chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body aches; Chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Broken wrist (Fell on ice and broke her wrist.) on 24-Dec-2020.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pyrexia: 37.77-38.77 degree Celsius (Inconclusive) Fever of 100-101 degrees F. In January 2021, SARS-CoV-2 test: negative (Negative) Negative.     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 events included Acetaminophen and ibuprofen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline.  Pt's wife had tested positive for Covid prior to him receiving Booster. (he was negative) After receiving Booster he developed Covid symptoms & tested positive on 1/19/22 He required hospitalization 1/25/22-1/26/22 for Covid Pneumonia & has been recovering at home & doping well currently
Vaccination was given Saturday, 7 June.  Mild swelling at injection site and typical burning post administration were the only immediate effects.  Saturday evening "the entire backside of my arm in the tricep are was bright red from the injection site to my elbow, probably about the size of a hand.  Swollen, red, sore and hot to the touch"  Member spoke to the doctor on Sunday and again Monday morning.  The doctor said to let him know if it got any worse.  Patient presented to the clinic today stating that the swelling had increased last evening and the redness had spread down his arm around his elbow.  The patient flew twice on Monday (patient is A-10 pilot) and reports that the swelling had increased quite a bit by that night.  Patient states "the swelling seems to be migrating down the arm, past his elbow."  He reports that his arm has been achy and sore since vaccination and that his elbow was swollen last night to the size of a baseball.  Additionally pt has had difficulty sleeping as a result.  Upon examination this morning, patient's arm is still red and swelling is still present though pt states it has decreased since yesterday evening.
On 4/4 I experienced fullness and loud ringing in the left ear. I woke up in the morning with light tinnitus in both ears. Very uncomfortable even though it is not too loud.
This spontaneous report as received from a pharmacist refers to an unspecified number patient of unknown age and gender. No information regarding the patient's pertinent concurrent or historical conditions and concomitant medications were reported. On unspecified dates (from 16-SEP-2016 to 29-SEP-2016), unspecified number of patients might have been vaccinated with unspecified number of doses of ZOSTAVAX subcutaneous injections (lot # L035283, with an expiration date of 15-DEC-2016) that had been improperly stored. Product information was received via product listing. The doses of the vaccine were exposed to a temperature of 44 degrees Fahrenheit for 10 days. There was no previous excursion and no Digital Data Logger was involved. No adverse effects were reported. Additional information has been requested.
Patient arrived to the ED on 10/21/2021 with shortness of breath x 3days
My arm was sore after about 6 hours. Later in the evening I started to experience body aches. This morning when I woke up: my arm still hurts, body aches, headache. I feel feverish but my temp is normal. I wool ibuprofen and it has helped.
Chest pain (feels like aches you typically have with the flu but just in the center of my chest). Started the afternoon of the vaccine and still occurring occasionally   Nausea lasted a few hour after vaccine  Arm soreness at injection site, lasted one day
About three hours later her tongue became numb and then her tongue and lips tingled. Returns to company with mild symptoms. Dr. evaluates her and administers Benadryl 50mg and Solumedrol 125mg IV push. It was kept under observation for about an hour. . Within this time he improved and was stable. Has remained stable
12/31/2022 Slight sore throat and a little postnasal drip.  At Home COVID-19 test on 1/1/2023, positive.  1/2/2023 Sought care with doctor.  Tested again with a PCR test which was positive.  Prescribed Paxlovid.  I experienced a slight cough, lethargy and aches.  Fatigue lasted a month, but all other symptoms ended when the Paxlovid prescription ran out.
Felt unwell after Covid Vaccine; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. The reporter mentioned while reporting her son's adverse events after the Pfizer Covid 19 Vaccine she mentioned that she was feeling unwell at the time also. No investigation assessment was provided. She declined to complete a report for herself. Stated she already did her own online. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
01/17/22 presents to ED for "Breathing Problem". PMHx of "AF on Eliquis, advanced dementia (AOx1 per EMS), COPD, throat cancer"
Acute congestive heart failure, unspecified heart failure type; Acute on chronic diastolic heart failure; Atrial fibrillation with RVR; CHF (congestive heart failure); Chest pain; Shortness of breath
Red blotches on her arms, face, back, thigh and chest areas; Itchy red blotches; Cannot sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Red blotches on her arms, face, back, thigh and chest areas), PRURITUS (Itchy red blotches) and INSOMNIA (Cannot sleep) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hyperthyroidism.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH MACULAR (Red blotches on her arms, face, back, thigh and chest areas), PRURITUS (Itchy red blotches) and INSOMNIA (Cannot sleep). At the time of the report, RASH MACULAR (Red blotches on her arms, face, back, thigh and chest areas), PRURITUS (Itchy red blotches) and INSOMNIA (Cannot sleep) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Treatment included an unspecified cream.
