chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of a child under the age of two being administered H1N1 LAIV, was received from a registered nurse concerning a 21-month-old female. The medical history included cold prior to vaccination, that was resolved in early December. The patient had not taken any concomitant medication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved. Additional information was received on 09-Dec-2009 and incorporated into the narrative: The patient's medical history and concomitant medication changed.
C/O pain in extremities and headaches since administration of Gardasil (HPV Vaccine), constant pain, rated 6-7/10 on pain scale. Does not interfere with daily activity.
pt recv vax 9-10AM;returned to clinic @ 11AM w/red, itchy, hives over entire body;given DPh sx resolving @ 12noon;
Initial unsolicited report received from a non-healthcare professional (Office Manager) on 09-Feb-2017. This case involves a 62-year-old female patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5478BA, expiry date: 05-Nov-2018; dose and dose in series not reported) in left deltoid on 22-Sep-2016. Patient's Illness at time of vaccination was reported as none and allergies towards penicillin and Compazine was reported. Patient's concomitant medication was not reported and any other vaccinations within four weeks of vaccinations were reported as none. On 22-Sep-2016 since time of the vaccination, patient had experienced arm pain, injection site swelling, swollen glands. On an unknown date, about one month after the vaccination, patient experienced muscle weakness of arm, patient stated that it felt like "arm muscle where shot was given is gone". Patient required an emergency room or doctor visit. Lab test and corrective treatment was not reported. Patient had not recovered from the events. It was also reported that till 09-Feb-2017, arm pain, injection site swelling, swollen glands were going on. Documents held by sender: none.
have cold sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (have cold sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (have cold sore). At the time of the report, ORAL HERPES (have cold sore) outcome was unknown.            The patient treatment data was not provided.
Fever up to 103 started the evening of 10/07/2013 and redness with swelling to area.
SEVERE HEADACHE; JOINT PAIN; NAUSEA; VOMITING; FEVER; This case was reported by a nurse via call center representative and described the occurrence of headache in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 9th June 2020, the patient received Bexsero. In June 2020, less than a week after receiving Bexsero, the patient experienced headache, joint pain, nausea, vomiting and fever. On an unknown date, the outcome of the headache, joint pain, nausea, vomiting and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, joint pain, nausea, vomiting and fever to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's grandmother who was also a nurse.  The patient received Bexsero and had severe headache, joint pain, nausea, vomiting and fever. The patient was experiencing all the symptoms after receiving this vaccine and not certain when the symptoms presented.   The reporter was concerned about patient symptoms which had not resolved. The reporter did not consent to follow up.
dizzy; constantly laying in bed; two big bumps on forehead; nausea; vomiting; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles) and NAUSEA (nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with ONDANSETRON at an unspecified dose and frequency and BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Patient has been treated with pain medications.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter salutation updated, Treatment medication updated, Added new event Shingles.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805429 was crossed linked to original case 201804863 due to same reporter.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case- 2018SA234692 (same reporter). This case involves a nine-months old female who received a 0.5 mL third dose in series of PENTACEL lot C5264AA, expiry date 29-Oct-2018 in right thigh on 20-Aug-2018. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PREVNAR 13 vaccines (Lot number, expiry date, dose and route of administration not provided). It was an actual medication error due to inappropriate reconstitution technique. It was reported that PENTACEL vaccine one full dose was split among two children and patient received only Dtap/IPV component. There were no known reports of symptoms or need for treatment. 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 and Module VI of the 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. List of documents held by sender- none.
On the 19th I started getting a welt on it. it spread, got inflamed and swollen. It was hot to the touch. Dr. said I had cellulitis. prescribed antibiotics.
Arthritis in hands went away; Arthritis in hands went away; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in hands went away) and THERAPEUTIC RESPONSE UNEXPECTED (Arthritis in hands went away) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Feb-2021, the patient experienced ARTHRITIS (Arthritis in hands went away) and THERAPEUTIC RESPONSE UNEXPECTED (Arthritis in hands went away). At the time of the report, ARTHRITIS (Arthritis in hands went away) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (Arthritis in hands went away) outcome was unknown.            Treatment information was not provided.  Concomitant product use was unknown by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No new information was received and patient denied for further contact.
