chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 51 years old male patient who experienced nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities while he received vaccine ADACEL. 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 Diabetes mellitus. On 04-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via intramuscular route in the right arm. The patient developed a non-serious he noticed a nodule in his arm pit that was extremely painful, (granuloma), feeling fatigue, brachial neuritis, my arm was sore, there was a round, red, 5 cm, 2 inch spot, weakness, feeling fever, feeling chills, sharp, burning pain from my arm pit to elbow almost daily, burning sensation, feeling similar numbness and tingling, feeling similar numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm(Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was nodule in his arm pit that was extremely painful, fatigue, brachial neuritis, pain in arm, vaccination site erythema, fever, chills, burning sensation, painful arm, numbness and tingling, could not perform daily activities because of weakness and the activity would aggravate his right arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of documents held by sender: None.
Had a sudden onset of nausea, dizziness, and muscle aches. Felt like she could not move legs well because they were so painful. Did also see a rash to (Lt) chest and (Lt) upper arm that was itchy. Arm was painful x 4 days.
pt recv vax 6MAR97 & 9MAR97 began having rash on legs, arms, torso,none on face;no swollen eye-some diff breathing, fever 102;seen by MD 10MAR97;
pt to ED with increasing weakness; positive for COVID; CA pt on chemotherapy; septic shock; AHRF; ARF; started on remdesivir, dexamethasone, barcitinib; unable to tolerate dialysis, became hypotensive and hypoxic; DNR; pt died in the hospital
Dizziness, vertigo, palpitations, tachycardia, weakness.  These started after about 10 days after vaccination and lasted for at least a month. Took physical therapy as well. Took physical therapy for vertigo, took rest.
Chills, fatigue, aches pains, soreness in arm, fever 99.3.
weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Congestive heart failure. Concomitant products included FUROSEMIDE (FUROSIMIDE) for Congestive heart failure, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Depression, METOPROLOL for Hypertension, VITAMIN D3 for Vitamin D3 deficiency, ATORVASTATIN CALCIUM (LIPITOR), NITROGLYCERIN, METHADONE, ACETAMINOPHEN, EZETIMIBE (ZETIA), POTASSIUM CHLORIDE (MICRO K), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (weakness). At the time of the report, ASTHENIA (weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included chlorodyne. Treatment information was not provided.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program SUPPORT. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first dose last 16Apr2021 and was scheduled for the second dose on Friday 07May2021. He tested positive for COVID-19 last week on an unspecified date in 2021 and he was not sure if he was fully cleared from it since he was still having a hard time breathing. Patient wanted to know if he should get his second dose this Friday or he should reschedule it. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.
My second Moderna vaccine was on 3/4/21.  On 3/6/21 an itchy, heat hot, red rash appeared on my right arm, on an area just under where my second covid19 vaccine was administered. This was only 2 days after my vaccination. I have been putting cortisone cream on it for 3 days. It's symptoms are subsiding. On that same day I also ran a fever of 100.3*, which I did not have from my first vaccine shot. FYI, On my first Moderna Covin19 vaccine on February 4, I had this same rash reaction but it was a week after the vaccination before it appeared.
Information has been received from a company representative about a physician's daughter who was vaccinated with her second dose of GARDASIL and experienced severe vomiting, diarrhea, dehydration and passed out in an emergency room four days after receiving the vaccine. Subsequently, the patient recovered at an unspecified time. Additional information has been requested.
A 76 year old female patient received Pneumovax® vaccine on 4/26/06.  After returning home, she developed chills but no fever, swollen arm from elbow to the shoulders, truncal warmth and redness and some skin blistering.  The patient had received Pneumovax® 4-5 years previously without any reaction. After she returned to the clinic on 4/27/06, she was advised to take Advil® and Benadryl®, and no fever was noted. She was instructed to return or visit the ER if symptoms worsened, or if she experienced trouble breathing.
CLIENT GIVEN HEPATITIS A DOSE 4 MONTHS AFTER FIRST DOSE. INTERVAL BETWEEN DOSES TOO SHORT. WILL HAVE TO REPEAT DOSE. CLIENT INFORMED OF ERROR. ERROR REPORTED.
