chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt wiped out/ Hit her hard; Left arm swelled up; Had a fever for 2 days; Big hive at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 012A21A and 004M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 13-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Adhesive tape allergy (Adhesives including band-aid adhesives) and Drug allergy (Prednisone injections). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for COPD.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, PYREXIA (Had a fever for 2 days) had resolved. At the time of the report, FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up) and INJECTION SITE URTICARIA (Big hive at injection site) was resolving.            After receiving the booster dose, left arm swelled up to elbow from the injection site and had a fever for 2 days. The patient had a big hive at injection site down to elbow. The patient reported the booster dose was so much worse than the second Moderna shot and felt "wiped out" until present day. The patient stated it "hit her hard, nailed her". The patient was using Benadryl cream as treatment medication.  On 05-Nov-2021, the patient was a little better.   This case was linked to MOD-2021-376966, MOD-2021-376927 (Patient Link).
Information has been received from a physician concerning a 15 year old female who was inadvertently vaccinated with an unspecified dose of GARDASIL (lot number unspecified) in the hip. Subsequently the patient experienced numbness on her leg. The patient sought unspecified medical treatment. The patient's numbness in leg persisted. The patient was re-evaluated after 2 days. Her symptoms did not improve. Additional information has been requested.
Moderna COVID-19 Vaccine Low-grade fever (99.2), muscle aches in shoulders, neck and arms, headache, fatigue - being treated with ibuprofen Symptoms started at approximately 8:30pm 1/18/2021
pt had a fever of 103 which would not come down w/APAP; cried for several hrs, refused to walk, & would not eat; pt was taken to hosp & told to watch pt & sent home p/being seen on 17SEP92;
MUSCLE PAIN, CHILLS, LOW GRADE TEMPERATURE, TIREDNESS, HEADACHE
It was reported that a female received Fluzone SV 98-99 USP on 10/20/1998. Reportedly on 10/20/1998 the pt experienced fever, swollen eyes, chills, and headache. From additional information received on 11/30/98, it was reported that the reaction started within 48 hours of shot on 10/22/98, reported on 10/26/98. Reportedly the pt recovered from this experience.
Patient given anthrax and typhoid on 15 Jul 2008. Followed by smallpox on 16 Jul 2008. Noticed metallic taste on 17/18 Jul 08. Morning of 19 Jul 08, noted right sided facial changes.  By 20 Jul 08, noted crooked smile and difficulty closing right eye. Seen in ER on 21 Jul 08 and diagnosed with Bells Palsy. Started on acyclovir 400 mg TID x 10 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-APR-2015 the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and route of administration were not reported; lot # K003598 with expiration date: 13-MAR-2015). No adverse events were reported. Additional information has been requested.
Patient was given an adult dose of Pfizer that was diluted using 1.3mL of sodium chloride and drawn up to administer a 0.2mL dose. Patient was observed for 15 minutes with no signs of allergic reactions. Patient's parents were contacted by Dr. and they report no side effects or symptoms.
had MRI with contrast- had severe allergic reaction; Red huge welt at injection site/Rash and hives developed on torso; Red huge welt at injection site.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy/right upper leg- very itchy; Couldn't move arm; Rash and hives developed on torso; right upper leg- very itchy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 13Sep2021 12:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis. Concomitant medications included levothyroxine sodium (SYNTHROID); estradiol (ESTROGEN); progesterone; vaccinium macrocarpon (ELLURA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Copaxone and clarithromycin (KETEK) and experienced allergies to both. The patient had no other vaccine in four weeks. No COVID prior vaccination and was not tested post vaccination. On 17Sep2021, the patient had a red huge welt at injection site. It was red, hot, swollen, itchy. She could not move an arm, rash and hives developed on torso; right upper leg was very itchy. Days later she had MRI with contrast and had a severe allergic reaction. Never in 20 years she had a reaction to MRI dye before. It was believed that the vaccine caused the allergy. She had a reaction twice, once after first dose and again on 20Sep2021 the day of her MRI. The patient took high dose Benadryl as treatment. The outcome of the events was recovering.
