chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a bachelor of science in nursing concerning a 20 year old female with environmental allergies who on 04-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot: 659962/1740U). On 15-DEC-2008, the patient received the second dose of GARDASIL (Lot: 660620/0571X) and on 17-AUG-2009, the patient received 0.5 ml of the third dose of GARDASIL (Lot: 661766/0652X) intramuscularly. Concomitant therapy included XYZAL. On 17-AUG-2009 two hours after the patient received the third dose of GARDASIL she developed a red, raised itchy rash on her arm at the injection site, that had extended down to her elbow. At the time of reporting on 20-AUG-2009, the patient's status was unknown. Follow up information has been received from a bachelor of science in nursing concerning a 19 year old (previously reported as 20 year old) with a history of allergies to trees, grass, pollen, cats, dogs from skin testing, who on 17-AUG-2009, was vaccinated with 0.5 ml of the third dose of GARDASIL (Lot: 661766/0652X) at 10:00 am. On 20-AUG-2009, the patient called the office with complain of "itch and rash with bumps" at injection site since 17-AUG-2009. The rash was half way down the arm to elbow with raised rash. The patient was treated with topical steroid cream with relief. On an unknown date the patient recovered. Additional information is not expected.
migraine; other body aches; abdominal pain; headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Myelitis transverse (declared better 2years ago). Previously administered products included for Product used for unknown indication: Flu shot on 10-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot.   On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose once. On 11-Oct-2023, the patient experienced MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.     No concomitant medications were reported. Day of shot just a little tired. Day 2: Headache, fatigue, nausea, abdominal pain, other body aches. Day 3 same as day 2 with minor improvement. Day 4 still fatigued with abdominal pain. Day 5 more easily fatigued but mostly normal. Day 7 major migraine causing nausea plus fatigue. Day 8 return of abdominal pain with fatigue and body aches. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
The first incident happened on 05/02/2021 with dizziness. I had vertigo before but the feeling was different and it has lasted since. When I got back from my trip I called my otolaryngologist. On 05/07/2021 I saw my otolaryngologist and he tested me for vertigo. I had nausea and my tinnitus was louder. He decided I needed an MRI on 05/10/2021 which I did get done on 05/20/2021. I did see my Doctor because I did have issues in right ear and on 05/10/21 I went back in because I was still feeling fullness in my head, vague headache, jittery, dizziness. I went to my Doctor on 05/18/21 or 05/19/21 and she felt it could be related to either initial Covid infection or perhaps the vaccine. They did not find anything on the MRI except typical white stuff on the brain which they said is normal in older age patients. I went in and saw My doctor again on 06/02/21 and she spent an  hour with me talking about my symptoms and she said they have seen a lot of neurological symptoms going on with covid patients and patients who got the vaccine. I saw my otolaryngologist again on 06/04/21 to discuss results of MRI and he said if symptoms get worse call back. They haven't got worse but they've stayed the same. I started with my balance therapy on 06/04/21 and I go 2x a week and the balance is getting better but not the dizzy feeling, but we are still working on it.  I will be seeing an ocular neurologist next week.
3 broken feet after first dose; This spontaneous case was reported by a nurse and describes the occurrence of FOOT FRACTURE (3 broken feet after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 FOOT FRACTURE (3 broken feet after first dose). At the time of the report, FOOT FRACTURE (3 broken feet after first dose) 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 information was not reported. Treatment medications included unspecified antibiotics.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored GARDASIL (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of pain in her arm from the shoulder at the site of injection to the elbow. The pain gets continuously worse and the patient cannot move her arm. Patient is no longer in the state and is advised to seek medical attention. Tried to reach patient as of 9/18/15 with no response to phone calls.
3 incidences since 2nd vaccination: 1. Sudden veritgo with nystagmus 3/13/2021  Duration -  20 mins (7:00 pm) 2. Night sweat, vertigo  3/17/2021  Duration - 20 mins (2:00am) 3. Sudden vertigo 3/27/2021  Duration 20 mins (10:00am)
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days .   tingling of hairline and under the eyes,  eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
A 47 year old female employee reported experiencing sore throat, cold symptoms and elevated blood pressure for a couple of days following immunization with BioThrax. On 26JUL2017 she received a third dose of BioThrax (FAV634) in the left deltoid. Symptoms began on the day of vaccination. Consumer noted that the first two shots did not present these symptoms. She was treated with CHLORASEPTIC SORE THROAT RELIEF SPRAY and ADVIL and experienced some relief. On 08AUG2017, consumer reported that she felt better. On 23AUG2017, she indicated that she was fully recovered on 10AUG2017. No additional information is expected.