2/6/21 - Began with injection site soreness, then progressed to full body/muscle soreness throughout the night. Fever and chills began the first night (didn't take temperature).  Short of breath on the evening of 2/6/21 with moderate activity.   2/17/21 - Fatigue throughout day. Slightly (less than 2/6) short of breath with mild- moderate activity on 2/7. Fever, chills, and body/muscle aches continued throughout 2/7/21 and were moderate (muscle/body aches severe) until about an hour after taking 1 pill of over the counter ibuprofen at 2 p.m. on 2/7/21. Symptoms returned as the ibuprofen wore off, and I took another 1 pill of ibuprofen at about 9:30 p.m. on 2/7/21. Symptoms then diminished except for some mild back pain.   2/8/21 - the only symptoms are some fatigue and mild back pain (could be unrelated and just due to activity). No medications taken on 2/8/21.
The night of my vaccination I had a headache which continued until the morning (it literally woke me up) it lasted for about 3 hours and then I took Tylenol and then it just subsided and I was feeling normal again.
Abnormally heavy menstrual bleeding after second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 17:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 at 17:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 07May2021, after the second shot, the patient experienced abnormally heavy menstrual bleeding. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event abnormally heavy menstrual bleeding was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Bumps and swelling in vagina area.  initially diagnosed with cyst and took antibiotics on 6/7. Pain increased went back to physician on 6/14. Got blood test was diagnosed with HSN1. Never had an outbreak prior to 6/7.
allergic reaction; couldn't swallow; shaking; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated, went on Sunday and had first Covid shot and they do not know if she had an allergic reaction or not. She went to ER and got prednisone and Benadryl. She was shaking (on an unspecified date) and got to where she could not swallow but they said there was nothing swollen. Stated, physician could not tell if she should get the second dose or not and told me to call you. Patient again stated, she should get the second dose of Pfizer vaccine or take Benadryl before getting the vaccine because she had an allergic reaction after the first dose and could not swallow (on an unspecified date). Therapeutic measures were taken as a result of allergic reaction, couldn't swallow, shaking. The outcome of events was unknown.   Information on lot number/batch number was requested.
Arm hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 45-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with PAIN IN EXTREMITY (Arm hurts). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other relevant concomitant medications were mentioned. N o treatment  was given.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
REDNESS AND RAISED INJECTION SITE AREA, TENDERNESS TO PALPATION.
Very regular periods for years. Period is late by 3 days. No signs of it starting like normal cramps or spotting. No possibility of pregnancy
Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice was different. Patient evaluated with. Was given Epi and Benadryl. Continued to cough. EMS called and patient transported to Emergency Room for further evaluation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 04Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Feb2021 as dose 2, single (Lot number: EL9267), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Anti viral details included COVID 19 Treatment, (brand was Paxlovid), started on 28Jun2022 to 03Jul2022. Other medication in 2 weeks product was Amlodipine, valsartan, atorvastatin. The patient previously received a COVID-19 Vaccine. It was reported as Covid recurred, positive test. No known allergies were reported.
This case was reported by a other health professional via call center representative and described the occurrence of skin eruption in a 60-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced skin eruption. On an unknown date, the outcome of the skin eruption was unknown. It was unknown if the reporter considered the skin eruption to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the pharmacy intern. The patient received the vaccine in the left deltoid. The patient called the pharmacy on 8th July 2018, to report that she developed a break out on both sides of her toes and hands. The patient felt that the break out was related to the SHINGRIX. The reporter was unable to provide additional details. The call was transferred to MI (Medical information).
10 x 7 cm local redness, edema - Pt states dizziness, muscle aches and back pain.
@ administration pt told can take tylenol for injection site pain and apply icepack. pt returned to pharmacy on 2/10 for seroid cream bc injection area turned read and little bump formed
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, pain at the injection site Narrative:  Other Relevant History:
Firm, slightly raised, 2-inch diameter swelling that is itchy (like a giant mosquito bite).  Pregnancy so far unaffected :)
This is a spontaneous report referring to a 20 year old female who on 5/21/99, received her 1st dose of Lymerix. The next morning, on 5/22/99, the pt was very itchy and had a very light rash on her arms and legs. She was treated with Benadryl for a "few" days. Symptoms resolved after a "few" days. The most recent information, received on 7/8/99, reports the condition of the pt as resolved.
This spontaneous report as received from a licensed nurse practitioner and a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with RECOMBIVAX HB (lot number, dose, route and frequency were not provided) which were improperly stored. The RECOMBIVAX HB was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the RECOMBIVAX HB had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Fever aches chills started after 12 hours, 24 hours after dizziness, weakness fatigue. Passed out at home after the 24 hour mark. After coming "to" was vomiting. Perhaps was a seizure. The paramedics were  called and I was evaluated and all was ok- O2 was fine, sugar 138, BP 110/60.  I was to drink pedialyte, rest .
