chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sick for a week or more.; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA306301, 2020SA302198, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033 and 2020SA308034 (same source).  This case involves elderly patient (unknown age and gender) who was very sick for a week or more (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was very sick for a week or more (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
patient received both the flucelvax (flu) and moderna covid-19 booster shot (3rd dose) on 12/22/21. per patients husband, she developed bells palsy the following day on 12/23/21 Went to ER, stroke was ruled out and patient was diagnosed with bell's palsy. Patient is undergoing steroid treatment currently.
She has had fever; aches; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198) via an unspecified route of administration in arm left on 23Feb2021 (at the age of 62-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included she had the COVID-19 virus on an unspecified date in Nov2020. The patient's concomitant medications were not reported. It was reported that, the caller had no other vaccines on the same day as her COVID vaccine. Enquired, the patient was 62-year-old, received the first dose of the Pfizer Covid vaccine. On 24Feb2021, the patient has had fever and aches since receiving the vaccine and wanted to know what she should do and whether there was anything she should take for it. The caller stated that, on Tuesday, she went down and got the COVID-19 Vaccine. The caller stated that, yesterday, when she got up was feeling kind of achy around where the shot was and around her neck. Stated that, as the day went on, she got more achy. The caller stated that, in the afternoon yesterday, she developed a fever of 100.5. Stated that, the lowest her temperature has been 99.0. Stated that, her fevers and aches that she was currently feeling, are just like what she had. The caller has been trying to get a hold of her nurse practitioner at the clinic where she goes and she has not gotten an answer from them. The caller was wondering what she needs to do, like does she need to stay home or go get checked out and how long are these symptoms supposed to last. On an unspecified date, the patient underwent lab tests and procedures which included she developed a fever (body temperature), resulted as 100.5 and she developed a fever (body temperature), resulted as 99.0 on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
client complained of dizziness after receiving 1st dose of Moderna Covid Vaccine. Client was sitting in post vaccine waiting room when he alerted EMTs he was feeling dizzy. EMTs  did first assessment. Vitals 0958: blood pressure 110/50, pulse 92, oxygen 97%. Client diaphoretic, face flushed. EMT gave client water. Vitals 1003: blood pressure 130/70, pulse 94, oxygen 97%. Per client feeling better.  joined EMTs. Per client no pertinent medical history or current medications. No history of allergies. Per client had completed 15min waiting time and was getting ready to leave when he felt dizzy. At this time dizziness improving, flushing resolved. Vitals at 1008: blood pressure 140/90, pulse 92, oxygen 97%. PHN asked client if he has hypertension, per client does not regularly follow up with provider. Client alert and oriented, denied chest pain, headache, dizziness improving. 1015 vitals: blood pressure 140/90, pulse 103, oxygen 98%. Per client no complaints, previous symptoms all resolved. Last vitals at 1024: blood pressure 140/70, pulse 104, oxygen 98%. Client alert and oriented, feeling fine, ready to leave. Client did not drive, here with family. Client advised to see primary doctor to follow up on blood pressure and to follow up with them prior to second dose. ER precautions given as well. Client left facility at 1025 with steady gait.
FEVER; NAUSEA; FELT NOT NORMAL; STOMACH ACHE; SORE ARM AND SHOULDER; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. 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 not reported) dose was not reported, administered on 21-MAR-2021 11:30 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced felt not normal. On 21-MAR-2021, the subject experienced stomach ache. On 21-MAR-2021, the subject experienced sore arm and shoulder. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.9 F. On 21-MAR-2021 20:00, the subject experienced fever. On 21-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 103.2 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, stomach ache, nausea, chills, sore arm and shoulder, and felt not normal. This report was non-serious.
