chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 minute post flu shot experienced dizziness, swollen throat, eyes swollen, anxious and difficulty breathing. 0.5 ml epinephrine administered and within 7 minutes symptoms resolved. Did not go to the hospital.
01/17/22 presents to Surgery for "right hemicolectomy". PMHx of "ILD (not on home O2), pulmonary HTN, OSA, and asthma"
pt recv vax 15DEC98 & c/o feeling like was going to blackout but could ambulate back to exam room;assisted on exam table 320P BP 110/60, P 60, resp 20, skin warm & moist & sweating;340PM cal no longer pallor;
pt recv vax 2JAN96 & on 7JAN96 pt exp dizziness;pt exp several short episodes of vertigo & blurred vision which occurred both while sitting & standing;there was only momentarily interrupted activity of daily living;
Area of injection was very sore about 6 hours after injection; Extreme tiredness about 11 hours after injection; Severe chills 13 hours after injection that lasted for three hours. No fever but took 2 Tylenol and went to sleep.
FOOT SURGERY; This spontaneous report received from a patient via other manufacturer concerned an elderly patient of an unspecified sex age and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose 40 mg/0.4 ml, citrate free, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced foot surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of foot surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220434284-COVID-19 VACCINE AD26.COV2.S-Foot surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Day 6 after shot broke out in terrible rash on back of hands and wrist, extremely itchy, day 9 after vaccine broke out on neck bilaterally and extremely itchy.  75% better now.
Took 4 shots and still got them/suspected vaccination failure; still got them bad; pain; Took 4 shots; Took 4 shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine, the 3rd dose of Shingles vaccine and the 4th dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, extra dose administered and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain, extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient took 4 shots, which led to extra dose administered. The patient still experienced shingles bad. The patient hate the pain. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
Information has been received from a physician concerning a 20 year old female patient who in July 2008, was vaccinated with her third dose of GARDASIL. In the same month, in July 2008, the patient was diagnosed with aplastic anemia. There was unspecified ongoing treatment for the patient. The patient sought treatment at the physician's office which was still currently ongoing to treat the anemia. Upon internal review, aplastic anemia was considered an other important medical event. No further information is available.
A report has been received from a Health Professional concerning a 4 year old, male subject, who has been receiving Nasal FLUMIST. FLUMIST was started on 02-Jan-2013. The reporter stated that they GAVE EXPIRED FLUMIST on 02-JAN-2013. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
covid vax 3/13 and 4/3/2021 new onset CHF Jun 2021
Patient complained of numbness of lower lip.  Nurse  and NP assessed patient, vital signs taken. NP suggested benadryl. Patient took 12.5mg po benadryl. Waiting for symptom to subside.
This spontaneous report was received from a registered nurse and refers to a 7 Months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020, intramuscularly (dose and frequency were not reported) for prophylaxis. The improperly stored vaccine was stored at a temperature of 0.6 Celsius degrees (C) (also reported as below 36 Fahrenheit degrees/2 C) for 53 hours. The call was made because of a data logger. There were no previous temperature excursions (it was also mentioned that there were multiple excursions (discrepant information). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of 2 reports received from the same reporter (MARRS # 1901USA003925). Sender's Comments: US-009507513-1901USA003925.
loss of appetite; severe headache; soreness; fever of 102; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), HEADACHE (severe headache), MYALGIA (soreness), PYREXIA (fever of 102) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), HEADACHE (severe headache), MYALGIA (soreness), PYREXIA (fever of 102) and ARTHRALGIA (joint pain). At the time of the report, DECREASED APPETITE (loss of appetite), HEADACHE (severe headache), MYALGIA (soreness), PYREXIA (fever of 102) and ARTHRALGIA (joint pain) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Information has been received from a physician concerning a 4 year old black female with eczema and no known drug allergies who on 9/17/99 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (lot # 630414/0302J). Concomitant vaccination therapy on 9/17/99 included a third dose of the oral polio virus vaccine (OPV)(lot #79906). Concomitant therapy included clotrimazole (unsuccessful treatment for tinea corpus), cefadroxil and fluconazole (secondary treatment for tinea, corpus, without success). On 12/30/02, while the patinet was noted to have tinea corpus, the physician noted herpetic lesions in a circular formation around the body tinea. It was noted that these lesions were not similar to typical chicken pox lesions and that they were painful but not pruritic. On 1/4/03 the vesicular lesions broke out in asynchronous fashion. These lesions were all over the patient except on the mucus membranes. The patient also presented with diffuse rash with erythematous, scaly areas and sloughening of the skin. Due to the atypical nature of this infection, the patient was hospitalized. The patient was diagnosed with chicken pox by the hospital pediatric infectious disease specialist. The patient also developed a secondary bacterial superinfection and developed a severe exacerbation of her eczema. The patient was hospitalized for 7 days and subsequently recovered. The reporter noted that chicken pox was disabling and also prolonged hospitalization. No further information is expected.
