chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional adverse effects reported; a 33-year-old patient started on GARDASIL 9; This spontaneous report was received from a pharmacist referring to a 33-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-FEB-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614898, expiration date 15-NOV-2021) (dose, frequency, route and anatomical location not reported) for prophylaxis (product administered to patient of inappropriate age).   It was reported that due to coronavirus disease 2019 (COVID-19) situation, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028656, expiration date 27-JUL-2021) on 08-NOV-2020. The patient did not experience additional adverse effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Developed fever of 102 the afternoon after mist administered in school mass flu clinic on 10/17/13.  Fever resolved that night but mom reports c/o of H/A for next week.  Did not take to MD.
Symptoms started on 8/27/06 with a swelling (silver dollar) redness and warmth along with tenderness.  Patient came in on 8/31/06 with redness to injection site.  Patient was treated with Loratadine 10mg 1 tab po qd #30 no refills.
PT ADMITTED TO EMERGENCY ROOM. DIAGNOSED CELLULITUIS OF LEFT ARM AROUND INJECTION SITES.
Patient received Moderna COVID vaccine on 4/30/21 and 7/26/21. On 1/21/22, patient tested positive for COVID. On 1/27/22, patient was found down in the bathroom, intubated in the field, transferred to the ER, and admitted to HCF for acute metabolic encephalopathy, respiratory arrest, COVID19 pneumonia, and acute exacerbation of severe COPD. As of today (1/28/22), patient is still admitted in HCF intubated.
Rash on both arms at sight of injection; headache (migraine) 3 days treated with tylenol 500mg - 2 PO q 8H; upset stomach (cramps and diarrhea) 4 days not treated.  patient confirmed she drank plenty of water to stay hydrated.
Muscle weakness to legs, muscle aches to thigh, buttock. Pt only mildly weak to leg on exam. Cannot get out of chair. Gait nl. Follow up information received - DOB, manufacturer, and  lot number.
This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced sore arm. No additional adverse event information was provided.
INJECTION SITE BRUISE; INJECTION SITE LUMP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (Unspecified) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-Nov-2021 (Wednesday), the patient had the Janssen Covid-19 vaccine booster shot administered. On a unspecified date in NOV-2021, the patient stated that she had a bruise and a lump at the injection site. She had not taken any medication or done anything to treat the area. No information was gathered from the consumer regarding this event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site bruise and injection site lump was not reported. This report was non-serious.
Laryngitis - 8/25/19 evening spasm/tremor/visual hallucination/slurred speech/shivering - 8/26/19 morning Auditory hallucination - 8/26/19 afternoon continued till wednesday morning
about 4 to 5min p/vax pt felt dizzy & very weak & then fainted from about 30sec & tonic convuls;recovered p/2-3min;
pt recv second dose of hep B vax; devel GBS; seen in ER and was hosp for 14 days;
Pt experienced fever, diarrhea, swollen are, swollen throat, huge bright red-hot area of injection, hives and puffy face.
delayed reaction 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (delayed reaction 3 days after vaccine) 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.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (delayed reaction 3 days after vaccine). At the time of the report, VACCINATION COMPLICATION (delayed reaction 3 days after vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Right eye blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Right eye blurred vision) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache, Hypertension, Parkinson's disease and Seizure. Concomitant products included METOPROLOL for Hypertension.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VISION BLURRED (Right eye blurred vision). At the time of the report, VISION BLURRED (Right eye blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
no adverse event; expired vaccine administered; This spontaneous report was received from a Registered Nurse, and refers to a 5 year old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-FEB-2015, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032358 with expiration date on 11-JAN-2021 (discrepant information) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis.    At the reporting time, the nurse was wondering if the patient needed to be revaccinated. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Pharmacist had  recommended patient to take Benadryl but patient only took Tylenol.
Patient had Tdap administered on L deltoid no reactions at time of shot. Patient left to pharmacy, came back, had a big red welts behind L ear. No itching, hives, etc. Patient walked to see doctor. Given Benadryl discharged. Have no other allergies.
