chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Between July 2014 and August 2014, the unspecified number of patients were vaccinated with doses of  (Merck) VARIVAX (dose and frequency not reported, J003706 expiration date 27-MAR-2015) that were improperly stored. The nurse reported that, there had been no reports of adverse events following the vaccination administration. The nurse also reported that the vaccines were administered to a population of pediatric patients "going into the seventh grade". Action taken on (Merck) VARIVAX was not reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to Case# 1411USA007487 as same reporter link. Additional information has been requested.
This spontaneous report as received from a patient's mother refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (also reported as unspecified vaccine) (dose, dose no., lot no. unknown). No concomitant medication was reported. On an unknown date the patient experienced unspecified adverse reaction. The outcome of unspecified adverse reaction was unknown. The causality of unspecified adverse reaction was not reported. Product quality complaint was not reported. Additional information has been requested.
Fever 100.8 Fainting upon standing 5:30am: stood slowly, took a few steps and began to have loud ringing in ears, sweating, nausea, then vision went black but was able to guide myself to the floor before becoming unconscious.  Moderate pain at injection site Headache Weakness, fatigue, malaise
SHARP PAIN AND PRESSURE ON LEFT SIDE OF FACE; HEADACHE TO LEFT SIDE OF FACE; FEVER; CHILLS; BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had no known drug allergy and no history of illicit drug use/abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced sharp pain and pressure on left side of face. On 09-APR-2021, the subject experienced headache to left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on APR-2021, and had not recovered from sharp pain and pressure on left side of face, and headache to left side of face. This report was non-serious.
Chronic testicular pain, alternating sides. Bloodwork ideal, no STDs, hormone panel normal, no inflammation, no cancer. Minor chest pains/palpitations. Onset three weeks after injection.
itchy face; swollen eyes; swollen face; itchy face around eyes; swollen neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A31A and 023M207A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-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 29-Apr-2021, the patient experienced PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck). At the time of the report, PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck) outcome was unknown.            No Relevant concomitant medications was reported. Treatment information included anti itch cream hydrocortisone over the counter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. .
It started with fatigue, nasal congestion, fever for a couple of days of 101, and very mild sore throat for a couple days. I took an at home test and tested positive. The fatigue lasted for a couple of weeks. I also loss my sense of smell. I talked to my doctor and I decided not to take PAXLOVID.
My doctor administered the shot and that evening I begun with severe arm pain, soreness and discomfort. Included in this was the inability to have full range of movement in my shoulder. The pain woke me up at night. The soreness and lack of movement kept me from being able to workout. The constant pain lasted up until December. Thought I do not have constant pain anymore, I still do not have full range of motion in my shoulder and when I do try to move it fully, I feel pain, soreness and stiffness. This has definitely been a burden as I can not resume normal workout activities.
body aches; headache; pain at the injection site; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-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 04-Feb-2021, the patient experienced PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). At the time of the report, PAIN (body aches), HEADACHE (headache), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Moderna Vaccine:  Arm that patient received both shots in, is still feeling weak, patient hasd last shot 08/31/2021
Fever; Tiredness; Body pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced fever, tiredness and body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, tiredness and body pain was resolving at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Dystonia, neck pain, speech disturbance, nystagmus - pt. was prescribed Keppra, but did not work.
After 15 month immunizations, pt lost eating, stop playing with brother, scream if you tried to take him in stores. Just went into his own little world. Diagnosed autistic by developmental ped.
Second Covid infection detetected 17Jun in pos. test.; Second Covid infection detetected 17Jun in pos. test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 18:00 as dose 1, single (Lot number: EL9264), on 25Feb2021 at 18:00 as dose 2, single (Lot number: EN6203), on 26Sep2021 at 14:00 as dose 3 (booster), single (Lot number: EW0187) and on 13Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 08Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jun2022, outcome "recovered" (23Jun2022) and all described as "Second Covid infection detetected 17Jun in pos. test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive; (13Jun2022) Negative; (17Jun2022) Positive; (23Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as the COVID infection detected on 08Jun2022 - positive. She was treated with Paxlovid. The patient tested clear negative on 13Jun2022. The patient had second COVID infection rebound, detected on 17Jun2022 positive test. No treatment. The patient was cleared 23Jun2022, negative test with continued low-grade fever.
