chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1 week of my vaccine in the morning I've noticed that when I try to used toothpaste  my mouth was burning from the minty flavor. I  feel  burning sensation in my mouth  every day in the morning and through out the day. I can't even put anything in my mouth it burns.  I can't have any kind of flavors in my mouth at all so, I decided to visit my ENT doctor's  office when I told him about my issue he told me that I was experiencing   burning  mouth and tongue syndrome. He ordered mouth wash and  prescribed gabapentin. I am still using the medication and the mouth was as of now. I  feel that the medication is helping. Am feeling better than before. It has improved but hasn't gone yet completely.
Dizziness; Fatigue; Headache; Arm pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included Blood Thinner, Flavrx                                                         Distorted Aortic Valve and CPAP Machine                                                   Sleep Apnea for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PAINFUL AND BODY ACHE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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: Unk, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced painful and body ache, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the painful and body ache, fever and chills was not reported. This report was non-serious.
On Friday, January 6, I was with relatives and I had a sore throat, around 2pm, and I took a home test for COVID-19 and it was Positive, with a fever of 100.1 degrees, I took a Panadol pill, I had a lot of cough and mucus. The next day the fever did not go down, I took Panadol every 6 hours, I drank a chicken broth, I put Vicks in my throat, that relieved me a little. On Sunday, my throat hurt less, I ate little and I put Vicks back on. On Monday morning he no longer had a fever. I called my doctor to do a test and the doctor did not answer me. I'm normal now, no fever, I'm eating well, I drink a lot of water.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain. On an unknown date, the outcome of the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain were unknown. It was unknown if the reporter considered the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Due to time constraints the reporter declined to answer specific questions for the form. After being vaccinated, patient had horrible pain up and down that arm and into her shoulder. Her pharmacist told her to contact poison control. Poison Control did not handle her inquiry, so her pharmacist told her to contact GSK. The patient called GSK on the day of reporting to inquiry as to what to do for these symptoms. The patient saw her physician. Her physician thought it was muscular and told her to use a heating pad. The patient used a heating pad but said that her physician was wrong and that it was not muscular. The patient did not think her health care professional diagnosed her symptoms correctly. The patient was currently in pain and can barely use that arm and was inquiring to GSK why she was having this extended period of pain that was just going all over that side now, her upper right torso, shoulder, neck, and back. The patient was referred to contact her health care professional as soon as possible on the day of reporting to address her inquiries and discuss her current symptoms. It would be okay to contact the reporter via letter for further details. The patient said she needed to end the call and was going to contact her health care professional and have her health care professional contact GSK to further discuss. No further information could be clarified or was obtained beyond what was documented above due to time constraints. The patient did not mention the specific arm, but the context of the call was that it would be the arm in which she received the vaccination to which she was likely referring. It was unclear to which part of her body she referred or what she meant by saying all over that side now.
Rash around mouth, Choking on mucus, High fever 103.6 reported to overnight doctor at office (6/26/2018), Congestion, Cries became extreme and shrieking where they had never been before, Not sleeping, Shaking, Temporary hearing loss, Inconsolable crying, Refusal to sleep, Unexplained pain. She only fussed when hungry or needing a diaper change before the vaccines. Now she hardly ever stops crying.
Swelling of the eyes (more prominent on the right side); Swelling of the lips (more prominent on the right side); "Face was hurting"; Fever 100°F; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)), FACIAL PAIN ("Face was hurting") and PYREXIA (Fever 100°F) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in February), Dermal filler injection (Patient had fillers in eye at least 2 years ago) and Dermal filler injection (5 or 6 months ago).    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Fever 100°F). On 08-May-2021, the patient experienced EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)) and FACIAL PAIN ("Face was hurting"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)), FACIAL PAIN ("Face was hurting") and PYREXIA (Fever 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 100 (abnormal) Fever 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Irritability and fever (102 degrees) developed AM on 04-03-04 and lasted 3 days. Tenderness Left ant thigh and generalized urticarial rash (prominent on Left thigh) developed AM 4-05-04 and lasted several hours. Symptoms resolved with Tylenol and Benadryl.
