chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from other health professional (pharmacist) via pharmaceutical manufacturer (Merck) on 16-Oct-2018, concerns a 69-year-old, elderly, female patient. The patient had allergy to aspirin, penicillin, codeine, sulfa drugs and iodinated contrast agents. On 04-Oct-2018, the patient was administered Influenza vaccine (anatomical location: right arm, route of administration: intramuscular, dose, batch number, trade name, manufacturer and expiry date: not reported) and the co-suspect included PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: left arm, batch number: R006465, expiry date: 24-Oct-2018 and dose: not reported). On 05-Oct-2018, the patient stayed at home from work. On 07-Oct-2018, 3 days after vaccination, the patient reported to the pharmacy, showing the pictures of her left arm. The pharmacist reported that, the picture showed, a red raised rash 3 inches away from the injection site covering the elbow and bicep. On an unspecified date, the patient used BENADRYL CREAM. On 07-Oct-2018, when the patient returned to the pharmacy, the pharmacist reported that, the left arm looked normal and no rash remained. At the time of the report, the patient had recovered from the event red raised rash and the outcome of the event inability to work was not reported.
severe chills (30 minutes), elevated heart rate (8 hours), elevated blood pressure (6 hours), fever (24 hours), headache (10 hours) Took tylenol or ibuprofin every 4 hours until bed, only slight fever at that time.
7 of 10 people who received their 1st dose experienced nausea & vomiting for 24 hrs. Sx then resolved.
Per 11/2 in person/event visit: Over the past few/2.5 weeks, when laying down after work, he's feeling like a "different rhythm to his heart beat."  When this happens, he feels a sensation that his heart is beating faster.  2 days ago, felt an isolated (2-3 minutes) piercing, non-radiating L-sided chest pain when he was not noticing his heart to be going faster. Denies any pleurisy over past 2.5 weeks.  No cough, no SOB. No preceding illness that patient remembers.  No known sick contacts.  Continuing to work and declines need for work note at today's visit.  Of note, received flu vaccine on 10/8/22 and 9/24/22 he received the bivalent COVID-19 vaccine (Pfizer).  No issues with strong responses/reactions following any previous COVID or other vaccinations. No associated dizziness or light-headedness, nausea, vomiting. Since symptoms started 2.5 weeks ago, no change in frequency in symptoms.Sleeps during day (after working at night).  Feels like it may wake him up from sleep. Denies taking any medications, OTCs, herbals, supplements. No illicit drug use.   For a long time, reports drinking lots of caffeine  - up to 3 16 ounce cups throughout the day, including prior to going to sleep.   Has been drinking this amount for years.  Physical exam - vital signs, including temp and HR WNL:  Neck:  no JVD  Lungs: no respiratory distress, CTAB no WRR.  Heart: regular rate and rhythm, S1, S2, no rub, no pleurisy.  In office EKG w/ diffuse precordial ST-elevations.  Official EKG with ? j point elevations, ? LVH criteria (though patient without HTN); RBBB.  Troponin, CRP, ESR, WBC, TSH WNL.  Rx:  Ibuprofen 800 TID for presumptive vaccinate-associated mild pericarditis.   11/9 f/u video visit:  Feeling better compared to our visit one week ago - "It's not that bad."  Has only drunk coffee x 1; tea x 1- no other caffeine since one week ago  Believes that sensation of racing/irregular heart rate has decreased in frequency  Down from > 1x/daily to less than daily - last felt day before yesterday.  No subjective fevers, no chills, no night sweats, no associated chest pain, pleurisy or shortness of breath.  No dizziness or light-headedness.  No abdominal fullness or lower extremity swelling.   Continues to have fine appetite, continuing to work.   Is taking Ibuprofen TID with food - about a week into 10 day course.   Okay with submitting symptoms as possible vaccine event to VAERS on patient's behalf.  Advised to complete 10 day course of NSAIDs, c/t avoid caffeine and will submit event to VAERS.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX with lots # L046885, expiry date 23-NOV-2017 and lot # L035129 and expiry date 14-SEP-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Went to hair appointment and water aerobics after vaccination. Arm started to hurt a lot. Went to bed at 10pm and at 12am was feeling really hot with a headache, chills, and shivering. Temp was 99.4.
