chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. called office to report reaction after receiving Flu, Pneumonia & TDAP vaccines. C/o weakness, fainting, body aces, chills 24 hrs. after receiving shots.
Pt was dc'd from the Hospital on 1/6/22 (after being treated for a positive COVID test on 1/4/21) to another facility med unit; was found unresponsive in the unit by staff on 1/16/22 and brought back to the hospital; pt's condition deteriorated; transitioned to comfort measures; in-patient hospice took over; DNR; pt died in the hospital
70-year-old female from an assisted facility tested positive today for COVID-19 was brought in by EMS with worsening altered mental status, hypotensive and respiratory distress. The nursing facility stated she has been declining for two weeks, anorexia, bed bound and not participating, but was COVID negative. They test them every 2 days. They reported 2 days of worsening symptoms prior to arrival and a positive COVID-19 (8/16/2021) swab at her facility.  Pfizer vaccination dates were 1/19 and 2/9. The patient was intubated immediately on arrival placed on mechanical ventilation and is not requiring sedation.  She tested positive for COVID-19 and was found to be in acute renal failure, hypernitremia, leukocytosis, with elevated lactic acid, electrolyte abnormality and elevated troponin. The patient presented to the ICU intubated and on vasopressors. Husband is at home, and the daughter, is listed as the emergency contact and is the first call. She is communicating with husband and sister and will be the person communicating with the critical care team. She states her husband said the patients wishes would be to be a DNR, a partial DNR was completed since the patient is already intubated.
fever, headache, back of neck pain, weakness, arm that vaccine was given very sore ( could barely life my arm, lack of hunger.
Sensation similar to not feeling clever; Small headache; Vaccine administered to pregnant patient; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 031B21A) for COVID-19 vaccination.     Previously administered products included for Pertussis: Tdap vaccine from 02-Apr-2021 to 03-Apr-2021. Past adverse reactions to the above products included Injection site pain with Tdap vaccine. Concomitant products included IRON from 17-Feb-2021 to an unknown date for Supplementation therapy, PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] from 19-Jul-2019 to an unknown date for an unknown indication.   On 02-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 01-May-2021, the patient experienced FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache). On 30-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. On 01-May-2021, FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache) had resolved.            Concomitant medication also included prenatal vitamins with DHA, one daily  with breakfast, orally from 19-Jul-2021. No treatment information provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-069858 (Patient Link).
Left neck pain/ swelling . Started almost immediately after injection. Radiated from injection up to shoulder, up to neck. Shoulder and arm pain went away after 3 days, however neck pain has continued daily since then
Fever up to 102.3; chills; night sweats; body aches; headaches; very swollen lymph node under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included depression and anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lorazepam (ATIVAN), paracetamol (TYLENOL), and ibuprofen (MANUFACTURER UNKNOWN) and cyclobenzaprine hydrochloride (FLEXERIL); all from an unknown date for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 05:00, the patient experienced fever up to 102.3, chills, night sweats, body aches, headaches, very swollen lymph nodes under the armpit. All the symptoms lasted seventy-two hours with the exception of swollen lymph nodes which was on going as of eighty hours. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, night sweats, chills, ache and headache was recovered on 27Mar2021 with lasting effects; while that of axillary adenopathy was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other complaints, denies itchy throat or shortness of breath. No hives or rash noted. Contacted medical director and observed for 1 hour. Will have patient recontact MD for any change in symptoms.
10 minutes after shot pt began to feel flushed. Face red. 2 BENADRYL given PO 25mg. Monitored pt for 1 hour. Fingers swole slightly. After 7 hours pt fine, no symptoms
Fever-t104.9, chills seen in ER; next day t102, 3 soft stools;
Initial and follow up information has been received from a nurse and a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning a 15 year old female who on 03-AUG-007 was vaccinated with the first dose of GARDASIL (Lot #, site and route not reported). Concomitant therapy included vaccination with the meningococcal vaccine (unspecified). Subsequently, it was determined that the patient was pregnant (LMP 15-Apr-2007). The patient sought unspecified medical attention. On 25-NOV-2007, '(also reported as 32 weeks gestation), the patient was sent for a amniotic fluid index (AFI) and the prenatal sonogram found that the patient had polyhydramnios. No numeric AFI was reported. On 20-JAN-2008, the patient delivered vaginally at term with "massive polyhydramnios". She delivered a healthy, and normal baby weighing 7 lbs, 6 oz. Both the mother and baby are doing well. Additional information is not expected.
