chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delirious; He woke up sick on stomach and throwing up; He woke up sick on stomach and throwing up; This is a spontaneous report from a contactable consumer (son). An 87-year-old male patient received BNT162B2 (lot number: EK9231, expiration date: 30Apr2021) first dose on 15Jan2021 around lunch time at single dose for COVID-19 immunization. Medical history included high sugar and COPD (Chronic obstructive pulmonary disease). Concomitant medications included gabapentin, metformin, ferrous sulfate, acetylsalicylic acid (ASPIRIN 81). Patient took the vaccine 15Jan2021 around lunch time and this morning (16Jan2021) he woke up sick on stomach and throwing up and kind of 'deluce' or delirious. Consumer just started giving patient fluids and Pepto Bismol as treatment. The outcome of the events was unknown.
Arm swollen and exhausted the second and third day. And both arms, neck and hips ached.  Fourth day my left armpit was very tender and still is on this fifth day.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to.  Patient came by the pharmacy on 5-11 to get her second dose of Pfizer. We explained the error to the patient. She did not want to get revaccinated and wanted to go ahead with her second dose.
Pt received vaccines, stated she felt weird, then passed out in chair. She remained semi-conscious and convulsing for 30 seconds-1 minute, she then woke up on her own and recovered. EMS came and cleared pt.
Redness and soreness of injection site yesterday; worse symptoms today with increasing redness and pain and very warm at site. Treatment in ER 7/22/05: Keflex, Prednisone. Will follow up.
Dose 1: headache chills body aches exhaustion 4 days  Dose 2: immediate chest pain radiating up neck to both ears & nausea. Felt like pins & needles. ER via ambulance. Pain Gone after one hour. Kept for 6 hours to rule out heart attack. Not heart attack.  Felt tired but fine next day.
Red spot at immunization site which has increased in size over 24 hours. 40 mm erythema with 10 mm center nodule.
I've been to hundreds of doctors appointments since then.  Symptoms are chronic pain in bones, muscles, and nerves, burning skin, migraines, diarrhea (constant for almost 2 decades), random vomiting, recent diagnosis of MGUS, a pre cancer almost always found in people in their 70's and 80's.
Headache, ache in arm, neck, abdomen, and chest, head fogginess.
I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion  and overall unwell feeling. This feeling persisted through the remainder of the day. By  46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch.  I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache.  At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2"  and swelling without redness now  extends about 2" past the redness down my arm.
skin had a reaction; broke out in hives; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional by phone.  This case involves a 11 years old male patient who experienced skin had a reaction and broke out in hives, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unspecified date of February 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number:U6302AA and expiry date: 30-Jun-2019).  On an unknown date, the patient developed a non-serious skin had a reaction (skin reaction) and broke out in hives (urticaria) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was broke out in hives and skin had a reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for both the events.  Documents held by the sender: none.
facial droop Left side 10/29/09 Medical Records received for office visit to primary care provider for date of service 10.21.09.  Dx:  Paresthesia, Acute Assessment:  Presents with numbness of left jaw, tongue, eye and ear.  Ear had improved, but experiencing pain in left ear,  rest of L side of face numb, not increasing, no droop or drooling noted.  Denies HA, gait disturbance, weakness, incoordination, lightheadedness.  Pain 4/10.       10/30/09:  Emergency Department Records received for date of service 10/19/09. Dx:  Paresthesia, facial Assessment:  Seen  for L side facial numbness after flu shot.  VSS.  Denied pain.  Discharged to home is stable condition.
On 11/3/2021, I started bleeding. I went to my OB twice and was informed the embryo stopped growing around 2 weeks after the booster shot. I fully miscarried 11/06/2021.
lt upper arm from deltoid-just above elbow erythematous,swollen,+warmth,mild tenderness + from motor strength-+5/5 for LUE&all extremities;sensory intact;
ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA  8/23/2022 -- RECURRENCE OF SAME SYMPTOMS
Information has been received from a health professional (LPN) concerning a 43 month old male child with no past medical history and NKDA who on 03/23/2001 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 05/15/2001, the pt presented with chicken pox. The child had "itchy pink bumps on buttocks, which spreads to the trunk". The pt sought unspecified medical attention. No other information was provided. Additional information has been requested.
