chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 22 year old female with penicillin allergy who consumes alcohol and has no other pertinent medical history who on 24-JUN-2008 was vaccinated with third dose of GARDASIL vaccine 1 dose. On 24-JUN-2008, the patient experienced black out. On 25-JUN-2008 morning, the patient was not feeling right and felt dizzy. The patient was bending over at work and then fainted. The patient came to the office 1/2 hour after fainting with a chief complaint of fatigue, myalgia, headache and dizziness. The patient had no symptoms in the office and was not treated. On 25-JUN-2008, the patient recovered from black out, not feeling right, faint, fatigue, myalgia, headache and dizziness. No further information is available.
Information has been received from a Registered Nurse concerning an unknown number of patients, names and demographics were unknown to the reporter. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis, of several lots (lot # N002915, expiration date: 24-JUL-2017; lot# M033215, expiration date: 09-JAN-2018; lot# N002915, expiration date: 24-JUL-2018; and lot# M039449, expiration date: 20-MAR-2018) (dose, frequency and route of administration were not reported). No adverse effect was reported in any of the patients. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 8.6 Fahrenheit degrees for 45 minutes. A prior temperature excursion was not reported. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1705USA014042.
INR levels went up to 3.9; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An 87-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283, unknown expiration), via an unspecified route of administration on 11Jan2021 at a single dose as the patient wanted to take it to be on the safe side.  Medical history included ongoing diabetes.  Concomitant medication included ongoing linagliptin (TRADJENTA) for diabetes. It was reported that the patient received the vaccine yesterday (11Jan2021). On 12Jan2021, his INR levels went up to 3.9 and is usually in the 2.2 - 2.3 range. The patient had no reaction today (12Jan2021), but he did have to go get his INR levels checked. The reporter wanted to know if this is due to the COVID vaccine. They are wondering if the vaccine could have anything to do with the jump in his numbers. He doesn't have a prescribing doctor. He set up an appointment in the next town over to get the vaccine. He is having another INR check next Wednesday. Besides that, he doesn't feel any different. He has had no reactions. He just decided he wanted to take it to be on the safe side down the road. The patient underwent blood tests and procedures which included blood tests: unknown results on unspecified date and height: lost a couple of inches. Outcome of the event was unknown.
Overnight I was in bed and my nose was stuffy. I just felt uncomfortable. I had post-nasal drip mucous. That was basically what was happening and kept me up most of the night. I didn't feel terrible in the morning but my head was stuffing like I was starting to get a cold. I had to go out that morning so I did put a mask on before I went out. Late in the afternoon, I decided to check for COVID-19. Prior to the 22nd I did not feel bad and had no symptoms. My COVID-19 test was positive. My husband and I double masked. On Friday morning 12/23/2022 I called into the doctor office and they setup the Tele-med visit with the nurse practitioner. I had no fever and no trouble breathing. The nurse practitioner got worse in the next couple of days she did not recommend the PAXLOVID.
Woke up this morning and stated "cheeks puffy and red circles". Stated this happened before with food and a spider bite. Stated she does not think its related to shot. Instucted her to call her MD.
This spontaneous report as received from a health care worker regarding male child of unknown age. Approximately on 02-JUN-2014 (also reported as yesterday), the patient was vaccinated with experienced VAQTA injection 0.5 ml (lot #, expiry date unknown), intramuscular (unspecified). No concomitant medication was reported. There was no product quality complaint. Outcome of the reported event was unknown. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient refused to provide any information regarding her pertinent medical history, drug reactions, allergies or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # R007721, with expiration date 01-MAR-2020, for prophylaxis (dose, anatomical location and route of administration were not provided). The patient stated that this was the second dose of "the pneumococcal vaccine", however, she could not confirm if the first dose was also PNEUMOVAX 23. On an unspecified date, after receiving PNEUMOVAX 23 the patient developed a rash and an unspecified heart issue. By the time of reporting the patient had not recovered from the events. She did not assess the causal relationship between the events and PNEUMOVAX 23.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In October 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 strain of herpes zoster. On or about 06-FEB-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful symptoms and chronic pain. 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. Additional information has been requested.
On 01/26/2001 the patient developed chicken pox. Subsequently the patient recovered. Unspecified medical attention was sought.
pneumonia; Blood clots in right lung; had blood clots on her right and left kidneys; This is a spontaneous report from a contactable consumer (patient sister). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm on an unspecified date (Batch/Lot number unknown) as single dose for covid-19 immunisation. Patient had no medical history and concomitant medications. Consumer reported that patient was hospitalized with pneumonia after both doses of product and blood clots in right lung in Apr2021. She was healthy for a while, then had blood clots on her right and left kidneys. She almost died from the blood clots. Her symptoms right after the shot were not fully developed, then it started getting worse and worse and worse and she thought it would dissipate. Stated something about really horrible side effects where she would wither away and it got worse and worse. She was hospitalized for two weeks, they put her on oxygen because she could not breathe, she did not want to be on a respirator since she did not want this to be a prolonged thing. Her sister was young, healthy, and vivacious. Her health declined and she was still struggling. When she talked to her sister it sounded like she was barely breathing. She also stated that her sister almost died from those blood clots back in April. She was hospitalized for 2 weeks then discharged to go home. Outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer (subject) and described the occurrence of joint pain all over body in a 50-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included anxiety. Concurrent medications included XANAX. On 9 October 2013 at 18:30 the subject received 1st dose of influenza vaccine unspecified (unknown details). On 10 October 2013, less than one day after vaccination with influenza vaccine unspecified, described as "mid-day", the subject experienced joint pain all over body. The subject reported that he "began aching in every joint in his body." At the time of reporting the event was unresolved.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that three patients received expired FLUMIST. The outcome of the event of three patients received expired FLUMIST is unknown. The report was considered to be non-serious.
