chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got flu last week with flu shot only 1 day horrible day then I was alright; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got flu last week with flu shot only 1 day horrible day then i was alright after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor 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 by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed i got flu last week with flu shot only 1 day horrible day then i was alright (influenza) (unknown latency)   It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was recovered for the event
Congestion, runny nose, body aches Started Tuesday evening late, tested positive Wednesday.  Symptoms very mild- gone by Friday
tooth infection; This is a spontaneous report received from a Pfizer sponsored program. A female consumer (patient herself) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 07Mar2021 as DOSE 1, SINGLE and patient had received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 27Mar2021 as DOSE 2, SINGLE both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tooth infection on an unspecified date. It was reported that patient was asking if she can take the prescribed antibiotic medication (Clindamycin) for tooth infection. She added that she already completed the 1st and 2nd dose of the COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
Immediately following vax, the pt's arm turned red, had blister type rash, started to itch. Red from shoulder to elbow. subsided by 4:30 PM. MD stated no more MMR or Varivax vaccines.
initially axial muscle pain and weakness, profound weakness, I initially suspected PMR but normal labs and inflammatory markers obtained, referred to neurology who agreed may be related to immunization,  responded best to prednisone 40-60 mg over several weeks
Healthcare worker given the Pfizer Bivalent vaccine per the consent.  Healthcare worker previously had received the Pfizer Bivalent vaccine about 2 months ago.
Information has been received from a health professional concerning an approximately 1 month old white male infant with mild jaundice (no phototherapy) who at birth on approx 10Aug04, was vaccinated with a first dose of hep B virus vaccine rHBsAg vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (manf unk). In Sept 04, the pt experienced rotavirus and febrile illness and the pt was hospitalized. The reporter indicated that it looks like the pt was just hospitalized overnight. Subsequently, the pt recovered. The was subsequently experienced mild reactive airway disease, apnea, cyanotic episode and seizure after vaccination with Hib conj vaccine (WAES0501USA03436). No further information is expected.
Tingling nerve sensation from injection site to entire left side of face, body, trunk and legs. Tenderness at injection site. Lasted for about 1 hour severely then faded over 12 hours.
Covid arm rash appeared suddenly on both elbows and also across face in mask pattern.  Also noted the day before that my left eye turned red and then cleared out too....not broken blood vessel.  After rash became itchy in various spots and also developed brain fog and mild headache and exaustion, but was fine and active during the day prior to this, also yawning a lot.
Patient called to pharmacy with concerns regarding tetanus vaccine received 3/20/07.  Per patient she is still having soreness in the deltoid muscle.  There is no redness and only a small mark at the injection site.  Patient states that she was sore the day of the injection and the day after.  The soreness then went away and returned two days ago.  Patient also states that the injection site feels warm.  Instructed patient to contact her physician to determine if she should be seen.  Patient said she would contact her doctor.
3 weeks, post vax, pt has developed hives. She has had hives X 1 week now. She is taking OTC Benadryl, 1 tablet, twice a day, which relieves itching but condition has not improved. She says her tongue "feels thick at times". She will continue Benadryl and see MD if no improvement. I observed some raised red areas on forehead and neck.
Seizures - antiseizure medication; Blood clot (left arm) - blood thinner. Extreme pain on left side, felt like a Charlie Horse. Irregular menstrual cycle - Oct '07 - Jan '08. Rashes/hives - ALLEGRA, ZYRTEC, BENADRYL. Brain inflammation. Phantom feeling on left side. Bedrest for 2 months.  10/14/2008 MR received for DOS 1/27-2/20/2008 with D/C DX:  Simple partial seizures with capacity for secondary generalization.  Epilepsia partialis continua manifested by L chest pain, L neck pressure, and L-sided numbness and paresthesias involving the arm and leg.  R parietal cortex lesion.  Pulmonary Embolism from probable hypercoagulable state.  Sinusitis. Pt presented after transfer from local facility. Has had 5-10 ER visits over the last 11 days for progression of symptoms which began 1/16/2008 with numbness and discomfort which begins in the L arm and progresses to chest and L leg. Symptoms have become more frequent and of increased intensity. On the night prior to admission pt was found unresponsive and gurgling. Seen in local ER and d/c. 2nd episode which involved flailing of all 4 limbs followed by becoming unresponsive and limp. Initial PE (+) for L sided weakness, tongue lac, and subjective decreased sensation of the L arm. Initially had some improvement in seizure activity on  anti-convulsants, however pt developed persisitant numbess of the L arm, thorax and L leg and increasing pain in the chest and L neck. PE was dx 2/11 and pt placed on anti-coagulants. IVC filter placed and removed 2/19/08. Symptoms of numbness and pain decreased as seizures under control. D/C home 2/20/08. 2/2/09 MR received from neurology consults dated 5/7/08, 5/9/08 and 11/6/08. DX include Refractory partial epilepsy, R central MRI abnormality, Pulmonary embolism, Coumadin anticoagulation, Urticaria, RUQ abdominal pain, Loss of taste and weight loss, New onset migraine H/A w/out oura, recurrent sinusitis and hx of neutropenia.  Hx as above.  Still with daily seizures. New onset migraines which began in 7/2008 with phono/photophobia and transient hearing decrease.  Some decrease in seizure with multiple meds.   1/27/2010 Patient continues to have seizures, but controlled with medication. 3 more emergency visits since 9/08. 2 for headaches, 1 for chest pain lasting 24 hours after seizures.