Pt recv vax on 10/13/95; on 5/5/99 pt exp chicken pox
devel red swollen area at inject site, eye swollen, red rash & white spot on torso & genital area; dx by MD w/ urticaria; MD recommended no more DPT/TD because might be life threatening; MD recommended medical bracelet & alert school RN
Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 VACCINATION SITE PAIN (Arm hurt). At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were provided No treatment were provided
The patient reported very itchy, red palms after waiting 15 minutes in our waiting area. I observed her hands and there was obvious erythema over the entire palm surface of both hands with slight edema. I had the patient wait for a further 5-10 minutes with no progression of the rash on both hands, no reaction in her upper respiratory system, and no rash on any other body areas. I gave the patient 25mg of liquid Benadryl and instructed her to wait in the area a bit longer for observation. I also instructed the patient's mother who was with her to have her take an additional 25mg before bed if the rash persists that long.
Throat tightness within 10 minutes of receiving injection. One hour later, experienced numbness and tingling in left arm, down to fingers. Shortly afterward, felt numbness/tingling in face. Arm and face numbness/ tingling lasted several hours, then subsided. Both then returned on and off for the rest of the day and during the second day. Three days after vaccination, facial numbness is more pronounced, and numbness has spread to neck/throat.
Sudden onset eyes reddened & blurred vision - fever & chills, coughing - pain in chest. SOB.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), VACCINATION SITE INDURATION (hardness around the injection site) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neuropathy since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN (NEURONTIN) and CHLORPHENAMINE MALEATE (ANTIHISTAMIN) for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness around the injection site). On 13-Mar-2021, the patient experienced POLLAKIURIA (urinating once an hour), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F). On 14-Mar-2021, the patient experienced DYSURIA (pain when urinating). On 15-Mar-2021, the patient experienced URINARY TRACT INFECTION (diagnosed with urinary track infection). On 14-Feb-2021, VACCINATION SITE INDURATION (hardness around the injection site) had resolved. At the time of the report, URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: high (High) 101F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Received Tylenol for the first couple of days after second dose on 12-Mar-2021. Received treatment antibiotic Nitrofurazone for 2 days and Sulfamethoxazole 400 mg for 5 days. Lab tests were performed to confirm a E.coli infection. No other information was reported. Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-073620 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-073620:first dose case.
pt recvd vax; 48 hrs later exp urticarial rash which lasted 2 wks & subsided w/out tx;
Shortly after receiving vaccines pt became flushed, slightly diaphoretic, dizzy and began to cough. Pt transported via ambulance to Urgent Care.
Fever of 102, sore throat, inability to swallow, ear pain (left), headaches, flu-like aches
Presented to ED with a chief complaint of throat swelling, difficulty speaking. Patient reports significant history of anaphylaxis. Intramuscular epinephrine, IV fluids, IV Benadryl, IV Pepcid ordered. In addition, p.o. prednisone ordered. Discharged in improved condition.
Breakthrough case admission after 3 vaccines  Pfizer 3/18/21 Lot# EN6200;  Pfizer 4/8/21 Lot# ER8733;  Pfizer 10/20/21 Lot# 30155BA THIS IS THE INFORMATION AS LISTED IN THE DATABASE
pt recvd vax;1 1/2 p/ vax, began high pitched crying,lasted x 3 hrs;took 20 mins nap then began 1 1/2 hrs of high pitched crying; t 101; lt leg swollen; apap given; attempted to put cold on swollen leg;
got the shots still got shingles/suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient's child via interactive digital media. The patient got the shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR043152, reported by same reporter for his/her father.; Sender's Comments:  US-GSK-US2023AMR043152:Same reporter
Upon exiting exam room, he turned a grayish color and collapsed to the floor in the Pharmacy where the clinic was located.  NP took his BP and it was rather low.  She continued to monitor him until he was showing signs of stabilizing. Once stable, we left the Pharmacy.  2nd episode occurred at around 2:20 PM.  Took him into the ER.  There he was put on a monitor, had an EKG, bloodwork drawn, blood sugar levels checked and an IV of fluids given.  Was in the ER for approximately 4 hours being monitored before being discharged.  He was diagnosed as having Syncope with collapse; vaccination side effect.  Upon arriving home from the ER stay, he started to feel bad once again and his coloring was grayish.  Once he was lying down, he started to regain his coloring and felt better.
