chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax 15OCT92 & on 31OCT92 devel nephrotic synd & was hospitalized; addtl info has been requested;
It was reported that this child received vax and 8 days post vax, experienced tiredness, lethargy, headache, pallor, puffy eyes, and swollen glands and developed a temperature of 99.1 to 99.9 degrees F. From additional information received on 02/03/00, the pt was seen at physician's office and dxed with ROM (right otitis media) on 12/21/99. Follow up #1 06/14/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added headache)
Rash all over my stomach with little tiny blisters. It appeared 48 hours after the vaccine and I still have it today. I also got hot and cold flashes, aches and pains the same time as the rash. The aches and pains, cold and hot flashes were gone Monday, March 15th, but as of today March 17,2021 I still have the rash and little tiny blisters. The rash is slowly getting better with Benadryl.
Narrative:  Pt had nausea and vomiting on 1/22 and 1/23. He had the vaccine on 1/13/201. No interventions were done and the vomiting resolved.
Patient had a severe allergic reaction after receiving first dose of Moderna vaccine on 10/30/21. Patient reports that she became immediately flushed and dizzy after getting the vaccine. She went home and developed chest pain, shortness of breath, wheezing, lip tingling and felt squeezing pressure that went up her neck and to the right side of her face. She went to urgent care and received solumedrol intramuscular injection and symptoms subsided within 15 minutes.
At 7pm, I bent down to clean my bathtub when i felt a very sharp pain in my right thigh. I laid on the floor for about 20mins, crawled to my kitchen, open my refrigerator, got a bottle of water and drank some, laid on the floor for another 20mins, then I was able to get up and get an ice pack out of the freezer, I put this on my thigh till I went to bed at 11pm.
This is the second of the three reports. This is a spontaneous report by a contactable nurse through a Pfizer sales representative. A currently 4-year-old patient (sex unknown) was administered a dose of PREVNAR 13 intramuscularly, in the thigh as catch up dose on 30Sep2010. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 30Sep2010, after vaccination, the patient experienced rash at injection site with a radius greater than 2-5 inches. Relevant lab data was unknown. At the time of the report the patient had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 15:30 as dose 1, single (Lot number: EL9265), in left arm, on 01Mar2021 at 15:30 as dose 2, single (Lot number: EN6200), in left arm and on 11Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Symptoms started all over again with low fever, body aches, sneezing, coughing, extremely congested and a dull headache. Anti viral details: [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=18Apr2022, treatment stop date=22Apr2022, indication=Treatment of COVID-19}]
Red; Rash appear on the left breast/ Light rash; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), PAIN (Sore) and RASH (Rash appear on the left breast/ Light rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor), Lymphadenectomy (Lymph nodes removed) in 2010 and Surgery in 2010. Concomitant products included ROSUVASTATIN for Cholesterol, CALCIUM and VALACICLOVIR for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red), PAIN (Sore) and RASH (Rash appear on the left breast/ Light rash). At the time of the report, ERYTHEMA (Red) and RASH (Rash appear on the left breast/ Light rash) had not resolved and PAIN (Sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted her Oncologist and HCP.  No treatment information was provided.   This case was linked to MOD-2021-275069 (Patient Link).
Large painful swelling under left arm.; Large painful swelling under left arm.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, diabetes, hypothyroidism and COVID-19. The patient previously received hydrocortisone (MANUFACTURER UNKNOWN) and paracetamol; dextropropoxyphene napsilate (DARVOCET), and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were reported as yes, but the medications were unspecified. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021 at 11:00, the patient experienced large painful swelling under left arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event large painful swelling under left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Within one minute of giving vaccines, patient got pale, became limp and passed out. Did have few jerky movements and did lose control of urine. Blood pressure 118/40. Woke up immediately and was aware of surroundings. Seemed very tired and vomited several times. Sent to ER via ambulance. Got 2 hours IV fluid. Seen 12/19 with face all swollen and blotchy rash  on arms and chest. Put on Prednisone and Benadryl.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored RECOMBIVAX HB lot # L010595/Expiration Date- 12-NOV-2016, lot # L048848/Expiration Date- 09-AUG-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Monday evening pain in shoulder and elbow. Tuesday a 2" knot at the injection site. Tuesday PM, had a rash around injection site. Wednesday had itching. Unable to life arm from Tuesday AM until Friday. On 3/12/03 continued to have some tenderness in shoulder and elbow but can lift. Knot is pin-sized and mild itching.