Shot given 9/18/18  3:15 pm Within 1 hour of the vaccine, I noticed the discomfort at the injection site was still very uncomfortable. Within 3 hours there was significant swelling and the area felt warm to the touch. The same evening I had the first incident of diarrhea. 9/19/18 An additional 3 episodes of Diarrhea, my right arm (injection site) developed a large bright red area. The site was sore and the swelling was worse. The area felt hard a circle roughly 3 in diameter. On 9/20/18 I decided to seek medical attention. The injection site swelling was approximately 4-5 in diameter, the redness was more predominant and the temperature around the site was hot to the touch. On 9/20/18 I also started to experience muscle soreness around the effected area. The Diagnosis on 9/20/18 from Urgent Care, was cellulites infection. A antibiotic was administered and a prescription called in. Several employees that received this shot on the same date, by the same company are reporting similar response.
Pt recvd shots about 845AM; waited 30 mins then gave APAP childrens 2 tabs; 1130AM pt fever 101; 8PM fever 102.4 gave more APAP; fever went back down; 2AM pt jittery, eyes rolled back & began to shake; took to ER fever 103.8; dx OM
Lips started to swell about 45 minutes after vaccine was received, Swelling lasted for about 30 minutes. I took a benedryl and the symptoms dissipated within 2 hours.
large red circular welt that is 2 inches wide and 2.5 inches long,; Welt is warm to touch; Welt is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen). At the time of the report, URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache & Myalgia dose 2 - day 2 - chills; fatigue ; ha
pt recv vax & devel a severe poppy seed allergy;pt mom stated that they have to have an Epi pen JR in case of anaphylactic shock;
Information has been received from a healthcare worker concerning a 12 month old patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot# not provided) 0.5 ml intramuscularly. Subsequently the patient experienced fever of 101 degrees Fahrenheit and became lethargic. Follow up information was received from the healthcare worker reported that the patient with an allergy to environmental allergens and peanuts who on 15-DEC-2008 at 1:30 PM was erroneously vaccinated with a first dose of PNEUMOVAX (lot # 661529/0868X) in her right leg instead of (PREVNAR) at well-child care. It was reported in follow-up that no adverse event was identified. It was also reported that the patient recovered and no follow up was performed. Follow up information was received from the doctor of osteopathy who reported that the patient had no reportable reaction. It was a case of nursing error nothing related to product confusion. Additional information is not expected.
Temporary arm paralysis that has continued off and on since the night of the shot. It usually occurs when driving and occurs for about 4 hours after. There sometimes is also acute pain in the shoulder, area between triceps and biceps, elbow, outside part of the forearm, wrist, middle finger, ring finger, pinkie, hand on side associated with the fingers listed above. So far, I have been trying to squeeze a stress ball, take ibuprofen or Alleve. I have not went to a clinic/doctor/hospital/etc to get it looked at, yet but I plan on going in at some point (appointment is not scheduled).
soreness of the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (soreness of the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MAGNESIUM, VITAMIN B COMPLEX (SUPER B COMPL), CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), TURMERIC [CURCUMA LONGA RHIZOME], APPLE CIDER VINEGAR, VITAMIN D3, BIOTIN, ORNITHINE ASPARTATE, SELENIUM, SILYBUM MARIANUM, THIOCTIC ACID (LIVERAID [ORNITHINE ASPARTATE;SELENIUM;SILYBUM MARIANUM;THIOCTIC ACID]), CALCIUM CITRATE and GINGER ROOT [ZINGIBER OFFICINALE RHIZOME] for Nutritional supplement, VITAMIN E NOS for Skin disorder NOS, ASCORBIC ACID (VITAMIN C ACID) for Unspecified immunity deficiency.    On 08-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021 at 2:30 AM, the patient experienced INJECTION SITE PAIN (soreness of the arm). At the time of the report, INJECTION SITE PAIN (soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Patient had a ZOSTAVAX vaccine & is complaining of itching & redness around site.
