chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Outside dosing interval invalid dose; COVID positive; Sinitus; Loss of efficacy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose), SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus), DRUG INEFFECTIVE (Loss of efficacy) and PYREXIA (Fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ERYTHROMYCIN and AZELASTINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever). On 09-Feb-2021, the patient experienced DRUG INEFFECTIVE (Loss of efficacy). On 27-Feb-2021, the patient experienced SINUSITIS (Sinitus). On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID positive). On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose). On 07-Feb-2021, PYREXIA (Fever) had resolved. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus) and DRUG INEFFECTIVE (Loss of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Doctor prescribed antibodies and performed PCR test (second test).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       prescribed antibodies and performed PCR test   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 20-SEP-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1707457, expiration date 23-FEB-2022 (dose not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number T026961, expiration date 02-APR-2023 (dose and route of administration not reported) both for prophylaxis.      The vaccines underwent a temperature excursion of 48.7 degrees Fahrenheit for 10 minutes. There were no previous temeprature excursions.
+ (pos) Chicken pox rash at trunk with spreading to LE, UE.
This is a 92 year old female, with past medical history significant for Paroxysmal Atrial Fibrillation, HTN, HLP, Depression, GERD, Diastolic CHF, Aortic Valve Stenosis, who presented to the ED with complaints of shortness of breath. On arrival she was hypoxic, 88% on room air which improved to 95% with 2L nasal canula. A chest xray showed bilateral infiltrates and pleural effusions R>L, CHF vs bilateral pneumonia. She was started on PO Dexamethasone. .  As per the ED notes, the patient arrived with SOB. She insists she does not have Covid. A Covid AG was positive, however PCR is still pending. Consults have been placed for ID, Pulmonary, and Cardiology and she will be admitted to inpatient medical with telemetry monitoring for further work up and evaluation. .
Rash, hives, itching on hives on abdomen, neck, and palm of left hand.  Upper lip slightly swollen.
Patient describes pain in her arm starting the evening after her vaccine. Patient says pain is in upper arm/shoulder area and has been so painful she can not sleep.
Gradually getting worse- swollen, red arm- tender to touch- extends to elbow- mostly on inner bicep- no treatment.
Approximately 3hrs after injection (around 11am) joint and muscle stiffness, progressively getting worse throughout the day.  Low grade fever into the evening and overnight. Fever broke the following morning. Awoke the following morning to stiff muscles requiring stretching to be able to walk normally. Moderate injection site soreness, with no visible skin reddening.
6-11-12 ZOSTAVAX given at 3:56PM. 6-13-12 Onset of swelling, redness and warmth at site. Told pt to ice it & elevate it. Pt called in AM & said she woke up with her arm swollen, red & warm. She was also dizzy. I told her it was not uncommon to have that rxn (as we had discussed on Monday). I told her I was unsure if dizzy was from that. I told her to ice it & take NSAIDs (since she is on Naproxen). I followed up her approximately 4:30 & she had iced it once. It felt about the same but she did not take Naproxen. I told her to continue with ice & also to elevate it. She was no longer dizzy. 6/14/12 F/U in PM. She said she just returned from hospital. She had problems with her heart. She said they iced the injection site at the hospital. They also elevated it. She said they were not concerned with the swelling & redness from shot, they were worried about her heart. I told her to continue w/ ice & elevation if it didn't get better to follow up with us. She was satisfied with it. Followed up with patient on 6/17/12. She is doing better but still has some swelling and redness at injection site. She stated that she has less swelling and redness than initially. She stated that she went to the hospital Wed 6/13 with shortness of breath, dizziness and palpitations. She stated that she was referred to a cardiologist for follow-up and that the doctor at the hospital thought the heart issues were unrelated to the immunization.
Diarrhea (moderate) for approximately 24 hours post vaccine, beginning ~12 hours after appointment.  No vomiting but stomach cramping and noticeable loss of appetite. By 9 Am on 4/29, all symptoms  had resolved   One bout of moderate diarrhea was noticed 12 hours after the first dose on 4/3/2021 @ 9 AM, but I did not know for sure if that was vaccine related or not.
