chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EWOL 76) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; GABAPENTIN; VALACYCLOVIR HCL; TYLENOL; BENADRYL. The following information was reported: MIGRAINE (non-serious) with onset 26Apr2021, outcome "recovered" (2021), described as "Migraines". Therapeutic measures were not taken as a result of migraine.  Additional information: Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as Emgality, Gabapentin, Valacyclovir, Tylenol, Benad. Reported Event: It seems like my Emgality shot that I had the same day did not work. I had nearly migraines for a month after the shot that could not be relieved until time for my next Emgality shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported as non-serious.  Follow-up attempts are completed. No further information is expected.
1. Headache the morning after the shot. 2. Sore arm. 3. Cold chills. The first bout started at 5AM and lasted for about 20 minutes. The second bout started at around 2:45PM and lasted for around 40 minutes. 4. Low blood pressure. At around 2:20pm I started feeling dizzy and had to lay down. I took my blood pressure, and it was below normal. The dizziness lasted around 30 minutes. I've never had any issues with my blood pressure.
Information has been received from a registered nurse reporting on approximately 10 patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On 06-SEP-2017, the patients received improperly stored doses of ROTATEQ lot # M041770 (expiry date 26-JUN-2018) or lot # M045546 (expiry date 12-JUN-2018), oral for prophylaxis (dose not reported). No symptoms reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 47.8 degrees Fahrenheit for 1 hour. The reported indicated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA005895.
This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) 0.5 ml. On 5th January 2019, 1 days after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On Saturday evening, the patient started to experience vertigo every time she changed her position from lying down to getting up. The reporter gave consent to follow up.
This is a spontaneous report from a contactable physician (internist). A 53-year-old female patient received PREVNAR 13; (lot M73332; Expiry Date Jul2017; NDC 0000609988), subcutaneously on 08Oct2016 at 0.5 ml single as vaccination. Medical history included ongoing HIV disease, due to which she was immunocompromised, constipation and pain. Concomitant medication included ongoing oxycodone tablet at 30 mg, 3x/day as needed orally for pain, ongoing AMITIZA tablet at 8 mg, 2x/day oral for constipation and AMARYL for HIV disease 600/200/300 once daily oral and other unspecified medications.  On 08Oct2016 pneumococcal 13-val conj vaccine was accidentally injected subcutaneously into the patient's belly with a short needle; on 09Oct2016 the patient developed a red reaction and quarter size induration at the site. Treatment included ZYRTEC 10mg tablet orally once a day for five days and BACTRIM DS one tablet twice a day oral for five days. As of 14Oct2016 the redness recovered, while induration was still present. Reporter stated the events were related to the vaccine and also possibly due to the fact that injection was not placed in the proper site.
BCG vaccine scar became red, swollen, and itchy. BCG vaccine scar is about 3 inches lower from COVID vaccine injection site.
Left ear hearing loss, tinnitus, vestibular neuritis, disequilibrium, nystagmus, nausea, vomitting, hospitalized 2/23/21 for 2 days Treated with Meclizine, Ondansetron, Promethazine, fluids
A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication  were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
11/08/2021 Right after the vaccine, I was hoarse and my throat felt itchy. I went home, I was not happy with the way I was feeling. I was unable to breathe a little bit and used my nebulizer. After that, I was fine, just felt really sick for about 3 weeks.
headaches; This is a spontaneous report from a non-contactable nurse practitioner.  An adult male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 14Dec2020 at 17:00 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced headaches (non-serious). The clinical course was reported as follows: The patient was a nurse practitioner who received the Pfizer vaccine. The patient reported getting headaches 15 days (as reported) after the first shot. The patient had no idea if the event was related to the vaccination, but he had no history of headaches. The patient took 600mg of ibuprofen (ADVIL) "to try to get the HA." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. It was unknown, since the vaccination, if the patient had been tested for COVID-19. Therapeutic measures were taken as a result of headaches. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
pt recv vax & exp pains in chest, back-lower back & almost paralyzing & a rash;pt sick
Vaccines 5/27/05. 05/29/05: low grade fever, lethargy, tachypnea, CXR. Possible RLL pneumonitis. WBC normal. 6/2/05: rash pinpoint on face with high fever. Resolved by 6/5/05. 6/8/05: high fever, blotchy rash on face, moving to  neck, torso sequentially. 6/8/05 Exam: fever gone, blotchy papular rash on face, neck,torso, red, purpuric on face. Normal inspection and general exam and neurologically intact.
I has a large rash that started 2 days after the 1st dose and lasted 10 days.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 10:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were 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. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 the patient experienced large rash that started 2 days after the 1st dose of vaccine and lasted 10 days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. On 06May2021, the clinical outcome of the event large rash that started 2 days after the 1st dose of vaccine and lasted 10 days was recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I felt fine for the first 9 days after receiving the first inoculation, but after 10 days I had an area around the injection site that my skin was bumpy, like a lot a mosquito bites type of bumps.  It was an area approximately 2" wide X 3" long on my arm.  The next day it was the same.  The third day, that area of my arm turned red and got warm and a little swollen.  The 4th day it remained red, warm, and swollen.  On the 5th day, my arm went back to normal and I had no other side effects.  I received my second Moderna shot this afternoon.  I'll let you know if I have side effects from it.
She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program by a Non-contactable consumer. A 15-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine. Outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine
Got the vaccine and broke out immediately/ Suspected vaccination failure; Broke out immediately; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles vaccine and broke out immediately and get them several times a year. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
24hr post flu shot not feeling well, 10/12/16 ER Visit Flu symptoms x 12d and hasn't ate in 4d. Has cough and tactile fever. 10/16-24 admitted to hosp, dehydration, nausea, muscle spasms/pain in neck, diarrhea and pneumonia. Transferred to different hospital.
