chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented for second COVID vaccine on 2/10/21 and reported nausea and vomiting which occured 5 minutes post-vaccination from the first COVID dose on 1/13/21. The client did not report this to staff during the observation period on 1/13/21. Client referred to a hospital setting for assessment and possible administration of the second dose.
shingles about 2 months after getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0175) via an unspecified route of administration on an unknown date in May2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 05Jul2021, about two months after getting the vaccine, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with an unspecified anti viral. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event shingles was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Headache, Arthralgia, Fever & Tachycardia Narrative: EMPLOYEE REPORTED SYMPTOMS TO EMPLOYEE HEALTH CLINIC WITHOUT EING SEEN.
The report information has been received from a physician, via a company representative, concerning a multiple unspecified patients. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration dates, concentrations, dosages and therapy routes were not reported). Concomitant therapies were not informed. The physician reported that on unspecified dates, the patients experienced mild cases of shingles. The outcome of shingles was unknown at the time of the report. The causal relationship between ZOSTAVAX and shingles was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a five-months-old male patient who received a 0.5ml dose of PENTACEL lot C5518AA, expiration date: 15-Sep-2019 via unknown route in unknown administration site on 07-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. A young child was administered only the diluent of PENTACEL that it DTAP, IPV and ACT-HIB lyophilized powder was not administered. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Hoarseness (one-day after I received the vaccine) on the 3rd day I began to take Bactrim DS because of asthma condition. One week later I am still hoarse.
A report has been received from a Pharmacist concerning a female patient. No information was provided regarding relevant history, concomitant diseases and concomitant medication of the patient. The patient had been receiving FLUMIST Quadrivalent which was started on an unknown date. The patient had been receiving FLUMIST Quadrivalent into one nostril of a patient on 24-OCT-2014 and stated that they inadvertently removed the dose clip. On follow-up pharmacist stated that patient reported no adverse reaction to the vaccine. The outcome of the event of accidentally administered FLUMIST Quadrivalent into one nostril of a patient was unknown. The report was assessed as non-serious by the reporter.
4/17, 61 days after receiving second vaccine Tip of right index finger went white, looked bloodless, slightly numb and tingly. After about 10 minutes it returned to normal
Patient states that symptoms of dry cough and throat started at 0330 this morning. She states she has generalized itchy hives and injection site pain on left arm, her back and abdomen. Pt states she also has a headache and had two  episodes of diarrhea this morning. Over the counter Benadryl recommended for hives and itching, encouraged symptomatic relief with cold application as needed and over the counter analgesics for pain.
Case number PHEH2013US010669, is an initial spontaneous report received from a nurse on 09 MAY 2013, and a follow up received from the nurse on 09 MAY 2013. This report refers to 15-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12002, expiration date: OCT2014) intramuscularly on 26 APR 2013. She received only MenCWY-135 liquid conjugate component, instead of being reconstituted with MenA lyophilized conjugate vaccine of MENVEO. No adverse reaction was reported.  Follow up information received from a nurse on 09 MAY 2013: Updated expiration date of MENVEO.
Within 2 days of the 1st vaccine, I developed a rash across upper chest, arm and back. Basically like a short cape. After the 2nd vaccine the rash extended down to my elbow  on my right arm. This rash has not gone away. It is extremely   itchy and nothing has resolved it that has been tried.  My sleep is often disrupted due to the itching.  There has been a change in my body chemistry such that foods and beverages  I was normally eating cause a burning sensation in my mouth. The deodorant I have used for years now makes me itch. In general there is a feeling of just not feeling well.
Developed right axillary pain and swelling beginning on 1/4/21 in the early morning hours. The pain and swelling persisted and was then accompanied by the development of an itchy, raised, erythematous rash over the injection site.
Patient receive FLUVIRIN PF 2014/15 0.5 mL IM in left arm on 10/16/14. She came to pharmacy and reported to pharmacy that her left arm at injection site has been sore since 10/16/14 and she is unable to raise arm up.