Originally diagnosed as spider bite, then poison ivy. Self reporting as side effect of vaccine, due to similarity of other reports.  Cellulitis spreading from left front ankle area to several areas on body; thighs, behind knees, between legs up buttocks. Surrounded by small blisters, some with yellow discharge. Large area of red skin patch beneath breasts. Itching around all areas. Sought help day 3 of onset started antibiotic (Cephalexin) and again day 6 when it was spreading more, added (Prednisone). Today, day 9 of onset, sores are starting drying out and red patches and measles-like blisters are starting to fade, though still having some itching. Some areas are scabbing.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included raloxifene. On 8th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 9th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness. On 10th May 2018, the outcome of the tiredness was recovered/resolved. The reporter considered the tiredness to be probably related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient reported that the tiredness resolved after one day. The patient had denied permission to contact their physician.
Extended localized allergic reaction 5 cm area of inflammation, swelling on days 3-9 following injection.
102 fever at 11:30 a.m. 01-October-2022 - no treatment 104 fever at 7 p.m. 01-October-2022 - treated with 10 mL children's acetaminophen
Upper left arm (shoulder to elbow) red, swollen and painful. Numbness on tips of fingers on both hands. Started about 5 hours after shot.  Shivering about 5 hours after shot. MD told her to take Advil.
Pt developed fever of 105 with seizures one week post vax. Pt also developed "blotchy, irritated" area on back and legs. Pt was seen in ER.
PATIENT CALLED PHARMACY AND SAYS SHE HAD A RASH ALL OVER AND IS GOING TO SEE HER DOCTOR
pt recv vax & cried & could not be comforted for 24hr;t104.9 ax;appeared to pass out briefly, revived when taken out into the cold air;fever dropped then to 103 & pt seemed to be much better;
PT feeling dizzy one minute aft administration. Went out of Rx. RPH speaking to pt and she fainted lowered her to floor. Conscious after about 5 seconds asked her if she was breathing OK...ans yes sweating.
re-dislocated right shoulder; This is a spontaneous report from two contactable physicians. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (at the age of 54-year-old) lot number: EK5730, intramuscularly at the left arm on 19Dec2020 at a single dose for COVID-19 immunization and experienced fractured and dislocated rt shoulder while doing exercise on 20Dec2020 0930 and torn labrum on 24Dec2020. The patient had no history of previous immunization. The patient is not deceased. Patient had no other prior vaccinations within four weeks. The patient experienced re-dislocated right shoulder on 11Jan2021 15:50 but did not require hospital admission. Therapeutic measure was taken as a result of the event which included wearing brace and surgery tentative. Outcome of the event was not recovered. It was reported that there was a reasonable possibility that the event is related to suspect product.; Sender's Comments: Based on the available information the event "re-dislocated right shoulder" is attributed to an underlying medical condition and assessed unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
10 min after flu shot given tounge swelled, difficulty breathing, dizziness. Sent to hospital in ambulance
Her arm was sore later that afternoon that she received the vaccine. Today every time she touches it, that same area is sore. The soreness has not resolved from the Prevnar vaccine in her right deltoid.
Moderate pain for 1 day,  Itchy rash, about 4 - 6 bumps, crusted over after about 4 days.
Mar 25 Day 1 -- 9:30 am vaccine shot. 10:00 am, nose cold, hands cold, chills slightly. 11:00 am headache and The start of my head feeling strange continued throughout the rest of the day, headache, strange feeling in my head (like my head was full of fluids and I was off-balance, a dizzy sick like feeling) flu like symptoms continued. 6:00 pm I was getting irregular heartbeats. Shortly after I got tachycardia which lasted about 15 to 20 minutes. Continued with a higher than normal heart rate. 8:00 pm went to bed to calm my heart. Could not sleep all night. Mar 26 Day 2 Continued with headache, strange feeling in my head (like my head was full of fluids and I was off-balance, a dizzy sick like feeling) no room.
