chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From 3 am he started with a high fever (102) headache and body ache. Have taken Aleve Extra Strength
About 8 hours after receiving the Jansen COVID-19 dose, the site around the injection point began to few sore and my entire body began to feel sore, especially at the joints. Furthermore, my heart rate became elevated and beat erratically. These symptoms continued for about 12 hours. I could not sleep overnight as I ached all over and my heart rate was rapid. The next morning, I began to feel much better. My heart rate began returning to normal, though my heart area still felt somewhat sore. By about 36 hours after receiving the dose, all of my side effects were minimal. By about 48 hours after receiving the dose, I had virtually no more side effects.
Day 1: extreme fatigue, mild fever (despite being on celebrex, cyproheptadine, fludrocortisone). Myalgias (full body aches, stiffness), chills. Soreness at site of injection.  Days 2 through 7: INCREASING fatigue, myalgias, chills. Most notable symptom is needing to sleep for 15 hours a night and STILL be exhausted.  Day 8: Left axillary lymph node so enlarged that I couldn?t place my left arm close to my body. Left sublingual lymph node also enlarged. Continued myalgias, fevers, and exhaustion. Called doctor. She said it was a side effect of the vaccine.  Day 9, 10, 11: Lymph nodes remained enlarged. Exhaustion continued.  Days 12, 13, 14, 15: Self medicated with 10 mg oral prednisone/day bc I could no longer handle the exhaustion and believed I simply had to have antibodies by this point. On day 15, left axillary lymph node normal.
Severe chills alternating w and 99.6 fever; 99.6 fever; joint pain; fatigue; Nausea; Vomiting, would vomit any water; No appetite; This is a spontaneous report received from a contactable consumer or other non hcp.A 59-years-old female patient received 2nd dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EN6204),via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00,at the age of 59 years old, as Dose 2,single for covid-19 immunization.Medical history included drug hypersensitivity,asthma,dust allergy and mycotic allergy from an unknown date and unknown if ongoing mold. Concomitant medication(s) included mometasone and levothyroxine taken for an unspecified indication,start and stop date were not reported.The patient experienced severe chills alternating w and 99.6 fever, 99.6 fever, joint pain,fatigue, vomiting, would vomit any water and no appetite on 11Mar2021 04:00. The patient underwent lab tests and procedures which included body temperature: 99.6 on 11Mar2021 and sars-cov-2 test negative: negative on 04Mar2021.The patient previously received her 1st dose of Pfizer covid 19 vaccine on 17Feb2021,10:00 am,lot number EL9266.The patient was not pregnant at the time of vaccination.The patient received other vaccines within 4 weeks of vaccination.The patient was not diagnosed with covid prior vaccination and not tested post vaccination.covid test name post vaccination was Abbott BinaxNOW Covid-19 Ag card.The patient received no treatment for the event.  No follow-up attempts are possible. No further information is expected.
Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose; Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose; This is a spontaneous report from a contactable nurse (the patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. Patient's family was sick with COVID-19, family was unvaccinated. Concomitant medications were not reported. Patient received pfizer covid vaccine several months ago. Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose. Events took place after use of product. Patient underwent lab tests and procedures which included SARS-CoV-2 test and was positive on an unknown date.  Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: As there is limited information in the case provided, the causal association between the events, Covid 19 and Drug ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Fever; Injection site pain; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via Intramuscular on 06Jan2021 08:00 at single dose in the left arm for COVID-19 immunisation. Medical history included Asthma. Concomitant medications were not reported. On 06Jan2021, the patient experienced fever, injection site pain, tiredness, chills, feeling unwell. The patient did not receive any treatment. Outcome of events was recovered on Jan2021.   No follow up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 02 July 2013. A child patient received only the DTaP/IPV component from PENTACEL vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Extreme pain in leg muscles, swelling of calves and feet, fever of 100.2. Pain relief with TYLENOL 500 mg 3xD. Very slowly getting better.
Headache 48 hours Fever 36 hours Arm swell and rash on arm at injection site to approx 2 inches above elbow - rash and itching lasted approx 1 week. Swelling lasted approx 3 days,  Scalp very sensitive to touch for approximate 1 week
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 12-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
12/22/08 patient called after hours with c/o fever, n/v/d since he received the flu shot on 12/18.  He told the nurse he would go to a local hospital.  I called and patient was not home.  Patient's wife stated that he was feeling better but that the arm where he got his flu shot was still red.  Will notify PCP and team nurse of condition for any f/u indicated.  12/23/08 presents to ACA for f/u on reaction to Pneumococcal vaccine administered to the L deltoid on 12-18-08.  States symptoms have resolved but rash on L arm remains.  Conveys that tricare was contacted by pt and PCP instructed pt to come in for f/u.  Alert and oriented x 4, steady gait currently denies pain.  12/23/08 chief complaint/present illness - patient is a 77 year old male in with c/o fever, and n/v/d after he received the flu shot on 12/18.  He went to a local clinic but did not require medication Tx other than Tylenol.  He is back in stating that he is feeling better but that the arm where he got his flu shot was still red.
