chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Massive stroke; After second vaccination, immediately felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.). Concomitant products included DIAZEPAM (VALIUM), ONDANSETRON (ZOFRAN [ONDANSETRON]), ATORVASTATIN CALCIUM (LIPITOR) and LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION COMPLICATION (After second vaccination, immediately felt terrible). On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criteria hospitalization and disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) and VACCINATION COMPLICATION (After second vaccination, immediately felt terrible) outcome was unknown.            Treatment included t pack clot bursting stroke medication.  Stroke has affected the patient's vestibular system and balance and has caused vertigo, she is now crippled. These symptoms are ongoing and similar to what the reporter experienced  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received first dose of Moderna 28 days ago when patient is only 16. Cdc recommends to finish series, second dose administered today.
Left deltoid swollen, red (approx 15 cm), worse 1st 24 hours, better 2nd 24 hours.
First attack of Ménière's disease; Severe spinning; Violent vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (First attack of Ménière's disease) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Breast conserving surgery on 03-May-2021. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MILNACIPRAN HYDROCHLORIDE (SAVELLA), FAMOTIDINE and OXCARBAZEPINE (TRILEPTAL) for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced MENIERE'S DISEASE (First attack of Ménière's disease) (seriousness criterion medically significant), VERTIGO (Severe spinning) and VOMITING (Violent vomiting). The patient was treated with PROMETHAZINE at a dose of 1 UNK and DIAZEPAM (VALIUM) at an unspecified dose and frequency. On 18-May-2021, MENIERE'S DISEASE (First attack of Ménière's disease), VERTIGO (Severe spinning) and VOMITING (Violent vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got diagnosed with Meniere's disease on 08-Jun-2021. Other treatment medicine included Diuretic.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sharp pain in left leg in the quadricep area.  Coming and going throughout the day, did not have these pains before the vaccine.
Initial and additional information has been received from a nurse practitioner concerning a 14 year old female who on 17-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #: 653735/0688) into the left shoulder. Concomitant therapy included ZYRTEC. In February 2007, the patient developed neck and right shoulder pain, later the patient was diagnosed with juvenile rheumatoid arthritis. The patient was seen by a rheumatologist. On 18-APR-2007, the patient's laboratory test revealed homogeneous antinuclear antibody (ANA) pattern 1 per 80. On 24-APR-2007, the patient's laboratory revealed rheumatoid factor 24.7 and C-reactive protein (CRP) 2.7. On 25-SEP-2007 the patient was seen by another rheumatologist. The patient also saw another physician and a homeopathic physician. On 21-APR-2008, the patient was seen by an orthopedist. On 09-APR-2009, the patient was seen by the physician in the reporter's office. The reporter stated that while the patient was waiting to see the physician, she was seated in a cross-legged position. It was reported the patient's mother request the patient to receive a whole body MRI. The physician was unable to examine the patient due to the patient's pain. The whole body was not ordered by the physician. The reporter stated that she thought the patient's mother was relating the patient's condition to the GARDASIL. Follow-up information was received from a medical assistant in a rheumatologist's office. The medical assistant stated that the patient was first seen the rheumatologist on 18-APR-2007. The patient's laboratory tests revealed a positive rheumatoid factor and a positive anti-CCP (anti-cyclic citrullinated peptide) test. The patient was diagnosed with juvenile rheumatoid arthritis. The medical assistant stated that there was no mention of the patient receiving the GARDASIL vaccine in the physician's notes. The patient was no longer a patient of the rheumatologist. Juvenile rheumatoid arthritis was considered to be disabling. Additional information has been requested.  6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. Assessment: Inflammatory arthritis, rheumatoid arthritis, anemia. Patient presents with neck and right shoulder pain. Numbness of R hand. 'Tightness', pain, erythema, effusion of R knee. Loss of color left hip. Limping. Back, hip, hand and wrist aches. Sore legs and ankles. Rash on legs, knees. Tired, nauseated, headaches. Jaw pain and swelling. Wrist nodules. Soreness of gums.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting chills Narrative:
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587:  US-009507513-1704USA001660: US-009507513-1704USA001661:
Breakthrough case 01/19/2021  cough, sore throat, fever.  No medical care required. Still coughing but recovered. I was still showing a positive antigen up to day 12 on Rapid Test.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm injection site sore) and HEADACHE (Major headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced VACCINATION SITE PAIN (Left arm injection site sore). On an unknown date, the patient experienced HEADACHE (Major headache). At the time of the report, VACCINATION SITE PAIN (Left arm injection site sore) had not resolved and HEADACHE (Major headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment information provided.
