chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash on site of injection; Red rash on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information use was not reported.  Treatment : Cold compress   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: No specific follow-up information recorded.
Chills that night, shaking in bed at midnight for about 10 minutes - like a full body shiver that just kept going; Chills that night, shaking in bed at midnight for about 10 minutes - like a full body shiver that just kept going; Felt a kind of cramp or something in my neck at the time too; My right eye is very bloodshot, and has been since Sunday (07Mar2021)... still bloodshot, not sure it has improved.; Had a fever maybe starting that night, and that lasted til at least Monday night; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 31-year) in left arm on 07Mar2021 at 07:45 AM as dose 2, single for COVID-19 immunization. Medical history included obesity, psoriasis, both from an unknown date and unknown if ongoing. Concomitant medications included triamcinolone taken in two weeks of COVID-19 vaccination, for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 administered in left arm on 14Feb2021 at 07:30 AM for COVID-19 immunization. Reported facility type vaccine was school or student health clinic. Patient received no other vaccine in four weeks. Patient had no COVID prior vaccination. The patient not tested COVID post vaccination. On 07Mar2021 at 05:30 PM the patient experienced chills that night, shaking in bed at midnight for about 10 minutes - like a full body shiver that just kept going; felt a kind of cramp or something in his neck at the time too; his right eye was very bloodshot, and had been since Sunday (07mar2021) ... still bloodshot, not sure it had improved ; on 07Mar2021 the patient had a fever maybe starting that night, and that lasted till at least Monday night. May be took until Tuesday or later to feel better. Patient received no treatment for the adverse events. The clinical outcome of the event "fever" was resolved on an unspecified date in Mar2021, while the outcome of other events was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Tingling in legs, pins and needle in legs; hard heavy legs feeling; high blood presure; brain fog; heart palpations; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Feb2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021, the patient experienced tingling in legs, hard heavy legs feeling, pins and needle in legs, high blood pressure, brain fog and heart palpations. The events resulted in doctor or other healthcare professional office/clinic visit, emergency visit room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events tingling in legs, hard heavy legs feeling, pins and needle in legs, high blood pressure, brain fog and heart palpations were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
tiredness/Got our second shot in May and still experiencing tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness) 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 26-May-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness). At the time of the report, FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported
Information has been received from a health professional concerning a 24 year old female who on 11-MAR-2008 was vaccinated SQ with the third dose of GARDASIL (659182/1757U). On 11-MAR-2008 the patient experienced injection site soreness and incorrect route of administration. Subsequently, the patient recovered from the injection site soreness and incorrect route of administration. Per the reporter, there were no reactions with the first two doses. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 24 year old (previously reported as 31 year old) female who on 12-SEP-2007 was vaccinated with the first dose of GARDASIL. On 12-Nov-2007, the patient received the second dose and on 11-Mar-2008 received the third dose SQ (lot# 659182/1757U). After the third dose the patient experienced increased soreness at the injection site and not experienced with the prior doses. The patient was seen in the doctor's office. The patient was recovered.
I am having some swelling and itching at the injection site and having pain in my kidney area. I thought it may be a uti but was medically cleared of any type of infection.
On 08/25/2021, patient was stung by a yellowjacket and started having breathing problems within 5 days.  Since then, patient has had COPD diagnosis changed to emphysema plus ECGs and echocardiograms which show PVCs.  The PVCs have resulted in a heart catheterization on 6/16/2022 which thankfully did not prove pulmonary hypertension however the cardiologist still wants to figure out why the patient is having the PVCs and the patient has been referred to another specialist.
I had, had what I think was bronchitis in October. I was coughing a lot; I was taking a lot of over-the-counter medication that did not alleviate the symptoms. I took a home COVID-19 test that came back negative. It finally went away. A couple of weeks later the couple coughing came back, a runny nose, headache, body aches, hoarseness. I took a home COVID-19 test, this one came back positive. I called my primary care doctor who prescribed a prednisone dose pack, PAXLOVID and another drug that I cannot remember. I did start feeling better in a couple days and everything was mild the hoarseness and coughing persisted a couple of weeks longer.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Proquad. It was reported that the patient developed a local reaction after vaccination. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a registered nurse concerning a 14 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-OCT-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
6 pts recvd Engerix-B vax & it was determined that they did not respond;
minutes p/the inject pt was SOB progressing to cyanosis & respiratory arrest; mouth to mouth resucitation, epi given x 3, DPH & albuterol, 02;
This spontaneous report as received from a physician via company representative, referring to a male of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 0.5 ml (route, lot and expiration date were not reported). Co-suspect or concomitant therapies were not reported. On an unknown date, within one week after vaccination, the patient developed pancreatitis. The patient would not receive further dosing with was vaccinated with GARDASIL. GARDASIL was not reintroduced. At the time of the report was unknown if the patient had recovered from pancreatitis. It was unknown if the patient may had sought medical attention. Upon internal review, pancreatitis was considered as medically significant. This is one of two reports from the same source. Additional information has been requested.
