chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800,000; general edema; extreme fatigue; migraine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (pneumonia) and SWELLING (general swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (general swelling) (seriousness criterion hospitalization), MIGRAINE (migraine), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), PAIN (pain), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein) and PLATELET COUNT INCREASED (platelets test was over 800,000). At the time of the report, PNEUMONIA (pneumonia), SWELLING (general swelling), PAIN (pain), MIGRAINE (migraine), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein), PLATELET COUNT INCREASED (platelets test was over 800,000), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: > 800,000 > 800,000. On an unknown date, Protein total: 2.0 2.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given narcotics for pain. Low protein was treated with albumin.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Swelling and redness around injection site. Lethargy. Benadryl and cool compress recomended.
Developed pruritis and rash on forearms.  No throat symptoms, chest tightness, shortness of breath, nausea or vomiting.  Rash improved and itching decreased without treatment.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis.  This report refers to 74 patients who, on unknown date, developed HZ in the 6th year after the vaccination (considered as lack of efficacy).The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010597). Additional information has been requested. Sender's Comments: US-009507513-1703USA010321.
Fever 100.7, nausea,  painful joints, no energy,  headaches,  mouth sores. Rash on arm and large swelling at injection.  Symtoms started next day and  lasted 2 to 3  days. Rash and swelling in arm started day 4 lasted 5 to 6 days.
Headache, cold sweat, sleepiness, muscle aches,  joint aches. 7 day duration
2 hours post vax pt experienced increased erythema at site and entire thigh - both thighs and to waist increased swelling a right leg.resolved with time waiting in ER. Pt developed redness, decreased with ice and Tylenol. Not seen at ER, 5 hour wait told to follow up with physician
The next day I got a fever just over 100 degrees which lasted for about 12 hours accompanied by a headache and chills. After the fever and chills went away the headache persisted. It would go away and come back but never went away for long. It enough to be very annoying on the pain scale and was not a normal headache. After 4 or 5 days the headache had not gone away, and I had gotten info about side effects from the J& J vaccine and decided to call my doctor because I have a preexisting blood clotting condition. My doctor sent me to the Hospital on 4/23/2021 and at that time I still had the headache. She wanted me to go to confirm I did not have a blood clot. The y ordered a CT scan of my head, and they checked my platelet count.  After the hospital visit the headache lasted for an additional 4 to 5 days.
Left thigh cellulitis vs local reaction to immunization. Impossible to R/o cellulitis treated with Augment BIO For 7 days. F/u fi needed.
Chills, Fever, nausea, dizziness, muscle fatigue (my fever was 100.8 oral) symptoms lasted for one day so far.
She was very nervous prior to vaccine. About 30 seconds to a minute after giving vaccine patient became pale and was guided to laying down by nurse. Her eyes rolled up. Patient then had whole body shakes and her left arm bend and her left hand came up to the left side of her face. Episode lasted about 10 seconds. She then woke up and asked what was going on. She stated that she didn't recall what happened prior to arousing laying down on the exam table. She was able to tell me where she was, who she was, and who was in the room with her. She denied headache. Heart, lung, and abdominal exam normal. Tongue examined and is without bleeding or bite marks. Normal patellar reflexes. She was given a cold washcloth and a cup of water.
Experienced blurriness of the vision; Sore arm; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jun2021 (Lot Number: EW0179) as dose 2, single for COVID-19 immunization at the age of 13-year-old. Medical history included ongoing acne. Concomitant medication included isotretinoin (ACCUTANE) taken for acne from Apr2021 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Jun2021 (Lot Number: EW0183) as dose 1, single for COVID-19 immunization at the age of 13-year-old. On 28Jun2021, the patient experienced a sore arm but felt better after taking Tylenol. When the patient woke up the next morning, on 29Jun2021, his vision was blurred for about 15 minutes to half an hour. He was unsure if it was a side effect from the shot that he got the day before. The patient's mother mentioned that she was going to check with his dermatologist because he was on Accutane and they were forewarned of blurry vision and a headache with Accutane, but the patient said that he did not have a headache. He had been on it for two months and was put on 30 mg because of his bloodwork that came back normal after the first round. The outcome of event blurriness of vision was recovered on 29Jun2021. The outcome of event sore arm was recovering.
