chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart surgery in Nov to repair a mitral valve; My fever is not as high as before; Congested like a bad cold; Congested like a bad cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2020, stop date: Nov2020, notes: I had COVID in November (confirmed 2020); "I take cholesterol medicine" (unspecified if ongoing), notes: I take cholesterol medicine. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: MITRAL VALVE DISEASE (medically significant), outcome "unknown", described as "Heart surgery in Nov to repair a mitral valve"; PYREXIA (non-serious), outcome "unknown", described as "My fever is not as high as before"; NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "Congested like a bad cold". Therapeutic measures were taken as a result of mitral valve disease.  Clinical course: Patient had the Pfizer Covid 19 vaccine back in Apr2021 of last year (confirmed 2021) and I had my second dose 5 weeks later. I got my booster in Nov2021 (confirmed 2021). I have COVID now. I have read time and time again. I had COVID in Nov2020 (confirmed 2020) before vaccines were available. Is having the booster in Nov led to a lesser degree of Covid? I had it really bad last year. I think it was congenital but I had to have open heart surgery in Nov to repair a mitral valve. I am 59-year-old. I am not dying over here. I called my doctor and they were going to put me on Paxlovid which I am hesitant to take with the side effects and my history. I take cholesterol medicine. I made it through ok last time. My fever is not as high as before, I am just really congested like a bad cold. It doesn't seem as bad. I don't want to take that pill. Is it going to be shorter lived. Is COVID shorter lived after 3 doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore injection site, fever of 3 degrees, body aches, back pain  Lasting 24 hours  Fatigue, lasting 48 hours
Narrative: Patient received first dose of COVID-10 vaccine on 2/2/21 and Overnight, had elevated temperature of 100, body aches, injection site pain, and diarrhea. Denies SOB, swelling, chest pain, itching, redness.
This spontaneous report as received from a registered nurse refers to a 7 month old male patient. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right lower thigh. ON 26-AUG-2014, the patient was administered PNEUMOVAX23 instead of PREVNAR13. It was due to staff error. No adverse effects were reported. The outcome of events was unknown. Product quality complaint was not reported. Additional information is not expected.
After getting my second Moderna vaccine, I COMPLETELY lost my sense of smell and taste. It has not returned.
exp some inc lymph nodes & malaise p/3rd dose of vax;pt woke up 3 days p/vax;inc lymph nodes & tenderness under rt breast, underarms in femoral area; also swelling or rt chest wall that caused pain inspiration;fever, allerg rxn, swelling
Patient was having her blood drawn for routine lab work after receiving both vaccines. While patient was having her blood drawn she fainted. She woke up immediately and was talking right away. Pt was given snacks and juice. Blood pressure was 116/72 and HR was 76, consistent with her vitals upon arrival as 106/70 and HR of 78. Upon further discussion with patient it came to light that she had not had anything to drink, nor had she eaten yet at this point in the day. After 30 mins of observation patient was able to leave the office. It is unclear what the true cause of fainting was.
Patient reports a one week history of generalized fatigue and shortness of breath. Due to desaturation on activity, the patient was placed on 2 L O2 by nasal cannula. The patient has received dexamethasone 6 mg IV. The patient is being admitted to the hospital.
Donor stated feeling lightheaded and dizzy approx 8-9 mins post injection of vax. He also appeared pale and diaphoretic. Ice packs applied to neck region. Approx 450 cc po fluids and craclars ? given. 2s taken. Reaction lasted about 8 mins. Donor reported last meal intake approx 10 hrs before donation.
Information has been received from a health professional concerning a 19 month old male, of unk race, with no medical history and no allergies, who on 07Dec04 was vaccinated with a SC first dose in the right arm of varicella virus vaccine live (lot 649281/0656P). Concomitant vaccines included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), hep B vaccine, recomb (manf unk) and a dose of poliovirus vaccine. There was no illness at the time of vaccination. On 02Jun05 the pt experienced 10-20 papular lesions on his trunk and thighs. Symptomatic treatment was given. It was reported that the pt recovered on approx mid Jun 2005. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. Additional information is not expected.
Patient became pale, diaphoretic and fainted after receiving vaccines. BP low at 73/34 after fainting. No shortness of breath, no rash, no pain. Ammonia was used.  Patient was assisted to lying position with legs elevated. Also given crackers and water. Patient and vitals were monitored closely. Patient had BP of 91/54 and 95/58 while lying down. Assisted patient to sitting in a chair but patient became pale and felt faint again. BP 71/43 and 73/32.  Once lying down BP 96/47 and 88/54.  Decision made to call EMS due to low blood pressure and feeling faint while sitting. Client had been monitored from 11:45 to 12:35 when EMS was called. Prior to EMS arriving patient started feeling better and sat up in chair with good color and no complaints of dizziness. BP 104/59. Walked client around in office and rechecked BP 112/72. EMS arrived at 12:55pm for evaluation. Patient was feeling much better and was discharge home with mother at 1:10pm.  Only adverse effect was fainting and low Blood pressure.
