chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 9 year old male student with an allergy to pencillin who on 02/12/1998 was vaccinated subcutaneously in the left arm with a first 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot # 624640 / 1424E).  There were no adverse events following prior vaccination.  Illness at the time of vaccination included fever on 02/12/1998, which was diagnosed as a viral syndrome and treated by the "fever protocol".  There was no concomitant medication.  On 03/18/2004, the patient presented with his father to the medical office with greater than 100 lesions scattered throughout and with a temperature greater than 100 degrees.  The reporter stated this was day two of the outbreak  and an onset date of 03/17/2004 was noted.  Calamine, camphor, pramoxine hydrochloride (Aveeno) and over the counter diphenhydramine hydrochloride (Benadryl) were recommended.  The reporter noted no aspirin and isolate.  On 03/22/2004, the patient had a re-check.  The elsions were scabbed and the reporter noted it was okay to return to school in the AM.  Laboratory tests were not performed.  On 03/22/2004, the patient recovered.  The reporter noted therapy with varicella virus vaccine live was discontinued.  A product quality complaint was not involved.  Additional information is not expected.
Headache, feel stabbing pains in my head; Pressure and burning in head; Pressure and burning in head; feels like my brain has the chills; my brain feels like it's shaking in my head; Arm sore at injection site; Termperature 99.9 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head) and VACCINATION SITE PAIN (Arm sore at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0132L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head), VACCINATION SITE PAIN (Arm sore at injection site) and PYREXIA (Termperature 99.9 degrees F). On 16-Jan-2021, the patient experienced HEADACHE (Headache, feel stabbing pains in my head). At the time of the report, HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head), VACCINATION SITE PAIN (Arm sore at injection site), PYREXIA (Termperature 99.9 degrees F) and HEADACHE (Headache, feel stabbing pains in my head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: other (High) 99.9 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Pt was given the wrong shot in office, was suppose to get a PCV (Prevnar13) instead of HPV. So far no adverse reaction, called the hotline and was advised that there was no need to worry unless child had a life threatening reaction.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE AND BOOSTED, MODERNA VACCINE. Patient is a 73-year-old gentleman who came into the emergency room with cough with yellow sputum, shortness of breath and fever with generalized weakness that started about 1 week prior to admission.  He has been vaccinated for COVID-19 including booster vaccine.  His COVID-19 PCR is positive.  He has lactic acidosis of 2.6.    He is started on dexamethasone, Zithromax and Rocephin. FOR DISCHARGE: On Rocephin, On Decadron, po steroids.
vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 09:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 10Nov2021 03:00, outcome "recovered" (10Nov2021), described as "vomiting".  Additional information: At 3am that night woke up with one strong short episode of vomiting. Normal behavior after the shot until 3am. No other symptoms and returned to normal after vomiting once. Have 2 older sisters (9 and 11 years old). Received COVID-19 vaccine the same visit and showed no symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
day p/vax pt unable bear weight on leg;c/o severe pain upon touch;refusing walk, fussy;minor swelling @ site;no tenderness;leg appears stiff when moved w/o bearing weight;will see MD for eval;
c/o elevated temp 104, poss febrile sz in ER;5min sz, eyes rolled back in head, vomited;slept 15min p/sz;ears & throat red;nasal congestion in MD office, upper resp infect; (Lorbid & Ibuprofen);
Vaccine was stored for freezer temperature for too long. We have recommended to the patient to get revaccinated.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient develop a bump at an injection site after receiving the vaccine. This is one of several reports from the same source. Additional information has been requested.
Per information provided to me by the immunizer and pharmacist on duty - patient had localized reaction, fever and flu-like symptoms on the evening of the day the shot was given. Per immunizer, when she followed up with the patient on 08/30 he had recovered and no longer had the symptoms.
Day 1: numbness/tingling in arm within 30 minutes of vaccine, extended for several hours Day 2: arm pain (all day), fever (around 2pm), fatigue (around 2pm), menstrual spotting Day 3: arm pain (all day), fever (around 3pm), fatigue (around 3pm), menstrual spotting
I passed out unexpectedly the following morning after the shot. I am in perfect health and this has never happened to me.
diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received bnt162b2 (BNT162B2, lot number EL3302) , via an unspecified route of administration on 21Jan2021 12:00 at single dose on left arm for covid-19 immunisation.  Medical history included none.  Concomitant medication included citalopram hydrobromide (CELEXA), zolpidem tartrate (AMBIEN). No other vaccine in four weeks. The patient experienced diarrhea on 22Jan2021 08:00. No treatment received. No covid prior vaccination, no covid tested post vaccination, no known allergies. The outcome of the event was not recovered.
