chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Patient got home after waiting 30minutes at the pharmacy and came out in a rash on her face and neck. This occurred at 11.15am roughly. Patient has taken 3 1/2 tablets of Benadryl at the time of reporting the issue. Patient feels fine otherwise and has access to an EpiPen and lives within 5 minute distance from an urgent care.
Patient complains of vaccine reaction after getting COVID vaccine on Sunday, "I just feel dumb", "I don't know what is happening", "it feels less today", "thinking and speaking were hard", "really drowsy" the next day, "feeling better today", "red lump where I got the injection", "swollen, itchy, warm" just noticed today in the morning, some swelling of face on Tuesday but resolved next day, "I took Tylenol with relief", "headache that doesn't go away" "5/10, not painful just annoying" "felt warm inside".  9/16/2021
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 23-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient brought into Covid Observation Area after reporting itchiness to her left forearm and tingling to mouth, lips and nose shortly after receiving Booster dose of Pfizer vaccination. Patient alert and oriented x 4, denies shortness of breath, itching or swelling to throat. No rash or hives noted to left forearm. No noted swelling to face, lips or tongue. Patient states she did not experience any similar symptoms after 1st two doses of Pfizer.    4:13 pm- VS: Temp 97.4, BP 150/84, HR 71, RR 18, 02 SATs 98%. RA.   4:16 pm- Call placed to on call ED physician, Dr. informed of patient symptoms above. Verbal order given per Dr. for Benadryl 25 mg capsule x 1 now. Per Dr., patient to come to ED via ambulance, for further observation due to tingling of mouth, lips and nose. Patient agreed to go to ED. Verbal order for Benadryl 25 mg capsule x 1 now, read back and confirmed.   4:20 pm- Benadryl 25 mg capsule x 1 given now as ordered.   4:23 pm- VS: BP 145/71. HR 75, RR 18, 02 SATs 98% RA. Will continue to monitor.   4:26- Called 911 for ambulance transport to Emergency Department. 911 Dispatcher recommended Epinephrine be administered to patient x 1 now. Patient and Nurse in agreement to administer Epinephrine.    4:30 pm- Epinephrine 0.3 mg auto-injector administered by nurse to patient left lateral thigh.   4:32 pm- Patient reports tingling in nose has resolved and the tingling to her mouth and lips improving. VS: BP 143/73, HR 71, RR 20, 02 SATs 98% RA   4:38 pm- EMT arrived, report of patient symptoms and interventions given to Paramedics. Patient reported tingling in mouth and lips  improving and agreed to go to ED for further observation. VS: BP 141/78, HR 78, RR 20, 02 SATs 98% RA.   4:48pm- Paramedics received notification that ED now at new location and provided ED options to patient. Patient agreed to be taken to another ED.    4:50: Patient transported to ED via EMT in stable condition.
Symptoms start   evening 2-1-2021 slight fever 2-2-2021 fever 99.6  muscle pain legs 2-3-2021 fever 99.7  extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help   2-3-2021 fever 99.9  extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help   2-4-2021 fever99.4    muscle pain whole body easing 2-4-2021 fever, pain  gone called Urgent Care, told to take Tylenol  did  not see a doctor, under lock down in this state,
Patient brought immunization records, staff member reviewed records but did not update our records and administered immunization already given.
Patient came to us and said that she received the Moderna vaccination series and has had menstrual bleeding that hasn't stopped since the first vaccine. She completed the series, but is still having this bleeding. She said that she is going to have to have surgery to fix this.  She says that the doctor thinks it could be from the Moderna vaccine.  She stated that she may have a pre-existing condition that causes this to happen.
Approximately 12 hours after injection, had severe body aches. Thinks she possibly had a fever, but has no thermometer to check.
2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath, back pain, fatigue and a cough. She was sent to the emergency room for evaluation. At that time, she was given a 7 day course of antibiotics. Patient then presented to the ED on 02/25/2021, with worsening symptoms, and was found to be COVID positive.
subsequently developed Bell's Palsy; symptoms of encephalopathy; swollen lymph nodes; Initial information received on 09-Nov-2021 regarding an unsolicited valid  serious case from a consumer/non-health care professional via Medical Information (under reference 00849473).  This case involves a 71 years old female patient who subsequently developed Bell's palsy (Bell's palsy), had symptoms of encephalopathy (encephalopathy) and swollen lymph nodes (lymphadenopathy), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant mediation(s) and family history were not provided.   In 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination (caller does not know which influenza vaccine the patient received).  On an unknown date, the patient subsequently developed a serious Bell's palsy (Bell's palsy) and had symptoms of encephalopathy (encephalopathy)(unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date, the patient developed a non-serious swollen lymph nodes (lymphadenopathy) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient still seemed to be affected by the experience.  No laboratory data reported.  It was not reported if the patient received a corrective treatment   At time of reporting, the outcome of all the events was unknown.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves a 71 years old female patient who had Bell's palsy, encephalopathy and lymphadenopathy, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Moreover, the patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Inability to regulate body temperature  (was freezing all day like I had been in the -17 degree weather for days)  101 degree fever Severe headache Severe muscle soreness throughout entire body  Extremely fatigued +20 sleep
J96.00 ACUTE RESPIRATORY FAILURE 5/13/2022 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 5/17/2022 CHF EXACERBATION, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 5/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 5/17/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 5/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 5/17/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Patient wanted varivax, but I (pharmacist) administered MMR II. I called patient afterwards and told her of the error and patient was very understanding and said she was fine when I asked her how she was feeling. I then fixed the script on file to update to the correct vaccine given (varivax changed to MMR II).
abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays.  Xrays were negative.  I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis.  Back and abdominal pain increase and soreness had spread to the stomach and groin.  After the news broke of the cerebral blood clots in 6 women.  See attached Continuation Page.
At about 2 AM he started getting Hives all over his face & he was screaming at the top of his lungs when the rash broke out(my baby NEVER cries), ran a fever, & started sweating when the fever broke. The next day he was extremely whiny and would not eat like normal. Didn't smile like he always does. Family noticed he wasn't acting like himself.
G62.9 NEUROPATHY 2/1/2023 PROSTATE CANCER
He stated he  had chill s, and just didn't feel right. Took  2  Tylenol at 3pm and by 7,  he felt ok and no further problems
Woke up at 1:00 AM with heart pounding and beating very fast, dizzy, chills followed by high fever. This lasted 2+ hours.  Then  my heart beat so faintly, that I was afraid to go back to sleep for fear I would not wake up.  Felt a little sick to my stomach.  Next day, I felt like I had the flu all day, lethargic, tired but couldn't sleep.  The injection site of the shot was very sore, big red circle about the size of a peach, hot to the touch and this lasted until day 5.  Concerned about 2nd dose, because if the reaction was worse than this, I don't think my heart can take it.
Pfizer 10/22/2021 and 11/12/2021. Positive on 1/9/22
At approximately 1:20 pm on Wednesday, October 12, 2016, pt's preschool teacher noticed that she had thrown up in her sleep. Upon further investigation, it was determined that Pt was in a complete seizure state, and was lethargic, eyes open, staring, pale, teeth clenched, trembling and completely unresponsive. EMS was called to the preschool and pt was transported to Hospital. During transport, pt remained disoriented and suffered an episode of Todd's Palsy. Hospital monitored her for vital signs.  No diagnosis was provided at that time. ER Doctor refused to request a Neuro Consult at that time. No fever noted. Blood sugar was normal. After Pt came out of the seizure and the post-ictal state, they fed her a popsicle which she threw up. Hospital personnel then administered an oral dose of Zofran.  Discharged with instructions to follow up with Neuro, after Pt was able to walk on her own.
The patient fell to his knee because he felt dizzy. He was asked to sit for 15 minutes after the vaccine but only did for a few minutes before leaving. He fell at the front of the store. Paramedics came and examined him. He did not want to go to the hospital.
Several couple weeks later, probably on 11/24/2021, I started feeling more tired which I do not usually feel. It became unusual fatigue. I went to the doctor and they did not give me any treatment because they thought it was a virus. They did blood work but I do not have the results yet. It is getting a little bit better. I still feel fatigued but not as bad as before. I also had 2 COVID tests done because of the fatigue and both were negative.
positive rapid antigen test for COVID-19 on 10Jul2022; positive rapid antigen test for COVID-19 on 10Jul2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 21Jan2021 as dose 2, single (Lot number: 5L3302), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "BPH" (unspecified if ongoing), notes: BPH; "osteoarthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "recovered" (22Jul2022) and all described as "positive rapid antigen test for COVID-19 on 10Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: positive rapid antigen test for COVID-19 on 10Jul2022; (11Jul2022) Positive, notes: RA test pos 11Jul2022, 12Jul2022, 13Jul2022 and 14Jul2022; (12Jul2022) Positive; (13Jul2022) Positive; (14Jul2022) Positive; (15Jul2022) Negative, notes: RA test neg 15Jul2022 and 16Jul2022; (16Jul2022) Negative; (19Jul2022) Positive, notes: RA test positive 19Jul2022; (20Jul2022) Positive, notes: RA test positive 20Jul2022 and 21Jul2022; (21Jul2022) Positive; (22Jul2022) Negative, notes: RA test negative 22Jul2022, 23Jul2022, 24Jul2022, 25Jul2022 and 26Jul2022; (23Jul2022) Negative; (24Jul2022) Negative; (25Jul2022) Negative; (26Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid 10Jul2022, took first dose 09:00, completed 5-day course as prescribed, Treatment stop date 14Jul2022 and then second course of Paxlovid treatment started.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid 19, and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
does not work; does not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "does not work". Clinical course: Nothing and it was reported that patient would never get the vaccine because it did not work and would cause more harm than if he did catch a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left deltoid red, swollen, hot.  No accompanying 5x IE: fever or malaise, child very stoic.
