chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from nurse on 30 Dec 2009: This patient was vaccinated with FLUVIRIN 0.25 ml, intramuscular, on an unknown date. The vaccine was injected into the thigh of the baby younger than 4 years. No adverse effect were noted after administration. The outcome of event was not reported.
tremors; thought it was sugar dropping and had been tested; voice changes; heart palpitations; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history included heart surgery/triple bypass surgery (The patient had open heart surgery at age 70, 2 years prior to getting the COVID vaccines, she was 70 and it was a triple bypass surgery and she has not had any problems until she got the vaccines). The patient did not have family medical history relevant to the adverse event. The patient's concomitant medications were not reported. The patient previously took a flu shot that last fall and a month before the COVID vaccine had a pneumonia shot. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines the same day of either COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military Facility. The patient did have a reaction with the vaccine and still had side effects from the Pfizer shot. On an unspecified date in 2021, after the first dose, the patient experienced tremors, voice changes and heart palpitations. She stated that after the first shot she started with the tremors and voice changes, now she knows what it was like when people stutter. The heart palpitations happened the first two days of getting the first shot. The tremors were still with her and sometimes were better than other times. She thought it was her sugar dropping and had been tested and it had nothing to do with it. She saw a heart specialist because she was very concerned whether something had happened. The heart surgeon/specialist did do some tests and he didn't see anything that would have indicated any trauma to her heart. The adverse events required a visit to Physician Office. The adverse events did not require a visit to the Emergency Room. The patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 10Mar2021 (age at vaccination was 73 years) as dose 2, single for COVID-19 immunization. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.  Follow-up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Pain and redness at injection site, warmth at site, fever; use of NSAIDs and ice to area.  Seen in office for evaluation 5/11/2016.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 35 year old male. 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: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M042853, expiration date 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008700: US-009507513-1707USA008701: US-009507513-1707USA002177.
- approximately 1 hour after receiving the vaccination, the  injection site was hard, swollen,  red circle approximately size of a half dollar, and sore to touch.  now, 48 hours after ae currently on going.   - later in the evening, same date of vaccination, I felt itchy all over, itchiness resolved approximately 3 hours after itching began.
I took Benadryl and Xyzal prior to receiving the COVID19 vaccine to counteract a reaction.  After several hours, I began to experience a reaction.  This included: - hives on my scalp and ears - dry cough - sore throat - headache - muscle aches - hoarseness
chronic pain in right side of her body/sharp pain; she was experiencing a sharp pain or sensation of  burning; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for similar events. This is the first of the two reports.  A female patient of an unspecified age received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of vaccine on 22Dec2020 and she was fine with just a little sore arm. On 29Jan2021, she was in the ER for chronic pain in right side of her body and also was experiencing a sharp pain or sensation of burning. The outcome of events was unknown.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149308 same reporter/drug/event, different patient
FLUSHING/ SOB/ FEELING HOT/ URTICARIA ON UPPER TORSO AND UPPER ARMS
DEATH; FROTHING AT MOUTH; COVID-19; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obese and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Mar-2021, (7-10 days after vaccination), the patient developed COVID 19. The patient self quarantined for 14 days. On 14-APR-2021, the patient went to emergency room with the complaint of shortness of breath. Her D-Dimer was very elevated, but had a ventilation/perfusion scan (VQ) scan which came back negative. They treated her with heparin. On 15-APR-2021, early morning at 06:00, the patient coded (cardiopulmonary arrest) and frothing at the mouth. The team gave her epinephrine, but did not get a return to circulation. It did not revive her. The patient coded for 30-40 minutes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid-19 and frothing at mouth was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-Death and Covid 19. 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).; Reported Cause(s) of Death: PATIENT CODED
chest heavy tingly lips tongue swollen and heavy palpitations tight throat and chest  pepcid 20 iv benadryl 50 iv oral prednisone sub q epinephrine
red blisters on backs of both hands and both arms up to the elbow 24 hours after the vaccine. On March 17th the patient states the blisters are almost gone and she feels fine.
My Arm Ache not all the time, It been over a  year When I wen to the Dr. She said after a year the pain would go away.  It been over a year and still have pain.