Pt. is 15yr 10 months old and received the Janssen vaccine instead of Pfizer. Spoke with her and her father, kept in observation for 45 min. Discussed possible side effects and gave printed information, phone numbers to contact if needed.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Mar2021 11:30 (Lot number: EN6199) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: OXYBUTYNIN; FLUTICASONE; PREMARIN. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headache". Additional information: After first shot, patient had a headache for 9 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
pt recv vax 2JUL96 & it was noted that pt had been exposed to chickenpox several days prior to vax;8JUL96 pt broke out w/a full blown case of chickenpox including fever;pt presented to MD;
Patient diagnosed with cellulitis of left arm - presented Keflex 500mg by PO BID x 10 days and to flu in 2 weeks.
Missed second vaccination dose.; A spontaneous report was received from a consumer concerning a female patient of unknown age who missed second vaccination dose.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     Patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 14-JAN-2021 intramuscularly for prophylaxis of COVID-19 infection.    Caller said one of her daughters (a nurse) received her first vaccine on 13-Jan-2021. The caller received her vaccination on 14-JAN-2021 along with her other daughter (also a nurse). The second shot was due on 11-Feb-2021, but the clinic nurse said that none of family members could receive the shot since they were in quarantine and the nurse refused to make an appointment for any of them. The nurse said that the caller and her 2 daughters had to start the shot series all over again. Caller did not want to do that, and has relatives who are physicians that said starting the vaccine series over is not necessary.  Laboratory details included SARS COV-2 positive.    No treatment medications were reported.     Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event,  missed second vaccination dose, was considered as unknown.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated Adverse Events.
started w/itching & rash on back 16AUG afternoon;rash from head to toe & taken to ER hosp 830PM; given pred & sent home w/3 more doses;mom states all cleared up;
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter.
Large, red, swollen local reaction. Seen in ER 10-27-07. Treated with Bactrim and Keflex for cellulitis. Seen by doctor in my office 10-29-07 and received Bactrim and Omnicef. Still swollen. Added Benadryl today.
Patient had registered for the Pfizer booster, but vaccinator mistakenly retrieved a booster dose from the Moderna container and administered it. No adverse effects were reported, and the patient was eligible for the dose received.
Terrible pain and swelling at site. 8 hours later felt like I had the flu. Terrible pain in my entire body, muscular. Next morning a mucusy cough, by 12:30 pm had trouble stopping coughing and breathing. Went to allergist. She saw me by 1 pm. Put me on a nebulizer with Albuterol. Prescribed 2 inhalers and a home nebulizer. Today, 4 days out, I have a giant hive on the inside of my right arm elbow.
Patient received wrong vaccine dose by clinic vaccinator 0.03mL instead of 0.3mL. Nurse was corrected onsite and reeducated on dosing practice.  Patient was then asked if he would be ok receiving another vaccine with the correct dose and received the 0.3mL dose of COVID-19 Pfizer vaccine.
EXPERIENCED SOMETHINGS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced experienced somethings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing somethings was not reported. This report was non-serious.
This spontaneous report as received from a consumer referring to her 14 year old granddaughter The patient's concurrent and historical conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot number and expiration date were not provided) dose, route and anatomical location were not reported. The patient's concomitant medications were not provide. On an unknown date the reporter stated that the patient got really sick just after her doctor gave her the vaccine. She was fine until then. The reported stated that this is not a good drug and it was making lots of children sick and dying (reported in MARRS case #1603USA002747) and that the vaccine was not safe. On an unspecified date the patient also experienced pain and she was using a cane for an unspecified reason. At the time of the report, the outcome of malaise, gait disturbance and pain was unknown. This is one of two reports received from the same source. Additional information is not expected because no contact details were provided.
