chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It hurts where I got a vaccine; down on my the same arm left arm on site of wrist there was kind of blue and black mark there is puffed up black and blue mark there; It hurts where I got a vaccine; down on my the same arm left arm on site of wrist there was kind of blue and black mark there is puffed up black and blue mark there; I am little bit nervous; It hurts where I got a vaccine; down on my the same arm left arm on site of wrist there was kind of blue and black mark there is puffed up black and blue mark there; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6206, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021 (at the age of 63-years-old), at dose 1, single for covid-19 immunization. Medical history included stroke on last summer. There were no concomitant medications. On 25Mar2021, two days after vaccination, the patient experienced that it hurts where she got the vaccine; down the same left arm, on site of wrist there was kind of puffed up black and blue mark and she was a little bit nervous about it. The outcome of the events was unknown.                 no follow-up attempts are possible. No further information is expected.
12/04/18 Patient is a 17 month old male who presents for evaluation of rash and other nonspecific skin eru. Shot reaction. Patient here with mom for PENTACEL. Vaccination given. Patient developed red rash around injection site almost immediately. Childrens Diphenhydramine liquid 12.5mg/5ml - 2ml given orally now per Dr. He had no other symptoms. Acting fine. No breathing or swallowing issues. Breast feeding ok. Rash disappeared quickly-in about 15 minutes. VAERS report will be completed. Phone call to mom 12/05/18. Mom calls back. Patient is fine today. She gave him one more dose of BENADRYL, then no more after 8pm. They checked on him through the night and he was doing ok. She has no concerns at this time. I explained to mom that we would be completing the VAERS report and sending it in just so she is aware. I told her what was in it and that a copy of the note that was written on the incident will be attached. I did tell her that she may hear from either the manufacturer Sanofi or Dept of Health, but I was not sure. She had no further questions today.
May, 2008 complained of acute severe pain, weakness. (R) leg with numbness. Admitted to local hospital. After seeing numerous MD's, neuromuscular specialist determined due to GARDASIL immunization.
Information has been received from a registered nurse referring to an adult patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was supposed to receive a dose of M-M-R. Instead, the patient inadvertently received a dose of PROQUAD (Merck) (lot number, dose and route were unknown). No symptoms reported. No PQC involved. Additional information has been requested.
Pt received Dtap and Prevnar and within 1/2 mom noted pt had red ear. 4 hrs later had red rash throughout body. Dr put pt on Rondec. Next morning, pt had erythematous macular, papular rash throughout her body resembling hives. Saw Dr, was given Benadryl and Solumedrol IM and placed on Orapred and oral Benadryl.
I felt dizziness while driving the day after the vaccine. I had a car accident that incurred in back and hand traumas
A fever to 104.5, slight rash, 20 second seizure (per mom)
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 49-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
This spontaneous case report was received from an other healthcare professional (PVX2018-3387) on 07-Dec-2018. The report describes a 20-year-old adult female consumer who fainted and vomited following the intake of VAXCHORA (company suspect) (lot no: 7000009 and expiry date: 28-Feb-2019). The consumer also "took an apple juice after taking VAXCHORA". The consumer also took Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM, (non-company suspect) for an unknown indication. It was reported that the consumer received several vaccines on 07-Dec-2018 (Hepatitis A, Hepatitis B, TYPHIM, and VAXCHORA). VAXCHORA was the last vaccine to be taken. She fainted about 45 minutes after the first vaccine was taken, or about 30 minutes after VAXCHORA was taken. As treatment, the nurse gave her water and apple juice and she also shared that, about an hour after administration of VAXCHORA, consumer had vomited. Furthermore, the nurse stated that the consumer had vasovagal response in the past with blood draws, but not with vaccines. The action taken with VAXCHORA, Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM with respect to the events fainted and vomited was unknown, while with respect to the event "took an apple juice after taking VAXCHORA" was not applicable. The clinical outcome of the events fainted and vomited was resolved, while with respect to the event "took an apple juice after taking VAXCHORA" was unknown. Company's Comment: In this case, it was reported that a 20-year-old female consumer fainted and vomited following the intake of VAXCHORA, Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM vaccines. There seems to be temporal association between the intake of VAXCHORA vaccine and the events. However, fainting episodes/ syncope are common adverse event after the intake of Hepatitis B vaccine, and TYPHIM vaccines. Also, fainting episodes could cause abdominal distress and can lead to nausea and vomiting as seen in this case. Hence, the causality of the events syncope and vomiting is assessed unlikely with VAXCHORA vaccine. The causality of the event " took an apple juice after taking VAXCHORA"was considered as not applicable.
