chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2  morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
Pt vaccinated with Meruvax II developed swelling & pain in the left thumb & both knees. Treated w/Ibuprofen (Motrin).
joint pain/ Pains; 101°F temperature; exhausted; Chills; Dizziness when driving; Could not walk; Red rash on arm and chest; chest pain; Pains , muscle , chest and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain) and MYALGIA (Pains , muscle , chest and joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), FATIGUE (exhausted) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (joint pain/ Pains) and PYREXIA (101°F temperature). At the time of the report, DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), ARTHRALGIA (joint pain/ Pains), PYREXIA (101°F temperature), FATIGUE (exhausted) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 f (Inconclusive) 101°F temperature. On 03-Mar-2021, Heart rate: 135-170 (High) The heart is racing , in a range between 135-170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
PAIN AND SWELLING FOR SEVERAL DAYS. QUARTER SIZE PIECE OF SKIN REMOVED WITH BANDAGE REMOVAL.
Within five min. after receiving pneumonia vaccine, I was overcome by chemical odor, became lightheaded, my throat and lungs closed up. I could not breathe. I received treatment in ER (x ray/breathing mach and medication). I am still under treatment they said it was not odor that overcome me. So It must have been vacine.
Pt developed hoarseness and intermittent, wheezing, 2 days post vax. Symptoms lasted a week. Self medicated with Dayquil and ibuprofen.
Patient given Flumist and above 49 years of age. Does not report any current illnesses. Patient is 66 years old. Experience minor body aches, took Tylenol for this and it's feel better. No other additional symptoms reported by patient.
hair loss; feeling unwell; Fever  (101°F); body ache; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss), PAIN IN EXTREMITY (soreness of her arm), MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 031B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included VITAMIN D NOS from 10-Jan-2020 to an unknown date for Deficiency vitamin, VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of her arm). On 17-Mar-2021, the patient experienced MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache). On 25-Mar-2021, the patient experienced ALOPECIA (hair loss). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-Mar-2021, PAIN IN EXTREMITY (soreness of her arm) had resolved. On 20-Mar-2021, MALAISE (feeling unwell) and PYREXIA (Fever  (101°F)) had resolved. On 22-Mar-2021, MYALGIA (body ache) had resolved. At the time of the report, ALOPECIA (hair loss) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test positive: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added one additional event-body ache
I had a fever of over 100, body aches, and my joints hurt. Today is 3-19-21 and I'm still taking ibuprofen for my fever.
Boostrix not shaken; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process 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: 22-NOV-2022 Reporter's comment: The reporter asked for prefilled syringes, what happened if the Boostrix vaccine not shaken. The reporter was unsure if there was a patient involved. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of Boostrix vaccine which was was not shaken, which led to Wrong technique in drug usage process.
Headache, Sedation, Myalgia, Arthralgia,  CHILLS Narrative:  Employee was instructed to contact PCP office for further care
Pain at injection site that was attributed to shot and lasted for 10 days.  Shoulder pain and muscle weakness has progressively gotten worse since that time.  Pain when sleeping and using shoulder or arm.  Muscles in upper arm sore all of the time.
She got a rash on her butt; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included herpes zoster, varicella from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller states she received her fist dose of the Pfizer COVID-19 vaccine on 02Jun2021 and is due to get her second dose on 23Jun2021, but 2 weeks after receiving the first dose she developed a rash on her butt, she does have a history of Herpes but this rash is different than that, and her husband did research and saw that there has been rare reports of getting shingles from the vaccine and she did have chicken pox as a child. Caller would like to know if it is okay to get the second dose of the vaccine even though she still had the rash, the rash is drying up and getting better but it is still there. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
A non-serious, spontaneous report of "dosage to left nostril never misted/sprayed" was received from a consumer, concerning a 48 year-old male patient subsequent to FLUMIST. Neither the patient's medical history nor concomitant medications were reported. As of thirteen days after administration of FLUMIST, the patient denies any occurrence of illness or adverse events. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received on 22-Oct-2008: confirmed that the patient did not experience any adverse effects.
