chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's mother). The consumer reported similar events for her 3 kids. This is one of the 3 reports. A 22-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration, on 11Dec2015, at 0.5 ml single. Relevant medical history included ovarian cyst on an unspecified date. Concomitant medications were none. A couple of days after vaccination the patient experienced not feeling well, slight fever, headache, nausea, she just had ache. The patient took TRUMENBA because she was a college student and she read to be in age group in high risk situation. The reporter mentioned that they talked to the patient's physician. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, ALEVE, she took some over the counter pain killer. The patient stayed at home and rested. The patient underwent lab tests and procedures which included: complete blood count (normal), hormone testing (normal). The patient had some test on 24Dec2015 and 30Dec2015 with unknown result. Outcome of the reported events was recovered. Follow-up (19MAY2016): Follow-up attempts are completed. No further information is expected.
Felt dizzy up to 10 minutes after the shot; then was okay drove home. Later that day  got headache which is unusual, as I never get headaches and feeling tired to the present time. Wed 4/114/2021.
71 y.o. male patient with history of A-fib, COPD, CAD, alcohol use disorder presented to Hospital following a fall at home. Covid positive with hypoxia.   Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms:4/4/23 Symptoms present on admission: Chest congestion, diarrhea Date of covid positive test: 4/5/2023 Vaccination status: Unknown Imaging: Chest CT-Lung fields are clear.  There is no hilar mass or mediastinal hematoma seen. Chest x-ray 4/7/23no acute infiltrate or fluid overload Oxygen requirements on admission: Room air Current oxygen requirements: 2LMedical therapy: Decadron 4/8 started, remdesivir completed therapy Consultants f  Medical therapy: Decadron 4/8 started, remdesivir completed therapy Consultants following: None Anticipated special isolation end date: 4/15/2023  FEES 4/10 with trace penetration - thin liquids recommended Discharged stable on room air   Hypokalemiaresolved Premature ventricular complexes Required aggressive IV electrolyte replacement over last 72 hours Potassium level up to 3.8  Possible blood per rectum Colon thickening on CT Nursing staff expresses concerns about bloodstained  bedsheets, negative FOBT Stable hgb  Diarrheaimproving Negative stool for C. difficile, stool PCR Continue IV fluid resuscitation  Severe vitamin D deficiency Started oral vitamin D replacement therapy   Elevated troponin Atrial fibrillation Noncompliant with Eliquis at home Troponin 47< 58 EKG -A-fib , T wave inversion in V3 to V6, PVC Hypotensive on presentation, blood pressure starting to stabilize, Continue Eliquis, carvedilol with holding parameters Alcohol use disorder Drinks a liter of tequila every day On CIWA protocolmost recent score 0 Continue with thiamine folic acid and multivitamin   Recurrent fall at home Deconditioning Secondary to generalized deconditioning, chronic alcohol use CT chest abdomen pelvis-no acute pathology CT TLS spine-no acute fracture PT OT eval - ampac 8 Case management consult for discharge needs-patient refusing to go to skilled nursing facility, discharge with HHC Working daily with pt to improve mobility for safe homegoing
Within 4 hours body aches, chills and severe headache. Next day diarrhea fatigue with the other symptoms. Lasted 3 days I was getting better day 4. Then on day 6 started getting sore throat, fatigue returned. Today is day 12 post vaccine and sore throat congestion is is a problem
The day after my second vaccine shot, and almost everyday since, I experience arrythmia and palpitations throughout my day. Sometimes as little as  or 6 times a day while other days it happens over 50-70 times a day, especially when walking or walking up or down stairs. I experience shortness of breath and extreme chronic fatigue in addition to these episodes of arrythmia. It has been consistently a challenge to get through the day but the severity of experiencing these episodes has been inconsistent. I have seen numerous medical professionals about this daily problem and I have been given the medical opinion that either the vaccine shot was the cause of this heart condition or a "trigger" to this heart condition becoming the daily problem that it is.
15 y/o M with hx of autism presents to the ED with chest pain. Pt received 2nd dose of COVID vaccine on Monday. Pt had body aches onset Monday and L sided chest pain onset last night. Per mom, swelling on L side of chest. Pt given Tylenol. Pt denies SOB, cough, diarrhea, emesis. Pt has 38.2C fever onset this morning. No PMH. No sick contacts. NKA. Vaccines UTD. No medications taken on a daily basis. EKG Findings Time 07/14/21 08:36:00, Rate 101, Normal sinus rhythm, T wave inversion in Inferior leads. Case d/w cardiology. Normal troponin level. Unlikely myocarditis induced by COVID vaccine. Recommends mom to follow up with Pediatrician. If pain persists next week can follow up with Cardiology or have Pediatrician do 2nd troponin test done outpatient.
