chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large bruise followed by clotting event; Large bruise followed by clotting event; Wound care; Skin grafting; This is a spontaneous report from a contactable other hcp (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm on 2021 (Batch/Lot Number: EL1283) (at the age of 21-years-old) as SINGLE for covid-19 immunization at Workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in left arm on 14Jan2021 (Batch/Lot number: EL0140) (at the age of 21-years-old) as SINGLE for covid-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies. Patient medical history was reported as no. Patient concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and pseudoephedrine (PSEUDOFED) and hair/nails supplement; all taken for an unspecified indication, start and stop date were not reported for any. The patient did not receive any other vaccines within 4 weeks. On 06Feb2021, the patient experienced large bruise followed by clotting event within a month post vaccination that leads to tissue removal, wound care and skin grafting. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. It was reported that the patient was hospitalized for all of the events for 2 days from 2021 to 2021. The patient underwent lab tests and procedures which included sars-cov-2 test (test type: nasal Swab) which was found to be negative on 05Mar2021.The patient was provided with surgery, wound care, lovenox shots as a treatment received. The reporter considered the event as serious (Requires inpatient or prolongation of hospitalization). The outcome of events was recovered with lasting effects.   Information on the lot/batch number has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, 4 doses of improperly stored (Merck) VARIVAX (lot # K006134, expired date 29-APR-2016, dose and route were unknown) were vaccinated to the patients. No concomitant therapy was reported. The vaccines were stored under -1.8 degrees Celsius for 4 hours and 3 minutes. The reporter stated that there was a previous temperature excursion (-0.8 degrees Celsius for 4 hours and 45 minutes) on an unknown date. No adverse effect was reported. Additional information has been requested.
Site of injection (left shoulder) was slightly sore after about 4 or 5 hours.  Shot was administered at 8:05AM.  Felt fine until about 6:45PM.  Noticed aches and painst beginning in neck, shoulders, and a slight headache which came and went.  at 8PM, was very tired and began to feel somewhat lightheaded.  Went to bed and felt chills.  Awakened six or seven times during the night to urinate.  Was a little dizzy each time I rose from the bed.  Also felt feverish and took my temperature.  It was elevated to 99.3F, which for me is definitely elevated, since it is usually no higher than 98.6 and is often around 97.9F.   Felt very tired the next morning and had continued mild aches and pains and occaisional shingles-like stabbing pains in rotator cuff of left arm , mastoid bone behind right and left ears, and occaisional  random stabbing pains in earl lobes.  The pains were mild to moderate on occaision.  Left arm was a little sore during movement, especially near the shoulder.  Felt very tired throughout the day and went to bed at 8PM the day after the shot.   That evening in to nightime when I would get up to go to the bathroom, I began to feel better and after midnight of the second day, I felt pretty much back to normal.  The lightheadedness, aches and pains, and tiredness all went away by the morning .   I would also report that I ate normally during these effects and did not suffer any nausea or feel like vomiting at any time.
Patient reported to ER 1 day after receiving H1N1 vaccine with "flu like symptoms", "hurting all over". VS and lab stable - treated for lower back pain. Sent home with instructions to report back if problems continue. Patient reported to ER on 11-20-09. Report is not available. Sister states pt. was treated and sent home. Boyfriend discovered pt. dead at home after returning home from store. 12/2/2009 ED record for 11/19/2009  and 11/20/2009 and dialysis records for 11/13, 11/16 and 11/18/2009. Patient presented to ED with c/o's  flu-like sx: "aching and pain all over", no other sx noted. PE was negative. Tx: IM pain meds Morphine and Dilaudid, po Zofran. Dc'd with Rx for Lortab On 11/20/2009 presented to another ED with c/o's "hurting all over and with c/o's nausea/vomiting. Tx: Demerol and Vistaril Dc''d with dx of chronic back pain.  Notes state that later on 11/20/2009 patient expired at home.  1/7/2010 Death Certificate received. DOD 1120/09. Cause of Death: Acute Myocardial Infarction. Additional information abstracted: Other Significant Conditions - Diabetes.
headache; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ1685, expiry date: Mar2021), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was experiencing a "really super bad headache" on the day of report (19Dec2020) after receiving the covid vaccine the day before (18Dec2020). She took Tylenol and wanted to know if she can take Advil. She was suffering from a terrible headache and did not know if she can take Advil and there was nobody that can tell her whether it was okay with the vaccine. Outcome of the event was unknown.
I got a headache about a day after I got the vaccine. That had happened with the first covid shot I got which was pfizer. However I started getting a visual aura with the headache. Ever since then every time I exercise I get a visual aura in the center of my visual field. It looks like a small flower and lasts about 30 minutes. I went to a neurologist and had an MRI MRA of my brain which was negative. They said it was from the vaccine but I do not think it was reported. The scans were done last fall and I thought by now the aura would go away but I still get it every time I exercise.  I tried reporting this earlier . Somebody called me after I responded on the be safe app. We were disconnected before I could tell her what was going on. She never called back. I had trouble reading the vaccine lot number. It may be 005M21H.