Information has been received from a 23 year old consumer, who on 15-NOV-2007 was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. Following the vaccination, the consumer ingested an unspecified amount of alcohol. On 16-NOV-2007, she developed a headache and nausea. At the time of this report, the consumer had not recovered. The consumer did not seek medical attention. Additional information is not expected.
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B218) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension, VITAMIN D3, VITAMIN B COMPLEX and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three days after the shot on 13-Apr-2021, the patient experienced tenderness and rash on the left armpit and arm that turned to hives and bump the next day on 14-Apr-2021 and blister the day after and on 15-Apr-2021 with some new blisters on his chest. Ten days later on 23-Apr-2021, he was diagnosed with shingles by health care provider and he continued to have itchy blisters and a few extra blisters on his back. He got treatment anti-viral agents, 500mg Famciclovir, Benadryl and Hydrocortisone. He asked if this shot might cause shingles and asked if he could still get his second dose given the anti-viral medications and current conditions.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a registered nurse regarding multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# L020002, expiration date 02-JUN-2017; lot# K007982, expiration date 03-JUN-2016; lot # J014152, expiration date 07-NOV-2015, route not provided). No adverse events were reported. Product quality complaint was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
rash started 6FEB99 on neck & few on stomach & legs;9FEB99 rash on legs absent, rash looks like little pimples 3" area raised, t100;parents believe it varicella disease;
High fever (102 by 10:30 AM up to 104 by 11:30 AM).  Patient vomited at 3:00 PM.  Administered Tylenol and was able to reduce fever.  Fever returns to as high as 104 when medicine wears off and he has vomited 3 times between 11/15/2012 and this morning 11/18/2012. He has not fully recovered yet.
After getting vaccine she felt that she maybe paniced after 15 minutes and felt like her throat (burning sensation up and down- reflux previously)  was closing. She just got home and her symptoms started When walking her chest wall (in the middle)hurt but not constants (after eating a taco and tomato  Has on and off chills Paramedics where called No rashes hives or facial swelling No arm pain, no redness or swelling of the area  Patient was transferred to ER Benadryl given in the ER  Pepcid given for stomach upset which she has not taken since leaving the ER
Developed mild -moderate abdominal pain towards the end of May (about 2.5 months following dose #2). Pain was intermittent over the summer, worsening and becoming more chronic and consistently moderate with associated fatigue and hot flashes. Had pelvic ultrasound showing apparent left ovarian hemorrhagic cyst. Surgery scheduled  for October 12 and at the time of surgery was found to have had ruptured appendix, pathology was chronic with no evidence of acute appendicitis.  The cyst reported on ultrasound was not present at time of surgery - appeared more like abscess; left fallopian tube and ovary also removed. Reporting now after reading that potential appendicitis/mRNA vaccine link is being investigated.
Pt recvd vax & that evening exp nausea,fatigue & left shoulder pain. L Shoulder warm,hard & swollen. Nurse practitioner dx sterile abscess. Tx w/Cephalexin 500 mg bid for 7 days.
fever of 100.2; swollen Lymph Node on left clavice; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 30Mar2021 at 07:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and arthritis. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN), HCTZ (Hydrochlorothiazide) (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via an unspecified route of administration in the left arm on 09Mar2021 at 17:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation.  The patient previously received niacin (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), Oseltamivir (TAMIFLU) and exemestane (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to 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 4 weeks prior to the COVID-19 vaccine. On 30Mar2021 at 22:00, the patient experienced swollen lymph node on left clavicle which appeared prominently at night after receiving the second dose. On 31Mar2021 at 04:30, the patient had a fever of 100.2 which lasted for approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events swollen lymph node on left clavicle and fever of 100.2. The clinical outcomes of the events swollen lymph node on left clavicle was resolved on an unknown date in 2021, while that of fever of 100.2 was resolved on 01Apr2021.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.   Information about batch/Lot number has been requested.
On 4/22/21 My arm started itching, throbbing, burning. A large knot was present to injection site. With redness and swelling. Also developed blisters on the roof of my mouth.  We I got off work I took some benadryl and Tylenol and put an ice pack to arm. Cont with benadryl the following day then made appointment with urgent care at 1 pm. Diagnosed with covid arm and given Acyclovir 400 mg every 8 hrs x7 days.
Patient does not need to return for re-vaccination per recommendations, Patient is homeless and unable to reach patient several times with phone number provided. Letter sent to facility attention to patient.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. On 15-MAY-2014 the patient was vaccinated intramuscularly instead of subcutaneously with a dose of ZOSTAVAX (injection in the left arm, dose 0.65 ml, lot# and expiration date not reported). The pharmacist reported that the patient was vaccinated with ZOSTAVAX at another health care provider facility. On approximately 15-MAY-2014, the patient experienced redness, warmth and tenderness at the injection site of left arm. There was no treatment given for the events. The outcome of the events was not recovered. The patient sought medical attention by speaking to pharmacist (in May 2014, exact date not reported). The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
Large 1 1/2 inch red, hard circle at injection site with warmth and itching started day 2 after injection, lasted 5 days - no treatment.
I had heart palpitations starting immediately after the vaccine. My doctor did do tests but at the time heart issues were not considered as a reaction to covid, although mine did start the day I got the vaccine. I had them for months and wore a heart monitor and was diagnosed with palpitations. These were a rare occurrence before the vaccine and I was having 12+ a day after the vaccine for weeks. They?ve largely stopped but I do get them occasionally now
Delayed reaction in day 7 itchiness, redness, swelling and hives due to scratching.
Patient stated after receiving 2nd dose that a couple of weeks after 1st dose of VACCINE that he developed hives that lasted about a day.  He did not contact his md or pharmacy and did not take anything for them and they went away