DAY AFTER VACCINE- PATIENT WOKE UP FEELING EXTREMELY LETHARGIC, MASSIVE HEADACHE, AND WHOLE BODY WAS IN PAIN (ESPECIALLY LOWER BACK AREA).   PATIENT HAS BEEN ON DEPO-PROVERA FOR 16 YEARS, AND NEVER EXPERIENCED BLEEDING. UPON ADMINISTRATION OF THE SHOT, PATIENT EXPERIENCED MENSTRUATION ONE WEEK AFTER BEING VACCINATED.   5 DAYS AFTER VACCINE- PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEVERE LOWER BACK PAIN, HEADACHE THAT WOULD NOT SUBSIDE, AND FEVER OVER 101. PATIENT WAS HAVING TROUBLE WALKING.  PATIENT REPORTS NOT FEELING COMPLETELY BACK TO NORMAL UNTIL APPROXIMATELY 3 WEEKS AFTER BEING VACCINATED.
Bilateral pulmonary embolisms requiring ICU admission. Patient presented to Emergency Room on 4/13/21 with presented to the ED with shortness of breath and chest pain. The patient notes that she developed shortness of breath, particularly with exertion, about 1 week prior to presentation. 2-3 days prior to presentation, she developed pleuritic chest pain on the right anterior chest. She denies any recent fevers, chills, weight changes, palpitations, cough, sputum production, abdominal pain, nausea, vomiting, diarrhea, constipation, lower extremity edema. She does note that she received her first dose of the COVID-19 vaccine on 3/16/2021 and was due for dose#2 on the day of admission. She denies a personal history of blood clots and denies current smoking, estrogen use, or recent surgery. She does note a history of blood clots in her sister, but she is unsure whether they were provoked or unprovoked. Patient required BiPAP on admission and was initiated on a heparin drip. Initial CT w/ some concern for R heart strain, however, echocardiogram showed no signs of R heart strain and she was hemodynamically stable. She was weaned from the BiPAP to Non-rebreather, and eventually nasal cannula. The heparin drip was transitioned to lovenox with plans to go home on a DOAC. Still hospitalized at time of event report.
Patient is a 85 y.o. female patient of MD with history of COPD, VTE, chronic pain syndrome, HTN, previous tobacco abuse,  and neuropathy who presented with shortness of breath and found to have COVID. Problem based management in the hospital is as follows:   Acute hypoxic respiratory failure due to Covid-19 Virus Infection COPD with Exacerbation Date of onset of symptoms: 12/7/2022. Date of covid positive test: 12/7/2022 Nonproductive cough, shortness of breath, generalized weakness, body aches and chills Vaccination status: vaccinated x4 CTPA with GGO in bilateral lower>upper lung fields O2 on adm up to  2L NC, now able to be on room air  Normal inflammatory markers.  Initially declined steroids due to GI disturbances but then agreeable as PPI were started together. .  Continued home Symbicort with scheduled and PRN Albuterol inhaler.  ID following.  Continued remdesivir.  Continued prednisone. PT/OT/UM   AKI, resolved Cr 1.29 on arrival. Down to 0.89 on day of discharge Resumed Hyzaar  Monitor renal function Avoid nephrotoxins   Hx of VTE With DVT 2014 and PE 2017 Continued lifelong Eliquis BID   Chronic Pain Syndrome Chronic OA, back pain and trigeminal neuralgia NARx with Percocet 10/325 mg 4x daily and Gabapentin 400 mg q6 hours  HTN resumed Hyzaar as BP elevated  Elevated Troponin TnT 22 on arrival in setting of AKI without CP MPI (6/2021) without inducible ischemia EKG with sinus tachycardic, PVC, artifact, but no ST changes  Depression Stable, continue home Wellbutrin   After 4 days of hospital stay, patient was doing well so she was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Vaccine given 10/16/00 AM. At 5 PM same day pt developed a fever of 104 F and swelling and erythema right upper arm and pain down to right hand X 2 days. On 10/18/00 fever 101 F. Motrin given for pain and fever. Follow up on 10/20/00 fever gone but still slight erythema and soreness.
After first shot, I felt nausea, fatigue, headache,tiredness, muscle pain on entire left side of body.  After second shot, I felt numbness, dull muscle pain in left arm, hand and foot.
2 days p/vax rt leg swelled >fifty cents piece & was red & hot to touch lasted approx 3 days then dec in size;
1 day after injection (10/2/12) developed high fevers, chills, nausea, body aches, weakness and fatigue and also had a noticeable racing heart.  This was documented in the ER as well, but before discharge it had declined to 100 BPM. Elevated WBC of 17.4 with a left shift. Blood cultures pending. Fatigued and sore. L upper arm around site of vaccine injection is very red and extremely tender. Dx: cellulitis and placed on Bactrim. 10/5/12: seen at office. Expanding, erythematous and tender left arm without fluctuance. Admitted to Hospital for IV abx for cellulitis.
