chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as  a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative   on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20220913642 and 20220913752.
Vac inated pt admitted to hospital with positive covid infection. No information available on type of vaccine, date, or time of vaccination
This spontaneous report as received from a medical assistant refers to a child of unknown gender. On 10-DEC-2013 the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous and VARIVAX (Merck) of unknown dose via unknown route. Lot and expiry date were not reported for either products. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a female with a history of irregular menstrual cycle who was vaccinated with her first dose of Gardasil (lot number unspecified).  Subsequently the patient experienced prolonged menstrual bleeding.  The patient experienced the bleeding for two continuous weeks after receiving the dose.  It was noted that the patient had a history of irregular menstrual periods.  The patient sought medical attention by calling the office and speaking to the physician's assistant.  Subsequently, the patient recovered from prolonged menstrual bleeding.  Additional information has been requested.
About 5 hours after vaccine, arm throbbed from shoulder to fingertips. Fingertips went numb. Ability to use (R) arm decreased daily. She would be awakened by pain at night. She still cannot use it normally, but it has improved some. Constant throbbing for first 3 weeks. PCP put her on MEDROL dose pak which decreased pain. Arm felt good for 2 days and then pain gradually increased. She still cannot reach over head to move her arm backward, not can she fasten her bra. She says she takes 1 ALEVE and 1 Extra Strength TYLENOL twice daily for pain. She says she never had anything like this before.
Sore Arm, consistent fatigue, achy muscles, occasional chills, occasional nausea
Heart palpitations, chest pain, severe headache, blurry vision, hypertension, nausea, vomiting,  severe joint pain, dizziness, unable to ambulate, paresthesia, near syncopal episodes,
Greater than 35 days between Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the caller would like to know if the patient should get his second dose of Moderna covid-19 vaccine as it has been more than 35 days between Moderna covid-19 vaccination. No treatment medications were reported.
Patient was to rece VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A
Had the vaccine on Sunday 9/26/2021. Monday 9/27/2021 woke up and had severe back pain, let that go for 4 days, and finally went to my doctor because I thought it may have been kidney or even a pulled muscle. I was unable to sleep for 4 days because of the back pain. Had an x-ray done and told her I had booster on Sunday. The doctor said they were hearing a lot more seniors are getting back pain from the booster. Prescribed muscle relaxers and iced and heated back. In two weeks' time the pain disappeared.
4 days following injection: Chills, extreme fatigue, running nose lasting for 1.5 days 6 days following injection: Redness and Welt at injection site 7 days following injection: swollen lymph node in neck 9 days following injection: rash/hives on chest
Received J&J vaccine on 6/4/21. COVID positive on 2/25/22. Presented to ER on 2/25/22. admitted on 2/25/2022 presented with shortness of breath, hypoxia.  COVID-19 positive on 02/25/2022. S/p remdesivir, ceftriaxone, azithromycin. Remain on dexamethasone      CXR-Bilateral pneumonia or pulmonary edema, on Lasix.  Respiratory discomfort and desaturation every morning when changing from CPAP to nasal cannula.-improving.              Walk test done- 2L O2 with activity. Patient is medically stable to be discharge Home with home O2. Discharged on 3/4/22
Information has been received from a mother concerning her 12 month old daughter with no known allergies who on 12/03/2001 was vaccinated with a dose of varicella vaccine. Concomitant therapy included Advil. On 12/04/2001 the pt developed a fever and irritability. On 12/06/2001 the pt had loose bowels. It also was noted that the pt developed a fever with an unspecified previous immunization. The pt sought unspecified medical attention. Additional info has been requested.
? Principal Problem: Acute on chronic respiratory failure with hypoxia     Overview Note:     Cardiology input:Likely secondary to AECOPD +/- Asthma +/- possible diastolic component of HF Patient with a PFT that showed moderate to severe obstructive disease 2-D echo done 2016 reports an EF of 55-60%, grade 1 diastolic dysfunction, pulmonary hypertension with a PA pressure 31 mmHg Elevated d-dimer 500, age corrected normal, CT PE protocol showed no pulmonary, bibasilar atelectasis   ? COVID-19     Assessment & Plan Note:     83y.o. year old female presents to hospital 12/25 with increasing shortness of breath. The patient was tested for COVID 12/23 and was notified of positive test 12/24 PM. Approximate onset of symptoms of shortness of breath 12/21. Patient was noted to have desaturated to 80% upon EMS arrival however appears stable on 2L O2 /NC at time of my exam. She reports her home O2 is usually 3L/NC due to asthma/COPD, CHF, HTN.  Vaccinated with PFizer 2-4/2021.  CTA : Scattered right-sided pulmonary emboli without evidence of right heart Strain CXR 12/25 atelectasis Patient counseled regarding COVID infection. In view of her stable appearance on baseline O2 requirements I have counseled her regarding Monoclonal antibody and reviewed EUA criteria. She is agreeable with proceeding with treatment. Due to patient not requiring more O2 than baseline O2 requirement she is not a candidate for decadron WRT Covid treatment however will defer to IM if decadron being used as treatment for COPD.     12/27: patient transiently increased to O2 6L, remdesivir initiated with decadron. Rapid return to 2L O2 therefore remdesivir dc'd. Patient on baseline O2 2L with longstanding COPD CTA with PE therefore discharge delayed per IM for anticoagulation S/p MAB
Pt became dizzy as he was leaving, sat in waiting room for 15 minutes, drank water, and ate a lollipop and left feeling "normal". We found that patient had not eaten breakfast which may have contributed to him feeling dizzy.