Information has been received from a 30 year old female pharmacist who was also the patient. The patient had no medical history or drug reactions/allergies. In 1995 the patient was vaccinated with (Merck) VARIVAX (dose, frequency and lot# were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and LIPITOR. In 1999 the patient was diagnosed with rheumatoid arthritis. As treatment, she was prescribed ENBREL and methotrexate. Pharmacist reported she had her varicella titers drawn on 06-MAY-2015 (reported as "last week") and results showed negative antibodies. Pharmacist reported she had no immunity from the (Merck) VARIVAX. The outcome of these events was reported as not recovered/not resolved. The patient sought medical attention via seeing physician. The relationship between these events and (Merck) VARIVAX was not reported. Additional information has been requested.
Why is my still hurting; 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 PAIN (Why is my still hurting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Why is my still hurting). At the time of the report, PAIN (Why is my still hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.
This spontaneous report was received from a nurse concerning a 24 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, strength, lot number, expiration date and route were not reported).  Co-suspect and concomitant therapies were not reported. The nurse stated patient had serologic testing conducted for employment reasons at unspecified hospital where she works. Nurse stated patient's "equivocal for mumps came back 1.05" (negative titer results). Nurse states equivocal was conducted on 07-JUL-2014 and reported 09-JUL-2014. No adverse effects reported. Nurse stated pediatric records not available for review of M-M-R II vaccinations yet patient reported to nurse that she had received M-M-R II series as a child. At the time of the report the outcome was unknown.  Additional information has been requested.
Requested consult for evaluation of diffuse myalgia, arthralgia and URI like symptoms following receipt of several influenza and anthrax vaccinations. He received his Influenza vaccinations on 3/2/2003, 12/30/2004, 11/26/2007, H1N1 on 2/19/2010, and FLUMIST on 10/16/2010. Approximately 5-8 hours following each of these vaccinations (with and without other vaccines administered) he complained of feeling diffuse body aches, headaches, and nasal congestion that would last 3-4 days. Headaches and nasal congestion were worse with 2010 FLUMIST. He self-treated with TYLENOL, ADVIL and/or OTC cold medications and advised he was treated for UTI in 2010. He remembers being out of work 3 days each time. He received his Anthrax vaccinations 6/27/2007, 8/24/2007, and 3/1/2008 with sequential worsening of diffuse myalgia and arthralgia to knees/hands, nasal congestion, fatigue and frontal headaches. He recalls onset of symptoms was about 1-2 hours post vaccination (each vac.). He remembers duration of all symptoms in 2007 was 2-3 days and 5-7 days in 2008 before fully resolving. He treated with MOTRIN and increased fluid intake. However, a review of available medical records documented an exam on 7/14/2007 for complaints of a sore throat, cough, bilateral ear pressure, and congestion beginning 6/29/2007 unrelieved with OTC medications (onset 2 days after AVA vac#1 versus above recall of 1-2 hours post vaccination). His exam noted enlarged erythematous swollen tonsils with exudate, mucoid nasal discharge, and expiratory wheezing that cleared with cough. He was diagnosed with bronchitis and treated with Z-PAK, albuterol inhaler, ENTEX PSE, and TYLENOL. There were no throat cultures obtained. He reported full recovery over next few weeks. On 4/7/2008, while deployed, he was examined for complaints of 2 week history of headaches, stuffed ears, sore throat, cough, sinus & chest congestion (symptom onset at 3/23/08 or 22 days after AVA vac #3). His exam was unremarkable with some clear nasal discharge and erythema cobblestone appearance to oral cavity. He was diagnosed and treated for sinusitis and URI with full recovery. Agency form on 8/15/2008 was marked yes for complaints of painful joints, back pain, heartburn and increased irritability. X-rays in Sept-Oct 2009 showed degenerative disc disease to L5-S1 and mild vacuum phenomena with spurring L5; and, DDD to C5-6 and C6-7 with straightening of cervical curvature. As of 2011 his diagnoses include hypertension, hypercholesterolemia, glucose intolerance, and he sees a chiropractor for episodic cervical, thoracic and lumbar spine somatic dysfunction (pain). He is currently preparing for a June 2011 deployment, is in smoking cessation program, voices no restrictions in daily activities, or an increase in seasonal URI like events pre-post vaccinations.
positive COVID-19 test; This is a spontaneous report received from a contactable consumer (patient's son) via medical information team. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown), via an unspecified route of administration on 22-Mar-2021 (at age of 50 years) as a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Son reported that, his parents took first dose of Pfizer COVID vaccine and tested positive for COVID on 02Apr2021. His mother had tested negative, but father was currently testing positive. Reporter asked that, can they get their second dose. Outcome of the events was reported as unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443011 same reporter/drug, different patients
Delayed over a week later redness at the injection site.  About the size of a dime.