Mild to moderate soreness for 2 days post vaccine. 7 days post vaccine, moderate inflammation, pruritus at the vaccination site
The patient received the Tdap vaccine on 1/7/09.  It had been 11 years since she last received the Td vaccine.  However, prior to her last Td vaccine the patient had received numerous Td vaccinations through a plasma center while attending college.  She received minor compensation for being involved in a study looking for tetanus titers in plasma.  On the morning of 1/7/09 at 10 am, the patient received her Tdap.  By late that evening, she had pain at the injection site which she attributed to a regular localized reaction.  The next morning though she noticed redness at the site.  Throughout this day she noticed progressive swelling, redness, and the site being hot to the touch.  On the morning of the third day, the arm of her injection hurt so bad she couldn't get out of bed.  She was also very fatigued and had severe weakness in the arm.  The size of the area was 2 1/2 inches wide and 1 1/2 inches long.  That evening, the patient went to a local clinic.  The doctor said for her to ice it and use pain medications as needed.  She was also told to mark the area to notice if the area was growing.  On her own, the patient used ibuprofen, neosporin, and topical hydrocortisone 1%.  None of these agents provided any relief.  The patient noticed the pain and redness subsiding afer about 5 days.  The swelling however took about 7-10 days to subside.  During this whole incident, the patient had contacted employee health where she received the immunization and was told that it probably wasn't due to the vaccination.
Started developing small red spots on her face, throughout the next 5 days spots spread, developed into larger red bumps scattered all over her body.
Low grade fever between 99 and 100 lasting 24 hours the day following vaccination, injection site reaction (moderate arm soreness starting 4 hours after injection
Pt received mumps virus vaccine live. Subsequently, the pt had a titer drawn and did not seroconvert. Addtl info has been requested.
PATIENT WAS ADMINISTERED A 2ND BIVALENT DOSE 2 MONTHS PRIOR TO BOOSTER DOSE BEING APPROVED.  PHARMACY NOTICED MONTHS LATER WHEN PATIENT REQUESTED ANOTHER DOSE.   PATIENT HAD NO NEGATIVE REACTION TO DOSE
Diagnosed with Covid; 3-4 Months later started loosing hair; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (3-4 Months later started loosing hair) and COVID-19 (Diagnosed with Covid) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 010M20A and 012L20A) for COVID-19 vaccination.     Patient had no allergies. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ALOPECIA (3-4 Months later started loosing hair). In August 2022, the patient experienced COVID-19 (Diagnosed with Covid). At the time of the report, ALOPECIA (3-4 Months later started loosing hair) and COVID-19 (Diagnosed with Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided. Patient stated he was diagnosed with Covid Aug2022 and it was after that, that he started losing his hair. Patient stated that he was trying to see if it was tied together with the vaccine. Patient also stated that 3 people that he knows have also reported hair loss. Patient was not hospitalized for COVID-19 in Aug-2022. No treatment medications were reported.  Company comment is not required as events are non serious non AESI.   This case was linked to US-MODERNATX, INC.-MOD-2022-670181, US-MODERNATX, INC.-MOD-2022-670192 (E2B Linked Report).; Sender's Comments: Company comment is not required as events are non serious non AESI. US-MODERNATX, INC.-MOD-2022-670181:cross link case MOD22-028969 (2 female patient) US-MODERNATX, INC.-MOD-2022-670192:cross link case MOD22-028970 (1 Male patient)
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 030H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen (Batch no was reported as 1816022.) on 25-May-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Loss of sight and hearing, headache, generalized weakness. No shortness of air, patient hadn?t eaten breakfast before the vaccine.
body aches; HA; chills; arm pain; severe migraines; all hair fell out; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:00 (Lot number: 301358A) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy induces asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "alopecia areata" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; HYDROCHLOROTHIAZIDE; LEXAPRO; VYVANSE. Past drug history included: Wellbutrin, reaction(s): "Allergy"; Ceftin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: F13246, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 11Jan2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Body aches", "HA", "Chills", "Arm pain", "Severe migraines", "significant worsening of alopecia"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 18Dec2020, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Body aches", "HA", "Chills", "Arm pain", "Severe migraines", "Alopecia". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "HA"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain"; MIGRAINE (non-serious) with onset 2021, outcome "recovered" (2021), described as "severe migraines"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "all hair fell out". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, chills, pain in extremity, migraine, alopecia.  Additional information: Known allergies to Wellbutrin, Ceftin. Other medical history included HTN, depression, anxiety, allergy induces asthma, endometriosis, migraines, alopecia areata. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included Labetalol, Hydrochlorothiazide, Lexapro and Vyvanse. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. Seriousness criteria was reported as non-serious. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received Spironolactone as treatment for the events.  No follow-up attempts are possible. No further information is expected.
