chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, warm, raised area at injection site with itching.  Area approximately 3 inches in diameter.  Ice pack given by pharmacist to apply to area on 8-14-15. Pt took Benadryl hour later. Gave her another ice pack at 1:45pm and a box of diphenhydramine at no cost.
brought to ED with increasing dyspnea and hypoxia; previously has tested positive for COVID; was using O2 at home with O2 sats in 70s on 2L/min; confused; poor appetite; admitted to hospital; placed on BiPAP; treated with Baricitinib; respiratory status worsened requiring intubation; transferred to ICU; family made pt a DNR; pt experienced asystole and passed away in the hospital
Patient less than 65 years of age was mistakenly given Fluad. No adverse events reported by patient
Cholestasis and Pneumonitis. Improved over 2 months after course of steroids. Noted to be jaundiced about 7 days after vaccine.  Liver biopsy  demonstrated likely drug injury superimposed on steatohepatitis. Then had worsening dyspnea requiring admission on 2/21/21 for 2 days.
There is a small spot approx 3 mm circle on arm where she states flu vaccine was given on 11-16-05, that is flesh colored or lack of pigmentation. She states it was not there prior to the flu shot. It is flat and doesn't itch or hurts. No treatment received.
PATIENT REPORTED PAIN, SWELLING, ITCHING, REDNESS, AND INDURATION AT THE INJECTION SITE. THE SYMPTOMS STARTED APPROXIMATEY 5 HOURS AFTER VACCINE ADMINISTRATION AND PERSISTED DURING 48 HOURS. THE PATIENT TOOK ACETAMINOPHEN AND APPLIED ICE AT THE INJECTION SITE FOR THE MANAGEMENT OF THE SYMPTOMS. THE SAME PRESENTATION RESTARED AFTER 10 DAYS OF VACCINE ADMINISTRATION.
feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  The patient slept for a day and she was fine.
Headache, chills, feverish without fever, tiredness, muscle pain, joint pain, nausea, vomiting, swollen throat, diarrhea
After about 13 minutes, patient stated that he started to have blurry vision about 80% of it was gone, he felt nauseous, and starting to sweat a lot. Then patient threw up a little bit. After that we gave gave him some water and glucose tablets. Patient hasn't eaten all day either.
Information has been received from the Merck Pregnancy Registry, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with not pertinent medical history or drug reactions/allergies who on 15-SEP-2009 and 24-NOV-2009 was vaccinated with a first and a second dose of GARDASIL (Lot # not provided). There was no concomitant medication. On 23-MAR-2010, the patient received her third dose of GARDASIL (Lot # 662299/1099Y, expiration date on 17-APR-2010) and was 3 weeks and 3 days pregnant at that time. The last menstrual period was on 27-FEB-2010 and the estimated delivery date was on 04-DEC-2010. On 07-MAY-2010 a red blood cell count was performed and the result was 3.72 (slightly anemic). On 17-MAY-2010 a urinalysis was performed and the result was normal. No adverse event was reported. This was originally reported by a nurse. Follow up information has been received from the physician who confirmed that the patient received the third dose of GARDASIL on 23-MAR-2010 (Lot # 662299/1099Y). On 28-MAY-2010, an ultrasound was performed which confirmed the pregnancy, size and date (12.9 weeks of pregnancy on that date). On 24-JUN-2010, a Maternal Serum Alpha-Fetoprotein (MSAFP) was performed without any result available. It was also reported the patient's obstetric history. The patient had had one previous pregnancy and full term delivery at 38 weeks from LMP without birth defects. Follow up information has been received via a Pregnancy Questionnaire from an obstetrician who reported that the patient underwent an ultrasound on 28-MAY-2010 (which showed 12.9 weeks), 02-JUN-2010, at 13 week from LMP which was normal, on 07-JUL-2010 (which showed 20.5 weeks from LMP) and on 06-NOV-2010 at 32.4 weeks from LMP. On 27-SEP-2010, the patient was prescribed with ferrous sulfate 325 mg, QD for anemia until 03-MAR-2011. At 36 weeks from LMP, on 27-NOV-2010 the patient's group B streptococcus (GBS) was positive for and treated during labor. On 05-DEC-2010 at 40.2 weeks from LMP the patient delivered a normal male baby, and no other complications or abnormalities. The baby's weight was 6 pounds 12 oz and height was 19, apgar score results: 8/9 in with no congenital abnormalities. Additional information is not expected.