On 10/31/2022 patient was given Monovalent Pfizer vaccine Instead of Pfizer bivalent.
I developed strong muscle cramps starting at the vaccination site and traveling through the right side of my body, into my neck and jaw and down my back throughout the morning.  In the afternoon, beginning around 3:30 PM, I began to feel delirious and light headed.  I came home from work with chills and sweating and had a temperature of 100.6 F and no appetite.  I had a fever into the night and early the next morning, but my temperature dropped to a degree and a half below my normal temperature during the second day.  I felt relatively normal by 2/20/10.
Approximately 2 and 1/2 hours after vaccine administration this person began to feel a burning in the chest and developed a cough. Also felt burning in the throat and chest pain. Reported to the ED at 3:09 PM and was treated with Epinephrine 0.3mg IM; Benadryl 50 mg PO; Pepcid 20mg PO; and Decadron 10mg PO. Was discharged to home in stable condition at 5:14 PM with prescriptions for an Epi-Pen for injection prn; Claritin 10mg PO daily; and Tessalon Pearls 100 mg po - 1 to 2 capsules every 8 hours as needed.
Information has been received from a nurse practitioner concerning a 56 year old male with COPD (emphysema) and thyroid disease and no drug allergies who on 24-NOV-2006 (also reported as 21-NOV-2006) at 11:30 AM was vaccinated with a first dose of Pneumovax 23 (0.5 ml) (lot # 651148/0087F), intramuscularly in the left arm.  Concomitant therapy included SYNTHROID.  On 24-NOV-2006 the patient had "severe arm pain" within one hour of receiving Pneumovax 23 that persisted for 24 hours.  The patient stated that "pain was worse than past surgical pain."  There was no redness or swelling.  The patient took PERCOCET with no relief.  At the time of the report, the patient was considered to be not recovered.  Additional information has been requested.
Patient had received Pfizer vaccine on 06/15/2021.  Came in for 2nd dose of Pfizer on 7/6/2021 and was mistakenly given Moderna.  Disclosed to patient.
Had a significant  headache for about 10 days after taking the vaccine. It was sever enough that I could not do my work.   Note I had had tested positive with COVID 2 months prior to taking the vaccine.  I am concerned about taking the second doze. Not sure if I should take the second doze or not.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-JUL-2016, the patient was inadvertently vaccinated with PROQUAD lot # L030589 expiry date 10-FEB-2017 (dose, route and anatomical site of injection were not reported), and also with VARIVAX lot # L019126 expiry date 27-MAY-2017 (dose, route and anatomical site of injection were not reported); instead of receiving the intended VARIVAX and M-M-R II. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
later after getting the vaccine every joint started to ache and felt like she was coming down with a fever, she was hot and cold at the same time, she put on 6 layers of clothing and got under 2 blankets and was like that for 2wks. she had very bad  headaches also was having piercing pains spirataly in her head, fatigue
About 30 minutes after the shot in my left arm the left lower corner of my lip felt numb. The numbness moved into my left cheek.  I could still move my face and smile symmetrically.
Hospital was aware that patient received first and second COVID vaccines: 1. Moderna 01/19/21, 2. Moderna 02/16/21.  Hospital administered booster with Pfizer vaccine on 01/27/22. On 01/28/22 hospital learned that patient had already received COVID vaccine booster in a different state, (He received a Moderna booster: 12/08/21). No adverse reactions reported by patient, just vaccination duplication.
Sore arm day of injection.  No problem after.  Eighth day following injection experienced redness, hard lump in arm 2-3 in diameter around site of injection, warm to touch and itchy.
Minor headaches started about 10:15 AM and Left arm started hurting at the injection site at 12:40 PM.  I Felt tightness around the front of the face upper cheek bones nasal area and from face of head. That night I woke up about 3 AM with a sinus headache and sore left arm, Sunday evening around 9 o?clock my temperature climb to 99.0 I took a nap and when I woke up it had returned back to normal. Today 3/15/21 my left arm is now just tender
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CVID (Common Variable Immunodeficiency)" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; LEVOTHYROXINE; HIZENTRA. Past drug history included: Fentanyl, reaction(s): "Allergy", notes: Known allergies: Fentanyl. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: positive test after completing the entire Paxlovid course and 4 days of negative tests; Positive, notes: positive test after, completing the entire Paxlovid course and 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Shaking chills 2 nights post injection redness and slightly warm, mild swelling (L) arm around injection site. 4 inch x 4 inch in diameter.
