chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body Ache; Coughing; Sneezing; Sinus congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 at 10:00 as dose 2, single (Lot number: FK9893) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 01; manufacturer: Unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset Apr2022, outcome "not recovered", described as "Coughing"; SINUS CONGESTION (non-serious) with onset Apr2022, outcome "unknown"; SNEEZING (non-serious) with onset Apr2022, outcome "unknown"; PAIN (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Body Ache"; PYREXIA (non-serious) with onset 24Apr2022, outcome "recovered" (2022), described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain, cough, sneezing, sinus congestion.  Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. Reporter stated, son had the second dose of the Pfizer, this last Saturday and was just called because he was having some side effects from it. He had a fever, body ache, coughing and sneezing and some sinus congestion. Date of administration: Reporter stated, Saturday, second dose was on Saturday, 23Apr. Reporter was informed about the role of Pfizer Drug Safety. When probed for date when the patient started experiencing the problem, Reporter stated, okay, so we had the second shot, Saturday morning about 10 o clock on the 23rd and then he woke up on the Sunday with a fever and the body aches. (Date clarified as 24Apr). When probed for if the patient got any treatment for the side effect, Reporter stated, well, pt mean we were just treating everything at home over the counter. Pt had not been, his fever went down immediately once he took the fever reliever that morning. So, he had not had the fever since the Sunday morning, but he still had some body ache and the cough. Pt was treating that over the counter. Pt had albuterol here, so he had taken one or two doses of that.  No follow-up attempts are possible. No further information is expected.
Fever, Chilld, Dizzy, Weakness, Fatigue Lasting 2 days
FLARE UP; HUMIRA STOPPED WORKING; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP) and DRUG INTERACTION (HUMIRA STOPPED WORKING) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis, Rheumatoid arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis, Rheumatoid arthritis and Plaque psoriasis.   In June 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP) and DRUG INTERACTION (HUMIRA STOPPED WORKING). At the time of the report, CONDITION AGGRAVATED (FLARE UP) had resolved and DRUG INTERACTION (HUMIRA STOPPED WORKING) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
I had body aches and a headache starting the morning after the shot body aches lasted around 20 hours and headache lasted longer than 48 hours from the time of the shot. Headache was at the forehead and the base of my skull on the back right. Lots of pressure and pain.
Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 89-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart & ureter Stents, mild heart attack, stroke, pacemaker, hysterectomy, temporary nephrostomy, blood pressure, pain, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medication(s) included mirtazapine (MIRTAZAPINE); blood pressure medication (unspecified), statins medication (unspecified) and pain medication (unspecified) all taken for an unspecified indication, start and stop date were not reported. The patient previously took isosorbide, heparin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on Feb2021 at 02:15 PM (Batch/Lot number:Unknown) as SINGLE DOSE for covid-19 immunisation and expereinced fatigue, vomiting, diarrhea, headache, loss of appetite and low grade fever lasting over 3 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021. On 09Feb2021, the patient experienced extreme fatigue, headache, loss of appetite, weakness, low grade fever and nausea. Therapeutic measures were taken as a result of extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea with otc tylenol, zofran. The outcome of the events extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea were recovering and unknown for other events.  Information about lot/batch number has been requested.
One day after Hep B vaccine #3, patient developed right buttock itchiness that progress to painful wounds in L2 distribution.
On the evening of 4/2/2023, I very quickly went into a trance when I started to feel ill. I was totally zoned out and immobile. I couldn't function mentally or physically. I didn't have the energy to move my body, and I couldn't focus on what I was watching on TV. It was all very sudden; it was like running into a brick wall. I went to bed. I didn't take any medicine on 4/3/2023. I also didn't eat or drink anything, because I didn't have the energy or desire to do it. When my wife arrived home from a trip later that day, she took my temperature, which was over 103. She called the doctor, who advised her to get me to the ER. I went to the ER and was admitted to the hospital. I was not released until 4/5/2023. At the hospital, I tested positive for COVID-19. I was also tested for RSV and pneumonia, and the results were negative for both.  I was treated with remdesivir, albuterol, Tylenol, dexamethasone, enoxaparin, and intravenous fluids for hydration. I was released from the hospital on 4/5/2023. It took about three weeks before I was completely back to normal.
6 hours of vomitting, acute sharp stomach pain for 4 hours, fever and body aches for 18 hours.
Starting about 24 hours after receiving vaccine I experienced nausea without vomiting and severe bone pain in my face (not a headache, bone pain specifically in my cheekbones).  I took ibuprofen for the pain which didn?t help. Symptoms resolved by the following morning.