Soreness in left arm where vaccine was given.; This is a spontaneous report from a contactable consumer, the patient. A 26-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 left arm on 30Jul2021 at 16:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and hypothyroidism. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) "5 mg/10 mg"; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination which included medroxyprogesterone acetate (DEPO PROVERA) in the left arm on 09Jul2021. On 30Jul2021 at 17:30, the patient experienced soreness in left arm where vaccine was given. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in left arm where vaccine was given was resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
She was given Tdap and Hepatitis A #2 and PPD 5-10 minutes, after immunization she felt dizzy became stiff and her eyes rolled back. The episode lasted 20 seconds.
Cough  Muscle or body aches  Headache  Congestion or running nose
Patient developed full body hives more than 24 hours out from vaccination but has kept them for almost a week at this point.  Has been on 2 rounds of Prednisone burst and Benadryl and Hydrocortisone.
I already suffer from mild tinnitus.  About 14 hours after the 2nd vaccine dose my tinnitus became noticeably worse for a period of about 24 hours.  I also experienced the typical flu-cold like symptoms after the 2nd vaccine dose including muscle ache, stiff and achey joints, and general I'll feel for a period of 8 after that began 14 hours after the 2nd dose was administered.  I experienced fatigue for roughly 4 days after the 2nd dose.   I had no symptoms nor adverse reaction after the 1st dose.  My biggest concern was the tinnitus.  The cold and flu like symptoms I understand should be expected.
Myalgia Narrative:  day 1 bodyache; chills lasting for 24 hrs
On 5-28-2022, I started having a itchy, red rash on my right breast. I had a physical already scheduled for 6-1-2022 so I told my PCP about the rash. He looked at it and stated this was not a normal occurrence with the breast. I have had breast cancer in the left breast but none in my right. He told me to schedule an appointment with my oncologist. I had my oncology visit with the APRN on 6-7-2022 and she did not think that it looked or felt like cancer. On that same day, they had me scheduled a diagnostic mammogram. An ultrasound was also done right after the mammogram at a local hospital. Neither test showed any cancer or reason for the symptom. The APRN ordered hydrocortisone cream, told me to keep an eye on the rash and to notify her if there was a significant change. The rash is still present but looks a little lighter.
48 hours later top of right shoulder began to be sore, within 24 hours,(afternoon of Sunday) SEVERE total arm pain (from top of shoulder down to wrist).  SEVERE pain all through the nite, Advil did not relieve any pain.  by Monday noon, pain was tolerable. Used heating pad throughout (without any relief) and continued Advil. By Tuesday afternoon slight pain at the top of left shoulder.  By afternoon, SEVERE pain from top of shoulder all the way to wrist.  SEVERE pain all nite, by mid day Wednesday, using heating pad and Advil, pain began to subside.  Still on Advil,(today is Thursday one week post injection)  pain still continues slowly to subside from both tops of shoulders. No heating pad required.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX 1 dose (reported as one single injection), intramuscular, lot # N020942, expiration date 26-OCT-2018. Other suspect therapies included sterile diluent intramuscular, lot# N007932, expiration date 06-MAY-2018 (dose was not reported). On 10-NOV-2017, the patient noticed swelling, redness, and a hard bump around injection site. No treatment was given for the events. The patient did not seek medical attention. The outcome of the events was not recovered. The causality assessment was not provided.
Pt fainted after 1minute of receiving menactra and Tdap and hit the wall with her head, fell to the floor and started to shake for about 3seconds and woke up and alert immediatly. Mom grabed her and Pt soon recovered with no residual symptoms.
This spontaneous report as receivd from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified number of patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were administered improperly stored doses of PNEUMOVAX 23 (dose and frequency were not reported). No adverse events were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. Additional information has been requested.
This study case was received from the investigator on 09 January 2013. An 44 year-old male subject whose past medical history included high blood pressure and elevated cholesterol was found to have "subendocardial infarction" 13 days after the subject had received the following vaccines on 04 October 2012: an injection of ACAM2000 (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported), Tdap vaccine (manufacturer, lot number, route and site of administration not reported and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 13 October 2012 recorded highest value of 00.13, an abnormal ECG on 15 October 2012 and a normal Echocardiogram on 15 October 2012. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Case number PHEH2014US016492, is an initial spontaneous report received from a nurse on 14 Aug 2014 with a follow up information received from the nurse on 16 Sep 2014. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. His vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on unspecified dates and was well tolerated. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X139054) without being reconstitution with Men A lyophilized component intramuscularly in the left arm on 13 Aug 2014. No adverse event was reported following this medication error. His vaccination status was reported as up to date. Follow up information received from the nurse on 16 Sep 2014: Updated patient identifiers (age, age group. height and weight), vaccination history, site of vaccination, date of vaccination and vaccination status in the narrative.
