chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINNITUS; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Large red, itchy area around injection site--continues to spread down the arm.   In addition, dizzy spells.
Pt called to report covid19 vaccine side effects on 5/11/21 at 5:18pm. Pt got Pfizer vaccine on 3/24/21 and 4/17/21 at Fairgrounds. Pt states after 1st dose vaccine he experienced some SOB and went to the ED for evaluation and covid19 test result was negative and that was 1-2 weeks after the first dose. Pt states coughing, sore throat and some mucus onset sometime between 1 and 2nd dose vaccine along with voice change. Pt denied emergency symptoms and advised pt if emergency symptoms arise to go to ED or call 911 and pt verbalized understanding. Pt spoke to doctor at clinic  last week regarding the cough and voice change and was prescribed Benzonatate. Pt has urgent care visit scheduled.
Mild breathing symptoms after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose). At the time of the report, RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-329780, MOD-2021-329985 (Patient Link).
About 43 hours after receiving the vaccine, I began experiencing a severe headache and nausea.  Two hours later I began vomiting, profusely.  After the vomiting subsided,  I was extremely fatigued.
Tinnitus in the right ear.  I noticed ringing in my ears intermittently at first and disregarded it.  Initially, I did not know that it was occurring inside my ear.  I thought it was the buzzing of the office light or the sound of cicada when running outside.  I then attended a silent meditation retreat and realized that it really was occurring internally, not an external sound.  The symptoms are worsening now.  It is daily and consistent.  It remains predominately in only the right ear, rarely in the left ear and much less prominent when on the rare occasion it occurs in the left ear.
This case meets criteria for vaccine breakthrough review. SxS include cough, SOB, chills, fever, chest pain, myalgia, wheezing.
Case number PHEH2013US021749 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 17 May 2013. It was reported that the vaccine administered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 27 Aug 2013. No further information was provided.
pt vax hepta B. pt devel arthritis and arthralgia.  pt vax 2nd hepta B. and ex same sx.
Patient had a fever of 103 with vomiting, chills, and "puffed-up" eyes. This was severe enough the patient felt the need to go to the hospital.
Red raised itchy hives / welts all over inner thighs, hips, wrists, forearms, neck,  elbows, inner knees. Going on 10+ days
Numbness on left side of body - Face, arms and leg. The same side the vaccine was administered. Also included, Heart palpitations.; Heart palpitations; This is a spontaneous report from a non-contactable other healthcare professional.   A 30-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 intramuscular, administered in Arm Left on 11Feb2021 09:00 (Batch/Lot number and Expiry date was not reported) (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunization Public Health Clinic. The patient's other medical history was reported as none and no known allergies were reported. The patient concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine and no other medications in 2 weeks of covid-19 vaccine. The patient did not have covid prior to vaccination and has not been tested for covid since vaccination. On 11Feb2021 12:30 PM, the patient experienced numbness on left side of body-face, arms and leg. the same side the vaccine was administered. also included heart palpitations. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Only has a cough; Sneezing; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Only has a cough) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included OMEPRAZOLE, MAGNESIUM OXIDE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3) and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On 19-Feb-2021, the patient experienced COUGH (Only has a cough). At the time of the report, SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) had resolved and COUGH (Only has a cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: unknown (Positive) COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included high blood pressure medication were noted. Treatment details was reported as corsidone for cough and cold. Reporter stated that patient took second dose vaccine at the end of February was noted.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received included Second dose information provided by the reporter. Corrections made on initial, lab data added, lab investigation removed from the event tab
Patient received 2nd dose of Moderna COVID-19 vaccine 17April and tested positive for COVID-19 24May via nasal swab.
Breakthrough symptomatic COVID infection; Breakthrough symptomatic COVID infection; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Oct2021 (Lot number: FN8027) at the age of 49 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EP6955) as dose 2, single and administration date 03Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough symptomatic COVID infection"; IMMUNISATION (medically significant) with onset 17Oct2021, outcome "unknown", described as "Booster". The clinical course was reported as follows: Breakthrough symptomatic COVID infection after 2 doses plus booster. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
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 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: patient treated with Paxlovid from start date 25Apr2023 to end date 29Apr2023, lot number:PAA1888974 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182508 Same patient, different product, different event;
Next day Severe headache body ache nauseous. Second day got worse same symptoms along with mild short of breathe, voice sounds horse, left ear pain had to call dr office and go to the urgent care. Was give erythromycin, medrol dosepak, ear drops due to ear infection. Still the same on the third day.
black and blue mark on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black and blue mark on her arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (black and blue mark on her arm). At the time of the report, VACCINATION SITE BRUISING (black and blue mark on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. Upon follow-up on 06-May-2021, the reporter stated that patient received the second dose of Moderna vaccine and had no adverse events.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received captured event outcome and dose details.