Pt states that the Last flu vaccine caused difficulty breathing and tighness in his chest for 3 days. He said that he did not go to the doctors because these symptoms have appeared each year following a flu shot, and assumed that "things are just that way, and has lived with it his whole life". I encouraged him to see his PCM for a professional assessment.
Pt cried & screamed continuously for about 3 hrs; both thighs, legs & feet swelled & turned red; more marked on lt (DTP) side; pt taken to ER but signed out AMA a/being evaluated; grandma stated they left because pt was okay;
This case was reported by a consumer via out of hour services and described the occurrence of allergic reaction in a male patient who received TWINRIX. On 20th February 2018, the patient received the 2nd dose of TWINRIX. On 20th February 2018, 30 min after receiving TWINRIX, the patient experienced allergic reaction, rash urticaria-like and itchy rash. On 20th February 2018, the outcome of the allergic reaction, rash urticaria-like and itchy rash were recovered/resolved. The reporter considered the allergic reaction, rash urticaria-like and itchy rash to be probably related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received TWINRIX earlier on the day of reporting and then a little around 30 to 45 minutes later she started to get an outbreak on my other arm right on the inside at the joint inside elbow. It was not hives but a kind of started to resemble hives. The patient stated that he got a weird reaction, which seemed like an allergic reaction, in his left inner elbow which was itchy and hive looking. The outcome was resolved after 45 minutes to one hour. The reporter stated that he was leaving the country soon so a form would not be of any help to him. The patient stated that he was fine now. The patient was not sure what caused it. The reported stated that he did not want to be contacted by mail and preferred to be contacted by phone or email.
Complained that her tongue feels like it is swelling, has diarrhea and vomiting. No problems breathing. Patient refused to go to urgent care.
Woke up with extreme abdominal pain. I then made it to the bathroom where I puke and had diarrhea. I got chills, temp was 96.6 (low for me). I had a little more diarrhea. Then I just had GI upset the rest of the day. I had to miss work but felt better by the next day.
Morning after 2nd shot felt great deal of fatigue, to the point of returning to bed. Spent rest of day on couch with no strength. Beginning of front of head headache. This headache has continued to this day, also some visual blurring. Fuzzy head thinking feeling. These conditions are on going as of today 03/25/2021.
Severe back spasms, shortness of breath, unable to sit or lie down, body contorted, visit to the ER
Classic appearance of zoster lesions in a 3 cm patch around the vaccination site. Coalesced pustules on a surrounding red patch.
pt recv vax 17JUL96 24 hr post vax pt exp stiff neck, lightheadedness & dizziness;the stiff neck has resolved but still feels lightheaded & dizzy when pt sits;
stroke occurred five days after receiving vaccine.  I was hospitalized overnight in General Hospital.  Have had two MRI's.
9/1/2021 Vaccination. Gradually into October 2021, I started to experience increase in pain. The pain radiated from hips, knee, shoulders, etc. It hurt to do daily functions. I had a hard time walking, driving, etc. 10/8 Prednisone, medication prescribed for inflammation. Treating me for PMR. 80 mg prednisone for about 3 weeks. Methotrexate prescribed, as well. Pain was still not under control. As time went on, I started to have pain in my wrist and thumb. The doctor stated then it was probably not the PMR but rather Geriatric Rheumatoid Arthritis. I am now receiving injections every other week.
Urticaria starting at ankles, rising to involve knees and wrists, then lip swelling.    Symptoms completely resolved within 48 hours (with Benadryl).
