chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I WOKE UP & HAD BODY ACHES & CHILLS & ALL OF MY LYMPHNODES UNDER MY LEFT ARMPIT & MY BREAST WERE SWOLLEN & VERY PAINFUL I COULDNT KEEP MY ARM DOWN AT MY SIDES I HAD TO HOLD MY ARM & SHOULDER IN POSITION AS IF I HAD ON A SLING I WAITED 2 DAYS TO GO TO URGENT CARE BUT COULD NOT GET APPT SO I WAITED 2 MORE DAYS & THEN I GOT TELEHEALTH APPT & WAS TOLD TO USE HEATING PAD & TAKE TYLENOL & IBUFPROFEN & SYMPTOMS STARTED TO DECLINE.
Erythematous rash at the site of the injection with central clearing and surrounding erythema (looks similar to Lyme rash).  Picture is available if needed, noted 2 weeks after inoculation.  No systemic symptoms.  Both IgM and IgG antibodies are present - were absent before vaccination and on 01/14/2021
This spontaneous report as received from a healthcare worker refers to unknown number of patients. On unknown dates the patients were vaccinated with improperly stored M-M-R II (dose and lot # not reported). No adverse effects reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several report received from the same source.
Patient called and reported that she still had severe pain in the arm she received her vaccine in 1 month following administration of the vaccine.
C/o tightness in chest, slight diff. Breathing. VSS. ABLE TO SPEAK . Code Green called, paramedics on site to assess.  feels better after 15min.
pt recv vax 9OCT97 & 19OCT97 T101.4, aching in arm where MMR given 22OCT97 sore throat, stiffness in elbow 24OCt97 stiff neck, ear pain still somewhat w/vesicular rash on side of nose;seen to ER seen by MD;
This spontaneous consumer report (initial receipt 19-SEP-2014) concerns a female patient. The patient had a medical history of suppressed immune system and colitis. She had drug reaction/allergies to amoxicillin, sulfa, metronidazole, infliximab and azathioprine. The patient received flu shot in 2008 and experienced same symptoms (refer to case 2014045212). On an unspecified date in 2013, the patient received flu shot (manufacturer and batch number not provided) in the opposite arm. She  concomitantly received PNEUMOVAX23 (batch number: J007059). On an unspecified date in 2013, on the second day after vaccination, the patient experienced body aches, 103 degree temperature, fatigue and general flu like symptoms that lasted for about a day. her arm was sore for two days.  The outcome was recovered. Reporter's comments: The reporter stated that the patient experienced same symptoms after each PNEUMOVAX23 injection.
Yellow fever vaccine site R/A SC site. Immediately noticed redness at injection site (dime-sized)  which increased over 1 week to a huge hive, raised, red, swollen area approx 1 1/2" x 4", warm to touch, itchy, applied Benadryl cream. Symptoms subsiding 5/3-5/6/05. No further MD treatment, no visit required.
Information has been received from a physician concerning a 22 year old female who in July 2007, was vaccinated with the last dose of Gardasil in the series.  Concomitant therapy included "OCT".  In January 2007 the patient tested negative for HPV.  In August 2007, the patient tested positive for HPV.  The patient sought unspecified medical attention.  The patient believed it was related to vaccination with Gardasil.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
ringing in the ears. Very disturbing it is like chirping. Dr diagnosed it as Tinnitus; unable to sleep well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:00 (Lot number: ER 8735) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EN8735, administration date=15Mar2021, administration time=10:00., dose number=1, vaccine location=Left arm), administration date: 15Mar2021, when the patient was 64 years old, for covid 19 immunization. The following information was reported: TINNITUS (non-serious) with onset 19Apr2021 12:00, outcome "not recovered", described as "ringing in the ears. Very disturbing it is like chirping. Dr diagnosed it as Tinnitus"; INSOMNIA (non-serious) with onset 19Apr2021, outcome "not recovered", described as "unable to sleep well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, insomnia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies.   No follow-up attempts are possible. No further information is expected.
Pt received quadrivalent flu vaccine about noon 10/24. By 10 pm she experienced severe chills, fever, body aches, a severe headache, fatigue, nausea, cough, vomiting. The fever did not break until afternoon on 10/25. Did not feel completely well until 10/26.
Burning, sore, itchy at site. Area was hard and localized rash. Patient felt exhausted for 2 days. Patient took Ibuprofen; will take BENADRYL after work today.
LEG CRAMPS ON BOTH SIDES AND ARM CRAMPS ON LEFT SIDE (INJECTION SIDE); ARM PAIN ON LEFT SHOULDER AND LEG PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, anxiety, seasonal allergies, non smoker, and non drinker, and other pre-existing medical conditions included non drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 04:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021 04:00, the subject experienced arm pain on left shoulder and leg pain. On 06-MAR-2021 04:00, the subject experienced leg cramps on both sides and arm cramps on left side (injection side). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps on both sides and arm cramps on left side (injection side), and arm pain on left shoulder and leg pain. This report was non-serious.
