chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cheek & lip swelling appeared in the night after the vaccination. Patient waited until morning and visited clinic. She was given a Depo Medrol injection and prescribed Benadryl for q4h for first day, q6h for the next 2-3 days. She was also prescribed Epi-Pens.
After my first dose, I felt an occasional fullness in my right ear. After the second dose, on the date above, I began hearing my heartbeat pulsing in the same ear. It has continued periodically for brief amounts of time. I am more sensitive to high-pitched sounds and feeling of fullness continues. Doctor said ears looked perfect the day after onset. Prescribed Claritin D and made a referral to ENT.
Trouble breathing; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing) and PYREXIA (Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 027C21A) for COVID-19 vaccination.     The patient's past medical history included Asthma (At age 15).   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever). On 28-May-2021, the patient experienced DYSPNOEA (Trouble breathing). At the time of the report, DYSPNOEA (Trouble breathing) and PYREXIA (Fever) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with respect to mRNA-1273 was not applicable.
Missed the 42 day window/ never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Missed the 42 day window/ never received the second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Missed the 42 day window/ never received the second dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Missed the 42 day window/ never received the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.  This report refers to a case of Product administration interrupted for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Product administration interrupted for mRNA-1273, lot # unknown, with no associated AEs.
Fever of 102 - 103 started 1/21/00.  Reddened area 3 1/2" length - 1inch wide.  ENT within normal limits.  Instructed to ice area and use Benadryl.
swelling at sites muscular pain at sites and throughout the body nausea chills for 3 days sweats-temperature at 102 for 2 days vertigo migraine and cluster headaches severe fatigue Sleep Advil Inhaler
This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number 03655AA, expiry date 09-JUN-2012) (0.65 ml, frequency not specified) subcutaneous for prevention of shingles. The patient was administered with an expired dose of ZOSTAVAX. No adverse events were reported. No product quality issue was noted. Additional information is not expected.
Severe nausea; vomiting bile; Sore arm (preventing sleep); Exhaustion; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15Apr2021 at 16:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia, asthma, depression and anxiety. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), buspirone hydrochloride (BUSPAR) and ethinylestradiol/norethisterone acetate (JUNEL) for an unknown indication from an unknown date and unknown if ongoing. On 15Apr2021 at 19:00, the patient experienced severe nausea (vomiting bile), sore arm (preventing sleep), exhaustion and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea (vomiting bile), sore arm (preventing sleep), exhaustion and headache was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 6 year old white female with no pertinent medical history or allergies who on 20Aug98 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 10Nov2003 the pt presented to the office with a mild case of chickenpox that was also described as a varicella rash. The onset date was reported as 09Nov03. The pt was treated with diphenhydramine (Benadryl) and colloidal oatmeal (Aveeno) bath. No prescription drug treatment was required. No diagnostic lab tests were performed. Subsequently, the pt recovered with no further problems. No product quality complaint was involved. No further information is expected.
It was reported that a 2 month old healthy male infant was vaccinated on 4/17/01 with IPOL, DPT and Hib-Titer. Reportedly, the parents found the baby dead in the morning of 4/18/2001. An autopsy is being performed. Sudden Infant Death reported. Autopsy report findings: Hirschsprung's disease.
Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 10:00 at single dose in her left arm for covid-19 immunization. The patient medical history was not reported. The patient concomitant that the patient received within 2 weeks of vaccination included "blood pressure" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced light headed, weakness, body aches on 05Jan2021 10:00. No treatment received for the adverse event. The outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
In June of 2022 had an abnormal mammogram. Needle biopsy in July showing precancerous cells. Doctor performed lumpectomy on August 4th. Pathology on the lump showed Ductal carcinoma in situ and the doctor began radiation and I completed my last round of radiation on Monday September 26th. On October the 3rd I begin anastrozole 1mg per day for the next 5 years.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Hardness, swelling, redness, hot, painful. Area of redness got larger each day and by 8/28 was covering 2/3 of upper arm. Went to urgent care and was given prescription for Benadryl and antibiotics for possible allergic reaction and infection.
A 16-year-old patient should not have received Moderna vaccine per the EUA. Patient advised to receive an age-appropriate Pfizer dose in 28 days to complete her primary series per COVID-19 administration errors and deviations guidelines.
