chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began cold symptoms Dec. 19 with runny nose and sore throat.  By 12/23/22 I had a bad cough and took an at home COVID test that was positive.  Due to a family cruise on 12/27 (that we canceled)  I went to an urgent care facility to be tested for proof of a positive test to submit to for travel insurance.  They gave me Paxlovid and Zpac to prevent Covid pneumonia.  I tested negative 12/31  at home and I ended with rebound Covid, testing positive on 1/2/23 with another at home test.1/11/23 I was finally testing negative with the at home test. I began having itchiness that I couldn't scratch to make it go away, it felt sub-dural and moved around the skin.  It only affect my upper chest and head.  Every day I'd wake to see where my skin felt itchy.  My PCP's PA prescribed Atarax for it which helped minimally.  Eventually I saw an allergy specialist who thinks the virus brought on Dermotographism and increased the Atarax which helped the itchiness to go away. Early February, out of the blue, I started having heartburn.  I tried Prilosec 40mg 2x/day and it was still burning.  A GI specialist changed me to Pantoprazole 40 mg/2x/day and that has improved greatly.  I have GI scope and capsule implantation scheduled for 9/7/23.  IDK if this was all triggered by contracting Covid (which I don't know where I picked it up from and was the only one in the home of 3 people with it) or if they are coincidences.
Nausea, "lightheaded", pale, clammy-moist skin 10 minutes; observed @ clinic 1 hr VS at 8:25 B/P - 78/40, P - 78; 4:45PM PC to mom stated pt "fine" & no problems;
Fever, body aches, swelling, cough. [Much of Box 7 is too faint to read]
This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
received the second dose 6 days after the first dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     On 19-AUG-2020, 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)(strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 25-AUG-2020, 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) (lot# 1637641, expiration date not reported, but upon internal validation established as 16-FEB-2022; strength, dose, frequency route were not reported) for prophylaxis (inappropriate schedule of vaccine administered). No other AE reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The lymph node in my collar bone area is very swollen and tender to touch. My neck hurts, and my arm hurts .
Patient developed chest pain about a week after the second dose of the COVID vaccine. He was seen at the ER and noted to have pneumomediastinum.
Flu: Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case from a social media via a consumer/non-health care professional Regulatory Authority.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got a flu shot once and it gave me the flu"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Initial report received from a healthcare professional on 14 OCTOBER 2014. A female patient, whose age, medical history and concomitant medications was not reported, had received a dose of FLUZONE QUADRIVALENT (batch number U1205AC, expiry date, route and site of vaccination were not reported), on an unspecified date. On an unspecified date, after vaccination the patient had extreme rash over chest, face and arms. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 30 DECMBER 2014. A 34-year-old female patient was vaccinated with FLUZONE QUADRIVALENT in her left arm on 08-OCT-2014. On 08-OCT-2014, patient had extreme rash over chest, face, arms. NDC number was reported as 49781-621-15. Documents held by sender: none.
Since receiving both FLUVIRIN (IM deltoid) and ZOSTAVAX (SQ arm) in the same arm on 10/24/12, the patient has had increasing pain in the muscle of the arm. It is not getting better. Pt will try to relieve inflammation in shoulder joint by alternating indomethacin and ibuprofen & will follow up w/physician if not better in 1 week.
Student with 4 days fever - on day 2 of fever rash developed. Seen today with crusted over vesicles.
Side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient was here for 1st dose Pfizer monovalent and received Pfizer Bivalent on the left deltoid by LVN. Patient was observed for 15 minutes without a adverse reaction. Called LVN Immunization Manager at 3:58 pm advised medication error done LVN. As per Recommended patient is to receive primary series in 4 weeks at one of the clinics near the patient. Advised patient to set up an appointment at the clinic near her and patient voiced understanding. Will follow up with on proper education information.
Red; swollen; heat - and some itchiness but not as itchy as first time. It resolved in 5 days.
Loss of sleep; Lymph node swelling; Injection site pain; Aches in joints/Aches in knees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MONASCUS PURPUREUS (RED YEAST RICE), OMEPRAZOLE, LISINOPRIL, IBUPROFEN, FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep). At the time of the report, LYMPHADENOPATHY (Lymph node swelling) outcome was unknown and VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included coQ10.  No treatment information was provided.  Lymph node swelling had continued for 1 week.
