chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient felt nauseated, said she was emotionally distressed from her dog dying this morning and had not had any food yet today.  She vomited but was feeling slightly better within the hour.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (dates unspecified) lasting for 2688 hours, with the lowest recorded temperature of 27 degrees Fahrenheit (-2.77 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
130pm - Outside; c/o feeling dizzy denies any SOB, no difficulty swallowing denies itchiness. Lips tingling. - Client positioned on cot with elevated feet. BP 112/62 pulse 84 reg R 16 easy. Color pale - c/o feeling warm checked by physician at facility. Once rested no further c/o BP 120/70 reg 70 reg 16 color improved. Had not eaten has good given no further c/o. Advised to follow up with primary care physician today 230 124/88 77 - 16- go to ER if s/s worsen.
Patient began experiencing fevers, body aches, back pain, fatigue, chills the night she received the vaccine. Symptoms progressed for the following four days when she was ultimately seen in PCP office. Laboratory evaluation demonstrated atypical pneumonia and elevated WBC count. Patient was diagnosed with Acute Myeloid Leukemia via bone marrow biopsy and is receiving treatment at the hospital.
More than 24 hours after the vaccine, my arm was red, swollen, hot and painful.  Less than 24 hours after the vaccine, my eyes began to become itchy. On the same morning I woke with the swollen, painful arm, my eyes were also swollen, red, itchy and painful. This required a visit to an urgent care facility.   I was prescribed an oral steroid, antibiotic, and antihistamine as well as ice packs to be used on my injection site.
LOCAL REACTION. RED, HOT, INDURATION MEASURING ABOUT 2' X 6".
it is very painful; Right breast became like engorged almost, like very hard and heavy; Right breast became like engorged almost, like very hard and heavy; Chills; Fever/my fever at the highest point was 102; Joint ache; Muscle ache; Fatigue; Heavy feeling in chest; felt like drugged; felt like drugged as if I was almost intoxicated; Right eye was burning and watering; Right eye was burning and watering; Pain and numbness in lower legs below the knees; Pain and numbness in lower legs below the knees; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "I am a teacher and we have received the first dosage of Pfizer COVID-19 vaccine on Thursday (11Feb2021) and I received mine early in the late afternoon, if that makes sense. And immediately after I had the shot, the best way I can describe it you is I almost felt like drugged as if I was almost intoxicated and my right eye was burning and watering and we were still teaching and then I came home and later that night, I had some pain and numbness in my lower legs below the knees and by that night, the next day, I was full blown with every side effects chills, fever, my fever at the highest point was 102 on 12Feb2021. I had joint aches, muscle aches, fatigue and a heavy feeling in my chest. But the reason I am calling is because most of those symptoms have subsided except for one. It's Tuesday which is five days after the inoculation and my right breast on Friday morning (16Feb2021) became like engorged almost, like very hard and heavy and that has not fully gone away, it is very painful and I read that there could be like a swelling of the lymph nodes but it was my entire breast. So that's not, I do not believe if that could be connected to the lymphatic but I am not sure and I called my Primary Care Physician first. They almost started almost immediately but then they continued to get worse. Friday was the worst, the 12th, 13th I was still experiencing symptoms. They were mostly subsided by the 14th except for the heavy feeling in my chest, that fatigue and this hardened breast. I am just trying to finding answers as to what I should do about this hardened tissue and if I should get the second inoculation." Outcome of fatigue, heavy feeling in chest, breast became like engorged almost, like very hard and heavy, it is very painful was not recovered; and of remaining events was recovering.
76 y.o.     Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Coronary artery disease involving native coronary artery of native heart without angina pectoris   Permanent atrial fibrillation   COVID-19   Acute diastolic CHF (congestive heart failure)   Type 2 diabetes mellitus   Chronic kidney disease, stage III (moderate)       HPI:   Hospital Course:   This 76 year old woman was admitted with sob and cough.  She did have covid and was treated with remdesivir and steroids.  She as well received systemic antibiotics as procalcitonin was elevated.  She is improved.   She did have chf.  She has received iv lasix.  Echo with diastolic dysfunction.  Her BP control is not to goal but she is not willing to stay and adjust medications.  She will go home on increased lisinopril and lasix.  She has a fib and is on xarelto.               Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO PULMONOLOGY IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
his brother died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "his brother died". The date and cause of death for the patient were unknown. Reporter was a medical assistant calling regarding the Pfizer Covid-19 Vaccine that has been administered to his family and now his brother died and he also mentioned (Name withheld) died as well after the vaccination; Also his Uncle and other family members are sick as well. Reporter was the only one who didn't receive the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300031636 same reporter/drug, different patient/AE;; Reported Cause(s) of Death: his brother died
Sore around the injection site Fever, chills, headache, mussel aches, nausea  lasted approximately 24 hours, took Tylenol and slept  felt fine  when I woke up
Experienced sudden onset of extreme fatigue at 8pm, followed shortly by chills and an extremely high fever that lasted until around 5am the following morning. Also experienced terrible headache and was extremely disoriented throughout the night. The following day the fever and chills had subsided, but was still very fatigued and the headache lasted until the evening. All symptoms had subsided by the morning of Friday 4/9.
