chrisvoncsefalvay/vaers-outcomes huggingface dataset:
underlying Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER2613 or EL2613), via an unspecified route of administration, administered in upper arm on 15Apr2021 at the age of 72 years as single dose for covid-19 immunisation. Medical history included atrial fibrillation from 2017, diagnosed around 4 years ago, stroke from 11Sep2001, osteoarthritis from 2019 diagnosed around 2 years ago. Concomitant medications included verapamil hydrochloride (VERAPAMIL ER) at 120mg for atrial fibrillation, apixaban (ELIQUIS) at 5 mg twice a day to prevent a stroke. Historical vaccine included the first dose of BNT162B2 (lot ENB208 or EN6208) received on 22Mar2021 at the age of 72 years for Covid-19 immunization. She had underlying Atrial Fibrillation and had 2 episodes where she sent to the ER after getting vaccinated with the 2nd dose. The first time the patient went into atrial fibrillation was on 24Apr2021 and she had to visit the Emergency room. Patient was given multiple IVs and had to stay in the emergency room for 24 hours. Patient was sent home on 25Apr2021 but she had an old stroke so she was unsure if they formally admitted her to the hospital or not. The second time patient went into atrial fibrillation she had to visit the Emergency room. It was on 15May2021 and the patient had to stay there for a little bit but then came out of atrial fibrillation and was sent home that same day, 15May2021. Patient had been out of atrial fibrillation since the 15May2021. Outcome of event was recovered on 15May2021.
Child reported to County Health Dept. where vaccine administered with clear watery looking blisters at site of injection given 8/4/04. Area on RUA was perhaps an inch in circumference.  Client denied burning, itching, pain, fever.  Surrounding area was unremarkeable. First noted by clt. yesterday. Advised use of neosporin BID topically, keep clean and apply ice pack if desired.  To return if no improvement.
Fever, body aches, inability to sleep, extreme fatigue, upset stomach, dizziness, headache, confusion for about 14 hours.
pt presents with c/o fever, chills, body aches, headache, sore throat, loss of smell/taste, cough, diarrhea and fatigue since tuesday
Pt. states he was here on 12-19-11 & got the flu shot & felt fine when he was here & about 6 pm that afternoon he started getting chills, elevated fever, HA & slightly disoriented. Appt for dr visit when flu shot was given at 1:00 pm. Pt states "that flu shot made me sick & I will never take another one."
Patient stated on form and questioned in person if she had ever received a COVID-19 vaccine. Patient answered no.  Vaccine was administered at 10:03 a.m. In the afternoon while entering vaccine in state immunization system , patient records show she received 2 doses of Pfizer on 01/18/21 and 02/08/21.   So the vaccination today was her 3rd dose and of a different manufacturer.
Shingles; Pain and pinching sensation in the buttocks area; Pain and pinching sensation in the buttocks area; Inappropriate age at vaccine administration; off label use; Suspected vaccination of failure; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a 19-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for an unknown indication.   Previously administered products included Humira (the patient experienced lack of response to Humira).   On an unknown date, the patient received Shingrix at an unknown dose and Xeljanz 10 mg twice daily (20 mg daily). On an unknown date, 84 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain (serious criteria hospitalization), inappropriate age at vaccine administration and off label use. The patient was treated with acyclovir and steroids nos (Steroid Therapy Nos). Xeljanz was continued with no change. On an unknown date, the outcome of the vaccination failure, inappropriate age at vaccine administration and off label use were unknown and the outcome of the shingles, buttock pain and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, buttock pain and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by Pfizer. It was reported that the patient was switched from Humira to Xeljanz 10 mg Bid because of lack of response to Humira. The patient received Shingrix nearly 4 weeks prior to start of xeljanz. The patient was able to get a prescription for Shingrix because she was hospitalized at that point, which led to inappropriate age at vaccine administration and off label use. Nearly 8 weeks into receiving Xeljanz, the patient contacted the physician with some pain and pinching sensation in the buttocks area. The patient was diagnosed with Shingles due to Herpes zoster. She was treated with Acyclovir. She was kept on Xeljanz and still is on xeljanz. The patient was better and the physician was planning to keep the patient on Xeljanz 10 mg bid. The patient was also on steroid therapy as well. The physician was gradually tapering her off of her steroid while on Xeljanz. The shingles symptoms happened when the patient steroid dose was down to 15 mg/wk. The physician expressed his surprise that patient shingles developed shingles while on lower dose of steroids rather than higher doses. This case was considered as suspected vaccination failure, since the details regarding the dose number were not provided. Reporter did not wish to be contacted for follow-up.
Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection. Client given Benadryl 50mg po x1 approximately 5 minutes after symptoms began. Client reported increased in facial/mouth tingling and complained of nausea. No vomiting. Client continued to report increasing symptoms of facial/mouth tingling which resulted in transport to the local ER. No notable external edema observed in facial area or otherwise.