April/5/2021  Found 10 cherry angioma on both arms and chest 5 hours after 1st dose. No treatments. April/6/2021  Random itchy skin, and rash all over the body. No treatments. April/7/2021  Found 24 cherry angioma on both arms, chest, and both upper legs. No treatments. April/8/2021  Found 47 cherry angioma on both arms, chest, and both upper legs. Went to get a blood test. No treatments. April/9/2021  More cherry angioma found on neck. Blood test result: Low WBC 2.9, Low NEUTROPHILS 26.3, High LYMPHOCYTES 54.9, High MYELOCYTES 3.8, Normal Platelet count 174. No treatments. April/12/2021  Cherry angioma increased the size,  some of them got bigger. No treatments. April/17/2021----April/21/2021 Numbness in right foot, right leg, right arm, and right hand. No treatments. April/21/2021  Found random bruise on left arm. Went to see Oncologist. Doctor said the vaccine caused Vasculitis. Need to follow up with the low WBC issue after a month. Doctor suggested do not take the 2nd dose.  No treatments.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) 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.   Treatment medication were not reported.   This case was linked to MOD-2021-370259 (Patient Link).
Worker stated site was itchy and red.  Later she stated she had numbness and tingling going down her arm.  No difficulty in breathing reported.
Tongue tingling, thickening, red blotches,   Took Benadryl to relieve symptoms,
This case was reported by a nurse and described an adult female pt who did not respond to Engerix-B immunization series. The nurse reported that another pt that was a smoker did not respond to immunization with Engerix-B, however, pt identifiers were not reported. The nurse reported that the pt was smoker and was "not older or obese". On unspecified dates, the pt received a series of 3 doses of Engerix-B. Approximately 1 month after the 3rd dose, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not become sero-protected".
This spontaneous report was received from a 46 year old female patient, regarding herself. The patient had codeine allergy and acid reflux disorder. The patient has no medical history. The patient was non pregnant at the time of reporting. On 02-AUG-2014 the patient was vaccinated with PNEUMOVAX23 in the left arm. Concomitant therapies included ZYRTEC-D and a medication for acid reflux gurd (details unknown). On 02-AUG-2014, the patient began with redness and irritation at the injection site. On 03-AUG-2014 (reported as the next day) she began to experience fatigue and exhibit "flu-like" symptoms. The patient also stated her arm was beginning to swell on 03-AUG-2014. On 04-AUG-2014 (reported as the third day after the injection) she began to experience body aches and her arm was completely swollen, burning and painful and she could not move her arm. During this period prior to going to the physician's office the patient self-administered ALEVE, TYLENOL, Ibuprofen (manufacturer and dose unspecified). No product quality complaint was filed.  On an unknown date in August 2014, the patient went to the physician's office (medical attention) and was prescribed an antibiotic (dose and manufacturer unspecified). No intervention initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of events was reported as not recovered. The causality was not reported. Additional information has been requested.
Acquired shingles including nerve pain and rash.  Treating with antiviral (acyclovir) and gabapentin
arm was bright red; tired; wave of nausea; arm felt really sore, hot, and hard at the shot spot; bad headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and VACCINATION SITE ERYTHEMA (arm was bright red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and FATIGUE (tired). On 07-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was bright red). The patient was treated with ACETAMINOPHEN on 07-May-2021 for Headache, at a dose of 1 dosage form once. On 07-May-2021, NAUSEA (wave of nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache), VACCINATION SITE ERYTHEMA (arm was bright red) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.
dizzy, flushed, lump in throat, heart racing. Evaluated by EMS-Cleared
Pt was given moderna vaccine on 4/12/21, presented to clinic on 5/8/21 stating he needed his second pfizer vaccination. pt given pfizer vaccine. was notified on 5/12/21 that his first vaccine was moderna. denies any adverse reactions.
