chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Body ache; mild fever; sore throat; joints hurt; headache; don't feel good; don't have energy; delayed second dose >42 days; This spontaneous case was reported by a patient and describes the occurrence of OFF LABEL USE (delayed second dose >42 days), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (don't feel good), ASTHENIA (don't have energy) and ARTHRALGIA (joints hurt) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Hypoglycemia and Fibromyalgia. Concomitant products included DULOXETINE, METHOCARBAMOL, AMITRIPTYLINE and GABAPENTIN for Fibromyalgia, VERAPAMIL for Hypoglycemia.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced OFF LABEL USE (delayed second dose >42 days). 01-Jun-2021, the patient experienced FEELING ABNORMAL (don't feel good) and ASTHENIA (don't have energy). On 02-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joints hurt), HEADACHE (headache) and PYREXIA (mild fever). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (Body ache). The patient was treated with PREDNISONE for Pneumonia, at a dose of 1 dosage form. At the time of the report, OFF LABEL USE (delayed second dose >42 days), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (don't feel good), ASTHENIA (don't have energy), ARTHRALGIA (joints hurt), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (mild fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The other concomitant medication provided was Epi pen, Glucagon shot, Rescue inhaler and Air duo Inhaler.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Non significant Follow appended for document attachment
Information has been received from the FDA from a physician concerning a 4 year old female with no preexisting conditions, or current illness, who on 23-FEB-2006 was vaccinated with MMR II (Lot # 649754/0378R). There was no concomitant medication. Within five to seven days after receiving the second dose of MMR II, the patient developed fever, lymphadenopathy and was diagnosed with Kawasaki's disease, and was hospitalized. An ER/doctor visit was noted. It was also noted that "21 days later", 16 MAR 2007, was the "onset date". The results of a rapid strep throat test performed, were negative. The WBC's were increased at 15.3. The patient was considered recovered at the time of reporting. The reported events were considered to be a life threatening illness. A lot check and batch review has been requested for Lot # 649754/0378R. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards and was released. Additional information is not expected.
Throat constriction, ears tingling and warm.  HR regular, color pink, no difficulty swallowing, no history of allergies to food or medications.  Monitored for 30 minutes with resolution of symptoms.  Instructed to go to the ER if symptoms worsen.
This spontaneous report as received from a registered nurse refers to a currently 20 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 11-AUG-2011 the patient was vaccinated with (Oka/Merck) VARIVAX first dose to prevent chickenpox (dose, route, anatomical location, lot number and expiration date were not reported). No concomitant therapies were reported. On an unknown date the patient experienced had negative titers after receiving the vaccine. The outcome of negative titers was unknown. The relatedness between the event and (Oka/Merck) VARIVAX was not reported. Additional information is not expected because the reporter refused additional contact.
PENTACEL adm in (L) thigh. Next AM, (lt) thigh hard & red. MOTRIN given. Few hrs later (L) thigh none except for hardness at site but (R) thigh & buttock: large hives.
patient showed symptoms of Covid/ felt exposure from a student; patient showed symptoms of Covid/ felt exposure from a student; This is a spontaneous report from a non-contactable consumer via a sales representative. This consumer reported similar events for two patients. This is the second of two reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date, via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history were unspecified. The patient's concomitant medications was not reported. The patient was vaccinated on Tuesday 26Jan2021 with no reaction. On Friday (29Jan2021), the patient showed symptoms of Covid. Patient felt exposure from a student. On Saturday night, the patient was administered with immunotherapy due to comorbid medical conditions. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112463 same reporter, product, events, different patients
pt recv vax 15OCT96 & OCT96 pt devel faint bumps on back & face two larger lesions on shoulder & exp a sl fever of 101.5;pt exposed to two children @ school who had or later devel chickenpox;
This case was received from a health professional on 03 June 2008.  A 36-year-old female patient was accidentally exposed to ACTHIB (lot number UE931AA, sanofi-pasteur SA lot number Z0578) via to eye.  On 03 June 2008, the patient was holding an infant during vaccine administration when the needle separated from the syringe and she was splashed in the eye (according to the reporter, it was not a pre-filled syringe).  Twenty minutes after exposure, the patient began complaining of eye itching, sore throat, facial tingling and itching, and runny nose.  No shortness of breath or breathing difficulties were noted.  The patient flushed her eyes with water; no other treatment was provided.  At the time of the report, the event was still ongoing.  Follow up information was received on 24 October 2008 from a health care professional.  The patient was splashed in the right eye.  The patient recovered from the event two hours later.  No other findings were reported.  List of Documents held by Sender:  None.