I21.4 ACUTE NON ST ELEVATION MI 4/7/2021 ATHEROSCLEROSIS OF BILAT CAROTID ARTERIES I21.4 ACUTE NON ST ELEVATION MI 4/7/2021 ADJUSTMENT DISORDER W DEPRESSED MOOD I21.4 ACUTE NON ST ELEVATION MI 4/7/2021 HX OF FALL I21.4 ACUTE NON ST ELEVATION MI 4/7/2021 NEOPLASM OF UNCERTAIN BEHAVIOR, LEFT URETER
Pt called at 11:30 am to report "my hand is cold, I am having some chest pain" after having received adult dose (1cc Hep B) in L arm this am. Advised to call private health provider with symptoms. Pt stated at 11:50 before call that she is on way to ER. Has no PMD. 245pm - Pt called to report ER MD said she had "mild reaction to vaccine" should not have another Hep B.
Patient is currently being monitored for side effects. She was given the vaccine without the vial having the diluent added. This resulted in the patient having too high of a dose given.
Night after vaccine had chills, nausea, body aches, and shortness of breath.  Was better on evening of 1/22/2021 and was OK on 1/23/2021.
Sudden onset of extreme chills, shivering uncontrollably until approximately 5am. This was accompanied by a severe headache and sore muscles. By about 10am the shivering/chills had subsided enough to be able to get out of bed and get Tylenol for the headache. This helped get some sleep. At about 1pm was the first time I checked my temperature and it read 102 orally. By this point the sore muscles had mostly subsided, but the headache and fever persisted until almost 11pm on the dot. The fever dropped from 102 to normal in under an hour.
Severe fatigue, joint pains, muscle aches lasting 2 1/2 weeks from date of receiving first dose of vaccine
11/19/21  -   10:30 0.5ml Vaccine IM left deltoid.                            - 18:00 PT reports noticeable but mild "flu like" symptoms -Self treats with 800mg NSAID 11/20/21  -   PT wakes to mild to severe symptoms that persist for the next 48 hours.  These include: fever <103F, muscle fatigue, soreness, headache, and lethargic presentation 11/23/21 -  PT's symptoms begin to subside to "mild" over the next 24-36 hours.
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
A couple of minutes of having the vaccine I started having heart palpitations. I didn't see much of it so I left but it kept on going for the next couple of days then on the following Sunday I ended up going to the urgent care & they sent me to the Emergency room from there. On march 1st I had a miscarriage I was 6 weeks pregnant, There was some questions when I found out I was pregnant to see if I was going to have some issues or not.
Headache, Arthralgia, Fever, CoughWheeze & Syncope Narrative:  Other Relevant History:
Redness, heat and swelling with site pain... level 4 out of 10 per patient.  By the next day 12/23/14 all symptoms increased with pain at 6 of 10. By 12/24/2014 13:30pm slight swelling noted by myself, some heat noted, 4"x3" are of redness over L deltoid. Patient stated pain level at 2.  Patient also stated it was getting better. I gave her a cold pack to ease her symptoms topically.
Some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects). At the time of the report, VACCINATION COMPLICATION (Some side effects) outcome was unknown.            Concomitant products were not provided.  Treatment medications were not reported.
Excessive yawning; lingering fatigue; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (Excessive yawning) and FATIGUE (lingering fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 YAWNING (Excessive yawning) and FATIGUE (lingering fatigue). At the time of the report, YAWNING (Excessive yawning) and FATIGUE (lingering fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.         No concomitant medication was given.  No treatment medication was given Reportedly, patient did not get covid and blood work was done last week.