Pt became diaphoretic, tachycardic, nauseous 10 minutes after vaccination; juice given; symptoms resolved
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the 2nd 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 not reported), via an unspecified route of administration on Jan2021 (reported as either 06Jan2021 or 07Jan2021) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This past weekend (Jan2021), the reporter, along with one other person in her office, tested positive for COVID-19 and wanted to know if they should still get their second dose or what do they recommend for that. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID-19) with BNT162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2021050758 Same reporter, same AE, same drug, different patient
I had headache - it was more than a day later. I woke up at about 03:00 in morning but when I woke up again, I was fine and could go to work. Got a rash on 4/17/2021 - It was hideous. Middle of bottom lip - circle right underneath in the middle - it felt like hives coming out - tingly. And then on the right upper thigh - dark, red circle. I have pictures of them. It started to clear up. It happened again on 5/31/2021 - the two spots happened on the exact same place and then also two on my right boob and two on my left boob and two on my shins (one on each shin) - the shin ones were very light. I have pictures of these of my thigh and face. On May 31st,  I had just taken Fluconazole - because I felt I was getting a yeast infection. But I don't remember taking that medication before I got that first rash on 4/17/2021. Dr (dermatologist)  doesn't think it's a reaction to the Fluconazole. The doctor said we don't know if it's from something being dormant in my body and the vaccine unleashed it. I still have the rash from the 31st - but not on my face it's on my thigh and my boobs. My right boob - where they were most dark Face on is totally gone. Doctor gave me some kind of ointment to put on the round things - Clovaxol  - topical cream - not sure about the name of it. And gave me another 5-7 days of Fluconazole and I did take it but it didn't give me a reaction this time with any new rashe/circles (rash).
No adverse effects reported.; On 30-JUL-2019 one patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.   On 30-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S004091, expiration date; 11-FEB-2021, route, dose and anatomical location were not reported) for prophylaxis. The sterile diluent (lot # N021583, expiration date; 18-NOV-2019) used to reconstitute the vaccine a was properly stored. The temperature excursion was for a time frame of 12 hours, from 15 to 46 degrees Fahrenheit and it was found by the digital data logger. There was no previous temperature excursion. No adverse effects were reported.
Itching, sore throat, shot site swollen and warm to touch pain when moving arm. Given a sling and pain medication told to apply warm compress.
No adverse event; Then another bivalent booster dose was administered on 8Apr2023; Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose), EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. ASKU and 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose). On 08-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose), EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose) and EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023).    No concomitant medications were reported.  The patient received 1st dose of Moderna vaccine on 23-Aug-2021 (lot no. 023D).  No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 02:00 as dose 2, single (Lot number: FR8737) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. She did not had known allergies.   The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid anti-viral as Covid-19 Treatment.  No follow-up attempts are possible. No further information is expected.
Pain in left arm (internal pain) affecting muscle down to elbow went from 10-16-14 to 11-03-14.
Presented with SOB, cough, weakness; + Covid in ED; Admit 9/13 to medical with Covid PNA; tx with : 9/13 Zinc, Vit C, Baricitnib, Rocephin, steroids, lovenox, singulair started 9/14 Zithromax started  9/15 remdesivir  started; O2 Requirements: 4 LPM at admit; 9/14 10 LPM NRB; 9/15 15 LPM NRB; 9/16 Airvo 60L/95%; 9/18 back to 15 LPM NRB; 9/22 6 LPM; 9/23 4 LPM; back to RA with rest adn 2 LPM with ambulation at time of d/c
Patient states 2 hours after the injection she developed Body pain, shaking, headache, nasal congestion and cough that lasted for 2 days.  While speaking to pt still have cough
5/11 itchy lower legs progressing to include upper leg with rash by evening. 5/12/12 itchy forearms followed by visual rash, rash on legs remained. Diphenhydramine 25 mg taken 7pm. 5/13/12 rash on neck chin and ear lobes diphenhydramine 50mg 11:30A, 3:30P, 9:30P. 5/14 rash remains on legs and arms but appears to be resolving. Itchiness on face and earlobes. Hydrocortisone 0.5% applied to legs, neck, face.
vaccine was administered outside of storage recommendations. patient returned on 6/7/21 to re-vaccinate
Febrile in the evening of 9/14, 9/15 am crying, mother picked up and pt hot, fever reducer given, pt rolled eyes back, stiffened head and neck and body "twitching", episode lasting 15 to 20 min?, pt seen in office that am.