she also tested positive for Covid; she also tested positive for Covid; Streptococcus infection; This is a spontaneous report from Medical Information. A non-contactable consumer (patient herself) reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021, she tested positive for Streptococcus infection and was prescribed with antibiotics. Later that day, she also tested positive for Covid. She said she rescheduled her 2nd dose on 04May2021. Patient said her quarantine period ends on 03May2021, so she wants to know if she can still get the 2nd dose on 4May2021 even if her quarantine period just ended or if she should reschedule it on a later date. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Immediately after receiving my vaccine, I had localized pain at the site which lasted 7 days. On the 7th day, I developed swelling at the site; and a rash down both arms, back, both legs and chest. Very itchy. Raised, red blotches. Quite ugly. I immediately took Benadryl at night and a small amount of cortisone cream. Did the same for the next night, and switched to Zyrtec as per doctor's orders along with cortisone cream again. Still itchy and blotchy.
Painful, swelling in left arm with itching, redness and burning, hot to touch 1/23 at night. Seen at emergency room on 1/26 and received a prescription for Prednisone 60mg a day and reduced by 10mg each day down to 10mg on day 6. Benadryl and Motrin PRN. Headache, elevated blood pressure and high heart rate; eyes were sensitive to light. Symptoms subsided after receiving Prednisone. Sight slightly tender/discolored below site.
2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, nausea on Sunday morning at 02:30. This continued the rest of the day but was improved with Aleve. Woke up on Monday feeling well.  Monday afternoon started developing a rash on bilateral thighs and arms.  The rash was itchy and inflamed.  Took Benadryl 12.5mg  the next 2 nights. Wednesday the rash had improved, still pinkish but not red.  Thursday the redness had resolved, but was still itchy.  The itching continues today, but very mild.
Patient says muscle hurts at vacc site. Also her scapula hurts. Hurts to raise her arm. Left arm.
took the second vaccine and the tinnitus increased in intensity and became louder; I experienced another migraine a week afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (administration time was03:00 PM, Dose 1, vaccine location Left arm.), administration date: 02Apr2021, when the patient was 38 years old, for COVID-19 Immunisation, reaction(s): "tinnitus"; Bnt162b2, administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 immunisation, reaction(s): "severe migraine headache". The following information was reported: TINNITUS (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "took the second vaccine and the tinnitus increased in intensity and became louder"; MIGRAINE (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "I experienced another migraine a week afterwards". The events "took the second vaccine and the tinnitus increased in intensity and became louder" and "i experienced another migraine a week afterwards" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, migraine.  Additional information: One week after vaccination I began experiencing tinnitus in my right ear, pressure in right ear, severe migraine headache. The next day the tinnitus spread to my left ear. It is a continuous high-pitched ringing. I have never had tinnitus before. The tinnitus began to subside after two weeks. Then I took the second vaccine and the tinnitus increased in intensity and became louder. I experienced another migraine a week afterwards. I visited an ENT and I have no ear infection, wax build-up, ear damage, significant hearing loss that would explain the tinnitus. The ENT suspected that I may be having a reaction to the vaccine. The patient was not tested positive for covid 19 since before and after vaccination. The patient had not received any vaccines within 4 weeks or other medications within 2 weeks. The patient received treatment with Antibiotics (urgent care suspected it was ear infection).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient came to pharmacy 2 days later complaining of pain, redness, and swelling at the injection site. Pt said she felt a knot where the injection was given. Could not sleep on the left side of her body. Had limited use of her arm due to pain. Thought the injection was given too high in the arm and worried that she has tendon damage.
Raised rash to chest and neck within 1 hour of vaccine. Itchiness and burning for the first 48 hours to rash site. Benadryl did not help.
Patient was given moderna booster today instead of shingles. They had a previous Pfizer booster on 9/22/22.
