chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling sick; current dose reported as 108µg (18 breaths), four times a day (QID) via inhalation(IH) route; Initial information received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient (81.6 kg) who experienced feeling sick and current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route while receiving vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included TADALAFIL (TADALAFIL); AMBRISENTAN (AMBRISENTAN); APIXABAN (ELIQUIS); and NIFEDIPINE (NIFEDIPINE).  On an unknown date, the patient started taking TREPROSTINIL SODIUM Unknown 108 ug QID (with an unknown batch number) for Pulmonary arterial hypertension. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Influenza immunization.  On 08-NOV-2022 the patient developed a non-serious feeling sick (malaise) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM. On 08-NOV-2022 the patient developed a non-serious current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route (off label use) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM.On 08-NOV-2022 the patient developed a non-serious feeling sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. On 08-NOV-2022 the patient developed a non-serious current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route (off label use) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (feeling sick, current dose reported as 108µg (18 breaths), four times a day (QID) via inhalation(IH) route).  At time of reporting, the outcome was Unknown for the event feeling sick and was Unknown for the event current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route.
itchiness all over her body; break out in hives; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included food allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced pruritus with outcome of unknown and urticaria with outcome of recovered. Consumer said that 3 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she had itchiness all over her body, and started to break out in hives. She said the hives already disappeared, but she now wants to know if it would still be safe for her to receive the 2nd dose. She also mentioned that she has a history of food allergy. Consumer also mentioned that her HCP already told her not to receive the 2nd dose since she had an allergic reaction.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
MODERNA COVID-19 VACCINE EUA: The patient received his Moderna dose then subsequently developed a "tremor" reaction during the observation period. The code team was summoned to assist. The patient remained awake, alert and oriented during the event. The patient reports he has similar reactions when having blood drawn. The patient was monitored for a total of 30 minutes then released to home without further sequelae.
Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 4th of 4 reports.   A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.
62 yo male Vfib arrest followed by PEA 2 days after vaccine, intubated, +MI
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site & exp muscle aches to a point where they could not lift arm;
Pt experienced a continuous high pitched cry that lasted for 3.5 hours approximately 2 hours post vax.
Initial unsolicited misuse case received from a nurse on 10 Oct 2016. This case involves a 57 year old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI684AA Expiry date: 30 Jun 2017) subcutaneously in left deltoid on 06 Oct 2016. The patient had a medical history of recent Upper respiratory infection and illness at the time of vaccination was reported as unknown and any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications were not reported. On 07 Oct 2016, one day after vaccination the patient had Redness swelling entire upper arm (Extensive swelling of vaccinated limb, Erythema and Vaccination site reaction). It was a case of incorrect route of drug administration (FLUZONE QIV given poss SC L deltoid). The patient was seen in the emergency room(ER). The patient lab tests were not reported. The patient had corrective treatment with antibiotics. The outcome of the events were reported as unknown. List of documents held by sender: none.
Patient complaint of dizziness, headaches, and feeling off.  Symptoms started 09/22/2021
1st dose on 07Oct2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 2 years ago on 7th October 2019). Concomitant products included NIRMATRELVIR + RITONAVIR (PAXLOVID).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: The pharmacist called to inquired any guidance or information regarding Shingrix and Paxlovid. The reporter mentioned that the patient received Paxolvid over a month ago and came in on the day of reporting to get a second dose of Shingrix. The reporter asked that any guidance on administering. The reporter reported that no second dose of Shingrix was administered and called to gather information on guidance of the second dose. The reporter was unable to provide vaccine details. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Lost voice then voice was hoarse for remainder of day into late evening.  Took Advil as was recommeded.