Tingling in tongue about 5 minutes after vaccination, pain in left side of neck and in should of injection site  Tingling in tongue lessened over time but having tingling in lips, especially left side of bottom lip Pain noticed around left collarbone area as well over time
patient give flu vaccine 11/13/07 in Medical clinic.presented to ER 11/17 for pain, swelling, redness left upper arm x 4 days. patient discharged home with motrin and benadryl po.
Information has been received from a physician concerning a 1 year old male patient who on 12/17/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 641878/0182M).  Subsequently the patient developed a severe measles rash and swelling in the hands and feet.  A culture (unspecified) was taken and was negative.  It was also reported that the patient was afebrile and did not require hospitalization.  Unspecified medical attention was sought.  The physician also reported another patient that developed a measles-like rash (WAES # .....2USA02437).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been check by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Pt to ED 8/11 for dyspnea. Pt c/o moist cough, generalized fatigue, fever, and SOB. COVID+ 8/11, prior infection in July,continue decadron, rx empiric ceftriaxone and Zithromax for possible bacterial superinfection. 8/13 pt AxOx4, VSS, no c/o pain. 8/14 pt alert and oriented x 4 C/O constipation, denies pain, pt with worsening leukopenia. Pt started on granix and leucovorin calcium due to low WBC. 8/15 Pt A&Ox4, ambulatory/independent. Denies pain or SOB. 8/17 leukopenia improved, remained a+ox4 c c/o headache pain relieved with prn pain meds. 8/18 pt received/remained A+ox4 c c/o mild pain at head 3/10 throughout. 8/19 Patient is A&O x 4. Ready for discharge. Pt discharged 8/ 19.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
age 13 years, patient received GARDASIL 9, the first dose/received GARDASIL 9, the second dose on unspecified date at age 15 years; no adverse effects; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date (in an age of 9 years), the patient received first dose of  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, site and route of administration, lot # and expiration date were not reported).       On an unknown date (in an age of 15 years), the patient received second dose of vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot number: R02757, expiration date on 23-JUN-2021; site and route of administration were not reported). No adverse effects were reported.
Pt recv vax on 7/16/98; on 7/17/98 pt exp nausea, vomiting, pain/ red/ swollen vax site (2 wk); dx=sterile abscess
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of VAQTA, which were improperly stored (incorrect product stored), were administered to unspecified number of patients, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were note. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
herpes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Feb2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date in Mar2021, as a single dose for COVID-19 immunization. The patient's medical history included autoimmune disorder. Concomitant medications were not reported. On an un-specified date, the patient experienced herpes. The patient asked if the booster dose was going to be the same as the original injections or something different and if her risk of getting herpes will increase if she got the booster dose of the covid vaccine. She reported having read that 1 side effect of getting the vaccine was herpes and stated, "she knew she had it, she saw her doctor and she had it in her notes on the portal, and she was put on Valacyclovir to get rid of it". The patient reported that she had an autoimmune disease and wanted to get the booster dose but asks if her risk of getting herpes will increase since she already had it twice since February. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up.
Patient was given dose in right arm; patient bled and stated that she normally doesn't bleed at all; held cotton ball in place for 30 seconds then applied bandaid when bleeding stopped; patient went to stand up and immediately felt dizzy and light headed and said this was abnormal. Pharmacist was called into the room to examine patient. ~1 minute later, eyes rolled back in patient's head and she was no longer verbally responsive. Epipen was immediately administered and 911 was called. Pulse was faint but present, breathing was labored, and patient began sweating, Around 1 minute after giving epi, patient was responsive enough to give name, dob, time, etc. She could open her eyes, but was still very dizzy. EMT recommended to go ahead with Benadryl oral dose.. Patient was able to swallow 1 25 mg tablet. EMTs arrived within 5 minutes and took over care; her blood pressure was 80/65 and had  improved to 108/80 right before she left.   The patient told us that she could hear us talking to her the entire time. However, she did not feel the  Epipen injection or realize that she had loss responsiveness. She did agree to go with the EMTs to Medical Center.
HYPOXIA, FEVER, HEADACHE, BODY ACHE, COUGH, SOB
Lightheadedness, nausea, sore throat, headache, sharp intermittent stomach pain, swollen lymph nodes in throat, pain with swallowing, chills, low grade fever, sore arm at injection site.