Information has been received from a pharmacist and a hospital employee who was the brother of a female patient who on an unknown date was vaccinated with PNEUMOVAX (site and route not reported) -  Subsequently the patient experienced severe reaction at injection site.  This is one of three reports from the same source.  Additional information has been requested.
after 2 days of shot pt arm sore. Difficult to lift.  Still experiencing difficulty after 6 weeks
Adverse reaction to shingles vaccine ZOSTAVAX mild redness and minor swelling. Patient allergic to BENADRYL. Recommended cold compress and Ibuprofen and patient has recovered.
Patient said he did not feel well, As we were attending to him he started to lose consciousness. We laid him down,  within  a minute he regained consciousness and after throwing up, over  the next hour pt gradually felt better, only complaint is that he felt tired. His parents came in  and took him home.
Diagnosed with Shingles 7 days after vaccine.  Symptoms appeared 6 days after receiving  vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 10Apr2021 as dose 2, single (Lot number: EW0153) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 22May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "elevated cholesterol (normal after statins)" (unspecified if ongoing); "enlarged liver" (unspecified if ongoing); "Year round outside and inside allergies" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: on home Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies.
joints became swollen and hot to touch; hot to touch; Developed ras and hives on his chest, behind both ears and on his legs; Developed ras and hives on his chest, behind both ears and on his legs; Low grade fever; This spontaneous report was received from a nurse referred to a 12 month old male patient with immunisation. The patient's medical history and concomitant medications were not reported. On 28-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036581 and an unknown expiry date for immunisation. Other suspect therapy included sterile diluent (lot# S011944 and expiry date 18-DEC-2021). On 28-JUN-2019, reporter stated that the patient developed a low grade fever(pyrexia) later that night and on 29-JUN-2019, the patient developed a rash and hives on his chest, behind both ears and on his legs(rash generalised and urticarial). On 01-JUL-2019, the patient's joint became swollen and hot to touch (swelling and skin warm). The outcome of pyrexia, joint swelling, urticarial, rash generalised and skin warm were reported as recovering. Causality assessment was not provided. No PQC found.
Headache treated with Tylenol, 2 hours Lethargy, 24 hours Unusual taste of all food, 48 hours
SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced sore arm. On 02-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and sore arm. This report was non-serious.
This spontaneous report was received from a consumer referring to her aunt a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU Injection by unspecified route; in gluteus muscle (dose, frequency, lot # and expiration date were unknown) for prophylaxis, the patient had no known adverse effects after receiving the vaccine. Subsequently, on 02-APR-2018, the patient received the first dose in the two dose series of SHINGRIX, and on an unspecified date after receiving the vaccine, the patient had been having redness and pain at the injection site, and nausea. At the time of the report, the outcome of vaccination site pain, nausea and vaccination site erythema was reported as not recovered. The patient did not mention the causality assessment between the events, and ZOSTAVAX and SHINGRIX.
freezing excursion, doses were administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On 8th February 2022, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that there was a freezing excursion in the fridge at her work location on 8th February 2022and some doses of Havrix may or may have not been in that fridge, which led to incorrect storage of drug. The reporter stated that two doses of Havrix were administered on 09th February 2022 at the facility but reporter did not know if the doses had been in the fridge that had the temperature excursion. The reporter consented to follow up.
Uncomplicated pregnancy.  41.1 weeks, medical induction of labor for post dates.  Vaginal delivery.  .  BW 3153gm.  Infant with respiratory distress, suspected spontaneous GI perforation and NEC presented on xray at 6hrs of age.  Bloody gastric aspirations noted at birth and persisted.   Required transport to level 4 NICU at 8hrs of age for surgical consult.
Shivering uncontrollably described as very tremor like.  Vomiting, severe dehydration, weak and sore.
A serious report of KAWASAKI disease has been received from a local study investigator concerning a 25-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 08-Dec-2009. The subject received one dose before the onset of the event. On 01-Jan-2010, the subject was traveling abroad and developed high fever of 102-104.3 Fahrenheit which lasted two days. On 04-Jan-2099, he had red eyes, rash in the body, swollen hands and feet, purple-red lips, and "strawberry tongue." The subject was not eating. On the same day, he went to see the doctor; however, " the medicine did not alleviate the symptoms." On 06-jan-2009, he went to the hospital, was diagnosed with KAWASAKI disease and hospitalized. He improved after several days of treatment. Discharge dates vary: 15-Jan-2010 per billing records and 21-Jan-2010 according to subject's parents. The outcome of the event was ongoing. The investigation assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. Alternative etiology was natural causes. The sponsor also assessed the causality for the event as not related to FLUMIST.