chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; temperature up to 100.8 degrees; This is a spontaneous report received from a contactable reporter(s) (Other HCP) received via COVID-19 Adverse Event Self-Reporting Solution. The reporter is the patient. A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 07:15 (Lot number: EW0151) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ITP" (ongoing), notes: about 10 yrs ago, Pertinent details : Platelets less than 150,000 but greater than 100,000; "hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Seasonal allergies" (ongoing); "Partial thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroidectomy (ongoing); ROSUVASTATIN taken for hypercholesterolaemia (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITIN [CLARITHROMYCIN]; CETIRIZINE taken for seasonal allergy (ongoing); LORATADINE taken for seasonal allergy (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: EK9231, administration time: 16:00 PM, vaccine location: Left arm), administration date: 30Dec2020, when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, lot number: EL8982, administration time: 14:00PM, vaccine location: Left arm), administration date: 22Jan2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Oct2021 19:00, outcome "recovered" (Oct2021), described as "Chills"; PYREXIA (non-serious) with onset 08Oct2021 19:00, outcome "recovered" (Oct2021), described as "temperature up to 100.8 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia.  Additional information: Vaccine facility type was reported as Hospital. Patient did not receive other vaccine in four weeks. Events started 12 hours after injection. Patient was not tested COVID post vaccination. Patient had no known allergies. The product had a causal effect to the adverse event. Prior vaccinations was reported as none.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 10OCT94 & arm felt warm p/1st day & was hurting; 28OCT94 sore arm could not get arm above head due to soreness; 15NOV94 seen by MD due to arm pain; 9DEC94 nerves are twitching & sore to touch, knot; diff breathing;
faintness in the morning; Skin itching; can't sleep at night tossing and turning all night; stomach upset; low grade fever; bruises on leg form scratching; hands burning; This is a spontaneous report from a contactable consumer (patient).  An adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 13:00 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunization.  Medical history included hypertension and glaucoma. Concomitant medications included losartan, amlodipine, and latanoprost, netarsudil mesilate (ROCKLATAN). On 26Mar2021 06:00, the patient experienced skin itching, faintness in the morning, can't sleep at night tossing and turning all night, stomach upset, low grade fever, bruises on leg form scratching, hands burning. Still experiencing some of the adverse events. The outcome of events was reported as recovering. Patient received shot of Benadryl and was prescribed prednisone as treatment.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Swelling of right arm, temp 99.5, numbness in fingertips.  Time: 5:30 PM. Physician visit on 10/4/10 and treated with hydrocodone/apap 5/500 mg for pain
My Father had a hemorrhagic stroke.  He passed away 13 days after receiving the second Modern?s vaccine.
This case was reported by a consumer via programs and described the occurrence of cold in a adult female patient who received HAVRIX 1440. Co-suspect products included ENGERIX B adult and SHINGRIX. On an unknown date, the patient received HAVRIX 1440 1 ml, ENGERIX B adult 1 ml and SHINGRIX .5 ml. On an unknown date, unknown after receiving HAVRIX 1440 and ENGERIX B adult and less than a year after receiving SHINGRIX, the patient experienced cold. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to HAVRIX 1440, ENGERIX B adult and SHINGRIX. Additional details were reported as follows: This case was received from the consumer via the program. The age at vaccination was not reported. The patient mentioned at the time of reporting that she had a cold. The reporter did not provide any additional information. The event did not include product complaint. The indication for product used was unknown.
On 10/12. I had soreness on my left arm. They next day the soreness got worse, and I had range of motion issues. On 10/14. 10/15, 10/16, the pain was so bad, I was unable to move my arm at all. On 10/17 to present, the pain has been gradually decreasing and I am getting my range of motion back. I have been taking Aleve around the clock since the pain started. When the pain was extremely bad, I would take Tylenol in between. I also iced my arm from 10/14-10/18. Today, I almost have my entire range of motion back. It is a little sore, but nothing compared to what it initially was
Rash on back AM following 2nd flu vaccine given. Spread to involve chest and inner arms. Described as hives. Afebrile. Seems fussy, uncomfortable. Hives confirmed at Dr. visit 2/19/15 at 1710.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. The nurse is reporting that an unknown number of patients may have been administered GARDASIL (lot #, expiry, dose and route not reported) and RECOMBIVAX HB (lot #, expiry, dose and route not reported) since August 2012 that had been improperly stored. No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. It was unknown if the patients had sought medical attention. Additional information has been requested.
cramps; fever; chills; headache; patient received 0.07 ml dose; abdominal pain; vomiting; sore arm; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2021SA357151 (CLUSTER).  This case involves an unknown demographic patient (unknown age and unknown gender) patient who experienced fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) and patient received 0.07 ml dose (underdose), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.07 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AB, expiry date- 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "2 patient had severe reactions. One had abdominal pain, cramps, vomiting and a sore arm. The other patient had those symptoms and also fever, chills and headache".  At time of reporting, the outcome was unknown for the events.
Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 4/22/2023  PRESENTING PROBLEM: Acute hypoxemic respiratory failure (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 85 y.o. with severe COPD on hospice who was found down this morning unresponsive by his family and brought into hospital where he was intubated and in shock. Labs consistent with shock liver, acute kidney injury, COVID positive. Difficulty with maintaining appropriate ventilation due to the severity of the COPD and auto-PEEP. Transferred to alternate facility.    After arrival his family reported that he did not want life support and did not want any invasive testing, he would be upset if he knew this was done. We discussed that with his worsening shock, severe underlying lung disease and multi organ system failure that this would not be a quick turnaround and he would require invasive monitoring and access to appropriately manage him. Upon further discussion the family (daughter and son) reported what we were doing was not consistent with his wishes and they wanted to transition to comfort care. There is one biologic child who was present, additional step-children who were not present, were in agreement. His wishes were well known to the family. Will plan to transition to comfort care measures. Anticipate initiating comfort care order set, no further lab studies, morphine GTT and prn Ativan, will plan to extubate with family at bedside. Date of Death: 4/22/23; Time of Death:  8:54 PM. Preliminary Cause of Death: COPD (chronic obstructive pulmonary disease) (HCC).
pt recv vax 7NOV97 & 8NOV97 pt exp herpes zoster;
Pt recvd vax 1DEC92 & 1/2 hr p/vax exp dizziness & sl nausea; felt lightheaded upon standing from a sitting position;
Developing angina/chest pains, continued to get worse of the course of 4 days. Woke up in middle of night with crushing chest pain/short of breath. Indicated participant had received heart attack. Abnormal tachycardia & dysautonomia.
Patient developed swelling and redness and extreme pain in left upper arm at the site of vaccination. Persistent for 10 days. She also developed a red rash on chest.
Information has been received from a registered nurse (RN) concerning a 12-year-old patient who on 03-AUG-2005 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Lot# 647242/0895N) and on an unspecified date in August 2005 with a second dose of varicella virus vaccine live. The RN reported that on 15-AUG-2005 the patient developed a rash. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Syncopal episode lasting 5 seconds. Observed by provider on site. No intervention required.
Inpatient on 6/13/2022 [negative admission test] Rapid PCR on 6/26/22 = positive Repeat PCR on 6/26/2022 = positive Testing to facilitate transfer.  Staff state patient has been asymptomatic.  Patient underwent general anesthesia on 6/16/2022 - bronchoscopy for valve removal Booster x1 on 4/22/2022 (too early for #2)
COVID breakthrough. Patient developed fever of 103 on 9/21/21 with labored breathing while hospitalized for other reasons. They tested positive on 9/22/21.
Nausea, and body shaking started 2 minutes after injection; chills, fever, severe headache, muscle aches started after
SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT Initial unsolicited report received from a consumer (patient) on 06 April 2016. This case involves 14-year-old male patient who was vaccinated with a dose of MENACTRA (batch number and site of administration not reported) intramuscularly, dose of TDAP (batch number, route and site of administration not reported), a dose of HEPATITIS A VACCINE (batch number, route and site of administration not reported) and dose of HEPATITIS B VACCINE (batch number, route and site of administration not reported) on an unspecified date in 2006. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2006, same day following the vaccination, the patient's arm was sore. seven days later, the patient was diagnosed with shingles. The patient felt sick and diagnosed with diabetes on an unspecified date. The patient required ER/doctor visit. Laboratory data and corrective treatment were not reported. The patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event diabetes. List of documents held by sender: none.; Sender's Comments: Diabetes mellitus, Pain in extremity and Herpes zoster are unlisted for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is not compatible with the role of the vaccine. This case is not sufficiently documented. Additional information including time to onset after vaccination, previous medical history particularly chicken pox, concomitant medications, and immune status at the time of vaccination is needed to further assess this case. Based on the available information, the role of vaccine cannot be assessed.
DOSE ADMINISTERED AFTER ACCEPTABLE TIME FRAME AFTER VIAL PUNCTURE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dose administered after acceptable time frame after vial puncture, and poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered after acceptable time frame after vial puncture and poor quality vaccine administered was not reported. This report was non-serious.