rash on both arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure on 03-Feb-2021 and Diabetes on 03-Feb-2021. Concurrent medical conditions included Allergy to plants on 03-Feb-2021 and Food allergy on 03-Feb-2021. Concomitant products included PROSTATE MEDICATION, CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES), blood pressure medication and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (rash on both arm). At the time of the report, RASH (rash on both arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided
4 hours after shot: arm pain at injection site 12 hours after shot:  body aches, nausea, chills, headache, tender skin, nasal congestion, fatigue, worsened arm pain at injection site 15 hours after shot: took Day Quil cold and flu syrup and that helped reduce symptoms 24 hours after shot: same as above
Acute demyelinating poly neuropathy-GBS vs CIDP. The medical record received on 3/5/04 states Guillain-Barre, chronic neuropathy, fatigue, numbness, tingling of hands, low back pain, fever, weak in legs, and facial paresthesias.
headache just like the day after but a little less severe since 09Mar (last dose); This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 67-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 09Mar2021 14:00 (at the age of 67-year-old) at a 2nd dose, single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamins (List of any other medications the patient received within 2 weeks of vaccination). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 67-year-old) at a 1st dose, single dose, for covid-19 immunization. On 10Mar2021 at 02:00, the patient experienced headache just like the day after but a little less severe since 09mar2021 (last dose). Patient did not receive treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovered with sequelae.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I was positive for COVID-19 on 03MAR2023, I was feeling tired, sore throat, mild cough an a runny nose. I was also congested, my voice was rough and for one day I had a mild fever. I was prescribed paxlovid, I started to feel better the next day after taking the medication.
Started with a headache that progressively got worse. Severe fatigue. Fever and the chills.
Child received vaccines on 6/13/18 evening. Developed seizure around 6:00 AM morning 6/14/18.
10/11: Dizzy, fatigue, redness at injection site. 10/12: Very red, pain, knot at site. Reported to provider at 10/13 appt. 10/13: Appointment: less red, pain same level as previous day. Area of edema, no fluctuant mass, tender to palpation. Assessment: aseptic abcess, rxn to immunization. Tx: 40mg Prednisone qd for 5 days; Motrin PRN, cold compresses PRN.
nervousness; anxiety; headaches daily; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (headaches daily), NERVOUSNESS (nervousness) and ANXIETY (anxiety) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027620A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (headaches daily), NERVOUSNESS (nervousness) and ANXIETY (anxiety). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Adverse event, at a dose of 1500 mg. At the time of the report, HEADACHE (headaches daily), NERVOUSNESS (nervousness) and ANXIETY (anxiety) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (anxiety) to be unlikely related. No further causality assessments were provided for HEADACHE (headaches daily) and NERVOUSNESS (nervousness).    The patient had anxiety previously and she did not relate that to the vaccine.
a six months patient received Kinrix instead of Pediarix; received Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a 6 month old patient was administered Kinrix instead of Pediarix, which lead to inappropriate age at vaccine administration and wrong vaccine administered. No further information was received. The reporter consented to follow up.
Fatigue during day and loss of sleep at night. Joint pain in knees the worst then back then pelvis/hip then neck. Fever of 100.4 Fahrenheit
This is a spontaneous report from a contactable pharmacist who reported for himself. This 38-year-old male patient received PREVNAR 13 (lot L04915, expiry date Jul2016, NDC number 0005-1971-01) at 0.5 ml single, intramuscular,in left deltoid, on 20Mar2015 at 3:20 PM, for immunization. The reporter specified that this vaccine was recommended by an oncologist at and was administered at the Pharmacy per protocol by pharmacist. Relevant medical history included Hodgkin lymphoma from Jan2008 to Sep2008 (cured). Illness at time of vaccination, adverse event following prior vaccination (unspecified) and concomitant medications were reported as none.   On 21Mar2015, the patient experienced drenching night sweats, fever, and chills. The pharmacist mentioned that for two nights he had been experiencing drenching night sweats. He did not have any other symptoms. Especially on third night after the vaccination night sweats got worse; he had a little bit of fever and chills, but the night sweat was getting worse. The pharmacist purchased the vaccine at the pharmacy. The events did not require an emergency room or physician visit or specific tests and/or treatment. The event night sweats had not been yet resolved and the outcome of the events fever and chills was unknown. The pharmacist considered there was a reasonable possibility that the events were related to the suspect vaccine.  Follow-up (15May2015): Follow-up attempts completed. No further information expected.  Follow-up (26Sep2016): New information from the same contactable pharmacist includes: updated patient age, medical history, suspect vaccine details, events onset date and details.; Sender's Comments: Linked Report(s) : 2015104669  Legacy paper report number
Patient received dose #2 of moderna vaccine on 3/2/2021. The next morning (3/3/21) she had a syncopal event with LOC for several minutes. She recovered and was not evaluated by physician until 3/9/21. On 3/10/21, she had a CTA of chest showing bilateral PEs.