High fever, 103 degrees from 6-18 hours after the vaccine.  Left axillary swelling starting 6 hours and lasting  x5-6 days (require massage therapy which was effective) New- onset Chest pressure event 4 days after vaccine.  New-onset hypertension 4 days after vaccine (requiring clinic visit, ER visit, PCP visit and medication treatment that is not yet effective). EKG in the clinic (physician was concerned about pericarditis, sent me to the ER) New onset tachycardia with minimal exertion starting 4 days after vaccine (previously an avid hiker and 2-3/week cardio classes with no issues)
bad bad angina; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (bad bad angina) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (bad bad angina) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (bad bad angina) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported as the patient got bad bad angina from Moderna shots and the doctors were afraid to report it.  Relevant concomitant medications were not reported.  Treatment information was not provided.  Company comment: This case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected event of angina pectoris. The event occurred after a dose of mRNA-1273. As reported, the patient got bad bad angina from Moderna shots and the doctors were afraid to report it. It is unclear what type of angina the patient experienced. No information regarding diagnostics or treatment was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected event of angina pectoris. The event occurred after a dose of mRNA-1273. As reported, the patient got bad bad angina from Moderna shots and the doctors were afraid to report it. It is unclear what type of angina the patient experienced. No information regarding diagnostics or treatment was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Two weeks after getting the shingles vaccine shot I developed the first cold sore of my life on my lips.  The cold sore took three weeks to go away.  I cannot believe this was not a side effect of the vaccine.
soreness; Injection site soreness; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 15:25 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness (non-serious) on 01Mar2021 17:25, injection site soreness (non-serious) on 01Mar2021. Patient wanted to report that after receiving the COVID-19 vaccine dose 1 at the (name), patient have experienced soreness around the injection site. This started about a two hours after injection (3:25 pm Monday, 01Mar2021) and has persisted. Product: Covid-19 Vaccine. Symptom: Injection site soreness. For events, soreness, outcome was not recovered, injection site soreness, outcome was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Arm swollen & red to elbow. Next day chills & fever by evening 102 degrees. Doctor prescribed cephalexin. Said I had cellulitis in arm. It took 3-4 days for swelling to recede.
Very bad ringing in my ears, that does not stop, I am having issues hearing because of it
Experienced very high blood pressure/blood pressure was 190/119; The blood vessel broke in her left eye/ there was blood in half of her eyes; Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease and Colitis. Concomitant products included MESALAMINE for Crohn's disease and Colitis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) (seriousness criterion hospitalization), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) (seriousness criterion hospitalization) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) had resolved and EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 141/90. On 16-Mar-2021, Blood pressure measurement: 136/84. On 17-Mar-2021, Blood pressure measurement: 140/91. On 22-Mar-2021, Blood pressure measurement: 155/94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported to be treated with beta blockers and test were performed and came out "okay". No further information regarding test results or types of tests was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2 PEOPLE GOT THE SHOT, STILL BROKE OUT WITH SHINGLESsuspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the Shingles shot and still broke out with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186362, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186362:Same reporter
seen in Er 2NOV92 coughing & cyanotic around mouth-no resp distress VS: t100.7, P120, R20-measle rash; 5NOV92 hospitalized-t97.8, vomiting, circumoral pallor, pharyngitis, inguinal lympathy, lungs clear, abd soft;
high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fifth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/event, different patient
my spine was sore to the touch like a bruise or something; my spine was sore to the touch like a bruise or something; pain; can't bend down to tie my shoes or put on pants; constant pressure and pulling sensation on my spine; constant pressure and pulling sensation on my spine; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 29Mar2021 at 12:00 (at the age of 56-years-old) (Batch/Lot Number: ER8733) single, for COVID-19 immunization. The patient's medical history was not reported. The patient had no other vaccines in four weeks, did not have COVID prior to vaccination, and was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took Levaquin and experienced drug allergy. The day after the patient's first COVID vaccine, on 30Mar2021 at 08:00 AM, it was reported that her spine was sore to the touch like a bruise or something. The pain had continued to get worse now for the past three months. She can't bend down to tie her shoes or put on pants. She had to sit on her bed to get dressed. She was a healthy active person before the vaccine and she had never had a problem with her back in the past. She had a constant pressure and pulling sensation on her spine. The patient had X-rays and MRI (results unspecified) on an unspecified date and was looking at some type of therapy now since the other tests didn't show what was causing the pain. She was not COVID tested post vaccination. The patient received treatment for the events (unspecified; also reported as lumbar X-rays and MRI). Outcome of the events was not recovered.
