chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; aches and pains; fever; headache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (aches and pains), PYREXIA (fever), HEADACHE (headache) and VOMITING (throwing up) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced PRURITUS (itching), PAIN (aches and pains), PYREXIA (fever), HEADACHE (headache) and VOMITING (throwing up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of unknown. At the time of the report, PRURITUS (itching), PAIN (aches and pains), PYREXIA (fever), HEADACHE (headache) and VOMITING (throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant Followup - events outcome has been updated.
This spontaneous report as received from a pharmacist refers to a 1 year old patient of unknown gender. On 26-SEP-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (SDV, MDV or ADDITIVE) (lot # reported as J006869, expiration date reported as 14-DEC-2014, dose and indication not reported), subcutaneous, which was an order received into the pharmacy and placed into the refrigerator at normal refrigeration temperatures of 36-46 degrees Fahrenheit (F) on 16-SEP-2013. The patient received PROQUAD (Merck) along with VARIVAX (Merck) (lot #, expiration date, dose, route and indication not reported) in error. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Symptoms - ear plugged, voice sounded in my throat, 1-22-09 visited MD, removed ear wax. 1-26-09 visited ENT no problem discovered; 1-30-09 visited another ENT, hearing test discovered left side hearing less due to viral infection.
Few hours after injection feelings of being unwell, fever and chills 3:00a.m following injection, fever next day.
warm at injection site; hard at injection site; red mark at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine, blood thinners and statins. Treatment included antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 and contains patient initials.
Area became tender, swollen and hot. Remained this way until Thursday, Feb. 4, 2021, at which time site began to also itchy and rashy .  Send a message to my doctor on Friday, Feb. 5, 2021. On Sunday, Feb. 7, 2021, swelling went down but area remained tender, hot and rashy and itchy and extended from shot site to elbow. Tenderness went away on Tuesday, Feb. 9, 2021. Heat and rash went away on Thursday, Feb. 11, 2021. On Sunday, Feb. 14, 2021, itchiness is still there but not as prevalent at before.
shortly after vaccine was administered patient presented back to pharmacy reporting dizziness.  I had patient sit on our bench.  Patient was given oral liquid benadryl (30ML).  Patient worsened and ambulance was called.
allergic reactions; rashes all over the body; itching; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; condition worsened; This is a spontaneous report from a contactable Nurse (patient). A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1, administered in Arm Left on 10Sep2021 14:45 (Batch/Lot number was not reported) at age of 27-year-old as DOSE 1, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included known allergies: Shell fish and Iodine, asthma, caesarean section, preeclampsia.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since receiving the vaccine just before 3 PM, on 10Sep2021 19:15 she have experienced allergic reactions in the form of rashes all over the body that has been itching, and burning sensation starting in the hands and gradually spread to neck, upper chest, upper extremity, scalp, abdomen, and the rest of all over the body. Went to ER, was sent home with steroids, but the condition worsened. Had to go back to ER and got admitted in the hospital in a very severe condition. AE resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Lifethreatening illness (immediate risk of death from the event)]. Events were assessed serious as Life threatening and Caused/prolonged hospitalization (days hospitalization: 3). The patient received Ampicillin, Solumedrol, Benadryl, Methotrexate as treatment. The outcome was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was Nasal Swab, name RTPCR on 16Sep2021 with result of Negative. The outcome was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the life threatening events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
syncope post vaccination. Mother was there expected this to happen said he does not do well with vaccinations. gave water, let patient rest in chair for greater than 30 minutes left in good health stable.
I started to feel bad on 12/10/2022. I had a headache, sinus pressure, scratchy throat, and fever of 100. I took an at home test and tested positive for COVID-19. I took some aspirin and on Monday and I sent a message to my doctor. He prescribed me PAXLOVID, MUCINEX, and nasal spray. I felt better within 24 hours. I tested negative for COVID-19 on 12/20/2022. On 12/23/2022 I tested positive for COVID-19 and I had some sinus pain. I was prescribed PAXLOVID again by my doctor.
aches & pain in upper arm (muscle area) approx 10-15 days;aches & pain cont in arms (shoulder to hands) extend depends on exertion of arms;unable to get pulse or BP reading either arm;blockage determined in artery;vasculitis;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
I received my 1st Maderna COVID-19 shot (right arm) on January 28, 2021 and the 2nd was on February 28,2021. After the 1st shot, I had a slight tingle on the back of my right hand, which I mentioned to the nurse in the waiting room. She told me she had only heard of one other person mentioning having that symptom. The tingle left after a few days.  Within a couple hours of getting the 1st shot, i noticed a numbness/tingle and a nasal drip in my right nostril.  Originally, the symptoms happened intermittently but now is constant.. I called the COVID line about a week after receiving the 1st shot to report what I was experiencing, but my symptom was not among the concerns mentioned in the message. So I didn't make a report.