Found to be COVID positive on admission.  Pt has a past medical history of ESRD and is on dialysis.  He arrived to the ED with generalized weakness, dizziness, and increasing fatigue.
vaccination site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, 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 Bexsero.  Additional details were provided as follows: The age at vaccination was not report. The reporter mentioned that the patient did not experienced any adverse events with Bexsero other than that the patient experienced pain at injection site.
Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     It was unknown whether patient has diagnosed/tested positive for COVID-19.  Acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was initially stored in the refrigerator on 27-May-2022. Date of administration of vaccine on 29th or 30th of Jun 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600655:Master case
Chills,  fever, muscle and body aches, headache,  fatigue, vomiting and nausea for three days.  Right arm sore and a rash with smelling
Patient reported severe pain at site of PREVNAR injection (right arm) and limited mobility in that arm.  She was concerned about possible injury in that arm due to previous rotator cuff surgery and tendon injury in that arm. Pharmacist advised her to ice it and take a pain reliever. The next morning, patient came to pharmacy and said she had a little more mobility but the injection site was still very painful and the pain radiated down her arm. She said she had iced  the area all night long. She had the arm in a sling. Pharmacist checked the site and did not see any redness or swelling at this time. Patient requested a report to be filed regarding this reaction. If pain/mobility does not improve, patient will contact physician.
Information has been received from a RN concerning a 16 yr old female who was vaccinated as a child with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number not available). There was no concomitant medication. On 12Apr04 the pt experienced a sore throat. On 14Apr04 the pt developed huge swelling of her neck. The pt was seen on 14Apr04, and also on 15Apr04 and 16Apr04. The pt was treated with acetaminophen (+) codeine phosphate (Tylenol with codeine). The pt was seen by an ENT on 16Apr04, who diagnosed a bacterial infection related to the mumps. The ENT prescribed amoxicillin (+) clavulanate potassium (Augmentin) for 2 to 3 weeks. On 16Apr04 a mumps titer was drawn, results noted as positive. The pt's conditions was reported as subsiding. No further information is available.
didn't receive the second shot; This case was reported by a consumer via (Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
I am 9 days late on my period. I had my period after the first dose, but have yet to get it again after the 2nd dose. I also had some spotting 2 days after the second dose.
AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED.   C/O DIFFICULTY BREATHING.  DENIED FEVER, CHILLS OR BODY ACHES.  MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF.  SENT TO ER WITH DIFFICULTY BREATHING.
Severe tinnitus - right ear- started immediately after 2nd injection - no treatment available Second menopause, hot flashing, weight gain, severe fatigue - have not been evaluated for this yet Hypertensive events - various times 140-180 s/ 90-120s - in midst of evaluating Fingers and toes twisting - no treatment beyond Tylenol, Ibuprofen - will need to see Rheumatologist  Decline in visual acuity, increased visual snow - new glasses/pescription, saw Optometrist Teeth pain - Tylenol - dentist found no reason All of these symptoms started at some point after 2nd injection
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored PNEUNOVAX23 injection, lot # K023328, exp. date: 23-JUN-2016 and lot # K010522, exp. date: 25-FEB-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter.  Additional information is not expected as the reporter did not wish further contact.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a outpatient clinic, (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 05-JUL-2016, the patient was treated by a physician for symptoms of a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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, and pain and suffering, and other damages. The reported considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Received Tdap around 9:00-9:30 am at school; felt drowsy all day afterwards. Later that evening felt tired, weak, dizzy, chills and fever of 102.6. complain of chest pains with deep breath on 5/6/09 at Doctors office.
This spontaneous report as received from a pharmacist refers to an approximately 90 year old male patient, with no drug reaction/allergies and no other pertinent medical history. In October 2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, intramuscularly (site and lot number not provided). In October 2012, after he had ZOSTAVAX administered, the patient developed pain at the injection site. The pain came and went and the patient still had this pain presently. No lab diagnostic tests were performed. The patient was treated with OTC anti-inflammatory medications. The patient contacted pharmacist for medical attention. The causal relationship was not reported. Additional information has been requested.
Headache, Myalgia,  sore throat, right arm soreness, chills 1/11 felt like she had chills and mild headache so took tylenol. 1/12 woke up with Sore throat, Headache, body aches. Improved throughout the day but the headache persists. 1/13 symptoms resolved.
