chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; Chills; Muscle ache; This is spontaneous report from contactable consumer, the patient. A 17-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in right arm on 24Mar2021, (at the age of 17-years -old), as a single dose for COVID-19 immunisation. The patients medical history was reported as reported as not applicable and she had no known allergies. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in right arm, on 02Mar2021 at 17:30, (at the age of 17-years-old), as a single dose for COVID-19 immunisation. the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 17:15, the patient experienced fever, headache, chills and muscle ache. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of fever, headache, chills and muscle ache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
A bad arm pain, fatigue and nausea. 2 days after, itchy, vein looked like inflamed, lump on right clavicle started as a size of a pea but has grown bigger to the size of a walnut, hard and painful, pain up neck and down right arm , tingling on fingers
Initial report was received on 07 October 2014 from a health care professional. A two month-old patient (date of birth not reported) had received PENTACEL (lot number, route, site and date of administration not reported) and later that evening, developed a fever of approximately 103 degrees. The patient was taken to the ER (emergency room) and was admitted. No further information was available at the time of the report. Outcome was not reported. Follow-up information was received from a health care professional on 03 November 2014. The patient was a 2-month old male infant, with no relevant medical history. The patient did not experience adverse events following vaccination in the past. He received an intramuscular right thigh injection of PENTACEL (lot number C4540AA) on 01 October 2014 and one day post-vaccination, on 02 October 2014, presented to the emergency room with a fever. No vomiting, diarrhea, cough, or rash was noted; the patient's sibling, however, was ill and was noted to have mouth sores. The patient was admitted to the pediatric unit to rule out sepsis, and underwent testing including complete blood count, c-reactive protein, blood cultures, urine cultures, urinalysis, and chest x-ray; all results were normal. The fever continued on 03 October 2014 (102.6 degrees), and the patient was fussy but consolable, with improving appetite. On 04 October 2014 he was afebrile, and was discharged home with instructions to follow-up with his physician in two days. The final diagnosis was fever post-vaccination, possible viral syndrome. The events recovered on an unspecified date. Documents held by sender: Physician notes from hospital.
Numbing sensation in face, neck and chest beging within 24hrs of vax and continuing presently.
PATIENT CAME IN12/11/20 SAYING SITE OF INJECTION SWOLLEN AND GETTING BIGGER, ALSO ITCHES AND SLIGHTLY PAINFUL. PATIENT HAS NOT TRIED ANYTHING TO RELIEVE IT
Nausea, fever, severe weakness, lost of appetite, fast heart beating, sensitivity to light, insomnia. Next day: Headache, strong muscle ache, severe weakness, no appetite, must be in bed.
Tdap was given to 4 yr. old child instead of a DTaP. No adverse reaction.
The booster dose for this patient was given just under 1 month too early. We shouldn't have given the Moderna Booster to her until sometime after 12/02/21 and we gave her the Booster on 11/04/21. No adverse events occurred and no treatments were needed.
Patient received first vaccine at 0910 on 25 May 2021. Patient began to have vagal related symptoms within 30 seconds of administration. Patient was experiencing headache, cool clammy skin, elevated BP and heart rate. Patient was put into the recovery position and treated for shock. At 0915 patient began experiencing itchiness in her throat. At that time 0.3mL of Epi was administered into her R deltoid. The rapid response team was contacted from the ER and patient was taken for observation and any follow up care.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-NOV-2012 04:32, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a 16 years old patient of an unknown gender. The patient was vaccinated with VARIVAX (merck) on 10-JUL-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on the following day on 13-JUL-2012, the patient had a fever up to 103 degrees. On 14-JUL-2012, the patient developed erythema multiforme. No treatment information was reported. The patient sought medical attention. The outcome of erythema multiforme and fever up to 103 degrees is unknown. The relatedness for erythema multiforme and fever up to 103 degrees is unknown for VARIVAX (Merck). Additional information is not expected.
