chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 01DA2ZA) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided. No laboratory data was provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No new information
Pt passed out after vaccine given, woke up for a few seconds then had a brief seizure.
suspected auto immune reaction exacerbated with Covid vaccination; sores developed in the mouth/were not healing; sores developed in the mouth/were not healing; mouth bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4163210-00.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)), second regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 1 wk)) and third regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "suspected auto immune reaction exacerbated with Covid vaccination"; STOMATITIS (non-serious), outcome "recovering", IMPAIRED HEALING (non-serious), outcome "not recovered" and all described as "sores developed in the mouth/were not healing"; MOUTH HAEMORRHAGE (non-serious), outcome "recovering", described as "mouth bleeding". The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of sores developed in the mouth/were not healing unknown onset and mouth bleeding with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event of suspected auto immune reaction exacerbated with COVID vaccination with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of sores developed in the mouth/were not healing unknown onset was not provided. The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was possible at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Autoimmune disorder which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Started with fingertip pain a week or two after getting second shot. A few weeks to a month after that joint pain in the fingers began to develop. 2-4 weeks after that muscle pain in the arms began to develop. During all of this I was seeing my primary care doctor and trying to diagnose these symptoms and was eventually referred to a rheumatologist, which I filled out in the report as the contact doctor. After running lab tests, he diagnosed me with Lupus (SLE). After starting treatment with hydroxychloroquine I have also developed pain around the chest/lungs when taking a deep breath in, which he said could be inflammation of the muscle lining around it but that has not been confirmed.
1 week after receiving MCV, patient started having outbursts of aggression & behavioral problems. She is hitting, biting, throwing & breaking objects at home. This has continued to the present day though there has been some improvement with time. Patient is nonverbal but previously could be redirected & parents cannot redirect through these episodes. She was biting occasionally before this but less frequent.
pt recv vax;4x4cm area of warm light rertyhema_ adjacent to site of inoculation;
03/08/21  - 2:15pm received shot - 3:00pm migraine - 9:00pm chills and nausea  03/09/21 - 3:00am sweats and body aches - body and joint aches and headache all day - 5:00pm chills and nausea 03/10/21 - 4:00am sweats and body aches - 6:00am no symptoms
Severe chills; Nauseous; Dizzy; Extremely fatigued, wiped out; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR), multivitamin (MANUFACTURER UNKNOWN), and vitamin d nos (VITAMIN D) all for unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 about 15 hours after the vaccine the patient developed severe chills for 3 hours, then felt very nauseous, dizzy, and extremely fatigued. This continued for the next few days. For about 24 hours the patient could not even keep water down without vomiting. Symptoms lasted about 36 hours. After 36 hours the patient felt much better, but still felt very wiped out for the next few days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, nauseous, dizzy, extremely fatigued and vomiting were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Pain in my left arm, left hand tingling, painful shoulder.  Range of Motion are severly limeted.  Have recieved a shot of toradal at Doctors office.  Also took a prescription of prednazone.  A nerve damage test is scheduled for november 27th.  I feel like I am losing strenghth in my left arm and shoulder.
day 3, swelling and pain at the injection site. Muscle swelling exactly the size of golf ball. Lasted 6 days.
HIGH SUGAR LEVELS POST VACCINATION; FLUSH FEELING ON FACE; FELT LIKE FEVERISH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included 5 blood clots, and concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known allergies and taking lit of anticoagulants for type ii diabetes mellitus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 2058A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included gliclazide for type 2 diabetes, metformin for type 2 diabetes, atorvastatin calcium, and metoprolol. On 03-MAY-2021, the subject experienced high sugar levels post vaccination. On 03-MAY-2021, the subject experienced flush feeling on face. On 03-MAY-2021, the subject experienced felt like feverish. Laboratory data included: Blood sugar increased (NR: not provided) Quite high. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from high sugar levels post vaccination, and the outcome of felt like feverish and flush feeling on face was not reported. This report was non-serious.
Patient woke up in the middle of the night with the shakes and chills. Patient had a fever. Patient went to the ER to have COVID and the test was negative. Patient also wake up with a bloody nose.
Patient states redness, fever, and swelling, arm swollen and extremely painful from shoulder to elbow.
Hands are numb constantly, face gets numb sometimes . Healthcare provider stated this was a side effect of the vaccination.
Swollen lymph nodes in right axillary area; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the right arm on 20Mar2021 at 09:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic with penicillin, cupro and erythromycin (MANUFACTURER UNKNOWN). Concomitant medications included unspecified birth control medications, acyclovir (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6198), via an unspecified route of administration in the left arm on 20Feb2021 at 09:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced swollen lymph nodes in right axillary area and itchy skin. The patient did not receive any treatment for the swollen lymph nodes and itchy skin. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph nodes and itchy skin was not resolved.  No follow-up attempts are needed. No further information is expected.
Rash on back of neck/moving throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of neck/moving throughout my body) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 032L20A and 032B21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced RASH (Rash on back of neck/moving throughout my body). At the time of the report, RASH (Rash on back of neck/moving throughout my body) outcome was unknown.            Treatment included  steroid cream, over the counter allergy medicine.   This case was linked to MOD-2021-406644 (Patient Link).
Severe dizziness to the point I was unable to walk or even sit without fear of passing out or falling and had to lay on the floor. Rapid heart rate, nausea, felt like blood pressure was going up a lot.  Afraid I was on the verge of having a stroke. Symptoms hit abruptly with no warning. Were severe for about an hour and then started subsiding.  Gradually felt better over the course of a couple of hours. After about 6 hours, symptoms completely gone and I felt fine.
