chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vasovagal syncope; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, a couple minutes later of vaccination, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. The patient was then transported to emergency department next door by the  emergency department staff where patient was monitored and ultimately discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syncope on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210401417 -COVID-19 VACCINE AD26.COV2.S-VASOVAGAL SYNCOPE. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
This initial spontaneous case, received on 30-Oct-2017, reported by other-non health professional, and concerns a 55-year-old female patient. The patient's medication history included PTSD (post-traumatic stress disorder) due to car crash (occurred and resolved on an unspecified date). Current conditions included sprained ankle since an unspecified date. The patient's concomitant medication included AMBIEN, MOTRIN, PAMELOR, NEURONTIN and unspecified steroid injections for sprained ankle. On an unspecified date in mid-October, the patient was administered with FLUCELVAX QIV of 4 strains (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: F95225A (as reported), expiry date: not reported). Immediately, after administration of FLUCELVAX QIV, the patient had extreme pain in the left deltoid and it hurts to reach forward. On an unspecified date, the patient went to a doctor and tried a steroid pack and a steroid shot. The pain worsened at first and then got little better. It was reported that, the patient's blood pressure "skyrocketed" after vaccine administration. The pharmacist had a note of patient's blood pressure and she was fine then. It was stated that, the initial injection was very painful. The patient had a continued bad arm pain, it was not easing and got worsened in the mornings. It was reported that, the patient's daughter also experienced the same pain (initial injection was painful). However the daughter's arm pain eased up after a couple of days. The daughter's arm hurt for just over a week and got cured. At the time of this report, the patient continues to have arm pain (not recovered). The outcome of rest of the events were not reported. The reporter considered the case as non-serious and assessed the event hypertension as related to the influenza vaccine. Follow-up report received on 21-Nov-2017: Outcome of the event injection site pain was updated to not recovered from unknown and narrative was amended accordingly with the relevant information.
Swelling in armpit with tennis ball size mass; Swelling on collar bone with a small ball size mass that rolls; Swelling in neck; Tender feeling; Awkward pain under arm; Shoulder pain; Collar bone pain; Neck pain; Soreness in arm; Could not raise arm above shoulder; Awkward pain radiating along back of arm, down to elbow and fingers, through the muscle in back and into the spine, also to the collar bone and into the neck; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 08May2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously also received ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN) for unknown indications and experienced drugs allergy. On 10May2021, second day after vaccine, the patient experienced soreness in arm, could not raise above shoulder. Awkward pain radiating along back of arm, down to elbow and fingers, through the muscle in her back and into her spine, also to her collar bone and into her neck. On 11May2021, on the third day, the patient was able to lift her arm over her head and also experienced awkward pain under arm, shoulder, collar bone, and neck. On 12May2021, day 4, the patient had same pain and noticed swelling in armpit with tennis ball size mass, swelling on collar bone with a small ball size mass that rolls, and swelling in neck. Pain was moderate but more of an awkward and tender feeling. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in arm, could not raise above shoulder, awkward pain radiating along back of arm, down to elbow and fingers, through the muscle in back and into the spine, also to the collar bone and into the neck, awkward pain under arm, shoulder pain, Collar bone pain, neck pain, swelling in armpit with tennis ball size mass, swelling on collar bone with a small ball size mass that rolls, swelling in neck and tender feeling were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
110PM nurse observed pt rt arm to see if any local rxn since this was 1st flu vax;pt arm was red/swollen, itchy;nurse proceeded  to obtain ice to put on arm then pt c/o dizziness on & off;severe h/a;clammy & sweaty;on 02;nail bed cyanotic
Blurred vision; This is a spontaneous report received from a contactable consumer, the patient and contactable health care professional. A 75-year-old male patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 18Mar2021 at 10:00 (at the age of 75-years-old) as a single dose, for COVID-19 immunisation. Medical history included kidney failure, heart, asthma and chronic obstructive pulmonary disease (COPD). The patient received unspecified medications in two weeks prior to COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, the patient had blurred vision for three hours during dialysis, which resulted in doctor or other healthcare professional office or clinic visit. No treatment was given for the event. The clinical outcome of event blurred vision was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After speaking with the immunizing pharmacist, no recollection of the incident occurred.  Once processing the paperwork, it was noted that the patient got the booster early.  1st 8/19/21, 2nd 9/9/2021.  Booster should have been in February of 2022, but received 1/20/22
I was vaccinated on 03/17/2021 with the Moderna vaccine.  On 03/24/2021, I developed a rash on my left arm where I was vaccinated.  It became itchy and then warm to touch.  It lasted for a couple days and went away.  On 03/30/2021, I developed the rash again only it was larger and redder on the same arm and area.  It also lasted a couple days.  I went to the doctor on 03/31/2021 because I was concerned about the reoccurrence of the rash and that it was bigger and redder than the first occurrence.  He prescribed Prednisone 50 mg and Banophen 25 mg, neither of which I took.  As of 04/03/2021 the rash is gone for the time being.