Child on 9/13/08 went to local Emerency room with a CC of vomiting x 2 and was sleeper and had an episode of eye deviation and unable to respond to to simple questions.  Tehre was no fever LOC SOB  Chold left the ER awake and well responding well.  Lumbar puncture was completed and child did well. On f/u exam 9/15/08 child well in office and 9/16/08 was seen at another ER with fever Judged to have a viral illness and did well.
Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called  at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her.
Chills; headache; fever 99.5 deg.F; This is a spontaneous report from a non-contactable consumer (Patient). A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was unknown if patient received other vaccines in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown, and COVID-19 tested post vaccination was also Unknown. On 10Feb2021, the patient experienced chills, headache, fever 99.5 deg. Fahrenheit. It was unknown if patient received treatment for adverse events. It was reported that colleague within the report communicated to me in informal conversation the AE post second dose for the COVID vaccine. His/Her understanding was his boost was on 09Feb2021 and presented with the symptoms in the document the following day, 10Feb2021. His/her awareness date was 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 99.5 deg. fahrenheit on 10Feb2021. The outcome for the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
JAW PAIN; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (JAW PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Jaw operation. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN JAW (JAW PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, PAIN IN JAW (JAW PAIN) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All dose of COVID-19 vaccine including booster taken one in once.   Patient reported had jaw surgery and was recovering at the time of report. Had some pain but overall doing good.  No treatment drug information was provided.  The reporter's causality for the event(s) of jaw surgery and jaw pain with PFIZER BIONTECH COVID-19 VACCINE was probable.  The reporter's causality for the event(s) of jaw surgery and jaw pain with humira (adalimumab) was no reasonable possibility.
History, Chief Complaint. Patient presents with Cough onset 2/18/2021. patient is a 66 y.o. female. HPI. Patient is a 66-year-old female who presents with cough and postnasal drip x1 day.  Patient did get her first dose of the Covid vaccine 1 week ago.  On February 3 she was treated for a sinus infection on Augmentin for 10 days which she did complete.  She denies any fever, body aches, or chills.  She denies any GI symptoms.  She denies any known exposure to Covid.  She is concerned she does have a back stimulator placement in 1 week.  Over-the-counter Mucinex with some relief when she is on it but the effects wear off and the symptoms come back. Symptoms started suddenly and have been persistent.  Admits to PND, nonproductive cough. Denies nasal congestion, rhinorrhea, ear pain, sinus pressure, sore throat. Denies chest pain, trouble breathing, abdominal pain, n/v/d.
Information has been received from a physician concerning her 15 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL (Lot number not reported) (dose number unspecified). The physician reported that on an unspecified date the patient passed out and had a seizure. It was reported that the patient fell and hit her head and had a concussion. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Left arm pain and swelling at injection site beginning 3 hours after injection, lasting 2.5 days and relieved with analgesics.  Headache and neck pain beginning the  same day as injection, lasting 3 days and partially relieved with analgesics.
Person reported swelling with redness in a welt like form at the injection site. The site is itchy and hot. Site is still swollen but under control after the injection.
extremely irritated left eye (red); eye infection; left eye with possibly herpes zoster; irritation in left eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019, but had no problems).   On 26th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, 2 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye irritation and eye infection. On 29th August 2019, the patient experienced eye red. The patient was treated with artificial tears nos (Artificial Tears) and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the ophthalmic herpes zoster, eye irritation, eye red and eye infection were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye irritation, eye red and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started having irritation in left eye, which the patient believed was a foreign body. The patient was tried flushing with artificial tears to no avail. Three days after vaccination, the patient woke up with an extremely irritated left eye and the eye was red. On 30th August 2019, the patient went to the eye physician who diagnosed the patient's left eye with possibly herpes zoster and was treating for an eye infection to be followed by some anti-virals based on the patient's response. The patient read the Shingrix literature and understand it did not contain a virus only proteins to mimic an immune response. The patient asked that, was there any reported side effects of eye infections was bacterial or viral with the administration of Shingrix.
This case was reported by a other health professional via call center representative and described the occurrence of generalized muscle aches in a patient who received BEXSERO for prophylaxis. On 12th June 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 12th June 2018, less than a day after receiving BEXSERO, the patient experienced generalized muscle aches and headache. On 13th June 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the generalized muscle aches was unchanged. It was unknown if the reporter considered the generalized muscle aches and headache to be related to BEXSERO. Additional information was received as follows: This case was reported by a Medical Assistant. The age at vaccination was not reported. The patient received BEXSERO on the left deltoid. The patient experienced full body muscle aches. The reporter did not have the lot number, expiration date or the patient information.