(Child had fever of 102 the day following immunizations. Rash developed after the fever subsided.) Diffuse pink macular rash developed approximately 48h after administration of vaccines, more concentrated over one of the injection sites.
In arm where shot was given. Tingling in 3 middle fingers (and sore shoulder) 30 days after FLUZONE HIGH DOSE vaccine given.
Rapid heart rate, some chest pain, feel very dizzy and see dark and like I will pass out. Also nauseous. Started 2 weeks after 2nd vaccine shot. The first time, my husband drove me to Hospital. It started to occur everyday, sometimes every other day. 3 weeks later I collapsed at work and Fire dept came and ambulance had to take me to Emergency Hospital. I have had EKG's, blood tests and many other tests like a heart monitor and everything comes back normal. Also have seen Cardiologist. They say it is anxiety, but I have never had this condition before the vaccine. Only the emergency room doctor lady said she has been seeing this condition alot recently with patients. I am still having this condition today and it is not getting better.
Patient continues to report bilateral upper extremity/shoulder pain.  Patient recalls pain started in 5/2021, one week after 2nd Pfizer COVID vaccine.  Pain now most intense over bilateral upper shoulder/upper back to base of neck with radiation down bilateral upper extremities to forearms and in past two months radiating into bilateral hands with electric ­shock type pain in hands/wrists with firm grip (eg: opening difficult jar or twist ­top bottles).
Headache, Myalgia, Fever, RespDepression, NauseaVomiting, Syncope, fatigue, arm soreness Narrative; Near syncope, SOA, nausea, headache, fever 100.0, myalgia, fatigue, arm pain. Took tylenol/ibuprofen; resolved 48 hours.
2 yr old with sudden onset of flaccid quadriplegia on 9/27/08. Pt awakened from a nap unable to move arm or legs. Pt had spontaneous respirations and was able to move head. Pt had received FLUMIST on 9/22/08 during her 2-yr well exam. Mom reported by Friday 9/27/08 she had a fever of 101. Around 12:30 pm pt was put to bed for a nap. The pt awoke at 2 pm screaming and unable to move. Neuro exam on 9/29 - abdominal and deep tendon reflexes are absent. Decreased chest wall movement, labored breathing noted - pt intubated. MRI - swelling of C-spine C2-C7.   1/22/09 MR received for DOS 9/28-~11/3/2008 with D/C DX: Longitudinally extensive Transverse Myelitis.  Flaccid Quadriplegia.  Respiratory Failure. S/P Tracheostomy.  Constipation.  UTI (enterococcus), resolved. Pt presented after abrupt onset of inability to move arms and legs. Pt had had 1 wk hx of rhinorrhea and cough & received Flumist 6 days prior to admission. Pt noted to have no movement in arms and legs in ED. Absent reflexes. 1 episode of emesis. T=101'F.  Initially able to breathe on own however developed respiratory difficulty requiring intubation and later a trach. Some fluctuations of HR due to autonomic instability. Tx with solumedrol and plasmapheresis with some improvement in lower extremities only. Developed anemia during plasmapheresis. D/C to rehab. Follow-up Information 05-NOV-2008: 2yo female present with sudden onset flaccid quadriplegia. No trauma - taken to hospital where head and spine CT nl. Approx 1 week hx of rhinorrhea and cough. Received FluMist vaccine 6 days PTA.
This spontaneous report as received from a physician refers to his now 25 year old son with no medical history or drug reactions/allergies. The patient was administered "two doses of M-M-R II on unspecified dates as per recommended timing when he was a child. He had titers drawn for antibodies to M-M-R when was an undergraduate student on an unspecified date and the results were equivocal. He was now applying to medical school and the medical school would not accept the equivocal titer results." Subsequently, the patient had a third dose of M-M-R II (lot #, expiration, route unspecified) administered on 16-AUG-2013. No concomitant medication. No treatment was given. At the time of report, the outcome of the event was unknown. Additional information has been requested.