Blood pressure increased; Injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure increased) and VACCINATION SITE PAIN (Injection site is sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation since 10-Dec-2018, Prediabetes since 2001, Hypertension since 2017, Enlarged prostate since 2009, Glaucoma (Glaucoma suspect) since 2005, Penicillin allergy, Allergy to antibiotic (Some quinolone antibiotics), Allergy to plants (Cedar), Pollen allergy (Elm pollen) and Fragrance sensitivity. Concomitant products included SOTALOL and ASPIRIN [ACETYLSALICYLIC ACID] for Atrial fibrillation, ALFUZOSIN for Enlarged prostate, VALSARTAN (DIOVAN) for Hypertension.    On 08-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased) and VACCINATION SITE PAIN (Injection site is sore). On 09-Jan-2021, BLOOD PRESSURE INCREASED (Blood pressure increased) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site is sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 149/71 (High) Higher than normal 130/70 and 162/78 (High) Highest blood pressure ever recorded on OMRON Model: BP786 sleeve type blood pressure monitor.. On 09-Jan-2021, Blood pressure measurement: 137/72 (Inconclusive) Inconclusive and 120/64 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Consumer email address added. On 19-Apr-2021: Added primary reporter information (address, email), HCP contact details, patient demographics, relevant medical history (Allergies: penicillin, some quinolone antibiotics, cedar, elm pollen, fragrances; Current conditions: atrial fibrillation, prediabetes, borderline high blood pressure, enlarged prostate, glaucoma suspect), batch number and site of administration of 1st dose, concomitant medications (sotalol, Alfuzosin, Finasteride, Aspirin, Diovan). Event outcome changed (from unknown to recovered).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient arrived to clinic today for flu vaccine and Covid-19 Pfizer booster vaccine.  Pfizer Pediatric vaccine was administered in error. Clinic NP, notified immediately in person. Per CDC guidelines, patient is to return for repeat of booster, in adult dose, may be administered immediately. Patient notified immediately via telephone. Patient arrived at clinic again, denied any symptoms, agreed with plan to receive adult Pfizer booster, this was administered.
Pt vaccinated 12/01/09 seasonal flu and H1N1. Early pregnancy. Pt had first sono 12/17/09 showing no fetal heartbeat.
Swelling, pain, red and warm Lt arm starting 3-3 1/2 hrs after inj LU arm. No prior hx or hx of allergy. 12/2/02 ok finish rx.
pt recv vax & devel local inj site pain,flu-like sx,an itchy foot & a high fever (103) that lasted for 2 days;
she has almost a sinus headache; the injection site was very, very sore; Chills/She couldn't get warm; cold; body aches; This is a spontaneous report from a contactable consumer (patient). This 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730) on 19Dec2020 15:15 at single dose on Left Arm for COVID-19 immunisation. Medical history included She had COVID on 10Nov2020. There were no concomitant medications. The patient received the COVID vaccine on 19Dec2020, the first dose. She didn't have much side effects or feel symptoms except the next morning on 20Dec2020, the injection site was very, very sore. As the day progressed, she had chills.  No fever, but chills. She couldn't get warm. This morning when she woke up she has almost a sinus headache on 21Dec2020. It's not really a headache, but around her eyes.  "Injection site was very, very sore" didn't really start until yesterday after lunch. She has not had chills this morning, just body aches.  She feels like she is about to get a cold. She had COVID on 10Nov2020.  She wasn't as cold this morning like she was when she went to bed last night.  She thinks the chills stopped some time in the night.  When she went to get in the shower this morning she felt the headache.  She still has the sensation around the eyes. She took some Tylenol about 11AM on 19Dec2020.  The outcome of the injection site was very, very sore was recovering, of other events were unknown.
I had a fever 101, cough worsen, for about two nights trouble breathing, fatigue
Client started to feel dizzy about 30 minutes after receiving vaccine and client alledged that he feel on floor in front lobby and was able to get up with no assistance. Client assesed by a nurse, vital signs done. Client able to walk and verbalize understanding.
ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB); UNSPECIFIED SWELLING; SICK; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK). At the time of the report, PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was doing well on Skyrizi, but had itchiness when was due for next Skyrizi injection. The patient also had unspecified swelling and was sick for one week following injection.  The reporter's causality for the events of UNSPECIFIED SWELLING and SICK with SKYRIZI(RISANKIZUMAB) was not related and for evet of ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI(RISANKIZUMAB) was a related  No treatment drug details was reported.
I had tearing, really watery eyes after about three days and my eyes burned really bad. I took some Zyrtec to help with it. I am still headaches and body aches. But they are a lot milder now.