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 31-JUL-2017, the patient was vaccinated with PROQUAD (lot # L042817, expiration date: 26-APR-2017, strength, dose, frequency and route were not reported) (expired drug administered) reconstituted with sterile diluent (lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported.
Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown date, the patient may had received an improperly stored dose of either  GARDASIL 9 lot # M023169 with expiration date 13-JUN-2018 (dosage and therapy route were not provided), for prophylaxis; ROTATEQ lot # M006111 with expiration date 18-NOV-2017 (dosage and was not provided) orally, for prophylaxis; or VAQTA lot # M027879 with expiration date 24-JAN-2018 (dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported.  The doses of GARDASIL 9; ROTATEQ and VAQTA were exposed to a temperature of 46.1F and were out of range for 18 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient experienced dizziness, ringing in the ears, and blurred vision. Symptoms started within 30 seconds and resolved within 5 minutes. No treatment.
The patient has dementia; trouble communicating; experienced side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of DEMENTIA (The patient has dementia) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (The patient has dementia) (seriousness criterion medically significant), COMMUNICATION DISORDER (trouble communicating) and VACCINATION COMPLICATION (experienced side effects). At the time of the report, DEMENTIA (The patient has dementia), COMMUNICATION DISORDER (trouble communicating) and VACCINATION COMPLICATION (experienced side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Company Comment This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Dementia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.     This case was linked to MOD-2021-415894, MOD-2021-416026 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of Dementia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. Patient´s age (91 years) remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Day of injection-normal injection site trauma-focus on range of motion left arm/shoulders - Day 2 5:00am Resting Heart Rate noticeably increased-disturbing normal waking pattern @ 10am Strong Headache, body ache, joint inflammation, injection site sore with normal range of motion, sore to touch, 3 red discolored lines in left shoulder appearing to following muscle striations. Symptoms lasted through the night. Did not use recommended Tylenol or any pain reliever to mask pain. Pain is there for a reason. Day 3 Sunday: Normal wake time 6:00am. Today 9:30am. Resting Heart Rate increased. Left arm injection site noticeably more sore than DAY 1 and 2 with normal range of motion. Range of motion limited. Headache intermittent throughout DAY3. DAY 3 evening - series of fevers -  sweating despite room temperature being 73 and sitting down. DAY 4 get up to alarm @ 6:30am to go to work. Body aches and chills, headache returns, injection site continues to be sore to touch surrounding injection site, entire lateral shoulder muscle. DAY 5 I am at work, injection site sore to touch, small headache in the morning, current brain fog.
Received 2nd dose of COVID vaccine on 1/30/2021.    Patient had family member diagnosed with COVID-19 on 4/15/2021.  Tested 4/19/2021 and positive for COVID-19 but no symptoms.
On April 26 she got her fourth COVID Pfizer shot.  On April 27 she became very fatigued by mid day.  By that evening she was unresponsive, and she was admitted to local Hospital for acute metabolic encephalopathy.   Labs showed nothing particularly abnormal.  CT head showed changes of age.   Stayed in hospital till April 30, was improved enough to go home, but she still is not really back to baseline.  Also, in retrospect, ever since she had her very first COVID Pfizer shot she has had some degree of brain fog and memory loss.   Her first shot was Jan 10, 2021, lot number EN5318.  Second shot was Jan 30, 2021, lot number EJ1686.  both of these shots were given at her senior living facility. If you need to contact them, I suggest asking for the nurse's station.  I don't know when she got her third shot, but it was probably at senior living facility in the fall of 2021.  The memory loss seemed to start after the first shot and gradually get worse in a linear fashion.  It then seemed to get much worse abruptly after the fourth shot.  Before that, the decline was not nearly as clearly linked in time with the first 3 shots.
The first one was hemorrhoids. I was complaining of pain on the right side on the inner thigh. I sent a message to my doctor because I was having so much pain May 10. I felt pain near my anus and then I went to the doctor on May 11 and he said it was a hemorrhoids, blood clot. Then I had high blood pressure and a this was a few days later and it was very high and abnormal for me at my age. I have never had issues with my blood pressure before. Propranolol 10mg once a day was given for the blood pressure. I was given medication for the hemorrhoids, hydrocortisone 25mg. I was also complaining of bad blood circulation on my right leg and my doctor sent me to get scan and they found varicocele in the right testicle. At this moment they have no medication for this and I might have to go under surgery if it continue.