This spontaneous case was reported by a pharmacist and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21A) for COVID-19 prophylaxis. Patient had no known allergies to medications, food, and other products. Concurrent medical conditions included Coronary artery disease since 21-Jan-2020, Atrial fibrillation since 21-Jan-2020, Hyperlipidemia since 21-Jan-2020, Hypertension since 21-Jan-2020 and Depression. Concomitant products included DIGOXIN from 21-Jan-2020 to an unknown date for AFib, ACETYLSALICYLIC ACID (ASPIRIN 81) from 21-Jan-2020 to an unknown date for Coronary artery disease, METOPROLOL TARTRATE from 21-Jan-2020 to an unknown date for Coronary artery disease and AFib, FLUOXETINE from 21-Jan-2020 to an unknown date for Depression, SIMVASTATIN from 21-Jan-2020 to an unknown date for Hyperlipidemia. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Jan-2021, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) (seriousness criterion medically significant). At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had no acute illnesses at the time of vaccination and up to one month before. Patient stated that he had no adverse events. It was unknown whether the patient had been diagnosed with tested positive for COVID-19. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning an 76-years-old male patient with no related medical history who experienced the unexpected event of Chronic Lymphocytic Leukaemia 14 days after the 1st. dose of mRNA-1273 vaccine. Furthermore, the patient received a booster dose of Moderna COVID vaccine on 6/21/22 with working expiration on 6/18/22.", then "expired product administered" is also an unexpected event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-593752 (Patient Link). Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 76-years-old male patient with no related medical history who experienced the unexpected event of Chronic Lymphocytic Leukaemia 14 days after the 1st. dose of mRNA-1273 vaccine.  Furthermore, the patient received a booster dose of Moderna COVID vaccine on 6/21/22 with working expiration on 6/18/22.", then "expired product administered" is also an unexpected event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
generalized hives 31JUL95 to ER DPH prescribed; lasted 2 days; no further problems
Tight throat, diff swallowing; lips & tongue felt swollen approx 10 min p/giving vax; Epi SC @ site lt arm; PDH recvd also;
Second dose given on day 69 First Dose on 4/3/21 Second Dose on 6/11/21
Approximately 10 mins post vaccination, patient started feeling dizzy and faint and stated her arm felt tingly. BP=110/86, P=80, No medication was given at clinic site. Patient remained dizzy sitting in chair and parent requested to call EMS. Vitals remained stable and patient was transported to Hospital by rescue. Followed up with patient and was told symptoms had totally resolved.
Information has been received from a registered nurse concerning a 14 year old male with no known allergies who on 06-NOV-1992 was vaccinated in the buttock with a first dose of Recombivax HB.  On 20-JUL-1993 (also reported as 26-JUL-1993) he received a second dose of Recombivax HB (Lot#606687/1617V).  On 27-SEP-1993 he received a third dose of Recombivax HB (Lot#606687/1617V).  On 24-JUL-2007 the patient tested negative for titers.  The value was less than 3.0 for the Hepatitis B surface antibody.  It was noted that the patient was in the office on 15-JUL-1993 for a bilateral otitis media and was on a maintenance dose of Lorabid for 3 weeks (at the time of the second dose).  Unspecified medical attention was sought.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested.
Immunized in AM on 10/19. By 6pm, client had fever to 101.3, arm tenderness, swelling 2/3 of upper arm. She called her own MD. I saw her for a TST read on 10/21-swelling was approx 2"x2", hard and warm to touch, no fever. Client said it was much better. Told her to do warm moist soaks TID, monitor for infection. Call MD if worse, s/s infection, or fever develops.
Patient in for well check, varicella, DTAP given, redness started in before 20 minutes of stay time.
Patient started complaining of itchy neck at 4:20.  She began coughing and vomitting x1.  She was given benadryl 25 mg by mouth.  Her symptoms improved.  Before she left, she had no signs of swelling or distress.
Very severe headache, worst I have ever had that came on 17 hours post-vaccination 1 and did not let up all day/night. Multipe doses of typelon did not alleviate it. Also returned the next day but for not as long and less in duration (maybe 6 hrs)
soreness; had a large bump with itching for a week were shot was injected; I had fever off and on; had a large bump with itching for a week were shot was injected; I was extremely tired; body aches; During the night only I had nausea for a week; This is a spontaneous report from contactable consumer (Patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in left arm on 03Apr2021 at 08:30 (at the age of 26-Year-old) as dose 2, single for COVID-19 immunization.    Medical history was none. There were no concomitant medications in two weeks. Patient had no known allergies.   Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in left arm on 06Mar2021 at 08:30 (at the age of 26-Year-old) as dose 1, single for COVID-19 immunization and experienced within three hours sore arm and within 6 hours waves of being tired. All were gone the next day.     The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 03Apr2021 "soreness within an hour, had a large bump with itching for a week were shot was injected. During that night I had fever off and on (even with taking Tylenol). On an unspecified date in Apr2021(the next day) I was extremely tired and body aches. On an unspecified date in 2021 during the night only I had nausea for a week". Patient received treatment for fever and did not receive any treatment for other adverse events. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been requested.