Very bad injection site arm pain starting 4 pm 2/08 and continues. Sever chills started 2 am 2/09/21, stopped 8 am 2/09. Fever of 100 started about 5am 2/09 and continues. Very bad whole body aches started 1am 2/09 and continues.
rash swelled slightly; rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again) and VACCINATION SITE SWELLING (rash swelled slightly) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rubella (she had shot in 30's when planning to get pregnant - got Rubella for the full 3 days over full body).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again). On an unknown date, the patient experienced VACCINATION SITE SWELLING (rash swelled slightly). The patient was treated with HYDROCORTISONE (BACTINE [HYDROCORTISONE]) at a dose of 1 dosage form. On 12-May-2021, VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again) had resolved. At the time of the report, VACCINATION SITE SWELLING (rash swelled slightly) had resolved. Not Provided          NO Concomitant products were provided.  treatment medications were provided   This case was linked to MOD-2021-185872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: events updated; second dose information updated, patient demographic details updated, outcome updated
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's husband. The patient received SHINGRIX in the left arm. experienced arm pain following the vaccine that lasted for approximately 3 days. The reporter gave consent for follow up. The physician contact details were provided. For tolerance to next dose, refer case US2018GSK223654.
Erythema and swelling around site 48 hours after injection. Seen in a local ER. Put on Keflex. F/U in office.
The vaccine was 2021 in December. I started having breathing and heart trouble in April of 2022. I was having trouble breathing at night. My breathing ended up squeaky. I went to the emergency room thinking it was allergies. They said it was my heart after he listened and heard crackling in my chest. He ordered the x-ray, and it showed fluid in my lungs and fluid around my heart. They ordered another test call an Angio CT and it showed heart failure. The blood was backing up and not properly pumping. I was admitted to the hospital to seek more care from cardiologist. I was given IV LASIX to get fluid off my lungs so I could breathe better. They completed an Echocardiogram and confirmed Heart Failure and prescribed LASIX pills day and metoprolol. I went to see the cardiologist and he prescribed lisinopril. Now my blood pressure is too low. It's been 80/50 initially but I have adjusted to these issues. I am really careful to not fall. They did another echocardiogram in September and the issues were getting worse. They said that I needed surgery for a defibrillator which I had on October 31, 2022. My symptoms are about the same. The defibrillator is to keep me safe from a bad rhythm.
Initially pain and swelling at injection site, treated with warm pack and pain reliever on 4/30/11.  Parent called again on 5/23/11, no redness or swelling, tender and sore when moving, continued care recommended fu in 1-2 weeks if not better.  Patient seen again on 7/12/11 had pain with palpation of the deltoid muscle and had left shoulder weakness of the biceps and deltoid.  Gripe was okay.  Recommend physical therapy and consider MRI.
One hour after ingesting a single dose of the oral typhoid vaccine developed a headache and abdominal discomfort. Took TYLENOL without relief. Approximately three hours later describes headache as "massive" and severe "stomach pain". Vomiting and loose stools came about in the "late morning" which lasted for "hours". Decided to go to bed to sleep it off. Awakened the following morning feeling fatigued but improved. Felt like her usual self by the evening of 1/25/2019.
Subsequent to receiving one dose of varicella virus vaccine live, the pt was diagnosed with chickenpox.  The pt had at least 50-70 lesions, some of which had already scabbed over. The child was afebrile and had no malaise. Additional information has been requested.
I passed out about 20 min. after the shot. I felt fine up until then. When I was walking to wash my hands, i felt intense heat, vision blacked out and I passed out for about 30 seconds. II was dizzy with delayed vision for the rest of the day.
Patient states she's had soreness in the injection arm with a bruise at the site of injection. She states has been unable to lift her arm up or sleep, and so she had to go to the ER for treatment
he states that his wife is deadly ill; patient stated that his wife "has all of them" (side effects); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)). At the time of the report, ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)) outcome was unknown.            No concomitant drug was reported.  The reporter stated that his wife was deadly ill and had all of the side effects.The only thing different they did was to take the Moderna booster on 20-Apr-2022. Reporter stated that he would take his wife to the hospital instead.  No treatment drug was reported.   Reporter did not allow further contact
This spontaneous report as received from a nurse practitioner refers to a 6 year old male patient with no pertinent medical history and no drug reactions or allergies. On 21-APR-2014, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot # reported as J009989, expiration date 12-AUG-2015) subcutaneously. There was no concomitant medication. The nurse reported that on 22-APR-2014, the patient experienced generalized rash after receiving VARIVAX (Merck). The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. The outcome of generalized rash was unknown. Additional information has been requested.
had one shot and the second exactly one year later; This case was reported by a consumer via (Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received second dose of shingrix vaccine exactly one year later from 1st dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient was told to get a third vaccine by one person and was also told that it was ok to having two by another person. No other information was reported.