13:05 - Male client,  at vaccination station 3 had received Moderna booster at 13:00 (Lot #069H21A) and immediately reported feeling faint to RN. RN alerted lead RN, upon arrival to station client appeared pale and diaphoretic and was sitting in a chair. Client was A&Ox4 and was instructed by lead RN to take mask off. Client reported no medical history, no medications taken, no allergies, and he had eaten lunch prior to arriving. RN arrived to station 3 at 13:07 with a wheelchair and took a set of vitals - BP: 90/50, HR: 65, SpO2: 98%, RR: 14. RN then assisted client into wheelchair and pushed client to the observation room and assisted client into anti-gravity chair. Client drank a bottle of water and ate two saltine crackers and stated "I'm feeling better". RN took another set of vitals at 13:25 - BP: 132/52, HR: 67, SpO2: 98%, RR: 12. Lead RN recommended client follow up with his PCP, client verbalized understanding. Lead RN also recommended client not attempt to drive and get a ride home with family, client verbalized understanding and stated "I will get an Uber for us to get home and come back later from the car". Lead RN educated client about adverse reactions and to call 911, client verbalized understanding. RN took a last set of vitals at 13:35 - BP: 144/91, HR: 57, SpO2: 100%, RR: 12. Client A&Ox4, appeared well with good color in face. At 13:38 lead RN escorted client and family to the exit, client ambulated well with no incident.
Eye irritation, sore throat, muscle pain and fatigue, joint pain, and insomnia.
Patient had 2nd COVID vaccine on 2/21/2021. He started having a temperature  on 2/24/2021. Patient then started having trouble breathing. We took him to hospital. He was admitted on 2/25/2021. He steadily declined and was sent to ICU and died on March 1, 2021.
pt recv vax & mom reports that on 9AUG98 had sx & fever 106;pt was hosp x 5 days ventilator x 2 days;prev vax was DT & on advice of neuro pt given DTAP for dose #3;
Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.; Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown, Since the vaccination, Patient was tested for COVID-19. Clinical course: Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bells Palsy to right side of face.  One small area  on lower lip has not returned to normal
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 03Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8714), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient admitted to hospital for diverticulitis on 06/08/2021. On admission, COVID nasal pcr was positive.  CXR negative.  Repeat swab was negative.
Severe chills and fatigue first night. Mild nausea and fatigue ending 28 hours after injection.
2 hours post vax, parent noticed hives, red raised whelps on pt. Rash started on legs and later noticed on abdomen as well. Denies any fever or other signs/symptoms. Pt was treated with Tylenol.
body aches in low back, legs around 12 hours post vaccine.  followed by chills and fever between hours 15-20.  diaphoresis , headache and aches continued for until following day around 11:00 am.  Fever of 100 at 14:30 even 1 hour after 800 mg of ibuprofen.  following date headache and brain fog continued along with fatigue.
Feelings of being slightly off balance/imbalance feeling in head which started 2 days after first vaccine and is still present today.  No change after 2nd dose noted.
Starting about 15 minutes after vaccine injected, began having a cardiac arrhythmia ... thumping in my chest ... irregular pulse (skipped beats palpated in radial pulse).  Lasted for 4 hours.
11:00PM Extreme chills, uncontrollable shaking, shortness of breath, chest pain. 11:15PM Left messages for doctor 11:30PM Call 911 11:40PM Ambulance & Fire Truck arrive   Took patient to ER after evaluation. 12:00AM Admitted to ER at Mercy General Folsom ER.  High fever, chills, shaking, chest tightness, shortness of breath. 3:30AM  Released from hospital. Fever continued until 9AM on 10/21/2010 when fever broke after 3 doses of Tylenol. NOTE: Patient has received "flu shot" for at least a decade with no reaction.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp. date. Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2022 at 11:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2022 at 11:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp. date. Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp. date. Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. The patient had received the vaccine dose number as booster with 0.5 ml. It was reported that, vaccine was administered on 11 Mar -2022 at 11:52:29. Its 30 days expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg. date of 04 Apr 2022. No treatment information provided. The Us Census Ethnicity reported as White. This case was linked to MOD-2022-542869 (Patient Link).
On day 1 injection day, sore arm; day 2 sore body and throat; day 2-3 blisters at the edge of my mouth which is very unusual as I don?t get cold sores.
dehydrated, couldnt get out of bed, chills, passed out, fever, red and hot at injection site
myalgias beginning 9 hours after injection and lasting additional 20 hours  more interesting is palm and lip peeling beginning 2 days after vaccine and lasting additional 5 days (peeled persistently for all 5 days, think scarlet fever type peeling).  Not bullous, not pemphigoid, confined to epidermis.  pictures available
Pt received second dose of Pfizer COVID-19 Vaccine, waited in waiting area ~15 minutes, was walking out of clinic and in the lobby area began to have "lightheadedness", "tight throat" and "heavy chest". Pt. did also have 2 episodes of slumping over w/o loc. Immediately upon notice of pt. s&s, epi pen 0.3 mg given in r thigh and 50 mg im Benadryl given r arm, 911 called. Pt. did not have a LOC, no wheezing, 4-lead ecg shows NSR 70-80, b/p 170/80, O2 sats mid to upper 90s. Pt transferred to EMS w/o issue or incident for transport and evaluation.
didn't feel good for a day, stayed in bed all day; weak; slept a lot; fever; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted). At the time of the report, MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted) outcome was unknown.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-008857 (Patient Link).
