chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an auto immune disease; mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this; My doctor, the booster on September 4th; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 (Lot number: FC3182) at the age of 35 years as dose 3 (booster), 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; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Sep2021, outcome "unknown", described as "My doctor, the booster on September 4th"; MOUTH ULCERATION (medically significant) with onset 06Sep2021, outcome "unknown", described as "mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "an auto immune disease". The event "mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: the sores and it came back inconclusive. Therapeutic measures were taken as a result of mouth ulceration, autoimmune disorder.  Additional information: Method of assessment for Mouth ulcer was Introspection and Drug result was Related. I have been the multiple doctors for Mouth ulcer and they have never seen them like this and nobody really knows what to do. They said it could be related to the vaccine but they don't know what to do as you know as an adverse to call and reported, that's why I am calling to do. I was fine before ever got the booster. I have tried antibiotic and then they tried some steroids and none of it seems to you know, it help a little bit (Further clarification unknown)) but never went away. The steroid was Prednisone and then the antibiotic they had me was Levaquin and the other medication was Amoxicillin (Intent: Treatment). I take immunosuppressant therapy for auto immune disease. Vaccination facility was Pharmacy, drug store. No other vaccines.; Sender's Comments: Based on the current available information and a possible contributory role of suspect product BNT162B2 to the development of events mouth ulceration, autoimmune disorder cannot be totally excluded. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Tinnitus. My ears have been ringing every since I got the vaccine. Never had this problem before. At first I had loud ringing and ticking noise all day and a constant buzzing. In the past few weeks it has been less ( since 08/1/2021) but it is still there.
rash/rash in stomach; rash in injected arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm). At the time of the report, RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient's symptoms subsided after a coupe of weeks.
the same day she got the vaccination in her R arm she has experienced lymph node swelling/tenderness and enlargement to R axillary and L supraclavicular area
This spontaneous report as received from a physician (contradicting information, also reported as a patient) as part of a marketing research program refers to unspecified number of patients older than 26 years of age of unknown gender. On an unknown date, the patients were vaccinated with doses of GARDASIL9 (dose, route and lot # not reported). Additional information is not expected. There is no contact information.
Headache, Myalgia, Fever, Rash, NauseaVomiting, joint pain, chills, and swollen glands, increased hip pain in replaced joint Narrative:  Employee had COVID in March of 2020. 24 hours after receiving the vaccination states he got tested for antibodies due to not feeling well and that he was still IGG positive. on 1/6 his temp was 102.7, rash, headache, myalgia, nausea, joint pain, chills, and swollen glands. He had a hip replacement in  September of 2020 and now has increased pain in that joint.
Flu shots make me sick every time; Initial information received on 31-Dec-2021 regarding an unsolicited valid  non-serious case received from a patient.  This case involves Adult and unknown gender patient who take flu shots make sick every time while receiving 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 (unknown manufacturer, lot number, formulation, strength, not reported via unknown route in unknown administration site, expiry date) for prophylactic vaccination.  On an unknown date in 1970 ,the patient developed a non-serious event "flu shots make me sick every time "(illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu shots make me sick every time).  At time of reporting, the outcome was Unknown for the event flu shots make me sick every time.
Both arm sores from this morning; From last evening and night she had ringing ears in both ears; Very lethargic; Still very drained; Having a constant headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Very lethargic), TINNITUS (From last evening and night she had ringing ears in both ears), VACCINATION SITE PAIN (Both arm sores from this morning), FATIGUE (Still very drained) and HEADACHE (Having a constant headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced LETHARGY (Very lethargic), FATIGUE (Still very drained) and HEADACHE (Having a constant headache). On 20-Apr-2021, the patient experienced TINNITUS (From last evening and night she had ringing ears in both ears). On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Both arm sores from this morning). At the time of the report, LETHARGY (Very lethargic) and VACCINATION SITE PAIN (Both arm sores from this morning) outcome was unknown, TINNITUS (From last evening and night she had ringing ears in both ears) had resolved and FATIGUE (Still very drained) and HEADACHE (Having a constant headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication was provided.
Typical manifestations of plantar fasciitis, pain on the right foot for two months, reduced now, bearable.
Sudden onset chest pain, shortness of breath at hour 11. 23 hour observation in hospital. Initially severe then low grade and constant. Fever to 38.7 on post vaccine day 2. No other symptoms until day 4. Day 4 nausea along with sudden onset, acute genital ulcers (not related to STI)
Potential adverse reaction to COVID19 vaccine Had Moderna booster 2/2/22 She immediately had strange taste in mouth, weird sensation down right arm  Within 1 hr felt ache in her chest Symptoms would calm down with breathing and rubbing her chest  The ache in her chest waxed and waned then fully resolved in a week She had these symptoms with second dose of Moderna vaccine too  She had extensive cardiac work up this year prior to 3rd vaccine, saw cardiology 1/20/22
Skin reaction. Started Sunday, April 4 in the evening maybe around 9:30 pm.  Thought a bug bit me, but woke up today with more spots.  Around 12 total. Some look like bug bites, some hives, some have raised center.  Red, itchy.  Some itch more than others. Located on arms, leg, stomach, back, near outside of armpit creases.