Within 5 minutes I had a headache which stayed with me for 5 weeks. Breasts were sore to the touch for several weeks. When  I returned for 2nd shot on 4-26-21 I shared my symptoms and they  chose not to give me 2nd dose. Referred me to my doctor if I wanted 2nd dose.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
A 60 year old male received six weekly instillations of Tice BCG for bladder cancer. On 06/24/2003 the patient informed the healthcare professional that his internist started his on Norvasc treatment for "malignant hypertension" that day.
Sep20: Receive vaccination Sep21-22: Slight prickly sensation like previously experienced with boosters plus normal injection site soreness, began to notice being a bit sniffly. Sep23: Very runny nose, periodic cough, increased prickly sensation, temp 99-100. Fitful sleep Sep24: Temp 101-102, increased sinus congestion and headache, still frequent runny nose and periodic cough. Went to urgent case - lungs and heart sounded fine, ears and throat clear, nasal passages inflamed, but nothing that indicated an infection. Practitioner recommended symptomatic relief with ibuprofen and acetaminophen and to follow up with primary care if not feeling better by Wed 27Sep. The ibuprofen and acetaminophen helped. Sep25: Runny nose and period cough continued, temp 99 with the ibuprofen/acetaminophen regimen. Very tired - slept much of afternoon. Through the night developed sore throat. Sep26: Sore throat throughout the day, but it did not look like strep from my personal experience. Fatigued. Temp 99. Sinuses still tender, but began feeling a little better overall in the evening, so discontinued ibuprofen/acetaminophen. Sep27: Throat less sore, nose not running as much, not coughing as much. Temp 98.6-99 without ibuprofen/acetaminophen. Had online visit with primary case - assessment is that this is immune response to vaccination rather than other infection. Still fatigued ? slept in the afternoon. Mild sinus headache this evening.
About 10 seconds after the injection, pt experienced a localized reaction. Swelling occurred at the vaccination site with a diameter of 1 cm. Pt did not experience any systemic reaction, and this is the only sign and symptom he has. Pt had no difficulty breathing, and no rash.
slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slightly sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (slightly sore arm). At the time of the report, VACCINATION SITE PAIN (slightly sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection for prophylaxis (strength, dose, route, lot # and expiration date were not provided). Subsequently, the patient received the second and third doses of GARDASIL 9 injection, also for prophylaxis (strength, dose, route, lot # and expiration date were not provided) on 19-AUG-2016 and 25-JAN-2017. No adverse symptoms were reported. Additional information has been requested.
I was six weeks pregnant when I started bleeding on September 4, 2022. I was not seen formally on 09/06/2022, which was noted that there was no pregnancy in my uterus but they knew from my HCG levels that I was pregnant before,  I had to go back two days later and they Biopsy on the fluid that was in my uterus and it came back abnormal, Molar Pregnancy was what they thought it was but they found out that it was not correct and I was treated with Methotrexiate to stop the rising the HCG levels. Blood work was done on the 6of Sept and they did an ultra sound as well.
8/10/21 - 3 pm-6 hr after receiving Vaccine, Headache started and progressively worsened over next 24 hrs.  Had taken1 Aleve before  supper. Overall muscle and joint pain and extreme fatigue started at around 8 pm.  Woke up at 1:48 am with severe abdominal cramps, nausea, Chills with Sweat running off of me, This lasted for well over an hour and half. Dizziness and weakness  throughout this time and all through the following 36 hrs., as well as bouts of nausea. I felt so ill during the night that if I could have made to the phone I'd have called the ambulance.
tested positive for COVID and had received their COVID vaccines; tested positive for COVID and had received their COVID vaccines; This is a spontaneous report from a contactable Nurse. A 33-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (at the age of 32-year-old) (Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunization. The patient past medical history and concomitant medication was not reported. On 01Aug2021, the patient tested positive for COVID and had received their COVID vaccines. This report is from a registered nurse who has a patient that tested positive for COVID and had received his COVID vaccines. She has two people who have tested positive for COVID who had received their COVID vaccines in Jan2021 and Feb2021 on site and she figured it would be better to call about this. Caller says that the patients reported to her because they must if they are sick on site or have COVID symptoms and that all must go through her. The caller didn't test him but he had tested outside and sent the caller the positive reports. The caller received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient had tested positive on Sunday, 01Aug2021. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on plausible dose event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events. Linked Report(s): US-PFIZER INC-202100996959 same reporter, drug, AE, different patient.