This spontaneous report as received from a consumer refers to her 16 years old daughter with no pertinent medical history and allergy to tree nuts. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) IM on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included: birth control pill for regulating her menstrual period. The consumer reported that on 29-AUG-2012, "approximately 24 hours" after receiving her first dose of GARDASIL, the patient experienced extreme dizziness. The consumer explained that the dizziness lasted for approximately 24 hours. The consumer was unsure at this point whether the patient would be receiving her second and third dose. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. The patient did not seek medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
My daughter is 13 yrs old and has received the gardasil vaccine during which before receiving the 3rd vaccine I was notified that there would be some information broadcasted.  I did decide not to give her the third vaccine due to her having some of the symptoms which included headaches, abdominal pain, nausea, fatigue, shortness of breath, chest pain or tightness, I have taken her to the emergency room twice this month for those symptoms and the physicians are not sure what is happening and say it could be asthma but I am concerned that it is more than that.  Please let me know what else we need to do.  Thank you.
Friday 3/19 Confusion, did not know her granddaughter, which grandchild she was kept confusing family names. That was very unusual for her. Saturday 3/20 didn't feel good that day, Sunday 3/21 around 3am got up to go to the restroom got very light headed and fell/fainted hitting her head on the night stand and falling to the floor. When EMS arrived she was in A-fib. That had never happened before. No known heart problems.
rapid and irregular heartbeat, 132 bpm...blood pressure rose to 151/101 lasted several hours... i took half of a metotropol 12.5mg  laid down and hour later heart rate decreased
Covid Arm- day 7, area of injection site swollen, red, and warm to the touch
The patient did not report adverse event yet. The patient was given Pfizer for first dose, came to Pharmacy for her second dose. However, it was overlooked and had given the patient Moderna vaccine for her second dose, which is all that location carries.
PE; blood clots; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA7484), administered in left arm, on 27Jul2021 at 10:00 (at the age of 60-years-old) at dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), high blood pressure, chronic sinusitis and gastrooesophageal reflux disease (GERD). The patient had not known allergies and had not COVID prior vaccination. Concomitant medications included lisinopril, pantoprazole, rosuvastatin calcium (CRESTOR), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); all reported as other medications in two weeks. The patient developed pulmonary embolism (PE), blood clots 7 days later, on 03Aug2021 at 15:00 and was admitted to hospital. The events resulted in emergency room/department or urgent care visit and hospitalization for 2 days in 2021. The patient had been tested for COVID post vaccination, on 16Sep2021, via nasal swab COVID test, rapid PCR: negative. A treatment was administered for the events and included ELIQUIS blood thinner. The patient was recovering from the events.
Pfizer 4/13/21 and 5/4/21. Positive on 1/25/22
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: After the patient received the 2nd dose patient complained of arm pain and then became unresponsive. Mother and I supported her head and asked if she was okay. Mother described that this had happened in the past when she was younger with vaccinations. She became responsive after about 1 minute. Patient became nauseated and vomited. We got her some water and some goldfish crackers because she had not eaten that morning. Patient and Mother stayed in the vaccine room for 30 minutes.
I received the first COVID vaccine Friday, 1/8/2021, I found out I was pregnant the next day Saturday, 1/9/2021. This was a planned pregnancy.  I had bloodwork done to confirm the pregnancy 1/12/2021, however my hcg did not double or rise significantly 3 days later. Over the next 1-2 weeks I had blood work and ultrasounds performed to determine if this nonviable pregnancy was an ectopic pregnancy or a chemical pregnancy. Thankfully it seems to be a chemical pregnancy.
Beginning the night of 5/14,  the injection date, I began to feels strong aches and mild fever. Through the night the aches became severe enough to prevent sleep and I began to experience intense bouts of chills, followed by fever and profuse sweating. These symptoms continued through the day on Sunday 5/16. On Monday 5/17 I felt the symptoms lessening, and on Tuesday I felt better after a full 7 hours of uninterrupted sleep. Wednesday 5/19 I woke up feeling dizzy and disoriented. My limbs were weak and I was feeling body aches again, though not as sever as after the initial shot. I have a fever of 101.1 degrees F and have reached out to my PCP to give me direction on what to do next.
Beyond use date for this vial of vaccine was 11/27/2021 and the vaccine was reconstituted and given on 11/29/2021. The vaccine had been stored at proper temperature.
Started getting hives a few days after the 1st dose but hives appeared worse after the 2nd dose i received  on 8/18/2021. On 8/29/2021 I had to go to urgent care due to hives and swollen eyes and lip which appeared to get worse throughout the day despite me having taken benadryl.
pt recv vax 26SEP95 & 12APR96 pt exp varicella like rash w/@ least 50 lesions;p/7 days the pt recovered;
Body aches, tiredness and headache. Resolved by 9:00 on 02/04/2021.