During our event today, here at the  Church in coordination with the Cleaning Services monthly training event, a patient had an anaphylactic reaction to the COVID vaccine.  Anaphylaxis:   45yoF w/ h/o Rheumatoid arthritis and Wegener?s granulomatosis who takes immunosuppressive infusion 2x/yr, most recently in April, no h/o anxiety, and h/o COVID x2 (4/2020 & 10/2020), experienced an anaphylactic reaction, with symptom onset beginning within 1 min of us administering a 1st dose of the Pfizer-BioNTech COVID vaccine.   Sx: throat clearing, cough, chest tightness, diaphoresis  PEx:  Alert throughout Hand over chest/ lower throat Shortness of breath  Voice hoarse, speaking in 1-2 word sentence fragments  Timeline:  10:35 - administered  10:36 - throat clearing  10:37 - advising pt to sign up for V-safe given her underlying autoimmune dz  10:38 - intermittent coughs 10:41 - drawing up epi  10:45 - Epi 0.5ml (1mg/ml) administered IM 10:46 - Called 911 for EMS  10:50 - Epi 0.5ml (1mg/ml) administered IM 10:55 - Diphenhydramine 50mg IM  10:57 - Pt notes throat feels more released from prior tightness 11:01 - EMS arrived, began evaluating patient  11:25 - Patient walked out to car, sister drove her home.   Advised sister for her or their dad (at home) to stay with/watch the patient for at least the next 3 hours, to be sure angioedema does not worsen; I?m happy to giver pt her 2nd dose on the return date, but recommend if she gets it, best to get while in a hospital setting; to discuss whether or not to get 2nd dose with her Rheumatologist, especially given her prior COVID illnesses x2, making this her immune system?s 3rd exposure; consider getting Epi pen to carry with her for future.    Following up with pt to advise her against getting an mRNA vaccine in the future, that currently the only other option in the U.S. is the Janssen/J&J vaccine, and that given her autoimmune disease, I would be concerned about her developing immune thrombosis and thrombocytopenia, so recommend she discuss with her rheumatologist, and that if she gets a subsequent dose of any COVID vaccine, to have it administered at a hospital location.
3 days p/flu vax devel stiff, achy  knee pain worsened w/bending-2day later shoulders achy & stiff w/inability to use rt arm;
Developed fever approx. 3/19- lasted approx. 3 days. Highest temp 104 degrees F. Developed rash all over body- itchy, red- recovering 3/22/04.
fatigue, described as being exhausted; headache; muscle pain; joint pain everywhere; being nauseous and vomiting; fever; tightening of her throat, described as it felt like someone was squeezing her throat; has been so sick and can't seem to stay out of bed; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (tightening of her throat, described as it felt like someone was squeezing her throat), ILLNESS (has been so sick and can't seem to stay out of bed), FATIGUE (fatigue, described as being exhausted), HEADACHE (headache) and MYALGIA (muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (tightening of her throat, described as it felt like someone was squeezing her throat) and ILLNESS (has been so sick and can't seem to stay out of bed). On 02-Apr-2021, the patient experienced FATIGUE (fatigue, described as being exhausted), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain everywhere), VOMITING (being nauseous and vomiting) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL DISCOMFORT (tightening of her throat, described as it felt like someone was squeezing her throat), ILLNESS (has been so sick and can't seem to stay out of bed), FATIGUE (fatigue, described as being exhausted), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain everywhere), VOMITING (being nauseous and vomiting) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug used was Pepto-Bismol (Bismuth subsalicylate)
Developed 103-104 fever 12-16 hours after receiving H1N1 vaccine (live). Also has cough & congestion. No treatment other than symptomatic treatment with TYLENOL/ADVIL, flds, etc. Sibling given H1N1 same day. No fever until 4 days after receiving vaccine.
Anaphylaxis. Patient began to have symptoms 5 minutes following the vaccine injection, was provided 50 mg IM benadryl at the site, another 50 mg IV en route to the hospital.  Patient stated difficulty breathing and voice changes. Pt has history of anaphylaxis. She did not use her EpiPen, 0.3 MG of Epinephrine was administered at 550 pm in the ED. Patient discharged at 2208.
Became fussy 1 1/2 hours after vaccine and returned for re-eval. No fever mild swelling at PENTACEL injection site.
Chills and fevers (102.6) for 5 straight days, non stop.  Body aches.  no appetite.  No energy.
pt had a fever of 105 p/administration of 1st DTP immun; pt fever was controllable w/APAP;
A health care professional reported the occurrence of an injection site reaction in a 5-year-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-021).  The subject's medical history includes fused L3-L4 and otitis.  Concurrent medications were not specified.  The subject had not experienced any adverse events following previous vaccinations.  On an unspecified date, the subject received his fifth dose of Infanrix (lot DTPA566B2).  Subsequently, on 08/15/2002, he experienced an injection site reaction characterized by a "10cm x 8cm sharply [defined] circular area of erythema and warmth on the left deltoid."  The physician examined the subject on 08/16/2002 and prescribed cephalexin monohydrate (Keflex).  The reporter stated that the outcomes of the events were unknown and that the events were possibly related to Infanrix administration.  This report is considered serious because the reporter stated that the events jeopardized the patient or required intervention.
mom describes on morning p/vax 17OCT96 pt not moving any part of body below chest, would not stand, very fussy;this persisted throughout day;seen @ clinic in afternoon by MD WBC elevated given ATB;MD felt episode vax related;
Area of injection is swollen, raised and bright red. Pt's Lt. deltoid is also hot to the touch. Pt. has a fever of 100.7 taken tympanically and reports that Wednesday night it was 102.0 F. Pt. Dx'd. with cellulitis of Lt. upper extremity and is being treated with KEFLEX 500 mg.