I broke out in a rash on most parts of my body; arms, legs, back, and buttocks/ Bad rash all over my body; will not go; The rash itches very bad, I scratch at it and it gets worse and seems to spread to more parts of my body; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 60-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6204), via an unknown route of administration in right arm on 25Mar2021 at 09:00 (at the age of 60-years-old) as dose 2, single for COVID-19 immunization at pharmacy. The patient's medical history included COVID-19 from an unknown date. No allergies to medications, food, or other products. Other medical history was none. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No, any other medications he received within 2 weeks of vaccination. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6206) in left arm on 04Mar2021 at 08:45 (at the age of 60-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. On 01Apr2021 at 14:30, the patient broke out in a rash on most parts of his body; arms, legs, back, and buttocks. Rash would not go away, his doctor prescribed some ointment, but it has not helped much, the rash itches very bad, he scratch at it and it gets worse and seems to spread to more parts of his body. On 05Apr2021 at 18:00, bad rash all over his body; will not go away. The adverse event result to visit doctor or other healthcare professional office or clinic. On 21Apr2021, the patient had COVID test post vaccination by mouth swab, resulted in negative. Triamcinolone and steroid shot were received as treatment for the adverse event. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Injection given approx 11:35AM. Patient felt "funny" 10 min. after injection, then was dizzy, pale and sweating. Pt laid down @ 11:48 AM, o2 sat - 96%, HR 98, RR 20,. Denied nausea or constant dizziness, no rash, airway open. 12:15 still dizzy, laying down o2 sat 98%, 12:25PM, no further dizziness, standing without issue.
Localized erythema and induration of about 5 cm.  Hot to touch.  No fever or other systemic symptoms.  No abscess.
Began 3/5 AM and con't to get worse. Now measures 6 1/4" x 4 1/2". Raised, red and hot. Complained of itching and pain. Recommended Benadryl, Motrin, cool compact and increase fluids.
Hypoaesthesia; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HYPOAESTHESIA (Hypoaesthesia), SINUS DISORDER (Sinus disorder), the second episode of HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (tingling in fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.  Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTI VITAMINS & MINERALS and IRON for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced the first episode of HYPOAESTHESIA (Hypoaesthesia). On 26-Feb-2021, the patient experienced SINUS DISORDER (Sinus disorder) and the second episode of HYPOAESTHESIA (Hypoaesthesia). On an unknown date, the patient experienced PARAESTHESIA (tingling in fingers). At the time of the report, SINUS DISORDER (Sinus disorder), the last episode of HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (tingling in fingers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-mar-2021, Event start dates and 1 dose information updated.
For 5 to 6 days after shot all muscles tightened, shaking alot, hot but cold. Jaw hurts from shivering. Etc. For a whole month, Right arm still hurts when moved in curtain directions. Lack of sleep because waking up in pain. after up awhile if I move in certain ways hurts with sharp pain, sometimes spasms. Occasionally tightens up. Seems to be getting worse.
Besides the immediate burning like my arm was on fire after getting each shot and having an egg shaped welt on my arm that was extremely painful. I began to have a lot of issues being outside in the sun. It felt as if I was having all the energy sucked out of me. My body would just radiate heat with in a matter of just a couple of minutes of being out in the sun. I very quickly felt as if I would pass out. As the years have gone by this issue has not gone away. I also now have anxiety issues not related to work because I did not go. This anxiety just seemed to come from out of no where. I also have degenerative disc disease and keep having positive results for arthritis but then don't show the signs for it. My joints feel weak and my muscles get really tight to where it is painful and I have to constantly be stretching. I already had to have my appendix removed and now have polyps in my gall bladder.