Per hospital history and physical: Rash broke out on both thighs on 11/17 & 11/18 and spread to legs, arms and face. Final diagnosis: Contact dermatitis. **Child ate shrimp on 11/12/2009...Mother has a known allergy.
Pt states (L) arm has been sore since vaccination no redness or swelling. Hep B vaccine recd on 10-30-13 in (L) arm. Pt has small palpable knot under skin. Encouraged to use heat pad and seek medical care if increased in size or redness appears.
Injection site became swollen to baseball size, firm and very tender to touch. Patient denied redness or warmth to the site.
patient reported getting hives a couple of days after vaccination.  They were mostly on her legs and she had started taking zyrtec to help them clear (at the time of reporting).  Patient did get hives a couple of years ago with a flu shot...but did not have a problem last year.
The patient reports nausea and vomiting with a jittery feeling.  Patients B/P was 132/73, HR was 83, RR WAS 18.  Patient denies any difficulty breathing.  The patient is awake and alert with no apparent distress.
Pneumococcal vaccine injected in error to potential new employee instead of TUBERSOL. Developed redness and "streak" at site. Appt at Clinic on 5/24/18 at 1200 noon.
Employee had fever of 99.8F and vomiting that started at approximately 10pm on 06/17/18. Injection site is inflamed and red. There is also pain on injection site. On 06/18/18 employee has fever of 99.8F and nausea. Employee took Paracetamol for fever and Piroxican for pain and swelling.
Patient received her immunization, was communicative and asked questions. She asked for a copy of her VAR. While me (the pharmacist) went to make a copy, she fainted in the immunization room.  She believes she hit her head on a table on the way down. She states she doesn't get vaccines so she did not know how she'd react to them. She also had not eaten food that day. She states she had fainted before on days she had not eaten. It took her approximately 30 minutes, a cold pack, a banana, and some water, but she was able to stand up and walk out. Her friend accompanied her.
Severe swelling, redness in arm, joint pain started right after vaccine and has continued for 7 yrs now.
Menstrual cycle changes. Started earlier than anticipated. Menstruation is darker and more stringy than usual. Instead of typical 7 day length, it has still continued for over 10.
Approximately 4 hours after injection, patient's husband called & said patient was light-headed & "tingly" with no fever. I advised them to go to urgent care because they have no doctor here yet. (Pt also had diarrhea).
Rash started within 12 hrs after vaccine shot. Rash has progressively spread across the entire body since injection.
Pt recv vax on 5/5/99; 15 min post vax pt exp tiny red spots on neck &behind ears; dx=pt "nerves"
Pt with history of asthma and bronchiectasis. Presented 10/21/04 with 4 day history of R posterior chest pain. Some wheeze; good peak flows. Received sx care for presumed chest wall prior, and Pneumovax. Admitted to hospital 10/25/04-11/03/04. Community acquired Pneumonia with large pleural effusion bronchiectasis.
pt stated that she started having severe body aches from her knees to her neck and could hardly move.  Pt stated these symptoms lasted about 15 hours.  She no longer has any symptoms.
Woke up with body aches and sweating.  Stomach and lower back was hurting extremely where I couldn?t stand, Could not get out of bed till after noon. Went to sit for lunch and got faint. Passed out but was slurring, drooling and couldn?t even open my eyes for over 10 minutes. My daughter called 911. I was still unconscious when EMT got there. They checked vitals and I slowly stabilized. Still have a lot of weakness and stomach ache
Inconsolable, excessive crying started within 5 hours of vaccines. Persisted >3 hours (resolved next morning per Mom). No treatment except Tylenol.
Received covid-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 062G20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior alcohol use.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROGESTERONE for Pregnancy.   On 29-Dec-2020 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 25-Jan-2021, EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information received included no new information.
