chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given vaccine at another medical facility but our facility received the nurse advice line note, perhaps because the patient just moved.  He received a 3rd meningococcal vaccine (2 previous in 2011 and 2016, unknown type) on 4 Aug and later that night developed hives on his arms.  Resolved with benadryl.  The next day he felt feverish and like he had the chills - resolved.  3 days later developed hives again - resolved with benadryl.  This promptoed his call to the nurse advice line.  No further symptoms.  Denies any other new exposure or illnesses.  I recommended he ask his new primary doctor for a referral to allergy for further evaluation.
Anaphylactic Reaction; felt like something was in throat; felt tingling on both hands and fingers; voice started to change; face turning red to white to purple; everything in mouth as tongue felt like it was growing; having chest pain radiating to left scalpel, and jaw; couldn't think of the words to say as it was hard to breath; chills; heart rate is racing; This is a spontaneous report from a non-contactable nurse via internet source via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included had a lot of food allergies. The patient's concomitant medications were not reported. The nurse told that her manager (patient) had an anaphylactic reaction shortly after receiving Pfizer's COVID-19 BNT162b2 vaccine on 18Dec20. Patient stated via Social Media indicated that she received the Covid-19 vaccine right after work. Easy breezy didn't feel a thing. She was asked to wait for 15 minutes, 5-10 minutes of waiting, she felt like something was in throat, so she kept clearing it. Patient felt tingling on both hands and fingers. Her voice started to change. She informed the ER team there, the ER nurse described her face turning red to white to purple. ER nurse started an IV right on patient's right AC, gave her a shot of Benadryl, steroids and the epi pen right through pants. Patient felt everything in mouth as tongue felt like it was growing, but she can breath. Patient was route to the ED via wheelchair, everything started to look hazy, she was having chest pain radiating to left scalpel, and jaw. Patient couldn't think of the words to say as it was hard to breath. When got to the ED they gave her another dose of Benadryl, solumedrol, decadeon, HHN tx with epi and that worked. Patient felt her throat opening up and started talking but then came the chills. It took almost 3 hours to clear the symptoms, even though her heart rate is racing (prob due to the meds), she opted to go home. The outcome of "heart racing" was not recovered, of other events were recovered on 18Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reactions with tongue swelling/voice alteration/hard breath/tingling/something in throat/skin discoloration, chill and chest pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021 and 02/26/2021. They tested positive for COVID-19 on 08/20/2021 at the facility at which they were a resident. They also  presented to emergency department via ambulance on 08/20/2021 with primary complaints of shortness of breath and hypoxia. They were admitted to hospital same-day and repeat COVID-19 testing x2 were also positive. They were found to be experiencing several complications and co-occurring conditions, including: acute renal failure, urinary tract infection with ESBL (also sepsis from the ESBL), hypotension, hypoxia, shock, COVID-19 pneumonia, respiratory failure. Due to declining condition, they were discharged to a hospice facility on 09/14/2021. They remained in this hospice facility until their death on 09/17/2021.
Brain Aneurysm, Blood Clots And Stroke- 17 Days In ICU At local Hospital. I Missed 6 Months Of Work.
1. Severe Headache (radiating from left eye), body aches and fatigue for about 24 hrs after 2nd dose. 2. General daily fatigue through today.   3. Constant headache (radiating from the left eye) beginning in early July through today, accompanied by scalp sensitivity on the left side.  Occasional vomiting when the headache becomes severe.  Ptosis of the left upper and lower eyelid since July, along with the recent diagnosis of Horner's Syndrome (left eye smaller).   Along with my primary physician, I'm seeing a neurologist and optic neurologist.  My neurologist believes I'm suffering from "an inflammatory reaction to the COVID vaccine".
After the second vaccination I started to experience fatigue that has got increasingly worse since over. I was given Cymbalta to help provide me some energy which did not work... Later they tried Wellbutrin and as of today they changed it to Desvenlafaxine. Besides the fatigue I don't have the desire to do much due to the energy loss. I also have had falls that were a result of the dizziness. The most recent fall was after leaving a doctor's appointment. I black out in the parking lot and the staff at the doctor's office found me and had me taken to the emergency room and I was in the hospital for 2 days. I also used to be very active so this is all new to me. This has all been going on for the last year and a half.
got really sick; Initial information was received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got really sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2021, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got really sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (got really sick).  At time of reporting, the outcome was Unknown for the event got really sick.