After my first dose of the vaccine, I got a fever the next day along with fatigue, weakness, headache,  racing heart, shortness of breath and an extremely sore arm. The fever went away that night but I still felt very fatigued for the next 3 days. By Wednesday, I was feeling better but still had some heart palpatations/racing heart. But Thursday, I was feeling good enough to go for a short run/walk, but Friday I woke up  feeling fatigue, nausea and headache again. My body does not feel strong enough to do simple things like walks outside. This morning i woke up with slight headache and a feeling that is hard to describe, but mainly fatigue and slight nausea.
This spontaneous report as received from a physician refers to a patient of unknown age. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL (strength, route, dose, lot, batch # and expiration date not reported). Concomitant therapies were not reported. On an unknown date the patient was administered the second dose of GARDASIL, 3 years after the first dose of GARDASIL. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected because physician did not want to be contacted.
cold sore developing/cold sore is at upper side of lip and inside his nose; woke up with feeling hot; numbness; itching; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching) and HEADACHE (headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included KETOTIFEN FUMARATE (ZADITOR) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
SM brought in emergently with b/l upper ext hand spasms, Carpal pedial spasm, no sob, no hx of hyperventilating, relates 3 episodes of vomiting and one episode of diarrhrea. Denies any health issues. Had anthrax and small pox about 5 hrs prior. No previous occurrence. In the Army and reservist. Injection Given Solu-Medrol 125mg IM, 2ml, given at 1400. Aseptic tech performed. Sm tolerated procedure well. Educated pt on medication injection. Will continue to monitor.
FEVER 101F; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and high blood pressure, and other pre-existing medical conditions included: The patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin detemir for diabetes, metformin for diabetes, carvedilol for high blood pressure, and furosemide for high blood pressure.  On an unspecified date, the patient experienced fever 101f. Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) Unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 101f was not reported. This report was non-serious.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L008684, expiration date: 13-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
On 01/16/2001 the patient developed approximately 20 to 25 lesions, mostly erythematous papules with 2 to 3 clear vesicles and one excavated, throughout the body especially on her trunk with 2 to 3 on her labia with 1 spot scabbed over. The patient was treated with Benadryl as needed for the itch. It was noted that the patient was exposed to chicken pox on 01/02/2001 through 01/05/2001. Additional information has been requested.
Additional information provided patient demographics, dose details, medical history, and test results. The patient's lab test came back showing lack of protection (laboratory test abnormal). Outcome was unknown. Information regarding PREVNAR 7 was received from a healthcare professional regarding a 22-month-old male patient whose antibody tests came back showing lack of protection. At 12 months of age, the patient received the fourth dose on 16-Feb-2009. The patient's antibody test came back showing lack of protection on 19-Dec-2009. The event persists. No additional information was available at the time of this report.
Upper Extremity Vasculitis, with persistent swelling of left arm for 2 months
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
I was having cold symptoms with fever so I took a home test. We also went to the pharmacy and got tested, They confirmed that I had COVID. I took OTC  medications and cold medication. One day I was having issues breathing and my daughter took me to the ER and they completed chest x-ray, ekg , and a blood panel. All test were normal. I was given an IV and discharged after 5-6 hours. I was given an inhaler for breating by the pulmonologist.
This case was reported by a consumer via call center representative and described the occurrence of arthritis aggravated in a 74-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (ganglion cyst surgery on left wrist and tendon eroded performed on 9th December 2017.), rotator cuff repair (carried out twice), diverticulitis (diagnosed on 30th April 2018) and constipation (diagnosed on 30th April 2018). Previously administered products included ZOSTAVAX and ciprofloxacin. Concurrent medical conditions included reactive arthritis (possibly related to previous ganglion cyst occurred in 2018), osteoarthritis, tendon rupture (possible side effect to ciprofloxacin, started on 1st July 2018) and arthritis. On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and skin warm. On an unknown date, the patient experienced arthritis aggravated. On an unknown date, the outcome of the arthritis aggravated was not recovered/not resolved and the outcome of the pain in arm and skin warm were recovered/resolved. It was unknown if the reporter considered the arthritis aggravated, pain in arm and skin warm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. But, it could be 73 or 74 years old. The patient received the SHINGRIX on the left arm. The patient experienced a warm and sore arm for three days and on 4th day the symptoms faded away. The patient claimed that his arthritis worsened after receiving the SHINGRIX for some days and was on and off. The patient claimed that, the arthritis was systemic but noted specifically in the left wrist, second digit, first knuckle, right wrist, knee and hip area. The patient claimed that, he was a set up for reactive arthritis.
