chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of unexplained taste, pain and itching. These reactions seemed to disappear after 5mins. Patient reported to returned to normal after 10mins. Patient was monitored for an additional 15mins.
Patient received Moderna COVID vaccine on 2/9/21 and 3/9/21. He lives in adult family home. On 11/28/21, patient is admitted to our facility with acute hypoxic respiratory failure due to COVID-19 pneumonia and acute hemorrhagic cystitis (recurrent issue with multiple prior UTIs). On 12/1/21, patient was discharged back to his adult family home in stable condition.
got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 06-Nov-2020.  This case involves male of an unknown age patient who got the flu (Influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient reported that the only time he got the flu (Influenza) (unknown latency) after getting the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding batch number for the case.
Pityriasis Rosea, ongoing after 6 weeks since start and still growing. Not itchy. No current treatment.
Patient had c/o being fatigued, joint pain, hard lump at injection site that was itchy
My son developed dizziness, nausea and a severe headache with severe pain in his neck and shoulders and injection site.  Treated with Tylenol.  He is unable to attend school today.
GARDASIL 9-12-07, 11-15-07 Patient reports fainting day after receiving GARDASIL. (reported 07/22/2008).
pt recvd vax; pt devel bacterial meningitis w/in 2-3 days pf vax & had sz;
Extra doses, of PEDRIX Hib and Prev 13 were given mistakenly due o non entry of dates in cir.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 28-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and dose were not reported) administered subcutaneously (lot # M042498 expiration date: 17-APR-2018) for prophylaxis. An sterile diluent (lot # and expiration date were unknown) was used to reconstitute the dose. According to the reporter, PROQUAD was exposed to the following temperature excursion: 73 minutes between 6 degrees Fahrenheit (F) and 14 F. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013987.
idiopathic thrombocytopenic purpura 06/14/06-4 page office notes received from MD, patient's pediatrician. Office note for 5/3/06 date of vaccine documented that child missed 15 and 18 month well baby visits. HX included pregnancy complication of beta strep colonization, pregnancy induced HTN, vaginal delivery. Physical exam within normal limits. Visit of 5/31/06 with complaint of rash 5 day duration, parent called office on 5/30/06 with c/o unusual bruising and rash. No fever noted, acting normally appetite and sleep fine, one nosebleed weekend prior to this visit. Physical exam revealed petechiae over torso with various sizes and stages of bruises in unusual places, no active bleeding, respiratory normal, cardiovascular normal, abdomen normal. Liver down 1 cm.  Referred to hospital for lab and ER visit.  08/03/06-ER report received. DC DX: ITP Chief Complaint: low platelet count 3,000, bruises and petechia. HX Present Illness: Red spots and easy bruisability began day before ER visit. Urine test at MD office prior to ER visit negative. CBC showed platelet count 3,000.  Physical Exam: Temp 36.4, HR 168. Pupils equal reactive to light. TMS are clear bilaterally. One petechia on her left anterior tongue. Tonsils non swollen and no erythema or exudate. Skin shows significant amount of bruising on her extremities bilaterally upper and lower as well as on her back and some petechia noted on her truck, particularly on her anterior chest. No signs of active bleeding, no nose bleeding and no eye bleeding. Small petechia on her right eye. Treated with IV therapy and discharged home from ER.
Numbness in upper arm leading to temporary paralysis of fingers on that arm next day. Generalized soreness, shooting joint pains, migraine, stomach pains.
COUGH 3/15/2021 - 3/19/2021 (4 days)    Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary           INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .       Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems            * (Principal) Pneumonia due to COVID-19 virus Yes       Hyperlipidemia Yes       HYPERLIPIDEMIA NEC/NOS;           Hypertension Yes       Obstructive sleep apnea Yes       Sick sinus syndrome (CMS/HCC) Yes       S/p atrial pacing          History of placement of stent in LAD coronary artery Not Applicable       Acute deep vein thrombosis (DVT) of popliteal vein of left lower extremity (CMS/HCC) Yes       Hypoxia Yes               Disposition: discharge to home with home health care CODE STATUS (LOI): Full Code   Consulted Services: none Operative Procedures Performed   _ Active Issues Requiring Follow-up COVID19 pneumonia with acute respiratory insufficiency-Home O2 evaluation completed and the patient requires 1 L of oxygen with rest and 3 L with exertion.  He will be discharged with 5 more days of Decadron to complete a 10-day course.  He received convalescent plasma while hospitalized.  He completed a 5-day course of remdesivir.  He already received his first Covid vaccine.  His second Covid vaccine was rescheduled for April 9 at 1245 at the Hospital.   Acute DVT of the left popliteal vein-started on Eliquis.  Patient will complete 7 days of 10 mg p.o. twice daily then start on 5 mg p.o. twice daily   Coronary artery disease-aspirin was decreased to 81 mg since he was started on Eliquis   Iron deficiency anemia-started on iron replacement.  Recommend further work-up as indicated as an outpatient.  The patient does report he had a colonoscopy 2 years ago which was normal.  He has had intentional weight loss over the past year of 35 pounds so this could be from his dietary changes but discussed outpatient monitoring through his family doctor.