Redness at sight of injection. Hot to the touch. When patient came in 9/16/15 it had been about 24 hours since patient had received the flu shot, the red area was about the size of a half dollar. Patient said she didn't feel bad, no soreness in the arm. I told her to take Benadryl and to keep a close eye on it, if the redness got bigger or she started seeing red areas other than at the injection sight or feeling itchy especially in the throat area to contact her doctor.
1st dose Oct2019, 2nd dose Jul2022/At time of call pharmacist had not administered the 2nd dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix  (received 1st dose on 15th October 2019).   On an unknown date, the patient received the 2nd dose of Havrix. On 11th July 2022, unknown after receiving Havrix, 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: 11-Jul-2022 Reporter's comment: The pharmacist reported the administration of Havrix beyond 6 months. The patient was back for 2nd dose of Havrix on the day of reporting. At time of call pharmacist had not administered the 2nd dose of Havrix. The reporter consented to follow-up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Havrix, which led to incomplete course of vaccination. As it was reported that at the time of call the patient did not receive the 2nd dose therefore incomplete course of vaccination was coded as event. Suspect was coded as reported narrative.
pt recv vax in DEC96 & pt appeared to be developing GBS & was transferred to another facility for tx;
4 hours after receiving vaccination, I woke up because my tongue seemed to be blocking my airway and made it very hard to breathe. I sat up and noticed my throat and tongue felt swollen. After 15 minu; 4 hours after receiving vaccination, I woke up because my tongue seemed to be blocking my airway and made it very hard to breathe. I sat up and noticed my throat and tongue felt swollen. After 15 minu; 4 hours after receiving vaccination, I woke up because my tongue seemed to be blocking my airway and made it very hard to breathe. I sat up and noticed my throat and tongue felt swollen. After 15 minu; I developed chills shaking, and a burning sensation in my neck; I developed chills shaking, and a burning sensation in my neck; My upper lip showed signs of possible swelling; This is a spontaneous report from a contactable consumer. This 27-year-old male consumer (patient) reported for himself. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 19:15 (at the age of 27 years), (Batch/Lot Number: EW0151) as DOSE 2, SINGLE for covid-19 immunisation at hospital. The patient medical history was not reported. Concomitant medications included One a Day vitamins and omega-3 fatty acids (ALGAE OMEGA 3) taken for an unspecified indication, start and stop date were not reported. The patient previously took Ativan and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021,07:15 PM (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation. Patient stated, on 19Apr2021 23:15, 4 hours after receiving vaccination, "I woke up because my tongue seemed to be blocking my airway and made it very hard to breathe. I sat up and noticed my throat and tongue felt swollen. After 15 minutes of feeling out the situation, I developed chills, shaking, and a burning sensation in my neck. The swelling was more of a personal truth than objective due to the fact that any swelling that was present could not be identified. My upper lip showed signs of possible swelling". The events resulted in visit to emergency room. The patient received treatment for the events as Steroid and Benadryl shot along with a Pepcid. The clinical outcome of the events was recovered in 2021.  No follow-up attempts are Possible. No further information is expected.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. In August 2017, the patient was vaccinated with a dose of VARIVAX, lot # N012132, expiration date: 17-APR-2019, for prophylaxis, which was reconstituted with sterile diluent (MRK) (lot # and expiration date were unknown). Concomitant medications were not reported. On an unspecified date in 2017, the patient developed a rash on an unspecified part of the body. Subsequently, a culture of the lesions was performed and the result was negative for varicella. At the time of reporting, the patient had recovered from the rash (reported as "the lesions healed"). The causality assessment between the rash with VARIVAX and sterile diluent (MRK) was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004204.
water blister at injection site about 1cm diameter, warm to touch x 2 days about 1 inch diameter area, No Fever.
Rash/Itching following FLUMIST (Flumist not an option as a vaccination in #13).
This spontaneous report was received from a healthcare worker. The reporter informed that an unknown number of patients (no details provided) had been vaccinated with improperly stored VAQTA (lot number, dose, dose number and route not reported). The vaccines were exposed to 30 degrees Fahrenheit for 15 hours. No adverse effect reported. This case is linked to case reports 1210USA001182 and 1210USA010300 (same reporter; same medication error reported for other vaccines). Additional information has been requested.