Patient developed hives on back, abdomen, arms and legs and face. They have been migratory and flaring and disappearing. They are pruritic.
Skin Rash, started on forearms back of hands and back and buttocks. Treatment Tanning booth. Same thing happened last time with flu shot in 2013.
still feels achy/Her body still hurts; This is a spontaneous report from a contactable consumer (patient). This female consumer of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 dose 1 on an unspecified date. On an unspecified date in 2021 patient experienced still feels achy/her body still hurts. The caller reported that the first time she had the covid-19 vaccine she had side effects. Caller asked, do some people have lingering side effects? She said that it might not be related. She has also heard that her doctor had effects for like 2 weeks. She has heard that some people have lingering effects. She would like information on this. The caller declined to complete a safety report and requested to be transferred to USMI to have her questions addressed. Caller declined to provide an email. The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Rash next day, then 3rd day rash an sore. Went to hospital and they said it was shingles could have been activated by the H1N1 from where I had Chickenpox.
The patient tested positive for Covid-19 on 2/4/22 and developed pneumonia. he was hospitalized on 2/4/22
Narrative:  Pt is a 81 y.o male who died on 04/21/2021 w/ h/o urothelial carcinoma, vascular dementia, HTN, diverticulitis with perforation s/p colostomy, COPD, bioprosthetic, AVR, chronic A.Fib., and hypothyroidism. Pt received Moderna Covid-19 Vaccination 2/2 on 02/19/2021. Pt consulted with palliative care 04/05/2021 for bladder cancer. Pt admitted to hospice services 04/08/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
Small itchy bumps appeared at baseline of hair on right side of neck, right shoulder, back of arm, right elbow, down back in spuratic spots . rash started early Wednesday 10-13 morning 3:30-4:00am and still have itchy rash as of today Thursday 10-14 7:30pm
SMALL RED BUMPS BELLY AND SPREAD UP CHEST/ RANDOM RED DOTS/IF DO NOT THINK ABOUT THEM, IT DOES NOT ITCH, WHEN DO THINK ABOUT THE DOTS, THEY DO ITCH; This spontaneous report received from a patient concerned a 56 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid. On 26-MAY-2021, the subject experienced small red bumps belly and spread up chest/ random red dots/if do not think about them, it does not itch, when do think about the dots, they do itch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small red bumps belly and spread up chest/ random red dots/if do not think about them, it does not itch, when do think about the dots, they do itch was not reported. This report was non-serious.
7pm fever 103.4° chills, tremors, vomiting. Fever remained for 2 days, low back and abdominal pain became increasingly worse. Finally went to ER 2/26 was septic hospitalized for 13 days
Hip arthropathy; Cartilage disorder; Sickness; Pain in arm; Tiredness; Nerve pain; Sacral Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHROPATHY (Hip arthropathy), CHONDROPATHY (Cartilage disorder), ILLNESS (Sickness), NEURALGIA (Nerve pain) and BACK PAIN (Sacral Pain) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Hip replacement on 23-Dec-2020. Concurrent medical conditions included Rheumatoid arthritis, Osteoarthritis, Sacral pain and Drug allergy (Morphine allergy infested by bad allergy). Concomitant products included MORPHINE for an unknown indication.   In December 2020, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced NEURALGIA (Nerve pain) and BACK PAIN (Sacral Pain). On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness). On an unknown date, the patient experienced ARTHROPATHY (Hip arthropathy), CHONDROPATHY (Cartilage disorder) and ILLNESS (Sickness). In December 2020, NEURALGIA (Nerve pain) had resolved. In January 2021, PAIN IN EXTREMITY (Pain in arm) had resolved. In 2021, ARTHROPATHY (Hip arthropathy), CHONDROPATHY (Cartilage disorder) and FATIGUE (Tiredness) had resolved. At the time of the report, ILLNESS (Sickness) and BACK PAIN (Sacral Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Magnetic resonance imaging: hip joint detoriation (abnormal) Hip joint deterioration and hip joint does not have cartilages.. In December 2020, X-ray: hip joint detoriation (abnormal) Hip joint deterioration and hip joint does not have cartilages..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness) to be probably related. No further causality assessments were provided for ARTHROPATHY (Hip arthropathy), CHONDROPATHY (Cartilage disorder), ILLNESS (Sickness), NEURALGIA (Nerve pain) and BACK PAIN (Sacral Pain).    Non smoker  Alcohol occasionally; Sender's Comments: Very limited information regarding these events has been provided at this time. The event may probably be related to the patient's comorbidities, additional information required.
