chrisvoncsefalvay/vaers-outcomes huggingface dataset:
According to mother, pt c/o discomfort RUA on 06/25/02 without any noted visual changes. Mother reported redness, swelling and warmth to touch noted in AM on 06/26/02. Pt seen by this nurse at 12:38pm on 06/26/02. Redness at swelling noted RUA measuring 13x14cm area warm to touch. Pt c/o area "hurting it itching." Mother reports no scratching. T 98.5. Advised to observe for sos of infection. Cold application and pain relief measures advised.
Patient reports developing tinnitus after receiving covid vaccine although she is unsure of exact timing. The date entered is an estimate. States that symptom has been increasing and provider suspects sensorineural hearing loss.
I got up and was light headed and dizzy the day after. I went to the Urgent Care and they said they couldn't find anything wrong, and gave me medication to help with the dizziness. Dizziness lasted one day and just some fatigue.
On 3/1 & 3/2/03, PT started having chest pain, tightness of chest, short of breath, gasping for air. She thought it was normal because at the present time she suffers from cardiomyopathy. She has a Hx of CHF and still has an emboli in right lung.
Unilateral laterothoracic exanthem, raynauds, purpura, migraines, weight gain, fluid retention, brain fog, personality change, hypersomnia within 2 weeks of vaccination; fatigue, fever, body aches, induration at vaccine site 12-24 hrs after vaccine
pt had dec appetite in the evening of immun day; mild cough devel into harsh cough & dec voice; irritability noticed by mom; pt taken to ER on 23APR93 due to above s/s & vomiting/diarrhea for 24 hrs; hospitalized;
could not hear with my left ear at all; hearing lots of noise in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (could not hear with my left ear at all) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DEAFNESS UNILATERAL (could not hear with my left ear at all) (seriousness criterion medically significant) and TINNITUS (hearing lots of noise in left ear). On 04-Apr-2021, DEAFNESS UNILATERAL (could not hear with my left ear at all) was resolving and TINNITUS (hearing lots of noise in left ear) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Acoustic stimulation tests: abnormal (abnormal) she has 90% of hearing lost.         According to the patient, 3 hours after receiving vaccine, she started hearing lots of noise in her left ear. She plugged her right ear and found that she could not hear with left hear at all. She went to emergency room where she was given a low dose steroid. She was prescribed a high dose steroid.  No relevant concomitant medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Diagnosed with positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19). At the time of the report, COVID-19 (Diagnosed with positive COVID-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) a few days after receiving the first dose of Moderna COVID-19 vaccine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications and treatment details were provided.   This case was linked to MOD-2021-023205, MOD-2021-022629, MOD-2021-022705, MOD-2021-022973 (E2B Linked Report).; Sender's Comments:  MOD-2021-023205:same reporter MOD-2021-022629:same reporter MOD-2021-022705:same reporter MOD-2021-022973:same reporter US-MODERNATX, INC.-MOD-2021-023205:
This spontaneous report was received from a nurse via company representative and refers to an 18 year old female patient (daughter of nurse's friend). The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. Three years ago, in approximately 2013, the patient was vaccinated with the first dose of GARDASIL (dosage information, lot number and expiry date were not reported) intramuscularly. One year later, in approximately 2014, the patient received the second dose of GARDASIL (inappropriate schedule of drug administration). After each dose of GARDASIL, later in the day, the patient lost consciousness (onset dates approximated to 2013 and 2014). Right after receiving the second dose of GARDASIL, the patient developed an unspecified autoimmune disorder, in approximately 2014. Patient sought medical attention and she was hospitalized, on an unknown date. The outcome of the events was unknown. The reporter's causality assessment was not provided for the events, although the patient's mother claimed that, the autoimmune disorder was a direct result of vaccination with GARDASIL. The reporter considered autoimmune disorder to be serious due to hospitalization. Upon internal review, loss of consciousness and autoimmune disorder were determined to be medically significant. Additional information has been requested.
Itching (injection arm); Bad rush (injection area); Really bad headache; Shaking; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to the company on 26-Jan-2021.    Case reference number MOD-2021-013998 is a spontaneous case report sent by a Other on 25-JAN-2021 00:00:00 .  On 25-JAN-2021 the patient developed headache. and started shaking which eventually went away. Later, the patient also developed Bad rush (injection area),Itching (injection arm) on the lower part of the arm where she got the vaccine (right arm)  15-Jan- 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 028L20A ) for prophylaxis of COVID-19 infection.    The patient was adviced to take Bendaryl.