pt recv vax; pt had an apparent sz; was afebrile at that time; was taken to hosp;seen for follow-up neurological;
Information has been received from a licensed practical nurse who received information from the surgeon general's office concerning a male who in 1964 was vaccinated with measles virus vaccine live (Moraten).  Subsequently the patient had a "significant reaction".  Unspecified medical attention was sought.  No product quality complaint involved. Additional information has been requested.
fatigue; low platelet count down from 124K to 99K; bruise at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site bruising, fatigue and platelet count low. On an unknown date, the outcome of the injection site bruising, fatigue and platelet count low were unknown.   It was unknown if the reporter considered the injection site bruising, fatigue and platelet count low to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fatigue and bruise at injection site.  The bruise lasted for about 5 weeks.  The patient also has experienced low platelet count down from 124K to 99K.. The reporter did not consent to follow up. This case was linked with the US2020026929, reported for patient's husband.      Lab Comments: lab test performed om unknown date
TDAP Vaccine given in the Emergency Room post sharps injury by an Emergency Room staff. The patient reported on 8/20/18 to Employee Health / Occupational Clinic that she developed red, hard lump and significant pain approximately 3 days post injection. She was seen by Dr. No numbness, tingling, weakness or fever noted. Pain with lifting her left arm above shoulder level.
Pt presented 2 days after receiving ZOSTAVAX with blistered, red rash on lower left rash. Pt advised to cover rash and seek medical attention.
Received a 0.5mL dose of vaccine.  SE WNL for vaccine admin- 1 day fatigue. Arm sore. Received high dose flu in right arm at same time, which had more arm soreness than left.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, had that with the first 2 doses) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036A21A) for COVID-19 vaccination. The patient's past medical history included Surgery in November 2019 and Surgery ((right leg) product of a clot for the previous surgery.) in January 2020.Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Anticoagulant therapy.On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm, had that with the first 2 doses). At the time of the report, PAIN IN EXTREMITY (sore arm, had that with the first 2 doses) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No treatment details were reported. The patient mentioned she got a surgery on Nov2019 and in Jan2020 got a leg surgery in right leg product of a clot for the previous surgery. And, in September or October she experience the same pain in the inner thigh. This case was linked to MOD-2021-395873, MOD-2021-395892 (Patient Link).
given the pediatric dose for dose 1 of series even though she was 12 at the time
This spontaneous report as received from a nurse practitioner refers to a 7 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAX HIB lot #K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
L arm swollen from shoulder to elbow, itchy, hot to the touch, red and hard
Swelling, tenderness, red that appears to be spreading, and hot to the touch. Getting worse each day, advised to be checked by urgent care, use ice and Tylenol as well
Patient reported itch the night of the immunization which was relieved by Benadryl but reported anaphylaxis about 24 hours after immunization
As per patient report right after he received the vaccinations he felt discomfort in his chest area. He had trouble walking. And later on he had muscle spasms, weakness, fever. He went to see the doctor and he was given antibiotics which he came to pick up today 9/15/17.
facial swelling; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; redness in the eyes and around the injection site; redness in the eyes and around the injection site; body aches; rashes all over the body look like goose bumps; itchiness in the eyes and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain) and OCULAR HYPERAEMIA (redness in the eyes and around the injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site), VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches), RASH (rashes all over the body look like goose bumps) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site). At the time of the report, SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches) and RASH (rashes all over the body look like goose bumps) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-092039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092039:
Information has been received from a registered nurse concerning a 20 year old female who on 22-DEC-2006 was vaccinated with Gardasil (yeast) (lot number 653978/0955F). On 22-DEC-2006 the patient passed out after vaccination. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student with no reported allergies who, at 10:00AM on 22-DEC-2006, was vaccinated into the left deltoid with a first dose of GARDASIL (Lot# 653978/0955F).  There was no illness at the time of vaccination.  On 22-DEC-2006, after the vaccination, the patient felt faint and passed out for a short time.  The nurse reported that the patient was watched closely and felt fine after a while and then left the office, recovered the same day, 22-DEC-2006.  Additional information is not expected.
Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy; fell to the ground; and hit his face with some bruising; Witness notice he was shaking for a few seconds after the fall.; His skin felt fine warm when touch.; This is a spontaneous report received from a contactable Pharmacist. A 29-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162) dose 1, intramuscularly administered in Arm Left on 15Apr2021 at 12:15 (at the age of 29-year-old) as dose 1, single for covid-19 immunization. Patient medical history was reported as none and patient's concomitant medications were not reported. other medications in 2 weeks was unknown.  Patient was not covid positive before vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19 since the vaccination. On 15Apr2021 at 12:30 Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy and fell to the ground and hit his face with some bruising. Witness notice he was shaking for a few seconds after the fall. He recovered conscious quickly and breath normal and said he was fine. His skin felt fine warm when touch. Paramedics came really quick and measure his oxygen levels and left shortly as his vitals are fine. Relevant laboratory tests included oxygen levels; result was unknown on 15April2021.They instructed him to seek emergency room if any symptoms arise. No treatment was received for the events. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Approximately 3 hours after receipt of vaccine left deltoid, tricep muscle contracted and remained contracted for approximately 15 seconds, followed by intermittent severe muscle contractions for approximately 3 minutes. Left arm from elbow down dusky and purplish in color, with pulse oximetry reading of 89%. Rt upper extremity remained normal in color with pulse oximetry reading of 95%.
