chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontaneous report from a contactable consumer (patient). This 53-year-old non-pregnant female patient received the first dose of BNT12B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unknown route of administration in the left arm on 26Jan2021 (at the age of 53-years-old) at 3:30 PM as a single dose for COVID-19 immunization. The patient's medical history included hypertension and penicillin allergy, both from unknown dates and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) from an unknown date for an unknown indication; amlodipine from an unknown date for an unknown indication; fish oil from an unknown date for an unknown indication; and vitamin B complex (VITAMIN B 50) from an unknown date for an unknown indication. The patient previously took levofloxacin (LEVOQUIN) on an unknown date for an unknown indication and experienced allergies; and influenza vaccine on an unknown date for an unknown indication and experienced pain. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported experiencing left arm very sore up through left neck; not red just aching and pain through the first night post injection. The patient reported being still sore on day two; much more pain than flu shot previous experience. The event was reported as non-serious and did not require hospitalization. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The clinical outcomes of left arm very sore up through left neck were recovering. It was also reported the patient was not diagnosed with COVID-19 prior to vaccination and that the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
subcutaneous lump, redness and pain started 3 days after vaccine was given, pain still present 4.5 weeks after vaccine was given, and child reports pain in arm with movement (not in shoulder joint), subcutaneous mass measures 1.5 cm and mom reported this has increased in size since the initial lump appeared 3 days after the vaccine.
This spontaneous report as received from a 70 year old male patient who was physician. The patient had drug reactions/allergies to APRESOLINE and sulphonamide. The patient has no pertinent medical history. On an unknown date the patient mistakenly dropped "1 or 2 drops" of ZOSTAVAX onto an open cut on his right thumb while drawing up ZOSTAVAX (indication: accidental exposure). Concomitant therapies included EDARBI, FLOMAX, and NUVIGIL. On an unknown date, the physician stated "2 weeks later" he developed shingles on his "right side which eventually spread all the way up to the right side of his face". The physician stated he had "minimal pain" and self prescribed VALTREX and FAMVIR. The physician stated "I have 2 patches of vesicles that were still present in their tertiary phase". None of lab diagnostics studies were performed. No medical attention was sought. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Rash all over my neck.  Severe sore throat, runny nose, headache.  I was out of work for two days.
11:32, RRT called to assess 46 y/o female in post vaccine area with c/o difficulty swallowing and feeling of warmth to bilateral upper arms and bilateral lower extremities, shin area.  Husband was present/driver of the vehicle. Pfizer vaccine had been given at 11:09 A.M. and symptoms began at 11:30 A.M. Patient w/no prior medical hx or chronic conditions and does not take any routine medication.  PHN assessment revealed: awake, alert and oriented x3, able to participate in assessment interview w/ease, no visual oral swelling/discoloration of mucus membranes, moving all extremities freely/warm to touch, no s/s of SOB, or change in sensorium. Vitals signs WNL. Monitored for an additional 10 in post vaccine area, all symptoms resolved, stable, discharged at 11:50 without further incident.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient received a dose of PROQUAD (Merck) (lot # H015643, exp 23-FEB-2014) that was exposed to refrigeration temperature for 168 hours; at the same time, the patient also received a dose of (Merck) VARIVAX (lot # H006952, exp 16-MAR-2014). The nurse stated, "Maybe the MM-R II component of the PROQUAD was still good, and the patient may not have to be revaccinated." This vaccination session occurred on 19-DEC-2012. It was unknown if the patient sought medical attention. No adverse effect has been observed or reported. Additional information has been requested.
Within a few hours after receiving her first and only Prevnar injection at the well baby visit on 01/25/01, the patient developed a high fever of 104. and a seizure. The patient was taken by ambulance to the hospital where additional seizure activities occurred. She was sent home after her ER observation on Tylenol and Motrin.
BLACK & BLUE, HARD LUMP AT SITE OF INJECTION, RED STREAK FROM SITE TO ELBOW NO FEVER, NO STOMACH UPSET & NO DIARRHEA.
