chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is linked to case 2018SA337505. This case involves infant male patient who experienced cellulitis, redness and swelling that extended to his upper back, while he received vaccine FLUZONE QUADRIVALENT (formulation Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that, In 2015 the patient got two doses of 0.25 FLUZONE QUADRIVALENT, one in October and December (LOT for both injections was U5304FA), and he had no reaction. In 2016, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5663TA, expiry date not reported via unknown route in unknown administration site. On an unspecified date, the patient developed a serious cellulitis, redness and swelling that extended to his upper back (inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. It was reported that, patient had test for egg allergies which were negative. Final diagnosis was cellulitis, redness and swelling that extended to his upper back. The patient was treated for cellulitis with antibiotics. The event outcome was unknown for cellulitis, redness and swelling that extended to his upper back. Documents held by the sender: none. Sender's Comments: This case involves an infant patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Headache; Nauseous; Drowsy; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 37-year-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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 08:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 20:30, the patient experienced drowsy, headache and nauseous. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events drowsy, headache and nauseous were recovering at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Rectangular patch on left arm, below injection site,  Patch was about 2"x4".  It was red, slightly swollen, warm to touch and itchy.  It continued for about 7 days and gradually subsided.
Information was received on 13-OCT-2016 from a medical assistant who reported that multiple unspecified patients were inadvertently administered improperly stored vaccines from 08-SEP-2016 to 12-OCT-2016. The vaccines involved were VAQTA, OMPC PEDVAX, RECOMBIVAX, ROTATEQ (lot number and expirations not provided). Temperature was 15 C for 3 hours and 40 minutes as per data logger. No adverse effects reported. Additional information not expected. No additional information is available.
Patient experienced strong heart palpitations, heart rate 156 and arrhythmias for 20 minutes, patient took a nitroglycerin sublingual tablet and reported to the local fire department.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (lot # not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
5 Weeks Pregnant Received One Dose of Heplisav-B; Initial Report Received on 18-Feb-2022  Follow-up Report Received on 18-Feb-2022 included communication with the patient from the Pregnancy Registry.  An advanced nurse practitioner reported that  a 24-year-old pregnant female patient (race and ethnicity unknown), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at 5 weeks of gestation. The pregnant patient, who is also a nurse, additionally self-reported the event separately.   No medical history was reported. The patient's last menstrual period (LMP) was 15-Jan-2022.   No concomitant medications were reported.  On 18-Feb-2022, the patient, who is also a nurse,  was drawing blood on a patient and experienced a needle stick injury. The nurse had a hepatitis B  titer drawn, and the result was 9.9 which was considered low. A "booster" dose of HEPLISAV-B (Lot # 935842, expiration date 29-Oct-2022, and NDC # unknown) was administered intramuscularly in the right deltoid by a medical assistant.   No additional information was provided. The patient declined to participate in the Pregnancy Registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Severe rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Severe rash) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Severe rash). At the time of the report, RASH (Severe rash) had resolved.            No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
H1N1 shot at 11 AM. Approximately 3 PM noticed itching of chest and arms. Rash and hives on chest and arms, shaking of hands. Gave 25 mg BENADRYL and cimetidine 300 mg at 15:40. Blood pressure high 173/110, HR 131, going down. No breathing problems.
This case involves a cluster of three unidentified patients who experienced "reactions" after administration of ADACEL lot number C4063 (U4308BA). Initial report was received from a health care professional on 12 March 2012. Three unidentified patient's (gender, age and date of birth not reported) received an injection of ADACEL, Sanofi Pasture Ltd, lot number C4063 (Sanofi Pasteur Inc. lot number U4308BA) (date, route and site not reported) and an unspecified amount of time later experienced "reactions." No further information was available at the time of the report. The patient's outcomes were no reported. Follow-up information was received from a health care professional on 20 March 2012. The three patient's were identified as female and developed reaction following vaccination. Two of the patient's experienced hives and itching all over. The patients outcomes were not reported. This reporter also reported other adverse events, which captured in case number 2012-03160 and 2012-03162. Documents held by sender: None.
