chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Septic arthritis in elbow. Telephone call to doctor's office revealed that on 1/20/02, he received a telephone call from the pt's mother, complaining that the pt's upper right arm was swollen, she was examined and admitted on 1/20/02 with a dx of cellulitis and discharged on 1/26/02. The pt was operated on her right elbow and fluid drained out. On 2/19/02, spoke with mother and she stated on the night of 1/20/02, the pt's right arm began to swell and then went to the elbow. As per mother, dx: strep in the blood stream due to the possibility of her immune system being lowered because of the immunization she received on 1/16/02. Pt was discharged from the hospital with Rocephin 470mg administered through IV once a day.
I received my first Pfizer booster for COVID-19 on 11/26/2021. On the evening of 8/5/2022, I began experiencing mild headaches and head congestion. On 8/6/2022, I developed a fever of 99-100 in the afternoon. I also had mild fatigue, sore throat, and began sleeping a lot and drinking hot tea. Overnight on 8/6/2022 and 8/7/2022, I felt like I had a strong flu. I may have taken Tylenol to reduce the fever, but I don't remember for sure. By the time I woke up the morning of 8/7/2022, I knew that my fever had broken, because I was drenched in sweat. I continued resting for the rest of the day. I was still sick, but I felt less sick than I had on 8/5/2022 or 8/6/2022. I continued to check my temperature throughout the day, and it stayed at 99 degrees, which is about a degree higher than my normal temperature. I took two doses of Tylenol that day to keep the fever at bay. I also developed a cough on 8/7/2022. On 8/8/2022, I felt a little better, but there was no change in symptoms. On 8/9/2022, I took a home antigen test for COVID-19, which yielded a positive result. I continued to self-isolate, and the symptoms gradually diminished over the following 5 days. However, the cough lingered. On 8/15/2022, I went to an urgent care clinic to get relief for my cough. I was prescribed a 10-day supply of benzonatate, which I began taking that evening. My cough symptoms improved. On 8/19/2022, I took another home test and got a negative result. After I finished the benzonatate, I still had a little of the cough left, but I had still experienced significant relief.
migraine; body aches; arm ache; arm felt heavy; strong headache; chills; fever of 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy) and HEADACHE (strong headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (cancer remission) and Immunocompromised (immune system is very low.). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), CALCIUM, COLECALCIFEROL (CALCIUM +D3), ASCORBIC ACID (VITAMINS C), MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F). On 22-Feb-2021, MIGRAINE (migraine), PAIN (body aches), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (arm ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 100.2°f (High) fever of 100.2°F.         The treatment information was unknown   This case was linked to MOD-2021-320164 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Second dose is scheduled 15 days after first dose"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as ""arm is very sore", it "hurts real bad""; MOVEMENT DISORDER (non-serious) with onset 09Mar2021, outcome "unknown", described as "he "can't raise his arm""; MYALGIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "muscle pain". Therapeutic measures were taken as a result of pain in extremity, movement disorder, myalgia. Additional information: The patient was scheduled to have his second dose on 20Mar2021 explained to caller was earlier than the recommended period of 3 weeks between doses. He reported that 4 days after the first dose on 05Mar2021 his whole arm is sore. He is concerned about what to do, if he needs to take the second dose of the vaccine or not. He also wanted to know how long the sore arm is going to last. He says he put some ice on it. He will be seeing his doctor on Monday. He said that he can hardly move his arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
18OCT95 started exp gen itching a few hrs p/vax;itching became very severe first noc;no rash on body-no reddness or swelling @ site;itching cont now & also c/o inability to concentrate, swelling around eyes, mild SOB, fatigue, sleeping
Child received vaccines 9/1/10. Spoke to mom 9/7/10 she had left a msg on phone patient's (L) arm hot to touch, painful to touch, whole bicep area swollen, no fever.
pt recv vax 29APR98 approx 10AM & approx 230PM pt had an episode of turning pale while crying w/cyanotic lips;p/being picked up & held pallor subsided p/10min;
50 cent piece area on RA with increased warmth, erythema & pain/itching.
Patient told provider he never received vaccination. Patient did receive vaccination year prior. Medication error occurred. Provider and patient notified. No issues at this time and no treatment needed at this time.
This spontaneous report as received from a nurse practitioner refers to an 11 year old female patient. The patient's medical history included syncope, 5 or 6 years ago due to hypoglycemia and drug reaction/allergies were none. On 04-AUG-2015, the patient was vaccinated with GARDASIL (lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). Concomitant medications were none. On 04-AUG-2015, the patient fainted or lost consciousness. The patient was repositioned in a supine position and her blood pressure was measured. Her blood pressure after she lost consciousness, was lower than it had been before she received the dose of GARDASIL. After an unspecified period of time, "a few minutes" the patient regained consciousness and the patient received some juice when she was able to sit upright. The patient received four additional other unspecified vaccinations after she was able to sit upright, and she did not experience any "light-headedness" or loss of consciousness after she received the other four unspecified vaccinations. The patient was released to home after this experience. The outcome of the events was reported as recovered on 04-AUG-2015. The relatedness of the events with the GARDASIL was not provided. This is one of several reports from the same source. Additional information has been requested.