Narrative: 36 y/o M received the Moderna COVID booster on 12/28/21. He  presented to ED on 1/9/22 w/ urticaria and pruritis x 1 day; received  methylprednisolone 125mg IV, diphenhydramine 25mg 1M, and topical  hydrocortisone cream in the ED and discharged home w/ prednisone,  diphenhydramine, and hydrocortisone cream. Symptoms initially improved then  worsened again w edema to hands and lip. He presented to derm clinic then to  ED and received methylprednisolone 125mg IV, famotidine, and diphenhydramine discharged home w/ cetirizine, hydroxyzine, and medrol dose pack with allergy  clinic consult f/u placed. Ongoing assessement to determine potential symptom  triggers-resuming regular chronic meds one at a time starting with  sertraline>quetaipine>prazosine. Per ID consult, pt had no rxn to first2 doses but cannot exclude Moderna booster as a possible cause of allergic rxn.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HYN" (unspecified if ongoing), notes: Other medical history: HYN. There were no concomitant medications.No other medication in 2weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknonw results, notes: Rebound of the symptoms 6 days after finishing the treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 05Jul2022 to 10Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
8Apr92 Coroner called stating pt was found dead by mom this am. Her body is being sent to state crime lab for autopsy.1Jun92 death cert list cause of death : cardiac pul failure D/T to sids
30 days after the vaccine was administered started to get swelling of ankles and edema. Painful not able to walk on. Diet or exercise did not change.  Heart flutters and dizziness may times.
Multi inflammation- 4 UTI's, 1 bladder inf, 1 yeast inf, bursitus, swollen ankles, rosacea on face/ eyelids,/in eye, psoriasis, from lifelong oily skin to extremely dry, dizziness,  chest pressure, fatigue, vomiting, bloated stomach, constipation, brain fog, poor concentration, hair loss
Patient arrived at the hospital 6 days after her vaccination.  She had been experiencing 4 days of increased agitation and 3 days of altered gait.
Pt recv vax on 1/12/99; on 1/13/99 pt exp vax site redness, swelling, warmth-rt arm, fever (99.8F); tx=cool compress, Augmentin  & Tylenol
pt recv vax 15JAN96 & 4FEB96 pt devel fever, lethargy, a clear runny nose & glassy eyes;@ time of this report the sx persisted;
Patient states that nausea began the same day as she received her first dose of Moderna COVID-19 vaccine. States she has been to the doctor several times and has tried many different prescriptions. States she has even seen specialists. Was dry heaving at first but denies ever vomiting.
The day she got the Hep A vaccin and a Tetanus shot, it shut down her system, she stop breathing and she broke out in hives all over. We took her to clinic. They gave her a shot and she come around was able to go home. The next night she did the same thing she stopped breathing was taken to clinic by ambulance that night. Was in hospital 4 days then. At first pt was having small seizures, like tremors and be disoriented. About 2 months after this pt has been having seizures full blown, Ever since June. We have Dr. He was not able to control them. So he sent us to Clinic, where she is under another MD, care now. She has been out of the hospital numerous times since she got the shots, and has lost her job. Right now she is on two diffrent seizure medicine, if this dont work in 3 months they might have to do a seizure surgery. She has not been able to go to school for over month now.
Initially dizziness and nausea occurred and began to experience a headache, body aches, vomiting, and cough. The next morning developed rash at site of injection and low grade fever. Nausea finally resolved on 06/18/17.
Patient received 4th COVID-19 dose twice by accident about a week apart in between. Informed contact person. Patient did not have any side effects so far and doing ok. Doctor will continuously monitor patient.
body aches and extreme fatigue. Was feeling bad but when I got up in the morning, it was over. Got COVID arm/rash reaction 8 days later. It lasted 2 days. No treatments were used for either condition.
Asthma; Brocho-spasm; shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Feb2021 (Batch/Lot Number: EL9269) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for myalgia and headache from 01Feb2021 to an unspecified stop date. The patient previously took first dose of BNT162B2 (Lot number: EL1283) in the right arm on 13Jan2021 for COVID-19 immunization. Post-second shot the patient symptoms were mostly related to asthma/bronchospasm- 2days-shortness of breath(SOB) accordingly since then. Albuterol was given as a treatment for bronchospasm since 03Feb2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.