This spontaneous report has been received from a pharmacist, and refers to a 79 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-SEP-2014, the patient received the first dose of ZOSTAVAX 19400 PFU for prophylaxis (dose, route of administration, lot number and expiration date were not reported, sterile diluent unspecified). On 26-OCT-2017, the patient received inadvertently a second dose of ZOSTAVAX lot number N023002, expiration date 20-NOV-2018 (dose and route of administration were not reported, sterile diluent unspecified). There was not adverse event or product quality complaint involved.
Hallucination at 6:20 to 6:25 AM. Nightmares,  excessive sleepiness for four days,  foul taste. Also my husband was vaccinated at the same time and woke up at approximately 4:00 AM with hives and swelling on his face and inside his mouth causing him to bleed through his mouth. Lasted two days. He?s age 64.
Pt got smallpox vaccination and 1.5mo later has pox crusting vesicles on arm going from elbow to shoulder around original site.  No other symptoms. Reporting done per doctor.
skin in my arms have a rash/ my face is also affected now; areas in my arms are very itchy/it weeps and expands more; allergies have gotten worse; puffiness in cheeks; congestion; This spontaneous case was reported by a consumer and describes the occurrence of RASH (skin in my arms have a rash/ my face is also affected now), SWELLING FACE (puffiness in cheeks), NASAL CONGESTION (congestion), PRURITUS (areas in my arms are very itchy/it weeps and expands more) and HYPERSENSITIVITY (allergies have gotten worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and IBUPROFEN for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced SWELLING FACE (puffiness in cheeks) and NASAL CONGESTION (congestion). On an unknown date, the patient experienced RASH (skin in my arms have a rash/ my face is also affected now), PRURITUS (areas in my arms are very itchy/it weeps and expands more) and HYPERSENSITIVITY (allergies have gotten worse). At the time of the report, RASH (skin in my arms have a rash/ my face is also affected now), SWELLING FACE (puffiness in cheeks), NASAL CONGESTION (congestion), PRURITUS (areas in my arms are very itchy/it weeps and expands more) and HYPERSENSITIVITY (allergies have gotten worse) outcome was unknown. Not Provided      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.   The treatment information was unknown.   This case was linked to MOD-2021-109926 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 6-MAY-2021 and added 2nd dose details. added concomitant medication. added new events.
Pain at injection site, general muscle aches throughout torso (flu-like), headache, lethargy.
My left eye twitches open and closes on its own, changes focus on its own, sometimes my eyes cross and uncross too. almost like a tick. But almost like a Robot too, my left eye wandered to a dog and lady walking past my house and I was trying to watch tv.  I felt as if someone else was controlling my eye remotely.
Child had HAV & Varicella on 2/24/11 at 4:30pm. There were no symptoms until patient awoke in the morning of 2/25/11 with a fever.
administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
On 7/13/01, mom called concerning a temperature of 100.3F and spots like pimples, on back (4) and has been exposed to chickenpox. On 7/17/01, mom called and the pt had no further spots and temperature stayed the same (100.3F-100.7F) all weekend but is OK now.
This is my son's first and only vaccine. He did not receive the Hep B at birth. Less than 24 hour after he received his DTaP shot he started to develop an unexplained red spotty rash on his face, especially his cheeks. At first it looked like heat rash but, as it became redder in color with raised hive like bumps over the next few days, I became concerned. He was also running a mild fever, 100.2 on March 28, 2012. I emailed his doctor a picture of his inflamed cheek on April 1, 2012 and asked what it is and if an office visit was required. His doctor said it was just eczema, which is very common in babies. Be assured my son had no issues prior to the vaccination. He now suffers from severe eczema requiring hydrocortisone for flare ups, daily oatmeal baths, and heavy creams applied 5-6 times per day. He also scratches his face and head at night resulting is bloody cuts, even with trimmed and filed nails. I often put socks on his hands at night to help reduce the cuts. He also has trouble sleeping when he has flare-ups. The eczema appears on his cheeks, eyebrows, forehead, ear lobes, scalp, back of neck, elbows, shoulders, thighs, front of ankles and lower back. His doctor has dismissed my concerns as a "coincidence". I am deeply troubled by the amount of aluminum in this vaccine and now the ongoing condition my son suffers from. For his body size (20 lbs, 1 oz as of July 10, 2012) he should not be exposed to more than 45.5 mcg's of aluminum at any given time. Whereas this vaccine (Sanofi Pasteur, lot # C40358A) contained 170 mcg's!