developed fever ranging between 99 and 100.9 degrees fahrenheit; Some stomach discomfort,; body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 55-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 in left arm on 19Feb2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included mixed connective tissue disease and Hashimoto's hypothyroidism. The patient had no allergies to medications, food and other products. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 29Jan2021 at 14:00 (at the age of 55-years-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Feb2021 at 12:00 (approximately after 20 hours), the patient experienced fever that ranged between 99 and 100.9-degrees Fahrenheit, stomach discomfort, body aches and chills. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcome of the event fever was recovered on 20Feb2021 at 20.00 (Approximately lasted for 8 hours), for events stomach discomfort, body aches and chills were recovered on an unknown date in Feb2021.    No follow-up attempts are needed; information about lot number cannot be obtained.
Pt developed a 11cm X 12cm red, enlarged, hot area covering entire deltoid of left arm. No RX. Symptoms resolved spontaneously.
I got the J&J vaccine at 9:31am on 4/4/21. At 4:30pm I began to feel lethargic and by 7:00pm I had chills so severe that a heating tower, 2 blankets and a comforter did nothing to warm me. I pulled muscles in my neck and back because I could not stop shivering. Around 9:30pm the shivering stopped and I became extremely overheated - I took tylenol every 4 hours (which was all I could take because I am breastfeeding) and my temperature still reached 103.8 and I threw up several times throughout the night. My fever broke around 4am. I have had stomach pain every day since then and do not know when it will stop or what to do about it.
Upon arrival, patient notified vaccinating RN that she became dizzy after she received her first dose. RN offerred for patient to lay down on the cot for the injection. Patient declined. Patient was vaccinated  at 0930 and escorted to an observation chair. At 0940, pt complained of feeling dizzy. Patient was helped to the cot and placed in a supine position.  Initial vital signs: 120/64  P=88, Resp-16  O2Sat-RA Skin cool & dry 0945 Pt stated that she felt back to normal.  114/64, P-83-91  O2sat-100% Skin cool & dry        Pt helped to a sitting position on cot. 0951  118/71, P-96  O2Sat-98%   Skin cool & dry. Patient stated she felt normal and told her mother that she felt ready to leave. Patient instructed to drink lots of fluids and avoid strenous activities today. Patient helped to a standing position and stated she felt fine. Pt assissted out of clinic by
ED visit for acute pancreatitis - treated and released. Admitted to hospital on 12/31/21 due to severe abdominal pain, nausea, and vomiting. She was found to have acute biliary necrotizing pancreatitis. She was made NPO and treated with copious IVFs and 3 days of meropenem. Her diet was advanced slowly. She was seen by general surgery and plan will be to have cholecystectomy on 1/12/22. She did have significant watery diarrhea during the later portion of her hospitalization. C diff was negative and this slowly improved with imodium. It was almost certainly due to her pancreatitis healing. On 1/9/22, patient was feeling well and was free from abdominal pain and nausea. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
A few hours after vaccine was given pt had menstrual spotting (she is on continuous oral contraceptives) which she felt was due to the shot. I discussed with pt and suggested this was not likely due to the shot but she is convinced it was due to HPV shot. Later pt had significant arm pain and has had night sweats each night for past 3 nights after immunization. No fever.
slight headache; painful weak left arm/shoulder socket; painful weak left arm/shoulder socket; painful weak left arm/shoulder socket; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscularly, administered in arm left on 02Mar2021 13:00 as dose 2, single for COVID-19 immunization (age at vaccination: 64-years-old). The patient medical history was not reported. Concomitant medications included zinc taken for immune enhancement therapy from an unspecified start date and ongoing, acetylsalicylic acid (ASPIRIN (E.C.)) taken for thrombosis from an unspecified start date and ongoing; colostrum taken for immune enhancement therapy from an unspecified start date and ongoing, allium sativum bulb (GARLIC EXTRACT [ALLIUM SATIVUM BULB]) taken for immune enhancement therapy from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date: unknown) via Intramuscular, administered in center of left arm on 09Feb2021 16:15 as dose 1, single for COVID-19 immunization and experienced lower back pain, soreness, chills and weakness in body. On 02Mar2021 the patient experienced slight headache and painful weak left arm/shoulder socket. Sometimes, have to use right arm to help move/lift my left arm, especially when it's been in one position for a while. It was reported that the patient was in process to seek physical therapy. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Intense muscle pain in an area 6 inches around vaccination site. I was warned about this and expected it. However, I also woke up with hives all over my body the next morning. I self treated with oral BENADRYL and topical CORTIZONE (I used several tubes) and the hives went away. However, they have reoccurred multiple times in various areas in the last 32 hours, especially while I sleep, sit still or wear tight clothing. Glaxo didn't seem interested in much of the details of the hives or sharing any information they may have of similar reactions. They just kept referring me to the package insert, which I didn't have. I was given the CDC Vaccine info statement dated 2-12-18 which warns of hives as a sign of a severe allergic reaction. The Glaxo rep claimed their product info didn't mention hives at all.