Onset less than 12 hours after vaccination: SEVERE CHILLS; DRY COUGH; INABILITY TO WARM; STABBING AND SHOOTING PAIN IN RIGHT LEG, RIGHT HIP, RIGHT SHOULDER, EPISODES OF HEART RACING; CHEST PAIN; NAUSEA; EXTREME MUSCLE WEAKNESS; SEVERE BODY ACHES. RED FACE/FLUSHING OF FACE. Onset 24 hours after vaccination: NIGHT SWEATS.  EXTREME FATIGUE.  GREAT EFFORT TO WALK DOG AND TO SHOWER. Saw PA in doctor's office for other matter on same day but Shingrix vaccine administered at the Pharmacy, 2 hours after doctor visit.  Currently have scheduled visit with M.D. on Oct. 1st.
After vaccination, arm was immediately sore as anticipated. Within a couple of hours, first symptom was extreme fatigue, followed by chills. The night of April 27, the fever was 99.9 and two 500 mg tabs of acetaminophen were taken, followed by one advil PM two hours later. Overnight the fever escalated to 104.4 (as of 8:30 am on April 28). At 8:30 am, two 500 mg tabs of acetaminophen were taken and the fever began to drop after 30 minutes to 103.6.
Swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis, Hypertension and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, MELOXICAM and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (Swelling) and ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING (Swelling) and ERYTHEMA (redness) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-076225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076225:Dose 2
On 1/17/2022 I felt very fatigue, muscle pain, sore throat, swelling of my lips and nose. Low grade fever. I went to the doctor because I thought I had COVID, but it was Mononucleosis. I had sinus infection. I was given antibiotic for this sinus infection, but I still feel very fatigue. Muscle ache, throat throat. Fast heart rate. Feb 10, 2022, I had to go back to the doctor.
Per report, patient woke up from sleep with tremors. Was unable to suppress. Did not lose or alter consciousness. Did not lose control of bowel or bladder. Increased heart rate and respiratory rate. Last about an hour.
Patient experienced stomach/intestine discomfort, and neck, injection site, legs, and feet ache non-stop. Patient claims very fatigued and have a headache. Patient treated with MOTRIN and rest. Symptoms lasted 2 and 1/2 days.
presents with generalized weakness.  Admitted with COVID-19 pneumonia  And acute pulmonary embolus. Patient noted to have altered mental status thought to be due to toxic metabolic encephalopathy in the setting of COVID-19.   Seen by infectious disease and treated with remdesivir, antibiotics and steroids.  She was started on Eliquis for pulmonary embolus.  Respiratory status has improved and she is stable on room air.  Patient had poor p.o. intake likely related to dementia and COVID.  Seen by dietitian and started on Clinimix. Diet has improved some and she is eating Less than 50% of  2 meals daily..  She was started on mirtazapine.
35 weeks pregnant, was administered Arexvy instead of Abrysvo on 17Oct2023 at a local pharmacy.; Administered Arexvy instead of Abrysvo; 34 year patient experienced Arexvy vaccine; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Administered Arexvy instead of Abrysvo) and inappropriate age at vaccine administration (Verbatim: 34 year patient experienced Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant, was administered Arexvy instead of Abrysvo on 17Oct2023 at a local pharmacy.). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter reported that his daughter who was 35 weeks pregnant received Arexvy instead of Abrysvo vaccine, which led to wrong vaccine administered. The physician did not have the lot number or expiration date information. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
No adverse event; they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Patient had no known relevant medical history, allergy, concomitant diseases and risk factor. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date) 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 EXPIRED PRODUCT ADMINISTERED (they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after the expiration date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was thawed directly from the freezer each time they needed to administer a dose. The vial did not underwent temperature excursions. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:same reporter
Wife developed Covid 19 after having 1st 2nd and booster dose; Wife developed Covid 19 after having 1st 2nd and booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Sep2021 (also reported as on 05Oct2021). (Batch/Lot number: unknown) at the age of 8 decade as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive. Developed Covid 19 after having 1st 2nd and booster dose of Pfizer COVID 19 vaccine. He stated that they were both in their 70s. The patient came down with what seemed like a head cold and she tested positive for Covid 19 virus almost 13 weeks to the day. The reporter had not tested positive but would retest in 3 days. Reporter asked what is the occurrence rate of breakthrough infections with both initial doses and a booster dose. The reporter has read that efficacy decreases 10 weeks after getting the booster dose and asked if that was true. The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd vax & 1-2 wks p/vax exp muscle & joint pain, & a rash;
Chills,  headache,,, fever  101..7,  swelling at site of shot,, itching,  I slept, took advil,, and ate chicken soup.