Started coughing a lot, while feeling really achy and tired with headache ache sweating. Took Home COVID-19 test the initial day of symptoms and it was negative. Then the next day, the Home COVID-19 test was positive. Reached out to provider through healthcare systems Chart. Was prescribed Tessalon Perles. Tested positive for 3 weeks. Have recovered.
Pt recv vax on 1/5/99; on 1/12/99 pt exp fever & rash
Initial and follow-up information has been received from a licensed practical nurse (LPN), concerning a 20 year old (previously reported as 24 year old) female patient with no significant medical history, who on 24-APR-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (lot # 655617/1447F). On 25-APR-2007, the patient experienced nausea, started vomiting and had diarrhea. The patient's vomiting resolved after 4 days, on approximately, 29-APR-207, the date of recovery for nausea abd diarrhea was reported 01-MAY-2007. The nurse clarified that the evets did not require an office visit or emergency room treatment. No further information is expected.
Upper arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 at 02:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, the patient experienced upper arm soreness. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event upper arm soreness was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalization for heart palpitations on dates 5/4/2023-5/5/2023. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Headache, Arthralgia, FATIGUE, CHILLS, SORE THROAT Narrative:
No adverse reaction reported by patient. Client was administered vaccine dose number 2 before the recommended date to be administered.
mom on 27MAy93 for vax; mom stated pt cried a lot & got hot; did not check temp; mom states pt didn't cry but screamed all noc-approx 6-7 hrs;
I had inflammatory arthritis 50 years ago involving large joints when I had sarcoidosis. That resolved and I have had no arthritis symptoms for 49 years. After my COVID booster I developed MP joint arthritis in my R and L hands with swollen and red joints. It lasted about 10 days after beginning some anti-inflammatory medications. I continue to have soreness in those joints a month later with use and stress but it is much better.
Localized reaction at injection site, cold sweats, chills, delirium - 4 days, referred to physician.
Within 24 hours or less after my second vaccination, I experienced the following to severe degrees: Diaphoretic, Confusion, Profound Weakness, Ground Level Fall, Unable to Get Up with assistance, Called 911 and was transported to the ER via EMT's and discharged after seven hours.   Have not felt well at all since my second and final vaccination; have never gotten back to where I was before the second vaccination in my course post being diagnosed with Covid-19 in January 2021. Still having myriad issues such as: shortness of breath, fatigue, headaches, weakness. After catching Covid-19, I was bradycardic in the 50's, and after the second vaccination I am now experiencing tachycardic issues. Last week, I had a 48 cardiac patch monitor and it revealed 23 episodes of atrial tachycardia up into the 160's.
I felt a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt a little fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 ( "Maybe" (several tests yielded negative results)  ).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (I felt a little fatigue). At the time of the report, FATIGUE (I felt a little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported by reporter.  Patient reported that he might had history of COVID 19 (Several tests yielded negative results).  Patient informed that he was fine and not to worry. He informed that he was just anxious the previous day.  No treatment medication reported by reporter.   This case was linked to MOD-2021-363021, MOD-2021-362956 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up information received contains No New Information. On 27-Oct-2021: Follow up information received on 28-OCT-2021 and contains NNI
Became nauseous and fatigued at about 6:00 a.m. nausea dissipated by about 2:00 p.m. As of the time of this report, 5:50 p.m. on the same day, fatigue continued.
Patient was diagnosed with extensive venous thrombosis of portal, superior mesenteric, proximal splenic and possible infrahepatic veins, as discussed with consulting hematologist, most likely related to his COVID vaccination.
1325- Patient received Janssen vaccine dose at drive through clinic. 1335- Patient?s son reports his mother is not feeling well. Patient able to respond appropriately to questions asked, however her responses were delayed. Patient presented with a blank stare and slow movements. BP 100/80, P 42, 99% RA, R16. EMS requested through 911. Patient denied CP, SOB, HA, N/V. Lungs CTA with respirations easy, unlabored. Radial pulses thready bilaterally. Water given to patient, air conditioning turned on in vehicle. 1339- BP 130/90, P 74, 96%, R18. Patient alert and oriented x3, responding appropriately. EMS arrived, patient verbalized she was feeling better and refused EMS assessment. Patient left in own car accompanied by her son who was driving the vehicle.
PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.; PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm, all intramuscular 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) all with onset 24May2022 at 13:00, outcome "recovering" and all described as "PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course-- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythematous area approximately 10 centimeters and warm to touch. Swelling of supraclavicular node cellulitis and abcess at site of vaccination. Keflex and clindamycin, and motrin given. Service member seen by provider a few days later and was determined that a robust take was experienced.
Cold chills, stuffy nose, cough dizziness, tiredness, diarrhea,
Patient came into office today to receive her Meningococcal vaccine. Patient was administered the Hib vaccine. Patient did not need the Hib vaccine at this time. Patient is aware of the adverse vaccination event. Patient's provider, PA, and manager is aware of this adverse immunization event, as well. No harm to the patient today.
Developed appendicitis on Friday March 12th and had to have emergency surgery to have appendix removed
Systemic: Seizure-Medium, Additional Details: Patient has no history of seizures or other neurological disorders. Patient had a seizure lasting approximately 45 seconds within 2-3 minutes after receiving these vaccinations.
onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. chills and fever continued through next day. feeling better on 04/02/2021. still weak. was hospitalized in October 2021 for five days due to COVID.
17 year old patient received the vaccine; A spontaneous report was received from a healthcare Professional concerning a 17 years old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and Patient was told that she could not receive her 2nd dose until she had an authorization from Moderna to do so.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-03-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 03-03-2021, The Patient was told that she could not receive her 2nd dose until she had an authorization from Moderna to do so.   Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration   for mRNA-1273, lot #013A21A with no associated AEs.