Erythema and induration of (L) upper arm fever and dizziness x2 days.
Severe muscle pain - neck, back, buttocks, thigh Weakness Could not walk for one day, could not eat a full meal for 4 days
Nurse administered Pfizer's 5-11 year of age COVID-19 vaccine to client that was 12yrs of age.  Client was monitored for 15 mins post vaccination. No acute signs and symptoms of distress noted. Client was discharged from clinic in the care of parent.
Information has been received from a physician concerning a 23 week old male with a history jaundice and group b betahaemolytic streptococcal positive who on 10-MAY-2008 was vaccinated with HIB (manufacturer unknown) (Lot # not provided). Concomitant therapy included PREVNAR. On 4-AUG-2008 the patient was seen in the office with a history of 5 days of diarrhea (10 or more loose stools/ day), decreased sleep and appetite and nasal congestion. The baby formula was switched to lactose free formula and it was recommended that PEDIALYTE be continued. Diaper cream was recommended to be applied three times a day, as needed. On an unspecified date the baby recovered from gastroenteritis. On 26-SEP-2008 the patient was seen in the doctor's office and diagnosed with otitis media and placed on therapy with AMOXIL. Subsequently, the patient recovered from otitis media on an unspecified date. Additional information has been requested.
Initial report received on 24 August 2011 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 13-month old male subject (initials not collected) was identified by the investigator based on review of data from a state Electronic Disease Surveillance System database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3494AA received on 09 July 2010, lot number C3558AA received on 17 September 2010, and lot number C3603AA (lot number invalid) received on 01 November 2010 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 25 June 2011 approximately seven months after the last dose. He also experienced posttussive vomiting and sleep disturbance. Laboratory testing included negative PCR on 05 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 05 August 2011 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 45 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient returned to the pharmacy three days after receiving vaccine to show a large hematoma that had formed as a result. After initial vaccination on 5/8 pharmacist noted signs of bleeding under the skin, although not seemingly severe yet, and asked patient if she was on blood thinners, to which she responded she was taking EFFIENT 10mg daily. Also noted multiple bruises along arms that she stated were due to the blood thinner. Pharmacist asked patient to follow up if it worsened, which led her to return on 5/11 to show the large area of bruising (around 3-4inches).  She is going to see her doctor regarding the reaction and will ask about switching or re-evaluating blood thinner.
Pt arrives after having a priority 1 in internal medicine. Pt was there to be seen for right ear infection. pt has been sob. Apparently pt got syncopal at the clinic but it is not clear that she actually passed out. Specifically there was no fall. pt is awake alert in the ER and complains of some sob. Pt denies cehst pain but has left shoulder pain. pt has no N/V/or ab pain. pt had an EKG done which shows couplets of PVCs. Pt  Associated Symptoms: shortness of breath
Patient claimed that they did not receive a covid vaccination and a second dose of Pfizer Bivalent inadvertently administered 28 days later
Varicella Information has been received from a pharmacist concerning a 12 month old female who in August 2005 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Three days later the patient developed a mild case of varicella which resolved spontaneously. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Arm pain and lymph node pain in first couple hours after Fever (up to 102), general aches and pains, headache, and uterine cramps starting 10 hours after and lasting up to 48 hours after.
approx 2hr p/vax pt c/o severe h/a;family transported to ER reports h/a persisted x2 days;
3/26/2021    was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Difficulty swallowing.   Assessment : Time of assessment 1810p. Alert and oriented .   Actions taken: Vital signs taken at 1810 , BP- 104/64      , P-   71   , O2-  97%   Water offered and accepted, able to swallowing without issue     Medications administered: No medications   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home.Husband with her.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/26/2021  5:50 PM 0.3 mL 12/11/2020 Intramuscular
I had chronic diarrhea for several weeks. I was going to the bathroom about four or five times a day. It was starting to get super inconvenient. I got really sick the day before I went to the doctor. I was experiencing weakness, lethargy, diarrhea, and nausea. I went to the doctor on February 17, 2023. They did blood work and prescribed ciprofloxacin and FLAGYL metronidazole. She told me to take my medications and to retest in two weeks. I retested in two week. Everything was normal.
Severe chills beginning at midnight, stopped at 1:30am.  Developed headache.  3:30 am fever developed of 100.9, took tylenol.  8:00 am developed neck and back aches.  Fatigued from not sleeping through the night.