24 hours after vaccine developed malaise, fatigue, flu-like symptoms including fever to 101.5F.  Rash on lower extremities - serpiginous and lacey most consistent with serum sickness like reaction.  Rash very classic for this, but unclear if flu-like symptoms and fever were typical immunogenic effects of vaccine vs SSLR.  Rash was not itchy and improved overnight prior to clinic presentation on 6/16 (vaccine on 6/14).  Took benadryl x 2.  Patient well in clinic with no residual fever and improved overall.  No treatment given in clinic and no medicine prescribed for home.
pt recvd vax 17JUN95 & 18JUN95 pt exp h/a & nausea;19JUN95 pt exp a lot of nasal congestion & discharge, yellow phlegm & upper resp infect sxs;felt like had the flu;19JUN95 exp body aches;back to nl in 5 days;
have been suffering with a very bad back ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (have been suffering with a very bad back ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (have been suffering with a very bad back ache). At the time of the report, BACK PAIN (have been suffering with a very bad back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a patient's mother via an online article regarding her 17 year old daughter. There was no relevant medical history or drug reactions/allergies reported. The article stated that "two years ago" the patient's pediatrician recommended the patient to get GARDASIL, which was given in 3 doses. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route, lot# and expiration dates unspecified). After the first dose, the reporter said the patient was fine but after the second dose the patient was sick within a week at the doctors with nausea which had not left her to this day. The patient said "I have nausea 24/7, dizziness, 24/7 muscle pain, weakness in my legs, back pain, joint pain. Some days I have to walk with a cane". "The events had been going on for the past two years". The reporter said "it was devastating for her, because she can't have a normal life". The patient's health got so bad after getting GARDASIL. At the time of reporting, the patient was undergoing IV treatments once per week. Outcome of the events and causality were not provided. This is one of several reports from the same reporter. Upon internal review, the events of muscle pain, weakness in my legs, back pain, joint pain were considered as disable due to some days the patient had to walk with a cane. Additional information is not expected as no follow up available.
Received the vaccine and I felt fine. I went home and laid and took a nap . When I woke up from my nap  my vision blurry. I still have blurry vision.   I have an appointment on Friday of this week I have an appointment with the eye doctor.
Patient was given Moderna Bivalent vaccine in September 2022 and had another Moderna Bivalent vaccine on December 21, 2022
Patient's both arms, hands, and fingers were all cramp up and couldn't move.  She was sweating and heart rate was 97.  After having some water and resting for 40-50 minutes she was able to move her arms, hands, and fingers again.  Her heart rate dropped down to 81.  She was able to get up and walk around the store using the shopping cart to finish her shopping with her boyfriend.  She did mention that she was under a lot of stress lately.  She had similar incident in 2009, her boyfriend thought it was due to dehydration.  Suggested her to follow up with her doctor.
pt recvd vax & w/in a couple of minutes exp a hypotensive react (BP 100//80), became pale & nearly fainted; pt was given OJ & the event resolved w/in 20 mins;
Stiff neck; Headache; Upper shoulder pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1st 48 hours - high fever - lethargic - ultra sensitive to loud sounds. Behavior deteriorated thru week at school that was "bizarre" for child including hitting and fighting.
COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.
Extreme pain in the shoulder began about 3 hours after the injection and has continued to the present, which is now one full week.  Range of motion also continues to be limited.  Probable diagnosis:  SIRVA, for ?shoulder injury related to vaccine administration??.
p/vax w/rash covering both arms & groin area;rash very itchy & appears to dry up w/the use of DPH;
RASH(RED AND RAISED BUMPS)ON TRUNK ONSET 3 DAYS AFTER ADMINISTRATION.  RESOLVING AS OF 11-5-03 WITH CONSERVATIVE TREATMENT.
