chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLIGHT BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophyalctic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slight body aches, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever 100.9 TO 103.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight body aches, and fever. This report was non-serious.
Resting heart rate was high over 132 vomiting flu like symptoms sinus congestion, headache slight cough, fatigue night sweats took MUCINEX by day five symptoms decreased except for fatigue.
red hives, itching started in palms and went all over, swollen hands and feet, all started 3-4 days post vaccination. This is the third year in a row w/this one being the worst.
Fever and worst headache of life led to lumbar puncture revealing increased OP of 31mm, 13 WBC (96% lymphs, 14% monos), normal glucose, and negative culture. Dx: viral meningitis. Hospitalized for three days for pain control/hydration/ R/O bacterial.
HAVE PACEMAKER; This spontaneous report received from a consumer concerned multiple (3) patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter stated that "3 others that got your shot the same day, now have pacemakers". The action taken with covid-19 vaccine was not applicable. The outcome of have pacemaker was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210946882.; Sender's Comments: V0: 20210946715-Covid-19 vaccine Have pacemaker. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Extremely itchy rash/eczema on both armpits spreading down towards torso; Extremely itchy rash/eczema on both armpits spreading down towards torso; Stomach ache; Vomiting; Diarrhea; Fever; Body aches; Chills; Stiff neck; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Apr2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). The patient previously took tetracycline, doxycycline, minocycline, Z-PAK and experienced drug allergy with all of these. On 17Mar2021, the patient received an allergy shot (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 03:30, the patient experienced extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event itchy rash/eczema and included treatment with steroid cream. The clinical outcome of the events extremely itchy rash/eczema on both armpits spreading down towards torso, stomach ache, vomiting, diarrhea, fever, body aches, chills, stiff neck and nausea were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Postmenopausal bleeding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025b21a and 014m20a) for COVID-19 vaccination.     The patient's past medical history included Cervical os suture in 2004. Concurrent medical conditions included Penicillin allergy, Drug allergy (Opioids), Drug allergy (narcotics), Fruit allergy (mango, pineapple, avocado, watermelon, pomegranate, kiwi and cantaloupe) and Shellfish allergy.   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown.            No treatment information was provided. Action taken with mRNA in respect to the events was not applicable.  Patient had a failed endometrial lining biopsy attempt on 21 Apr 2021 due to scar tissue from a previous cerclage placed in 2004. On 07-May-2021, patient was waiting on lab results from hysteroscopy and Dilatation and Curettage (D&C).  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Individual fully vaccinated with COVID-19 Moderna vaccines on 3/4/21 and 4/6/21 and tested positive for SARS-CoV-2 on 5/7/21.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 22 year old white (caucasian) male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and drug allergy (Unspecified) and other pre-existing medical conditions included: The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 at 14:00 on left arm for covid-19 prophylaxis. Age at time of vaccination 21 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUL-2022, the patient tested positive for covid-19 which led to confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on 31-DEC-2021 at 14:00 on left arm for covid-19 prophylaxis.  On 02-JUL-2022 Patient tested positive for (confirmed covid-19 infection) Covid on (Saturday) (dose number in series 2). Laboratory data included: COVID-19 virus test Positive The patient received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 02-JUL-2022 till 06-JUL-2022 for covid-19 treatment. Patient had a paxlovid prescription and just over 6 months after receiving the booster patient took it for 4 days. After that point patient had been feeling much better. On JUL-2022, after testing negative twice (on 09-JUL-2022 COVID-19 virus test negative and SARS-CoV-2 test negative) over the following 3 days. After then getting symptoms again patient tested positive (nearly instantly with the rapid test, COVID-19 rapid POC (point of care) test Positive). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and paxlovid was drug withdrawn on 06-JUL-2022. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246036.; Sender's Comments: V0:20220820796-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Hives beginning 2 weeks after the booster dose. The hives have lasted 2 months so far, and have not stopped.
Also had a tetnus vax in right arm same day.   Adverse event--very bad pain, so bad I could not sleep at all, temp of 100 and nausea, lasted for 2 days.