My son started to get a eash on his back and thighs that seemed to get bigger and more red and inflamed with every vaccine he got. Nothing helped it and it was clearly bothering him. Its gone now, though his skin has white patches from the scarring now.
Around 6 pm or so I started feeling chilled, the back of my neck hurt and I felt strange. By nighttime, I was having bad bad chills. My body was shaking uncontrollable because I was so cold. My body felt like it was made out of old rusty bolts with dagger ends and when I moved pain would shoot to different parts of my body, and my eyes hurt when I moved them. Normally, I run around playing hide n seek and freeze tag with my grandkids. But last night, I had to take 2 extra strength Excedrin, put lots of warm clothes on, and go to bed. After a while, my body stopped shaking and the Excedrin was taking the body hurts away. The next morning, April 22, I wasn't having chills or pains, but my body was still didn't feel normal. I felt so so tired, fatigued and my head hurt some. I had to go back to bed because I was so tired. I just got up around 5 pm and my body doesn't feel so tired. I feel better. I don't feel 100%, but much better, Thank God!
bleeding; stomach pain; felt light-headed; legs start shaking; her legs were shaking so much she couldn't even feel them; goosebumps; headaches; body aches; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 004M20A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]) and HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), PILOERECTION (goosebumps), HEADACHE (headaches), MYALGIA (body aches), VOMITING (vomiting) and FATIGUE (fatigue). 05-Nov-2021, the patient experienced HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them). At the time of the report, HAEMORRHAGE (bleeding), HEADACHE (headaches) and MYALGIA (body aches) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them), PILOERECTION (goosebumps), VOMITING (vomiting) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not provided.  Company comment- This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-378037, MOD-2021-378042 (Patient Link).; Sender's Comments: This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
4 hours after injection started coughing, felt tickle in throat, 1/2 hr. later eyes irritated, then eyes swollen & "oozing", 830 diff. breathing "swollen throat" - took family members inhaler - symptoms resolved.
Medical status of Sarcoidosis discussed prior to immunization and counseled that there are limited data and benefit of vaccine would outweigh the risk of COVID infection. Observed for 15 minutes.  Patient started to leave the facility and felt dizzy. Then her entire face became numb around mouth and cheeks. She did not have difficulty breathing or feel her windpipe swell. Patient chose to go to her vehicle in parking lot and called her Mom. In that process her cell phone battery needed charged. She drove home. Her face, mouth, and cheeks remained numb and dizziness subsided.  Family and friends contacted EMS Ambulances to look for her when it was determined she did not elected to go to the ED.  A friend of patients Mom called the Hospital switchboard operator to report the situation at 2:45 pm.  The operator went to the Medical Staff member oversee for Vaccination Clinic ,CRNP, and informed her of the concern and potential reaction to COVID vaccine.  CRNP called the patient and spoke with her at 3pm.  She identified no dizziness, no airway or breathing problem and lessening numbness of face.  She stated she felt better and did not elect to return to ED.  A buddy system of family, neighbors and her husband (out of town) continued to check on her.  CRNP did a second phone call 5pm where patient stated she had very mild left cheek numbness.    Total Estimated time of Facial Numbness is 4 hours.  Patient was counseled to have followup with PCP for possible Bell's Palsy if numbness returned, and go to ED or call EMS with difficulty breathing.
This is a spontaneous report from a contactable physician via Pfizer sales representative. An elderly female patient received PREVNAR 13, intramuscularly (site of administration unknown) on 17Dec2014, as a single dose in combination with the Flu vaccine. The patient medical history and concomitant medications were not reported. The patient experienced swollen tongue on 17Dec2014. Clinical course was as follows: PREVNAR 13 was given in combination with the Flu vaccine. The male elderly patient experienced swelling of tongue within 8 hours of receiving the vaccines. She went home and then returned to the emergency room. The physician does not think that the patient was admitted. The outcome of swelling of tongue was unknown. The physician did not believe that they are related. Follow-up (12Feb2015): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning multiple patients (unspecified number) of unknown age and gender. No concurrent conditions or medical history were reported. Multiple patients were vaccinated with an improperly stored GARDASIL (Lot No., expiration date, dose, route and date of administration were not reported). No concomitant therapy was provided. No adverse effects reported. Additional information has been requested.
Pt presented to office one day after receiving injection with left arm hurting and rash on arm about size of baseball.  Pt then went to urgent care on 7-2-09 for further treatment rash larger rash going down arm.