chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an investigator concerning a 12-month-old male who entered study. On 04-SEP-2007 the patient was vaccinated subsequently in the left arm with a first dose of 0.5 ml of ProQuad (Oka/Merck upgrade process) (lot3 656445/1482F). Suspect vaccination included a second intramuscular injection in the right thigh of Menactra (lot# U21722AA). On 22-SEP-2007 the patient developed a fever "but was acting fine" and his parents treated with acetaminophen (TYLENOL). On 23-Sep-2007, the patient developed a rectal temperature of 104.9 degrees Fahrenheit, and experienced a grand-mal seizure lasting "a few minutes". He was noted to be post-focal for five minutes following the seizure. The seizure was reported by his mother, who is a pediatrician. His parents treated with fever with acetaminophen (TYLENOL) and a sponge bath, and the fever resolved the following day. No additional seizures were noted. Per the investigator, the patient had no history of febrile seizures. He recovered and continued in the trial. According to the investigator, the event was not related to Menactra. The reporting investigator felt that febrile seizure was related to ProQuad (Oka/Merck upgrade process). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.
For the first 3 to 4 weeks my arm hurt so bad I couldn?t sleep at night. It?s been eight months since my last shot and it feels as though there?s damage to the muscle in my shoulder at the exact spot of injections.
Patient has given Pneumovax 23 Vaccine on 08/17/2021 and given again on 11/26/2022. the pneumovax 23 vaccine was given 15 month apart.  No adverse event reported .
Urticaria beginning on palmar side of hands bilaterally on morning of 12/20/2021, which gradually progressed to full body (including face and scalp) urticaria by 12/22/2021 and has not yet fully resolved. Erythema multiforme on palmar sides of hands bilateral developed 12/21/2021 and has not yet fully resolved. Low grade fever ranging from 99.7 degrees to 100.8 degrees began on 12/22/2021 and persisted until 12/27/2021. Facial swelling beginning 12/24/2021 and resolved 12/26/2021. Over-the-counter topical hydrocortisone cream was applied as needed starting 12/20/2021. Over-the-counter anti-histamines were taken twice a day starting 12/21/2021 (loratadine 10mg was taken qAM and fexofenadine HCl 180mg was taken qPM from 12/21/2021 through 12/23/2021, and then on 12/24/2021, switched to cetirizine HCl 10mg bid). Oral prednisone was initiated on 12/23/2021, with dosing of 40mg x 3 days, 30mg x 3 days, and then 20mg x 3 days. Intramuscular injection of diphenhydramine (dose unknown) was given 12/23/2021. Topical triamcinolone acetonide cream was applied as needed beginning 12/22/2021.
face, neck, ear, chest, and shoulder turned red.; Skin Rash; Rash areasfelt hot; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 23Mar2021 at 12:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos, Sjogrens syndrome (Sjogrens), systemic lupus erythematosus (Lupus), and polymorphous disorder. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to morphine, prednisone and some antibiotics(unspecified). Concomitant medications included levothyroxine (25mg) (MANUFACTURER UNKNOWN), sertraline (25mg) (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient also received ADVIL 2 days before the vaccination on 21Mar2021. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 12:45, within a couple of minutes of vaccination patients face, neck, ear, chest, and shoulder turned red. The patient developed rash in some areas and also felt hot in those areas. It was reported that this lasted an hour at that severity and when it started to improve, patient left home. The areas were red but not as bright and they didnt feel as hot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events skin red and rash was not recovered; while that of the event hot feeling was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Appoximately 3 days after first dose, noticed heart arrhythmia, especially upon first waking in morning and moving into vertical position, during yoga when body goes from horizontal to vertical positions.  Cannot walk up a flight of stairs or exercise without my heart going out of rhythm.  Episodes last about 20 minutes.  My blood pressure machine picked up the arrhythmia.  When I went to urgent care to see if it was safe to take second dose, Doctor performed EKG which was normal, but referred me to a cardiologist, and said I should take my second dose.  I am still having daily arrhythmia's.   Side effect two.  Sharp shooting pains up my neck into my head, subsides after a few seconds, but is very painful when happening.  Started a week after 1st dose and has not subsided. Happens up to 30 times a day.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 04-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and it continued for 2 weeks (explicitly coded as incorrect product storage). On 05-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature for an unknown indication (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
chest pains; loss of breathe; dizziness; light headed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 16:45 (Lot number: FD8448) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Had a heart murmur for a brief period while an infant" (unspecified if ongoing), notes: Had a heart murmur for a brief period, while an infant. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Product: COVID 19, Brand: Pfizer , Lot number: Fa7984, administration time: 04:00 PM, Vaccine location: Left arm), administration date: 01Aug2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "chest pains"; DYSPNOEA (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "loss of breathe"; DIZZINESS (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "dizziness"; DIZZINESS (non-serious) with onset 23Aug2021 15:00, outcome "unknown", described as "light headed". The events "chest pains", "loss of breathe", "dizziness" and "light headed" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, dyspnoea, dizziness, dizziness.  Additional information: The patient had not received other vaccine in 4 weeks and other medications in 2 weeks. The patient was not covid prior vaccination, was the patient was not covid tested post vaccination and no allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a nurse and concerns of an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was stated that on unspecified date, an improperly stored dose of PROQUAD (Merck) lot # L034932, expiry date 03-MAR-2017, (dose and route were not reported) were given to the unspecified number of patients. It was reported that the vaccine was at 6 Fahrenheit of temperature and its time frame was 4 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Immunizing technician did not mix the Pediatric Pfizer (PEDS) vaccine vial and administered undiluted vaccine to the patient. Patient's mother was contacted when pharmacy found the event, and was informed the possible side effects/risks. Patient has no adverse reaction.