Headache, day of injection burning sensation at injection site and heaviness in left arm, 1 day after: chills, headache, "feel my heartbeat", nausea Narrative:
The patient began having vaginal bleeding and contractions on 3/11/21 at 24 weeks 6 days and presented to labor and delivery in preterm labor.  We were able to delay delivery for about 24 hours but she did deliver at 25 weeks 0 days.  Earlier in her pregnancy she had some vaginal spotting (last time was on 1/15/21 and her cervix was closed on sonogram).  In her first trimester she had significant hyperemesis treated with medication and IV fluids but this resolved after the first trimester.
My dad received his first COVID vaccine on January 14, 2021.  On January 16, 2021 he ate breakfast around 7:00 am and went back to his room.  When the staff checked on him around 8:00 am they found my dad unresponsive.  His blood pressure was over 220 and his pulse was 43.  They began manual CPR until the paramedics arrived, but my dad died.
Extremely dizzy, room items spinning for minutes. Vomiting. Arm soreness.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date lot #GL0447. Patient has been notified. No adverse effects reported. Reports filed. -  Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a Do Not Use sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include entering vaccine information into Epic prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and CIIS reconciliation o Training on how to enter information into Epic when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Vasovagal reaction,  patient was lightheaded and sweating, he remained consciousness and  was placed on the floor in a supine position.  Remained After about 15 minutes he was able to resume a sitting position and had no other problems.  He was able to leave with parents
Child passed out for about 3-5seconds after Flu shot head and eyes rolled back, dropped phone she was watching a video on came back up. Gave her orange juice, she initially said she could not feel body after and was hungry but was fine after the drink.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date not provided) in her arm. Subsequently (exact dates not provided, reported as "a very long time ago"), the patient developed a little rash on her arm post vaccination. The patient sought medical attention and came into pharmacy. No treatment was needed. The rash resolved within 5 to 7 days on it's own, the patient's status was reported as fully recovered. The relatedness between vaccination site rash and ZOSTAVAX was not reported. Additional information is not expected, as the reporter did not want to be contacted regarding this event.
Right greater than left hand joint swelling, pain and stiffness, starting with Right index MCP (Dec 10, 2021), then Right middle PIP, Right ring PIP and Left middle and ring PIP (started Dec 20, 2021). Slowly resolved after Jan 15, 2021. Right middle trigger finger starting 12/29/21.  Sudden onset left index finger finger pain, tenderness, soft tissue swelling with violaceous sc nodule, lasting 48 hours then complete resolution. Sudden onset left ear ringing and decreased hearing started 1/4/22, resolved 1/11/22.
Patients left arm was very read at the injection site. Very red and warm and hard it was the size of a quarter or larger. The surronding area was red and warm completely around about 3 to 4 inches all the way around. I asked if he had done anything and he said not. I suggested cold compresses and benadryl. We call the on call md and he said warm compresses and benadryl and if not better by morning go to er.
Last year received the flu vaccines after a long time; had flu-like symptoms. This year a few minutes after vaccine got headache, felt lightheaded. By 9:30pm got severe chills, shaking body, severe body aches especially in joints, bad lower back pain. Took ADVIL felt too sick to go to ER. This morning chills gone but lower back pain remains. Took more ADVIL. Fatigue at same level as yesterday. Doesn't feel that bad today. Left eye swollen. About 1-2 hours ago took TYLENOL with codeine to take edge away from pain.
The patient was given the second dose 2 weeks after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was given the second dose 2 weeks after the first dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was given the second dose 2 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was given the second dose 2 weeks after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was provided.
approx 1wk p/shots fever began & lasted 1wk;mom unsure of dates;had 1 sz 2wk p/shot while fever of 104;went to see MD 2 days p/sz;no rx x/to keep fever down w/APAP or Advil
Chest pain, back pain, painful respiration (within hours post-vaccine). Treated by physician as bronchitis. Muscle relaxer also ordered along with antibiotic.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 16-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Strep throat and flu like symptoms. Weakness in arms and legs. Chronic fatigue. Rapid weight loss with no change in diet.
There are no additional AEs; MA calling with a dose of expired MMR-II administered inadvertently.; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, lot # R031681, expiration date 01-NOV-2020 (route of administration and anatomical location were not provided), for prophylaxis. There was no adverse event reported.