Left arm where injection given had red bump, reddened around area painful and warm to touch, c/o mobility. Motrin x2 days. Referred to PCP.
This spontaneous report was received from a physician via a company representative regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown dates, the patient was vaccinated with the complete series of GARDASIL injection (dose, route and lot numbers were not provided). Concomitant medication was not provided. On an unknown date, after completed the GARDASIL series, the patient came down with an HPV infection. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
first dose at an unspecified time then patient received second dose 6 days prior to 6 months recommended schedule.; No symptoms or additional adverse effects reported.; This spontaneous report was received from a physician via company representative referring to a pediatric patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.     On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength 25/0.5 (unit not provided); dose detail, lot#, route and expiration date were not provided) for prophylaxis. Then the patient received the second dose 6 days prior to 6 months recommended schedule (inappropriate schedule of product administration). No symptoms or additional adverse effects were reported.
About two days after my second shot, I started experiencing a lot of dizziness and/or lightheadedness. It has persisted for several weeks. The only other time I had experienced dizziness like this before was when I actually had covid over a year ago.
No adverse event; Received 0.25ml Bivalent booster instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 24-Oct-2022, the patient experienced UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2022-664522 (Patient Link).
rash on both of his arms; This is a spontaneous report received from medical information team. A contactable male reporter (patient) reported for himself that a 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 at 16:30 (at the age of 62-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Other Products and patient History was reported as none. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) and event following prior vaccinations were none. The patient experienced rash on both of his arms on 31Mar2021. Reporter was asking if he should get the second vaccine dose if he is still experiencing a side effect from the first? Reporter reported that he received his first vaccine dose and 1 week later he started getting a rash on both arms and nowhere else. He reported that he wasn't concerned and thought it would go away but now he was scheduled to get his second dose and it still hasn't gone away and he doesn't know what to do.  He asked Is it ok to get my second dose if I still have a rash? He said, I had a side effect after the first dose of the vaccine.  Should I get the second dose? Event was reported as ongoing. Further reporter said that he doesn't know if it was a severe reaction. He developed a rash on both of his arms. It was not his entire body, just both arms. He is scheduled to get the second dose today, but the rash hasn't gone away. He didn't know if that would be concerning or not in regard to getting the second dose. Reporter clarified product as Pfizer COVID19 Vaccine. The rash on both of his arms started around 31Mar2021. Reporter clarified that would like to speak to USMI about rashes after the vaccine and what that means for the second dose. He has not received any treatment for the rash. He has not had to go to the Emergency room or to a physician's office. Reporter seriousness for the event was unspecified. PQC was not present. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Patient was seen 11/15/2021 please see attached notes Patient here with mom for eruption that started 11/11 or 11/12 24-48hrs after her 2nd pfizer covid vaccine. The rash started on her left arm/elbow area (distal to the injection site, also left arm). The rash was initially reportedly itchy, but now "feels hot". She has taken benadryl, unclear if it helped. Patient is also on Augmentin rx'd by UC for an acute cough/respiratory illness (dx unclear, notes not available for review at time of visit) that she started on 11/1 and has not been taking as directed (she has missed doses).  The appearance of the rash is most consistent with a viral exanthem, similar to a mono-type rash, also possibly caused by Augmentin. Discussed this with mom and pt. Recommended testing for mono, esp due to recent URI illness.  Pt denies fatigue, no lymphadenopathy, no organomegaly.  Pending lab test results will fill our VAERS paperwork if mono negative as this is possibly a vaccine reaction or an immune mediated response from vaccine (not necessarily "allergic reaction" or contraindication to future boosters if indicated). Ok to take zyrtec 10mg daily or benadryl. If needed may take 1-2 benadryl before bed with zyrtec, but not to exceed that dosing. F/u prn.  Check CBC w/auto diff Check infectious mono qualitative Check epstein barr virus evaluation
Same day access visit with a chief complaint of reaction to PNEUMOVAX injection. Pt received this injection on 1/5 and right arm now has red hard area the size of his hand surrounding the site. Pt also c/o temp as high 101 today and has been taking ibuprofen 800mg. Pt temp spikes about every 3 hours. Takes ibuprofen every 6 hours for the pain and then breaks out in sweat. Pt been rotating TYLENOL and ibuprofen since last evening. Pt has pounding headache with pain that runs up the back. Pt c/o dry mouth with dry cough. Pt has a lot of pain in the top of head when he coughs. Denied any chest discomfort when breaths or coughs. These symptoms began 24 hours after receiving the PNEUMOVAX. Pt also received TDaP on 1/5 with no reaction noted on the left arm. Pain management plan - pain score - 7. Pain type - acute. Allergies - ANCEF injection. PE - Alert, oriented x3. Extremities - negative edema and erythema of extremities. Skin - not remarkable. Symptoms 1. Myalgia, 2. fever, 3. skin rash, 4. rash. Treatment drugs used: ibuprofen 800 MG PRN PO. CEPHALEXIN 500 MG QID PO.