24 hrs p/recvd vax on 11MAR92 devel a splotchy rash on cheeks & front of neck which spread for about 2 days; p/6 days, rash had dec to a few red spots on cheeks;
Red rash around my trunk, mostly on the front and flanks, of my body from neck to waist line. Very itchy & red. I took a Loratadine tablet & used cortisone cream. Before bed I took Benadryl. It's the next morning now & the symptoms are unchanged. I get a flu vaccine every year and have never had this reaction.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9 and patient will consider getting revaccinated.
LOSS OF VOICE; SINUS INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; PNEUMONIA; This spontaneous report received from a patient concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included doxycycline. On an unspecified date, the patient received the second dose of covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose, 1 total, administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date in 2021, the patient experienced sinus infection and had been sick for a month (dose number in series 1). On an unspecified date in DEC-2021, the patient experienced pneumonia (dose number in series 1). On an unspecified date, the patient experienced loss of voice (dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, had not recovered from loss of voice, and the outcome of sinus infection, off label use and inappropriate schedule of vaccine administered was not reported. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. On an unspecified date, the patient received Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2), (intramuscular, form of admin, and batch number were not reported), dose was not reported, administered for prophylactic vaccination.  The action taken with risankizumab, and Pfizer biontech covid-19 vaccine (tozinameran) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220138480--. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX (Merck) injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
01/13/2021 Pt calling to report possible side effects of covid-19 vaccine.   Pt c/o cough, fever(101.1°F), nasal congestion, body aches and HA this morning. Pt received vaccine @ 6PM last night. Pt stated she has been experiencing slight cough and sneezing for about a 2 weeks, which she attributed to allergies, but woke up with additional sx listed above around 4am this morning.
Information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medications.  On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant.  The gestation period was 7 months.  The patient has had a lot of complications with the pregnancy.  Unspecified medical attention was sought.  On an unspecified date blood work and an ultrasound was performed.  No additional information was provided.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with a history of genital herpes, no previous pregnancies or spontaneous abortions and no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included prenatal vitamins. On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant. The gestation period was 7 months. The patient's date of last menstrual period was in October 2007 and the estimated date of delivery is 28-JUL-2008 by an ultrasound. The estimated date of conception is unknown. The patient has had a lot of complications with the pregnancy. Unspecified medical attention was sought. On an unspecified date blood work was performed. On 07-DEC-2007 and 25-FEB-2008 an ultrasound was performed (results were not reported). On 08-FEB-2008 a maternal serum alpha-fetoprotein test was performed and was normal. On 06-Mar-2008 an amniocentesis was performed and revealed "46, XX choroid plexus". On 12-May-2008 a diagnostic laboratory test was performed and was AHN 1 p.p.: 140mgm. On 18-JUL-2008 the patient had a normal baby girl weighing 2635 grams. The APGAR score was 8/9. During labor/delivery the patient had a non-assuring fetal heart tone. Additional information is not expected.
Fever started about 24 hours after the vaccine and lasted 12 hours. Broke an hour after taking Tylenol and didn't resume. Skin was sensitive to touch and muscles were tired and slightly achy. Headache formed around hour 10 of the fever. Once the fever broke, I had drenching night sweats.
Patient received Moderna COVID vaccine on 4/19/21, 5/17/21, and Moderna bivalent COVID vaccine on 10/11/22. On 11/28/22, patient was diagnosed with COVID infection in the community. On 12/5/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia (requiring 5-6L NC O2), COVID-19 pneumonia, and intermittent asthma with acute exacerbation due to COVID-19 infection and pneumonia. As of today (12/9/22), patient is still admitted in the med/surg unit.
Lump at the site of injection with some redness which went away as per patient on the upper right arm.
Friday initially elevated temperature with chills on 10/16 - TYLENOL and fluids advised. 10/19 "flaming itchy rash" on trunk and legs went to PA and took BENADRYL over the weekend - rash resolved.
Rash or hives all over my belly, first pregnancy and due date 10/19/2021
Patient stated he had fluctuating fever (97-100), soreness and redness at injection site. Injection site was not warm to the touch. Went to urgent care where they told him it was a bacterial infection
Blood clot in thigh. 4 months later, gradually dissolving. Have to continue to wear compression socks and be seen by vein specialist
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-DEC-2015 at 04:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.