First time caller received first covax and then 2 days later she tested positive; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose and then 2 days later she tested positive for the virus, the event outcome was unknown. No treatment information reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. states she developed a rash at injection site & rash all down right arm the day after injection, she also stated having blurred vision lasting 1 day after injection.
Pt said arm swollen and turned red the next day.  Her arm continued to swell and the red spot continued to get larger and feel warm to the touch.
withing 72 hours, woke up sweating heavily, couldnt walk from exhaustion, heavy breathing, lost hearing in left ear, short of breath,
This is her first flu shot. She has declined all others. She awakened with a painful, enlarged (R) deltoid & under arm lymph area. She reports increased achiness in arm over days, with pain from shoulder to elbow. She is able to work.
10/15/12 40 minutes after leaving clinic & arriving home, N & V began, sx worsened, went ER 10/16/12 with N & V, fever, bilat arms, swollen, redness & pain, drop in BP per ER, tx for bacterial infection by ER MD sx unabated, returned to ER 10/18/12, N & V for 5 days, localized rx to arms lasted x 2 weeks.
Sore arm; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm) and tiredness (Verbatim: tired). The outcome of the pain in arm and tiredness were not reported.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient self-reported this case via interactive digital media. The patient Did not get the CV jab but after much research did do the 2 shingles shots.  In this case the benefit outweighed the risk.  The reporter was not sick after either dose. Just sore arm and tired.  The reporter would take that any day over chronic nerve pain. The reporter said difference here was that you had a choice. The follow-up would not possible as no contact details were available.
Initial report received from a health care professional on 18 MARCH 2013. An 87-year old female patient, had received a dose of FLUZONE (lot number: UH712AA, expiry date: 06/30/2013, dose number and route of administration was not reported) in left deltoid on 22 AUGUST 2012. The patient had no illness at the time of vaccination and concomitant medications were not reported. The patient's previous medical history includes Thyroid disorder and heart disease. ON 22 AUGUST 2012, the patient developed tenderness and redness at the site but not unusual  to her. The patient has persistent muscle soreness, like a "tight band around the arm" and difficulty in picking up things. Corrective treatment and laboratory details were not reported. As of 18 MARCH 2013, the patient had not recovered from the events. Documents held by sender: none.
p/vax pt has contracted Aplastic anemia;blood counts were nl in '92; recv shots;2/22/93, 3/25/93, 9/8/93;next time counts were checked was '97;they were all low;60 day follow-up states the pt has not yet recovered.
Patients is a 13 year old girl who came into facility to receive her Pfizer vaccine. She was nervous upon receiving her vaccine and after the shot was administered she stated she feels a little warm. The vaccinating pharmacist told her to sit and wait in the sitting area for 15 minutes after receiving the vaccine. A couple minutes after her vaccine was administered the girl started not feeling well and fainted in the store and her father caught her. We immediately called 911 and checked in with the young girl. The ambulance came and did a physical exam. They offered to take her to the hospital but the patient declined. Patient left the store shortly after with her father.
As I was leaving the doctor?s office  developed chests pains on the left side.  Chest pains continued for next 3 hours, and after consulting doctor?s office I was advised to go to ER.  I was at the ER for over 6 hours and cardiac testing ruled out a myocardial event.  In fact, cardiac testing has been normal , and I had a follow up echocardiogram on Monday 10/30/23.  I did continue to have chest pains the remainder of the day on 10/17/23 even after discharge from ER.  Chest pains were more intense with movement. I received a toradol shot at ER about 9:00-9:30pm.  When I got home I continued to have chest pains and went to bed around 11:30 pm with continued pain.  When I woke up the next morning my chest pains were gone.  I did not feel well on 10/18/23 but mostly I was tired from the ER ordeal.  I was back to normal by 10/19/23.
THE PATIENT WAS GIVEN PEDIATRIC PFIZER DOSE FOR 5-11 YEAR OLD RATHER THAN THE FULL ADULT DOSE.
11:30pm: fever, chills, teeth chattering, achy. Lasted through the AM. Around 1pm the next afternoon nosebleed began.
Patient was in office for routine visit.  Pt was ordered HPV vaccine, menactra (meningococcal) vaccine, and adacel (tdap) vaccine.  Gave all three immunizations and right after giving the HPV vaccine, patient stating she felt like she was going to pass out.  Patient leaned forward onto her mom while sitting on exam table and passed out, became very pale.  Pt did not fall off table.  Myself and another nurse immediately laid pt back on table.  Pt awoke after only 1-2 seconds.  We elevated pt's legs and had pt lay there while monitoring her for approximately 10 minutes.  Pt was awake, alert, and oriented.  At that time we gave her a small cup of orange juice and elevated pt's head.  Pt laid there for approximately 10 more minutes and then we had the doctor check the pt.  Pt was stating she was feeling fine, awake, alert, and oriented/walking around in room.  Dr. gave the okay for pt to go home.