Initial report was received from a healthcare professional on 20 September 2013. A 67-year-old female had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the emergency room (ER) and was seen by her oncologist. She presented with coughing up blood, bruising and a fever. The patient died four hours after arrival to the ER. There was no bleeding or bruising at the injection site after vaccination and a 1 inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9, hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN, acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide (HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems. Outcome was fatal. Documents held by sender: None.
during injection patient said his arm felt tingly, shortly after injection patient said he didn't feel right, said he felt dizzy, light headed, I offered him water, before getting water he fell down at pharmacy counter, I offered to call EMS but patient refused, I helped him to waiting room, gave him water, he sat for 20 minutes for further observation, said he felt better after drinking water, offered to call someone to pick him up but he refused, said he felt better, patient decided he was ok to leave, I called to check on him and he had made it back to work ok and was feeling normal again, patient then came by store later around 6 pm to shop and said he was still feeling ok
Extreme pain and stiffness in neck.  Has persisted four months later.  Am in the care of an orthopedic physician and a physical therapist as a result.
Child was seen in a clinic for marked swelling, redness on right leg at injection site (approximately 8 inches long and covering most of the thigh). The child was seen in the ER with swelling  that started approximately 24 hours post injection. The pt saw an MD the following morning for follow-up. Pt is on antibiotic and was dx with cellulitis.
HIGH BLOOD PRESSURE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported.  On an unspecified date, the subject experienced high blood pressure, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and high blood pressure was not reported. This report was non-serious.
During 1st vaccine, I had COVID arm after about 1.5 week and lasted a week. Aside from that, all was fine. The day after the vaccine 4/17/21 I had body aches, nausea. Today, 4/18 I had raised rash with big bumps all over my body. I?ve taken Zyrtec gel caps per urgent care and itching has stopped. Bumps are still present.
Arm swollen from shoulder to elbow. Very red and hot to touch. Entire swollen area is hard. Painful and itching. Joint pain all night in leg, foot, knee and arm. The next day swelling extended to forearm. Hotness, redness, swelling, pain and itching continue. Painful to move or touch arm.
Redness and swelling around injection area immediately after shot, lasting one week. Soreness in left arm joint lasting at least 3 weeks - ongoing.  Can not lie on left side without pain in shoulder joint.
The patient was vaccinated with both vaccines then she proceeded to sit down. Less than 3 minutes had passed when she tells me that she is bleeding. When I look at her, I see that she is bleeding from her nose and I give her a gauze. But I see that the bleeding was a lot and it didn't stop. We waited a few minutes and the nosebleed continued and it was heavy. Since it didn't even stop, the patient was told that she had to go to the hospital.
In the evening I had body aches, chills, headache and fever of 101.  The next day fever lessened but headache persisted.
Fever, muscle aches, nasal congestion, eye pain and dryness, fatigue.
per mom pt started uncontrollable high-pitched screaming @ 4PM until about 5-530PM;pt recovered p/crying-mom stated pt was tired but no other problems;felt sl warm early 13SEP96;pt given APAP & mom checked on pt but seem OK now;
Fever started 4:00am reaching 101 degrees. The day after the injection symptoms kept patient from pursuing normal activities. Patient took ibupropen to lessen symptoms. Symptoms were gone by the morning of 1/20/23.
"FLOATER" APPEARED IN MY EYES.  THE VISUAL WAS A STRING OF CONNECTED, DIAMOND SHAPED FLASHING LIGHTS IN THE LEFT PERIPHERAL FIELD OF VIEW.  IT WAS VISIBLE WITH EYES BOTH OPEN AND CLOSED AND WAS VISIBLE FROM EITHER EYE.  PART OF THE STRING WAS AT THE SEVEN O'CLOCK POSITION IN THE FIELD OF VIEW AND WAS SO INTENSE THAT IT BLURRED OUT WRITTEN TEXT AS I WAS TRYING TO READ.  THE SYMPTOM HAD COMPLETELY SUBSIDED BY 8:00 AM, MAKING THE DURATION NO LONGER THAN 28 MINUTES.  I HAD NOT BEEN EXPOSED TO BRIGHT LIGHT PRIOR TO ONSET OF THE SYMPTOM.  SINCE IT SUBSIDED, I DID NOT REPORT IT TO CLINIC PERSONNEL.  AFTER DISCUSSING IT AT WORK I WAS ENCOURAGED TO SELF REPORT THE EVENT.  I HAVE NEVER HAD AN EVENT OF THIS NATURE BEFORE.