Chills; Diarrhea; Cramping and pain in my stomach terrible; Cramping and pain in my stomach terrible; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified gender and age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On the 5th day after vaccination the patient experienced little chill before but had diarrhea and cramping and pain in stomach terrible. The outcome of the events were unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
3-28 10 pm congested throat 3-29 9am fatigue, achey muscles; throat no longer congested 3-29 12pm chills, headache
have a tooth infection; This is a spontaneous report from a contactable consumer (Patient) and Follow-up received on (21May2021) spontaneous report from a Pfizer sponsored program COVAX US Support processed together with initial.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included tooth repair from an unknown date and unknown if ongoing I had tooth work last year and every now and then my cheek swells. The patient's concomitant medications were not reported. On an unspecified date the patient stated that she is scheduled to get the second dose of the Pfizer BioNTech covid vaccine tomorrow and questioned if it's ok to take antibiotics. "I had tooth work last year and every now and then my cheek swells. When I go see my dentist, he says there's an infection and prescribes antibiotics. I'm going to call my dentist (about a current swollen cheek) and I know he's going to prescribe antibiotics again. This has been going on for a while. I didn't have any reaction from the first dose of the vaccine, no pain or anything.  I read online that it's ok to take antibiotics and get the vaccine, so I just wanted to be sure. wondering if they can still take antibiotics for tooth infection that developed after the first dose. The Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. .
Achy joints, feeling very hot, nasal drainage, sneezing, coughing, sore throat and weak, started on 12/25/00. On 12/26/00, symptoms were slightly better; dry lips.
pt had fever & then had a generalized, brief (2min), tonic-clonic seizure;
COVID Breakthrough. Patient was admitted to the hospital on 8/16/22 for a fall, unrelated to COVID. She tested positive for COVID on 8/26/22 while in process of getting discharged to a rehab facility. The patient complained of sore throat, diarrhea, and nasal congestion starting on 8/25/22.
2 weeks after vaccine/booster (11/3/21)  I developed a rash on my neck.  I tried cortisone, benadryl, steroids, cold compresses and witch hazel.  I will visit my dermatologist for the second time tomorrow 5/3/2022
Upon leaving morning shower, visually and physically experienced red spots/rash on shoulders and upper chest and arms.
booster; Home Ag positive; Home Ag positive; dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: EL3247) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 18Feb2021; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Jan2022, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Home Ag positive"; COUGH (non-serious) with onset 09Jan2022, outcome "recovering", described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of immunisation, drug ineffective, covid-19, cough.  Clinical Course: Adverse Event: covid sx dry cough 09Jan2022 and home Ag same day - twin lives with her and she has same and same Ag. If covid prior vaccination: Unknown, If covid tested post vaccination: Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037718 same reporter/ product, different patient.
Pain; swelling and redness at injectionsite; swelling and redness at injectionsite; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure (HBP), hyperlipidemia, depression and obesity. The patient received concomitant medications within two weeks, but were not specified. The patient previously received bupropion hydrochloride (WELLBUTRIN) from an unknown date and experienced allergy to the medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 15:45, the patient experienced pain, swelling and redness at injection site and runny nose. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, swelling and redness at injection site and runny nose was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
2 minutes after vaccine patient loss consciousness and passed out. Very dizzy with headache, nausea and some chest pain.
Elevated temperature of 99.5 degrees, hives from neck to groin, restlessness.  No treatment needed.
tongue swelling, oral lesions, then 4 days after vaccination, rash over torso, arms, neck
Pt developed herpes zoster infection (shingles) on left neck. He is going to start acyclovir today.
pt recvd vax & each time exp sl tingling of lips & a vague headache; on f/u recvd 1JUN93, pt indicated that recovered;
Chills, shaking, fever, pounding headache, nausea, joint and muscle pain, sweats. Symptoms lasted from about 9:00 pm on 8/14 until about 2:00 pm on 8/15. Then muscle weakness and fatigue.