Day 5 - Aching in knee joints, dull headache, more tired than usual; Day 6 - Aching in elbows, wrists and fingers; Day 7 - Aching in hips, stiff and slightly swollen fingers.
Morning following 2nd vaccination patient was confused and not able to keep herself upright in a char, stand or feed herself .  All of which she could do the day before.  She was sent to medical center for MRI and they found no evidence of stroke and sent her back.   She was then sent to rehab where she continued to weaken and not be able to eat or drink .  A week later she is now under Hospice care.
J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung
No additional AE reported; GARDASIL 9 was administered to a 2-month old patient today 1/5/2023; This spontaneous report was received from a nurse referring to a 2-month-old female patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On 05-JAN-2023 (also reported as "today"), the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: U029033, expiration date: 13-MAR-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event details available. No additional adverse events reported (no adverse event).
the patient had Bell's Palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (the patient had Bell's Palsy) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: moderna (Dose 1), moderna (Dose 3) and moderna (Dose 2). Past adverse reactions to the above products included No adverse event with moderna, moderna and moderna.    On 17-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (the patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (the patient had Bell's Palsy) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported. About 3 weeks ago, the patient had Bell's Palsy.  Company comment- This is a spontaneous case concerning an 80-year-old female patient with no medical history reported, who experienced the expected and serious (medically significant) AESI Bell´s Palsy. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered.  Exact onset date of the event was not provided; hence, latency cannot be assessed. No further information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Dec 15th pt received his vaccine at 6:50 pm and when he was home getting ready for bed at 8:30pm his mom noticed a rash on his back. She brought him back to the sight of the clinic and a group of RNs were available to assess. His back was covered with hives that were raised and combined so the appearance was one of large raised areas. Pt complained that they were itchy. He denied have any breathing problems or feelings of throat closure or unusual sensations in his throat. He was ambulatory and alert and playing with his sister. Mom was able to contact her MD by phone while at the clinic sight and was instructed to give him BENADRYL and bring him into the office the following morning. The nurses at the sight were concerned about the severity of the hives and advised mom to take him to a local ER. TC to mom the next morning Dec 16: Mom states that the ER physicians diagnosed pt with Serum Syndrome and prescribed/administered corticosteroids and BENADRYL. His temperature at the ER was 101.7 and the hives had spread around his sides and onto his stomach. As of the morning of the 16th, she states his hives were gone and he was at the doctor's office with his dad. Dad reported that he was coughing a lot while waiting to see the doctor. This was pt's first injectable influenza vaccine. He had the seasonal influenza mist in 10/15/09 and also in years past with no reactions noted. His childhood vaccinations were all given without incident according to his mom.
A consumer report has been received. The report concerns a, consumer of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, unknown. The patient experienced cough hurting after receiving FLUMIST which started on 05-Jan-2016. The outcome of cough hurting after receiving FLUMIST is unknown. The reporter's description of the event(s) was as follows: Unknown. The report was considered to be non-serious.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.; Reporter's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with the second dose of  GARDASIL 9 (lot# L037554, expiry: 25-DEC-2017) four days after the administration of the first dose of GARDASIL 9 (dosing details, lot# and expiry date were not reported) for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Patient passed away a few days later.   at the time of the 2 mo wcc patient was well and no concerns noted, patient had been ill with cold sx on 11/04/2021 and at that time flu, rsv and covid negative
Pt had 2nd dose of DTAP, IPV, HIB and Prevnar on 5/23/02. Sleepy on 5/24/02 for a few hours around noon time and then woke up crying X a few minutes and then had seizures X 7-10 minutes, mainly on left side. Temperature 100.8F in the office. Non-focal exam in the office.
2 inch red raised oval patch, hot to touch, streaking. Placed on Augmentin 400/5cc and and tsp PO Bid for 10 days.
Sudden chills and body ache took 2 advil at 6am and finally got out if bed at noon.  Effects subsided by 3, which is when i noticed the injection site was swollen and sore to the touch.  And still is but i see that is a possible side effect.
Provisional admission dx COPD, s/p rt femoral neck fracture; since prior vax, pt had been deteriorating clinically (intermittent confusion, disorientation, incontinent, poor appetite); final dx septic shock, UTI; pt died 9NOV91;
About 1 week after administration of Td. Since it has been sore which has limited range of motion.  No redness, swelling.  Note induration at the time.