First pregnancy,  Est. Due Date April 11th At time of injection, patient felt rush in lower abdomen/uterus Pregnancy symptoms diminished over the next few days after injection Miscarriage began on August 14, confirmed by physician on 8/16/21.  Pregnancy loss
pt recv vax & 29AUG98 not feeling well;Saturday evening sl fever, swollen lymph nodes;Saturday noc all through the noc ran fevers up to 102 & 103;used nothing to relieve fevers;broke out back, upper thighs & arms;had h/a;
no adverse reaction or symptoms; a dose of PNEUMOVAX 23 was ordered to be given in December 2022. However, the dose was given today, 06/30/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-DEC-2021, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, route of administration, anatomical location, indication, lot# and expiration date were not reported). On 30-JUN-2022, the patient was vaccinated with an early dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U022984, expiration date was not reported, but upon internal validation established as 29-JAN-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, which was ordered to be given in December 2022 (inappropriate schedule of product administration). The patient had no adverse reaction or symptoms from receiving either vaccine.
Severe body aches. Stiff neck muscles, unable to turn head. Tiredness. All those symptoms started before 10p on 3/8/21. 5am on 3/9 same above symptoms plus temp of 100.2. No change in body aches or stiffness. Temp at 3p was 102
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 at 16:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2022) Positive, notes: Rebound COVID-19 infection with symptoms 4 days after completion of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Anti-viral COVID 19 Treatment with Paxlovid and Treatment start date was 19Aug2022 and stop date was 24Aug2022, Lot number was GE5197. Adverse events start date was on 27Aug2022 at 12:00 PM. No treatment was reported, no known allergies and outcome was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The evening after receiving vaccine began having headache, severe nausea and vomiting, chills, and body aches. Headache and body aches lasted 4-5 days as well as deminished appetite. Took over the counter medications for headache. Was not seen by health care provider for any further treatment.
L anterior thigh with erythema and mild swelling. Fever 102.4F. Given Motrin x 96 hours and Benadryl 1 tsp every 6 hours.
DIARRHEA; BODY PAIN ALL OVER; CHILLS; MUSCLE PAIN; FATIGUE; HEADACHE; COULDENT SLEEP; VERY SICK; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER) and CHILLS (CHILLS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatitis (pancreatitis 10 years ago.). Concurrent medical conditions included Arthritis and Difficult digestion. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (VERY SICK). On an unknown date, the patient experienced SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE). At the time of the report, ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE) outcome was unknown.            Reporter did not allow further contact
This spontaneous report was received from a healthcare worker refers to a 66 year old female. Patient's concurrent conditions included unspecified kidney problem, diabetes mellitus and renal impairment. Her medical history was not provided. Patient was reported as allergic to Penicillin. On 21-AUG-2015 the patient was vaccinated with subcutaneous injection of PNEUMOVAX 23 (lot # L012521, Expiry date: 01-FEB-2017). No concomitant medications were reported. Reporting healthcare worker stated that the patient experienced following side effects 24 hours later injection: red circular rash around injection site, pain at injection site, swollen arm, nausea, slight fever, and itchiness on 22-AUG-2015. Patient sought medical attention and she came to office on 25-AUG-2015. She was treated separately with unspecified antibiotics, TYLENOL for each symptom. Outcome of the events were unknown. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer referring to a 74 year old female patient. The patient's pertinent medical history included high blood pressure and "afiv". Drug allergies included Sulfa and penicillin. On 28-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#/expiration date, dose, strength and route unknown, one time injection). Concomitant medication included Diltiazem XR and XARELTO. On 11-NOV-2013 (reported as two weeks after) the patient broke out shingles. The patient also reported getting outbreaks of shingles every six to seven months. The patient did not seek medical attention. No lab diagnostics study was performed. Acyclovir was given for the treatment of the event and the event was improved on the therapy. At present the patient recovered from the event. Additional information is not expected as no contact details were provided.
Large(hand-size)black-and-blue hematoma starting 3" below injection site and extending to elbow
Patient made staff aware that she had fainted right after getting a shot in the past. So, we watched her carefully for the first fifteen minutes after administration and told her she could wait longer if not feeling well or dizzy at all. Patient said she was feeling normal and decided to leave the pharmacy. While on her way out of the store she was making a purchase at the front register and told the cashier she was going to faint then went pale and fainted, hitting her head in the process. She immediately re-gained consciousness, emergency number was called who instructed staff to not move her. So, she was supported in a sitting position on the floor while pressure was applied to her head which was bleeding. She was coherent, knew who & where she was. We asked her if she wanted us to call anyone and she asked us to call her husband and was able to give us his phone number. We continued to monitor her until appropriate help from the emergency call arrived.