This is spontaneous report from a contactable healthcare professional. A 68-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced red bumpy rash in front and behind both ears on an unspecified date 3 or 4 days after receiving vaccine (reported as 06Apr, year unspecified) with outcome of recovering, rash was itchy on an unspecified date with outcome of unknown.
Hardness and redness at injection site, 48+ hours after injection. Itchy at injection site, warm to touch, sore to touch.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Replacement aortic valve (congenital)" (unspecified if ongoing); "Ascending aortic aneurysm" (unspecified if ongoing); "Aortic stenosis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "vasomotor symptoms related to menopause" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN oral, start date: Oct2005; CYMBALTA oral, start date: Apr2019; ASPIRIN [ACETYLSALICYLIC ACID] oral, start date: Oct2005. Past drug history included: Lipitor 5 mg; Premarin vaginal cream. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "started taking Paxlovid for COVID 19 Treatment/ coming back positive". The patient received COVID 19 Treatment, Paxlovid from 30Jul2022 (evening) to 04Aug2022. On 07Aug2022, the patient had noticeable increase of sneezing, congestion, aches, and feeling tired/malaise. On 08Aug2022, the patient took two home test (one I watched her do properly) with coming back positive. Currently the patient has been taking acetaminophen and naproxen for aches & pain with no appreciable relief. The patient also took a cetirizine (ZYRTEC) 10 mg to help with sneezing and congestion to some effect. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Mild
Started with a headache about 6 hours after the vaccine which has lasted 9+ days, Right arm with swelling and redness that did not start until 8 days after vaccine administration, joint pain and fatigue
Abdominal pain, diarrhea, ileus - 2/21/11 - 3/11/11.
Patient received flu shot 10/27/03 and on 10/29/03 developed unusual sensations of lower extremity and right sided twitching. Taken to ER where had witnessed episode of global aphasia and confusion. CT there showed white spot found right lateral ventricle. Transferred to another hospital after 1 further episode, but MRI was normal. EEG showed rare suspicious left temporal sharp waves. Questioned of patient had TIA versus SE of vaccine. The medical records state lightheaded, slurred speech and flushing.
I was fine the remainder of the day. Today, I was pleased to note that I had ZERO pain, aches, sickness, etc. HOWEVER, as this day has progressed I?ve had less and less ability to taste food and/or drinks. It doesn?t matter how strong I make the tea... it?s just wet.
6 hours after vaccination presented with swollen lymph nodes in the armpit and back part of arm, at 8:00 that evening my first episode of 38.6 fever started and with paracetamol I was able to control it. In the early morning of July 28th I presented with swollen clavicular lymph nodes of vaccination arm that are noticeable to the naked eye and redness with inflammation of the skin of the left armpit and breast (Where vaccine was applied), once again 39 degree fever, pain in joints, bones, gums. On July 29 I had severe redness and thickening, like little bubbles on skin of left arm, armpit, face (nose and cheeks) and left breast, with a generalized burning pain on the skin of whole body even light clothing caused pain, redness in gums and acute pain and lymph nodes on backside of ears became visibly enlarged swollen lymph nodes on back side of arm, with various episodes of fever higher than 38.8, difficulty breathing, constipation, like a common cold, severe headache, joint pain, constipation every day after vaccine, with pain and general discomfort and extreme weakness. On the 30th almost all the symptoms, and the bone, joint and head pain disappeared only thing present is the swollen lymph nodes in the armpit and the part in the clavicle although now visibly smaller and a slight redness in the area of vaccination in the arm and in the armpit and the thickening of skin also disappeared. Weakness and tiredness almost completely gone and no other symptom exists of constipation or anything from the day before. I only took Paracetamol 500mg every 8 hours.
pt devel erythematous rash & edema @ inj site;1 days post vax w/progression into a urticarial rash & erythema multiforme in the next 24hr responded well to DPH & resolved in the next day w/o other problems;no fever, coryza, koplik spots;
Upon wakeup next morning, patient had fever of 100.7, severe headache, body aches, occasional chills, fatigue. Symptoms lasted all day with gradual diminishing toward evening.
MYAGLIA, NAUSEA, COLD SWEAT, CHILLS, HEADACHE Narrative:
Two shingles shots / After two years, shingles; Shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she got the two shingles shots. Now after two years the patient had shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
9/8/2021 patient became very weak and unable to walk. Patient presented to the ER was admitted acutely for observation.
Injection site was swollen; Rectangle hard lump like; Headache; Hot around the injection/injection site was hot; Red spot aound the injection/little red spot at the injection site again and it's gotten bigger each day/injection site was red; Hurt around the injection; A spontaneous report was received from a consumer, concerning her husband, a 65-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the same day after vaccination, the patient had a red spot that was hot and hurting around the injection, which seemed healing for the first 2 days but worsened after 8 days and turned to hard lump like  a small bump, very itchy and round without pain by 11th day. Patient also had headache on the 5th day and resolved on the same day.Treatment details were not reported.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events around the injection site were not resolved at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.