Headache,  Pain, swelling and redness in arm  for a week.  Chills, upset stomach, fever for 2days.  On day 3 pain in armpit that spread down my side and eventually into my breast along with swelling and redness. Everything finally subsided after day 7 of vaccination.
Severe body aches inability to sleep body twitching hallucinations--seeing bugs, flashing lights, animals, hearing things that weren't there, misinterpreting sounds (thinking the rain was a fire in the house) SVT--constant mini-SVT attacks.  Fluttering would last about 10-15 seconds and would reoccur every 2-3 minutes--this lasted for about 8 hours.
pt. c/o dizzness, sweating, fullness in ears post. vax. pt. recovered in 3 mins with water, rest, reassurance & move to cool area of room
Patient complained of CP seen in ER 04/07.  States C/P started 03/27, worsening 04/01 episodes ~1-2min of up on a day-sensation of heat and stabbing pain.  Occured right and left side of chest, tingling in on fingers oc. dizzy.  Feels need to defecate at end of episode.  Vital signs normal, tropomn (-), CXRNI, EKG ni.
muscle spasms; muscle pain; This is a spontaneous report received from a female contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Right arm on 18Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, Muscle spasms and muscle pain on 19Mar2021. The patient reported, she received the Pfizer covid vaccine 18Mar2021 in her right arm. However, as of 19Mar2021, she is having issues on her left side: muscle spasms, muscle pain all down by her neck, her arm. The outcome of events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a Health care worker pharmacy technician refers two patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot # J012515 14-APR-2016) 1 adult dose (dose and route not provided) and RECOMBIVAX HB (lot # J010164 exp 03-FEB-2016) 1 adult dose (dose and route not provided). Health care worker (pharmacy technician) stated that two patients may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Woke up from his nap and limped the rest of the day, complaining that his leg hurt. I called the doctor's office - the nurse said to give him Tylenol and warm compresses. The next day, his leg was red, tender, swollen, hard, and hot. The doctor's office was closed, so I called the ER, who referred me to the state nurse's help desk, who said to give him ibroprofen, cold compresses, and follow up with doctor after the weekend. If it got worse, he needed to go to the ER.
18mo given vax 21MAR94 & spiked temp to 103 & cried fro 10PM 21MAR94 to 3PM;
WOKE UP ON 2/82019 W/ SWOLLEN RT. FOREARM THAT WAS RED, HOT, TENDER, BELOW INJECTION SITE ON RT. DELTOID AND MEDIAL BICEPS AREA. NO TREATMENT OR RX GIVEN. THE SYMPTOMS WENT AWAY BY THE EVENING OF 2/9/2019. ON PE 2/11/19 - THE RT. ARM WAS COMPLETELY NL W/ F.R.O.M. W/O ANY PAIN, NL SENSORY/MOTOR EXAM. P.S: PT. WAS ON AMOXICILLIN 875 MG BID FOR AROM, DX 2/7/19.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 30-OCT-2014, administered by a licensed practical nurse at a medical facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 02-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
In addition to some of the expected symptoms (arm soreness, chills, headache) I experienced the most debilitating sciatica pain from 18-36 hours post shot. I thought  my back condition was worsening but honestly think it was an effect. Nothing I had been using for pain relief helped. I was in agony during that period. Agitated.  At 5AM on 1/29/21, I woke up soaked in sweat and finally had some pain relief. From that point on, my pain returned to my normal level.  I never reported this to any healthcare professional since at the time, I did not think this pain was related (also not sure what could have been done).