49y.o. female presenting with palpitations, chest pressure. Upon presentation she had significant lactic acidosis 7.0. She also tested positive for COVID, however she was recently positive less than 2 months ago, CT chest was negative for PE as well as any signs of viral pneumonia. She was given large fluid resuscitation in the EC. Her lactic acid improved to normal levels. Additionally, cardiac work-up including troponin and EKG was negative. She had some bacteria on UA, however no urinary symptoms, fever, leukocytosis. Antibiotics were not given. By the following day, she had improved almost completely with fluid resuscitation alone. Noted procalcitonin 0.9, however without signs of active infection she was managed expectantly. She was then stable for discharge home with instructions to maintain aggressive oral hydration. She was additionally given information on isolating for positive COVID test. I attempted to contact microbiology lab to obtain cycle threshold from her positive test, however I was unable to contact them. Patient was recommended for continued COVID isolation at home with repeat testing. If she has 2 consecutive negative rapid tests, this is reassuring that her PCR was a hold over from previous positive infection and isolation can be successfully removed. On a final note, patient asked for appetite stimulant. She stated that cannabis-derived appetite stimulants were not successful for her in the past including Marinol. Main barrier to her nutrition is her lack of taste and smell which is secondary to previous chemotherapy. She was given a trial of low-dose Remeron. Patient was discharged home in stable condition with no restrictions on diet or activity to continue medications and follow up with physicians as listed below.
headaches; This is a spontaneous report from a contactable physician. An 81-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 02Feb2021 16:00 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 12Jan2021 16:00 as single dose for covid-19 immunization. Patient medical history included known allergies: Penicillin and concomitant medications were not reported. No immediate effect for 2 days. The patient began to have headaches and now severe headaches lasting up to 8 hours at a time and persistent on 05Feb2021 14:00. No other vaccine in four weeks. No treatment given for the adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Unknowingly pregnant at time of vaccination. Had a miscarriage one week later. Due on October 12.
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. Between 24-Sep-2012 and 27-Sep-2012 (exact date of vaccination was unspecified) the patient received AFLURIA (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The injection site reaction did not start to resolve quickly (stayed red, hot and hard longer, but no exact time frame provided). The patient sought medical attention. The event outcome was recovering.
HEART ARRHYTHMIA; This spontaneous report received from a patient concerned a patient of unspecified age and sex of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose,1 total and start therapy date were not reported  for prophylactic vaccination (Dose number in series was 1).The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart arrhythmia "I've developed it too." (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211265817-Covid-19 vaccine ad26.cov2.s-Heart arrhythmia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
first dose of Shingrix on August 11th, 2019 / not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine which led to incomplete course of vaccination. The reporter did not provide more information. The reporter did not consent to follow up.
arm pain at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case. The patient received Shingrix in left arm.   The patient experienced arm pain at the site of injection that had persisted. The reporter did not consent to follow-up. This case has been linked to US2019168251, reported by the same reporter.
Vaccines given on Thurs and leg seemed painful all wknd. Went to bed at 8:30PM Sunday awoke 11PM having trouble going to sleep. She was up all night , would cry and scream out loud. Didn't seem to want leg touched. Couldn't walk when she got up the next morning. Toward noon started limping. R knee swollen, no red. Child hot to touch all night. Called and came in Monday afternoon.
Patient was admitted to Hospital on 11/25/2021 for COVID related symptoms. This is considered a breakthrough case.
3 days after receiving his 4 month booster vaccines patient started having seizures which have resulted in several hospitalizations, numerous medications and he is still currently having 1-3 seizures a week which have been very difficult to control  05/8/09 ED records received for DOS 10/1/07-10//2/07 FINAL DIGANOSIS: Seizure Lip smacking, staring, unaware of surroundings. Later head turned to right, eyes deviated to right, pale, lip smacking. Later head deviated to left, eyes to left, stiffened.  PE - Irritable but easy to console, Ant fontanel opened but slightly small, slightly unsteady on sitting.
Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and my daughter was driving. My daughter asked me why I was stretching my mouth. I did not know this was happening and my daughter said she was taking me to the ER. We called the 24 hour nurse. Two days before I did notice that I got a headache in the evening and it was still there all the next day. I just thought I was coming down with a cold. The headache was still present on the day of the facial symptoms. It was mostly on the left side of my head. The left side of my face is effected by Bells Palsy. I still had mild headaches for two weeks. I still have problems with memory and speech after eight weeks. I feel like I have some good days which are better than others. I have problems with dry eye and balance. The ER doctors diagnosed Bells Palsy. I have been unable to work for eight weeks so far.
I had urinary bleeding which resulted 2 hours later in retention, blockage of the urinary canal. I went to the emergency room and through the use of catheter they flushed the urethra until they got all the blood out. on Jan 21 they did a procedure and found the blood vessel that burst in the prostate gland and cauterized it.
About 30 seconds after receiving the second shot (FLUZONE HD), patient claimed to be dizzy and sweating. She stayed seated with her head between her knees for 5-10 minutes before saying that she felt better and the dizziness had stopped. Patient stood up and walked away under her own power, denying any need for food water or other treatment. No treatment was needed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On 29-JUL-2014 the patient was vaccinated with 0.5ml expired dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-JUL-2014) intramuscularly. No adverse effect was reported. Additional information has been requested.