2 days after I got the COVID vaccine, I began  smelling cigarette smoke without there being any smoke around me. It has been nonstop and is very distressing.
Patient was in today for first TRUMENBA and second MCV4. MA administered injections and approximately 5 minutes later the patient walked out of the exam room to the front to make an appointment. At that time the patient passed out and was caught by MA before hitting the floor. LVN and provider was called immediately. She was laid on the ground with legs up. Vital signs were taken B/P was 98/56 O2 99 initially. Patient was unresponsive for 2 minutes. We placed ammonia inhalant under her nose and she was aroused shortly after. The Dr repeated vital signs about 5 minutes after and they were 103/71. After she woke back up she began to regain color. There was no loss is pulse or respirations. Patient stayed for 20 minutes after episode before MD allowed her to leave. Also was given ER precautions. Then today at 430 the patient came in with complaints of R arm pain and swelling. Dr went in to assess the patient and saw that her arm was not red or hard, however her right arm was visibly swollen and tender to touch. She was advised by the provider to ice it 3x's a day and take MOTRIN. She may return in 1 week if the swelling continues.
Information has been received from a health provessional concerning a female consumer with an amoxicillin allergy who on 02/08/01 was vaccinated with MMRII 0.5 ml IM (Lot 628755/1147J). There was no concomitant medication.  On 03/26/01 the patient complained of swelling pain and discomfort at the injection site.  Follow-up information from the same LNP indicated that the patient was administered the vaccine IM in the deltoid instead of SC and C/O a sore arm. The patient subsequently recovered from her sore arm. Additional information is not expected.
Prolonged heavy periods; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 16:30 (Lot number: EW0168) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID vaccine details: product: COVID 19,, Lot number: EW0129,, Lot unknown: False,, Dose number: 1,, Vaccine location: right arm), administration date: 21May2021, when the patient was 14 years old, for COVID-19 Immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12Jun2021, outcome "not recovered", described as "Significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm)". The event "significant swelling in right arm pit/front of shoulder (pectoral muscle) and right bicep (vaccine arm)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling.  Additional information: The patient had no COVID prior vaccination. The patient was not tested COVID post vaccination. Patient had no known allergies. The patient was treated with Ibuprofen and Benadryl.  No follow-up attempts are possible. No further information is expected.
Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 1994 and Sjogren's syndrome since 2005. Concomitant products included TOCILIZUMAB (ACTEMRA) in 2019, METHOTREXATE from 1998 to 15-Sep-2021 and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) from 1994 to an unknown date for Rheumatoid arthritis, CICLOSPORIN (RESTASIS) from 2021 to an unknown date for Sjogren's disease, ATENOLOL from 2021 to an unknown date for Tachycardia.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.            No treatment medication was reported. Patient states that got Moderna vaccine booster dose 0n 09-sep-2021 and experienced vomiting and diarrhea.    This case was linked to MOD-2021-324289 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received, updated patient details, medical history and concomitant medications.
Injection site pain, overall physical pain, especially joint pain, loss of appetite, no energy, slight fever
Cannot turn head to the left; Sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Cannot turn head to the left), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Cannot turn head to the left), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (Cannot turn head to the left), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball.; Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball.; Patient told reporter that it was hard for her to get up and get around for the first week. Patient had to force herself to get up.; Reporter states that patient received second dose two weeks after first dose; Reporter states that patient received second dose two weeks after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Verbatim: Breast cancer; "Open heart surgery" (unspecified if ongoing), notes: Verbatim: Open heart surgery; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: COUMADIN. Vaccination history included: Covid-19 vaccine (Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "recovering", LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball."; MOVEMENT DISORDER (non-serious), outcome "recovering", described as "Patient told reporter that it was hard for her to get up and get around for the first week. Patient had to force herself to get up."; OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Reporter states that patient received second dose two weeks after first dose".  Additional information: Patient had a big purple circle around her arm. It looked like patient got hit by a baseball: Patient sent reporter pictures of her arm. Reporter believes that patient's big purple circle around her arm began the day after she received the covid vaccine. Patient told reporter earlier on the phone today that it was getting better, but the spot was still there. Patient told reporter that it was hard for her to get up and get around for the first week. Patient was taking care of the grandkids. Patient had to force herself to get up. Patient was feeling better now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 1st dose of COVID-19 vaccine 12/24/2020.   On 1/1/2021 patient developed chills, rhinorrhea, headache, loss of taste/smell, and cough.
Coronavirus test positive; This is a spontaneous report received from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medication; patient mentioned as taking concomitant products as yes, as patient have hypothyroidism. The patient was tested positive after taking the first shot of the Covid19 vaccine. Patient was just wondering if she will get the next dose on 28Mar2021. Patient was tested positive (Covid test) on the 17Mar2021; also reported as Coronavirus test positive. The outcome of the event was unknown.