chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very weak; hardly walk; can't sleep; couldn't stand up; is quite sick; started throwing up; chills; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up) and PYREXIA (is quite sick) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Patient reported rash and itching "hive-like" approx. 3 inches in diameter at site of injection. Advised cold compresses and antihistamine. Will follow up next day.
Within approx 24 hours of vaccine administration, the patient developed acute onset of SOB, and was seen in the ER. Found to have fever, chills, cough, bilateral infiltrates on CXR and suspected ARDs, admitted to ICU, hypotensive, ultimately intubated, required pressure, broad spect antibiotic but recovered, now well.
Right facial numbness the day following first injection.  Now 2 weeks late still have facial numbness
myocarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "myocarditis".  Clinical Course: The reporter stated that My son was one of the unlucky few who developed myocarditis shortly after receiving the booster vaccine. As this was a direct result of the booster vaccine and is a rare but well documented vaccine injury.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As per available information, the casual association between the event myocarditis and suspected drug cannot be excluded.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, within 3-4 hours post-vaccination, the patient experienced pain in the injection arm, from the shoulder to the forearm, and chills.  The patient's outcome was unknown.  Additional information has been requested.
In the evening of 3/25/21, I felt excruitiating pain in the left shoulder/arm.  Took Tylenol 500mg at bedtime as instructed by nursing clinic that administered the vaccine earlier that day.  Over the next couple of days, pain was not improving and I was unable to reach behind with left arm.  Continued to take Tylenol 500mg as needed for pain.  On 4/1/21, experienced dizziness that resulted in going to the ER.  Imaging and blood work was performed.  D/C home same day with instructions to f/u with PCP.  Saw PCP on 4/5/21 for f/u for continued dizziness and muscle pain in left arm.  Medications prescribed. Contacted PCP regarding continued pain in left shoulder.   MRI of left shoulder ordered by PCP.  Due to MRI findings, PCP referred me to orthopedic specialist for further evaluation/SIRVA injury.  Orthopedic prescribed medication and exercise handouts.  CDC contacted me and recommended I complete an AE on VAERS concerning this information as I am still experiencing left shoulder shoulder/arm issues.
Patient called complaining  of low grade fever, aching muscles and stomach soreness on 6/6 and felt poorly for several days. She had an episode of diarrhea on 6/9 and felt back to her normal baseline after this. Patient was advised to treat with OTC meds for muscle aches.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/15/2023 Discharge Date: Mar 17, 2023  PRESENTING PROBLEM: Hypoxia [R09.02] Acute hypoxemic respiratory failure [J96.01] Community acquired pneumonia of right middle lobe of lung [J18.9] Sepsis without acute organ dysfunction, due to unspecified organism [A41.9] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is a 85 yr old F with PMHx of Insomnia, Dyslipidemia, OA presented to ED on 3/15 with concerns for confusion, shortness of breath and hypoxia. On ED admission - patient found to be febrile, hypoxic requiring 2L NC, WBC of 10k, procalcitonin of 1.6, and initial lactic acid of 2.1.   COVID PCR positive, CXR confirmed Right lower lobe pneumonia - she was started on IV Rocephin/Azithromycin and admitted for further workup.   For her COVID pneumonia - she was started on Decadron and Remdesivir. For her Community Acquired Pneumonia- Urine Strept came back positive so she was continued on IV Rocephin. Her blood cultures were negative. She was weaned off oxygen.   She was transitioned to oral abx and discharged home in stable conditions.   She will need repeat Chest X ray in 4-6 weeks outpatient to ensure resolution of pneumonia.
Pt noted onset of arm pain, redness and swelling below the injection site that began within 72 hours of administration.  The area of redness increased and is warm to the touch.  Has pain in this area.  Erythematous area measures 18cm X 19cm with minimal induration.  No discharge noted.
Racing heart clenching jaw difficulty speaking dry mouth The patient was given BENADRYL Oral Capsule 25mg by mouth now and every 6 hrs as needed symptoms children TYLENOL chewable 80mg 4 by mouth.
Possible palpitations - heart rate was between 198 and 208 for more than 2 hours
About 10 minutes after administration of DPaT, IPV and MMR. While pt is playing in the waiting room and mom was attending to some paperwork in receptionist window, pt starts to have some dry cough. After administering shot, hives developed and were gone in 2 days, eventful after left office.