This spontaneous report as received from registered nurse refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On 29-APR-2014 the patient was vaccinated with VARIVAX (dose 1, 0.5 ml, subcutaneous) (Lot/Batch number: J014854 with expiry date of 06-DEC-2015) in the left arm. Concomitant medications were not reported. Nurse reported that the patient experienced injection site reaction, that was 30mm x 30mm, erythematous, tender, warm, painful and swollen after receiving the first dose of VARIVAX. Patient sought medical attention by health care provider in the employee health department on 09-MAY-2014. No treatment was provided for the event. The outcome of the events was unknown. The causality of the events with VARIVAX was not reported. Action taken with suspect therapy was not applicable. Product quality issue was not involved. Additional information has been requested.
COVID PNEUMONIA; SCARRING OF LUNG TISSUE; BEGINNING OF FIBROMYALGIA; This spontaneous report received from a consumer concerned a female. The patient's concurrent condition included beginning stages of chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 29-MAR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the patient had a COVID pneumonia and was hospitalized. The patient was hospitalized for 9 days (also given as 8 days) till 23-APR-2021, and received a 5 day course of an unspecified medication. The patient was not ventilated, but due to preexisting COPD status, the patient followed up with pulmonologist on 23-APR-2021, who confirmed that the patient had scarring of lungs tissue due to COVID and the beginnings of fibromyalgia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from COVID pneumonia on 23-APR-2021, and had not recovered from scarring of lung tissue, and beginning of fibromyalgia. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0 20210651198-covid-19 vaccine ad26.cov2.s -COVID pneumonia, scarring of lungs tissue due to COVID and the beginnings of fibromyalgia. 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: MEDICAL HISTORY, NATURE OF EVENT
Facial nerve pain; This is a spontaneous report from a contactable pharmacist (patient). This 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 14Jan2021 16:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient received the first dose on 23Dec2020 13:00 on the left arm. Patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 21:00, one week after second shot, the patient started experiencing facial nerve pain. Patient has no medical history of any pain before. Negative etiology from dentist. Patient received 5 day course of prednisone 50 mg, daily which resolved the pain, however, one day after finishing course, the pain returned. It was worse at night with bouts of pain every 30 minutes when trying to sleep. Patient received steroids and carbamazepine 100 mg from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a mother concerning her daughter who in August 1993, was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  In January 1994, she was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  In approximately 1994, several months after the second dose she developed a skin disorder (MORPHIA).  No other symptoms or treatment were reported.  At the time of the report, the outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Client received J&J vaccine at 3:45pm. In post-vaccination observation area, client started to rock back and forth in chair with eyes closed. No signs of distress. At 3:50pm, client became diaphoretic and complained of dizziness. Denied ability to stand up or assist in moving to cot approx. 6 feet away. At 3:55pm, speech noted to be somewhat slurred and Lead observation nurse activated Rapid Response. Client complained of nausea and vomited in trash can moderate amount one time. Clinic rapid response team arrived at approx 3:57pm. Client already reporting feeling significantly better, opening eyes, and speaking coherently. Client reported having nothing to eat/drink in last 3-4 hours and working as landscaper outside all day prior to arrival (in 90-95 degree heat with Unhealthy air quality due to wildfire smoke). Client in no distress; Vital signs at 4:00pm were: pulse 66, blood pressure 87/57, O2sat 98%. Attending provider assessed client; determined client was most likely experiencing heat intolerance & dehydration, and recommended we push oral fluids and monitor client until returned to baseline. Client given 32 oz water, 8oz juice, and 2 granola bars; which he tolerated well with no nausea. Family joined client in observation area and wife updated on what happened. Both client & wife given education (including heat-illness related care) and verbalized understanding of when to seek further medical care. Vital signs at 4:19pm were: pulse 66, blood pressure 108/71, O2sat 98%. Client still in no distress, no longer diaphoretic or pale, able to stand independently without dizziness. Discharged home with family.