patient reported on 9/21/22 that her arm swelled up within 24 hours of shot and she continues to have pain in her arm from elbow up to halfway to shoulder, arm feels weak
Discharge Provider: MD Primary Care Provider: NP Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Hyperkalemia [E87.5] AKI (acute kidney injury) (HCC) [N17.9] Urinary tract infection due to Proteus [N39.0, B96.4] Urinary tract infection with hematuria, site unspecified [N39.0, R31.9] UTI due to Klebsiella species [N39.0, B96.89] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  50 year-old female with PMHx for restrictive lung disease secondary to obesity, CKD stage 3, diabetes type 2, CHF, bipolar disorder, depression, neuropathy, morbid obesity presenting with shortness of breath.  The patient was found to have COVID-19 and a severe persistent asthma exacerbation with acute on chronic hypoxic respiratory failure.  She uses 2 L by nasal cannula at baseline at home.  The patient was treated with IV Solu-Medrol with improvement.  She was switched back to Decadron to finish a 10-day course for COVID 19.  She was also treated supportively with nebulizer treatment, Mucinex and subcutaneous heparin.  Of note she had acute kidney injury on admission in the setting of acute urinary tract infection and hypoxia.  This resolved.  She does have chronic kidney disease stage 3. Her diuretics were resumed.  She was treated with IV ertapenem due to multi-drug resistant urinary tract infection.  Infectious Disease evaluated the patient with recommendations for 7 days of therapy.  The patient received a midline to complete IV antibiotic therapy at home.  Pulmonary rehab ordered a home BIPAP device as she qualified due to her CO2 levels on ABG. They also provided the patient with a nebulizer machine.  Ultimately the patient was discharged home with home health care in improved and stable condition.
Redness, swelling, pain and itching (7 x 10 cm erythema).
Patient received routine vaccinations of DTaP and Varicella at his 4 year old well child check on 8/15/05. On 8/22/05, he had gone to school during the day and then soccer in the evening. No trauma or injuries. He was his normal self with no signs of illness. About 7 PM he had a snack and then at 7:30 he went to bed. About 8 PM, mom checked on him; he was awake but seemed glazed over. Later in the evening, at about 8:40 PM, dad went in to check on him, and still his eyes were open, but he had no response. This time, they tried to rouse him, and he was limp. They were very concerned and picked him up, put him in the car to take him to the Emergency Room. In the car, he vomited twice. They pulled into an Urgent Care clinic and called 911. He was given an anti-epileptic medication and eventually his seizure stopped. Mother reports that during the event he would occasionally seem to respond, but most of the time his eyes were deviated to one side. The suspected length of his seizure was about 45 minutes to an hour. He was admitted to hospital and underwent a complete work up, excluding a lumbar puncture. Head CT and MRI were both normal. His EEG was noted to have some focal abnormalities. He was discharged from the hospital after 2 days. Discharge medication includes Keppra and Diastat, as needed for any further seizures. Since discharge he had not had any further seizures and has been in good health. Mom reports that after the vaccinations he had a small, localized reaction on his right thigh (where the DTaP was given). She describes it as a dime sized area of redness with a small blister on top. It was also slightly tender. He had no fever, no entire limb swelling, and no significant behavior changes. His growth and development has always been normal. He has had no recent illnesses, no rashes, bug or tick bites. He has no recent complaints of headache, abdominal pain, vomiting, diarrhea. No known ill contact. Information from 60 day follow-up report states no further seizures but is on antiseizure meds.
This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
10 days p/vax mom stated pt had high fever of 104 which lasted for 24 hrs; pt was seen by MD who stated fever may be related to MMR; devel fine dot in the body lasting to 1APR93;
It was reported that a 6 month old female patient was vaccinated with Tripedia, IPOL, ActHIB, and HBV on 7/10/98. On 4/26/99, at age 16 months, the patient reportedly had a positive routine culture for pertussis. The symptoms reportedly started on 4/8/99. From additional information received on 6/18/99, additional patient, responsible physician and lab data were given. Follow up #1 (8/5/02): during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added lack of drug effect).