On the third day after injection, she woke up with severe muscle pain all over her body. It was so bad that she could not lift either of her arms. The pain began to subside gradually the following day. She called her doctor first thing this morning and had to leave a message and then she came in to speak with me about what happened. I took all the information on the checklist from her and asked her to call back if she had any other issues to report. She was planning to follow up with her primary care doctor once they returned her phone call.
After leaving the office patient experienced shortness of breath, swelling and hives. Patient went to the ER.
This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (lot # R023607, expiration date: 06-MAY-2021, dose was not provided) for prevention of HPV. On 28-DEC-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly into left arm (lot # R023607, expiration date: 06-MAY-2021, dose was not provided) for prevention of HPV and with a dose of FLULAVAL. On 30-DEC-2018, the patient experienced achiness in an unspecified part of the body. On 02-JAN-2019, the patient experienced a lump on the left side of the neck. On 04-JAN-2019, the patient was examined in the physician's office and the second lymph node was noted on the left side of the neck and one lymph node was noted on the right side of the neck. No inguinal or axillary nodes were involved. An unspecified lab work was performed and results were unremarkable. No treatment was given for the events. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 was not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GS2524) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Lot number: EM6201) and on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "Secondary Hypothyroidism" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (16Jan2023) Negative; (19Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received Paxlovid for treatment of COVID-19 from 09Jan2023 to 13Jan2023. He completed the 5-day Paxlovid treatment on 13Jan2022. He tested negative on 16Jan. He tested positive for Covid on 19Jan. He had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a 68 year old male patient regarding himself. The concurrent condition of the patient included prostate cancer, high blood pressure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and allergy to ZOCOR and PERCOCET. On 31-DEC-2015, the patient was vaccinated with ZOSTAVAX (subcutaneous, dose not provided). The concomitant therapy included unspecified medications for treatment of diabetes, high blood pressure, COPD and prostate cancer. On 31-DEC-2015, after 30 minutes of vaccination, the patient experienced pain and swelling in his left arm and in his neck. The patient sought medical attention and called pharmacist. No treatment was given for the events. No lab studies were performed. On 12-JAN-2016, the patient contacted unspecified physician. The patient was waiting to hear back from his physician. The outcome of the events was not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
When receiving the tetanus vaccine the injection was placed near my left shoulder instead of the deltoid muscle. Receiving the injection was extremely painful. Since the vaccine, I am experiencing loss of shoulder function, strength, and am in extreme pain.
PVC's-started 4/9/03. Saw cardiologist 4/11 and 4/14. Echocardiogram-pericarditis, pericardial effusion and myocarditis.
Starting around noon the day after the vaccine she began getting chills and joint aches, then a fever up to 101.6. She took Tylenol for the fever. The following day she only had a headache and some soreness. Starting around 11:00am she had chills again and a rising temp. She took Tylenol again with some improvement.
Up to 102.5 degree fever, chills, headache started less than 24 hours after shot.  fever subsided about within 24 hours.
A report has been received from a Physician concerning a 5 year old, female patient. No information regarding relevant history concomitant disease and concomitant medications were provided. The patient received FLUMIST (Intranasal) on an unknown date. Patient was seen in the office on 24-Oct-2013 with a fever and other flu symptoms, she tested positive for Flu A and was treated symptomatically. She was seen again on 06-Jan-2014 with flu symptoms with symptoms beginning 04-Jan-2014; she was treated symptomatically. The patient was seen again on 13-Jan-2014 and was diagnosed with pneumonia and was treated with Z-Pak. Patient was not hospitalized. She was recovered. The reporter considered the event of tested positive for Flu A to be non-serious. Event of pneumonia was identified and captured by the company physician as non-serious event. Corrected report 13-Feb-2014: the key ingredient of the suspect drug was corrected from FLUMIST to Q/LAIV. Drug as reported also corrected from FLUMIST TO FLUMIST. Narrative updated. Corrected report 06-May-2014: This case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
I experienced a fever, chills, body aches, and fatigue. These symptoms lasted for about 18 hours.
Received my Pfizer bivalent booster vaccine on 10/16/22. Had the usual right deltoid soreness around the injection site for about 3-5 days, which was more severe than any of my other injections. About 2 days after the initial vaccination I had severe pain running along the backside of my right armpit and extending a few inches beyond down my back. The area was painful and more dense than the surrounding tissues. This pain and swelling resolved within 3-5 days of onset.