chrisvoncsefalvay/vaers-outcomes huggingface dataset:
QUADRUPLE VESSEL BYPASS GRAFT; INTENSIVE CARE; This spontaneous report received from a patient via AbbVie concerned a 69 year old female of an unspecified race and ethnicity. The patient's weight was 135 pounds, and height was 63 inches. The patient's concurrent conditions included: non smoker, no alcohol use, and psoriasis. Patient was treated with 2 doses of non-company suspect vaccine tozinameran (Pfizer vaccine) (Dose number in series 1) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose was not reported, administered on 05-MAR-2021 and 07-NOV-2021 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 in total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced quadruple vessel bypass graft and her medicines were discontinued. Patient was hospitalized from 27-DEC-2019 to 03-FEB-2020 for 38 days and was in intensive care unit for eleven months. Patient was hospitalized and was in intensive care for three times. The patient took no concomitant medication. Patients intensive care unit medicines were discontinued and patient was back on her medicine. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks from 27-DEC-2019 to 03-FEB-2020 for psoriasis. No concomitant medications were reported. Laboratory data (dates unspecified) included: International normalized ratio (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with tozinameran was not reported; and treatment with adalimumab was withdrawn on 03-FEB-2020. The patient recovered from quadruple vessel bypass graft, and intensive care. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220535287-covid-19 vaccine ad26.cov2.s-  Quadruple vessel bypass graft, Intensive care. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt recvd vax & Hep B antibody was not sufficient to provide protection against Hep B; NOV92 elevated liver enzymes were detected; pt also had elevated triglycerides;
fever of 101.9F; booster dose given at 0.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml) and PYREXIA (fever of 101.9F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 014M20A and 012M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml). On 26-Oct-2021, the patient experienced PYREXIA (fever of 101.9F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 25-Oct-2021, ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml) had resolved. At the time of the report, PYREXIA (fever of 101.9F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 101.9f (High) Fever.         The patient is not immunocompromised. No concomitant medications were reported
Received second dose of Pfizer on 5/26/21. 7 weeks after first dose.
low temperature last night; sore throat; This is a spontaneous report from a contactable Consumer (patient) that. A 12-years-old male patient received BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection), via an unspecified route of administration on 27Jul2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller asks about if the vaccine could cause a sore throat as a side effect for a 12-year-old because her grandson went swimming yesterday and had a low temperature last night but complained of a sore throat on an unspecified date in Jul2021. Caller states she didn't know if it was the pool that was treated the day before with chlorine or would it be the vaccine. Caller asks if it is known which manufacturer is suitable for a heroin or opioid addict or is it recommended, they get the vaccine? Caller asks if there is a specified time that an addict stop using before receiving the vaccine such as five days or ten days? Caller states the person she is calling about does not have any health issues other than he has used before. Caller states she can't believe that after developing the vaccine that his question hasn't arisen to as to how it would affect someone on heroin or opioids because this had to have been a concern and been in a clinical trial or something. The patient underwent lab tests and procedures which included body temperature: low on Jul2021. The event outcome was Unknown.  Provided disclaimer that Pfizer cannot provide individual treatment recommendations.
09/04/22 presents to ED for "shortness of breath". PMHx of "diabetes type 2, obesity, anxiety"
Heart pain/inflamed feeling developed 2 weeks after seconds dose and last 4 days. I experienced a squeezing/painful sensation in my heart every 1-2 minutes for over 72 hours. Also experienced dizziness. Went to ER on 05/26/2021 to make sure heart was okay. Released.  I am an avid runner, extremely healthy, no surgeries, and have never experienced anything like this in my entire life.
Per patient report over phone: Redness, warmth, severe pain at the site where the PNEUMOVAX was administered. Experienced some body aches and a mild headache for the three days after the administration of shot. Patient tried using NORCO, Ibuprofen and AMBIEN to help sleep with the pain and tried Ice packs at the local site. As of 9/04/2018 the pain is improving and getting better. Patient reported that there feels like a hardness is present in the area where the shot was administered.
Pale, sweating, dizziness, severe headache. Vitals wnl. History of almost passing out with shots. Water provided.
Barre syndrome; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from non health care professional via social media.  This case involves patient (unknown demoghraphics) who experienced barre syndrome (Guillain-Barre syndrome) while received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious barre syndrome (Guillain-Barre syndrome) (GBS), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case details- Patient had Barre syndrome that's why avoided the shot.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for guillain-barre syndrome.  Information on batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed."
Elevated heart rate, elevated blood pressure, shaking/chills, headache, metalic taste
On day 5 after vaccine I noticed a lump at the injection site.  The lump is approximately 4 inches in length and 2 inches wide.  The lump is not especially tall.  It is red, slightly soar and itches.  I wouldn't classify it as a rash.  It has been 10 days since the injection and all the above are still occuring.  Just wondering when it might go away and if I should have my second dose of the vaccine in the opposite are if still have the same symptoms?   My second dose is scheduled for March 22, 2021.  I would appreciate in advice.