Arm (Left) turned red, most of upper arm red and swollen. Resolved by 10/3/16. (Arm just very slightly red on 10/3/16).
I experienced  after the second dose itching and hives, headache, my fibromyalgia was 1000 times painful, low grade fever, my experienced right right arm was on fire, I vomited once,  and I felt like I was going to faint.
This spontaneous report as received from an office manager refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with, 0.65 ml ZOSTAVAX (lot# and route not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced hair falling out. "The patient's hair grew back but in patches", so the representative felt that this adverse event happened a while back go. The office manager thought that the patient had not sought medical attention. Additional information has been requested.
I couldn't breathe; my left side of my arm and leg gos numb here and there; nerves in my feet are messed up and really sensitive to socks and shoes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 14:45 (Lot number: ER8727) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose brand= Pfizer, prev dose brand unknown: False, prev dose dose number:1, other vaccine same date lot number: ER8727,, prev dose vaccine  location: Left arm ), administration date: 29Apr2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (disability), outcome "not recovered", described as "I couldn't breathe"; HYPOAESTHESIA (disability), outcome "not recovered", described as "my left side of my arm and leg gos numb here and there"; NEUROPATHY PERIPHERAL (disability), outcome "not recovered", described as "nerves in my feet are messed up and really sensitive to socks and shoes.". The events "i couldn't breathe", "my left side of my arm and leg gos numb here and there" and "nerves in my feet are messed up and really sensitive to socks and shoes." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of dyspnoea, hypoaesthesia, neuropathy peripheral.  Clinical course: As reported no other vaccine was give to the patient prior to four week of vaccination, and after 2 week of vaccination. The things got even worse, he couldn't breathe, and his left side of my arm and leg goes numb here and there, he can't wear any shoes because the nerves in his feet was messed up and really sensitive to socks and shoes. Ae resulted in disability. For adverse event treatment he was put on medication. He was not tested post covid vaccination. He had prior covid vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200500526 Same patient and drug, different event separated in time.
24 yo male who received SPV 25 MAR 19 and has a hx of syncope attributed to heat injury, who presented to ER 18 APR 2019 with acute CP of 2 hour duration starting at 22:00 17 APR 2019 (day 23). He noted stabbing midchest pain with a positional component. ER noted elevated troponin which peaked at 12.4, CK 976. CRP 0.5, discharge doc states .34 and is elevated; ESR 5, CBC WBC 14; lytes OK normal EKG Echo & cath. Examine note chest wall pain was tender to palpation. He was monitored overnight and discharged at host country facility.
Low-grade fever, diarrhea x 2 days. One loose bowel movement was greenish-yellowish in color, nasal drainage, redness, swelling, yellowish discharge from both eyes and a cough for 3 to 4 days. Acute OM, acute RAD; no injection site swelling, redness or induration.
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient who was vaccinated with three 0.5 ml doses of GARDASIL on an unspecified date (lot number not provided).  The patient became pregnant after getting all three doses of GARDASIL and delivered a baby on an unspecified date.  Two months later, the baby died from "DNA trim".  No additional information was provided.  The patient sought unspecified medical attention.  Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 21-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
48 hours after vaccine was administered patient developed a 3-4 minute tonic seizure (generalized), followed by post-ictal stage. EEG nl.
Initial unsolicited report received from a physician via Pfizer under reference number 2015427606 on 06 February 2017. This case involves a 64 year old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On 18 April 2012, following the vaccination the patient experienced swelling. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Experienced a small rash with the first MMR vaccine in March 2019. A much more extensive skin rash occurred after the second MMR in April 2019. Rash is itchy and occurred on both arms and the right shoulder.