Pt developed hives to neck arms and legs approx 2 hours after vaccine was administered. Pt took 1 Benadryl at 1:00pm, before coming to be seen.
gut hurts; gut area was swollen and described as "looked about 8 months pregnant" as if the patient was exposed to gluten/ extremely bloated; felt terrible; extremely tired; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: E19267 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 22Feb2021 12:30 (at the age of 51 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Hypothyroid/Hashimoto, ITP (idiopathic thrombocytopenic purpura), and celiac (celiac disease). The patient has known allergies to penicillin, sulfur, statins, peppers, and gluten protein. Concomitant medications included levothyroxine sodium (SYNTHROID) and cetirizine hydrochloride (ZYRTEC) taken for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 22Feb2021, within an hour after receiving the vaccine, the patient's gut area was swollen and described as "looked about 8 months pregnant" as if the patient was exposed to gluten. The patient also felt terrible and was extremely tired. On 26Feb2021, four days after receiving the shot, the patient was still extremely bloated and reported that her gut hurts. The patient will not take the 2nd shot. The patient did not receive any treatment. The outcome of the reported events was recovering.  No follow-up attempts are possible. No further information is expected.
Blood pressure is really high; When he lays down, he is spinning a lot/ Room is spinning; Throwing up; Doesn''t feel good/ He is not well; Had his second Pfizer shot and at the same time they gave him the flu shot (Unspecified Flu Shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), administration date 17Oct2021 (Batch/Lot number: unknown) as dose number unknown single for immunisation; insulin (INSULIN) (Batch/Lot number: unknown) for diabetes mellitus. Relevant medical history included: "Diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 17Oct2021, outcome "unknown", described as "Blood pressure is really high"; VERTIGO (non-serious) with onset 17Oct2021, outcome "unknown", described as "When he lays down, he is spinning a lot/ Room is spinning"; VOMITING (non-serious) with onset 17Oct2021, outcome "unknown", described as "Throwing up"; MALAISE (non-serious) with onset 17Oct2021, outcome "unknown", described as "Doesn''t feel good/ He is not well"; PRODUCT USE ISSUE (non-serious) with onset 17Oct2021, outcome "unknown", described as "Had his second Pfizer shot and at the same time they gave him the flu shot (Unspecified Flu Shot)". The action taken for insulin was unknown.  Additional information: it was reported that patient was given Insulin twice at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 26AUG98 & devel local discomfort to lt upper arm several min p/vax;5 days later devel more upper chest muscles aches which sometimes makes breathing uncomfortable d/t pain;
The event was a vaccine error in that in that pentacel and IPV was given, no adverse reaction occured
Patient complained of "high" fever several hours after injection (although did not have a thermometer). Sweating, could not sleep, numbness and tingling in both legs. Symptoms resolved in approximately 24 hours. Was patient's 2nd injection.
Information has been received from a pharmacist concerning an adult female who was vaccinated, "awhile ago," with one dose of Varivax. It was reported that the patient failed to seroconvert. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Shingrix on February 10, 2020 / 2nd dose on the 16th of September 2021; outbreak of shingles; Exhaustion; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th February 2020).   On 16th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16th September 2021, immediately after receiving Shingrix, the patient experienced shingles, exhaustion and drug dose administration interval too long. On an unknown date, the outcome of the shingles and exhaustion were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. Shortly after receiving the second dose of Shingrix, the patient had an outbreak of shingles and exhaustion that lasted about 5 weeks. No lot number or expiration date was known. The patient declined to provide healthcare professionals information. The reporter did not consent to follow up.
This spontaneous report was received from a nurse practitioner and refers to an unspecified 4 month old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 07-MAR-2017, the patient was vaccinated with GARDASIL 9 (dose and route of administration were not reported) (lot # reported as M041990 and expiration date 28-JUN-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 31-DEC-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) lot # L029467 with an expiry date 06-AUG-2017 (incorrect product storage). No concomitant medications were reported. No adverse symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Pain in my shoulder Red rash from the injection site up my left arm , shoulder and shoulder blade some irritation, itching  lasted about a week and a half.
I had sudden malaise, lost consciousness and my wife says was not breathing briefly. I revived and was taken to the hospital, and treated for 2 1/2 days with heart catheterization and TPA injected into my clot in the pulmonary arteries with good resolution. I did have cor pulmonale with acute severe right heart failure as part of that, Dr. thought the clot came from my right calf by his examination. Diagnosis was confirmed by CAT scan cardiac Echo and right heart catheterization.