Initial unsolicited report received from a Pharmacist on 05-Oct-2015. This case involves a male patient (age was not reported) who was vaccinated with a intramuscular third dose of FLUZONE HD (batch number- UI478AB, expiry date- 09-May-2016 and site of administration was reported as unknown) on 01-Oct-2015. It was reported that patient received two previous doses of vaccinations. Patients illness at the time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included Amoxicillin and VICODIN as previous drugs. Other medical history and concomitant medications were not reported. On 02-Oct-2015, next day after vaccination, the patient experienced painful redness on both hands and feet which got worsened on 03-Oct-2015. Patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was not recovered from the events. Follow-up information received from a pharmacist on 04 December 2015. This case involves a 68-years old patient who was vaccinated with a dose of FLUZONE HD in right deltoid. The patient was vaccinated at private doctor's office/hospital. the patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergic to amoxicillin causing faintness, allergic to VICODIN causing chest discomfort, diabetes, cardiomyopathy, hypotension and hyperlipidemia. Concomitant medications included Aspirin, Furosemide, Lisinopril, Pravastatin, and Triamcinolone topically. On an unknown date, following the vaccination, the patient was diagnosed with erythema multiforme after developing painful planus and palmos lesions. The patient had ER visit on 03 October 2015 and was admitted to hospital. It was reported that there was no changes in diet, medications and furosemide was stopped during hospitalization due to reports of erythema multiforme with it. On 06 October 2015, the patient was discharged from the hospital in stable condition. The patient was previously vaccinated with FLUZONE HD in 2013 and 2014 with no reaction. On 04 October 2015, C-reactive protein was 88.5. On an unknown date, the patient was recovered from the events. The reporter assessed the causal relationship with suspect vaccine as related by temporal history. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Raynaud's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allerigies: Erythromycin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a male patient who was vaccinated with a subcutaneous dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  Subsequently the patient developed swelling, tenderness, soreness and redness at the injection site.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Chills; body pain; migraine; headache; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 55 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Lot Number: EL9269) via intramuscular route, administered in Left Arm on 12Feb2021 at 17:30 (at the age of 55-year-old) as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications within 2 weeks after vaccination were reported as none. No known allergies were reported. Vaccination facility type was reported as Other. The patient had not received any other vaccine within 4 weeks prior to Covid vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Lot Number: EL9262) via intramuscular route, administered in Left Arm on 26Jan2021 (at the age of 55-year-old) as a Dose 1, single for COVID-19 immunization. She mentioned that with her first dose (26Jan2021) she did not have any reaction, but with her second dose (12Feb2021) well past a few hours she began to feel chills, body pain and migraine, headache. Since vaccination the patient was not tested for Covid. No treatment medications received for the events. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
In about a minute, ears "closed off", quickly became dizzy,  feeling like going to "pass out". Some nausea. Indicated he had never experienced this with any other injections.
She began having fever and bloody stools on 1/1/15.  Was taken to Dr's. office on 1/2/15 in the afternoon. From there she was sent to the Emergency Room to rule out intussusception.  Was seen by pediatric hospitalist in ER.  Ultrasound was done and confirmed intussusception.  Pediatric Surgeon was called.  Attempted contrast enema was unable to reduce the intussusception, so was then taken to OR emergently and had surgical reduction.
Sweating, feeling dizzy. Don't know if fever, no rash or swelling.
After second dose of MODERNA Covid-19 vaccine administration, patient reported persistent chest pain including palpitations and nausea.  911 activated at 11:36am and arrived at facility at 11:48am.  EKG completed by paramedics.  Patient was then transported to emergency room via ambulance.