Moderna COVID-19 Vaccine EUA The evening of the day the vaccine was received I started feeling flushed, low grade fever, chills, sweats, severe headache, dizzy, nauseous and extreme fatigue. This continued for 3 days and on the 3rd day I developed a tickle cough that progressed. I?m now on day 6 and the extreme fatigue, cough, cold sweats and chills have continued consistently.
Information has been received from a physician concerning an approximately 85 year old female with no reported pertinent medical history, and an "allergy to penicillin years ago" who "sometime in February, March or April 2007", was vaccinated with 0.65ml of ZOSTAVAX. Concomitant therapy included LINSINOPRIL-HCTZ, NORVASC, baby aspirin and calcium (unspecified). "In the late part of August into September 2007" the patient developed shingles under her right breast and down towards the hip bone after receiving ZOSTAVAX. At the time of reporting the patient was recovering, and only had pink spots left from the rash. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostics studies performed. No further information is available.
approximately 5 minutes after receiving the vaccine the patient started complaining of wheezing and voice became raspy. We listened to her chest and it was clear and she was able to take a deep breath. Benadryl 25mg/10ml solution was given at 10ml dose. The patient remained on site and she started to feel better (she stated) and her voice started to return to normal. Before leaving we instructed her to immediately go to the ER if any additional symptoms presented and that I was going to follow up with her this afternoon to make sure she was not having any other issues.
hair loss/Hair Falling out like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss/Hair Falling out like crazy".  Additional information : The patient stated he had the Pfizer COVID bivalent booster vaccine for 12 years of age and older. His hair was falling out like crazy. He was wondering what information they had on that and declined to complete a report. Caller stated, The Pfizer booster shot was causing hair loss. And his hair had been falling out pretty fast. His beard. He used to shave it every other day. Now He can go a week and a half without shaving. He saw this on the news that it was causing hair loss. He was near bald now. he wasn't like that before. Caller stated he was calling about the Booster Shot for Covid 19 that he took. Caller stated his hair was falling out like crazy and he saw that was being reported with the Pfizer booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In AFIB 3 hours after receiving vaccine, sinus rhythm,  2 weeks later went back into AFIB, same thing another two weeks later. Blood clots in right leg
This spontaneous prospective pregnancy report as received from a Healthcare Worker refers to a 17 year old female patient. On 15-OCT-2013 the patient received a urine pregnancy test which was negative for pregnancy. After the test, the patient received vaccinated with GARDASIL (lot # J002641, intramuscular, exp 10-DEC-2013) that day. There was none concomitant medication and none medical history. The patient had none drug reactions. On an unspecified date "about 2 weeks later", the patient had another urine pregnancy test which was positive for pregnancy. The EDD was 18-JUN-2014. Initial exposure to GARDASIL was at 5 week(s). The pregnancy outcome was outcome pending. The patient went to see the nurse practitioner. No known adverse effects. Additional information has been requested.
For two days after my vaccine, I experienced only the normal discomfort at the site of injection. There was no redness and minimal swelling, and all symptoms had vanished completely after two days. However, one week after the injection date,  I experienced a renewal of discomfort at the site of injection, accompanied by swelling, redness, and itchiness. So far, these are my only symptoms. It has about 18 hours since these new symptoms appeared, and they seem to be improving slightly.
Received Kindergarten immunizations and about 24 hours later, noted redness and swelling with no pain or muscle stiffness/tenderness. Measured 4cmx4cm.
New Left Bundle Branch Block found on routine physical exam approximately 2.5 months following third vaccine dose. Patient (self) had been otherwise healthy except for a right total hip arthroplasty which was performed in November 2020. EKG conducted in October 2020 prior to surgery was unremarkable. Other than surgery in November 2020, there were no intervening events or issues. Recovery from surgery had been unremarkable, and patient has been fully functional and very active throughout the time following recovery from surgery.
27APR93 mom states pt irritable, crying; pt fell asleep for 20 mins-woke up & cried, screaming would not be consoled; t100; advised to call MD; mom spoke w/MD who felt rxn was to pertussis;