & sentinel lymph node biopsy 11/5/08.
Whole neck of prefilled syringe broke off; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: PAA167474) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Whole neck of prefilled syringe broke off". Additional information: No patient involvement. The syringe was being disposed of after injection when the whole neck of the prefilled syringe broke off when they were safety clipping the needle.  Follow-up attempts are completed. No further information is expected.
large amount of blood in stool x 1 (so far) also with mild fatigue, body ache and abdominal cramping
No adverse effect were reported; the patient was administered one dose of PEDVAX HIB (lot, exp unknown) on 4/24/2019, and was administered the booster dose of PEDVAX HIB (lot R021083 exp 6/13/2021) on 5/24/2019; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On 24-MAY-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), injection, one dose (strength, frequency, route of administration, lot # and expiry date unspecified)  and on 24-MAY-2019, the patient administered booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dose of  lot # R021083 with expiry date 13-JUN-2021 (strength, frequency, route of administration unknown) for prophylaxis (inappropriate schedule of product administration). No adverse effects (no adverse event) were reported. The outcomes of events were unknown. No product quality complaint was involved.
Low body temp on 2/20 followed by elevated temp on 2/21.  Normal temp by 2/22.  Soreness and lump at injection site evening of 2/22, with local burning pain.  Left arm muscle soreness on 2/23 with red skin patch approx 3cm x 6cm at injection site.
I had no mental cycle following the vaccine for four continuous months. Nothing else had changed except reviving the vaccine and my next mental cycle never came. Labs were repeated over and over and nothing was showing wrong or incorrect. All my hormone levels were great, no miscarriage, this had never happened in the past, etc?
Collapse while walking. Legs do not respond and I fall. It happens while I?m out walking. It is lasting longer. I have been seen by go, neurologist and neurosurgeon, pt assessment, MRI s, blood work