chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
A report was received from a health care professional on 12 November 2003, concerning a 17-month-old female vaccine who inadvertently received Fluvirin on 11 November 2003.  On 11 November 2003, the vaccine inadvertently received Fluvirin 0.25ml intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 23 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine inadvertently received 0.5ml Fluvirin.  No adverse event had occurred at the time of reporting.  No follow-up pending, all information received.
First sign was itching on Right Wrist and Palm.  Then blisters appeared mostly on the Upper Right Arm.  The blisters were diagnosed as Bullous Pemphigoid by Primary Care Doctor and confirmed by Dermatologist.   They resolved themselves after a few weeks.  This was the first such blistering event and we believe the Bullous Pemphigoid was triggered by the second shot of the COVID vaccine.
Fever > 101 F, chills, severe body aches, pain 10 out of 10,  injection site red, raised, and swollen, diameter 7cm
Historically since my late teens, I?ve had predictable periods. After my vaccinations, I?ve noticed heavier periods and for 2 days longer than average.  My most notable change is after my booster (3rd dose) of my COVID vaccine. My periods have been early and late (ranging from 23 days to 32 days between), and also heavier. When I say heavy, I mean the first 3 days, I go through a super plus tampon every 2 hours. This is not normal for my body, and it?s important for research that I report it.
66 year old female to  with dizziness & hypertension during post vaccination observation period.  Taken to  ED with dizziness, lightheaded, hypertension & bradycardia, given hydralazine IV & Norvasc (orally) . COVID & flu testing negative. Improved & discharged to home.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of VAQTA with lot# L036300 and expiration date: 04-NOV-2016 and with lot # L015460 with expiration date: 20-JUL-2017; with lot # L023232 with expiration date: 25-FEB-2017; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Facial Numbness, partial swelling to nose, upper lip, cheeks ( Dr. Visit Tested for Herpes - Negative Possible Lupus)
Patient had site reaction of itching right after administration of vaccine and has continued to date. Area of site reaction is approximately 3 inches and is red and slightly swollen. Patient has not tried anything to alleviate itching.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got the pfizer vaccin 11:00am and after 2-3 min after din't answer back my question like you have to stay 15 min then i'll give your immunization card which will be 11:15am but was mummering and showed syncope symptomes soI make th patient kind of lie down and check patient in 2 min. but she was still said feld so dizzy so I had to call 911 and 911 came check bp & Temp. BP was low so 911 team took her ER. About 4:33 pm patient came home checked 5-30-21 she was fine
This spontaneous report was received from a nurse from the Vaccine for Children program refers to unspecified number of unspecified patients. The nurse reported that a physician's office stated that doses of VARIVAX (Merck) underwent defrost cycling due to the freezer, and therefore an unspecified number of doses of VARIVAX (Merck) injection (each single dose was 0.5 ml, subcutaneously, once) (indication and lot # not reported) improperly stored had been administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects reported. Additional information has been requested.
LOCAL REACTION-ONSET OF REDNESS ("ABOUT QUARTER SIZE")  NOTICED  BY SCHOOL BUS DRIVER APPROXIMATELY 24 HOURS AFTER INJECTION. SYMPTOMS AT THIS TIME 2/19/2009 @ 9AM HARD, RED WARM-SITE 8SMWX8CML PATIENT WILL FOLLOUP WITH MD TODAY.
Patient reported complete paralysis in his arm following the flu shot, lasting for about one day and then continued weakness in the arm for several days.
Patient admitted for shortness of breath and congestion, admitted for COVID PNA. Of note, vaccine lot number, site, and place of vaccination are not available for reporting.