Felt dizzy x 2 days -- described low grade temp the following day, but didn't take her own temp. Felt better with medicine and TYLENOL
Altered mental status, confusion, subdural hematoma. Was lifeflighted to Clinic and remained there about 5 weeks, developed a stage IV pressure ulcer on buttock. Diagnosed with multi organ failure. Went to a SNF for rehab after being discharged. Wife said then patient received 2nd dose of vaccine about 2 weeks ago and is currently at Hosptial in town for a GI bleed, passing frank blood and clots. He was admitted 5/9/21.  Patient is still confused and lethargic. Before the vaccine, he was taking care of his farm and home. Now he doesn?t even know his wife or what is going on.
Patient is communicated to notify that on May 21, 2022 the Covid 19 booster vaccine (modern) was given and on May 31 the dose of Repatha was put on. A week later on June 8, 2022 he began to present a skin reaction of itching, redness and burning. She went to the emergency room and was treated with Benadryl by later discharge.On Friday, June 10, 2022, I return to the emergency room with chest pressure and the same skin symptoms. She had EKG, chest x-ray and blood tests, but the results were all negative. She was treated with Benadryl and discharged.
No other AE; Customer reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On 15-JUN-2022, the patient was vaccinated with one (1) improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were provided; lot # U039948 that has been verified to be a valid lot number with expiration date reported and established as 16-DEC-2023) for prophylaxis.  The administered vaccine experienced the temperature excursion of minus (-) 2.5 degrees Celsius (C) for a timeframe of 5 hours and 6 minutes. There was no previous temperature excursion. No other adverse event (AE) occurred (no adverse event).  This is one of five reports received from the same reporter.
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced otitis media. The outcome of the event of otitis media is unknown. The report was considered to be non-serious.
Received vaccine 8/22/19.  I am experiencing muscle pain in the left deltoid (site of the vaccine) since then with decreased ROM and function due to burning, aching, throbbing pain if I move it in certain ways or lift heavy objects.  I cannot lay on the arm to sleep, I cannot move my arm behind me.
Swollen eye lid; Red eye; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533) via an unspecified route of administration in the left arm on 14Apr2021 at 11:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 16:00, the patient experienced swollen eye lid and red eye. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen eye lid and red eye were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
5" X 3" area erythema left upper arm lateral aspect at site of Pneumovax. Rx: Cipro, infirmary admit, Prednisone 20mg BID x 4 days. Diagnosis: local reaction secondary to Pneumovax, allergic reaction. Chart label allergic to Pneumovax. Resolved completely by 6/11/07 followup appointment.
I had uncontrollable chills, shivering, my body hurt, muscles , a low grade fever and an awful migraine headache. I felt like this for about 5 day
transient (45mins) weakness, hypotonia? noted by parent (unable to sit up or stand); this resolved by the time pt arrived for MD eval;
Client states around 9 PM she had a low grade fever which maxed at 100.8 degrees F. She also stated she had night sweats, she took an ibuprofen and felt better. Night sweats returned the next night - 3/9/16. But went away and she has had no other symptoms since.
had partial lost of taste; Vaccination site swelling; Vaccination site warmth; Vaccination site erythema; Vaccination site Pruritis; Vaccination site rash; diarrhea; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea), CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0263(B?)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea) and CHILLS (chills). On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site Pruritis). On 15-Apr-2021, the patient experienced AGEUSIA (had partial lost of taste). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. On 07-Apr-2021, VACCINATION SITE RASH (Vaccination site rash) had resolved. On 10-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site Pruritis) and AGEUSIA (had partial lost of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jun2021 (Lot number: EW0217) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VAGINAL DISCHARGE (non-serious), VAGINAL DISORDER (non-serious), VAGINAL DISCHARGE (non-serious) all with onset 13Jul2021, outcome "recovering" and all described as "vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis". Therapeutic measures were not taken as a result of vaginal discharge, vaginal disorder, vaginal discharge.  Additional information: Patient did not receive any other vaccines within 4 weeks and any other medication within 2 weeks of the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Two weeks to the day after shot, I experienced headache and nausea. My arm started to swell and ache. A huge painful rash was on my arm around injection site. I had no symptoms at all prior. My arm was not even sore before.
Pt had whole body sweat, followed by vomiting (1 case), throat irritation (difficulty swallowing slight)
Pt. developed swelling & erythema on right buttocks, went to Urgent Care & was told had tissue inflammation, take BENADRYL, antibiotics if needed.