Pt states 6/3/09 she noticed onset of itching, redness, and that area was (hard). Pt states 12-15 hours after injection Sx began to appear. She denies previous adverse reactions to any other vaccination.
Runny nose; lots of cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Feb2021 (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced runny nose and lots of cold. Outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a female patient with no pertinent medical history and no drug reactions or allergies, who, on 20-MAY-2013, was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # J001002, expiry date 25-APR-2014). It was reported that, on 21-MAY-2013, the patient developed a red, itchy, varicella like rash all over the arms, legs and back, that was still continuing to present (the pharmacist saw the patient on 18-JUN-2013, "two days ago"). The pharmacist reported that the patient went to their physician on an unspecified date and was given BENADRYL and unspecified steroids as treatment, but the treatment did not help. The patient did not recover from red, itchy, varicella like rash all over the arms, legs and back at the time of the report. Relatedness for the patient's rash was not reported for ZOSTAVAX. Additional information has been requested.
No adverse event; HCP accidentally administered an expiry dose of Moderna Covid19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP accidentally administered an expiry dose of Moderna Covid19).    No concomitant medications was reported. No treatment medications was reported.
Child received DTaP/Hep A left biceps and MMR/IPV on right 6/21/06. He presented 6/23/06 with edema, swelling (proximal -->distal) of left biceps/arm. Positive warmth to touch, febrile, biceps circumference L >> R. Started on Augmentin for cellulitis. Mother declined Rocephin.
Pt recvd vax & approx 2 hrs p/vax exp nausea & vomited one time; began coughing & had chest tightness & pain; devel a blister on chin; 12 hrs later presented to MD who dx asthma attack; 30 mins later completely shut down & turned blue;
Patient had numbness, tingling down left arm up to 3 weeks after the administration. Patient also had swelling (grape size lump) near injection site for almost 3 weeks.
pt recv vax; T 105 in eve of vax, cont thru day; T nl; no fussiness; mood good thru out per PAR;
Pain in chest/lungs near sternum.  Felt like someone stabbing me in chest.  Thought was gas/heartburn.  Took gas-x and stretched.  No relief.  Woke up at 2:00am with sharp pain in area below sternum.  Pain so bad, made me vomit.  Never felt like this before.  Went to Emergency Room.
20 minutes  post vaccine she notified us she was feeling lightheaded, nauseous and was afraid she was going to pass out. 911 arrived 30 minutes post dose and she was tachycardic but feeling better. She was cleared and left on her own.
Loss of consciousness with tonic-clonic seizure-like activity 20 minutes after vaccination, lasting 20 seconds but with post-ictal phase.
Pt was given an "extra hep B" shot in error. He became lethargic for three days after the vaccines were administered. Pt died from Adrenoleukodystrophy. His mother was not the carrier, symptoms of ALD began three months after vaccines.
12/30/99:Pt recv'd MMR vax.On 1/1/00:Pt developed facial flushing,petechia & purpura on the face,chest,neck,& upper arms.Pt was hospitalized & tx w/ IV antibiotics.It was noted that the purpura started to fade & areas looked bruised. 60 day follow-up received on 10/25/00 states the pt has recovered.
Information has been received from a female reporter concerning a 12 month old white male with no known drug allergies and no past medical history who on 06/12/03 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (reported lot # 0074M).  There was no illness at the time of vaccination. Concomitant vaccinations that day included a first dose of MMRII (Lot # 644709/1179M) administered SC in the left arm. On approximately 06/17/03, about 5 days later, the pt returned to the office with 15-20 papular lesions, a low grade fever and slight, clear nasal drainage. No other symptoms were noted. No treatment was required. No product quality complaint was involved. Follow up information indicated that on 06/18/03 the pt presented with a fever, a clear runny nose, and 15-20 papular lesions. Unspecified medical attention was sought. The outcome was reported as unknown. The outcome was reported as recovered. No further information is expected.