A consumer report has been received. The report concerns a 4 year old, Male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient inadvertently administered expired FLUMIST QUADRIVALENT given on 21-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
It was reported that an adult female patient, date of birth unknown, received a Fluzone SV 2001-2002 vaccination, lot # U0705AA on 12/10/01 at the health department. For the past 3 weeks she has experienced severe pain and stiffness in the arm of injection from injection site to her hand. She is going to be evaluated by her doctor.
Fever (101.9 at highest) Body aches Allodynia- anything that touched my skin caused a painful/tingling sensation Nausea  Headache Fatigue
Reported per patient via message to clinic: "Sometime in June, I will undergo a left knee replacement. My blood tests showed a lower than normal hemoglobin level. I told (my PCP) that I had an unusual reaction to my second COVID (Pfizer) vaccine which was administered on Sunday, March 21.  I was pretty sick for two days and then for four weeks, every time I had a bowel movement, my hemorrhoid bled. During the first week, it was pretty bad, and gradually bleeding got less and less and as of three days ago, I am back to normal. In the past, I had problems with inflammation of external tissue that caused bleeding but it was nothing like this and I have not had a problem for the last few years. First, I got scared but then when I talked to a cousin who had the same problem following her second vaccination for COVID. I thought there might be a connection. "
On car ride home after receiving HPV9 vaccine,  patient reportedly started to wheeze "his-throat"  felt "funny"  Father is physician - when got home he  evaluated him, gave albuterol nebs, Benadryl & oral steroids
Patient reported to pharmacy on 12/15/16 that she had a swollen bicep that was warm to the touch and itchy. This was not at the injection site. This resolved itself in a couple of days from injection date.
Information has been received from a registered nurse concerning a 28-year-old female with no pertinent medical history or allergies who was vaccinated (as a child) with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (vaccination dates and lot numbers unknown). Subsequently, the patient had an equivocal rubella antibody titer. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Swelling, redness, pain (L) arm. Chills. Temp 101.8 on 9/28/07.
PATIENT REPORTS REDNESS AT AND AROUND INJECTION SITE, SWELLING AND HOT TO THE TOUCH
Called the patient and she states that she is feeling better. She is still weak, a little sleepy, not pain.  No headache or sinus pain at this moment.  No fevers.  She is still having some sinus drainage-clear.  No diarrhea.  She was out of commission for about 10 days.  She had the pneumonia shot about 20 years ago. Her blood pressure is stable.  She reports no other unusual symptoms.  No chest pain, no SOB.  She is not reporting any other unusual symptoms.  This all began 24 hours after the injection.  Please overbook pt. for an appointment with me next week.
Information has been received from a healthcare professional concerning a 62 year old female patient with no known allergies who on 10-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck). The patient was being treated for "staph infection" at the time of vaccination. Concomitant therapy included tetracycline. Subsequently, on 13-JUL-2008 the patient developed nausea, dizziness and fatigue after vaccine administration. The patient's throat was sore and swollen. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 25-MAR-2019, the patient was vaccinated with an expired dose of M-M-R II (lot # R013129, expiration date 03-FEB-2019; dose was unknown) subcutaneously for prophylaxis. No known adverse effects. The outcome of the events was unknown. No product quality complaint (PQC) presented.
lip swelling, urticaria to neck, diaphoresis, epigastric pain, dyspnea starting approximately 1 hour after receiving 1st dose of Pfizer vaccine (had received J&J previously), in ER found to have urticaria over face, torso extremities initially, then developed worsening angioedema, swelling of epiglottis, arytenoids, facial swelling requiring intubation and overnight stay in the MICU.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race, and ethnic origin. 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that after getting initial dose of Janssen covid 19 vaccine, on an unspecified date patient was diagnosed with covid (suspected covid-19 infection). Reportedly the symptoms were mild. On an unspecified date, the patient had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0 - 20211058684 covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from pharmacist referring to unspecified patient. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. The patient was inadvertently administered a dose of ZOSTAVAX (lot#/batch# reported as: M025699, expiration date: 16-DEC-2018) (strength, frequency, and route were not reported) on 27-DEC-2018, that was expired. No adverse effect reported.
Information has been received from a registered nurse concerning a 9 year old white male who on 16-NOV-1998 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 621060/1363D). There was no illness at the time of vaccination. On 06-FEB-2006, the patient developed acquired varicella signs and symptoms. The patient had an office visit only. No diagnostic laboratory tests were performed. The patient recovered on 20-FEB-2006. Additional information is not expected.
Patient reported having 2nd Pfizer COVID-19 vaccine on 5/15/21 at 1pm.  Approximately 40 hours later developed arm numbness.  This office evaluated him 5/18/21 and directed him to the ER but he left without full evaluation.  5/20/21 a CT scan was ordered and completed the same day which revealed a potential stroke.  MRI was ordered and completed 5/21/21 which confirmed a left frontal lobe stroke.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.