I did NOT have an adverse reaction to the vaccine, I got covid 11 months after my booster and the CDC called and said I need to report it here.  Again, no adverse reaction to the vaccine.  I was 3 months pregnant when I got my booster (3rd shot, Pfizer) in October 2021 and had a healthy, full term baby in April 2022.  He weighed 9lbs at birth.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/30/2020, 01/27/2021, and 11/02/2021. The individual was admitted to hospital on 10/16/2021. They tested negative for COVID-19 on 10/16/2021, 10/20/2021, 10/26/2021, 10/27/2021, and 11/01/2021. On 11/07/2021, an antigen test was negative but a PCR test was positive. The individual remained hospitalized until their death on 11/15/2021, which is 13 days after receiving the third/booster dose.
fall; flu; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who experienced fall and flu (influenza), while he/she received vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious fall and flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  Information on batch number will not be available
Awoke with violent chills and some achiness. Chills and aches persisted on and off for about 12 hours. Bundled up and drank lots of fluids, took Vitamin C, Vitamin D & Zinc, and rested for the duration.
Daily bloody noses; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 the patient experienced daily bloody noses. The clinical outcome of the event daily bloody noses was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
chest pains; pain at the injection site, left arm; horrible chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), VACCINATION SITE PAIN (pain at the injection site, left arm) and CHILLS (horrible chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (for which she had chemotherapy and radiation.), Knee injury (she gets regular injections.) and Heart disorder (hole in heart). Concomitant products included TAMOXIFEN for Breast cancer.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHEST PAIN (chest pains), VACCINATION SITE PAIN (pain at the injection site, left arm) and CHILLS (horrible chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pains), VACCINATION SITE PAIN (pain at the injection site, left arm) and CHILLS (horrible chills) outcome was unknown.
Information has been received from a healthcare worker concerning a 67 year old female with allergies to erythromycin, aspirini (+) oxycodone hydrochloride (+) oxycodone terephthalate, prochlorperazine maleate, propoxyphene hydrochloride, codeine, cefaclor, dexamethasone, ranitidine hydrochloride, and naproxen sodium who on 10/26/05 was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). Concomitant therapy included esomeprazole magnesium, levothyroxine Na, estradiol, trazodone HCl, Lactobacillus acidophilus (as drug), PROTAZYME, OSTIVORE, albuterol sulfate (+) ipratropium bromide, salmeterol xinafoate, budesonide, and tramadol HCl. On approximately 10/26/05, the patient experienced numbness in the arm that received vaccination, tightness in chest, fever of 102, and hot red spots on her body. The patient sought medical attention and was hospitalized. The patient's outcome was unknown. Additional information has been requested.
Information was received from a registered nurse, who reported that multiple unspecified patients (demographics unknown) received oral ROTATEQ (dosages, routes of administration, lot numbers and expiration dates not provided) on multiple unspecified days, which had been improperly stored. No adverse effect reported. No additional information available. Additional information has been requested.
Initial unsolicited report received from a nurse on 31-Oct-2017. This case involves a female patient (age between 30 to 90 years), who was vaccinated once with 0.5 ml FLUZONE QIV via intramuscular route (batch number: UT5899LA, expiry date, dose in series and site of administration not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the experienced severe arm pain following vaccination. Arm pain was so severe that it was difficult to move the arm. Lab test was not reported. It was reported that PARACETAMOL (Tylenol) did not help reduce the pain and were given OXYCODONE (Oxicodone). Patient may also took METHYLPREDNISOLONE ACETATE (DEPO-MEDROL INJECTION) 31-Oct-2017, patient's events were resolving. Documents held by sender: none.
Information has been received from a physician concerning a 21 year old female who on 14-AUG-2007 was vaccinated with the first dose of Gardasil (Lot # and route of vaccination not provided). Post vaccination that same day the patient fainted. Unspecified medical attention was sought. The physician reported that the patient did not appear to be injured, her vital signs were stable (actual value not provided). The physician reported that the patient was recovering in the office. Additional information has been requested.
This spontaneous report was received from the patient's mother referring to a 19-year old female patient. The patient did not have any medical history, concurrent conditions and concomitant medications. On 11-MAY-2018, the patient received her first GARDASIL 9 0.5 ml (route, lot and expiry date not reported) for the prevention of Human papilloma virus. It was reported that one to two days later (approximately 12-MAY-2018), the patient broke out in a full body rash (rash generalized). The patient saw physician for the event and unspecified treatment was provided. Biopsy was performed and results were not reported. Outcome of the event was not recovered. Causality of the event was not reported.
Back pain increasing with each day, resulting in immobility due to severe pain on 10/19/13.
Received vaccine - post that - very lethargic on 2/19/10 AM. Per mom had twitches at nite, but no seizure that she knows of. Did have bite on both sides of tongue. Poor response to mom at home, decreased response in the clinic, very tired. In the ER all labs were normal except HCO3 was decreased. Was give IVF and improved lethargy from AM to 4PM. Follow up information - HAVRIX correct vaccine lot number provided.
We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per agency recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.