chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clots; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clots) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at a dose of 20 milligram. At the time of the report, DEEP VEIN THROMBOSIS (blood clots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: blood clots blood clots. On an unknown date, Ultrasound scan: blood clots blood clots.         Concomitant product usage were not provided.  This case concerns a  73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately  19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose.  The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a  73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately  19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose.  The benefit-risk relationship of Spikevax in not affected by this report.
She referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness; She referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included asthma and history of SARS-COV-2 from 2020, reported as 6 months ago. The patient is taking breathing treatments (unspecified). The patient referred to herself as a "long-hauler" still experiencing symptoms of muscle pain, tightness on an unspecified date. The patient has not recovered from the events.   Information on the lot/batch number has been requested.
patient called in and spoke with writer.  She reports that the evening of her second dose she could not pick her left arm up over her head.  Unable to bear weight or grip.  States that she attempted to contact her PCP and  MD on 3/5/21.  She received a call back on Monday 3/8/21 and was sent in for an MRI of Lt Arm.  Per patient, her PCP followed up with her about MRI results stating she could go for a walk -in appointment at the Clinic. Patient states she has not gone to the clinic as of yet and has not followed up with PCP at this time but plans to do so.
Pain in deltoid where injection took place.  Patient went to an Urgent Care.  The Dr. diagnosed her with a hematoma.  No medicinal treatment prescribed.
Patient came with his father who put his date of birth as date. I verified his birthday and I also talked for several minutes about this birthday being on the same day as his vaccine. When I went to data enter information on the patient we had rxs and documentation from his doctor that his birthday was date. We tried to call the father to ask about the discrepancy but did not hear back from them.  The child will be 12 in 6 more days.
Pain to right arm since getting flu shot. Aching pain that extends into the right shoulder. Tenderness to palpation and decreased ROM ongoing. Of note - our documentation shows injection was given in the left deltoid
Trouble breathing.  Grasping for air.  Just like I did when I had Covid.
Slight fever, loss of strength, headache, extreme difficulty breathing.   Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home.  No accute pathology but  hyperinflated WBC was 19.  Sent home with oxygen
This case was reported by a physician and described the occurrence of erythema multiforme in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date, the subject received an unspecified dose of Pediarix (unk). After an unspecified time after vaccination with Pediarix, the subject experienced erythema multiforme. The physician reported that this erythema has occurred always with Pediarix. The physician reported that the subject is an allergy pt of his. He also reported that the only other times the subject had experienced this reaction was with Poli Vi Flor and other Pediarix immunizations. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with Pediarix.
pt devel swelling to both hands w/rash to hands & buttocks w/in a period of 6 to 8 hrs p/vax was administered; DPH given;
Soreness in arm, headache for 2 days, diffuse swelling and redness to left upper extremity affecting a greater area than where the shot was given.
Arm hurt; Chills; Fever; Aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine) via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Lot Number: EN6201) at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Hospital for Covid: Apr2019 - 05May2020), pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine, lot number: EJ1686) via an unspecified route of administration, on 19Jan202110:00 AM at single dose for covid-19 immunization and Past drug reaction included night of shot arm hurt so bad I could not sleep, arm still sore, achy, chills, heavy sweat from 19Jan2021 with no Admission to hospital due to event , no treatment received and outcome of recovered. The patient experienced arm hurt on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown, fever on an unspecified date with outcome of unknown, aches on an unspecified date with outcome of unknown. Vaccination facility type was senior Independent Living. No vaccine administered at Military facility. There is no other product(s) that were taken together with those indicated above.   The clinical course was reported as follows: Second shot on 09Feb2021 was a lot worse. Arm hurt but not as bad as first shot. Chills, fever, aches a lot worse. 36 hours very bad.
Fatigue, Nausea, Extreme Dizziness, Body Weakness. Lasted two days and has minimized on the third day.
Severe headache for 16 days following vaccination. Ibuprofen not sufficient to dull pain. Sometimes headache causes lack of sleep. Also had chills and fatigue for 6 days.
2 wks after the vaccine he started to not wanting to do anytime, lack of energy. He woke up one morning with knife sharp pains under his chest he went to the ER and found out he had blood clots in his lungs.
Pt reports she got a fever Tuesday at 3 pm 101.2 at 6:50pm 100.5. she took Tylenol at 4 pm she also had a headache. Wednesday, she has vomiting and diarrhea. Thursday she still having diarrhea. She tested for covid Monday and Tuesday for covid and she was negative. She states that her arm as a little pain but no redness or swelling. She did have some chills last night but did not check temp. This could be a virus that started at the same time as her shot but to be on the safe side will call this a vaccine reaction and add to allergy list and fill out a reaction form.
I had a sore throat, sneezing, slight headache, and muscle aches on back. I tested positive for COVID-19 at home on 12/10/2022. I talked my doctor, and they prescribed me PAXLOVID. I am also having sinus and nasal congestion as well. This started 12/19/2022.