100.5° fever for 36 hours Nausea Chills Tiredness Headache Pain at injection site  Inflammation at injection site Sore injection arm
blood clot in the lower abdomen/colon.; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clot in the lower abdomen/colon.) 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 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (blood clot in the lower abdomen/colon.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the lower abdomen/colon.) outcome was unknown.            No concomitant medication was reported.    Patient got her first booster on 21-Nov-2021 and 10 days later she got a blood clot in the lower abdomen/colon. No treatment information was reported.  Company Comment: This spontaneous case concerns a female patient with unknown age , with no medical history reported , who experienced Serious  ( medically significant ) , unexpected. AESI of thrombosis which occurred 10 days post vaccination with the 3rd dose of mRNA-1273 vaccine . The information regarding the 1st and 2nd dose of Covid 19 vaccine of this patient was not reported. The thrombosis was described as blood clot in the lower abdomen /colon.The details surrounding the event  like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report   This case was linked to MOD-2022-580280 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient with unknown age , with no medical history reported , who experienced Serious  ( medically significant ) , unexpected. AESI of thrombosis which occurred 10 days post vaccination with the 3rd dose of mRNA-1273 vaccine . The information regarding the 1st and 2nd dose of Covid 19 vaccine of this patient was not reported. The thrombosis was described as blood clot in the lower abdomen /colon.The details surrounding the event  like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
The day I received my second dose of Moderna vaccine, I was so ill I could not get out of bed except to use the bathroom. The next day, I started my period. For the first time since I started having periods (when I was around 13 years old), I was doubled over in pain, sweating and experiencing the worst cramps of my entire life. The bleeding was so heavy I couldn't keep up with it. This continued for several menstrual cycles before the symptoms lessened. I am still experiencing heavier and more painful periods than I was prior to receiving the COVID-19 vaccine series, but almost an entire year later my cycles have not returned to baseline.
Information has been received from a health professional concerning a 10 year old male, with no medical history and no allergies, who was vaccinated with subcutaneous 0.5 ml doses of varicella virus vaccine live (Oka/Merck) on 17-SEP-1998 and 07-FEB-2008 (Lot# 659730/1781U). There was no concomitant medication. On 09-FEB-2008, the patient's mother called into the office to report that the patient had a hot patch on his left arm at the injection site, beginning on 07-FEB-2008. It was also reported that he had a low grade fever for 2 days, was very angry, and had a red inflamed area at the injection site. The patient was treated with ice and elevation. Subsequently the patient recovered. No laboratory or diagnostic tests were performed. No product quality complaint was involved. No other information was provided. Follow up information from the healthcare professional indicated that at 10:00 on 09-FEB-2008, the patient developed a low grade fever (specific values not reported), "angry" red reaction, and swelling. It was indicated the patient experienced the fever for two days. Additional follow-up information from the reporting health professional indicated that on 07-FEB-2008 at 14:00 (also reported as 15:00) the patient was vaccinated with his second dose of VARIVAX (lot # 659730/17910) in the left arm. On 08-FEB-2008 9 also reported as 09-FEB-2008 at 10:00) the patient experienced a low grade temperature for 2 days and was angry. The patient also developed a red, swollen upper arm. On 15-FEB-2008 the patient recovered. This is one of several reports from the same source. Additional information has been requested.