Swollen, painful nodes on collarbone area,  neck stiffness and soreness. Unusual palpitations, almost a "jolt-like" feeling since day of injection, persistent throughout the day and night not related to any specific activity. Severe headache day following injection, and milder headaches throughout the week.
About the second week in May I started having light headedness. This was something that was happening everyday. I was unable to think and my thoughts were not clear and it made it hard to speak. It was gong on everyday and finally went to the ER in June. They had me follow up with my cardiologist, which I did and we did a number of tests. They did not find anything wrong with my heart or blood flow. I ended up following up with a second cardiologist who wanted to do a catheter to check my heart its self but I did not want to do that because it was a large move to figure this out. I ended up also seeing an ENT and they did not find anything wrong- thinking maybe this could be due to my inner ear. I had an MRI of my brain with a neurologist and we nerve conductivity testing as well. I am seeing another provider today to follow up as well.
pt recv vax;pt exp numbness in the injected arm,swelling in the fingers & hands of the injected arm & flu like illness manifested by n, dizziness & a feeling of warmth;to MD,advised not to take any more vax for HEp B;recovered;
Initial dose leaked out around hub of syringe. Clinician estimates is was more than 50% that leaked out. Clinician discussed with patient and moved forward with repeat initial Moderna dose.
Fully vaccinated with Pfizer. Admitted to Medical Center on 12/04/2021. Tested positive for COVID 19 on 12/4/2021. Expired on 12/12/2021 while still hospitalized.
Pt no known history of syncope. Staff reported syncopal event in the shower shortly after returning home from flu vaccine. Pt was found unresponsive in the bathroom.
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol  which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities.  Treated with meclizine
gap between dose 1 and dose 2 would be > 18 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had a patient that was requesting that they complete her Shingrix series however, gap between dose 1 and dose 2 would be more than 18 months. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter was looking for safety and efficacy data and to determine if this dose would be appropriate. The reporter mentioned that, first shot for this female patient was not given at his pharmacy therefore he was not able to provide the lot number and expiration or the route of administration. The consent to follow-up was granted. This case had been linked with US2021094168, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094168:same reporter
on hypertension medication; allergy induced asthma; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient (reporter's wife) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (My wife and I have each had a Pfizer double jab and would like to know if we can volunteer for a booster clinical trial). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced on hypertension medication and allergy induced asthma on an unspecified date. Therapeutic measures were taken as a result of on hypertension medication. The reporter stated, we unfortunately live in a low vaccination area and want to volunteer for a booster clinical trial. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Large red swollen area on Lt. deltoid. Measures 5 3/4 in width and 4 in long. C/O itching and soreness. Area warm to touch. Started on Sunday 7/13/14, area continues to get larger. Advised to apply hydrocortisone cream for itching.
rashes all over his body; fever of 100.8°F; rash on his left breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his left breast), RASH (rashes all over his body) and PYREXIA (fever of 100.8°F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 024m20a) for an unknown indication.     Concurrent medical conditions included Allergy.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced RASH (rash on his left breast). On 18-Mar-2021, the patient experienced RASH (rashes all over his body) and PYREXIA (fever of 100.8°F). On 11-Mar-2021, RASH (rash on his left breast) had resolved. On 19-Mar-2021, PYREXIA (fever of 100.8°F) had resolved. At the time of the report, RASH (rashes all over his body) outcome was unknown.            Treatment information were Steroid cream, antibiotics (only for the symptoms following the 1st dose), Advil provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non Significant Follow-up Append
Patient had swelling at injection site of her right arm. She also develped a full body rash shortly thereafter. She also reported suffering with slight fever and chills for 2 days. Patient reported personally and has fully recovered.
Pt received vaccines on 06/01/17. Were given in legs and a rash broke out a few days later on both deltoids. Denies pain/fever/itching. Has had MENACTRA in past with no reaction. States this is the 1st TRUMENBA vaccine. States (L) leg is sore but no rash.