1.5-2 days after receiving 2nd dose I am experiencing nausea, headache, slight increase in body temperature and muscle aches
I have NEVER had headaches, and since my first vaccine shot I have a headache EVERYDAY, along with pain in my upper back near kidney area on my left side.  I have also had my second shot 02/19/2121.
Called c/o of arm red/hot and swollen going down to elbow. Denied fever. Encouraged to put ice pack, push flushed. OTC antihistamine OTC q 6 hrs and Tylenol or Ibuprofen (which ever she could take). If no better in 24 hrs call and come in to be seen. Called back on 06/05/17 and stated "she had to go to ER via EMS-"got dizzy and heart rate irregular" Was given IV fluids and IV antibiotic- was told had cellulitis and was sent home on Doxycycline per patient-stayed approximately 5 hrs in ER. Informed to continue to push fluids and the tx the ER dr had given her and if any other problems to call and come in and be seen by Dr.
THIGH AREA WHERE INJECTION GIVEN SWOLLEN AND HOT TO TOUCH WITH SWELLING ON POSTERIOR THIGH ALSO
Vomiting; Headache; Mild Fever; This is a spontaneous report from a contactable other-HCP (patient herself). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9261), via an unspecified route of administration in left arm on 11Feb2021 at 10:00 (at the age of 57-years-old) as single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included patient was allergic to Sulfa Based medications, Zythromycin. The patient concomitant medications were not reported. On 11Feb2021 at 10.30, patient experienced vomiting, headache, mild fever. The patient took vaccine at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. The outcome of all the events was reported as not recovered.
Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache and fatigue are persisting.
ACUTE NON ST ELEVATION MI ACUTE MI  12/29/2022  --  RECURRENCE OF SAME SYMPTOMS
Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth.   Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21.  It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.
Rash on (L) shoulder and upper arm to elbow that formed blisters. M.D. said to use BENADRYL. Rash (red/purple) on lower arm to hand. Severe pain; pain pills. (L) shoulder, arm to hand and thumb and index finger were also very sensitive to touch. Blister subsided but still red/purple color / rash spots and periodic pain.
For 48 hours after immunization pt cried inconsolably and had a fever of 100 two days post vax. Pt was irritable. 72 hours post vax pt was back to her usual self.
Fever for all of April 3rd, ending on the 4th Soreness throughout whole body April 3rd, ending on the 4th Fatigue Fatigue start after about an hour after injection on the 2nd and ended on the 4th
Monthly cycle has always been predictable.  A week after I had slight speeding. And from this dose on my period cycles became irregular, I had break-through bleeding, cramping all month and gained 8 pounds. In November, 7 months after receiving the dose (and probably as the medicine left my body) my periods once again became regular , my cramping throughout the month and weight gain just went away.
p/vax pt rpt chills & temp 100-101f x48hr, c/o h/a, sore throat & feels achy. mild SOB x24 hr, lt arm @ inject site swollen, no redness
dull h/a, aching all over & chills started approx 6 hrs p/vax; did not take temp; was back to feeling nl by 12noon next day;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on unknown date, refer case US2018177053). On 7th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient's husband could not remember the vaccination date for the 1st dose of SHINGRIX. The reporter's wife experienced injection site pain for a day after vaccination. This case was linked with case US2018177053, case reported for 1st dose.
both eyes swollen;rash on stomach, redness, low grade fever;notice swelling in eye;pt taken to hosp;
This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. No concurrent condition or medical history was reported. On 05-JUN-2015, the patient was vaccinated with VARIVAX (Merck) (dose and route of administration not provided). No concomitant therapy was reported. The physician reported that patient conceived 8 days later (Maternal exposure before pregnancy) and her last menstrual period was 14-MAY-2015 (estimated date of delivery was 18-FEB-2016). No treatment was provided for the event. The outcome of the event was unknown. The event was considered to be not related to VARIVAX (Merck). No product quality issue was involved. Additional information has been requested.
Flushed face after injection.  oral mucosa intact, lungs clear & vitals stable  monitored for every 15mins
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was provided as 7-may-2021.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Bilat lateral thigh redness, swelling, warmth - (R) worse. (R) thigh is from just below greater trochanter to knee. (L) in golf ball size; there were scratch marks; no drainage. No fevers. Started 1 day after vaccine admin - worse today; no similar hx. Received all vaccines prior.
headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 17-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included pain medication for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.    Headache was treated with Barbuteral.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
VACCINE WAS ADMISTERED WITHOUT BEING MIXED WITH THE DILUENT. PATIENT HAD NO REACTION AT THE TIME OF VACCINATION AND WAS OBSERVED FOR 15 MINUTES.