Itchy rash started as a patch on his upper arm and spread to truck, neck and upper legs. Diagnosed by his Dr as  Pityriasis rosea.
Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back
A cold started one day after the vaccine was given. It turned into a fever and so forth. It has been a roller coaster ride since then. She has been falling sick a number of times after that.(Fevers/ear infections probably due to school) But associated with these fevers are cough and cold. The cough stays on for a long time and does not go away. First time it stayed for 7-10 days and now it has been almost a week. Paediatrician now put her on steroids for lungs(symbicort,xopenex) and today diagnosed it as asthma. My daughter never had asthma before and she never got this cough before even in the last winter. The flumist was given on oct 8 but at that time my daughter was not diagnosed with asthma. One of the warnings on flumist handout is to avoid giving it to kids with asthma. My daughter also has eczema and food allergies. I regret getting flumist now with all these warnings abt asthma and 24 months(she was 5 months over but the warning says increased risk of wheezing for kids <24 mo) and feel that this coughing might be due to that.
Past lot that had also been expired that was administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients).    Patient age was reported as 71 year 5 months.  No concomitant medication was provided.  NDC ID number was reported as 80777027398.   It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
After taking 2 doses of VIVOTIF, deep pink colored rash to face, neck noted. Eyes swollen almost shut, c/o pruritic. Referred to PCP. Placed on steroids and anti histamines. Given permission by PCP to go abroad in 2 weeks.
INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 26 year old male. 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: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 26 years old. No concomitant medications were reported. On 09-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945831, 20220948255 and 20220945933.
Lost hearing in left ear in evening. Went to bed and hearing was back when I woke up the next day
pt recvd vax & devel erythema locally @ MMR site; color of erythema pink not hot to touch; pt returned 15APR for PPD reading; redness was noted then;
Patient is a 81 y.o. female who received the Moderna vaccine on Monday.  On Tuesday she developed oral purpura and began spitting up blood.  She developed some large hematomas.  She was seen in clinic today and had a platelet count of 5k previously normal.  Labs are still pending right now.  No head ache or neuro changes.  No obvious GI bleeding.  No chest pain or shortness of breath.
Shingles rash @ forehead to mid nose - inner aspect of left eye  Valtrex 1 gm TID Medrol dose pack > treatment
pt recvd vax JUL93 & devel redness & soreness from shoulder to elbow; area was hot to the touch; sx persisted for approx 1 wk or more; No further details were provided
Elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time I reach the trash can.; Elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time I reach the trash can.; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 54 years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route, administered in Left arm on 04Feb2021 (54-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included hypertension and known shellfish allergies. The patient's concomitant medication(s) included carvedilol 25mg 2x/day (twice daily); buspirone 7.5, 2x/day (twice daily); famotidine. The patient previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246), via an unspecified route, administered in Left arm on 15Jan2021 at 13:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type vaccine was reported as Other. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had not received any other vaccine within 4 weeks of Covid-19 vaccination. On 08Feb2021 at 06:00 AM, the patient had experienced elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time she reached the trash. The patient had not received treatment medication for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Reported "rapid heart rate" after vaccine. Pulse 135, BP 223/102.  Otherwise appeared well. No other c/o of any adverse reaction sxs. Reported being nervous about getting vaccine. MD was present. MD Stat was called, and MD and RN responded.   BP rechecked 214/98, Pulse 133.    Patient taken to ER via w/c per MD order. She was conversant throughout, and other than feeling heartbeat "faster" had no other symptoms. She ambulated to gurney in ER and report was given  to RN who assumed patient care.
04/10/08 Client stated right arm hurt and that she could not feel her arm but she could move it.  Client denied swelling, itching but husband stated it was swollen.  Husband stated she was moving her arm but complaining it hurt.  Instructed husband to take her to doctor numerous times.  Return call from client that she could feel her hand, it just hurts her arm to move.  4/11/08 10AM TC to client did not go to MD, it feels much better.
Headache, Arthralgia, NauseaVomiting, fatigue,chills Narrative:
she is not doing so fine; pain at the injection site; muscle pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunization. Medical history of the patient included no spleen, no pancreas, immunocompromised state (her system is a lot more compromised), diabetes and few other things going on (unspecified). All (medical history) occurred many years ago and was prior to getting the vaccine. Concomitant medications of the patient were not reported. On an unspecified date in 2021, after receiving vaccination, patient was not doing so fine and had some side issues but not severe. Patient had pain at the injection site, muscle pain, chills, and nausea. Reporter states that since patient immune system is compromised this could be the reason of patient's symptoms. Reporter asked if patient could take a Tylenol extra strength or something like that. Outcome of the events were unknown. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.