Patient walked into clinic complaining of: Redness in the left arm goes all the way under arm;  Redness on each side of the face;  Low grade temp since Saturday; and Swollen Arm, hard and hot to touch.   Physician directed RN to send patient to Urgent care where she was diagnosed with severe allergic reaction, treated with steroids and antibiotics and sent home with prescriptions for both.
Son received mist on Friday, on Sunday started acting tired, had fever, complained of arms hurting. Said he couldn't walk and would lay on the floor. On Monday fever continued and new complaint of legs hurting. Tuesday morning lower fever complaining of stomach pains followed by vomiting.
Patient states that she has been fine until yesterday.  So 9 days after vaccine, her arm started itching and has a rash .  I advised her to take benadryl and put hydrocortisone on rash. She is calling her doctor to inform them. I told her that if it gets any worse,  she needs to go to urgent care
This case was reported by a medical representative via call center representative and described the occurrence of hives in a 18-month-old female patient who received HAVRIX pediatric. On 8th May 2015, the patient received the 1st dose of HAVRIX pediatric. On 9th May 2015, 1 days after receiving HAVRIX pediatric, the patient experienced hives, fever, swelling arm and rash. On 10th May 2015, the patient experienced facial swelling. The patient was treated with ZYRTEC and Steroids. On 13th May 2015, the outcome of the hives, fever, swelling arm, rash and facial swelling were recovered/resolved. It was unknown if the reporter considered the hives, fever, swelling arm, rash and facial swelling to be related to HAVRIX pediatric. Additional information provided: The initial reproter, a Medical assistant to the treating physician, reported that a patient was given the 1st dose of HAVRIX on 08 May 2015. On 9 May 2015, the patient experienced rash, fever, swelling of arms and hives. The patient was treated with steroids. On 10 May 2015, the swelling worsened, having spread to her face so she went to the emergencies. The patient was treated with steroids and ZYRTEC and symptoms resolved on 13 May 2015.
Pt was administered a third dose of the covid vaccine in error. nursing home staff presented the patient to Pharmacy staff as someone who needed a 'second dose'. Pt had already had a second dose (1/5/21, 1/26/21, 2/16/21). No adverse effects were reported. Error was discovered by Pharmacy healthcare supervisor on 5/10/21.
lightheadedness, dizziness  BP: 113/65 97% pulse ox pulse:65
I had flu like symptoms, chills, headache. The big issue though is that I have had tinnitus (a slight ringing / high pitched buzz) in my ears since my second dose of the Moderna vaccine. It has been almost 4 months and the ringing persists.
ADACEL was administered to patient on Jan 4th. On Jan 5 & 6 the patient experienced sore arm & on Jan 7 & 8, swollen lymph nodes. Pharmacist recommended IBU w/c helped with swelling and pain.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 05-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested Sender's Comments: US-009507513-1706USA007776.
Arm soreness, fever, chills, headache, every muscle and joint aches, tiredness and nausea, had to stay in bed for 2 days.
5 adults exp local rxn @ the inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/inj;
SORE ARM FOLLOWING COVID VACCINE; PSORIASIS FLARE; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLARE) and VACCINATION SITE PAIN (SORE ARM FOLLOWING COVID VACCINE) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In October 2021, the patient experienced PSORIASIS (PSORIASIS FLARE). In November 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM FOLLOWING COVID VACCINE). At the time of the report, PSORIASIS (PSORIASIS FLARE) and VACCINATION SITE PAIN (SORE ARM FOLLOWING COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of SORE ARM FOLLOWING COVID VACCINE and PSORIASIS FLARE with respect to Humira was not provided.