I was under  two thick winter blankets with bad,bad chills. A severe headache. Dizziness to the point where I could not get out of bed. Nausea, bad body aches, chest hurt,throat hurt. I was in bed sick from 5:30 , Tues April 6 until Wed April 7th around 10;30. I had to stay home from work on Wed. I am still having mild headaches and dizzy spells where i have to lean against a wall or hold on to something.
Case number PHEH2014US020348 is an initial spontaneous report received  from a pharmacist on 07 OCT 2014 with a follow-up received on 14 OCT 2014. This report refers to a 66-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly at a dose of 0.5 ml on 06 OCT 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. IT was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within that total duration. No adverse event was reporting following this administration error (incorrect storage of drug).   Follow-up received on 14 OCT 2014. Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within that total duration).
Information has been received from a registered nurse referring to unspecified number of pediatric patients of unknown age and gender. The patients' medical history and concurrent condition were not reported. On an unknown date the patients were administered with PEDVAXHIB (Lot# L051122, expiration date 12-OCT-2018, dose, route and frequency not reported). The vaccine was undergoing a possible (but not verifiable) second temperature excursion at 30.8 degree Fahrenheit for 15 hours. It was noted that the reading of "30.8" was based on a handwritten record that was not clear. It was strongly believed by the reported that the vaccines instead remained in range at 38.8 degree Fahrenheit and that the reading of "30.8" was based on a clerical error (handwriting legibility issue). The vaccines involved previously underwent an excursion. No adverse effects were reported. This is one of several reports received from the same reporter. No additional information has been requested.
sore arm; had so much energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy) in a 76-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy). At the time of the report, PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications were reported.  No treatment information was provided by the reporter.  Patient took second dose on 15-MAR-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-046458 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046458:2nd dose case
Swollen lymph gland on left side 15 days after last vaccination.; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 15Mar2021 at 08:00 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 22:00, the patient experienced swollen lymph gland on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for swollen lymph gland on left side. The clinical outcome of the event swollen glands was not resolved at the time of this report.  No follow-up attempts are needed; No further information is expected.
patient got one flu shot in my life and got a horrible case of the flu; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case was linked with 2020SA356005 (same reporter).  This case involves a patient of unknown age who got one flu shot in my life and got a horrible case of the flu (influenza), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got one flu shot in my life and got a horrible case of the flu (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Almost exactly 24 hours after the injection I became extremely cold with violent shaking and could not get warm. I stood in a warm shower, it did not help.   The total episode lasted about one hour. I have had no further problem.
Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; Tiredness,vomiting, diarrhea , nausea, joint and muscle pain.; nausea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Lot Number: ER8732) as single dose for covid-19 immunisation; amlodipine besilate (AMLODIPINE BESILATE), valsartan (VALSARTAN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  Medical history included known allergies some antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness,vomiting, diarrhea , nausea, joint and muscle pain on 05Apr2021 03:00 with outcome of recovered. The action taken for amlodipine besilate and valsartan was unknown. No treatment was received.  No follow-up attempts are needed. No further information is expected.
Patient received vaccinations on Sunday Oct 1st, 2017. Patient came to pharmacy this morning & said that when he was in the shower that he noticed the swelling & redness on his arm where he received the vaccinations. He presented with at least a 6 inch red band on his left arm around injection area with oval swelling towards inner arm about 3 inches long & about 1 inch wide in the center. He said that he had been nauseated since he received the vaccines & had had some fever since Sunday as well. Recommended patient get Benadryl & if not getting better in 24-48 hours or if symptoms worsen he should go to MD and may possible need a steroid of some sort.
Information has been received from a consumer reporting on one of his 3 day old ("recently born") twin daughters with no pertinent medical history and no drug reaction or allergies who on 01-MAY-2011 was vaccinated with two doses of RECOMBIVAX HB (thimerosal-free) (lot # 669600/0230AA, expiration: 22-OCT-2013) (route, and dose not reported). There was no concomitant medication. The consumer reported that he suspected one of his twin daughters received two injections of RECOMBIVAX HB. The consumer suspected this because the nurse noticed two injection marks on the baby's arm. The consumer reported that the baby seemed "lethargic and drowsy", but had since recovered. The consumer was concerned of there would be any further effects if in fact the baby did receive two injections. No treatment was given for the adverse events and no lab diagnostics studies were performed. The patient sought unspecified medical attention. No further information is available.
Sore at injection site.; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced sore at injection site on an unspecified date. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment for adverse event. No covid prior vaccination. Covid (Nasal Swab, Rapid test) was tested with negative result post vaccination. No known allergies. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 13-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2013, the patient was treated by her physician for a painful rash that was diagnosed as shingles. The patient has been prescribed valacyclovir  to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Generalized edema w/ 5" diameter to injection site, IM R deltoid with associated pain, FROM.
Flu-like symptoms; fever; chills; aches; tiredness. Treatment: OTC ibuprofen Outcome: Effective at relieving symptoms
p/vax c/o lt upper w/lump;no redness, no tenderness to touch but palpable lump;VS T99.6, R40, P138;
Several red spots, some elevated, no pustules, on L side of chest, front and back, mostly on site of previous mastectomy, itching at first, then subsided.
Systemic: vomited x 2-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
Pain in chest; Arm hurt; Got tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Got tired) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Got tired) and CHILLS (Chills). At the time of the report, CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Got tired) and CHILLS (Chills) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Patient present with a fever, vomiting, SOB, wheezing. Patient positive for COVID-19 and fully vaccinated.
Headache; Tired; Achy; Felt crappy/Felt very lousy; fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Health Department via an unspecified route in left arm on an unspecified date, at the age of 80-years-old, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included metoprolol succinate taken from 2019 and ongoing, ciclosporin (RESTASIS) taken from 2020 and ongoing and paracetamol (TYLENOL) taken as needed from an unspecified date and ongoing, all taken for unspecified indications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (solution for injection; Lot #: EL9269) administered via an unspecified route in right arm on 11Feb2021 at 10:45 (at the age of 80-years-old) and, after which, she had headache and felt tired, achy and crappy. The patient reported that, on an unspecified date after the second vaccine dose, she experienced all the above plus fever at night for three days. She had vaccine on Friday and felt good on Wednesday. All the reported events resolved after 5 days without any treatment.  The Lot number for the vaccine, BNT162B2 was not provided and will be requested during Follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154659 same drug and patient, different event and drug dose
Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about 40 hours, symptoms decreasing after about 30 hours.
coldness; Sleepy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (coldness), SOMNOLENCE (Sleepy) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, CLONAZEPAM, CITALOPRAM, FINASTERIDE, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), VITAMIN B12 [VITAMIN B12 NOS] and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING COLD (coldness), SOMNOLENCE (Sleepy) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (coldness), SOMNOLENCE (Sleepy) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had a heart episode (thurs 8/26) where I was playing with my dog, and a sharp, stabbing chest pain came on that knocked me to the ground and knocked the wind out of me, I couldn't catch my breath. It then was episodic about every 5-15 minutes, coming on quickly. It was in the middle to middle/left side of the chest. Sitting up and leaning forward worked  to ease the pain. I went to the ER thinking I was having a heart attack, and ECG/Chest X-ray and blood work were all conducted. I was told it was not life threatening and not a heart attack but they couldn't tell me what exactly it was and I was discharged about 4 hours later. I was told it could be muscular/skeletal or acid related. Take tylenol and pepcid. It did not resolve with these treatments so I called my doctor the next day (fri), and got on advil and muscle relaxers. the following day (sat) I spoke to my doctor again, and we started a higher dose advil protocol. a week later the symptoms were fully resolved.
Got shot on Tues. 16, Wed 17, started having chest pain, and stabbing pains came back to clinic, then Thurs. 18, patient was still in pain so I took him to Emergency room --> Dx pericarditis, onset 24 hrs after immuniz.