Information has been received through a Merck Pregnancy registry from a 38-year-old female with no medical history or allergies who on 16-AUG-2004 was vaccinated with a 0.5 mL dose of VARIVAX (Oka/Merck) (lot # 646135/0848N). Suspect vaccination on the same day included a dose of RECOMBIVAX HB. There was no other concomitant medication. The patient discovered that she was pregnant on 13-SEP-2004. No medical attention was sought. A product quality complaint was not involved. Additional information was received from a nurse in a physician's office who reported on 31-MAR-2005 that the patient was still pregnant and continued to be seen at the practice. Follow-up information was received from a physician's office which indicated that the patient's pregnancy history included three previous pregnancies and three full-term births. No birth defects, stillbirths or miscarriages occurred in any previous pregnancy. The date of the patient's LMP was 12-AUG-2004. Her estimated date of delivery was 19-MAY-2005. Prenatal testing due to "age" included an ultrasound on 07-DEC-2004 which was normal. On 25-MAY-2005, the patient gave birth to a 8 lb. 15 oz. liveborn female infant at 41 weeks from her LMP. There were no congenital anomalies or other complications or abnormalities. There were no complications during pregnancy or labor and delivery. There were no infection, illnesses, or concurrent medical conditions during pregnancy. The infant had no features of congenital varicella zoster syndrome. Additional information was received from the patient. Additional concomitant medication included MICRONOR. She reported that her daughter is now 35 months old and is Rh negative, has a low hemoglobin, is a little anemic, and is neutropenic. Her daughter was diagnosed on 13-APR-2007 with acute lymphocytic leukemia. The mother is Rh positive. It was noted that diagnostic laboratory tests included alpha-fetoprotein and "all pregnancy tests." Follow-up information from the patient indicated no new information. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 11Sep2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Feb2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on an unknown date (12:00 PM) as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Severe peripheral nueropathy" (unspecified if ongoing); "Nasal allergies" (unspecified if ongoing); "Mold allergy" (unspecified if ongoing); "House dust allergy" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM (brand= Teva), start date: 17Jan2019; METOPROLOL TARTRATE (brand=Mylan), start date: 01Sep2020; LIPITOR (brand= Lupin), start date: 01Oct2020. Past drug history included: Cipro, reaction(s): "known allergies cipro"; Erythromyacin, reaction(s): "known allergies erythromyacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid (Lot number= 0069108506) from 08Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate swelling after administration of Fluzone in left deltoid. Pt offered ice pack but Pt refused. Pt said they take a blood thinner. So did not want Ibuprofen. Pt observes for approx 10 min, swelling was less but still present. Pt decided to go to family Dr. Pt said Dr told them they were ok, no further treatment necessary by Dr.
diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 (diagnosed with COVID). At the time of the report, COVID-19 (diagnosed with COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wanted to know whether he can get his second dose. Treatment medication was not provided. Concomitant medications were not reported.
1 week, post vax, pt developed a hard abscess with surrounding erythema. Dx'd with aseptic abscess.
This spontaneous report was received from a mother refers to approximately 12 year old daughter. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date between nov -2012 and jan-2013, the patient was vaccinated with dose 1 of GARDASIL,(lot number, expiry date and route was not reported). On an unknown date in MAY-2013, the patient was vaccinated with dose 2 of GARDASIL,(lot number, expiry date and route was not reported). The patient was scheduled for dose 3 in September 2013. There was no concomitant medications reported. On an unknown date (reported as days after dose 1), the patient complained that her feet hurt. The bottom of her feet had raised areas and were discolered at that time. Yesterday the patient went to the physician with 5 to 8 warts on the bottom of each of her feet. She was seeing a dermatologist today. The patient was also administered with an unspecified dose of unspecified hepatitis vaccine(manufacturer unknown) along with first dose of GARDASIL. There was no laboratory diagnostics performed. There was no treatment rendered for the events. The outcome of the reported events were not recovered at the time of this report. The patient sought medical attention. Additional information has been attention.
After receiving my second dose, about ten minutes after, I began to feel dizzy and very warm. I fainted and it lasted 5-7 seconds.  During this time my arms seized up and my leg was twitching. I bit my tongue and my eyes were super dilated when I woke up (according to the attending nurse). I was very sweaty and had to wait and sit there for about a half hour. Then when I returned home I felt so sick and ended up vomiting. It was horrible. Now I have a slight headache, a sore arm, and am super tired.
2 hours after administration of vaccine, patient reported shortness of breath, abdominal pain, and difficulty swallowing. Patient returned to the clinic where he was given supplemental oxygen via nasal cannula and EpiPen. Oxygen removed and vitals stable. Due to EpiPen administration and continued feeling of throat swelling, patient sent to ER via EMS. Patient given 1L NS and Solumedrol IV. Discharged home in stable condition from the ER.
Information has been received from a medical assistant concerning a 4-month-old male who on 06-APR-2007 was vaccinated PO with a 2mL dose of rotavirus vaccine (human-bovine). Subsequently the patient spit up some of the rotavirus vaccine (human-bovine) 5 minutes after it was administered. The reporter believed he spit it up because he was crying and upset because other vaccines were being given. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.