Information has been received from a registered nurse concerning a 61 year old female with seasonal allergies who on 18-MAY-2006 was vaccinated into the right hip, at the head of the femur, with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination included a dose of tetanus toxoid.  Other concomitant therapy included " LEXAPRIL" and fexofenadine hydrochloride (ALLERGA).  The nurse reported that the patient presented on 24-MAY-2006 with a bruised right hip.  The patient also told the nurse that she was having difficulty sitting.  At the time of the report, the patient had not recovered.  Additional information has been requested.
aching all over her body everything was aching; bedridden; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL3248; expiration date: Apr2021) via an unspecified route of administration administered in arm right on 28Jan2021 as single dose for covid-19 immunization (at the age of 78-years-old). Consumer said she had medical history of breast cancer and has undergone chemotherapy and radiation on an unknown date 2-3 years ago and unknown if ongoing and had ongoing blood pressure and thyroid from an unknown date. Patient has not had any positive test for Covid prior to the vaccine. Concomitant medication(s) included anastrozole taken for breast cancer from an unspecified start date and ongoing; furosemide; losartan; metoprolol and amlodipine all those were taken for blood pressure, start and stop date were not reported and warfarin, omeprazole, and vitamin D3 taken for an unspecified indication and levothyroxine taken for thyroid disorder and start and stop date were not reported. The consumer stated that she received first dose of vaccine and on 29Jan2021 she had aching all over her body and everything was aching, and she was just bedridden the 2 days till 30Jan2021 however she did not go outside of the house after that because of not feeling well on Jan2021. She further mentioned that aching was not like before, it was all over her body before, before everything was aching, now the aching was just on her arms, on right arm in particular. She further stated that she was scheduled for the second dose 18Feb2021 and first dose of the vaccine was given on her right arm because she has breast cancer on the left side. She wanted to ask if having side effects like this after the first shot was an indication the person may have had the covid prior to the vaccine and that was why there is a reaction like this after the vaccine and if the second shot going to be the same. The outcome of the event bedridden was recovered on 30Jan2021 and patient was recovering from the event of pain and outcome was unknown for the event of malaise.  Follow-up attempts are completed. No further information is expected.
This also happened; This spontaneous case was received on 27-Aug-2021 via Med Communications (reference number: SEQW21-01771) from pharmacist and concerned an unknown age, female patient.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; route of administration, dose, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms, reported as this also happened (case 202102927).  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.   The case is linked to case 202102927 (the same reporter and patient).  Company comment: A patient of an unknown age was administered Fluvirin. On an unknown date, an unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms. The patient's medical history and concomitant medications were not reported. Due to unclear information regarding temporal relationship, causal role of the suspect vaccine is assessed as unassessable.; Sender's Comments: A patient of an unknown age was administered Fluvirin. On an unknown date, an unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms. The patient's medical history and concomitant medications were not reported. Due to unclear information regarding temporal relationship, causal role of the suspect vaccine is assessed as unassessable.
Information has been received from a registered nurse concerning a 5 year old female with respiratory issues who on 6/9/05 was vaccinated wit a dose of Pneumococcal 23v polysaccharide vaccine lot 650082/0691P. Concomitant therapy included an unspecified respiratory medication. On 6/10/05 the patient developed an injection site reaction. The nurse reported that on 6/10/05 the patient developed fever (measurement not reported), hives, rash and redness at the injection site. The patient was treated with cefdinir (Omnicef), acetaminophen Tylenol. and Ibuprofen Motrin. The patient's outcome was unknown. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 15th May 2018, the patient experienced chills, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the pain in arm, chills, muscle pain, fever, headache and weakness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, chills, muscle pain, fever, headache and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One day after receiving SHINGRIX, the patient experienced chills, muscle aches, fever, headache and weakness. The limited information was provided by the patient. The patient wanted to remain anonymous and has denied permission to contact their physician.
VOMITING  DIARRHEA HEADACHE BODY PAIN TYLENOL,CYCLOBENZAPHRINE, HYOSCYAMIN ONDANSETRON
Pt received vaccine and stood up roughly 1 minute after vaccination and passed out. she hit her head on the plexiglass and then hit her head on the floor, lost consciousness, used smelling salt to wake her up. Patient woke up and begin to vomit. lost consciousness again, used ice packs on back of neck and forehead. Cold compresses on cheeks. Pt lost control of bladder and urinated. Pt came to after about 15 minutes after - was under supervision of two pharmacists for the entirety of the full 15 minutes. Pt went with EMS.