Immunization: COVID-19 PFizer-BioNtech 12yrs-adult, external   I95.9 HYPOTENSION 8/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 8/17/2021 ATRIAL FLUTTER, UNSPECIFIED
Third dose of Pfizer manufacturer of Covid 19 was given to patient. Date of second dose was January 13, 2022. No immediate reaction in patient.
she was tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Jan2021, 10 days later after she received her first dose, the patient was tested positive for covid. She stated she had not received her second dose of the vaccine and was asking when can she get it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. Outcome of event was unknown.  Information on lot number/batch number has been requested.
Itchy, red, blotchy area on back and ankles - has spread to most of back, buttocks, legs, under sides of arms, (entire body except for head).
Patient had immunization in the afternoon. That evening she started having flu-like symptoms. Then she had a migraine which she took medication for and found relief. Diarrhea started and lasted 2 weeks. Also her left eye became very red.
asymptomatic- tested positive for covid on binax rapid antigen test done as f/u to new admission per regs
it was itchy; it had a lump; arm soreness; it was red; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE MASS (it had a lump) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Previously administered products included for Tooth ache: Tylenol since an unknown date. Concomitant products included SIMVASTATIN, CARVEDILOL, AMLODIPINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (it was red). On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE MASS (it had a lump). On 17-Jan-2021, VACCINATION SITE MASS (it had a lump) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness) had resolved and VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE ERYTHEMA (it was red) outcome was unknown.        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.   Treatment for the event included ice for 20 minutes.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient describes muscle spasm/pain/tightness of (R) anterior thigh 2 days after ADACEL given in (L) arm. Episodes about 6-7 times over 1 1/2 day period - no redness/warmth/swelling.
Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the unspecified number of patients were vaccinated with an improperly stored doses of M-M-R II lot # L015282, expiration date 30-APR-2017 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 47.4 Fahrenheit (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted. Sender's Comments:  US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1611USA013515.
Broke out in hives, with itching 2 days post vaccine and has continued for 2 weeks every since vaccine except for 2 nights.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: HJ5342) at the age of 72 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 19Jul2022 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Lot number: 023M20A), in left arm and on 19Mar2021 as dose 2, single (Lot number: 006B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Environmentally induced asthma" (unspecified if ongoing); "known_allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt received Varivax 09/17/2001, but was seen at hospital on 06/16/2002, Dx: Chicken pox
jerky; vomiting worse than average reflux; mucous too which choked pt;aspirated on some vomit;colic all day/night; red rash on body;severe crying nights/days;fever; now has lead;mercury;arsenic;alum poisoning;developmental delays
Nauseas; Vomited; Felt crumby; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt crumby), CHILLS (Chills), NAUSEA (Nauseas) and VOMITING (Vomited) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt crumby). On 14-Mar-2021, the patient experienced NAUSEA (Nauseas) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt crumby), CHILLS (Chills), NAUSEA (Nauseas) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified number of patients of unknown age. The nurse reported that multiple unspecified patients received on an unspecified date M-M-R II (confirmed Lot # K020188 and exp. 15OCT2016) that was improperly stored (dose and route of administration were not provided). No adverse effects or PQC were reported. Additional information has been requested.
Localized at injection site. Patient described it as a "knot". Patient was instructed to keep warm compress on it so "knot" would go down. And problems (if patient was to get worse) or complications patient was instructed to call pharmacy and family doctor. Follow up will continue with patient.
Pt recvd vax & 48 hrs later devel a rash on chest, arms & back; no treatment given; rash resolved in 5-7 days;
I had to go into my Doctor and the ER for heart palpitations and I had an irregular heat beat, dizziness, shakiness, nausea with some vomiting and mild chest pains. I am scheduled to see a Cardiologists and will receive the final diagnosis upon going for the office visit. My Doctor said that I will probably be placed on a heart monitor and that the Cardiologist will perform a stress test to make sure my heart is ok. I'm having mild symptoms now but not as bad as before. It's an overall improvement from the last week and a half.
Covid arm very sore for 3 days. Woke up feeling achy, needing to stretch, head hurting and feeling fuzzy. very cold.
Swollen lymph glands behind ears, neck, groin area; pain under both arms; lethargy; pain in both knees, ankles & lt foot;
Information has been received from a patient who "a week ago" was vaccinated with VARIVAX (Oka/Merck).  The patient reported that she went to a clinic to have ZOSTAVAX (Oka/Merck) (MSD), but the vaccine that was given to her was VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) (MSD).  Additional information has been requested.