chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Whole body ached; Had a headache all day; Injection site was hot to touch; Bull's eye rash; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th February 2021, less than a day after receiving Shingrix, the patient experienced injection site warmth and injection site rash. On 17th February 2021, the patient experienced general body pain and headache. On an unknown date, the outcome of the injection site warmth, injection site rash, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site rash, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first shot of Shingrix on (16th February)Tuesday morning and on the same day evening he started to have a bulls eye rash near the injection site and the injection site was hot to touch. On the night of 17th February 2021(Wednesday), his whole body ached and he had a headache all day on Wednesday. He did not have any difficulty in breathing. The reporter did not consent to follow-up.
Loss of appetite after the 2nd shot; Slight temperature after the 2nd shot; Fatigue after the 2nd shot; Chills after the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot). At the time of the report, DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  After the 2nd shot, the patient experienced fatigue, chills, a slight temperature and loss of appetite.   This case was linked to MOD-2021-375387, MOD-2021-375404 (Patient Link).
Tinnitus since 1st or 2nd shot....I don't remember exactly when it started
heart attack, open heart surgery, quadruple bypass surgery.  Still not leading a normal like after almost a year since the injection followed closely by a heart attack.
Dyshidrotic Eczema 8 days after vaccination. I have never had a previous eczema reaction in my life before. It began with small red bumps on the palms, then on elbows, then on feet. It would progress slowly day by day. The small red bumps started to look like blisters.
Patient presented with bumps that are itchy similiar chicken pox. She is using lotion stop itching will contact her MD.
suspected vaccination failure; have had shingles, I've had it seven times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles seven times. The patient asked what was the reason. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Predominantly left side facial rash began around left eyelid ~1 week after vaccination. Associated with swelling and numbness. Lesser but similar findings present on right side of face. Rash responded to 2 courses of Valtrex. Rash resolved completely within 6 weeks without apparent sequelae.
dizziness; Weakness; diarrhea; A spontaneous report was received from a Consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, weakness, diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the events dizziness. weakness, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, dizziness, weakness, diarrhea was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081324:1st dose case
I had a persistent rash on the top of both arms, it had spread to the underside of both arms and was showing up on both ankles. Dr took two biopsies. They came up with the diagnosis of interface dermatitis.  No treatment provided, was told to let it run its course.
ITP-bruising dx 15APR98;platelet counts as follows 15APR98 11,000;16APR98 28,000;20APR98 120,000;25APR98 16,000;29APR98 34,000;4MAY98 13,000;6MAY98 10,000;14MAY98 17,000;21MAY98 31,000;4JUN98 5,000;9JUN98 56,000;now on pred;
Lichen planus oral cavity autoimmune occurrence. Gum redness, inflammation, pain. Vertical white line from tooth to gum. Symptoms occurred beginning Sep 20, 2021 (6 days after first dose of Moderna COVID vaccine).  Diagnosis by dentist  on Sep 24, 2021. Treatment: Dexamethasone elixir-swish 1 tsp. for 2 minutes, 4 times a day. Follow-up appointment Oct 1, 2021. Also mucocele inside of bottom lip (etiology unknown).
1 day after immunization, pt developed red area (L) arm, red & sore. The following day, she noted temp 100. Appearance more c/w local rxn 6.5 x 10 cm oval well circumscribed, but increased over next 24 hours, on Ibuprofen/ice pack. Treated 9/23 & 9/24 with IV Vanco/ceftriaxone with much improvement by 9/25. Switched to oral Dicloxacillin.
Fever onset right after vaccine and continue 102-103 fever for three days, swelling at injection site, also has mild thrush to mouth which I think is unrelated.
Had a brain aneurism; This spontaneous case was reported by a consumer and describes the occurrence of INTRACRANIAL ANEURYSM (Had a brain aneurism) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL ANEURYSM (Had a brain aneurism) (seriousness criterion medically significant). At the time of the report, INTRACRANIAL ANEURYSM (Had a brain aneurism) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected. Also it is not known if patient received the Moderna COVID-19 vaccine.