This spontaneous report as received from a pharmacist refers to a 64 year old male patient with blood pressure abnormal. On 10-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M020902 for prophylaxis. Concomitant therapies included aspirin (manufacturer unknown) and losartan potassium(COZAAR). On 10-AUG-2017 the patient experienced expired product administered. On AUG-2017 the patient experienced injection site swelling, chills and injection site pain. The outcome of chills, injection site pain and injection site swelling was reported as recovered/resolved. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX. The reporter considered injection site swelling, chills and injection site pain to be related to ZOSTAVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007456:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (treated with Paxlovid from 29Jun2022 to 30Jun2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
it was rpt a pt recv 1dose of varivax 5/13/98 & 5/14/98 pt became sleep & devel a fever 104f & D lasting 4 days.
PREVNAR 13 injection given in left deltoid on 12/3/15. Patient presented today with 4 inch x 2 inch reddened area on left deltoid. Area warm to touch and area hardened with palpation. Physician assessed site. Placed patient on KEFLEX 500mg 4 times per day for 7 days.
suspected Vaccination failure / have shingles in the vaginal area after receiving the second dose of Shingrix; vaginal shingles / have shingles in the vaginal area; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that female patient had vaginal shingles after administration of Shingrix occurred a week ago with no exact date informed. The reporter consented to follow up.  No patient's identifiers, batch number or vaccines expiration date. No vaccination date informed. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation were not provided. The case has been linked with the case US2020AMR197665 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197665:Same reporter
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, "outside the dosing schedule according to the prescribing information"; no further clarifying information was provided. No adverse effects reported. No further details provided. There was no product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008277.
expired Covid vaccine administered to patient      Event details:  o         Vial opened on Wed 2/16 at 3pm; Vial was dated/labelled. Evening nurse was to take the booster, then discard. At the end of shift she refused booster, but vial wasn?t discarded/waisted.  o         Opened vial was refrigerated, dated/initialed.  o         CN/CM were at another clinic due to bad weather. A nurse from another clinic offered to help with vaccinations and gave a booster dose was given to employee from opened vial.  o         Vaccines given Friday 2/18 at 3pm to 3 employees.  o         CM/CN noted there was still one unopened vial left in refrigerator on Monday.
I had COVID-19; I had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 27Nov2022, outcome "recovered" (05Dec2022) and all described as "I had COVID-19".  Clinical information: Patient just came off COVID. Patient had COVID-19 back in 27Nov2022 and was diagnosed clear on 05Dec2022. Stated never had any side-effects from any other vaccines of Pfizer was asking if one case still get vaccinated even though you have just gone through COVID-19, 5 days later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369378 same patient/drug, different AE/dose;
Head and body aches, felt weak, not sick to my stomach, but very weak.  Heavy sweats at night.  Difficulty sleeping.  Hallucinatory gruesome dreams.  This was basically one very bad day -- the day after the vaccination, which was my second vaccination.  The night sweats and nightmares went on for 4-5 nights after the vaccination.  Everything is OK now though.
Occipital headaches (worse when lying down), started within a week of vaccination. Minimal relief with analgesics. Never had headaches before. Unable to sleep prolonged.
Nurse inadvertently gave this 13 year old the Pediatric Pfizer formulation. He should have had the age 12 and older formulation.
My symptoms were severe myalgias, fatigue, moderate cough, some chills no fever. My doctor treated me with PAXLOVID and all symptoms have gradually improved.
Patient had severe case of gastritis (had diarrhea for 6 days), headache, fatigue and nausea.
Patient received his first SHINGRIX vaccination at pharmacy on 3 /26 /2018. Patient began to have pain along the left side of his waist on 5/3/2018. Pain progressed and was having trouble sleeping because of it. He scheduled an appointment with his PCP for 5/8/2018 at which time a rash was identified along the left waist area. Patient was diagnosed with Shingles on 5/8/2018. Patient did receive a ZOSTAVAX in the past  on 6/21/2012.
This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX (batch number BN9L9, expiry date 30th March 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain. On an unknown date, the outcome of the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain were recovered/resolved. The reporter considered the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on right deltoid. The batch number reported for SHINGRIX (BN919), did not exist and was updated as BN9L9, as per sales database.
Severe leg pain, I could barely walk for 3 days.  Pain was about a number 8 on a scale of 1 to 10. It started about 3 hours after the vaccine.  I also had extreme fatigue and weakness.
The evening after getting the vaccine I developed a severe headache, fever, and rigors. Headache resolved within 24 hrs after which I was able to rest and recover, while having a low grade fever and minor fever on day 2 (48hrs). Total recovery took 3 days. The reason for reporting is that this headache was unusually severe and prevented me from sleeping, delaying recovery.
Swollen lump at injection site showed up after 9 days post injection.  Started as a small red circle and grew all day.  Hot & itchy. My arm aches.
2nd dose received beyond 36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J2121A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.