This spontaneous report as received from a pharmacist refers to a 69 years old female patient. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history are unknown. On 05-SEP-2014, the patient received a dose of PNEUMOVAX23 (strength, dose, and route not reported, lot # J004080) that had expired on 22-AUG-2014, for an unknown indication. It was unknown if there was relevant lab data. As of 05-SEP-2014, it was unknown if the patient was still on PNEUMOVAX23 and the outcome of receiving expired PNEUMOVAX23 was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around October 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or about November 2016, the patient was treated at a hospital for lung infection, which was diagnosed as zoster-related pneumonia. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful zoster-related pneumonia and neurological 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, pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Upon internal review, lung infection, zoster related pneumonia was determined to be medical significant. Additional information has been requested.
1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was brought back to assessment area. Vitals checked  1450- 142/82 1506- 133/90  Recommend diphenhydramine for symptoms- Pt refused treatment recommendation. Emergency Response Team called to discuss with Pt. Pt signed recommendation refusal form and left clinic.
Approximately two weeks after the second Gardasil 9, otherwise very healthy 43 y/o patient developed R facial herpes zoster w/ Ramsey Hunt syndrome complicated by secondary bacterial infection.  Sequence of his recent vaccine history: COVID 19 Pfizer 2/23/21, 3/15/21, 12/8/21 HPV9/Gardasil 11/10/21, 12/29/21 Seasonal influenza 11/10/21 Subjective (patient) attribution to getting Shingles outbreak following numerous recent vaccines.
weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020.  The information on the Lot/batch number has been requested.
shingles; Information has been received from a laywer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an outbreak of shingles. As a result of these symptoms, the had been seen and treated by medical providers was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter regarded the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
No other AE reported; an expired GARDASIL 9 vaccine dose was administered to a patient; This spontaneous report as received from a pharmacist refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # R003557, expiration date reported as November 2020 and upon internal validation established as 20-NOV-2020 (route of administration and anatomical location were not reported). No adverse event was reported. The reporting pharmacist inquired whether he needed to repeat the dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: F78762) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE, start date: Jan2019; LISINOPRIL, start date: Jan2019; ATORVASTATIN, start date: Jan2019. Past drug history included: Solumedrol, reaction(s): "known allergies: solumedrol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient called reporting whole body rash including scalp.  States that started 24 hours after administration and is still present 5 days after.  Rash resulted in visit to urgent care and is now on oral steroid therapy.
PAINFUL RED BUMPS ON LEGS AND ARMS STARTED OFF SMALL AND THEN GETTING LARGER AS NICKEL TO QUARTER SIZED; INJECTION SITE REDNESS; FEVER; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included not taking any medications no medical diagnosis, and other pre-existing medical conditions included the patient was not taking any concomitant medications at the time of this report. The patient had no medical diagnosis. the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced injection site itchiness. On 09-JUL-2021, the subject experienced injection site redness. On 09-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 19-JUL-2021, the subject experienced painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itchiness, injection site redness on 16-JUL-2021, and fever on 11-JUL-2021, and had not recovered from painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. This report was non-serious.
Nausea and headache within a few hours. Chills, muscle aches, a;omg with continued headache and nausea, within 15 hours. Large, red, tender lesion surrounding injection site the next day. Treated symptoms with acetaminophen.
achy at first, then fever for 5 days of 102, chest pain, sore throat
MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
patient requested to have the third dose of GARDASIL 9 about 10 months after the second dose; No additional AE; This spontaneous report was received from a pharmacist regarding a female patient of unknown age. No information about concurrent conditions, medical history or concomitant medications was given.   On an unknown date, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient requested to have the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) about 10 months after the second dose. There were no other adverse event details available.
experienced fever; chills; malaise; diaphoresis; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic.   On 11th December 2020, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. On 11th December 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, malaise and diaphoresis. On 15th December 2020, the outcome of the fever, chills, malaise and diaphoresis were recovered/resolved.   It was unknown if the reporter considered the fever, chills, malaise and diaphoresis to be related to Shingrix.  Additional details were provided as follows: Upon follow up, this case considered as valid case. The case was reported by patient itself. The patient had first dose of Shingrix and experienced fever, chills, malaise and diaphoresis. All events recovered after 3 days of vaccination. The patient was bit by a bug on 21 May 2021 and seen in local emergency room and took sulfa antibiotic and had an anaphylactic reaction her throat was closing up. The patient may not get her second shot by 11 June 2021. The patient did not know was allergic to Bactrim of which was her first antibiotic of 3. The patient did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINxE-US2021125140:Same reporter US-GLAXOSMITHKLINE-US2021125130:FU3 DELETED