Information has been received from a registered nurse concerning an 11 year old white female with no past medical history who on 11/9/95 was vaccinated with a first dose of varicella virus vaccine live (site unknown). Concomitant therapy that day included a first dose of hepatitis B virus vaccine and a Mantoux Test. On 6/25/03 the patient developed multiple macules, vesicles few scabbed on trunk, arms, legs. The patient had a doctors visit and received symptomatic treatment. There were no other relevant laboratory or diagnostic tests and the patient was not hospitalized. It was reported that the patient recovered. It was also noted that the patient did not experience any adverse events following prior vaccinations. No further information is expected.
Flu vaccine - Son has had vaccine every year, no side effects. This year, his shoulder is swollen, red, sore and itchy.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 15-NOV-2012 was vaccinated with an improperly stored (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
patient has an interruption in schedule administration ofGARDASIL 9; No additional AE/PQCs reported.; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced interruption in schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administration. No additional adverse events were reported.
She got the vaccine then she was exposed to COVID + person; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person). On 23-Feb-2021, EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person) had resolved.            No Concomitant products were reported. No treatment information was provided. Patient was tested following quarantine and did not test positive.   This case was linked to MOD-2021-257793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Second dosing regimen added, hence action taken updated from unknown to not applicable.
1st dose Pfizer; 2nd dose Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination.    No Medical History information was reported.   On 10-Jul-2021, the patient received first dose of COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) 1 dosage form. On 02-Aug-2021 at 4:21 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Aug-2021, the patient experienced OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna). On 02-Aug-2021, OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non significant information received.
Got up to use bathroom in middle of night, got lightheaded and fainted.  Wife woke me up and I was on floor of bathroom.  Not sure how long.  Wen to bed with racing heart, cold sweats.  Symptoms subsided after about 30 minutes in bed.  Went back to sleep.  Woke up sore all over body, rash on torso.  Sore and tired all day.  Symptoms persisted for about 36 hours.
Email received from patient on 05/10/17 stating: I am out on leave, I have Guillain Barre Syndrome (GBS). I have been out since 1/7/2017. I was not properly diagnosed until 1/25/2017, I had been in one hospital but they sent me home unable to walk. I was at Hospital from 1/25/2017 until 2-3-2017. Then I went to Rehabilitation Hospital also in. Discharged 3/2/2017 I have been going to outpatient rehab 3-times a week since then.
Excessive itching at scalp, face, neck, and upper back and chest. Persisted for 12 hours, very minor effects after that point to about the 24 hour period. Redness but not a full rash. Treated with benadryl and prednisone.
COVID-19; Lack of Efficacy; After second dose patient said injection site was not as sore as with first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose). On 06-Oct-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Efficacy). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Result: Patient tested positive for COVID-19. On 08-Oct-2021, SARS-CoV-2 test: positive (Positive) Result: Patient tested positive for COVID-19.         Concomitant product use was not provided by the reporter.   Patient received MAB injection to treat COVID-19.  Company comment-This spontaneous report concerns a 71 year old male patient with no relevant medical history who experienced non-serious events of COVID-19 (unexpected) and vaccination site pain (expected). Lack of efficacy was considered as an additional event. The event COVID-19 occurred 8.5 months after the second dose and nearly 9.5 months after the first dose of mRNA-1273. The patient did not have any symptoms and was treated with MAB injection for COVID-19. The event vaccination site pain occurred after an unknown duration after the first dose of the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-364478 (Patient Link).; Sender's Comments: This spontaneous report concerns a 71 year old male patient with no relevant medical history who experienced non-serious events of COVID-19 (unexpected) and vaccination site pain (expected). Lack of efficacy was considered as an additional event. The event COVID-19 occurred 8.5 months after the second dose and nearly 9.5 months after the first dose of mRNA-1273. The patient did not have any symptoms and was treated with MAB injection for COVID-19. The event vaccination site pain occurred after an unknown duration after the first dose of the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Nightsweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced NIGHT SWEATS (Nightsweats) and CHILLS (Chills). At the time of the report, NIGHT SWEATS (Nightsweats) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-020538 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-020538:MOD21-035367: Same reporter, reporter's husband
Generalized rash no treatment began about 8 days after MMR and Varicella Vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety due to shot. has anxiety disorder-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
STING AT THE VACCINE SITE ON MY ARM FOR ABOUT 2 MINUTES; 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: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced sting at the vaccine site on my arm for about 2 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting at the vaccine site on my arm for about 2 minutes. This report was non-serious.
pt recv vax 10MAY05 & 23 days p/vax broke out w/a non-raised red rash on legs; rash was spreading to back & arms; MD described as a nondescript viral rash;
Painless skin color change on top of hand on same side shot given. Dark pink color. Mild edema. No edema/discomfort at site of injection. Mild headache. 1 cm mild erythema/edema diameter at site of injection.
