chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 10:30 as dose 3 (booster), single at the age of 67 years, in right arm 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 and concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment: Paxlovid, treatment start date: 07Sep2022 and stop date: Sep2022. Patient was taking Paxlovid 300mg Nirmatrelvir 100mg Ritonavir for covid 19.
Patient received Vaccine- while in observation area, patient complained of dizziness and Passed out. Patient almost immediately woke up-and was diaphoretic and pale. MD stat was called, Patient completed observation on gurney in presence of RN. Vital signs taken and MD assessed patient. Patient was ok to go to home.
pt recv vax  19MAY & 29MAY pt devel weakness in legs;30MAY pt had numbness from knee down;1JUN pt was dx w/GBS;
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Concurrent conditions or medical history were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose number, anatomical location, route, lot number and expiration date were not reported). On an unknown date, the patient had an antibody test that was negative, the patient sought for medical attention but was not treated for the event.  The patient was not recovered from antibody test negative at the tine of the report. Additional information has been requested.
"Fully vaccinated patient who admitted to the hospital on 09/25/21 with positive COVID test.  Patient had recently discharged from facility on 09/23/21 after a repeat pneumothorax and returned on 09/25/21 due to weakness and inability to care for self and upon admission testing was positive for COVID.  Discharge summary from provider below:  "42/F with long-standing history of COPD and recurrent pneumothorax for which she L partial lobectomy in 2015 and VATS/pleurodesis recently 9/2021.  Pt had just been in our ICU August 2021 for respiratory failure due to COPD Exacerbation and was on the vent for 12 days. Unfortunately, she contracted COVID-19 PNA despite being fully vaccinated and was admitted to the hospital for that reason. We believe she had an anaphylactic shock and acute respiratory failure/bronchospasm due to Regeneron that caused her cardiac arrest with prolonged resuscitation 9/26/21. She developed multi-organ failure -- shock liver and aneuric renal failure thereafter. She was profoundly hypotensive, acidotic and hyperkalemic despite HD/CRRT and bicarb infusion. She had limited ventilatory compensation /difficult to ventilate because of underlying COPD with possible bronchospasm from anaphylaxis.  She had coded multiple times in the ICU this am and family decided to stop CPR during the last code"  Pharmacy has submitted a report to the FDA.
Information has been received from a registered nurse concerning a 15 month old female with no drug reactions allergies and a history of low birth weight and failure to thrive (starting at 6 months) who on  4/25/2006 was vaccinated SC with a 0.5ml dose of MMR II (lot 650104/0828R). there was no concomitant medication. On 4/30/06 the pt developed some behavior changes. The mother reported to the nurse that the child appeared panic stricken, clingy, lost verbal communication, and was irritated with anything too close to her face. She also stopped walking. The child was seen by a neurologist and developmental pediatrician. An EEG and MRI were normal. The pt recovered on 8/28/06. There was no product quality complaint. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
I am in the COVID vaccine monitoring program and was called after my latest V-Safe report. I had 1-2 miscarriages this spring and had a D&C in June 2021. The V-Safe called asked me to file a report for CDC tracking. I was not pregnant at the time of my COVID vaccines (Dec 2020, Jan 2021), so unlikely to be related. But wanted to do what was asked and file the report. I am also an ob-gyn.
Systemic: Joint Pain-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.). Additional details: Patient's wife reported his shoulder is stiff/muscles tight. Denied pain but unable to move above 90 degrees.
Narrative:  At  1004, c/o feeling hot & itchy all over. VS HR=81, BP 177/108 Discussed option of taking Cetirizine 10mg and reports he would like the med. At 1006, HR=81, BP 137/99 At 1012, Cetirizine given. Patient informed he will be monitored for another 30min. At 1014, Declined going to ED w/ED staff. At 1018,  VS HR=81, BP 138/100, RR=16 Still reports feeling itchy &hot. No c/o SOB - respirations 16. Informed medication will take 30min. At 1028, Stated feeling worse, would like to go to ED. Itching worse, visibly scratching. No c/o labored breathing but taking deep breaths. VS HR=76, BP 132/94. ED contacted 2nd time. Above per monitor RN.
