chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clots; 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 THROMBOSIS (Blood clots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. 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.; 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.
Severe headache and ?brain fog? for several days. Unable to work the following day due to intensity of headache. Headache continued from Thursday through Tuesday.
exacerbation of asthma; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (exacerbation of asthma) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 01-Jan-1994, Hypertension since 11-Jan-2002, Osteoporosis since 09-Jan-2017, Drug allergy (Levaquin), Pollen allergy and Allergy (nylon suture material). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 01-Jan-2000 to an unknown date for Allergy, MONTELUKAST from 01-Jan-2000 to an unknown date and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 01-Jan-2018 to an unknown date for Asthma, LISINOPRIL from 01-Jan-2002 to an unknown date for Hypertension, ALENDRONATE SODIUM (ALENDRONATE) from 01-Jan-2018 to an unknown date for Osteoporosis.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ASTHMA (exacerbation of asthma). The patient was treated with PREDNISONE from 02-Feb-2021 to 13-Feb-2021 for Asthma, at a dose of prednisone tapering 40mg down to 5mg. On 15-Feb-2021, ASTHMA (exacerbation of asthma) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated patient demography , relevant history , concomitant medication and the event outcome.
Had sore arm for 4 days, no other problems until the 14th then arm started itching at injection site and wes red and somewhat swollen.  No other symptoms , it is still somewhat red and itching at time yet.
At time of injection on 12/20 pt immediately noted paresthesias in ulnar distribution of L arm, the next day still had L upper extremety symptoms and she felt myalgias and bilateral leg weakness.
Suspected Transient Ischemic Attack four days after receiving second dose of Pfizer Covid vaccine, with symptoms including sudden onset, inability to focus eyes, facial numbness on left side, headache, numbness moved around, involved left leg, left arm, left side of face, left side of lips and tongue. Numbness symptoms resolved after approximately thirty minutes; headache remained for approximately 6 hours; fatigue lasted until the following day. No medical care was sought at the time or subsequently.
I had my vaccination on 12/27/2022. On 12/28/2022 I started to experience a headache. By 12/30/2022 I had extreme fatigue with congestion and temperature of 99. I went to urgent care on 01/02/2023 with a temperature around the 100s. I tested COVID-19 Negative Chest xray was negative Influenza negative.  I was put on Mucinex DM and a steroid.  I saw my allergist on 01/04/2023 and lungs sounded clear. This was a regularly scheduled appointment.
2 Days after immunization Patient experience increased heart rate for 5 minutes. Swollen and rash on conjunctiva sac of left eye for 1 week. After 2 weeks patient start having rash on arms.
This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
After giving the vaccine to the patient, I began cleaning up my vaccine area and picked up the empty vial to record the lot and expiration on our paperwork and the bottom of the vial completely came apart and glass shards were left on the countertop. After further inspection, there was no trace of residual vaccine and the counter wasn't wet. I next inspected the vial box and there were little tiny shards of glass in the box, barely visible to the naked eye. It is my assumption that the vial was damaged during shipment and all the vaccine leaked into the vial box and dried to the cardboard container.
Patient received COVID-19 vaccine (1st dose on 4/30/21, 2nd dose on 5/21/21, and booster on 12/22/21). Patient developed rash on June 1, 2022 on the left arm which spread to eventually cover full body around July. Patient saw me at the end of September 2022. We did two skin biopsies, which were consistent with Lichen Planus. Patient does not take any medications and has not had hepatitis virus, which can be associated with development of lichen planus. There have been other reports of COVID-19 vaccine inducing lichen planus.
Severe migraine started 2 hours after vaccination (7 pm) and stopped 48 hours later.
This spontaneous report as received from a pharmacist refers to a 33 year old female patient with no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of M-M-R II (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient had positive titers for measles and mumps, however she had negative titers for rubella. The patient was unsure whether she ever received vaccination against measles, mumps and rubella as a combination vaccine or monovalent vaccines. The titer results were returned to the pharmacist on 01-JUL-2013. The pharmacist did not report that the patient had any adverse effects other than the negative rubella titer. The patient sought medical attention by seeing the pharmacist. The outcome of all the reported events was unknown. Additional information has been requested.
Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
The pt had a lack of sero conversion - negative titer on 2/16/01.