8/21/2021: fever/ chills started at midnight and lasted for the next 36 hours.  headache /fatigue started later in the day on the 21st, closer to 12 hours after the dose was given.  8/23/2021: blood in urine, very dark brown urine.  fatigue, headache, chills/ fever resolved after about 3 days. dark urine lasted for 4 -5 days post vaccination.  9/1: fever and chills restarted 9/2: headache/ fatigue/ tightness in chest/ shortness of breathe started.  9/3: blood in urine started again 9/4: fever is resolved. Headache, fatigue and blood in urine remain.
Information has been received from a medical assistant referring to an unspecified number of patients with unknown ages and genders. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (route, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multiple days, with multiple nausea, visual disturbance, aphasia, and facial neuropathy phases. These have been common for me in the past, but have only rarely occurred the last few years. Migraines would fade after 3-4 days, then come back 1-2 days later for the 3 weeks following the injection.
DTAP and MMR administered same arm (L) came back 2 days later for PPD reading (L) arm swollen, hot to touch no pain and itching noticed the swelling and redness next day and T-99.7.
I felt pain in my abdomen and it started swelling; when this didn't end I went to the emergency room. When they will check me they thought it was fluids due to dialysis. I don't have appendix, gallbladder or ovaries so it wasn't those things. I followed up with the Gastroenterologist and was given antibiotics.
My lymph nodes in my arm pit swell and caused my arm to go numb. My arm at the injection shot was red, swell, and hot all the way down to my elbow.
redness and itching at site of the injection 4 months after the injection. Applied allergy cream and antibiotic ointment. I suggested hydrocortisone cream today and to contact his doctor Monday
Postural orthostatic tachycardia syndrome (POTS); dysautonomia; Syncope; Constipation; Arm/Shoulder/ Joint Pain; Sinus Tachycardia; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-1) on 04-FEB-2022.   This spontaneous report has been received from a parent (also reported as guardian or caregiver), referring to a non-pregnant 14-year-old female patient. Her concurrent conditions included allergies to bee venom and strawberries, and asthma. Concomitant medications included hepatitis a vaccine inact (HAVRIX) syringe (SYR). It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of application, lot number and expiration date, were not reported).  On 02-MAR-2018 at 15:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (dose, anatomical site of application, lot number and expiration date were not reported) for prophylaxis.   On 03-JUN-2019 at 8:00, the parent reported that the patient experienced postural orthostatic tachycardia syndrome (POTS), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia.    On an unspecified date, the patient was admitted to the emergency room/department or urgent care and was hospitalized due to his experience for two days. The following medical and laboratory tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), holter monitor for 1 week; holter monitor for 30 days; full laboratory panels, thyroid panels (results were not provided). A Genetics review and counseling was also performed to rule out the potential for anything else that could have contributed, and the result was negative. It was noted that patient had a Medtronic LOOP Monitor Implant in chest wall.  At the time of reporting, the patient had not recovered from the adverse events.  The causality assessment between all the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The reporter considered that postural orthostatic tachycardia syndrome (POTS), dysautonomia, syncope, constipation, arm/shoulder/joint pain, and sinus tachycardia events were disabling or caused permanent damage.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information had been unsuccessful. No further information was available.
Pt was seen for routine 6 month WBC on 8/15/01 and  received vaccinations. That night baby was noted to have simultaneous squirming, grimacing and jerking body lasting around 1 second. Initially occurred every 5 or 6 seconds and gradually tapered off over nest 2-3 hours. Seen in ED for evaluation. Last episode noted less than 24 hours after vaccines. Pt's mental status between events seemed normal, smiling.
local reaction on leg at site of injection (minimal lymph nodes) 12 days after Varicella #1 vs cellulitis, blood work showed increased WBC  (15) neg blood cultures antibiotics given. Improving.
Imm rec'd 9/23/2020.  Called office on 9/25 complaining of fever of 102.5 and vomiting. Advised to go to ED where dx with Left arm cellulitis and admitted