Severe flu at 7 pm approx, feeling of being sucker punched upon standing; severe aches throughout body(especially head and neck area), chills, sweats, mild nausea, next day same through midday  of following day-to reach with injection site arm was extremely difficult to do.
Large localized reaction with redness on (L) arm at ADACEL injection site and below.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with 25 - 50 lesions and a slight fever.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-OCT-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had temperature excursions for 480 hours with lowest recorded temperature of 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved and no adverse events were reported. This is one of several cases received from the same reporter. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 66 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "vitamin D deficiency" (unspecified if ongoing), notes: Patient had started oral vitamin D; "vitamin B12 deficiency" (unspecified if ongoing); "unknown cardiac condition and patient reported heart was weak" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: DYSPNOEA (non-serious), outcome "recovering", described as "prior to the start of therapy shortness of breath after receiving second dose of Covid-19 vaccination". Additional information: Cycle: Ibrance 125mg capsule by mouth daily for 21 days on and 7 days off in conjunction with anastrozole by mouth daily as prescribed by MD. Patient reported prior to the start of therapy shortness of breath after receiving second dose of COVID 19 vaccination, unchanged after the start of therapy. Reported unknown heart condition, previously reported, and remains unchanged, unknown cardiac condition and patient reported heart was weak and was pending to follow up with cardiologist. Also reported vitamin D and vitamin B12 deficiency. Primary care MD has prescribed patient with oral vitamin D to take once week and cyanocobalamin injection to be given at MD office. Patient had started oral vitamin D, shortness of breath has improved and patient was able to walk a lit bit. MD was aware. Other Relevant History, Including Pre-existing Medical Conditions, reported to CVS/Caremark by: Patient/Caregiver. Follow-up attempts completed. No further information is expected.
Patient reports that she vomited within 10 minutes of getting the vaccine and had nausea for the remainder of the day. After 2 hours, she developed a fever of 102 degrees. These symptoms resolved later that evening. She had a PPD on 7/26/17 and a Tdap on 5/18/17. She describes getting anxious prior to getting vaccines. In the past, she has had muscle pain following vaccination. This is her first vaccine reaction with nausea/vomiting and fever. Patient reported that she felt better on 8/1/2017 and did not need to see a doctor.
After receiving injection, I walked out of the pharmacy, opened my car door and sad down in the driver's seat, turned on the ignition and experienced a raging pain in the mid to lower mid portion  of my back. I had to stiffen up and scream to bear the pain. The pain began to ease a little, then returned. I cried out again and knew I needed to get help. The pain eased up again a little. I got out of the car and walked carefully back into the pharmacy to the nurse. I sat and waited for an hour. The pain subsided. A family member came, followed me driving home, and then took me to Patient First. No pulmonary embolism or other obvious adverse symptoms. Diagnosed with muscle spasm. Am having mild aches in arm and head at 10 pm. Otherwise, no particular symptom.
Red raised area/blisterlike area appeared under varicella vaccine 5 minutes after vaccine given.  Pt given Attarax with instructions to return if area does not decrease in size or gets larger in size.
Patient admitted after syncopal episode and fall.  At time of admission, no respiratory needs, however did require supplemental O2 during current hospitalization.  Positive COVID-19 result with admission, >14 days post vaccine completion.