BLOOD GLUCOSE WAS AT 350 MG/DL/BLOOD GLUCOSE REACHING 420 MG/DL; LOST CONTROL OF BLADDER, THIS CONTINUED ON AND OFF; NOT TO FEEL WELL; SHAKE/FREEZING; FEVER; EVERY MUSCLE IN HER BODY WAS SORE; LICHEN PLANUS AUTOIMMUNE; WAS VERY SORE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: implanted tooth, and lichen planus autoimmune. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lichen planus autoimmune, was very sore, and every muscle in her body was sore. On 10-MAR-2021, the patient experienced blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lost control of bladder, this continued on and off, not to feel well, shake/freezing, and fever. Laboratory data included: Blood glucose (NR: not provided) 350 mg/dL, 420 mg/dL, Body temperature (NR: not provided) 100 F, and Oxygen saturation (NR: not provided) not reported. On 11-MAR-2021, Laboratory data included: Blood glucose (NR: not provided) 140 mg/dL, 210-220 mg/dl range. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 22.5 antibodies, 173 antibodies, 66.9 antibodies, Body temperature (NR: not provided) 97 F, and SARS-CoV-2 antibody test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lichen planus autoimmune, every muscle in her body was sore, and fever, and the outcome of not to feel well, shake/freezing, lost control of bladder, this continued on and off and was very sore was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207694.
Client claims she had a stroke d/t covid vaccination. She developed symptoms of weakness, nausea/vomiting 5 days after receiving first dose of Moderna (February 4, 2021). On Feb. 5th client fell 3 times while at home and on Feb. 6th her daughter took her to the ED where she was diagnosed with having a CVA. Client was hospitalized 2/6/2021 thru 2/16/21. On 2/16 she was transfered to another hospital where she had another stroke and was discharged 2/23/2021.   Please note client received her second covid vaccine on 02/27/2021. Writer called client's PCP office and spoke with RN. RN verified client was prescribed medications listed in box 9 prior to stroke. RN also stated client had diagnosis of hypertension prior to stroke but did not have any record of medications to treat hypertension on file prior to stroke.
fever > 102 X 48 degrees.  Fever decreased with TYLENOL & IBUPROFEN.  Q 4 degrees.
Spontaneous nosebleeds. Severe and several times a day. Lasting around 30 minutes each time.
59 y/o F with hx of chronic intermittent CP with recurrence. No cardiac risk factors. EKG shows normal sinus rhythm.
Patient complained of a throbbing headache. His body temperature was stable around 96 degrees Fahrenheit. Four hours after administration, his temperature rose to 99.8 degrees Fahrenheit. He also complained of increased sweating. Motrin 800 mg oral was provided to the patient per request. Temperature returned to normal around 12:30 AM of 11/13/13. The patient no longer had a headache. He was still slightly diaphoretic.
2nd dose of Moderna given after expriation of 9/25/201 per medical center.; patient's 2nd had undergone a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Hyperthyroidism.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical  center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical  center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  2nd dose of Moderna given after expriation of 9/25/201 per medical  center. There is no expiration on the box or vials of the Moderna, vaccine was givn 9/27/21.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Significant follow-up contains patient's Race, dose details, vaccine facility, concomitant medications information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient had Rebound Covid infection after this for which he was recovering and no treatment was given for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/13/2021 @11:20pm- fainting episode with vomiting. Convulsing chills for 24 hours post vaccine. Arm heaviness with headache for 24 hours.  Morning of 2/15/21- butterfly like rash bilaterally on cheeks and nose resolved with 25mg diphenhydramine.
Patient was due for 2nd dose of Pfizer and was given Pfizer Bivalent booster dose instead.
Severe eczema occurred upon vaccination. Treated by pediatrician by the second month as "heat rash" despite lack of heat in April. Treated in later months by same pediatrician as "eczema" whereupon steroidal topical medication was prescribed.
45 minutes after receiving the second dose of the Moderna Covid vaccine, I began suffering with tachycardia, nausea, dizziness, and shaking throughout my body.  I went to the ER, was told it was side effects and anxiety, and sent home.  The symptoms continued throughout the evening.  I then began to have sharp pains in my extremities, shortness of breath, heaviness in my chest, numbness in my hands.  I went back to the ER on Sunday 5/16 as my condition was worsening.  They did a chest X-ray and bloodwork to rule out pulmonary embolism, gave Benadryl, Pepcid, and Ativan via IV which did not eliminate symptoms, and sent me home.  I contacted my primary care doctor on Monday  5/17, he increased dosages on steroids and Benadryl etc.  Symptoms continued, I met with my primary care doctor three additional times in the following two weeks as well as a cardiologist to address my rapid heartbeat, palpitations, and heart fluttering.  I wore a heart monitor for 7 days, from Monday 5/24-Monday 5/31.  I am awaiting results.  I am still experiencing all of the same symptoms wIth no relief nearly three weeks later.
Information has been received from an office manager concerning a 20 year old female who on 09-NOV-2006 was vaccinated with a dose of Pneumovax 23.  On 09-NOV-2006 the patient experienced swollen arm and redness.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information has been requested.
Seizure. Full body shaking, eye deviation, seen in ED and had fever to 101.2.  Consult by Pediatric Neurology. This was the first of two seizure with fever events following vaccines at 2 and 4 months of age.
This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA006682: US-009507513-1805USA007506:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-APR-2018, the patient was vaccinated with a dose of expired ZOSTAVAX subcutaneous injection, lot # M038350, expiration date 06-DEC-2017 (exact dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent. It was reported that both ZOSTAVAX and sterile diluent were properly stored. No adverse effects were reported.