2 x 3 cm erythematous rash at site of prev. injection of TD began 1 day after vaccine administered and increased in size over period 5-6 days. TYLENOL and cold pack.
On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to my neck, left arm and under the arm and clavicle. My lymph nodes are swelling and I am concerned since I never had my lymph nodes swell up. On my second injection 01-06-2021, I continue with lymph node swelling and my symptoms do not seem to go away. I went to see my doctor, that said  it was probably a reaction to the Pfizer injection and he is recommending that in February 2021,  if I still have swelling to my lymph nodes then lab work will be performed.
2 days after receiving vaccine patient developed hives and itching. Treated with OTC diphenhydramine.
administered three doses; first in OCT-2019, second in NOV-2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number DP2D3, expiry date 25th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03rd October 2019).   On 3rd November 2021, the patient received the 2nd dose of Shingrix. On 17th February 2022, the patient received the 3rd dose of Shingrix. On 3rd November 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 17th February 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient also received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Acute allergic reaction, throat tightness, chest heaviness, IV established, diphenhydramine, 25mg IV, Transported by Ambulance
RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 18-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 18-NOV-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150600, 20230150423, 20230150157, 20230150777, 20230150716 and 20230149982.
Employee received second dose of Moderna vaccine on 1/28/21. Within 15 minutes she started to feel warm, dizzy, headachy,  general numbness and tingling & nauseated. Symptoms persisted/worsened and she then began to experience a scratchy throat and a sensation that her throat was swelling up. Patient given 50ml Benadryl IM. Many symptoms still persisted but no furthering of anaphylactic symptoms and eventual reduction in these symptoms as well. Patient stabilized after 3-3.5 hours and was allowed to be taken home by a family member and advised to continue monitoring for any ongoing or new urgent symptoms w/instructions to go to ER or call 911 if so.
Patient came in for her second dose of pneumococcal vaccine. She know she had received a dose about a year ago and wasn't sure which one. The pharmacist did not verify with MD and gave a dose of PREVNAR. The patient had actually already received a dose of PREVNAR and needed a dose of PNEUMOVAX instead.
Coughing and loosing her voice because of dry cough; Loosing her voice because of dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing and loosing her voice because of dry cough) and APHONIA (Loosing her voice because of dry cough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian cancer. Concomitant products included OLAPARIB (LYNPARZA) for Ovarian cancer.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COUGH (Coughing and loosing her voice because of dry cough) and APHONIA (Loosing her voice because of dry cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Coughing and loosing her voice because of dry cough) and APHONIA (Loosing her voice because of dry cough) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Developed edema to lips the day after the vaccine was given along with expected reaction to include fever and bodyaches.
3/2/21-throat slightly tightening and feeling scratchy, sore arm, nausea at night; 3/3 & 3/4-extreme fatigue and still scratchy throat, sore arm: 3/5-still tire but feeling better: 3/6 through 3/8-feeling as if a foot is on my trachea and back, and as if a flame thrower is down my throat, unable to bend over without pain in chest, unable to take deep breaths without pain, fever, chills, thought I may have to go to hospital, maybe heart attack, collapse lung, to tired to get up;  3/8-went to urgent health care to get covid tests which both came back negative.  Follow up telehealth with personal physician on 3/10.  Still having symptoms of breathlessness until today 3/12.  Also, very sad, weirdly sad.
23APR94 AM rash & welts appear on face, elbows & knees; by mid afternoon, rash was spread & covered entire body by early evening given DPH & soda bath; 24APR93 vomited, hands & feet swollen & sore; rash is very itchy; t99.4; hands & legs l;
Rash on left arm one week after first dose of Moderna. Itchy, irritated eyes 3 days after first dose. Swollen tongue one week after first dose. Taking Benadryl for symptoms.
Patient is fully vaccinated.  Presented to the ED and tested + for COVID.  Patient presents with chest pain and cough. Patient presents with 1-2 days of dry cough, congestion, occasional shortness of breath and chest soreness. Positive for chills, sore throat, cough and chest pain.  Vital signs reviewed and interpreted by myself. Afebrile. No hypoxia or tachypnea. Slightly tachycardic. Patient discharged and instructed to return to ED if symptoms worsen.