Hives in axillae, on torso, and inguinal. Redness and swelling of bellybutton. Left thigh swelling.
ACUTE ONSET OF PERIORAL TINGLING, WHOLE BODY FLUSHING AND HIVES AND TIGHTNESS IN THROAT WITHIN 10 MINUTES OF VACCINE ADMINISTRATION. HEART AND LUNG EXAM NORMAL. VITAL SIGNS NORMAL. GIVEN 50 MG OF ORAL BENADRYL AND OBSERVED OR 6 HOURS WITH COMPLETE RESOLUTION OF SYMPTOMS.
4 hours after the shot, the patient developed blurry vision and could not read anything, her ears filled up with fluid, and she stayed like that till this morning (Tuesday).
No additional adverse effect reported; Patient received improperly stored PROQUAD on 7/7/2020 which was administered via unspecified route.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and historical drug were not provided.  On 07-JUL-2020, the patient was vaccinated for prophylaxis with inappropriate storaged Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S008570 (therapy type rha), expiration date 16-SEP-2020. Strength, dose, and routes of administration were not provided. The vaccine was reconstituted with a properly stored sterile diluent.   The temperatures involved were: -14 to -10 to -14 degrees Celsius in a timeframe of 50 minutes. It was not reported a previous temperature excursion and a data logger was involved. No additional adverse effect was reported.
SLEPT FOR A DECENT 15 HOURS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slept for a decent 15 hours, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for a decent 15 hours, and chills. This report was non-serious.
It was a few weeks after the vaccine, I started having cold symptoms and by next day - wheezing and coughing up yellow sputum; 100.8 fever. I had a headache too. I prescribed myself a z-pack - Zithromax - and I was coughing up a lot of stuff still on Wednesday. Steroid inhaler and rescue inhaler. Gradually getting better. I am still a little congested.
Severe body aches, fever, headache and chills starting 8 hrs. after vaccine and lasting for 2 days.  Could not get out of bed.
On 02/03/05 mother informed me that infant had a fever and was very sick about one week after I had given immunizations. Mom also stated that infant was coughing for 6 weeks but is finally better. Infant was seen by Dr. and he did some tests and put her on medications. She stated Dr had said something about if a test was positive but it was negative. Mom apologized for not calling me sooner. I told her I would contact Dr regarding pt and further immunizations. I telephoned clinic and spoke with Dr's nurse. She check pt's chart and told me infant was another Dr's pt and referred it to another nurse. I told her I was concerned about what mom had told me and wanted to know if it was safe to give next immunizations if mom called to make an appt for the next ones or if I should refer her back to Dr. Nurse said she spoke with Dr and had tried to reach mom on phone but was unable to do so. She said she would keep trying though. Nurse advised me that Dr wanted parents to bring infant in for a well baby check. I told nurse that if mom called us we would advise her to take pt to see Dr.
Pediatric patient presented to the office on 11/14/2016 to catch-up on vaccinations. 3 vaccines were pulled and administered without checking the expiration date. The patient received a Varicella vaccine that had expired 11/10/2016. Error was caught at 5:00 PM when charting the information into the electronic health record. Healthcare team was notified of the situation the next day, 11/15/2016. The patient and parent/legal guardian were notified of the error and given the option to get Varicella titres in 6 - 8 weeks or re-vaccinated in 4 weeks.