Sent:10/18/2022 9:47 Subject: Medication questions~Side effect questions  I received a flu shot at the facility last Friday, Oct. 14. My understanding was that it was the heavier dosage version for seniors. That evening, after dinner, I had tremors in my upper body. I laid down for a bit and warmed up. The tremors did worsen for a bit, especially, it seemed, in the area of my sore shoulder that's been causing problems. The tremors did die down after five or ten minutes. I have noticed some upset stomach problems the last few days, but nothing too serious.
w/in 3 minutes of receiving the 1st does of gardisil she was dizzy, pale, light headed, saying that she couldn't breathe. it sounded like she was gasping for air.
Muscle twitching in bicep and forearm of the arm in which received the vaccine; Muscle spasms in bicep and forearm of the arm in which received the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, supraventricular tachycardia and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and aspartame (MANUFACTURER UNKNOWN); both for an unknown indication from unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 09:00, the patient experienced muscle twitching and spasms in bicep and forearm of the arm in which the patient  received the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle twitching and spasms in bicep and forearm of the arm was not recovered at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt was admitted to facility from ED for COVID-19 infection on 4/8/2021 after receiving the first dose of vaccine on 3/30/2021. Per guidelines, all hospitalizations are reported.
Patient came in for 2nd dose of Moderna vaccine.Shot given at 13:52H,  after injection nurse gave the second shot patient became pale and sweaty. Vital signs checked as follows: BP: 179/116 P 129 O2 Sats 100% offered crackers and water, patient was able to tolerate but was occasionally passing out. Patient said he didn't have any decent meal since last night. Patient wanting to go home, rechecked V/S and still on the high side, BP 178/103 P 119 O2 100% called for team alert and endorsed to Dr. and patient transferred to Medicine C.
Quarter size hive @ site of Varicella vaccine. No other signs or symptoms. BENADRYL given.
I did not have an adverse reaction to the vaccine. In November, I have had severe headaches and a bad cough. I have had multiple tests and my doctors could not explain what is going on. I tested positive for COVID-19 in 03/2023. I had a very mild case but I had a really bad cough.
This spontaneous report was received from a pharmacist, and refers to an approximately 17 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2011, the patient received his first dose of GARDASIL (route of administration, lot number and expiration date were not provided), for prophylaxis, and the patient was 11 years old. In August-2017, the patient received a dose of GARDASIL 9 for prophylaxis (route of administration, lot number and expiration date were not provided). No adverse effects were reported.
COVID-19  04/07/2021  1 of 2  Comirnaty 30mcg   COVID-19  04/28/2021  2 of 2  Comirnaty 30mcg   COVID-19  11/22/2021  3 of 2  Comirnaty 30mcg       Admitted with COVID symptoms and positive test 6/28/22. Patient is pregnant
Redness and swelling around injection site, fever, nausea, diarrhea and headache began within 8 hrs of booster vaccine. Redness and swelling spread on left arm to elbow.  Vomitting and diarrhea ceased on 01/15. redness gone after 6  days but pain, swelling,headache and now itching continue 7 days after vaccine.
Left Deltoid at immunization site, swollen, painful, hot, fever at home 100 at office 8cm annular area. (Cellulitis).
Pfizer-BioNTech COVID-19 Vaccine EUA. Received vaccine in left deltoid at 1300 on 1/7/21. Had sore left axillary lymph nodes upon waking the next morning around 0800 on 1/8/21 that lasted approximately 96 hours. No treatment needed; resolved.
epididymitis, edema in upper and lower legs, skin rash on shin and calf for both legs, Covid feet
Received a subcutaneous injection for second dose of Moderna vaccine; Chill; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine) and CHILLS (Chill) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0112A01) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine). On an unknown date, the patient experienced CHILLS (Chill). On 31-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine) had resolved. At the time of the report, CHILLS (Chill) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067548, US-MODERNATX, INC.-MOD-2021-117024 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: NNI On 10-May-2021: Follow up contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-067548:crosslinked with dose 1 US-MODERNATX, INC.-MOD-2021-117024:same reporter
pt recv vax & devel an inj site rxn characterized by redness, soreness & a lump;
Left arm near injection site: redness, swelling of deltoid muscle, raised hive-like area near injection site, itchiness, sore, warm. Has lasted for 36+ hours and still continues. Took Famotidine, chlorpheniramine, and aspirin. However, symptoms continue.
Pt called a few days post immunizations and reported sever cellulitis which need to be treated by a medical doctor
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK receipt date: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  For additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.