chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme pain to my right shoulder and neck. Pain on my neck felt like an extremely painful pinched nerve that started from the left side of my upper neck down to my left shoulder blade. The pain on my shoulder was pain that was felt down to my elbow but it mainly stayed on the upper left shoulder area. The extreme pain lasted until Feb 2, 2021 and then it slowly decreased. I'm still experiencing pain today (Feb 5, 2021) but it has decreased slowly.
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 30-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Large knot in left upper leg. Red rash approx 4"- 5" in diameter. Blotchy
Headache, Seizures, UrticariaPruritus & NauseaVomiting Narrative:  NORMALLY HAVE SEIZURES EVERY EVENING, BUT THIS SEIZURE ABOUT 5.5 POST VACCINE WAS MUCH MORE SEVERE WITH "EYES ROLLING IN BACK OF HEAD" AND FELT "IN A DAZE". TOOK AN EXTRA DOSE OF CLONAZIPAM 1 MG
8/2/07 mother noticed "raised, little red bumpy rash - covering entire upper left thigh", extending all the way around.  Questionable slight temp, flu at doctor's office 8/3/07.  Benadryl taken night of 8/2/07, AM 8/3/07 & night of 8/3/07.  Cleared with no respiratory difficulty.
Hives and itching developed about  230pm on 12/28/20. patient self treated with oral Benadryl. presented to clinic about 830 am on 12/29/20  with continued c/o hives and itching . She was sent to ED at Hospital for evaluation. patient denied any other symptoms
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 3:15PM. Patient has not reported to Medical Clinic with symptoms at this time.
1st vaccine, my lips tingled, sore mouth, sore arm and developed a chronic cough for more than six weeks. 2nd vaccine, tingling lips, lethargic, cough and developed a rash under my right breast several weeks later. Rash lasted for more than four weeks. 3rd vaccine, sore arm, lethargic, headache and fever. 2 ½ weeks after vaccine, developed a rash over left-side back shoulder area.  Second rash on right-side above breast. Also developed a rash on right-side hip. All of these rashes constantly itch. It has now been three weeks. I now also have the feeling of that when you've gotten into fiberglass. This is how it feels all over my body. I am constantly itching and feeling a "fiberglass" feeling all the time. I'm itching all the time. It's driving me crazy along with the rash in areas that are non-stop. I also have numbness in my hands and feet and bruising easily. It has now been over four weeks that I'm suffering with the skin condition. I cannot get an appointment with my primary care. All facilities have no appointments due to the fact that all people are wanting to get a COVID-19 test. I have tried antihistamines, steroid creams and diazepam to help me sleep at night because I'm constantly feeling itchiness/tingly/prickly. Nothing is helping.
(Moderna COVID-19 Vaccine EUA) (1st unusual reaction) 02/22/2021: Started to experience "COVID Arm". Became red, slightly itchy rash that spread to area surrounding injection site. Also swollen & hot to touch (2nd adverse reaction) 02/28/2021 Apx 6PM: Started to break out in itchy rash. Over next 2 days, rash spread all over back & front of torso, arms and had started down legs.  By end of 3rd day, rash had started to fade.  Also on 2nd day, voice was affected.  Hard to describe. Could tell that it was affecting my vocal folds.  Voice was raspy, kine of like when have sore throat. Was not able to hit the right notes when trying to sing.  This went away after apx 8 hours.  No other symptons.  (No pain, no fever, no
chills; shaking; not feeling well; This is a spontaneous report received from a contactable Consumer (patient's husband).  A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration, in right arm, on 06Feb2021, Saturday (at the age of 78 years), as a single dose for covid-19 immunization. The patient medical history included A Fib and mitral valve replacement (caller states that his wife has had two mitral valve replacements, as she out-lived the first one). Concomitant medications included Jantoven (warfarin sodium) for a fib and mitral valve replacement. The patient had taken Covid vaccine for Covid prevention. On 07Feb2021, the next day, the patient had experienced not feeling well, chills, and shaking. Caller states that he wrapped his wife in a bunch of blankets and finally after about three hours, it subsided. Caller states that this morning, his wife got up and went to the bathroom and before she could get back to bed, she started to shake again. Caller is wondering if this is a normal side effect of the product. Caller confirmed that his wife had no other vaccines on the same day as the COVID vaccine. The outcome of the event chills was recovered on an unspecified date in 2021. The outcome of the event shaking was not recovered. The outcome of the event not feeling well was unknown.  Follow-up attempts are completed. No further information is expected.
Itching of eyes, ears, nose & throat, followed by mild anaphylatic episodes.
First COVID19 vaccination: pain to injection site when lifting arm Second COVID19 vaccination: upon waking next morning - intermittent nausea, temperature of 100.4 degrees Fahrenheit, fatigue, arthralgia, pain to injection site when lifting arm.  On the second post-vaccination day, I still felt fatigued. Since the completion of the vaccination series, I have felt almost continually bloated - without flatulence. My bowel movements have become irregular and at times skip a day. I feel intermitted nausea to varying degrees. I have neither gained nor lost weight nor have I changed my dietary habits since the COVID19 vaccination. I have scheduled an appointment with my primary care physician for evaluation.
? (Principal) NORMAL DELIVERY       8/1/23: SVD @39w3d; QBL 382 mL; 2nd deg repaired; rec'd methergine for oozing COVID pos/ symptomatic on admission Welcome baby girl   ? COVID-19 DISEASE IN CHILDBIRTH       8/1/23: COVID pos/ labor
Headache, Myalgia, Arthralgia,  CHILLS Narrative:
HEADACHE; FATIGUE; RANDOM NAUSEA; RESTLESS LEG SYNDROME; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced restless leg syndrome. On JUL-2021, the subject experienced fatigue. On JUL-2021, the subject experienced random nausea. On 25-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fatigue, restless leg syndrome and random nausea was not reported. This report was non-serious.
A 43 year old female reported that she received Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 12/14/00. Within "a few hours" of vaccine administration, she developed an injection site reaction characterized by a "large" hive that swelled to the size of a "baseball", itching, and redness. The reporter indicated that both vaccines were administered in the left deltoid.
Bump on leg that is red. Itchy and uncomfortable. Possible cellulitis vs. local inflammatory reaction. Rx Bactrim if site gets wors, but improving at time of follow-up visit on 11/22- monitoring clinically.
Serum sickness potential; fever; body aches; rash; fatigue; headache; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: E19265; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on an unspecified date in Jan2021 (with the reported time of 09:00 AM) (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and no concomitant medication. The patient has no known allergies. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. On 31Jan2021, the patient experienced serum sickness potential that was diagnosed by primary doctor, severe reaction , fever, body aches, rash, fatigue and headache. Events resulted in a doctor or other healthcare professional office/clinic visit and emergency room visit. Treatment with steroids, antibiotics and symptom management were taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19 test (Nasal swab): Negative on 06Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
shaking chill 12 hours after the injection; headache; No appetite for 4 days; retained fluid weight gain 5 pounds.; small and minor redness at the injection site; my blood pressure is down; Cold; This case was reported by a consumer via call center representative and described the occurrence of chills in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in september 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold were unknown.   It was unknown if the reporter considered the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had a shaking chill, cold and had headache and shooyingvpaus from neck down. No appetite for 4 days retained fluid weight gain 5 pounds.  The reporter reported that did all they said was it happens take tylenol and drink water and the blood pressure was up and at the time of reporting it was down. The patient said just that arm at the site of injection was negative. Nothing but a small and minor redness barely noticeable.      Lab Comments: lab test performed on unknown date
Shingles diagnosis by PCP on 12/13/16; Treated w/VALACYCLOVIR 1 gm TID x 7 days.
Severe body aches and muscle aches.  Jaw tension. Lymph nodes in neck swollen 72hrs later. Lung pain. Ear pain
Information has been received from a registered nurse concerning a 21 year old female with no pertinent medical history and no allergies who on 12-MAY-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. On 04-AUG-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM (lot # 660391/0063X). Concomitant therapy included YASMIN. Approximately on 11-AUG-2008, one week after receiving her second dose, the patient experienced bruise on the injection site. The bruise seemed to spread down to her bicep. She has no fever and no redness. She has full range of motion. She had no problem with her first dose. The patient was noted to be recovering. The patient sought medical attention and saw the nurse practitioner. Additional information has been requested.
My menstrual cycle started early and has not stopped/a similar side effect; My menstrual cycle started early and has not stopped/a similar side effect; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (herself, sister, and friend). This is the second of three reports for the consumer's sister. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced similar side effect to the reporting consumer. The reporting consumer described that the week after her second vaccine shot she had experienced her menstrual cycle started early and had not stopped with 12 days of menstrual bleeding as of 10Apr2021. The consumer stated her sister and friend had a similar side effect. The outcome of similar side effect was unknown. The consumer stated they thought it was a side effect of the "COVID-19 cmvacvine."  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392948 same reporter/drug/event, different patient.;US-PFIZER INC-2021407010 same reporter/drug/event, different patient.
A 3 yr old child in 1999 was vaccinated with varicella virus vaccine live. The pt developed 250-500 lesions of chickenpox and fever of 2 days duration. Unspecified medical attention was sought and it was noted that a wild type virus was isolated from a cutaneous lesion.
Pt devel fever of 105, unconsolable crying; Both started about 22 hrs p/immunized; Seen by MD & treated to reduce fever;
Site became red and swollen immediately after vaccination. Site is red and warm to touch.  Red rash now present with itching x 2 days.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
1)2  hrs after vaccine, lightheaded, vomited light brown vomitus 2)4 hrs after vaccine large black tarry stools 3)overnight large black tarry stools total to may be  4 4)3/04/21-0400 took BP-> SBP 88 lightheaded, feeling dizzy 5)around 0500 decided to call ambulance, not allowing spouse to drive me as i started to be symptomatic 6)at Medical Center (where PCP is), Hgb on this admission was 8 (prior was 11)->given 2 unkts PRBC right away 7)since had nothing to eat  midnight of 3/04->upper endoscopy was done-> (-) result 8)colonoscopy done (still with black tarry stools, occasionally bloody->(-) result 9)H&H trended, Hgb went down to as low as 6.5-> total units PRBC received=6 10)Bleeding scan-> (-) result 11) was on Protonix IVP and IVF; ice chips on this admission 12)PRAYERS in JESUS' NAME & claimed Mark 5:29 by faith (plus family/friends' intercession), 3/07 bleeding stopped 13)3/08 discharged home 14)3/15 capsule endoscopy as out patient -> (-) result 7
Received shot in left arm on Monday night. The following day, was extremely achy and was in bed most of the day. Muscles were extremely fatigued and had trouble walking. Severity of symptoms prevented me from doing daily activities. Also had chills and bad headache on Tuesday and Tuesday night. On Wednesday, developed hives and red rash on stomach, legs and left arm. Felt better on Wednesday afternoon and was able to walk, but hives are still present. Taking BENADRYL but still not 100%.