5/10/22 2nd booster 5/26/22 aware of increased sweating. 5/30/22 on or about this date, knee 3 raised spots like bug bites on right of outer knee. 6/2/22 on or about this date, hyperhydrosis started. I thought it was from heat. Right leg and foot was cramping in night. Hyperhydrosis continued... 6/6/22 headache, tired. 6/7/22 headache, nausea, dry heaves. On 6/7/22, I was so sick and dizzy, I missed a scheduled appointment with LHI, a VA provider. 6/8/22 a few small red sores (not pus-y nor like blister), pain at tip of 2-3 toes and front ball of right foot. right calf sore.  6/10/22 red sore outer side right foot. tired, slight nausea. mild headache. 6/12/22 toe/ball sharp pain; burning right foot. tired, slight nausea. mild headache.  6/12/22 These symptoms persist: Pain and burning at tip of 2-3 toes and front ball of right foot. Right calf sore and leg are painful, like muscle ache.  Red sores are still present. tired, slight nausea. mild headache. I have no respiratory symptoms.
Patient had redness and swelling at site next day but then 2 days after injection also experienced soreness and pain under arm hurts to move arm. Patients PCP was consulted and did not advise treatment.
Approximately 5 minutes after administration of 2010-11 AFLURIA 0.5ml IM, pt fainted & had a LOC of about 5-10 seconds. Pt responded to verbal stimuli, but remained dizzy/confused. Was transport to ER via EMT for follow-up tx.
Information has been received from a healthcare worker referring to unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # K020214, expiration date 25-MAR-2016, orally (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 17 to 18 year old female with no known drug allergies who on 6/28/85 was vaccinated with the 1st dose of MMRII. There was no concomitant medication. On 8/20/01, it was reported that a recent titer did not detect sero-conversion to rubella. The pt sought unspecified medical attention. Additional information has been requested.
sore arm (at injection site); redness (at injection site); swelling (at injection site); hot (at injection site); Fever; Head hurt; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (1st dose received on 27th April 2019 (batch no:99D9F; expiry date 14th April 2020) in right arm and developed bad reaction.).   On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: Age at vaccination was not reported, but patient could be 54 years old. The reporter confirmed the shingles vaccine as Shingrix. The reporter gave permission to follow up.
Patient had a shingles vaccine on Saturday 9/15/18. On Sunday he had a upset stomach, ear ache and a headache. By 6pm on Sunday his knee was hurting and his left foot was hurting from the ball of his foot to the toe. Monday morning both of his feet hurt from heel to toe, he did not have any swelling. He went to see his PCP and thought maybe it was gout. His uric acid level was tested and it was normal. His feet were still hurting from heel to big toe on Thursday 9/20/18. Dr. thinks that it must be a nerve reaction to the shingles vaccine.
This spontaneous report was received from a pharmacist via Pfizer Inc. (Manufacturer Control No. 201503126) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and Lot number were not reported). No concomitant therapy was provided. On an unknown date, the patient experienced injection site reaction to PNEUMOVAX23. The outcome of injection site reaction was unknown. Additional information has been requested.
Mom states infant became pale, pasty, limp about 10 minutes after last immunizations event lasted about 5 minutes.
Headache, SkinRash, Constipation, Palpitations, Tachycardia, Flushing throughout, abnormal menstruations, pink patches on tongue,  Narrative:
Patient developed red rash on inner left arm and edema on back of left arm (nothing at site of injection). Sore neck and swollen neck glands on left hand side.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot #K008334 and expiration date 09-JUN-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. The temperature of excursion was 1 Celsius degree. The time frame of excursion was not available at the time of the report. There was no previous temperature excursion. It was stated that the call was because of a data logger. On the same day, the patient received an expired dose of M-M-R II (captured in 1607USA004581). Additional information is not expected as no contact details were reported.
Half hour after receiving vaccine child came back to clinic itching and whelps on face. Dr examined child ordered 25mg IM Benadryl.
102.3 Fever (lasted 2 days). 1/1/2016 Rash on trunk and face.
Patient developed acute onset of chest pain on the 3rd day after receiving Pfizer vaccine. Patient describes pain as squeezing in his chest. Pain resolved after about 20 minutes, but patient's mother brought him to emergency room where he had an abnormal ECG and was admitted for further evaluation.
The patient experienced swelling and pain of the left arm. The patient was seen in the ER and was advised to use Tylenol for the pain and cool soaks to the area.
March 2018:Patient had itching, pain, and a firm raised area over the muscle where she received her flu shot on 11/1/17. May 2018: Patient reported that she had used cortisone cream and is doing better. She plans to avoid that arm for her shot this year.