06/05/2003: Per mom, appt time 14:45.  24:00 - 9 hours later, child was presented in ER: hives over entire body and throat swollen.  Given Benadryl and steroids in ER.  No reaction at injection site.
I contracted COVID-19 in 01/2023. My eyes became really red. I had a burning sore throat and it was hard to swallow. I was very tired too. The post nasal drip was really bad. I was coughing badly as well. I had trouble breathing and I went to an urgent clinic. They gave me an inhaler which helped quite a bit. In April 2023, I also experienced a really bad sore throat again. I started coughing and my throat tickled a lot. My blood pressure was high as well. I went to the urgent clinic and I took a few tests.  They gave me some antibiotics and gave me an inhaler. But I continued to cough and I was dealing with these mucus issues. I went to the ER recently and they gave me a liquid syrup medication to deal with the coughing. They also gave me a z pack.
This spontaneous report was received from a licensed practical nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date since 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # K017572, expiration date: 18-MAR-2016 and lot # K013868, expiration date: 27-MAY-2016) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
PATIENT WENT HOME AND HAD A SEVERE LOCALIZED REACTION IN THE ARM OF INJECTION RESULTING AND A MILD SYSTEMIC RECTION WITH SHLIGHT SWELLING IN FACE AND FEVER.
Individual with history of kidney transplant, on anti-rejection medication, scheduled a COVID-19 Pfizer vaccine. At the visit, the Individual was seen by the site medical evaluator prior to receiving first dose of vaccine which was administered on May 10, 2021. The individual did not mention receiving Moderna first dose (3/10/2021) and second (4/10/2021), nor indicated receiving a COVID vaccine on screening questions. Moderna  doses were administered by Pharmacy in. The site learned of the Moderna vax when speaking to the patient to obtain information. NYSDOH clinical team advised that the individual not receive the second dose of the COVID-19 Pfizer vaccine.
Rash fever all over body 10 days after immunization pt examined 2/9/09 rash resolved
This case was reported by a consumer and described the occurrence of a reaction to aluminum in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manf unk) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date on or before 16Nov05, the subject received a dose of Dtpa (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 16Nov05, the subject experienced, a reaction to the aluminum in the Dtpa. The subject was seen at a physician's office. The outcome of the event was not reported. Follow up will not be available. Report received via manf.
does not rise up from the bed; weak; pain in her body; throws up; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 93-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 2021 (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: BEDRIDDEN (non-serious), outcome "unknown", described as "does not rise up from the bed"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; PAIN (non-serious), outcome "unknown", described as "pain in her body"; VOMITING (non-serious), outcome "unknown", described as "throws up".  Additional Information: The reporter classified the events as not serious. The reporter mentioned that her mother, who was the patient, got the first dose of the Pfizer COVID vaccine at the end of the last month (2021) and tomorrow (date unspecified), she was scheduled for an appointment and she would like to know if her mother should get it or not since she was worried it might be detrimental for her. She mentioned that her mother had been a little delicate of her health. She was not rising up from the bed, weak, had pain in her body, and was throwing up. She believed this was because of her age.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began feeling weak and feverish at 10pm. Woke up next morning with a fever and cold chills, along with muscle fatigue, light sensitivity, headache, and heavy breathing. Fever reached a max of 101 through the day. Continued until the next morning, where the symptoms lessened, but didn't go away until about 7pm.
Symptoms (L) arm started 8:00 am 11/6/12 - Following varicella imm. 11/5/12 in afternoon. Client reports extreme tenderness (L) arm from shoulder to fingertips (fingers "tingly"). Reports no fever, but (L) arm exhibits area of erythema 50 mm x 35 mm on back of arm at site of injection (subcu).
Numbness in both thighs down to feet, pain, itching, shortness of breath for a month
Metallic taste beginning 20 min after injection. Chills beginning 15 hours after, then  fever up to 100  F  at18 hours after.  Treated with   400 mg ibuprofen every 6 hours. Fever resolved at 20 hours after injection.  Lymphadenopathy in left axillary nodes with  tenderness.