Narrative: COVID infections following completion of COVID vaccine series 05/26/21 COVID vaccine dose #1 (J&J) 07/03/21 Pt presents to screening reporting cough, congestion, and shortness of breath that started Monday (06/28)l; states he had close exposure to someone COVID positive; COVID POSITIVE 08/01/21 Pt reports chills, cough, fatigue, fever, muscle pain, runny nose, congestion, shortness of breath 08/03/21 Pt reports cough and shortness of breath upon exertion, improving 08/05/21 Pt is clinically resolved; reports fatigue and cough: using cough syrup 08/13/21 Pt presents to screening for retesting for work; denies symptoms and reports close exposure to COVID positive person; COVID POSITIVE 08/14/21 Pt reports chills, cough, occasional diarrhea, fatigue, headache, muscle pain, congestion, SOB upon exertion 08/16/21 Pt reports feeling fatigue, SOB, productive cough with clear sputum; he reports cough is worsening
Leaned to left for 3-4 days with no fever and no pain. Stared 3 or 4 hours, post vax. Mother states child's body and head just leaned to the left. Was able to straighten without pain from movement.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Fatigue, diaphoresis, flu-like illness Additionally, patient refusing second COVID-19 vaccine shot
Pt feeling overheated 2 hours post vax, followed by several days of fever and malaise. No symptoms at injection site. Suspected coincidental illness.
Approximately 12 hours after the 2nd COVID shot, patient began experiencing random erections that came on every 30 minutes and lasted for 5 minutes each. Each erection got larger and harder as time went on. This went on for approximately 8 hours. The symptom didn't subside until the patient was able to have sexual relations with his wife.
Information has been received from a physician concerning a patient (age and gender unknown) who in approximately April 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In approximately April 2007, the patient experienced patient came down with shingles after receiving Zostavax (Oka/Merck).  Unspecified medial attention was sought.  No product quality complaint.  Additional information has been requested.
pt recv vax 8OCT96 & 9OCT96 pt devel a h/a, nausea & sleepiness;pt has not yet recovered;
Information has been received from a 61 year old female with asthma bronchial and no drug reaction/allergies who on approximately 18-JUL-2010, ("6 months and 3 weeks ago" as reported) was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously, lot # not reported. There was no concomitant medication. On approximately 18-JUL-2010 (about "6 months and 3 weeks ago as reported") the patient experienced joint pain while on ZOSTAVAX (Merck). The patient sought an unspecified medical attention, no treatment was given for this adverse event, and the adverse event did not improve, the patient had not recovered at the time of reporting. No lab diagnostics study was performed. Follow up information was received from the physician, who stated "have not used it" and "NA". No further information is available.
Pregnant due November 19th 2021, loss of hearing in right ear with ringing as well. No wax build up or anything that can be seen.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 20-APR-2015, the patients were vaccinated with improperly stored of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed fever, chills and had a syncopal episode during the night after receiving the PNEUMOVAX.
p/vax pt slumped over & fell on floor;loss consciousness 5 sec;awoke c/o h/a;hit head on floor;vitals BP 130/70, P80 regular;vasovagal rxn dx;
The pt experienced inconsolable crying for 3 hours within 1 hour of vax.
3MAR95 mtr states pt had fever 102.8 on 28FEB & 1MAR even though used APAP q 4hrs; states high pitched cry all noc 28FEB, w/episodes 28FEB & 1MAR of twitching of extremities & eyes rolling back w/blank stares;
Redness at injection site.; Slight itch; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809; Expiration Date: Unknown) via an unspecified route of administration in Arm Left on 04Feb2021 12:30 as single dose for COVID-19 immunization. The patient medical history included Cardiac and penicillin allergy. The concomitant medication included atorvastatin. The patient experienced redness at injection site and slight itch on 05Feb2021. The patient had not received any other treatments for adverse events. The patient was not tested positive since the vaccination. The outcome of events was recovering.
Felt really bad/felt worse for about 24 hours; fever for about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours). On 23-Aug-2021, FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were  not reported. Treatment information include ibuprofen.   This case was linked to MOD-2021-341011 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated subcutaneously with dose 1, 0.5 (Merck) VARIVAX (Lot # not reported) in 1999, the second 0.5 ml dose of (Merck) VARIVAX (Lot # not reported) SQ in 2009 and inadvertently received a third 0.5 ml dose of (Merck) VARIVAX (Lot # not reported) SQ on 16-JUL-2012. No adverse effect was reported. Additional information has been requested.