Swelling and readness of arm, pin and needles feeling in arm 3 days now.  Massive headache on right side behind ear, stabing and burning pains
26 year old female developed bilateral thigh swelling, pain, and redness associated with a "rash" at the inner thighs about 4-5 hours after several vaccines. Rash 01/11/2007. Rash noted on the inner thighs starting a few hours after vaccines. Tumor 01/11/2007 - 01/12/2007 Patient reports swelling in both thighs and at the rash site. Erythema 01/11/2007 Redness reported at the rash site and still persisting. Tenderness 01/11/2007 The thighs and the rash areas were reported as "tender".
Patient received INFLUENZA vaccine at approximately 11:10 am. Shortly after, she began to complain of not feeling well "and feeling" "very bad". She began to breathe rapidly, but at no point did she become unconscious or have labored breathing. At approximately 11:30 am , EMS arrived and administered oxygen to her. She was then escorted out by EMS.
had pain in her lower legs and her knees hurts too and walking was difficult; had pain in her lower legs and her knees hurts too and walking was difficult; had pain in her lower legs and her knees hurts too and walking was difficult; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: -AMGEN-SP2021090895). This case was split from master case 2021754646 for a patient taking bnt162b2 and experienced leg pain, knee pain, walking difficulty.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number:unknown), via an unspecified route of administration, on 25May2021 as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient had always had allergies to medications from the time allergies to penicillin, Biaxin, Z-pak, clarithromycin. The patient's concomitant medications included Enbrel (ETANERCEPT), Otezla (APREMILAST), Methotrexate (METHOTREXATE) and TILDRAKIZUMAB from an unspecified date for an unknown indication while AMLODIPINE from an unspecified date taken for blood pressure and ATORVASTATIN from an unspecified date taken for blood cholesterol, Taclonex (BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL) from an unspecified date taken for palmar-plantar psoriasis, PLAQUENIL (HYDROXYCHLOROQUINE PHOSPHATE) from an unspecified date taken for pain. The patient's co-suspect medications included Humira (ADALIMUMAB) from an unspecified date for an unknown indication. The patient received an unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: unknown), via an unspecified route of administration, on an unspecified date  as single for COVID-19 immunization. On 28May2021 the patient experienced had pain in her lower legs and her knees hurts too and walking was difficult. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
slightly tender; half dollar size purple mark around injection site; A spontaneous report was received from a consumer concerning an 87 year old female patient who developed/experienced half dollar size purple mark around injection site.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin, venlafaxine, pregabalin, cefalexin and lisinopril.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 21-JAN-2021. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient's husband called in to report side effects from first dose of vaccine. The patient received the vaccine on 21-Jan-2021. On 25-Jan-2021 the patient noticed that there was a purple mark around the injection site about the size of a half dollar coin.  The patient reported that there was no pain, but the area was slightly tender. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events vaccination site discoloration and vaccine site pain were considered not recovered/not resolved. The outcome of the events was unknown/not reported.
This spontaneous report as received from a consumer refers to a 13 year old female patient (the report's daughter) with no pertinent medical history or drug reactions. On 14-OCT-2013 the patient was vaccinated with the second dose of GARDASIL (lot # J007354, expiration date: 20-FEB-2016), dose and route not reproted for "prevent HPV". The reporter was unable to provide the date of the first dose. No concomitant medication was reported. The reporter reported that her daughter developed redness at the injection site after receiving GARDASIL on 14-OCT-2013 that was involved in a recent recall of the product. No treatment was given to the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient was recovered from the adverse event. The patient had not sought medical attention. Additional information has been requested.
Patient had a fainting spell with convulsions when arriving at home after vaccination. Patient was able to come to and went to the mall two hours after spell.
NEURALGIA; NEURITIS; VOMITING; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: XD955 and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced headache. On 11-MAY-2021, the subject experienced neuralgia. On 11-MAY-2021, the subject experienced neuritis. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, vomiting, dizziness, neuralgia and neuritis was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
I had a cough and a little bit of a fever, a bit tired. I used a home COVID-19 that came positive, so I an emergency clinic and they also tested and their test also came back positive. I was not prescribed any medications but did use over the medications for the cough. It took about eleven days for me to test negative.
Experienced symptoms of trigeminal neuralgia in face; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Trigeminal neuralgia.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face). At the time of the report, TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
No additional AE; a patient was administered VAQTA after the expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot #T040581, expiration date: 28-MAR-2022, for prophylaxis (strength and route of administration was not provided). It was reported that hepatitis a vaccine, inactivated (VAQTA) did not experienced a temperature excursion. No additional events were reported (no adverse event).
Received MMR 3/10/04. Developed rash with itching on chest on 3/14 rash spread up to, but not on to neck and shoulders. Saw PCP who reported rash looked like measles.
This spontaneous report was received from a physician via a company representative referring to a 77 year old female patient. Information regarding concurrent conditions and drug reactions or allergies was reported as nothing abnormal. On 29-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 dose 1 (route of administration, lot #, expiration date, and dose were not provided). Concomitant therapies were reported as multiple unspecified medications. On the same date of vaccination the patient's arm "double in size" (Peripheral swelling), felt dizzy and was in pain, these events happened at her home; no treatment was provided, however the peripheral swelling was going down on its own; according to these information the patient called to the medical attention office in order to seek medical attention. Product quality complains was not involved. The physician stated that no laboratory studies were performed, neither the events caused disability or hospitalization, additionally these events were not considered life threatening. At the time of reporting the outcome of dizziness, peripheral swelling and pain was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
VACCINES GIVEN LEFT ARM  7/26/2023.  7/27/2023 IN THE EVENING, AREA WHERE THE VACCINES WERE GIVEN, WAS SWOLLEN.  OFFICE VISIT 7/28/2023 LEFT ARM, WHERE VACCINES WERE GIVEN WAS RED,  ITCHY, PAINFUL TO THE TOUCH AND THE CIRCLE SURROUNDING THE INJECTION SITE WAS LARGER THAN A TENNIS BALL.
covid vaccine breakthrough case   dose 1 Pfizer 3/17/21 EN6207 dose 2 Pfizer 4/7/21 EW0150
My family and I are sensitive to chemicals like fabric softener. Two days after the vaccine, I had a whole body rash that lasted 2 days. I had a telehealth visit with my doctor and was told to take antihistamines. The rash was extremely itchy. I did not this reaction with the first or third dose of Pfizer.
Cold; In Nov2021, the patient experienced tested positive for COVID-19; In Nov2021, the patient experienced tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362657-00 (Agency).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159098) at unk, citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant) with onset Nov2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Nov2021, outcome "unknown" and all described as "In Nov2021, the patient experienced tested positive for COVID-19"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "recovered", described as "Cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. The action taken for adalimumab was unknown.  The reporter considered "in nov2021, the patient experienced tested positive for covid-19" and "cold" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2 cannot be excluded.
slight sore throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (slight sore throat). At the time of the report, OROPHARYNGEAL PAIN (slight sore throat) outcome was unknown.            The action taken with the drug was not applicable.   Reporter did not allow further contact
Sudden onset of violent shivers. I left my clothes on, including sweater, wrapped in sheet, 2 blankets, quilt. shivers began to subside to when I fell asleep. Around 1AM, I woke up feeing hot, so I began undressing and kicking off blankets
PT FAINTED AND EXPERIENCED SPASMODIC TREMORS ABOUT 1 MIN AFTER GETTING THE JANSSEN VACCINE. PT WAS LAID ON THE FLOOR UNTIL SPASM SUBSIDED. ONCE PT WAS ABLE TO TALK AND IS ALERT, WATER, CANDY AND ICEPACK WAS GIVEN.  BLOOD PRESSURE WAS TAKEN (122/76) 62 HR. THE PT SAID SHE FELT NAUSEA AND WEAKENED. PT IS BEING MONITOR FOR 30 MINS AND LONGER IF NEEDED.  PT ALSO MENTIONED SHE USUALLY FEELS ANXIOUS DURING BLOOD DRAWN AND WITH THE THOUGHTS OF NEEDLES.
Patient has also been unable to work because his license was taken away due to his seizures; Weak; Dizzy; Severe seizure/he had three severe seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Severe seizure/he had three severe seizures) and IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021 at 2:30 AM, the patient experienced SEIZURE (Severe seizure/he had three severe seizures) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures) (seriousness criteria disability and medically significant), ASTHENIA (Weak) and DIZZINESS (Dizzy). At the time of the report, SEIZURE (Severe seizure/he had three severe seizures), IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures), ASTHENIA (Weak) and DIZZINESS (Dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Laboratory test: abnormal (abnormal) seem to think it was the vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had three severe seizures. He had the seizures on 12-May-2021, 2:30 am, 24-Jun-2021, 11:30 pm, and 14-Nov-2021 in afternoon. Patient's wife called emergency services and patient was taken to the Emergency room. The Emergency room ran several tests and seem to think it was the vaccine. Patient was under a Neurologists care and on different medications. The medication had altered his personality and everyday health.  Company comment: This case concerns a 58-year-old, male patient with no previous relevant medical reported, who experienced the unexpected events of seizure and impaired work ability. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 58-year-old, male patient with no previous relevant medical reported, who experienced the unexpected events of seizure and impaired work ability. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.