Pt stated that she had trouble breathing, had tingling in her Lt arm and both wrists. immediately after receiving the Modera injection.
Moderns COVID-19 Vaccine EUA. Experiencing cramping in both calves.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/6/2021 SHORTNESS OF BREATH R09.02 HYPOXIA 5/10/2021 SHORTNESS OF BREATH J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/6/2021 LUNG MASS R09.02 HYPOXIA 5/10/2021 LUNG MASS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/6/2021 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 5/10/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Four days after receiving MMR pt complained of "colitis", unable to eat, no vomiting, no diarrhea but states passed bloody mucus per rectum. Seen in ER
Pt received MENVEO vaccine on 12/20/13. Developed rash at injection site on 11/25/2013. Rash also spread albows, nees, abdomen, hands. Itchy at times. No difficulty breathing. Pt referred derm and seen 12/7/13 and told by derm rash due MENVEO vaccine.
Within 5 minutes of vaccination, pt reported rash and urticaria in left arm where vaccine received.  12.5 mg of Benadryl administered po, no change in symptoms.  Another 12.5 mg of Benadryl administered and symptoms began to resolve.  Pt sent home with spouse. Patient instructed to also complete a VAERS report and told that we would not administer second dose of Moderna in 4 weeks.  Recommended patient follow up with CDC regarding option of receiving Johnson and Johnson vaccine.
This spontaneous report as received from a Registered Product (R.Ph.) via a company representative, refers to an unknown number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On unknown dates, the patients were vaccinated with ZOSTAVAX, subcutaneously (dose and lot numbers not provided). No co-suspect or concomitant therapies were reported. The pharmacist reported that, on unkonwn dates, when he pulled the needle out of the patients' skin, some liquid leaked onto the patients' skin. Additional information has been requested.
I got my first vaccine on 2/3/2021, my second dose on 2/24/1986. I was being monitored for MS following a bad case of viral meningitis where I had optic neuritis and MRI showed one other lesion. This was attributed to the viral infection. I was monitored for the development of MS, but had been told this was pretty unlikely. (80/20 chance was the number I was told). I went through a pregnancy and everything was completely stable in terms of MS. After my first dose I was fine but felt a little funny feeling on my face that went away after a week or so. I attributed this to a reactivation of a feeling I had during viral meningitis.  After the second dose I felt alright. My main side effect was nausea and fatigue. I was due for my final monitoring MRI for MS on 03/22/2021. They found two new lesions. One an active lesion on my c2 location on my spine. I was given a week of prednisone to calm inflammation. I believe that the vaccine?s inflammatory aspect caused my predisposition to MS to be activated giving me the new lesion and pushing me over into full RRMS. I was not on any medication for MS prior to this new discovery in March. The timing is so close that it is hard not to connect the two. My neurologist told me that he thinks the vaccine likely trigger the c2 lesion. Although he can?t figure out the other lesion I developed on my frontal lobe (which has now shrunk my half). I have not gotten a booster yet.
Morning after vaccine became dizzy and passed out.  One week later on April 16, 2021 woke up with my head feeling like I was on an airplane.  Heard echos and vibration everytime I spoke or someone spoke to me in my left ear (right ear is deaf due to Acoustic Neuroma surgery).  April 19, 2021 saw the ENT.  Hearing test showed decline in hearing in my good ear.  He put me on Prednesone.  Today April 30, 2021 echo is gone.  Will be going in to check my hearing next week.
7 other people got rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (7 other people got rheumatoid arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment drug was provided by reporter.  On 29-MAR-2022, case MOD-2022-523941 became invalid as the case contains multiple patients and no information about the patient provided with the source document.
Swollen red lump just below the injection, chills, fever of 102.3, nausea, achy all over,headache..the same way i felt when i had the virus on November 16,2021
"Moderna arm rash": hot and swollen red rash at the vaccine site. Fatigue.
After receiving 2 doses of Moderna COVID vaccination on 1-20-21 & 2-22-21, patient became infected with COVID in September 2021 and was hospitalized due to this breakthrough infection.
Throat closure, tightness when eating or swallowing within 45 min of 2nd dose.
Post immu. hives on arms immediately below injection sites bilaterally. BENADRYL 1 1/2 tsp in office cold compresses and watched in office x 15 min.
injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, resolved - sleep swollen lymph nodes, start within 30 minutes, duration 8 hours, resolved no treatment throat swelling, start within 1 hour, duration 6-8 hours, resolved no treatment dizziness and weakness, start within 2 hours, duration 6 hours, resolved - sleep
I had a head cold, runny nose, and some sore throat after coming back from a wedding on 04/02/2023. I took an at-home COVID-19 test on 04/03/2023 which came back positive. I contacted my doctor telling him about test, and he prescribed me PAXLOVID for treatment. As of now, I feel about 90% recovered but still finishing the prescription.