Child developed high grade fever approximately 8 hours after vaccination. Fever peaked to 103.5 F. Improved after treatment with Ibuprofen after 2 days.
Achy at first and chills.  Headache and dizziness followed with fever of 102.1 by 8:00 PM.  Treatment with Tylenol was not effective.  Advil seemed to alleviate the fever and achiness somewhat.  It is now more than 48 hours later and I am still dizzy and extremely fatigued.
No additional AE; improperly stored temperature excursion / VARlVAX (-50°C to -15°C) (10.8 °C); DOB: 10/12/2020; This spontaneous report was received from a medical assistant concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated (inappropriate age at vaccine administration) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S022755 and expiration date 22-JUL-2021 were verified as valid) (formulation, concentration, vaccination schemes frequency, route of administration, anatomical site of vaccination were not reported) for prophylaxis. The vaccine was exposed to a temperature excursion as it was improperly stored at 10.8 Centigrade degrees for 1 hour, 45 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 50 Centigrade degrees to minus 15 Centigrade degrees. There was no previous temperature excursion. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003927: US-009507513-2105USA004015: US-009507513-2106USA001126:
Some swelling & redness. Some itching. It is still that way as of right now, 1/22/2021, 4:30 pm.
I became extremely tired.  I also got a bit dizzy and HAD to lay down for a few minutes.  The dizziness stopped but I had to sit down about 15 minutes later and sat for about an hour to rest.  I was fatigued the rest of the day.  The second day after the vaccine I was also fatigued but could keep my regular schedule.
A report has been received from a Health Professional who is a patient herself of 39 years old, who had been receiving FLUMIST. FLUMIST started on 09-Sep-2013. The patient experienced fever, chills, bronchitis and congestion which started on 09-Sep-2013. FLUMIST was discontinued on 09-Sep-2013. The patient recovered from the event of fever, chills, bronchitis, and congestion on 23-Sep-2013. The report was considered to be non-serious.
Severe chills, fever, nausea, diarrhea, heart racing, dizziness, jaundice, severe headache, pain behind eyes.
ache in the arm with first dose; felt like mild tetanus; stiff arm for a couple of hours; s is a spontaneous report from a contactable consumer.   A 68-years-old male patient received bnt162b2 (BNT162B2), at the age of 68 years old, dose 1 via an unspecified route of administration, in left arm on 02Mar2021 at 14:30 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing type 2 diabetes mellitus he was diagnosed almost 30 years ago , plague plague shot a long time ago the black plague shots, states it kicked the heck out of him, had a low grade case of the black plague and it made him feel pretty miserable. He got it over seas, when he went to Africa. It was so long ago, over 15 years ago. Concomitant medication(s) included insulin degludec (TRESIBA) taken for type 2 diabetes mellitus from 2015 and ongoing; semaglutide (OZEMPIC) taken for type 2 diabetes mellitus from 2017 and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication from an unspecified start date about 5 years agoand ongoing.  Patient states that after his first shot he felt pretty good, it didn't bother him, felt like mild tetanus and a stiff arm for a couple of hours. Ache in his arm with the first dose, patient confirms started the day after he got the first dose, but only lasted a few hours. Patient clarifies his muscles aches recovered 80-90%, states it is fading away, it is more like he is just worn out. Patient states that his hips were aching, but that is gone now. The outcome of the remaining events was unknown.
EPILEPSY, UNSPECIFIED 1/26/2023 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/28/2023 ALTERED MENTAL STATUS, UNSPECIFIED EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 2/28/2023 METABOLIC ENCEPHALOPATHY EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W KETOACIDOSIS ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W KETOACIDOSIS EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W HYPERGLYCEMIA ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W HYPERGLYCEMIA EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS