chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-FEB-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 01-JAN-2016, the patient was again treated by a physician for new and worsening symptoms of zoster outbreaks. The patient was prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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.
Patient reports chills, fever, as well as soreness at site and visible redness with defined border near injection site.  Pain still occurring at day 3 post vaccination and swelling.
Dizziness, tachycardia. BPs 136/87 (pulse 53), 136/86. Told to increase water intake on 4/22-4/23.
stiff rotator cuff, arm soreness-8-12 hours duration, feeling better today after seeing dr.
My arm was so sore that I could not move it.  I took two (2) Extra Strength Tylenol.  On 5/23/15, I developed a fever of 100.6 which is unusual because I never develop a fever.  It is now 7/20/15--almost two months later--and my arm is still sore and I cannot raise it towards my back or criss-cross my arms to remove a shirt.  I have to use my right arm to lift my sore left arm.
Rash on arm that was hot, sore, itchy. Started very small and spread over the course of 3 days. Eventually was my entire upper arm. I took benedryl 2 tablets and 800mg ibprofeun.
Intractable Pain at L Hip 48 hours after injection given pain meds and Hospitalized for 5 days.
Skin Outbreak on back and chest where my mom had heart surgery. The outbreak looks like a cluster of pimples.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, redness and soreness at injection site Narrative:
Very Bad Migraine After Second Dose; Not Able to Sleep After Second Dose; Tender Skin on her Thighs and Right Arm After Second Dose; Out of Breath when Climbing Stairs After Second Dose; Hurting Neck and Shoulders After Second Dose; Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose; Chills on and off (Hot and Cold) After Second Dose; Joint Pain After Second Dose; Fatigue After Second Dose; Nauseous After Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose) and NECK PAIN (Hurting Neck and Shoulders After Second Dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Osteoarthritis.   On 31-Mar-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) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose), ARTHRALGIA (Joint Pain After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of UNK dosage form. On 03-Apr-2021, MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose) had resolved. At the time of the report, TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose) and ARTHRALGIA (Joint Pain After Second Dose) had not resolved.            No concomitants provided   This case was linked to US-MODERNATX, INC.-MOD-2021-069576 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069576:CROSS LINKED WITH DOSE 1
STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke  was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
approx 20 hrs after Menactra vaccine pt. developed fever up to 102 deg with severe muscle aches, pain, symptoms resolved within 12 hrs with Benadryl and Motrin
Swelling of throat - heaviness of chest - severe headache, chills, muscle aches, weakness. Took 2 BENADRYL, ADVI, bed rest for 2 days.
Pt recvd vax & w/in 6 to 8 hrs of vax devel stiff painful neck, elevated temp of 102, or 103, & generalized muscle aches which began w/in 24 hrs of vax; No further details were provided;
Patient received 3rd dose HPV with no prior reactions but today had significant erythematous macular patch extending down posterior aspect of upper arm within minutes of receiving injection. BENADRYL 25 mg po given prior to departure from clinic.
pt said she woke up at night and couldn't even walk. She had to hang on to the wall to get to the bathroom. And she was tired for 2 days. She called her dr (we don't have any dr on file except our protocol dr) the office never returned her call. She just called us 11-2-20 to report this incident.
WEIRD BUT NON SERIOUS COVID-19 VACCINE SIDE EFFECT; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced weird but non serious covid-19 vaccine side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird but non serious covid-19 vaccine side effect was not reported. This report was non-serious.
13 days after receiving the 1st dose of Moderna COVID vaccine my arm started itching at the injection site.  The next day my arm was very red and hot at the injection site.  Went to my primary care physician this morning and was given antibiotics.   I was the second person in my Dr office to have this exact same reaction. it measured 6x6..
DID NOT FEEL WELL; PERSISTENT LIGHT HEADACHE; BURNING LUNGS SENSATION (LUNGS FEELING LIKE THEY ARE ON A FIRE); This spontaneous report received from a patient concerned a 37 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a pretty healthy. Patient lift weights and also run a mile or two on a regular basis (usually a mile in less than 7:30 so at a very fast pace). 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 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced burning lungs sensation (lungs feeling like they are on a fire). On 18-AUG-2021, the patient experienced did not feel well. On 18-AUG-2021, the patient experienced persistent light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning lungs sensation (lungs feeling like they are on a fire), had not recovered from persistent light headache, and the outcome of did not feel well was not reported. This report was non-serious.
Since getting the shot I have had problems with getting an erection. The first week following the shot I got no erection whatsoever for 5 straight days. I thought it was just a side effect that would subside with time but it has persisted. I got an limp erection on the sixth day but only a limp one. I do not get my morning wood which I have had since I was about 12 or so. Please help
I have been experiencing entire body hives, triggered by certain foods, lotions, detergents that have never caused an allergic reaction in the past. By avoiding those items I no longer have entire body hives but I continue to get hives upon any contact with clothing, pressure, scratching or any kind of trauma to the skin. I manage with anti-histamines daily.
Pain in shoulder going down spine on left side.  Flu injection given in left arm. Felt hot and flushed and very irritable.  These symptoms lasted 4 days and then began to resolve.  Six days later still pain in arm.  This has not happened with flu shots before.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX, lot # N031002 with expiration date 03-NOV-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F (7.2°F) during 5 hours and 10 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA006003.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 06-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J005721, expiry date 29-AUG-2014 (also reported as 28-AUG-2014), 0.65 ml) subcutaneously. No adverse effect was reported. Additional information has been requested.
joint and muscle pain; Exhaustion; earlier and increased menstrual symptoms; earlier and increased menstrual symptoms; brain fog; shortness of breath on exertion; sleep disturbances; joint and muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 11Apr2021 12:00 (Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included wolff-parkinson-white syndrome (WPW), Atrioventricular nodal reentry tachycardia (AVNRT), anaemia, arrhythmia, psoriasis, Psoriatic arthritis, Ankylosis spondylitis, Premenstrual dysphoric disorder (PMDD), endometriosis, tinnitus, hip impingement, Raynaud's syndrome, Irritable bowel syndrome (IBS), depression, anxiety, celiac, unspecified seizure disorder and allergy to gluten. The patient received other medications within 2 weeks of vaccination. The patient previously received vancomycin, cardizem and experienced drug allergy. The patient experienced exhaustion, earlier and increased menstrual symptoms, brain fog, shortness of breath on exertion, sleep disturbances, joint and muscle pain on 13Apr2021 14:30. It started 2 days post vaccination, and has continues for 12 days, so far. It waxes and wanes. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
ARM SORNESS AND REDNESS AROUND INJECTION AREA, FOLLOWED BY FEVER, CHILLS, HEADACHE, MUSCLE AND JOINT PAIN ABOUT 6 HOURS AFTER RECIEVING VACCINATION. SYMPTOMS LASTED ABOUT 3 DAYS.
Pt developed rash @ site of injection The following Morning, swollen, red & itchy. Following day, spread To her axilla, across chest and neck, back and chin. very itchy. Did not go below breast. Looked like white blisters, neck had hives, Throat got TighT ++ itchy, Tx w Benadryl w + relief, most resolved after 11 days but still w some Tightness in ThroaT
VACCINE ADMINISTERED 11:15AM;  I RECEIVED NOTIFICATION AT 11:22AM THAT ALL MODERNA BIVALENT COVID19 VACCINE ADMINISTRATION WERE TO BE HALTED AND VACCINES TO BE DISCARDED.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (lot # L015280 with expired date 30-APR-2017, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the temperature excursion of the vaccine was 10.3 degrees Celsius for 30 minutes. No previous temperature excursion was found. No adverse effect was reported. This was one of several reports received from the same reporter. Additional information has been requested.
10 days after vaccine started with cough. Next day  fever and chills and headache.  Lasted 2 days and gone.  After 2nd vaccine on Feb 10th at,   6 days later fever, chills  and headache or 2 days and then gone.   Treatment was acetaminophen.    Pfizer in left arm.   Were these delayed reactions????
Employee received the flu vaccine at flu clinic being held for employees at the Medical Center by the Employee Health Team. She did report some localized itching at injection site last year after receiving the vaccine, so she was asked to stay and be observed by an RN after today's injection for at least 10 minutes. While under observation following  her vaccine on 11/8/17, employee reported some localized "itching" at the injection and arm feeling :heavy and weird" site within 10 minutes of getting injection. Area was inspected by Employee Health RN and found to be normal, with no redness or erythema noted. VS were taken by RN at that time and were as follows: 122/82, AP 80 and regular, RR 20. Pale color, hands clammy. Denied shortness of breath and was not diaphoretic. Benadryl 25 mg administered by RN per protocol, which did cease itching within 20 minutes, however, employee began to describe additional symptoms such as: being cold, pins and needle sensation in affected arm and feet bilaterally and numbness in mouth. She also began to describe c/o "tightness" in chest area at which time she was transported to ED at Medical Center for further evaluation and treatment.
Within 5 min. of receiving vaccine pt standing to leave clinic, felt blurred vision, pallor, nausea. Pt brought back to room, lay down took V.S. pt rested, drank fluids, ate 2 pieces pizza while monitoring BP & pulse. Once color & VS back to normal. Pt d/c & home approx 1hr after incident.
CRAMPING MUSCLE PAIN AT THE UPPER ABDOMINAL PART OF THE BODY; UPPER ABDOMINAL MUSCLES TIGHTENING UP; UNUSUAL SENSATION; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy and had no heart related issues or medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the patient experienced cramping muscle pain at the upper abdominal part of the body. On 27-MAR-2021, the patient experienced upper abdominal muscles tightening up. On 27-MAR-2021, the patient experienced unusual sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramping muscle pain at the upper abdominal part of the body, upper abdominal muscles tightening up, and unusual sensation on 03-APR-2021. This report was non-serious.
While waiting ini observation area pt reported "not feeling well" was given water and asked to stay for aditonal amoutn of time.  SOrtly after she reported "feeling like i am goinog to pass out" .  Lightheaded dizzy, no other physical complaints.  Pt is cool, lips pale.
Pt received Anthrax & Typhoid vaccines on Thursday. On the following Sunday, small red spots appeared on upper back. On Monday spots turned into acne-like whitehead pimples. Headache started on Monday.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 26-NOV-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
After patient received vaccines, the patient passed out on exam table and came to shortly. No O2 required. Patient recovered shortly after episode and went home.
About 6 days after receiving the vaccine, I developed a sore throat. Then, I developed a chest cold, and then it went into my sinuses. I was not prescribed medications for this. I am still dealing with upper respiratory issues at this time.
? intussusception. Pt presented with bloody stool, vomiting. Sx within 2 weeks of getting 1st ROTARIX.
huge pockets of fluid under his eyes, I inch long by 1/2 inch deep; mild swelling below his eyes; "feel whoozy"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wheezing in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-SEP-2023, the patient received the 1st dose of Arexvy (right arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced wheezing (Verbatim: "feel whoozy"). On 16-SEP-2023, the patient experienced eye swelling (Verbatim: mild swelling below his eyes). On 18-SEP-2023, the patient experienced bags under eyes (Verbatim: huge pockets of fluid under his eyes, I inch long by 1/2 inch deep).  The outcome of the wheezing, eye swelling and bags under eyes were not resolved.   It was unknown if the reporter considered the wheezing, eye swelling and bags under eyes to be related to Arexvy.     It was unknown if the company considered the wheezing, eye swelling and bags under eyes to be related to Arexvy.   Additional Information: GSK Receipt date: 18-SEP-2023 A pharmacist reported that a patient received Arexvy vaccine on 15 September 2023.  He woke up on Saturday and Sunday (16Sep2023 and 17Sep2023) with some mild swelling below his eyes, but today 18Sep2023, the patient has huge pockets of fluid under his eyes, 1 inch long by 1/2 inch deep.  The patient came back today and showed RPH that he had large swelling pockets under both eyes and states he feels whoozy. The reporter did not consent to follow up.
After about 15 minutes the subject asked to use a pulse oximeter, reading normal. Then said it was like looking in a tunnel. We asked him to sit an d applied an ice pack to the back of the neck. At the time this provider did not know the patient had a seizure disorder. He slid to the floor with full tonic clonic involvement. His head and neck were protected. 911 was called and an ambulance. After about 3 minutes the subject regained consciousness.  He did not wish to be checked out at the hospital. He signed a release and his mother picked him up
I am feeling nauseous; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose and had no reaction.).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and after two hours felt nauseous. Not sure if just a coincidence.