Large, bilateral, unprovoked pulmonary emboli 3 days after a Moderna first dose vaccine in a patient with no risk factors for DVT or PE and no history of any sort of pro-thrombotic disorder. He is in the hospital and work up is in progress, and so we might find another reason for his PE, but as of now we have no other explanation.
Injection site reaction 2 hours after first booster; Pain on injection site  2 hours after first booster/Pain on injection site continued to linger; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 028A21A and 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger). At the time of the report, VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) outcome was unknown and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had Injection site reaction 2 hours after first booster vaccination, also patient had lingering pain on Injection site 8 months after first booster. Patient had not discussed the issue with doctor. Patient called the pharmacist and asked what should be done. Unspecified treatment received on 14 Nov 2021.
Dizzy and diaphoretic at first. Placed supine with legs elevated and then placed on left side when nauseous. Vital signs stable. Received benadryl 50 mg at 3:20pm as arm was itchy. Nausea and dizziness continued as well as difficultly swallowing and throat closing up. Received Epi pen 0.3mg at 4:20pm. Sent to ED via ambulance.
The pt experienced a febrile seizure on 3/27/00. The vaccine was administered on 3/23/00. Temp was 105. Pt experienced 1 seizure only. Fever started on 3/24/00 at 103 and on 3/25/00 it increased to 104. After the seizure the fever dropped to 101.
Itchy, swelling, redness, pain on area of vaccination. HA started following day, 4/10 and swelling has been worsening.
Could not get 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received @ 6:45pm.  Woke up following morning @ 7am with fever 100.7, nausea, body aches, fatigue, trouble breathing, diarrhea, headache, lack of appetite, some loss of smell.
The patient developed hives approximately 5 hours after administration of the Hep B vaccine (ENGERIX-B). He was evaluated in an urgent care facility and was administered Dexamethasone and BENADRYL. The hives gradually improved.
felt really bad; not myself, no energy; bedridden; I'm worn out doing laundry; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), ASTHENIA (not myself, no energy), BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose: 1, Lot number: 035C21A) on 15-May-2021, Moderna COVID-19 Vaccine (Dose: 2, Lot number: 0090214) on 15-Jun-2021, Moderna COVID-19 Vaccine (Dose: 3 and Lot number: 022521A) on 13-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Asthma, Allergy to antibiotic (Allergic to Bactrim) and Sulfonamide allergy (Allergic to sulfa). Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    On 10-Dec-2022, 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 11-Dec-2022, the patient experienced FEELING ABNORMAL (felt really bad), ASTHENIA (not myself, no energy), BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry). At the time of the report, FEELING ABNORMAL (felt really bad) and ASTHENIA (not myself, no energy) outcome was unknown and BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry) was resolving.            Patient stated that, on Sunday he felt really bad, the previous vaccine doses boosted his immune system, after next vaccination he was bedridden, not himself, and had no energy. Today, he was doing work around the house, and he was worn out doing laundry. He further stated, this dose was wow, holly moly. He was 75 percent better but not his normal self. He was hoping he would be protected.  No treatment medications were reported.
pt recvd vax; local red area, 10-20mm, that inc in size p/ 2nd dose given in opposite arm; as of 31aug is dissipated; no itching or systemic rxn;
Patient came to the pharmacy with significant swelling throughout arm under where shot was administered the day prior. She also had redness which was severely itchy. Pharmacist advised her to go to MD office and MD prescribed Prednisone course for patient and said she should not have any further Pneumonia vaccination as she had an arthus reaction.
Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from a pharmacist on 05-Dec-2018, concerning a 33-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration) for active immunization against influenza.  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 (same reporter).  Non-significant follow up was received from the pharmacist on 02-Jan-2018: Reporting pharmacist's county was provided. It was confirmed that the pharmacist did not give permission to contact the patient so no patient contact information could be provided. No changes were done in the narrative.; Reporter's Comments: A 33-year-old female patient (under 65 years) was administered Fluad (TIV) (inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event painful arm as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event inappropriate age at vaccine administration as not related to suspect vaccine due to accidental nature of the event.