For about 30-40 minutes, I had frequent heart palpitations. A burst of palpitations every 10 or so seconds. The palpitations were more frequent and more severe while standing. Palpitations were very frequent for 30-40 minutes, after which I?ve had one or two more palpitations, over the course of about 12 hours by now.
From telephone call recived on 12/04/02, it was reported that on 11/08/01, Fluzone vaccine was administered and patient developed swelling at injection site the same day. The next day, the injection site was grossly swollen.  Patient  was seen by physician, who ordered warm soaks, Symptoms completly resolved.
pericarditis diagnosed in setting of positional chest pain, minimal EKG changes, trop negative, + leukocytosis
On 4/26/2022, I felt like I was possibly coming down with a cold. I took an at-home COVID test, and the result was negative. At about 11:30PM, I woke my roommate up to let him know I couldn't breathe and that he should call the emergency number. The paramedics came and took me to the ER. I don't remember much after that. They ran various tests, though I don't know the names of them. On the morning of 4/27/2022, I was taken from the ER to a hospital room. I had an episode in which I couldn't breathe, and the staff performed different procedures to aid my breathing, but I can't describe what they did. I don't know how long this lasted, but I was able to breathe again eventually, and they were all relieved. I was released from the hospital  4/29/2022 at 11 AM. They prescribed me various inhalers and an oxygen machine, which I use only at night. I was also given an antibiotic. Many years ago, I was diagnosed with COPD, but I never had problems until now. The doctors told me that I had hypoxia consistent with COPD.
Didn't feel great; Little shaky; Side effects made her nervous; Lightheaded; Warm at injection site; Knot at injection site; Hard at injection site; Rash at injection site 5 inches wide; Swollen at injection site; Arm soreness for 2 to 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous) and DIZZINESS (Lightheaded) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness for 2 to 3 days). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 added Email ID of reporter.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site induration, injection site rash, and injection site swelling are consistent with the known safety profile of the vaccine.
Patient developed shingles after receiving the shingles vaccination. She received the vaccination on 9/3/2017 at the recommendation of her oncologist. Patient saw an express clinic on 10/11/2017 for the infection and received valacyclovir 1 gm three times daily at that time. The shingles blinded the patient in her left eye.
SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 in the morning for prophylactic vaccination. The batch No. was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness at injection site. This report was non-serious.
Expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided   This case was linked to MOD-2021-357985 (Patient Link).
Migraine, sore throat, then started wheezing approximately 15 min after receiving FLUMIST. Given nebulizer treatment.
Patient received a vaccine that had been reconstituted beyond the recommended 6 hour time frame. It had been reconstituted for 6 hours and 35 minutes at time of administration. We contacted Pfizer and they provided excursion data that stated the product is good for an additional 18 hours beyond the initial 6 after reconstitution. The patient did not complain of any adverse effects.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 2:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.48.  Concomitant products were not provided.  On 24-MAY-2021, Excursion time was 08 AM, and 9AM. temperature was 35 and 35 respectively. total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-MAY-2021, vial was moved to clinic on 24-MAY-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-JUN-2021.  On 24-MAY-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
18 minutes after receiving second covid19 dose, patient complained of "not feeling well" and chills.  10:23a pulse 86.  complaint of chest tightness.  EpiPen dose given at 10:27a, oral Benadryl 25mg given 10:30a.  10:30a BP 188/92, pulse 98.  patient sent out of facility to ER via EMS.
Patient noticed 1-2 inch raised bump. Bump was red, hot, and itchy. Patient spoke to urgent care doctor to go in for antibiotics. She is currently taking benadryl and ibuprofen for the itchiness.
Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, headache, dropping things.