Information has been received from a registered pharmacist concerning a 60 year old male patient with no drug reactions or allergies who on 19-OCT-2010, was vaccinated in the left arm with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664636/0874Y). It was reported that on 19-OCT-2010, the patient experienced stinging at the injection site. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 11:00 as dose 1, single (Lot number: EM9809), in left arm, on 27Feb2021 at 11:00 as dose 2, single (Lot number: EN6203), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid from 21Feb2023 to 25Feb2023.
12/5/06 Patient received routine vaccines including DTaP IM, left deltoid and MMRV SQ left upper arm SQ. Received IPV, Influenza and Hep A in right arm. Approximately 2pm, 12/7/06 mother noted inflamed, swollen left upper arm. reported to pediatrician and PHN arranged appointment with pediatrician who saw at 10 am 12/7/06. Report from pediatrician indicates left arm 4 cm circumference larger than right, too redness, swelling and pruritic. Treating with chewable Benadryl TID, prn itching.
0930: Patient reporting "tingling" in tongue after J&J COVID vaccine. 0933 Patient reports difficulty swallowing.  Epi 0.3mg given IM R thigh.  0937 Patient reporting continued tingling, feels as though tongue is "thick". Reports swallowing has improved.  Itching on bottom lip.  0946 Patient taken to ED by ED RNs via stretcher.
Morning post vaccination, raised red and itchy area about baseball size. Lasted intensely one day then tapered off for 2 more days.
1st shot - like I had a light case of the flu 2nd shot - almost totally incapacitated, in bed for 3 days, extremely dehydrated and had to get IV fluids at doctor's office, lost 20 pounds in 14 days, kept getting chills.
Flu like symptoms for 24-36 hours with extreme aches and fatigue  approximately 8 hours after injection  However, approximately two days after receiving the booster I experienced break through hives all over my body.  Treated with Benadryl to no real effect.  Received a shot of Xolair to no real effect.  Symptoms subsided over two weeks.
Patient given Moderna Covid Vaccine Booster 0.25mg and 5 minutes after receiving informed us that she felt her heart racing.  Brought from waiting room area to exam room and checked her vital signs.  Pulse was 143, Oxygen Sat 98%, B/P 210/110.  Doctor brought in to exam room.  Patient denied any shortness of breath.  Decision made to send to Hospital for evaluation and treatment.  Emergency was called and within 5 min Paramedics arrived.  Pulse then 138 and BP 210/100.  Transported to Hospital next to clinic.
staff member inadvertently administered Havrix today after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number J95h7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-Sep-2022 Reporters comment:  The reporter reported that another staff member inadvertently administered Havrix on 8th September 2022 after the expiration date 22th May 2022. The reporter did consent to follow-up. The health care professional was very pressed for time during the call. The caller declined to provide additional information. Additional Supportive information: The staff member inadvertently administered Havrix which was already expired on 22th May 2022 which led to Expired vaccine used.
Started getting pain in my right leg on May 1st, seen my Family Dr. on 4/29/21 clean bill of health. Pain wouldn?t go away was going to my chiropractor the whole month of May 2 times a week, for my right leg, I favored that leg never missing work, I?m a childcare provider. On 31May2021 the pain went down my leg and behind my knee just throbbing, I was walking up steps and a loud snap happens in my leg dropped me right there couldn?t move. Was taken to the ER, where they found a blood clot in my leg which caused pressure to build up on my knee which ruptured my meniscus, damaged joints, and cartilage in my knee. They put me on blood thinners, have to have surgery and can?t for 3 months I have to be off blood thinners. Can?t work and was forced to close my daycare business of 18 yrs and sell everything due to this injury. My Dr has linked it to the vaccine my blood wok showed high levels of hormones. Never ever had an issue until I got second shot. So now I?m trying to get disability, not looking good due to me being self employed. So who is gonna step up and help me financially, I was open threw the whole pandemic and this is how I go out of Business! Devastating to say the least?. My Community is shook up over this, so I took one for the team my family refuses to get the vaccine and others have decided NO after hearing my story.
Pain at site of injection, left deltoid persistent for 3 weeks. Pain with active range of motion with left arm abduction greater than 90 degrees