Suspected vaccination failure; Never had shingles UNTILL after, I got the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient stated that the patient never had shingles until got the shot. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not provided.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I'll tell you my experience. I got sick right after receiving my second shot in March of 2000 from FAV044. I consider myself lucky because the only permanent damage done was to my parotid gland. The vaccine caused my immune system to turn on itself and attack healthy cells. I'll have an uncomfortable lump below my right ear lobe for the rest of my life. The joint pain and chronic fatigue went away after a couple of years and thousands of dollars out of my own pocket to pay for a homeopath that knew effective treatments for people that have been poisoned by such things.
Red, swollen, itchy rash appeared 24 hours after injection. Pt presented to clinic for care on Tues.
SHARP SHOOTING PAIN IN LEGS AND ARMS; This spontaneous report received from a patient concerned a 72 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastrointestinal problems, hypothyroidism, anxiety, non alcohol user, non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 12-MAR-2021 for prophylactic vaccination.   On 12-MAR-2021, the patient experienced tiredness (dose series 1).  On 16-MAR-2021, the patient experienced vomiting (dose series 1).   The outcome for tiredness and vomiting was reported as resolved.   The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 213A21A, and expiry: 21-DEC-2021) dose was not reported,1 total, administered on 02-DEC-2021 (also reported as 04-DEC-2021), at 11 am on left arm for prophylactic vaccination. Concomitant medications included mirtazapine for anxiety, omeprazole for gastrointestinal problems, enalapril maleate for high blood pressure, levothyroxine sodium for hypothyroidism and OTC (over the counter) multivitamin.  On 02-DEC-2021 (also reported as 04-DEC-2021), the patient experienced sharp shooting pain in legs and arms (dose number series 2). Treatment medications (dates unspecified) included: paracetamol.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  On 05-DEC-2021, the patient recovered from sharp shooting pain in legs and arms.   This report was non-serious.  This case, involving the same patient is linked to 20211212813.  This case, from the same reporter is linked to 20211212835.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 08-AUG-2015, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a male who on 23-JAN-2009 was vaccinated with "one dose" on PNEUMOVAX 23 (lot number was not available). On 27-JAN-2009 the patient developed swelling at the injection site. The patient had "unspecified test". At time of the report the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Client received first pre-exposure rabies vaccine on 02/09/07. On 02/15/07 clients instructor  notified us that client would not return for completion of series due to a possible reaction. Instructor reported that client said   that evening she experienced rash with itching on her body, and within 12-24 hours fever, vomiting, and chills.  Instructor indicated client did not say what temperature was. Client contacted and was seen by a physician who told her she had strep throat and advised her to not take any further rabies vaccine as this may be a reaction.
Shingles like rash on my arm vaccine was administered; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient received Shingrix on an unknown arm. The patient stated that, after vaccination experienced shingles like rash on arm  the vaccine administered. Rash was within a week after receiving the dose. At the time of reporting, the patient was due for 2nd dose of Shingrix and asked information to receive for 2nd immunization
Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain  tiredness headache muscle pain chills  joint pain fever - 101.2 injection site swelling injection site redness nausea  arm pain
pt recvd vax & did not develop a titer p/8wks;MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Fever started Wednesday pm, continued until Saturday AM, vomiting Friday and rash started behind her ears Friday, rash was all over by Saturday.
memory loss, tingling in skull, itching in skull, fatigue, numbness in legs.
Acute respiratory failure with hypoxia POA:  Unknown Severe sepsis. POA: Unknown Community acquired bacterial pneumonia.POA: Unknown Pericardial effusion POA: Unknown  Atrial fibrillation  POA: Unknown Leukocytes is POA: Unknown Elevated LETs POA: Unknown  Acute kidney injury  POA: Unknown
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT STATED HER ARM WAS RED, BUT STATES THAT ALWAYS HAPPENS AFTER ANY TYPE OF INJECTION.
Vaccination arm developed a red rash that burned two days after injection of PNEUMOVAX 23. Pt. call pharmacy and PCP. PCP instructed pt to take APAP or Ibuprofen and apply Ice to site (area).