Gave Flu shot. When needle retracted site started to bleed. Put cotton ball and slight pressure to site to help stop bleeding. Site began to swell and started to get slightly hard. Put bandaid on. About 15 min. Later site stopped bleeding and swelling went down.
Skin lesion - Information has been received from a physician concerning a 33 year old female family member who in approximately february, 2000 was vaccinated with one dose of varicella virus vaccine live (site unknown).  Approximately two weeks post-vaccination. the patient experieced about 5-10 vesicular lesions diffusely over her body,  the patient received unspecified medical attention and the rash subsequently resolved.
big red area like a soft ball size; pain; tingling sensation from under her arm to her chest-breast area; burning sensation; her arm felt funny; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red area like a soft ball size), PAIN (pain), PARAESTHESIA (tingling sensation from under her arm to her chest-breast area), BURNING SENSATION (burning sensation) and LIMB DISCOMFORT (her arm felt funny) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (big red area like a soft ball size), PAIN (pain), PARAESTHESIA (tingling sensation from under her arm to her chest-breast area), BURNING SENSATION (burning sensation) and LIMB DISCOMFORT (her arm felt funny). At the time of the report, ERYTHEMA (big red area like a soft ball size), PAIN (pain), PARAESTHESIA (tingling sensation from under her arm to her chest-breast area), BURNING SENSATION (burning sensation) and LIMB DISCOMFORT (her arm felt funny) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Fever 101.5 f, headache, blurred vision, runny nose, chills, arm pain
day two - soreness, itchy near shot area, day three - red spot were shot was given, area felt hard, day 6 or 7 - bad taste in mouth, smell was off,
chills; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced chills and fever.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 08-Jan-2021, patient experienced chills and fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events experienced chills and fever were considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected events of pyrexia and chills.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
Left arm felt "heavy" at the time of injection; pain, heaviness, and numbness have occurred since (from shoulder to tips of fingers). Sometimes every other day. Patient has also had numbness in left leg at certain areas. She went in for a physical with her physician and spoke to him about it, prescribed her medicine, patient is unsure of which med he give her at this time.
Rheumatoid arthritis flare; episode of being incoherent; stroke like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4313804-00 (Agency).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "stroke like symptoms"; RHEUMATOID ARTHRITIS (hospitalization, medically significant), outcome "unknown", described as "Rheumatoid arthritis flare"; INCOHERENT (hospitalization), outcome "unknown", described as "episode of being incoherent". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 1 day(s)). The action taken for adalimumab was unknown.  The reporter considered "episode of being incoherent" related to bnt162b2. The reporter's and manufacturer causality for the events of stroke like symptoms was not reported and rheumatoid arthritis flare was not reported for PFIZER BioNTech Covid-19 Vaccine. The reporter's causality for the events of stroke like symptoms, episode of being incoherent following covid vaccine and rheumatoid arthritis flare was not provided for Humira (Adalimumab). Agency's opinion is that the event of stroke like symptoms is not assessable for Humira (Adalimumab). Agency's opinion is that there is no reasonable possibility that the events of episode of being incoherent following covid vaccine and rheumatoid arthritis flare are related to Humira (Adalimumab).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events Cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient received influenza .25cc on 10/7/03 and also received Synagis same day. No illness/fever reported. Patient put to bed; last checked at 3AM 10/08. Found dead in crib on 10/8 about 9 AM. No autopsy done. Hospital discharge summary received on 11/21/03 states cardiopulmonary arrest. Death Certificate received on 10/29/2003 states pneumonia and chronic lung disease.
Patient's Covid 19 vaccination card has recorded three (3) doses of Pfizer dated as 1/6/2021, 1/27/2021 and 11/18/2021. Admin found Website #4713593, #5594160 and #4674639. All Website numbers did not show first recorded Covid19 vaccination to match patient's card. RN called pharmacy to verify dates, pharmacy tech stated there is record of two Pfizer doses given on 3/8/21 and 1/27/21. Vaccination dated 1/6/21 was given at a different store. Patient was given another dose of Pfizer of 0.3ml on 05/17/2022 by RN. Supervisor RN was made aware.
Immediate swelling and hives at site, followed by 103F fever for 3 days prior. Given Benadryl at doctor's office and stayed for 30 minutes to make sure breathing would not be effected.