Approximately 20 minutes after receiving the vaccinations, patient reported urticaria on her thighs, bilateral.   Patient also reported feeling "tightness" in her throat.    Patient given Epipen in clinic at approximately 12:40pm and Benadryl 50mg PO.    After administration of EPIpen patient reported throat symptoms resolved.  Approximately 30minutes post Benadryl and Epipen Urticaria resolving.     Patient left clinic AMA.
On 01/10/2002, the infant received her first injections of Infanrix and Prevnar. Immediately, the infant developed hives on her face and she turned pale. The vaccinee was treated with diphenydramine (Benadryl) and observed for one hour in the physician's office. The event resolved.
PATIENT EXPERIENCING SORENESS AND REDNESS AND WARMTH DOWN LEFT ARM WHERE VACCINE ADMINISTERED. PATIENT INSTRUCTED TO TAKE TYLENOL FOR PAIN AND ICE IF NEEDED. PATIENT INSTRUCTED TO MONITOR ARM OVER NEXT 24-48 HOURS FOR INCREASING OF SYMPTOMS. IF THESE CONTINUE, FOLLOW UP WITH PRIMARY PHYSICIAN.
My symptoms start the same day 6/28/2021, I started running a high fever, later that night I felt like I couldn't breath. My chest felt tight and hurting. I slept for 3 days, I couldn't do anything, I was weak, vomiting, diarrhea and nauseated. I couldn't keep anything down. Three weeks later I started having back problems, my legs hurting and I couldn't walk. And now I can't lift my arms up over my head. That hurt really back and goes into my fingers. I can't even comb my hair, because of the pain. I been off work for about a month and a half. I can't work a full week. My muscles hurt just that bad. My Doctor set me up an appointment for a Bone Destiny Scan.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # N002202, N006321, M031574, N009802, M023892 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB.     ; Sender's Comments:  US-009507513-1708USA007447: US-009507513-1708USA002081:
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received ENGERIX B (batch number995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patient got ENGERIX B which was not stable. No AE reported.
Inflamed and hard rash at injection site developed the day after injection and subsided after one to two days.  Left arm was also sore at injection site starting the day of the injection and during the time of the hard rash.  Later, on the morning of the seventh day after injection, an inflamed and itchy rash developed at the injection site.  Rash is also warm to touch.
Eye was being irritated to blink or rub it; Is still able to see, but is very blurry; Felt like someone was scratching her eye with sandpaper; It woke her out of her sleep; Eye swelled up; White of her eye was red as if she had pink eye; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, sinus drain through her nose and eyes will dry out (no, allergies and sinus drain through her nose and her eyes will dry out. Dr. said that was not the cause.). There was no corneal abrasion. She has no pink eye. It was very irritated and swollen.  Historical vaccine included BNT162B2 for COVID-19 immunisation (Received both doses in her right arm).  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 28Jan2021, 1 Day after vaccination the patient experienced eye swelled up and white of her eye was red as if she had pink eye. On an unspecified the patient experienced eye was being irritated to blink or rub it and was still able to see, but was very blurry, felt like someone was scratching her eye with sandpaper, it woke her out of her sleep. Only blurry when the light would hit it. She put hot towels on it. White of her eye was almost puffing out and white of her eye was red as if she had pink eye. On an unknown date, the patient underwent lab tests and procedures which included eye pressure (eye pressure was checked and was good) and eye stain with unknown results (eye stain to make sure it wasn't scratched). The patient went to eye doctor on Tuesday. Eye pressure was checked and was good. The patient took Prednisolone Acetate 1% (NDC: 60758-119-05, Lot: 91118PY, E89581 and Exp: May2023), one drop 4 times a day for ten and left eye. The patient had to get a steroid eye drop from the doctor on Tuesday. The outcome of events was unknown.  No follow-up attempts possible. No further information expected.