Information has been received from a patient's mother concerning her 7 month old son who was vaccinated with a dose of GARDASIL instead of the flu vaccine by mistake. No adverse event reported as a result. Additional information has been requested.
2-2 1/2 hrs p/vax rt thigh, local redness & swelling; inc crying noted; suddenly limp, reportedly apneic, & unresponsive for almost a minute-episode resolved spontaneously;
Gave a 3rd dose; This case was reported by a physician via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first and second dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix, which led to Extra dose administered. The reporter consented to follow up.
101.3 fever, arm pain extending from the site of vaccination to neck, chills, strong headache, body aches, leg pain
Severe respiratory illness lasting two weeks; sore throat; cough; congestion; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 36 years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation for Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient 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 vaccination. On 06Apr2021 the patient experienced Severe respiratory illness lasting two weeks, including sore throat, cough, and congestion. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered on unspecified dates in 2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
CHRONIC LYME DISEASE; PATCHES OF PSORIASIS (SYMPTOMS RETURNED); MIGRAINE HEADACHE; DIZZINESS; FELT LIKE GONNA DIE; OVERALL FEELING OF SICKNESS; This spontaneous report received from a patient via a company representative concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: Chronic Lyme disease and concurrent conditions included: moderate to severe chronic plaque psoriasis and other pre-existing medical conditions included: Patient had not reported medical history. Patient was treated with MS medications at a specialized Lyme/oncology center for Chronic Lyme disease in childhood and believed that disease was dormant at that point. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total (1 in 1 once), start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  Consumer reported that on an unspecified date, the patient was at 99 percent clear, late took the dose of risankizumab medication by two weeks and symptoms started to return and not subsided. on an unspecified date, patient was itchy all over all of the time and some patches of psoriasis (psoriasis flare-up). Doctor was considered changing medications. On an unspecified date, patient took covid-19 vaccine and within minutes had a migraine headache, dizziness, and overall feeling of sickness. The patient felt like she was going die and likened it to had to take MS shots that she was given to treat Lyme disease. Laboratory data (dates unspecified) included: Lab test (NR: not provided) with result of Chronic Lyme Disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic lyme disease, and patches of psoriasis (symptoms returned), and the outcome of migraine headache, dizziness, overall feeling of sickness and felt like gonna die was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259244-COVID-19 VACCINE AD26.COV2.S- Chronic Lyme Disease. This event is considered unassessable. The event 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.
Irritable for 5 hours post vaccination and had 30 second chronic seizure. No fever at the end of the 5 hours and then infant became cheerful and was observed in the hospital overnight and remained well. He had a seizure at 1 hour of admission and had marginal seizure. Given Phenobarbital.
Quick onset of nausea, fever, chills, diarrhea, tiredness, headache, joint paint lasted approx. 36 hours.
noticed he became withdrawn acting as if he couldn't hear developed rapid eye movement hand flapping type movement by his 2 year birthday his head was irregular with a protruding forehead
Muscle ache and limited range of motion in the shoulder persisting for 2 weeks. Pain relieved by NSAIDs per patient.
Patient received pfizer vaccine on 2/12/21. Presented to ER on 6/22/22. COVID positive 6/18/22. Patient recent COVID-19, went to other hospital, at that time showed oxygen, not treated with any antiviral her medication, discharge and came here after that. Patient was suspected to have significant metabolic encephalopathy per COVID.  Since she was more than 10 days there was no further treatment visible.  Patient was symptomatic treated.  She had a significant agitation.  So she refused medications sometimes. Overall she has recovered to baseline. Discharged on 7/7/22
10Oct96 Pt recv 1 dose vax. 20Jan98 Pt exp 6 lesions & pruritus. Went to MD 28Jan98 w/crusted lesions on legs,back & chest consistent w/varicella. Another Pt had similar exp (WAES98020629). Pt recovered 28Jan98
Postpartum patient on day 11, presents intense vaginal bleeding with clots (equal to the immediate postpartum). Duration of the event: about 4h approx.
Fever; headache for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (headache for 1 day) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (headache for 1 day). At the time of the report, PYREXIA (Fever) outcome was unknown and HEADACHE (headache for 1 day) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-057824 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, subcutaneously for prophylaxis, with lot # M035694 and expiration date 07-NOV-2017 (strength 19400 PFU, dose not reported). The administered dose of the vaccine experienced a temperature excursion that was greater than -15 degrees Celsius but less than -10 degrees Celsius for 17 minutes. Another temperature excursion in the same temperature ranges was reported for 3 minutes. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012982: Original Case : 1701USA012977.