Back pain; Leg pain; Right knee swelling; foot numbness in both left and right feet; Light headed; Felt odd; Tired; Queasy; Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route of administration in right arm on 12Mar2021 at 13:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The medical history included lower back disc surgery on 12Mar2014 was successful but had low level pain on right side and constant slight numbness in right foot 3 small toes and high blood pressure. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril (MANUFACTURER UNKNOWN) 20 mg daily for high blood pressure. The patient received no other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 13:15, the patient felt light headed and felt odd initially after injection. At 1-3 days felt tired , queasy and experienced sore arm. On 15Mar2021, at 3-4 days the patient experienced back pain and leg pain, right knee swelling, foot numbness in both left and right feet  which made the patient difficult to be active and experienced continued same symptoms as day 1-3. At 7-10 days, the patient was mostly back to normal. The patient did not receive any treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of light headed, feeling abnormal, tiredness, queasy, painful arm, back pain, leg pain, swelling of right knee, numbness in feet was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Felt dizzy and light headed immediately following injection Had flu like symptoms from 1pm through 9pm I took 1,000 mg Tylenol at 5pm Developed generalized, all over body severe itchiness at 9pm Took Benadryl at 11:45pm Woke at 6:00am on 1/23/21 with continued all over body itchiness, although more mild/moderate Reporting at 6:55am on 1/23/21
Fever - 100 degree, lasted all day, headache, upset stomach, fatigue, ache in muscles and joints
Syncopal episode, c/o nausea, heaviness in arms.  BP 90/60 pulse 68 Resp. 20 5 minutes after injection. After arrival at her home, she c/o nausea and vomiting that lasted until late evening.  Also c/o arm soreness at injection site.
Pt. came to health dept. 7/16/10 with large 1"x2" wheal on outer upper (R) arm where VARIVAX #2 had been placed on 7/15/10. Area was "hot and swollen". Pt. denied other symptoms at this visit and was advised to use ice pack.
90-year-old male, who has a history of atrial fibrillation, benign prostatic hypertrophy, congestive heart failure with coronary artery disease and cerebrovascular disease among other comorbidities. Resident of a group home and was brought to ER with one week of decreased appetite and generalized weakness. CXR with PCP showed pneumonia and he was started on antibiotics. Family stated that since then he has not eaten or drank anything. They state he is not acting like himself and is overly tired. He tested positive for COVID upon admission to the hospital.
Information has been received from a physician concerning a 33 month old white female with no known allergies or medical history, who on 14-JAN-2005 was vaccinated in the right thigh with a dose of Varivax (lot # 648317/0439P). Concomitant vaccination included a first dose of MMR (lot # 647282/0345P) given in the left thigh. There were no other concomitant medications. There was no illness at the time of vaccination. On 07-OCT-2006 the patient presented to the physician's office with shingles that appeared below her left breast on the chest, also reported as herpes zoster on the left chest wall, T7 and T8 dermatomes. It was reported that it did not seem to be painful. At the time of the report the patient had not recovered. It was reported that the patient has not had adverse events following prior vaccinations. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Developed hives on face, neck, chest and stomach on 4/20/11-she took Benadryl and hives gone on 4/24/11. Pt. states had mild sore throat, headache and tired. Didn't call pmd.
7cm X 11cm erythema and induration at injection site. Also, tender and warm to touch on 1/10/03. Injection given 48 hours earlier. TX: Benadryl 50mg bid X 2 days, ice on and off X 24 hours.
Chills and fever about 14 hours later. Resolved in a day.  Aches all over that didn't respond to OTC pain meds. Resolved in 2 days.  Headache a day later . Resolved in a day.  Swollen, warm rash at infection site about the width of a softball.  Started a day after vaccine. Ongoing. A deep ache as well at rash site.
pain; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE RASH (injection site rash). On an unknown date, the patient experienced PAIN (pain). At the time of the report, VACCINATION SITE RASH (injection site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Received.   Reporter did not allow further contact
Severe chills, severe joint aches, fever, trouble standing, disorientation, nausea, headache, swelling, pain at site of injection   All symptoms persistent despite taking ibuprofen, fluids, and electrolytes
We received on 24 JAN 2008 from a healthcare professional the following information: A 71-year-old female patient, born on 16 SEP 1936, was vaccinated i.m. with Fluvirin (batch no. unknown) on 09 OCT 2007. The patient experienced severe bruising on the extremities. It was reported that the patient experienced idiopathic thrombocytopenic purpura the last 2 years after vaccination (see cases MA2008-0090 and MA2008-0091). The outcome is unknown.
Patient was brought by her mother to the hospital for suicidal ideation and mental health evaluation . Patient tested positive for COVID 19, her chest x-ray was normal. Patient did not have any symptoms from her covered positive situation she was not hypoxic on.  She did not require any dexamethasone for any COVID specific medications. Follow up COVID test on 2/8/22 was negative.