Information has been received regarding a case in litigation concerning a male who in 1999 was vaccinated with a dose of MERUVAX II. The patient was not sure if the rubella vaccine he received was rubella virus vaccine live or not. On an unspecified date (after receiving the vaccine) the patient developed "a lot of problems", a rash, fibromyalgia, chronic fatigue syndrome and "thyroid problems". At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Narrative:  74 yr old male with PMH for COVID-19 diagnosed on 8-19, OSA, obesity, HTN, HLD, CAD s/p stenting, HFpEF (60-65%), OSA on CPAP, Insulin independent DMII, CML, and COPD presented to ER with increased shortness of breath and fatigue. Pt received both doses of Moderna in the community. Patient stated that since being diagnosed with COVID-19 on 8-19, he has had increased shortness of breath, more fatigue, and had reduced abilities to do activities of daily living. Pt did not require oxygen during his hospital course. He was given dexamethasone for covid19 treatment. On 8/28, he was found to have PE and was started on lovenox, discharged on apixaban, discharged 8/31/2021.
lost appetite; chills; ache/pain; bad cough; fever; aching in joints; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache in November 2020, Joint ache in November 2020, Cough in November 2020, Appetite lost in November 2020, Loss of weight in November 2020 and Muscle ache in November 2020. Previously administered products included for an unreported indication: Antibiotic therapy (Patient took Z-pack for 5 days and returned to normal.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (ache/pain), COUGH (bad cough), CHILLS (chills) and PYREXIA (fever). On 02-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite). In April 2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (aching in joints). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 04-Apr-2021, PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) had resolved. In April 2021, ARTHRALGIA (aching in joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Body temperature: 102.5 (High) 102.5F. In November 2020, Blood count: normal wbc count (normal) normal WBC count. In November 2020, COVID-19: negative (Negative) Negative. In November 2020, Chest X-ray: cloudiness in the lung (Inconclusive) cloudiness in the lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included fluid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up information was received and added new events spiked fever of 102,headache,appetite was back,aching in joints, cough. On 12-May-2021: Follow up information was received and Contact information updated
on the eighth day after the injection, the hand at the injection site began to hurt and an allergic reaction appeared- swollen shoulder ,itches
This spontaneous report was received from a licensed vocational nurse (LVN) refers to unspecified patients of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of oral, ROTATEQ, (lot # K024700, expiration date 30-JUL-2016 and Lot No: L008051, expiration date 17-NOV-2016) (dose was not provided). The licensed vocational nurse (LVN) reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored oral, ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of injection site rash in a 82-year-old female patient who received SHINGRIX (batch number 32GR4 ?, expiry date unknown). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site rash, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site itching were not recovered/not resolved. The reporter considered the injection site rash, injection site warmth and injection site itching to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The reporter did not know how soon the events were started after the vaccination. The pharmacist recommended BENADRYL for the patient.
6hr p/vax getting 1st hep b vax pt broke out in hives on back & vomited x 2;
Wouldn't feel very good the next day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received first dose of the new vaccine and not felt very good the next day. The reporter mentioned that, it would better than having shingles of course. The follow-up would not possible, as no contact details were available.
No adverse event; patient received the first dose of gardasil 9 on 08/02/2019 and the second dose of the series on 05/03/2019; This spontaneous report was received from a medical assistant regarding to a 23 year old patient of unspecified gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 via intramuscular (strength, dose, lot#  and expiry were not reported) for prophylaxis. The medical assistant described that, on 05-MAR-2019, the patient vaccinated 2nd dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular (strength, dose, lot#  and expiry were not reported) for prophylaxis, outside of the recommended time in the prescribed information (inappropriate schedule of product administration), and no adverse reactions reported.
pt recv vax 14AUG97 & pt exp tiny, mild bumps under rt eye, back, belly & some on arms;
Parent reports child extremely fussy and agitated following HIB vaccine, she further reported that her child's eczema became more severe and inflamed after vaccine.
Fever; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Real tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21 and 013M207) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, 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 experienced PYREXIA (Fever) and FATIGUE (Real tired). At the time of the report, PYREXIA (Fever) and FATIGUE (Real tired) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-406401 (Patient Link).