Pneumonia due to 2019 novel coronavirus.  Acute respiratory failure with hypoxia  Bacteremia due to methicillin susceptible Staphylococcus aureus (MSSA) continue current support with O2 Device: Nasal cannula at Oxygen Delivery - Labs: Daily COVID labs ordered x4 days (CBC, BMP, D-dimer, CRP).  Continue to trend after 4 days as needed.  - Imaging: Chest x-ray 7/16/22 showed Right basilar pneumonia.COVID-Focused Medications:  Dexamethasone 6 mg x 10 days or until hospital discharge, started on 7/16/2022  Remdesivir x 5 days or until hospital discharge DAUGHTER DECLINED on admissionE  - DVT Prophylaxis:  PROPHYLACTIC dosing: lovenox 40mg daily..
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months of age. The patient demographics were updated. On 18-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unspecified dates on or after 23-NOV-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (albumin status rHA, lot# L034933, expiration date 11-MAR-2017, strength, dose, dose# and route unknown). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Admission Date: 8/23/2022 Discharge Date: 9/5/2022  PRESENTING PROBLEM: Left-sided weakness [R53.1] Acute left-sided weakness [R53.1] Acute nonintractable headache, unspecified headache type [R51.9]   HOSPITAL COURSE:   The patient is a 66 yo woman with a history of T2DM on trulicity, HTN, fibromyalgia, who presented to hospital on 8/23/22 with headache, dizziness, and L sided numbness. On presentation she was afebrile with stable vital signs. Stroke code was activated and she underwent evaluation with CT head, CTA head/neck and CT perfusion without evidence of acute infaction. MRI brain and cspine was negative for infarct but did show previous ACDF at c5/c6 and new disc bulge at C7-T1 but no high grade stenosis. Neurology was consulted and recommended starting the patient on an asa 81mg daily due to her stroke risk factors, zio patch at discharge, and followup in stroke clinic. The patient was also noted to be covid +, which was felt to be the cause of her headache and likely her symptoms of dizziness as well. She otherwise remained on room air without SOB or hypoxia. PT/OT were consulted and recommended SAR. She was recommended to followup with her previous spine surgeon after discharge for her cervical disc disease.   Her stay in the hospital was prolonged with covid isolation precautions at the SAR facility. Discharged in a stable condition to SAR on 9/4/22 with recommendations to follow up with PCP, Neurology and her spinal surgeon.
Patient is experiencing severe arm pain to the point she can't lift her arm up in the mornings.
enlarged aorta; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613), via intramuscular route, administered in left arm on 21Mar2021 at 13:30 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The vaccine was not administered at facility. The patient medical history was not reported. There were no concomitant medications. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205), via intramuscular route, administered in left arm on 28Feb2021 at 15:30 as dose 1, single (at the age of 60-years-old) for COVID-19 immunization and experienced tinnitus. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient never had heart issues prior to vaccine. On an unknown date in Mar2021 (reported as on 2 flights (airplane) within one week after second vaccination), the patient experienced enlarged aorta. The event was assessed as Persistant/significant disability/ incapacity. The event resulted in emergency room and physician office visited. The patient lab test which included echocardiogram was enlarged aorta with 4.2 centimetres on 13Apr2021. No treatment medication was received for the event. It was reported by the patient that follow-up echocardiogram to be done in the next year on an unknown date Apr2022. The patient reported that echocardiogram was 4.5 cm or above surgery may be necessary. The outcome of the event was not resolved at the time of report.
The pt complained of a sore arm, chills, achy joints, temp of 100. Tylenol was recommended.
Patient presenting with bruising, petechiae, thrombocytopenia about 3 weeks following MMR administration. ITP. Treated with IVIG infusion x1.
Erythema and swelling of left upper arm distal to injection site. Hot to touch.
DropSafe syringe with safetly needle.  The needle easily separates from the syringe.  You are unable to tighten the needle to the syringe.  It comes apart multiple times while trying to use the item.
HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; This spontaneous report was received from a medical assistant and refers to a pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccinations included 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 10-JUL-2023, the patient was vaccinated with a fourth dose (extra dose administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered as prophylaxis (maternal exposure during pregnancy) (strength, lot #, expiry date, and route of administration were not provided). No adverse events were reported.
injection site pain tiredness headache muscle pain chills joint pain fever injection site swelling nausea feeling unwell swollen lymph nodes dizziness and weakness
Patient sweated and almost passed out after received the shot. He recovered after 10 minutes and BP resumed normal.
8 days after vaccine I noticed a round hive rash about 1 inch away from the injection site. The next day the hive rash was much larger. Rash completely went away after about 4 days.
Second dose given 2/25/21.  covid +/admitted to hospital/ on oxygen + dexamethasone + remdesivir
1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030