The vaccine gave me shingles; I had the shingles shot when there was just one and still got shingles; Neuralgia; This spontaneous report as received, via GlaxoSmithKline, from a female patient of unknown age, concerning herself. The patient also posted on an unspecified social media page regarding herself. The patient had familiy history of shingles, her son was not vaccinated against shingles. No information was reported regarding the patient's concurrent conditions or concomitant medications.  On an unspecified date (reported as "several years ago",  and also reported as "about a year ago"), the patient was vaccinated with zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX) for prophylaxis, she did not remember exactly which vaccine she got. (dose, frequency, route, lot number and expiration date were not provided). The patient reported that she only got one shot. On an unspecified date, a couple of days after the first shot (also reported as "five years ago"), even though she got the vaccine to stop it (vaccination failure), she got a shingles outbreak on her breast and back and around  her neck and hairline, which made her miserable. The patient reported that the vaccine gave her shingles and 12 years of unspeakable pain. The patient's pharmacist told her that the vaccine had a little bit of chicken pox in it.  By the time of the report, the patient still had rash with her and she had side effect of neuralgia around her right scapula, since an unspecified date. She takes acetaminophen (TYLENOL) 3 times a day. She reported that she did not think neuralgia would ever leave her. The outcome of vaccination failure was reported as "resolved". The patient had not recovered from neuralgia and shingles.   Upon internal review, the vaccination failure was determined to be related to suspect vaccines. The patient considered the shingles related to zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX). No assessment was provided between the neuralgia and zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX).
fever 104, seen by MD w/otitis in rt ear; pt also was crying, fussing & pulling up rt leg;
This spontaneous report was received from a licensed practical nurse refers to a 13 years old female patient with no drug reactions or allergies or pertinent medical history who was vaccinated intra muscular (IM) with the first dose, 0.5 ml GARDASIL (lot # not reported) on 01-JUN-2012. There were no concomitant therapies. The nurse, reported that a female patient was administered her first dose of GARDASIL on 01-JUN-2012 and later the same evening experienced arm swelling "the size of a softball" and injection site area was hot to the touch. The patient's outcome for arm swelling "the size of a softball" and injection site area was hot to the touch was reported as recovered, "3 or 4 days after initial reaction". The patient did not seek medical attention. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. Additional information has been requested.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 87 year old patient. Weight: not provided. Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 07-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 07-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Light headed; hypertension lasting approximately an hour/hour and a half; "Mental fuzziness" lasted until the headache took place.; "Mental fuzziness" lasted until the headache took place.; photo sensitivity; This is a spontaneous report from a contactable consumer. A 27-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date was unknown), via an unspecified route of administration on 18Dec2020 14:30 at single dose in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. There were no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 18Dec2020 14:30, the patient experienced light headed, hypertension lasting approximately an hour/hour and a half, ''Mental fuzziness'' lasted until the headache took place and normal side effects accompanied such as a headache and photo sensitivity. No treatment received for all the events. The outcome of the events was recovered in Dec2020.  The following information on the batch number has been requested.
Vomiting, headache, dizziness, need assistance walking to bathroom,  exhaustion . Joint pain throughout spine and feet. Tylenol did not improve symptoms. Lasted all day on day following second injection.
This health authority report (initial receipt 08-May-2012) concerns a 14-year-old female patient. On 10-Jan-2012 the patient received AFLURIA (batch no: N56907) intramuscularly in the right arm and GARDASIL (batch no: 1261AA) intramuscularly in the left arm. The patient previously received 3 doses of flu vaccine and no doses of GARDASIL. The patient was seen for an appointment at 09.08 where her blood pressure was 109/70 and temperature was 97.8. Five minutes after the vaccinations the patient developed a 4/10 headache, pain in the back of the head and was feeling hot. Her blood pressure increased to 129/80 and temperature to 100.8. Ten minutes after the vaccinations the patient stated that she was feeling better with a 2/10 headache, her blood pressure was 116/72 and temperature was 100.8. Reporter's comment: On 11-Jan-2012 the health authority considered the events as not serious.
seizure event ocured on 10/15/21 at work place, patient was admitted to ER facility . patient is stable and back home on 10/16.
Impressive red, warm, tender local reaction 8x5 cm deltoid area, moving into axilla.  From 5/21 to 5/22.  No fever.  Decreased arm movement.   well.
Body ache; Headache; Fever; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for the case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache and fever was not reported. This report was non-serious.