REPORTER STATED THAT HE WAS TESTED FOR COVID 19 IN THE MONTH OF FEBRUARY, MARCH AND APRIL 2021 AND ALL THE THE RESULTS CAME BACK NEGATIVE.  HE FINALLY GOT THE JOHNSON AND JOHNSON VACCINE IN  APRIL 2021 AND SINCE THEN HE HAS BEEN EXPERIENCING HEADACHE THAT WILL NOT GO AWAY.  HE FURTHER STATED THAT HE FELT ALL BODY ACHE AND WAS VERY SICK AFTER TAKING THE VACCINE. REPORTER BELIEVES HIS HEADACHE IS FROM THE VACCINE.
Hospitalization: 9/3/22 admit, 9/8/22 discharge.  Presentation to the ED: shortness of breath. COVID-19 + date: 9/3/22. Treatment: Rocephin, azithromycin, dexamethasone, supplemental O2, remedesevir. Discharge to: home w/ health care services.
HALLUCINATION: FOR ONE DAY PATIENT COMPLAINED OF HAVING AN OUT OF BODY EXPERIENCE. CHILLS, FEVER, MUSCLE ACHES,  HEADACHE, FATIGUE, GI EFFECTS, SWELLING/REDNESS AT SIGN OF INJECTION
Broke out in 4 pox on face.  Low grade temp. Continue to have pox as of today 9/15/2010.  Also grandmother got Chickenpox from child.  Denies known exposure to chickenpox.
This spontaneous case reported by a consumer, describes the occurrence of dizziness and severe headache in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 023M20A and 006B21A) for an unknown indication. The patient's past medical history included no adverse event. On Feb 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced dizziness and severe headache. At the time of the report, dizziness and severe headache outcome: unknown/not provided.
On 11 APR 20 (day 11) in the evening he experienced progressing severe chest pain and pressure. ER notes document peak trop of-I on 13 APR of 35.072, ESR 27, CRP 7.4; which corrected to trop -.2 CRP 0.6 & ESR 11 at discharge 16 APR. Echo LVEF 55% 12 APR and 60% 26 MAY 20, no effusion. EKG 11 APR demonstrated diffuse ST elevation and one episode of NSVT 12 APR was treated with amiodarone.  Treatment was Toradol, ibuprofen, colchicine, ASA, Percocet and Protonix. No beta blocker due to low BP. He was discharged on ibuprofen, colchicine and Protonix.   He saw cardiology at 6 weeks for follow-up. He had ETT and repeat echo which were normal. He will see them at 6 months. He is currently on no meds and released to usual activity.
Diarrhea,  nausea, vomit, fatigue, dehydration, gastric pain Emergency room advised by primary care, received 1 liter IV saline Blood draw and CT scan all negative
Intense ache at left armpit at lymph node - a "burning" sensation for the afternoon and evening. Intense soreness along arm at injection site from shoulder to elbow. Tired, achey, runny nose.  Sluggish.  No appetite.
large-golf-ball sized of injection, red, hot knot at site of injection;described as an "abcess" by MD
Significant pain at site of injection. Unable to life arm above shoulder for 24 hours. Sense of fatigue, exhaustion for several days.
Patient reported a decrease in breast milk production following her first dose.  She was not willing to provide additional information, she wanted to ensure it was reported.
Given HIBtiter vax 30May91-developed sz like activity 7Jun.DX:as having hypsarrhythmia on 11Jun. Now on ALTH
vaccine had 3 previously reported temperature excursions; expired dose was administered; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-month-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of INFANRIX with expiration date of 26th November 2021, which led to expired vaccine administered to patient. No other information was provided. Lot number was not available. He was also advised that the vaccine had 3 previously reported temperature excursions, the last being reported to GlaxoSmithKline on 21st December 2021. He wanted additional information on what to do after administration of expired vaccine. The reporter consented to follow up.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient phoned and informed and stated no adverse effects.
Information has been received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II lot # M002419 and expiration date of 12-JAN-2018 and lot # reported as L02266 and expiration date 09-AUG-2018 (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of 36 Fahrenheit (2.2 Celcius) for 34 days, the entire 24 hours each day, and a lowest recorded temperature of 46 Fahrenheit (7.7 Celsius) and a highest of 77 Fahrenheit (25 Celcius) for 24 hours. No previous temperature excursion was reported.  No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012928: US-009507513-1702USA002770: US-009507513-1702USA002768:
Patient never had history of confusion or altered mental status.  She had episode of nausea, vomitting, difficult to enunciate words, and seemingly confused as reported by ER physician and patient family report.
Severe back pain, random and involuntary muscle jerking, headache. Pain at injection site, muscle aches