Pt was brought back to pharmacy due to dizziness. High blood Pressure while in our care
Breakthrough case admission after 2 vaccines  Moderna 3/20/21 Lot# 047A21A;  Moderna 4/17/21 Lot# 040B21A
Mother of the patient refers that after vaccines were administered, she started complaining of pain in the left arm but the mother didn't think much of it and thought the patient was exaggerating and it was normal because of the vaccine. Then after a few days the area was red and the mother thought it would go away in a few days, seeing that it had lasted a week, and it was red and hot, then the mother decided to call our vaccine clinic on 3/5/20. Around 3pm we asked if she had called the patient's primary care doctor and the mother said no. She was advised to take the patient to be evaluated by her pediatrician. The pediatrician's office was closed that day so the office manager gave the option for them to go in early in the morning the next day, to which the mother replied it would be the patient's first day of school but that she would still take the patient to the Peds. Mother was advised the situation got worse to take to the ER the same day. Next day, Friday 3/6/20, we received at the vaccination clinic, from the pediatricians office to get the recent vaccination records since the patient was having a localized allergic reaction per physical exam.
patient received vaccine on 6/18/20 noticed the injection site was very red warm to touch and had some swelling. She also noticed swelling from the injection site to her groin. Patient was examined on 6/22/20. Lymph nodes were enlarged on examination
Face Drooping and paralysis.  Extreme neck pain and headaches on the left side.
Crying, "not acting like herself", refusing to feed, sleepy, redness, swelling (L) thigh; diarrhea.
Information has been received from a certified medical assistant concerning a 15 month old male who on 03-AUG-2006 was vaccinated in the left arm with a first dose of Varivax (lot # 652803/0262F). Concomitant vaccination on the same day included a fourth dose in the right thigh of PREVNAR (lot # B08651E), a first dose in the right arm of MMRII (lot # 653751/0499F), and a first dose of VAQTA (lot # 653616/0201F). The patient was seen on 24-AUG-2006 by the physician for a rash times two days. There was no fever. The patient was possibly itchy. The lesions were noted to have started on 22-AUG-2006. There were vesicular lesions on the buttocks, hands, a few on the trunk, and one on the right ear. Ears, nose and throat were clear. The neck was supple without nodes. Chest was clear to auscultation and percussion. The heart had a regular rhythm without murmur. The abdomen was normal. Mild varicella after vaccine was noted. No further information is expected.
Patient accidently received two doses of Pfizer in one day.  He had already received his first dose 21 days prior.  He has not had any adverse outcome at this time.
Nasal passage on fire, hard to swallow, vomiting, serve chills and shaking.  From Emergency Room admitted to Hospital for 24 hours. Administered several types of drugs along with IV's. Several blood samples taken and tested due to only having one kidney.
19APR95 pt recv vax 3PM 18APR95; mom notified by babysitter @ 730PM; took pt to hosp t100.7;; t102 this AM; pt slept from 1030PM to 345AM w/o diff; 21APR95 pt fine today; dx from ER rxn to immun;
Roughly 12 hours after receiving vaccination, I started to feel sick. I got up to get water from the kitchen as I was starting to feel nauseous and fainted. I hit my head as I passed out and shortly after regaining consciousness, I began to vomit. For about 10 to 15 minutes, I could not get myself off the ground. I also experienced severe abdominal pain.  The reaction as a whole lasted about 2 hours.
Both eyes were itchy; red eyes; dry and flaky eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes). At the time of the report, EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mother called to report information for son. All information documented was information obtained. Luanne counseled to have son contact PCP for further recommendation. 04/02/2021, symptom of nausea, headache and feeling flushed instantly after receiving the vaccine. Client did not report symptoms or wait 15 minutes prior to leaving mass clinic. Symptoms on 04/02/2021 were resolved by morning of 04/03/2021. On 04/04/2021, client woke with swollen eyes and red blotches to face. Client took 50mg of Benadryl, 3 times on 04/04/2021. Symptoms improved over the day, but did not resolve.
She states she noted itching at Flu vaccine shot site left deltoid, 45 minutes after shot - noted hives, (L) arm, left abdomen and inner thighs and (L) neck at 3 PM when she came back to show us. We sent her to the clinic where she got Epinephrine and Dexamethasone Inj and she reports all symptoms resolved immediately.
Hoarseness, paleness, weakness, dizziness, feeling of brain rattling in head, uncontrollable shakes
pt recvd vax 13DEC95 & 24hrs later noted low grade fever & lymphadenopathy which then resolved 2wks later;31DEC95 pt bilat knee pain & stiffness;2JAN96 also c/o bilat hands, wrists & feet pain & swelling;
SARS COV-19 Infection. Congestion, runny nose, fever, loss of taste and smell, headache, shortness of breath, sore throat, fatigue, chills, muscle aches.