Patient reported back with adverse reactions due to second Shingirx vaccine. Patient reports to have had raised swelling and redness at site of injection for two days after immunization was given, headaches for two days, and left-sided tingles leading to her toes for two days. Patient is feeling normal now and did not use any treatments to alleviate symptoms.
fatigue; headache; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. An unknown age female patient received 1st dose of BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. She received Pfizer COVID vaccine 1st shot she experienced some fatigue and headache for 24 hours. She does take an immunosuppressant agent. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different event and drug dose
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. Message has been left for patient to call the clinic in regards to the potential error. Patient has not returned call as of this time.
Shingles on my right back and leg. Diagnosed by doctor that it was shingles.
Fever 104.5, erythematous rash,  and mucus membrane involvement & sloughing of skin in genital region, irritable, throat inflam, diarrhea, some cough;
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. Since 01-MAR-2017, the patients were vaccinated with VARIVAX (which had the lot # of M039317, M039318 and M041079, the vaccines and sterile diluent expiration dates were unknown) (dosage information and route of vaccination were not informed) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014463.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # was reported as J004271, Exp date 12-JUL-2013) (dose unknown) subcutaneous. On 05-NOV-2013, the patient received improperly stored ZOSTAVAX which exposed to refrigeration for 2 weeks. No known adverse effects. Additional information has been requested.
5 days p/vax on 23NOV92 pt became unresponsive, stopped breathing @ home; became half-way responsive @ home, min later; pt now having staring spells & isotropia;
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The pharmacist stated that doses of PROQUAD lot# reported as N00291 with an expiration date 24-JUL-2018 were placed in the refrigerator in error because they were mistaken for M-M-R II. No doses of the improperly-stored PROQUAD have been administered to patients. No additional information was provided. Additional information has been requested.
these hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date and experienced hurt refer case US2021AMR175049).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the 2nd shot last week from the date of reporting.  The patient could take shots very easy but these hurt.  The patient said he/she would rather have the shots than the Shingles for sure. No contact details were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175049:Same reporter
Head was throbbing, arm was very painful, developed large lump in arm (about 2inches by 3 inches), fever at injection site, rash at injection site (about 4 inches in diameter). It has been 15 days now since shot. Only symptom left is slight soreness. I have a photo of what my arm looked like... but I don't see a way to attach it to this comment. I would have gone to the doctor afterwards, but I do not have insurance, I only work part time, my husband is on disability for cancer, and I couldn't afford to go to the doctor.
Coughing, Chills, Fever, Sore Throat, Body Ache, Fatigue/Tiredness, and A lot of Sleeping.  These symptoms lasted for 9 days.
A wheal reaction with a hard nodule approximately 1.5 inches in diameter at the site of injection.
[Pt] called for a nurse via phone at 11:40 6/1/04. He c/o hyperemesis and diarrhea the day of 5/31/04 and night/morning of 6/1/04. Enc'd BRAT diet and to see MD/ER if needed. No further rabies vaccinations.
large knot-like swelling & redness @ site of inject diameter of a quarter @ first but gradually subsiding over a wk; irritability/fussiness & sleep disturbance lasting 2 days;
FEVER, COUGH, RASH ON ARMS AND LEGS, JOINT PAIN, MUSCLE PAIN,  CHILLS,  LETHARGY
11:30PM - Chills late that night and up for an hour for them - went to go to bed with a lot of clothes and lots of blankets but I fell asleep. Morning they were gone. Slightly after that, I had some fatigue but nothing major. I was pretty normal. Then I noticed a few weeks later some swelling under my arms - lymph nodes swollen. I was very aware that they were touching. That seemed to last for a couple of months. I have just become aware the last few weeks that those symptoms with the swollen lymph nodes are gone. About 6 weeks to two months ago - I have been getting pounding heart and a bit of difficulty breathing. May be related stress. It comes and goes and then about a month ago I started a stress reduction supplement protocol and started doing meditation but they were still there and so I went to the doctor. She did an EKG  and general physical and she didn't find anything that showed up abnormal with heart. The  heart pounding and the breathing issues I'm still noticing.
Patient discharged after (3) days inpatient admission. Patient has documentation of home care following discharge. Patient is a 73 y.o. female with past medical history of Type 2 DM, HFpEF, OSA, hypertension, hyperlipidemia, DVT 2009 associated with leg fracture, CAD s/p lower extremity stenting 2015/2016, and COPD with ongoing tobacco abuse (55 pack year smoking history) who presented to outside hospital due to respiratory distress and hypoxia. The patient presented to outside hospital due to respiratory distress and hypoxia.   She was admitted for acute hypoxic and hypercapnic respiratory failure due to COPD exacerbation and CHF exacerbation. She was treated with BiPAP, IV steroids and IV diuresis and subsequently exhibited clinical improvement.   During her hospitalization, she was found to be Covid positive. She received treatment with dexamethasone. She was discharged to home with her niece.On the day of discharge, the patient felt well and she had no complaints. She had been tolerating PO intake and has been ambulating in her room. She felt well enough to be discharged. Any questions were answered in a satisfactory manner.
Side effects show up 10 to 14 days after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination). At the time of the report, VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination) outcome was unknown.        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.