This spontaneous report as received from an 89 year old female patient refers to herself with allergy to dust and grass clippings. The patient's medical history included "heart trouble was irritated when shingles occurred", rheumatic fever as a kid. In October 2009 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported), (0.65 ml, subcutaneous). Concomitant therapies included KEFLEX, FAMVIR and ZOVIRAX and clindamycin. The patient reported that she had experienced shingles, twice a year, for the past 14 years. She reported that since receiving ZOSTAVAX she had gotten shingles twice a year, every year, in the Spring and in the Fall. She described the most recent case of shingles that occurred in approximately August 2014 "a month ago" as "a red and raw rash on the back as big as an apple". She was still experiencing this case of shingles and described that she was "experiencing pain on one shoulder, then the other, and one arm was almost useless. The nerves in her back were almost gone." She went on to say that she believed if she got the shingles again this Spring that she would die. She was currently trying to get ZOSTAVAX again. She reported two physicians that she had seen to try to get ZOSTAVAX. She sought medical attention from a physician at an unspecified time after the latest case of shingles, and he would not give her ZOSTAVAX again or any other treatment. She then sought medical attention from another physician who would not give her ZOSTAVAX either, but prescribed famciclovir in May 2014. She did not specify when the other concomitant medications were prescribed or by whom. No lab diagnostics studies were performed. The patient also reported non-highted AE related to clindamycin used at unspecified time that resulted in urinary tract infection and stomach aches. The outcome of shingles (occurred before August 2014) was unknown. The outcome of other events was reported as not recovered/not resolved. All the events were considered as life threatening and disability by the reporter. Additional information has been requested.
Got Flu shot Mon, and Tuesday got pneumonia same arm site today 12/06 shoulder right sore hurts to move his arm, he is not got redness ore warmth to area, has been using hear advised him to use anti inflammatory Q 4-6, ice to sore area 3-4 x today with movement of arm, ability, when RX has lessened pain. Call tomorrow 12/07/06
I had a headache got progressively worse. I had blurred vision, I was hot. The headache never left. It was a terrible headache. I was light sensitive, I had big black spots in my vision, and I couldn't put sentences together. I went to a clinic here they said it was a mini stroke. An MRI was done and found a lesion in the brain. I have recovered but the headaches have resurfaced in a different area. I was only prescribed preventative measures. A heart scan was also done. I am taking Tylenol for the headache that is in a different spot than the TIA.
High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 11May2021 as 1ST DOSE, SINGLE DOSE and received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 13:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got a flu shot 6 or 7 or 8 years ago. She lost the pigmentation on her arm. She has not had a flu shot since. She gets allergy shots but that is weekly. She has not had one in over a month. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first vaccination last month and she did have a reaction of soreness, high fever, tired, and headache on an unspecified date of May2021. Yesterday she got her second dose and now she is back to the way she was with the first dose. Fever went as high as 99.3 which is not high, but the last time with first dose she got up to almost 103. It was 102.98 or something like that. Time of fever with first dose: it was within that night of getting it. Second dose was same thing. She got it yesterday at 1:00 and by 8:00 she was crying about being tired, so cold, achy, and fever. Caller clarified that all adverse events with second dose started at the same time around 20:00 the night of the 2nd dose. Patient had not received any treatment. Caller reported that the last time she did call the hospital and they said it would subside, which it did within 48-72 hours. Then she was back to being normal except with sore arm. Caller clarified it was left arm soreness. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
COVID BREAKTHROUGH CASE - ASYMPTOMATIC, POSITIVE TEST ON 4/14/21
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 28-JAN-2013 was administered a dose of GARDASIL (lot # H011350 expiration date 21-FEB-2015) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
pt recvd vax; devel 2-3 cm erythema of inject site 24 hrs p/ vax;rapidly spread to involve entire leg from inguinal ligament to top of ankle w/ massive swelling;MRI of leg showed no focal abscess;probable fasciitis;improve 48 hrs p/ IV ATBs
Vocal and Motor tics began about 24 hours after vaccine. They are continuing still -- 12 days later. They are frequent-- occurring every 1-5 minutes.
fever 102 for 2 hrs p/vax given; high pitched crying-cont for 5 hrs;
Narrative:  COVID infection following COVID vaccine series 08/17, Pfizer, dose #1 10/27, Pfizer, dose#2 COVID swab, result: detected 12/25 pt cc: chills, myalgia, nasal congestion, exposure: unknown clinically resolved
received bnt162b2; dose 3 (booster); Severe fever (103 degrees); joint pain for two days; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm on an unspecified date (batch/lot number was not reported) as dose 3 (booster), single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no covid prior vaccination. The patient previously took dose 1 and dose 2 of BNT162B2; both on unspecified date (batch/lot number unknown for COVID-19 immunization. The patient had no other vaccine in four weeks. On an unspecified date, the patient experienced severe fever (103 degrees), joint pain for two days. The patient had no covid tested post vaccination. Therapeutic measures were taken as a result of severe fever (103 degrees), joint pain for two days which included OTC medication. The outcome of the event severe fever (103 degrees) was unknown, while joint pain for two days was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.