Muscle weakness left side, arm and leg. All on left side. Left knee buckles, weakness. Left hip weakness. Left foot pain, weakness.
her tinnitus is really really bad; her tinnitus is really really bad; Booster; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 320308D), via an unspecified route of administration, administered in Arm Right on 04Nov2021 at 13:45 (at the age of 73-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing tinnitus. Concomitant medication included influenza vaccine inact sag 4v (FLUAD QUAD, Lot number: 312828), received within 4 weeks prior to the vaccination, administered in right arm taken for an unspecified indication on 18Oct2021. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK4231), via an unspecified route of administration on 30Jan2021 (at the age of 72-years-old) as dose 1, single and received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ENU207), via an unspecified route of administration on 20Mar2021 (at the age of 72-years-old) as dose 2, single both doses for covid-19 immunisation. The patient did not receive any other additional vaccine on same date of the pfizer suspect. On 06Nov2021, the patient experienced her tinnitus was really really bad. Her tinnitus WAS really really bad was reported as worsened. Patient stated since she got that shot on 04Nov2021, her tinnitus was really really bad. She has had tinnitus for at least 20 years but it has been mild and then it has increased and was really loud. The patient did not required emergency room or physician office visit. Patient Stated that the tinnitus was ongoing and had been at a steady loud rate and that was noticed on 06Nov2021 after the booster vaccine. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
The patient reported that left upper arm was very painful that evening and redness developed.  At his appointment for wound care on 08/02/19, arm redness with mild induration measuring 20.5 x 26 cm was noted on his left upper arm.  He was seen by APN at the wound center and prescriberd Keflex 500mg 1 tab po every six hours x 7 days for both the right foot wound and the left arm.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm). At the time of the report, FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-404066, MOD-2021-404276 (Patient Link).
Received the first dose on October 16th 2021 and has not received the 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 16th October 2021, batch number 3y7nl).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Twinrix and had not received the 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter cnsented to follow up.
I had fatigue, vague gastrointestinal disturbances, burping, no vomiting or diarrhea I did do home COVID-19 testing but they have come back negative. I called my primary care physician and scheduled an appointment. I had a physical and an abdominal ultrasound that back negative. I was advised to stay away from alcohol and coffee, stay well hydrated and see my physician if it gets worse.
Night of the injection, developed itching on left side of the neck and hives, which has developed to include hives/swelling of the R arm as well as hives/swelling of the left wrist
21FEB98 had temp 100-staring into space & trembling-no response to verbal stimuli duration 3min;parents report occurred x 2;p/episode tried to focus then started crying;
Patient was diagnosed with bilateral pulmonary emoboli the month following his vaccinations with Pfizer COVID-19 vaccines.
Extremely severe headache for about 36 hours.  Fever 101.5-102 for about 36 hours. Severe body aches stomach cramps.
unconsoluble crying for 2 hours, doctors then gave Benadryl so baby could sleep.
Pt was vaccinated at approximately 840am and per pt "8 minutes after my injection I started to feel burning in the back of my throat" and notified RN. Pt stated "it feels like I ate a bag of spicy chips and it is irritating the back of my throat really bad". Pt denied any redness, swelling or sensations of tightening. She was able to swallow her own saliva without incident, -stridor/wheezing. Vital Signs stable and after drinking water, pt reported the "burning sensation" became worse and ED provider notified. Verbal orders for Benadryl 50mg po obtained and pt tolerated medication well at 0920. At 0930 pt reported that the burning sensation was subsiding. She continued to remain conversive and had no acute respiratory distress. Lung sounds clear to auscultation. After monitoring for 45 minutes and follow up with ER MD. Pt discharged home with wife to drive her home. Vaccine instruction sheet and educational tools provided and reviewed with pt who verbalized understanding. Also advised pt to seek medical attention in the ED should her symptoms not improve, changes or becomes worse, pt verbalized understanding and ambulated with steady gait out of Vaccine clinic.
1/2 hr p/vax had pain in shoulder-neck; cont pain eve of 17JUL92 queasy stomach, dizzy when 1st laid down; fever 100.6 & arm inject site red, hot, hard, swollen 4 cm area; vomiting; h/a;
0.25 ml H1N1 vaccine administered to this patient (who is 3 months old).
No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U029496, expiration date 21-SEP-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.