PATIENT HAS HISTORY OF SEIZURES. SEIZURE ACTIVITY X 4 MINUTES. PATIENT IS ALERT AND ORIENTED X 4. BP 141/64, HR 46, O2S 98%. 911 WAS CALLED AND EMS ARRIVED AT 10:52. PATIENT WAS TRANSPORTED TO HOSPITAL AT 10:53.
pt recv vax 16JAN96 & 22JAN96 pt was examined @ MD office w/an attenuated case of chicken pox, w/greater than 50 to 75 lesions on trunk & face;there was no fever;dx of varicella
0900 RASH. 0912 NO SOB, NO INCREASE RASH. 0922 DENIES SOB OR RASH,SPEECH CLEAR,MOOD CALM.D/C HOME
Sub-therapeutic dose: Patient should of received a High Dose Varriation.  No adverse event reported
Developed total body rash with itching 4 hours after receiving FluMist. Case complicated by a 3 week viral illness that had just resolved and pt had taken Levaquin for 3 days and stopped the medication 2- days before receiving the vaccine. Dermatitis, Diffuse, generalized.
Low grade fever, shaking, body hurts so bad could hardly walk headache....did not go to my doctor
Mother called, said patient woke up not feeling well.  Developed chills maybe a fever.  Father decided to take him to ER, fever 103 degrees, kept patient overnight.  Discharged with diagnoses of immune response to vaccine.
Patient received the vaccine on Monday, November 8th. She was not anxious to get the vaccine, she was excited and proud to get it. She didn't have lunch before the vaccine, but did have cereal for breakfast. Immediately after getting the vaccine (while still sitting in the chair), Patient held her head and said "my head mommy, my head hurts so much" and then they had her stand up and she opened her eyes wide and said "I can't see mommy, everything is white" and I asked the person who gave the vaccine to help. She laid patient on the ground and put her feet up. She was clammy, very pale, and still. She shivered a little as if she was cold. She laid there with tears, but awake for about 20 minutes. They brought a wheelchair and moved her to a cot. We gave her some crackers and they asked us to leave about 10 minutes later.   She was very tired following the event and for the rest of the day, but she was awake and talking and walking. On Tuesday and Wednesday, she complained of a "bad headache" and said her ears and her head were hot.  On Thursday she was a little pale, but didn't complain of anything. On Friday in school they sent her to the school nurse becasue she was pale and clammy and said her head hurt really bad.   On Saturday (11/13) evening, she started throwing up. She threw up and had water-diarrhea all day on Sunday. She coudn't sit up or move on her own.   I took her to a Pediatric Urgent Care on Monday (11/15), and they sent us to the Hospital Emergency Room (details below). They tested her for everything they could think of, and the only abnormal result was a positive Strep test.   Today is Thursday (11/18) and she has been at home since we left the ER on Monday, but only very slowly feeling better. She hasn't eaten much since Saturday (11/13), though she is drinking fine. She has thrown up 1-2 times each day and still feels very weak and tired. She's slept most of the day, every day. This morning is the first time she's willingly eaten a little bit. She's definitely not been herself over the past 5 days.   I'm honestly terrified to get her the second dose of the vaccine. I realize the illness could be completely unrelated to the vaccine, but I'd like to get an opinion on whether or not to get her the second dose on time, or wait a while.
Information has been received from a medical assistant concerning a 19 year old female patient for the pregnancy Registry for GARDASIL with no known allergies and a history of papanicolaou smear abnormal who on 08-DEC-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot: 658563/1063U) intramuscularly. There was no concomitant medication. On 09-DEC-2008, the patient broke out in a rash on the chest and both shoulders. The patient's rash disappeared on an unspecified date in December 2008. The patient was seen by the doctor on 29-DEC-2008 and there was no terrace of the rash.  The patient found out that she was pregnant on 23-DEC-2008. The gestation was on to two weeks.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information has been received on 22-JAN-2009 from a completed pregnancy questionnaire by a physician, concerning a 19 year old female patient who on 08-DEC-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot: 658563/1063U) intramuscularly, subsequently, on 23-DEC-2008 the patient found out she was pregnant (The LMP: 07-NOV-2008, EDD: 14-AUG-2009). Additional information expected.
Sick for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 3-4 days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for 3-4 days). At the time of the report, ILLNESS (Sick for 3-4 days) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
This was NOT an adverse event.  It was a vaccine administration error.  We thought we were administering the Pfizer bivalent vaccine and discovered in the mid afternoon on 9/8/22 that we were actually administering the Pfizer Grey Cap (monovalent/original) formulation of the vaccine.  Upon discovery corrective action was taken.  Patient was notified of vaccine administration error as was the Department of Health.