Fatigue; headache; Pain at injection site; itchiness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Sep2023 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for immunisation. The patient's relevant medical history included: "Essential tremors" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VENLAFAXINE; BUSPAR; ATENOLOL; COLACE. The following information was reported: FATIGUE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2023, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious) with onset 02Sep2023, outcome "recovering", described as "itchiness at injection site". Therapeutic measures were not taken as a result of fatigue, headache, vaccination site pain, vaccination site pruritus.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Patient reports almost two weeks after receiving vaccine developing some redness that appeared like a mosquito bite and then turned into a open area.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Headache, Myalgia, injection site swelling, nausea, fatigue Narrative: N/A
Heart palpitations, PVC's, PAC's, going into A-Fib then cycling into V-Tach.  Went to ER and was hospitalized for 5 days.  Received multiple EKG's, a stress test with contrast, chest x-rays, and an ECHO; all were unremarkable.  Blood work was drawn and also came back as unremarkable.  Was placed on Metoprolol and Flecainide to normalize rhythm and maintain heart rate.  Was placed on a 30 day halter monitor after being released from the hospital.  Several weeks after my hospitalization I started having chest pains and heart palpitations that percussively got worse.  I was hospitalized again for 2-3 days and was diagnosed with anxiety and was prescribed Xanax.  I continue to have severe anxiety related to my cardiac events.  I also continue to have mild/moderate heart palpitations and chest pain.
No additional AE; Temperature -14°C up to-10°C (-14.04C) of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On 20-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T032315, expiration date: 22-SEP-2022, administered for prophylaxis (strength and route of administration were not provided) (product storage error). The vaccine underwent temperature excursion of was -14 Celsius degree (C) up to-10 C (-14.04 C) for 40 minutes. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006350: US-009507513-2208USA006425:
Sore upperarm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in shoulder on 22Jan2021 09:45 (Lot Number: EK9231) as a single dose at the age of 46-year-old for covid-19 immunisation from doctor's office/ urgent care, hospital. Patient's medical history, concomitant medications and prior vaccinations were none. The patient experienced sore upper arm after the first dose. The outcome of event was unknown.
Fever as  high as 102.4 (took Tylenol at 1:30 a.m. on 3/11/2021), shaking chills, elevated heart rate (up to 107) (all overnight on 3/10-11/2021).  Felt sluggish during day of 3/11/2021 with low grade fever, mild chills (took Tylenol one more time at 11:00 a.m. on 3/11/2021).   Rested most of day.  Overnight of 3/11-12/2021 woke up at 4:30 a.m. completely drenched, but no further fever, chills or elevated heart rate.  Have felt fine on 3/12/2021.
Swelling of upper left limb, redness. Patient  was sent for MRI to rule out cellulitis /possible abscess.
sore arm, with a strong headache. at 11:40 A.M. headache reseeded. Arm is still sore.
Sharp stabbing pain when I raise my right arm or move my arm towards the back. It has been over a month & the pain has not gone away. I have also noticed the temperature on my right hand is cold.
Small lump under skin where shot was given. Patient reported some pain after shot was given but then pain dissipated.
Information has been received from a pharmacist concerning a 68 year old female with sulfonamide allergy and a history of uterine cancer, cervical cancer and appendicectomy who on 21-APR-2009 was vaccinated with ZOSTAVAX (Merck) (0.65ml, SQ, lot number: 664029/0196Y). Concomitant therapy included aspirin, VITA C, omega-3 marine triglycerides, vitamins (unspecified), SYNTHROID, alendronate sodium (MSD), chondroitin sulfate sodium (+) glucosamine sulfate and levoglutamide. The pharmacist reported a patient developed a raised, red pruritic and warm area at the site of injection on 23-APR-2009. The size of the area was 1 inch by 3 inch. The patient sought medical attention via pharmacist. No additional information was provided. Additional information has been requested.