Around her shoulder and around her back is all swollen; Pain started going to her back; Pain was initially on area where she got the shot; Upper arm (the area she got the shot) is all swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Around her shoulder and around her back is all swollen), BACK PAIN (Pain started going to her back), VACCINATION SITE PAIN (Pain was initially on area where she got the shot) and VACCINATION SITE SWELLING (Upper arm (the area she got the shot) is all swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Around her shoulder and around her back is all swollen), BACK PAIN (Pain started going to her back), VACCINATION SITE PAIN (Pain was initially on area where she got the shot) and VACCINATION SITE SWELLING (Upper arm (the area she got the shot) is all swollen). At the time of the report, SWELLING (Around her shoulder and around her back is all swollen), BACK PAIN (Pain started going to her back), VACCINATION SITE PAIN (Pain was initially on area where she got the shot) and VACCINATION SITE SWELLING (Upper arm (the area she got the shot) is all swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.  No treatment product was reported.   Reporter did not allow further contact.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Influenza vaccine. Previously administered products included nebulizer Concurrent medical conditions included chronic obstructive pulmonary disease and chronic bronchitis. In 2012, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to influenza vaccine. Additional details were received as follows: The reporter herself was the patient. In 2012, the patient had a flu vaccine and another flu vaccine over 65 years of age. The reporter stated that, she experienced a violent reaction to the flu vaccine received in 2012 (had almost all of the side effects listed on the form). After 2012, the patient did not receive the stronger vaccine. The physician's office and the county health department were unable to find out what ingredient caused the patient those adverse events. So, they could determine potential problems in future vaccines.
Shortness of breath. 12/11/ to 12/12 2021 with exercise intolerance combination with increased heart rate. Elevated Heart rate pounding heart and carotid artery?s on 12/13 2021 07:45 . Superventriclar Ectopy  with ER diagnosis of PVCs.
At 30 minute mark following vaccination, patient started to report problems swallowing.  No SOB or other swelling.
Info has been received from an RN concerning her 2 or 3 year old daughter who in 1998 was vaccinated, SC, with a 1st 0.5ml dose of varicella virus vaccine live. Concomitant therapy included acetaminophen (Tylenol). In approximately 2001 or 2002, the pt experienced breakthrough chickenpox. The case was considered mild with 20-25 lesions and involved a low-grade fever. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. Additional info has been requested.
1:20PM Patient C/O feeling nausea. Placed cool pack on neck BP:100/70 R:18, P:74 O2 Sat 99% temp:97.0 at 1:38pm. Pt denied nausea dizziness and light headedness. Pt stated "I feel better and I want to go home" Mom was with the patient. Pt cleared to go home.
PT EXPCD URTICARIA ON ARMS 3:10 PM, APPROX 6 HRS AFTER 1ST INJECT OF ENGERIX-B. 9:20 PM IN ER FOR TREATMENT OF RASH. GIVEN BENADRYL(IM) AND DISCHARGED ON ATARAX. 3-22-90 PERSISTANT ITCHING AND RASH VISIBLE ON ARMS.3-27-90 ARMS CLEAR NOSYMPS
3 in diameter rash around injection site. Warm, tender, swollen, red macular Papular rash. Three small blisters.
pt recv vax & devel a rash & a golf ball hard knot @ inj site; the area was very hot;the rash was very a small rash & did not resemble varicella;
had a blood clot; Initial information received on 15-Feb-2022 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves an unknown age male patient who had a blood clot while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer via Unknown route in unknown administration site (with an unknown strength, dosage, formulation batch number and expiry date) for immunization .  On an unknown date the patient developed a serious event of blood clot (thrombosis) (Latency : Unknown) following the administration of influenza vaccine. This event blood clot (thrombosis) was assessed as medically significant.  Action taken : Not Applicable  It was not reported if the patient received a corrective treatment for the event (had a blood clot).  At time of reporting, the outcome was Unknown for the event (had a blood clot).; Sender's Comments: Sanofi company comment dated 23-Feb-2022: This case concerns an unknown age male patient who experienced a blood clot after vaccination while receiving influenza vaccine. The time to onset was unknown. Additional information regarding condition at the time of vaccination, medical history, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
pt is DNR/DNI; pt had a positive COVID test on 1/21/22 in the nursing home; per the death certificate, pt died in the nursing home with causes of death being:  COVID 19, HTN, Dementia
headache; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported for a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache and nausea. The outcome of the events was unknown  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt received first covid-19 vaccine with Moderna. Pt was given Pfizer covid-19 vaccine for her second dose.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the health care professional (HCP) reported that patient (co-worker) underwent laboratory test for COVID-19 antibody test which was found to be negative (suspected immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196839 This case, from the same reporter is linked to 20211017311, 20210445531 and 20211007061.; Sender's Comments: V0: 20211017208- COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient came on 12-4-2020 at 2:12 pm. She indicated she has never had flu-shot and is first time receiving it.  She felt fine until that night. she indicated she cough for 1/2 hours, sore throat, shortness of breath, fever (102 oF), headache, nausea and dizziness. Her husband took her to the emergency room.