Patient developed a blood cloth in his bladder. As a consecuence a lithotripsy was performed and the patient is still in the hospital.
Initial information regarding this sponsored solicited case was received from a patient via patient support program on 01-Sep-2016. This case involves an approximately 77 years old female patient who had cough all morning unknown duration after receiving therapy with influenza vaccine and Praluent. No past drugs, medical history, concurrent condition or concomitant medications were reported. On an unknown date, the patient started therapy with 75 mg/mL subcutaneous alirocumab at the dose of 75 mg every other week for mixed hyperlipidemia and on an unknown date with influenza vaccine (other therapy details, lot/batch no and expiry date: unknown). Unspecified time duration later, on an unknown date, the patient reported that she got her flu shot yesterday (date unknown) and have had a cough all morning. Action taken: no action taken with alirocumab and unknown for influenza vaccine. Corrective treatment: unknown. Outcome: not recovered. Company causality: not associated. Reporter causality: not reported for influenza vaccine and unknown for alirocumab.
Evening of vaccination: fatigue, sensation of feeling hot Day after vaccination, AM: mildly sore arm at injection site, sore joints elsewhere, continuing fatigue Day after vaccination, PM: continuing fatigue
The pt received vaccines on 8/25/01. On 8/26/01 became febrile to 102, experienced and episode of atonia, unresponsive with forward staring. The pt regained consciousness with lethargy. The pt was taken to ER and given 1 dose of Tylenol and became afebrile thereafter.
S: Patient stated, "I don't like seeing the needle." Within 5 minutes of the injection patient reports feeling weak, faint, nauseated." Should lie down with feet elevated. Pt stated, "Did not think I would have problems today, usually do flu shot at doctor's office or public health clinic." Denies medications. Denies allergies.  O: Alert and oriented, pleasant, NAD. Skin clean, warm, dry. 10:40 AM - Pt pale, diaphoretic. Denies chest pain and shortness of breath. Position changed from chair to carpeted floor, feet elevated. BP rt arm 74/52, pulse 64. Respirations silent, non-labored, no loss of consciousness, no confusion, speech clear, coherant, oriented. Facial pallor, diaphoresis. PERRLA. No tremor. 10:47 AM - Pt Feeling better, no nausea. BP 116/80, pulse 76. Facial skin warm, dry, pink. Arms warm, dry. Moving all extremities. No tremor, jerking, seated on floor without complaint. 10:55 AM - Standing walking about room. No sway, ataxia, tremor. Reports feeling recovered. Feels able to work. A: Presyncope; vasovagal response related to injection. P: Returned to work.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-APR-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # K000737 and expiration date 16-JAN-2016, an albumin status therapy type, dose and route of administration were not reported. Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. On the same day, the patient received an improperly stored dose of RECOMBIVAX HB (captured in MARRS# 1607USA005367). Additional information is not expected as no contact details were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 18Oct2022 as dose 5 (booster), single (Lot number: gh9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: tl9262), in left arm, on 18Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301308), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure; "heart disease" (unspecified if ongoing), notes: Other medical history: heart disease. The patient's concomitant medications were not reported. Past drug history included: Opioids, reaction(s): "Known allergies: most opioids", notes: Known allergies: most opioids.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Joint pain and muscles aches beginning within 2-3 hours of vaccination which persisted 24+ hours.  Overnight fever developed (highest recorded 100.7 F but not checked until early morning). Poor sleep due to fever and muscle/joint pain. Decreased appetite.
Information has been received from a physician concerning a male, who "8 months ago", in approximately May 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) in the thigh.  It was reported that the patient experienced pain in his thigh where he got the vaccination with zoster vaccine live (Oka/Merck)for the last 8 months. Subsequently, the patient recovered. No product quality complaint was involved. No other information provided. Additional information has been requested.