Approximately 35 minutes following the innoculation, I felt my heart beat speed up and could also feel my heartbeat in my lower mouth and jaw line, my jaws clenched and were not exactly itchy or tingly but some mixed sensation thereof. My heart would seem to race and then slow down (off an on). I had onset of localized intense headaches. For the course of 24 to 48 hours (varied depending on which event), I experienced heart palpatations, fluttering, sensations of something swelling and filling my chest cavity - to where I felt I could not expand my chest and sit upright, I had to cave in to breathe; headaches from mild to migraine level in different spots - it would come and go and move around my cranium; my face cheeks broke out and I was itchy on cheeks, across jaw line, back of throat, neck, chest, and left arm;  my lips and tongue were midly tingly (like a food allergy, but not intense) - this occurred the least amount of time. The worst event was between 6 and 7 PM on Friday night: my left arm hurt from my left ear, down my neck, all the way down the arm (at bone), and to the fingertips - the only way to describe the sensation is a combination of a cold burn and what I think it would feel like in the nerves to be electrocuted - the hair folicules ached - that only lasted for about 15 minutes but was intense - so intense that my jaws were still tense and slightly sore for a while following. On Sunday, 09/12/2021, I experinced mild abdominal cramping and on this morning (09/13/2021), I had two instances of severe abdonimal cramping which felt worse than any menstrual cramps experienced. I felt nauseous (mildly) off an on from Friday to Sunday - I did not get sick and vomit or have diarrhea at any time. I did not experience any events which seemed to be an immune system response, so I was able to eat - I drank water and gaterade. My arm was terribly sore so I took 2 200 mg ibuprofen every 4 to 6 hours for the first 48 hours. The injection site did swell and get a knot on it, but I could not get a good picture. Yesterday, the injection site began to be itchy. My arm is still tender and sore today, but not like over the weekend - on Saturday, my arm was about a 5 in pain.
Initial report was received on 08 October 2014 from a nonhealth care professional. A 66 year-old female patient had received on 03 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5015BA) and one hour later experienced a scratchy throat. The patient also experienced throat closing, hoarseness, lip swelling, mouth and eyes burning described as if had "eaten a mouthful of tabasco". The patient went to the ER (emergency room) where she was treated with BENADRYL. No further information was provided at the time of the report. Outcome was unknown. The reporter for this case is the same as for case 2104SA140049. Documents held by sender: none
Lost peripheral vision and can not drive anymore; Lost peripheral vision and can not drive anymore; Stroke; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Controlled).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (Lost peripheral vision and can not drive anymore) and VISUAL FIELD DEFECT (Lost peripheral vision and can not drive anymore). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had not resolved and IMPAIRED DRIVING ABILITY (Lost peripheral vision and can not drive anymore) and VISUAL FIELD DEFECT (Lost peripheral vision and can not drive anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Patient had about 8 strokes from the date of administration of the vaccine. Patient was yet to take the second dose. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-219228 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Approximately 6 minutes after receiving the above vaccines, the patient was very apprehensive, and began to complain of vertigo, heartburn & temporal-area headache.
Presented to ED 9/16/21- CC swelling of deep layers of skin. She had immediate symptoms following COVID vaccine (mild diaphoresis and lightheadedness) but symptoms are mild enough that she was released. Significant swelling at injection site started night of vaccine, later progressed to L lateral hip and L anterior thigh. Took Benadryl. No difficulty breathing, throat, or tongue swelling. Was given diphenhydramine, famotidine and dexamethasone in the ED. Discharged home without additional medications. (hx of angioedema to shellfish and seafood).
1) 3-4 days after vaccination I developed a mild, itchy rash on my abdomen. It lasted about 24 hours. 2) About 4-5 days after vaccination, I developed painful, sensitive toes. The toes turned dark red/purple.  The skin was sensitive to touch. The toes felt tingly and hot. This lasted about 3-4 days, but has recurred more mildly and transiently a few times since then.