Person noted to be drowsy and minimally responsive.  Epinephrine 0.3mg IM and diphenhydramine 25mg IM administered and within two minutes of the epinephrine the patient started talking and saying she was feeling a little better.  Reports that she started feeling numbness and tingling in her lower extremities which progressed to her upper body (bilateral).  Also reports hx of hypoglycemia and states she ate and drank approx 90 minutes before the event.  Reports this happened one other time when she was exposed to smoke in her classroom and that she was admitted to a local hospital for three days.  VSS 124/72, 90, 100% ORA.  Apple juice given after patient became more responsive.  Transported via EMS to ED for eval, alert, oriented, stable, and in no apparent distress.
left jaw line/cheek to chin hurts to touch, lower lip to chin whole lip swollen and hard to touch
Vomiting & diarrhea for 2 days, nausea and headache for 10 days
The above mentioned client was given a bivalent vaccine instead of the intended 1st dose that she should have received.
Shaking chills, body aches, head ache, pain upper left arm (injection site), nausea, feelings of panic and paranoia.
MMR vaccine given as well as DPT#3 and HIB#3. The MMR was mistakenly given.
Information has been received from a nurse practitioner concerning a 15 year old female with no drug allergies, who in March 2007, was vaccinated with a third dose of Gardasil.  In September 2007, the patient's deoxyribonucleic acid test for human papillomavirus was positive.  The nurse practitioner noted that the patient was sexually active.  The patient was seen in the doctor's office.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Anaphylactic reaction; Scratchy throat; Pain-near injection site; A spontaneous report was received from a consumer concerning a 48-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, scratchy throat and pain near the injection site.  The patient's medical history included COVID-19. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 06 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, almost immediately after receiving the vaccine the patient reported having a scratchy throat and pain near the injection site. She stated she spoke with her health care provider who advised her she was having an anaphylactic reaction.  Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events anaphylactic reaction, scratchy throat and pain near the injection site were unknown.; Reporter's Comments: This case concerns a 48-year-old female patient. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant, and an unexpected non-serious event of Scratchy throat along with an expected non-serious event of pain near the injection site. The events occurred almost immediately after receiving first dose of first of two planned doses of mRNA-1273 (Lot number 039K20-2A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. Treatment included Benadryl. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced feeling fatigue. On APR-2021, the subject experienced being weak. On 10-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 97.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, feeling fatigue, and being weak, and the outcome of severe nausea was not reported. This report was non-serious.
Soreness, redness, heat, swelling and pain at injection site.  Pain on moving the arm.  Joint stiffness (may be partly due to arthritis).  Dry mouth.  Still painful, swollen, red and hot three days later.
Information has been received from a nurse practitioner concerning a child who was vaccinated with a dose of Proquad. Subsequently the patient developed a fever over 101 and a measle-like rash 10 days post vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
the following morning I went to go work out and I started smelling cigarette smoke out of nowhere. Every breathe I take I smell cigarettes.
the expiration date of the Daptacel was 16 May 2019 was given to a patient; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml first expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202BA and expiry date: 16-May-2019) (route and site of administration were not reported) on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
High fever for 10 hours the first time I took temperature was 106.3 F . I took several showers to lower the fever and acetaminophen but it was not enough and the fever continue all day Severe headache, pain all over the body  Severe pain on the lower back that almost cannot walk
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Child developed hives on a large portion of his body, including back, legs, face and arms.  Symptoms were reduced when given Benadryl, but increase again either when very active or immediately prior to bedtime.  Again, symptoms reduce with Benadryl.
Patient was admitted to hospital for severe allergic reaction. Both hands, lips and eyelids swollen-after vaccine was given.
Soreness that gradually became more like a sharp pain when lifting or rotating arm. Symptoms have been present for a month. Patient has been moving arm to keep limber, taking Ibuprofen/ALEVE around the clock, and using hot and cold compresses.
Heart beats changed.  Normal before Vaccine, 65-71 bpm  Now average,  75-85  with bpm. As high as 108.
lesions on hands;recurrent hives;swelling of various joints (fingers, wrists, knees, elbows, shoulder);had rash for approx 6mo a/vax to see dermatologist 17JUN;
20 minutes after injections pt developed three 1cm area of erythema on both feet and right lower leg, at about 500 pm mom called from home resolved. Dr will examine pt in office.