Fever (99.3), nausea, diarrhea, fatigue, body aches.  Symptoms other than fever began around 12:30pm on 3/7/21.  Fever began at 3:30 pm on 3/7/21.
12-24 hours after each COVID19 vax, the osteoarthritis in my fingers would worsen. The knuckles closest to the fingertips would turn bright red and ache. This would ease after about a week. After receiving the COVID19 booster, however, huge nodes showed up on either side of the knuckles, the nodes turned fiery red, the fingers became super stiff and ached 24/7. The pain was so bad, it would wake me up in the middle of the night. I could also feel the bones twisting and mutating. Fluid-filled cysts showed up on several of the nodes. It became difficult for me to write, hold certain items, open containers, etc. Sometimes,  my fingers would stiffen so much that I would have to manipulate them manually to open and close.  After two months of these issues, and continued pain, I finally consulted a rheumatologist for help. She said my auto immune-system had gone into overdrive because of the booster.  She had X-rays taken; then she prescribed Tylenol, Meloxicam, and a topical cream. She also prescribed visits  to a hand specialist so I could occupational therapy, ultrasound therapy, and exercises to strengthen
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medication was not reported. In April 2015 (reported for all products as since 01-APR-2015), the patients were administered improperly stored GARDASIL (route, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I just got COVID after getting my first shot; I just got COVID after getting my first shot; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. This report received from program.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced just got covid after getting first shot. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on an unspecified date. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Developed fever evening 04/04/2002, fever again on 04/08/2002, Diarrhea, Started 04/05/2002-vomiting started 04/06/2002-continues today 04/08/2002.
On 11/17/2021 I had a stabbing type pain in the stomach are thru the whole night and a lot of gas, under the right rib cage. On 11/29/2021 same symptoms but not as bad. Pain is still going on but subsided.
This is a cluster of 2 patients who had received FLUZONE ID and experienced some reactions. The event for the one patient was captured in case 2011-09633. A female patient (age not reported) received FLUZONE Intradermal injection in deltoid, lot number UT4163AA. On 05 October 2011, within minutes after receiving the injection the patient complained of lightheadedness, dizzy, diaphoresis, vomiting, nausea and seeing spots. However, diaphoresis and lightheadedness were resolved after vomiting; all other symptoms remain. The patient has never had an allergic reaction to any vaccine. No further informational was available at the time of the report. The patient outcome was not resolved/not recovered. Follow-up information received on 29 February 2012 from a nurse. The patient had no concurrent illnesses at the time of vaccination with FLUZONE vaccine, which was at 9:40am on 05 October 2011. The onset time of the reactions were 9:41am the same day. The patient recovered the same date at 14:00pm. The reporter reviewed the case and has no additional information at this time. No further information is expected. Documents held by sender: none.
About 2 or 3 hours after the initial Moderna shot, I started to have mild stomach discomfort and pain, along with the onset of nasal congestion.  There is also soreness at the injection site.  For the stomach ailment I drank ginger tea, for the congestion I took Mucinex and I took Tylenol before going to be for the arm soreness.
Her Husband Started taking Paxlovid for Covid-19 treatment; Her Husband Started taking Paxlovid for Covid-19 treatment; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Her Husband Started taking Paxlovid for Covid-19 treatment". The event "her husband started taking paxlovid for covid-19 treatment" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient's wife reported her husband (patient) started taking Paxlovid on Monday, 03Oct2022, at 4pm. He has been having nausea, extreme diarrhea and vomiting. Reporter stated "he almost had to sleep in the bathroom it's been so bad." The reporter stated the patient's symptoms started before he started taking the Paxlovid, was he doing something wrong? Reporter stated they have both had the Pfizer-BioNTech COVID-19 Vaccine primary series and the patient (her husband) has also had the Pfizer-BioNTech COVID-19 Vaccine booster dose. She still needs to get her booster dose but was currently being treated for cancer. They spoke to her husband's doctor and they suggested he take acidophilus, which he has been taken along with Imodium DM, which was not helping the symptoms. "He has one more dose and he may not take it."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
The patient presented a rash in the chest area and in both arms, for which Dr. was called to consult on the case. She orders that he be given Benadryl 50 mg via IM GI. After approximately one hour in the observation area, at 6:53 pm, Dr. is called to notify her of the patient's condition and report her improvement; and for this reason, she was discharged.