RECIEVED VACCINATIONS ON 28TH OF JULY 2017 SORE AROUND THE INJECTION SITE A LITTLE FATIGUE THROUGHOUT THE DAY CONTINUED NORMAL ACTIVITIES. AROUND 11:45 STARTED TO FEEL BAD WOKE UP MULTIPLE TIME THROUGHOUT THE NIGHT IN CHILLS/SWEATING AND FLU LIKE SYMPTOMS. THOSE SYMPTOMS CONTNUED THROUGH THE DAY OF THE 29TH OF JULY AND STARTED TO SUBSIDE AROUND 1200 TO 1300 OF THE 29TH OF JULY.
terrible muscle/joint pain; terrible muscle/joint pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: 9266), via an unspecified route of administration, administered in the left arm on 14Feb2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing lung cancer and known allergy to lobster and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 25Jan2021 on the left arm for COVID-19 immunization. On 16Feb2021 at 03:00 the patient had terrible muscle/joint pain since the second dose of the vaccine. It gets worse everyday. The event caused a doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. The events were reported with a seriousness of disability.
Itching on face/ears/mouth/buttocks and arms/hands started 5 minutes after injection.  Shortness of breath, itchy eyes, crying, dizziness and voice pitch changed started 20-30minutes after injection. Took tylenol.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patients drug allergies and concurrent conditions were not reported. On 11-AUG-2014 the patient was vaccinated with expired does of ZOSTAVAX (Dose Frequency: 0.65 ml, Therapy Route: Subcutaneous) (lot # J011211, expiry date: 31-JUL-2014). No adverse effect was reported. No product quality complaint PQC was reported for ZOSTAVAX. Additional information has been requested.
Pt fainted and became diaphoretic. HR in the 60's, BP 140/80, SPO2 100%. Had pt lay down for 15 minutes, provided water and a granola bar, and had client sit another 15 minutes. HR remained in the 60s/70s, SPO2 remained stable, and BP was 125/70 after 30 minutes. Client reported feeling back to baseline and went home.
anaphylaxis (states her face blew up) to another medication when her knee was aspirated for fluid; face blew up; aspirated her knee and removed fluid from it; This is a report from a contactable consumer (patient). A female patient of unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) received in 2015 (reported as 6 years from the time of the report) via an unspecified route of administration at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and had a bad reaction 6 years ago (2015). It was  an anaphylaxis (states her face blew up), they even aspirated her knee and removed fluid from it. She ended spending overnight in the hospital because of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). The outcome of the events was unknown.   Information on the Lot/Batch has been requested.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M004663 with expiration date 27-JAN-2018, once; dose was unknown), subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
91 y.o. female who was admitted on 1/2/2022 to the outside local Medical Center due to cough and shortness of breath. She was found to have COVID positive. She was started on steroid and antibiotics for possible superimposed bacterial infection. Patient found to be hypoxic. Echocardiogram was done and found to have severely decreased ejection fraction with global hypokinesis. Cardiology was consulted and recommended diuretics. Prognosis was discussed with patient and family members, patient transitioned to comfort care. Palliative care team was able to assist the patient who was found to be a systolic at 14:75 with family at the bedside. Patient was pronounced dead at 14:65. Family and loved ones at the bedside. Autopsy offered. #Pneumonia pneumonia, Chest x-ray with bilateral infiltrates more pronounced on the left. Likely from Covid. Decadron 6 mg daily, Trend Covid labs including CRP and D-dimer, As needed supplemental oxygen, Avoid aggressive volume replacement, #Acute on Chronic respiratory failure, #Increased Dyspnea with orthopnea, #COPD- likely multifactorial. CHF exacerbation vs underlying PNA- BNP 2,914- ECHO done and showed severely decrease SEF with global hypokinesis- Cardiology consulted- she was given Lasix 20 mg IV TID- Foley cath. was placed to monitor I&O- she was started on ceftriaxone and Azithiram for possible CAP. #DM2: allergy to NovoLog and changed to Humulin- SSI- Likely needs scheduled insulin with steroids. #Hypertension- BP currently mildly up- Resume home meds. #AKI on CKD 3:- Creatinine slightly up from baseline-Likely secondary to prerenal AKI. #Chronic microcytic anemia- Likely related to known HO CLL- Hgb at baseline. #History of CLL- Gets monthly Fulvestrant- Follow with Oncology as OP. #Hypothyroidism- Resume home meds.
(L) shoulder was swollen (red & warm). Had body ache, chills & low grade fever 12 hours after immunization. (L) upper arm still a little swollen as of today Nov. 1, 2010. Was given BENADRYL 25 mg IM & MOTRIN by Dr., a private physician on October 29, 2010.
Tingling and numbness in injected arm, radiating down through forearm, and into all fingers, most notably pinky and ring fingers. Grip strength weaker than unvaccinated arm.  The sensation came on a minute or two after injection, and has continued to get worse over the course of the past hour.
Chills, fever up to 101 degrees, fatigue, muscle aches, light nausea, sore arm/muscle pain.
Issues with leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LIMB DISCOMFORT (Issues with leg) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Issues with leg). At the time of the report, LIMB DISCOMFORT (Issues with leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.