Excruciating headache; Chills; Fatigue; Slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Excruciating headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION HYDROCHLORIDE (WELLBUTRIN), MAGNESIUM, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and FERRIC CARBOXYMALTOSE (INJECTAFER) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Excruciating headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea) had resolved. At the time of the report, HEADACHE (Excruciating headache) had not resolved. Not Provided
AT time of injection felt warm feeling go up her neck and down her arm when vaccine was administered.  Within 5-10 minutes of the vaccine felt palpitations.  Then summoned help.  Nursing staff monitored her, Heart rate up to 135.  Denied c/o chest pain or SOB.  Pulse oximitry =98%.  The palpitations subsided within 15-20 minutes.  Later that evening at home her raced again and took her own pulse =110.
18AUG98 -24AUG98 broke out in hives;denies any new foods, soaps, etc;MD placed pt on pred;
11/01 flu vac at 3pm leg sore, hysterical did not sleep, 1102 lethargic vomiting 103.5 Tylenol given, called ER Motrin added. ER visit Viral Syndrome Temp 102.5 suppository N/V. 11/03 feeling better in am, still SX in pm.
Chills, low grade fever 96.5, bad body pain, sleepy, thirsty. headache.  Lasted all day Saturday 4-10-21. Sunday 4-11-21 no energy, tired. My right arm had a large pink shadow on my skin, arm was sore for 3 days. By  Monday 4-12-21 I was ok.  1 week later had a pea size nodule under my  right arm.  It was sore.  It went away after 2 days.
HEADACHE; FATIGUE; NUMBNESS ON ARMS AND LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included stroke.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the subject experienced numbness on arms and legs. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from headache, and numbness on arms and legs. This report was non-serious.
heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't breath /Shortness of breath; muscle pain; weakness; inflammation; high BP; muscle weakness; pain; This is a spontaneous report form a contactable consumer reporting for herself. A 51-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot Number: unknown) via unspecified route of administration in right arm on 31Mar2021 13:00 (at age of 51-years old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient had no other allergies. 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. Post vaccination, the patient was not tested for COVID. Patient received other medications in two weeks Birth Control. Patient had reported that, had her first shot on Wednesday, 31Mar2021. By Thursday, 1Apr2021 09:30 AM she was experiencing muscle weakness and pain. Tuesday morning at 5:30 am 6Apr2021 she woke up experiencing what now known to have been a heart attack episode. She felt like abs elephant was sitting on her chest while left side she had pain into her jaw and down her arm as well as could not breath. Shortness of breath. This lasted 15-20 min. She has since for the past 2 months been in and out of doctors trying to figure out the source of her muscle pain and weakness. The Adverse events resulted in visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability, or permanent damage. She went from only seeing her doctor every couple of years only when not well to she has now seen a cardiologist, rheumatologist, orthopedic. She has had EKGs, Computed tomography (CT) Scan of her heart, stress test, been put on BP meds, anti-inflammatory, antidepressants. To try and regulate her inflammation and to help keep the inflammation from causing stress on her heart aka. high BP. She went from a healthy active self-employed 51-year-old woman to her body literally giving out since shot. Treatment received for adverse events through Medication. Patient underwent lab test and procedure include Electrocardiogram, CT Scan of her heart, stress test on unspecified date result was unknown. The outcome of all events recovered with sequel (Recovered with lasting effects).   Information on batch/Lot number has been requested.
MA approached RN regarding Expiration date on COVID 5-11 vaccine. Coming up in system as 9/30/2022, Beyond use date shows as 10/14. Was taught by previous RN that we use the Beyond use date. We gave vaccine to child 5 days after expiration. Pfizer called and verified with RN the 9/30 date is what we should follow, was not able to give any information regarding the vaccine given and if patient should be revaccinated, sent nurse to CDC website which states, "Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval)" Doctor notified immediately about the above incident and reccomendations that were given, she was not concerned and will repeat the vaccine at 3 weeks. The rest of the vaccine was removed from the fridge and wasted. New vaccine was ordered.
Jansen COVID-19 Vaccine EUA After waiting 15 min post vaccination, I got in my car to drive home. I started to see arcs of color in the peripheral vision of my left eye. Later this became more prominent. Overnight, I developed a headache and saw wavy colored/blurred lines in my left eye for about 10 min that obstructed my vision. I saw an ophthalmologist as I was very concerned. They suggested that as my eyes looked healthy under examination that it might be an ocular migraine. I still have a painful headache 26 hrs post vaccination. I?ve never had an ocular migraine previously.
2 hours after vaccine chills began Chills became severe and lasted approximately 10 hours Within 90 minutes of chills ending...developed fever which spiked at 102.3 and last for about 90 minutes after taking ibuprofen
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by pharmacist who himself was the patient. The age at vaccination was not reported. After vaccination only reaction the patient experienced was mild pain at the injection site. The reporter was agreed to be follow up from GlaxoSmithKline For tolerance to next dose, refer case US2018GSK174738.