7/06/2022-07/13/2022 I had off and on chills,no fever, nausea and severe pain in right hip area and lower back. 7/11/2022 I felt a cluster of bumps on my right lower back. By 07/13/2022 in the evening they covered my lower right back, right hip, groin, upper right leg and right side of stomach. Called primary on 7/14/2022, she wasn't available but saw another doctor in the practice for in office appt at 3 pm. After describing my syptoms she diagosed me with shingles. She prescribed an 5 day course of antiviral medication. Rash lessoned as the weeks went on but the nerve pain is still there 4 weeks later. At the time I saw that doctor I did not connect the COVID booster to shingles, but after doing some research and and talking to friends and one person who had COVID in June and got shingles also, I reported my diagnosis to VSafe, who asked me to fill out this form. I did not include the doctors name who diagnosed me because we didn't talk at the time about any connection to my COVID booster 2 months prior to my outbreak. If you need her name, let me know.
Iron level dropped to 4 causing SOB, required 2 iron infusions to correct.
Pt was fine for approximately one minute following  vaccination. She then experienced syncope. She was examined by EMS and determined to not need additional care.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 16-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1140 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lump in clavicle started small and painful, increased in size, pain also felt underneath breast and in the underarm region.  Lump increased in size and is tender to touch.  It hurts to move or lie in certain positions.  I had an ultra sound on  January 29.  I was told that it may be a reaction from the vaccine but not certain and I was given a referral to a general surgeon- I have an appointment with that doctor on February 2, 2021.   After the ultrasound visit on January 29 another lump has appeared on January 30 in front of the clavical, it is shaped different than the initial lump and is also tender.  It has increased in size since it appeared.
fever of 101.6; headache; chills; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265), dose 2 intramuscular, administered in Arm Left on 16Feb2021 at 13:00 (65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no other vaccine within 4 weeks prior to the current vaccination. The patient had received the first dose of the bnt162b2 on 01Feb2021 and had experienced Itching rash/ hives.  Concomitant medication included prednisone. On 16Feb2021 22:00, the patient experienced fever of 101.6, headache, chills and body ache. It was reported that the patient was advised to get 2nd vaccine. The patient had lowered prednisone on 26feb 2021 by dermatologist visit. Being weaned off prednisone slowly. At the date of report rash itching 99% gone, some residual marks on arms prednisone dose 2.5 mg every other until 26Mar2021 then wean off antihistamine. It was reported that the second dose of vaccine had typical adverse reaction. As bad as all of this was she felt blessed to have received and complete covid 19 vaccine and thanked Pfizer. The patient gave consent to contact her if additional information was required. The patient underwent lab tests and procedures which included blood glucose: high on 12Feb2021, blood test: high   on 12Feb2021 Out of range , covid-19: negative on 08Feb2021, neutrophil count: high on 12Feb2021, white blood cell count: high on 12Feb2021. Treatment was given with Motrin for the events. Outcome of the events were recovered on 17Feb2021 at 22:00 hours.   No Follow-up attempts are needed. No further information is expected
School nurse called informing me of a headache he had. An hour later she called alarmed. His headache has turned into a massive migraine and he lost vision in his left eye. Went to Pediatrician right away who sent us to the ER. Had an MRI to rule out any tumors. We left without a reason why this was happening.
This spontaneous report has been received from a nurse practitioner referring to a 12 month old patient. The patient's current condition and medical history was not reported. On 19-MAY-2016, the patient was inadvertently vaccinated with the first dose of PROQUAD (lot # L044056, exp date 02-MAY-2017, dose 1) concomitant with first dose of M-M-R II (lot # L027591, exp date 23-JUL-2017, dose and route unknown). It was reported that the M-M-R II was vaccinated in opposite unspecified area. No adverse effects were reported. Additional information has been requested.
Sore arm; After receiving the vaccine started experiencing a relief for the arthritis. Now lost the pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the vaccine started experiencing a relief for the arthritis. Now lost the pain in the joints) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (breast cancer survivor.). Concurrent medical conditions included Arthritis.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the vaccine started experiencing a relief for the arthritis. Now lost the pain in the joints). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the vaccine started experiencing a relief for the arthritis. Now lost the pain in the joints) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Description included Arthritis treatment.  No Treatments were reported
Fever; Chilliness; Body Pain; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient took vaccination on Wednesday around 10:30 AM. It had been 48 hours, the patient got fever in 14 hours and chilliness and body pain. The patient was not having fever today but getting headache. The patient wanted to know whether it was normal. Outcome of the event fever was recovered and other events was unknown.  Information about batch/lot number has been requested.