Extreme fatigue, soreness in arm and shoulder, headache, extreme chills, sore throat.
SICK; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In June 2021, the patient experienced ILLNESS (SICK). In 2021, ILLNESS (SICK) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included Xeljanz.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for co-suspect RINVOQ(UPADACITINIB) for the event of sick was not provided. opinion was that there was no reasonable possibility that the events of sick was related to RINVOQ(UPADACITINIB).  Treatment medications were not reported.   This case was linked to MOD-2022-586880, MOD-2022-586888 (Patient Link).
2/22/21:  armpits sore, bilat., L > R.  2/23/21:  3" red area at injection site through 2/24/21.  2/2/21:  deltoid sore, sore up neck on L, achy joints, chills, fatigue.  Temp 1 degree higher than usual at 98.7.  2/24/2:  mild headache.  2/25/21:  L deltoid area redness resolving.  Armpits barely sore.  2/26/21:  chills.
BROKE OUT IN HIVES BOTH ARMS AND STOMACH. GIVEN BENADRYL 50MG IM.
Delayed rash after 6 days, arm has a large red rash almost halfway around arm, firm to the touch and very sore & tender.
Pt stated she has had pain radiating down left arm to hand since vaccine. She also stated having pain radiating from shoulder up through neck. Pt stated movement has improved but cannot sleep on left side due to pain. The pain does not radiate down to hand any longer but does go to elbow. Pt stated heat makes pain worse and has taken ALEVE some to help with pain. Pt stated certain movements are very painful but has full range of motion.
I have been on the couch since the 21st of March; Since I got the shot, 2 days after I have been dizzy; It is very difficult to stay balanced; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Since I got the shot, 2 days after I have been dizzy"; BALANCE DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "It is very difficult to stay balanced"; BEDRIDDEN (non-serious) with onset 21Mar2021, outcome "unknown", described as "I have been on the couch since the 21st of March".  Additional Information: She had problem with and wanting to know if anyone else reported side effects from the vaccine. She had a lot of trouble and already filed a report. she just finished with my neurologist. Since  got the shot, 2 days after she has been dizzy. Not spinning but she cant drive, and she cant tell how far the car is from me. It is very difficult to stay balanced. She has been on the couch since the 21st of March. This was my second dose, the first dose she had no problems at all. It's been 20 days since my vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No symptoms reported by any of the patients; temperature excursion for frozen products; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 29-JUL-2021, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S037503 with an expiration date on 20-NOV-2021) for prophylaxis  (strength, dose, frequency, and route of administration were not reported).         The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were exposed to a temperature excursion of 46.6 degrees Fahrenheit (°F) during a time frame of 1 hour. There was prior temperature excursion of 6°F for 5 minutes (47.3°F) for 6 minutes.   No symptoms were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003837:
This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot# M047658, expiry date: 28-OCT-2017, lot# M032492, expiry date: 02-MAR-2018; lot# M021124, expiry date: 02-FEB-2018; lot# M039202, expiry date: 11-MAR-2018, (dose, route and site of administration were not reported). No adverse effects were reported. The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013727:
sl fever 23SEP relieved w/APAP; fever agian 2OCT & 3OCT (temp not taken w/thermometer) seized 3OCT 3AM; mom called 911 states pt stopped breathing, lips blue; stayed in ER 3 hrs & discharged;
This spontaneous report was received from a 47 years old female consumer refers to herself. It was reported that on 17-APR-2012 the patient was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). Additional information has been requested.
Patient developed moderate vaginal bleeding and cramping 2 days after receiving the vaccine. She was not hospitalized and did not require transfusion.