104 temp within 12 hours, flu symptoms, infection in throat, swollen lymph nodes, never got better within 7 months, checking for throat & thyroid cancer says all symptom appeared right after vaccine.
February 26th 2021, I was awakened in the morning from my sleep with tachycardia thus shortness of breathing. It lasted about 2 hours. I got up and moved around. I thought I might have to go to the hospital, but it slowed down. After that I noticed when I did exercises around my home, in the spring, I had a lot of shortness of breath. I would have to take frequent breaks to catch my breath. I had a fast heart rate and fast breathing while doing physical chores. My cardiologist referred me to a pulmonologist who I'm going to be seeing soon. My shortness of breath has gotten better in June, July, and August of 2021. I'm starting to feel how I did last year before vaccine.
Lymphadenitis. PE indicates 3 tender, lymph nodes of (L) supraclavicular and periclavicular chain.
sudden onset sob, wheezing, chest burning, uncontrolled coughing, eyes burning turned very red used 50mg benadryl po to calm symptoms lasted about 30 minutes continued with coughing dry red eyes and hoarse voice for 3 hours after eyes still slightly red next morning
Fri. evening (1/29): fatigue, diarrhea, nausea Sat. (1/30): fatigue nausea Mon.-Thu (2/1-2/4); soreness, redness and itching at injection site
The vaccine vial was not diluted with the diluent and the medical assistant drew 0.2 ml from the vial for the 5y -11 y Pfizer COVID vaccine. The patient was given 0.2 ml. However it was not diluted as it should have been.
PT is complaining of severe arm soreness however after seeing MD was moved to therapy for severe arm stiffness where a diagnosis of possible nerve damage was identified.
?Moderna COVID?19 Vaccine EUA?  Headaches and body aches and injection site pain from 4:30 pm to 10 pm 12/29 Fever started at 10 pm 101 - Fever 103 at some point early morning - took Tylenol at 8 am 12/30 At 11 am, very bad chills and body shaking, uncontrollable Took a hot shower and tried to get under lots of warm covers, didn't go away for some time Around 1 pm, fever 103.2 Scared to take tylenol and get shakes again, waited it out, fever went down to 101.6 on it's own COVID swabbed at 3:45 pm
Presented to ED complaining of abnormally fast heart rate.  Patient had second COVID vaccine on 9/8/21.  Also running a fever, feeling shaky.  Temperature in ED was 101.8 F and she had taken some Tylenol prior to arriving at ED.  No chest pain or shortness of breath.  Patient was observed in ED and patient started to feel better and was discharged home.
42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
mom of child phoned clinic 815AM 16AUG96 reporting that child had recv vax 14AUG96 & awoke 15AUG96 fussier than usual & by afternoon had a red sore lt arm;redness was about size of a fifty cents piece;fever x 2 days but given APAP;
I vomited all night and had horrible all over body pain. I am sick from this, I refuse to take the second shot.nonenon
Pt was seated in waiting area and lost consciousness. Pt regained consciousness and was A&O x4.
General Rash/Skin Lesion HPI For quality, patient reports itchy and red. For location, she reports face, chest, arm, and legs. For severity, she reports moderate. For duration, she reports has noted for 2-3 weeks. For onset/timing, she reports gradual onset. For context, she reports no new detergents or skin products and no one else with similar rash. For aggravating factors, she reports nothing makes it worse. For associated symptoms, she reports no fever, no cold symptoms, no nausea, no vomiting, no diarrhea, and no urinary symptoms. 86 yo female with a hx of HTN, anxiety and depression and insomnia presents today with a rash. It is mostly on arms and legs. She had her 2nd covid vaccination on 2-9-21 and 3 days later the rash started. She had extreme itchiness. She has tried moisturizers. Itchiness is a little better than last week. She has no history of eczema, psoriasis, or rashes. She denies any new medications, detergents or skin care products