Numbness, tingling in L arm. When pt was in observation area, pt had onset of hives and itching. Administered 45 mg BENADRYL PO, monitored vitals and condition of pt. Condition improved. No longer had hives and itching. Pt released back to class.
Fri 10/31/03 and Sat 11/1/03: Extreme fatigue; Sun 11/2/03 Upper resp Sx develop, throat pain (Hx every severe case of pertussis in 2001), much like with pertussis. 11/4/03 physician visit, checked out OK, just head congestion and throat discomfort. No fever or chills. Sx continue thru 11/5-8 (missed work) non-productive cough, head and throat congestion. Resolved now other than continues to have "tight throat" with some discomfort, (Redness and pain at site of injection for 10 days).
accidentally administered double dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (accidentally administered double dose) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 03-Jun-2021, the patient experienced ACCIDENTAL OVERDOSE (accidentally administered double dose). On 03-Jun-2021, ACCIDENTAL OVERDOSE (accidentally administered double dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-207329 (Patient Link).
Hives, swollen throat, swollen joints, red bumps looks like chicken pocks. All day long
Visited ER on 5/3/21 with symptoms of shortness of breath, cough, fatigue, oxygen sats 90-91% on room air, tachycardia (HR 114), BP 182/127
He began with the chills, then developed a fever of 103.2. I was putting cold compresses on him, administering Tylenol, ice water, popsicles. Fever continued to climb to 105. I then pulled out cold packs out of the freezer and a bowl with cold water and ice. I just kept alternating to different parts of his body.  After two hours of "ice bathing", the fever came down to 99.5, and then broke later in the morning.  It was a scary night.
Patient stated that 4 weeks after having received her second Shingrix vaccination that she had an outbreak of shingles.  Patient also reported that she had 2-3 outbreaks following her first dose of Shingrix.
BOOSTER DOSE WAS DUE ON 3/25/22 BUT WAS ADMINISTERED ON 1/23/22
PT RECEIVED COVID VACCINE. WAITED THE REQUIRED 15 MIN OBSERVATION TIME. AFTER THE 15 MINUTES PT STATED  SHE NOTICED SOME LIP SWELLING AND THROAT TIGHTNESS. PATIENT ALERTED STAFF. PT ASSISTED TO SITTING POSITION. PT REFUSED TO LAY DOWN. BP AT 1233 WAS 160/102 HR 99. PT VISABLLY SHAKING. PT STATED NO DIFFICULTY BREATHING. PT ADMINISTERED 25MG IM BENADRYL PER EMERGENCY ORDERS AT 1235. BP BP AT 1238 WAS 150/91 HR 80 SAT 96. CALLED TO PATIENT. NO INCREASED SYMPTOMS. PT WAS TOLD TO STAY TO BE MONITORED FOR FEW HOURS. RECHECKED PT AFTER 15 BP 151/76 HR 90 O2 100% ON RA. AT TIME OF THIS ENTRY PATIENT NO LONGER COMPLAINS OF FURTHER SYMPTOMS AND IS IMPROVING.
My parents do not have a smart phone so they cannot participate in the mobile app to report symptoms. I understand that there may or may not be a link between my mother's symptoms and the vaccine, but I want to make sure that it is looked into.  Three days after dose, my mother woke up with shortness of breath.  Over the last week, the shortness of breath has lingered and she has also had stomach issues.   She has now been hospitalized since yesterday.  These are not uncommon symptoms with her, but she  has definitely been worse since the vaccine.  Assuming she recovers, I am concerned about her taking the second dose, scheduled in two weeks.  Her symptoms are very similar to those of a Physician in an article I read today.
Patient received third booster shot of Pfizer which has not been yet approved by CDC for age group,  Patient has not experienced adverse events per parent.
Patient received the first dose of the SHINGRIX vaccine and experienced redness, soreness and itching for about 4 days following the vaccination.
One day following injection of 9-valent HPV vaccine (1st 2 injections were 4-valent), developed mild tenderness, heat, redness to injection site. Measured 5 cm diameter.
pt devel abdo cramping and diarrhea; pt believes this to be from the Hep B inject;
Patient had Shingrix vaccine, first dose 9/11/2019, second dose 11/12/2019. 3 weeks later she noted onset of rash which was later diagnosed as eczematous dermatitis. She does not have a history of eczema.