This spontaneous report as received from a nurse practitioner refers to an adult female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (lot # and expiration date not reported), 0.5 ml, subcutaneous because the patient had no immunity to varicella. On an unknown date, the patient developed redness and 2 small chickenpox lesions near the injections site. This occurred 10 days after vaccination. The patient recovered 2 days after onset of symptoms. Patient had not received any treatment for her symptoms. Additional information has been requested.
p/ pt recv vax approx 7days later the arm was warm to touch w/a 4x3 cm section & puncture wound at the inject site lasting approx 10 days
Swelling, redness, itching at injection site - (R) deltoid. Afebrile. No problems breathing.
red itchy bumps on both arms and large bumps that have turned white on left elbow and red itchy bumps on right hand.
Tachycardia (180+/-) starting approx 7-10min post injection.  Was taken to medical monitoring area and held for approx 45min.  Severe hypertension (approx 180/110 initially) was noted.  Both improved over monitoring period, but did not resolved.  Continuing to monitor both at home.  Still experiencing random intermittent elevations to both parameters 3 days post injection.  Also experiencing inj site rxn starting 12 hrs post and still present at 3 days post.  Redness, swelling, pain (reducing), and now mild itching.
Patient received Moderna on 2/3/21 and 4/20/21. Was admitted to the hospital and COVID positive on 5/16/21 for severe sepsis secondary to COVID 19 viral infection or UTI.
On 11/17 staff reported that they have been exposed to COID-19 over the weekend. We performed rapid and PCR COVID-19 tests in the parking lot of our facility. The rapid test came back positive and we are still waiting on the PCR results. No symptoms to date
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 10-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of  24 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 2 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 15-MAR-2018, the patient was administered an improperly stored VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
got injection in left arm, as day went on starting to hurt,  swelling at site,   About 12:30 a.m. that night I woke up  shivering, teeth chattering,  whole body aching, ribs on left side very painful, horrible headache, nauseous, could not get comfortable, very, very thirsty, could not get up to get drink or get more blankets.  All these symptons went on all night till about 7:00 a.m.   Got up at 8:30, most everything gone except bad headache,  took Ibuprofin through out the day, never went all the way away but was tolerable,  had absolutely no energy all day, sat in chair, watched t.v., slept soundly that night, had slight headache on Sun., eventually went away.  I have never been that sick ever.  I have never taken any flu, pneumonia, shingles, etc. vaccine in my life. As i lay in bed that night, I was real sorry I took this one !!
3 inch red hardened area at injection site, fever (up to 101.8) that persisted despite antipyretics, nausea and vomiting, chills, sweats, loss of appetite, severe soreness and pain at the site, intractable headache.
Patient presented with two dime sized nodules in left arm that she state "itch and hurt constantly". She says they have been there since 11/08/18.
Nauseau - 5 am 8-25 Dizziness - Ongoing for 48 hours Left armpit lymph node swollen and painful to touch - ongoing for 48 hours
This case was reported by a consumer (the subject's mother) and described the occurrence of allergic reaction in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included eczema. Concurrent medications included Vitamin. On 26 August 2013 at 14:00 the subject received unspecified dose of INFANRIX (details unknown). On 27 August 2013 (in the morning), 1 day after vaccination with INFANRIX, the subject experienced allergic reaction. The consumer reported that the subject's eczema "normally flares up when he has a vaccine but not to the point it did this time". It was not specified whether the allergic reaction corresponded to the eczema flare up, or if other events had occurred. The consumer reported that a healthcare provider was consulted regarding the events. At the time of reporting, the allergic reaction was improved and the outcome of the eczema flare up was unspecified. Follow up was received on 29 August 2013. The case has been upgraded to serious. On follow up, the mother reported that the subject was "severely allergic to bovine casein." The mother reported that the subject "recently had an injection of INFANRIX" and reported anaphylactic reactions "to it". The mother reported "it to her physician but was not satisfied with his response." A physician or other health care professional has not verified this report. Additional information was received on 29 August 2013 from the mother. The mother stated that 1 day after vaccination with INFANRIX, the subject experienced anaphylactic reaction, hives, "hive-like itching", swollen (described as "swollenness"), swollen mouth, swollen throat, hyperactive (described as "became very hyper"), and feeling hyper (agitated) (described as "very 'hyper' and or agitated"). The outcome of all events were unknown. A physician or other health care professional has not verified this report.
pt recv vax 12OCT95 & 8AUG96 & exp a varicella rash w/18 lesions under, 1 lesions on face & 3 lesions on leg;also had low grade temp;
Headache, Diarrhea, NauseaVomiting, Chills, Injection site pain, axial pain Narrative:
shingrix powder was reconstituted with sterile water and administered to a patient; shingrix powder was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 3A3TC, expiry date 05-AUG-2024) for prophylaxis.   On 03-JUN-2023, the patient received the 2nd dose of Shingrix. On 03-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: shingrix powder was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: shingrix powder was reconstituted with sterile water and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Shingrix powder was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.