When I received my Johnson & Johnson vaccination, it hurt incredibly. By the time I got to my office, my left arm deltoid, was swelling and hurt. The pain continued for days after, radiating to my bicep and left hand. The medical facility did a cat scan and and MRI, before sending me to an orthopedic specialist.
Patient's blood sugars have always been well controlled with an a1c about 7%. After receiving the 2nd covid vaccine, the patient experienced sustained high blood sugars (300's-500's) for about 5 months reaching an A1c of 10.9%.  Patient needed additional meds such as glimepiride and insulin therapy for several months in order to control blood sugars.  After about 5 months, patient's blood sugars began to normalize and she has tapered off insulin therapy slowly.
24-27hr p/vax pt began to run a fever of 102 & exp chills;area around inj site of lt arm became inflamed 4 1/2" x 3" area;warm to touch & tender;pt denies exp hives or dyspnea;pt states swelling & tenderness has since gone;
My daughter started to become very lethargic, very tired, and started to spike a fever. It proceeded to get much worse, with little or no relief from Children's Tylenol. She was hallucinating, crying out, shaking, and stated her tongue was itchy and couldn't stop moving her mouth at one point. The fever reached 103.8 and I considered taking her to the emergency room, but kept trying fluids, cold compresses, and Tylenol throughout the night Saturday and into the early hours of Sunday the 16th.
7/6/21 4:43PM PATIENT PHONED CLINIC  STATING SHE RECEIVED VACCINES THIS MORNING. PATIENT HAVING FOLLOWING SYMPTOMS: EYES SWOLLEN AND FACE BREAKING OUTIN RASH AND STARTED A LITTLE WHILE AGO. ENCOURAGED PATIENT TO GO TO THE ER BECAUSE OF SWELLING OF EYES COULD CAUSE BREATHING PROBLEMS IF SWELLING PERSISTS. PT VERBALIZED UNDERSTANDING.  7/7/21 10:25AM PHONED PATINET TO F/U ON SYMPTOMS AND PT STATED SYMPTOMS OF SWOLLEN EYES AND RASH CLEARED UP WITHIN 30 MIN OF REPORTING SYMPTOMS YETERDAY. PATIENT REPORTS SORENESS TO SITE OF INJECTION. DR. UPDATED ON PATIENT STATUS.
After the the first dose of the vaccine they developed Covid; received first dose of the vaccine dose 12 weeks ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (After the the first dose of the vaccine they developed Covid) and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After the the first dose of the vaccine they developed Covid) and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago). At the time of the report, COVID-19 (After the the first dose of the vaccine they developed Covid) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
This spontaneous report was received from a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses LIQUID PEDVAXHIB (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Sore swollen lymph node in left armpit. Swelling, burning, itching at injection site. Symptoms lasted approximately 6 days from onset
Pain in left eye, lasting from March 10, 2021 - March 25, 2021.  My neighbor had the exact same reaction, plus headaches
fever @ 103 x 2days w/o sequellae-well today 4APR97;
Found dead in restroom about four hours after administration of vaccine. Patient has been rapidly declining w/ Metastatic lung CA.
Flu vaccine 10-1-12. Four days later had rash on both thighs a& itchy scalp. Along with facial pruritus/erythema. Tx: OTC antihistamines.
pt recv vax 22SEP97 & the following day pt exp a local rxn (3.5 inches size) consisting of swelling, redness, heat & induration;no fever;pt could hardly move arm;
Patient says tat ringing started in both ears three to four days after the vaccination. He says the ringing started very loud and has decreased over time but is still ringing.
On 5/6/2021, developed chills, body aches, headache, loss of taste/smell, congestion and sore throat. Tested positive for COVID-19 despite history of 2 vaccine doses.