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022 at 4:33 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 10-Feb-2022 at 4:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 10-Feb-2022 at 16:33:20) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's ethnicity was reported as white. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Pfizer COVID monovalent vaccine was given instaed of Bivalent vaccine. Patients were notified of the vaccine given. Local DOH was notified of the Pfizer COVID monovalent vaccine given instead of Pfizer COVID  bivalent vaccine. Client advised to check with healthcare provider.
Injection site discomfort; Sore shoulder; Wheezing; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), RHINORRHOEA (Runny nose), INJECTION SITE DISCOMFORT (Injection site discomfort) and MYALGIA (Sore shoulder) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Robaxin. Past adverse reactions to the above products included Hives with Robaxin. Concurrent medical conditions included Parkinson's disease, Obesity and High cholesterol.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced WHEEZING (Wheezing), RHINORRHOEA (Runny nose) and MYALGIA (Sore shoulder). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Injection site discomfort). On 09-Feb-2021, WHEEZING (Wheezing), RHINORRHOEA (Runny nose) and MYALGIA (Sore shoulder) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (Injection site discomfort) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported.  No treatment information was provided.  Patient took prednisone week before a time of vaccination which was not ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI Source doc On 09-Jul-2021: Follow up received on 09-Jul-2021, Patient details (height), concomitant medications, concurrent conditions were updated. New event was added.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced minor pain after receiving a dose of SHINGRIX. The reporter declined to provide any additional information.
Within hours of my shot I experienced severe pain in the injected arm (left) that traveled into my neck and across my jaw.  I was also experiencing swelling in my lower face.  It was decided by my PCP that I should go into the ER just to make sure it wasn?t cardiac related or something more severe.  I went ER at noon on 2/5/21, where they did and EKG and gave me benedryl for the swelling.
pt had entire upper arm swelling, pain, burning, and a red ring around arm, and some dizziness/drowsiness. Used cold compress, BENADRYL, and TYLENOL per Md.
Information has been received from a health professional concerning a 10 yr old male who on 14Jan98 was vaccinated with a first SC dose in the left arm of varicella virus vaccine live (lot624649/1108E). Subsequently the pt experienced mild breakthrough chickenpox characterized by pink papular lesions on his face, trunk, and extremities. It was reported that he also experienced vesicular lesions behind his ears and on his thigh. The pt was being treated with oat (Aveeno bath) and calamine lotion. There were no lab or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 18Jan06 the pt experienced a fever, pink papules on the face, trunk and extremities, vesicles behind the ear and on the thigh. The pt was diagnosed with varicella. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 5/12/2006.  Follow-up information from a health professional indicated that the patient had a generalized rash and the event was documented/evaluated by a medical doctor.  Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm, as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lost spleen in 2001", start date: 2001 (unspecified if ongoing), notes: Lost spleen in 2001; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: It was unknown if patient received other medication in 2 weeks. Treatment with anti-viral (Brand: Paxlovid) was started on 12Nov2022 and stopped on 16Nov2022 for COVID-19. Symptoms returned two days after second negative test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness occurred evening of vaccination of left arm. Patient states it resolved in 2-3 days".
Fever, chills, aches, fatigue, muscle weakness, headache X 4 days, dizziness, confused, sweating, nausea, increased blood glucose and pain in shoulder and shoulder blade.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Systemic: bruising below biscep and complaint using arm-Mild, Additional Details: patient arrived for his 2nd moderna dose (28 days after 1st) and had a bruise below the biscep and above elbow fold - patient states that is were he received the orginal vaccine and he has had the bruise and can barely use his arm since  and he is a mechanic.  patient was very negative receiving his second dose of the vaccine
Metallic taste in mouth, severe fatigue, muscle, joint, and nerve pain, nausea