and then she had bumps under her arm; arm got really, really red; then there was a lot of swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101352721 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset Oct2021, outcome "unknown", described as "arm got really, really red"; SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "then there was a lot of swelling"; SKIN DISORDER (non-serious), outcome "unknown", described as "and then she had bumps under her arm".  Additional information: Caller says that she was calling because her cousin did not have a cell phone number and later noted that she was not sure if her cousin had the Moderna or the Pfizer-BioNTech COVID-19 Vaccine, past weekend on the west side of town, she believes  and her cousin really had some side effects from it. Her arm got really, really red and then there was a lot of swelling and then she had bumps under her arm, it was under the same arm that she had gotten the vaccine in. There was a lot of redness, swelling and bumps. Caller says it was very frustrating for her cousin because she was going to go out of town and then she could not travel and she had to stay home because she did not know what to do. Phone out at 14:27 PM , 1st attempt by phone to Consumer to obtain contact information. Call answered by Consumer who refused to provide contact information. Consumer does not wish to be contacted any further.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EP7533), on 10May2021 as dose 2, single (Lot number: EW0176) and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: other medical history: Obesity; "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 105 degree; Oxygen saturation: (unspecified date) 93 %; SARS-CoV-2 test: (09Aug2022) Positive, notes: had a positive antigen test on 09Aug2022; (14Aug2022) Negative, notes: my COVID symptoms had resolved by 14Aug2022, and that day I tested negative on an antigen test; (16Aug2022) Negative, notes: and tested negative on antigen tests taken 16Aug2022 and 18Aug2022; (18Aug2022) Negative, notes: and tested negative on antigen tests taken 16Aug2022 and 18Aug2022; (19Aug2022) Positive, notes: I took another antigen test on the evening of 19Aug2022 and this time it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Aug2022 to 14Aug2022.
Patient received expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case
I woke up with a sore throat. I tested for COVID-19 and tested negative. Then we went to go get our booster shot and when we came back home, I had chest tightness and congestion. I took another at home test and tested positive for COVID-19. I called my doctor and he prescribed me Paxlovid for 5 days. My chest congestion got better but I still had a sore throat for 3 days. I had COVID-19 for 10 days. I started to feel better and go out again. Then a couple days later I started to feel sick again and tested positive again. I just felt like I had a minor cold. I started having sneezing, congestion, and running nose for about 2 days. Also, it seemed like my Gurg that I already had under control got bad. I had burning in my chest.
ADMINISTERED EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced administered expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955498, 20210955712, 20210955936 and 20210955852.
Possible PE Pt was sick prior to PE and put on antibiotics by urgent care. She was not covid tested at the time. When seen on 9/22/22 She stated: sob and dizzy sept 8-16, 22 nothing else to talk about.  Having Sob since Sept 8. Saw urgent care and did EKG and xray. Was really tired. couldn't stay awake. Dizziness. Didn't do covid test. Difficulty breathing starting Sept. 8, recurred on Sept 16. Feels extremely fatigued and dizzy. Drinking a lot of water. Didn't do any COVID testing done at urgent care or home test. Went to hospital for testing (later found out she had CXR). No loss of taste or smell. chest pain, no diaphoresis or nausea. some sob with activity but can have at rest. Sometimes she has problems just walking to go to the bathroom. Sometimes it acts up while standing to cook. No N/v. Swelling when she was having problems. Better now. Sometimes problems with left side of guts problems.  On 9/30 she was admitted for a PE in both lungs. Had an embolectomy. Seen in follow up today. She is able to breath better but still has some SOB with exertion. Asking if COVID Vaccine the cause. (I personally think she may have had covid which didn't show up on testing.)
On or about July 10th I began having severe exhaustion.  It lead to heartburn even when I didn't eat.  I had severe migraine and weakness.  These symptoms lasted from July 26 through the 28th of July.  My back began to hurt on the July 24 through the 27th.  The pain was in my lower back, stiff and tight.  The weakness  I had felt like I could not get a grip on anything to hold and I was shaky.  No matter what position I was in my back hurt for several days.  I contacted my doctor and was advised to take ibuprofen and drink fluids.  The weakness and the migraine concerned the doctor and I was scheduled for tests on August 1st.  No diagnosis was offered as the tests were all normal.
Information has been received from a consumer concerning his son with general sensitivity to all vaccines (no specific vaccine or manufacturer given) and fever after receiving shots, who on an unspecified date was vaccinated with a dose of MMR II. It was reported that on an unspecified date after receiving MMR II the patient had a reaction which resulted in him turning blue and having fever for four days. It was reported that the patient was hospitalized for a couple of days due to the reaction. The reporter stated that the report was already given to the CDC through the pediatrician's office. No further information is available.
pt recvd vax & 10 days later exp flu-like sx & achiness in bones; pt is currently overseas;
8 days after 1st dose, noticed the injection site was warm and raised up. very itchy.
Pt given 2 shots on 2-8-16, called and then presented to office with rxn on (L) deltoid. PNP notified, pt assessed - determined to be local rxn given BENADRYL in office and told to do cold compresses at home to call if any ?'s or concerns.