chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme Fatigue and night sweats on the same night of the injection.   Arrhythmia were off and on for seconds at a time.  Achiness started less than 48 hours after injection.   Would get better with less Arrhythmias over several days then all the symptoms would appear again.  The extreme fatigue got worse on 9-26-21 with achiness and night sweats.  No arrhythmia's noticed at this time but a few sharp seconds of chest pain across my chest.  Had to sleep 14 hours for the fatigue to resolve enough to go to work.  No temp at any time during this period of post vaccine.
Rt arm edema, redness induration pain. Generalized malaise w nausea.
This spontaneous report was received from a pharmacist and refers to a 67 year old male patient. The patient did not have any drug reactions or allergies. His pertinent medical history and concomitant medications were not reported. On 02-OCT-2017 (reported as 2 days ago), the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (site of administration, dose, lot number and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) solution for injection (strength, dose, frequency, indication, lot number and expiration date were not reported). On 03-OCT-2017, the patient experienced fever, redness and hardness around the injection site. The affected area around the injection site was about the size of a palm of a hand. The patient sought medical attention as he spoke to the pharmacist. No lab diagnostic studies were performed. No treatment was given for the events. Product quality complaint was not involved. The outcome of fever, redness and hardness around the injection site was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was not reported. No additional information was provided.
OBSTRUCTIVE SLEEP APNEA 3/10/2023 SEVERE OBESITY, BMI 45-49.9, ADULT
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had horrible pain at the injection site and he could not move his arm and this pain was still occurring and it had been months since patient received SHINGRIX. The reporter could not remember the patient's name or demographic information since the initial reason for his call was to ask about timing of SHINGRIX vaccine in the patients receiving steroid injection, then the healthcare professional mentioned the 3 separate patients with rare side effects these patients were complaining about after receiving SHINGRIX, but healthcare professional did not remember these patient's names or demographic information. Three separate adverse events for three separate patients reported for this one healthcare professional. This case has been linked to the US2019015728 and US2019015736, reported by the same reporter.
Paresthesia in right leg from calf to tips of toes. Went to Emergency Room of the Hospital. No treatment.
Patient has developed strange sensations of internal tremors, dizziness, and fatigue that has been constant since the vaccine
This is a spontaneous report from a physician and a 68 year old male pt who, in September of 1999, had symptoms of Lyme disease; severe fatigue and rapid arrhythmia. He received antibiotic treatment and the fatigue resolved immediately but the arrhythmia persisted. Lyme test (December, 1998) was negative. On 7/13/1999, the pt received his 1st dose of Lymerix and 1 week later on 7/20/1999, he experienced minor joint pain in both knees, myalgia and stiffness in ankles, knees and feet which soon went away. On 8/19/1999, the pt received his 2nd dose of Lymerix and on 8/20/1999, he again experienced joint pain in both knees, myalgia and was very stiff to a more severe degree. His knees were x-rayed and he was treated with Celebrex after the 2nd dose. The most recent information, received on 9/9/99, reports the condition of the pt is unknown.
She had soreness in the area of immunization, but a ew days later developed elbow pain that then migrated to her left forearm and wrist. She is still having left forearm and wrist pain 1.5 months later. She reports that the pain is limiting her activity.
In early November, tingling of toes.  Mid-November had tingling of hands as well, shortly followed by clumsiness, numb mouth, stiff joints, trouble rising, difficulty with stairs
nurse accidentally gave an expired fluzone high dose quadrivalent with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other-health care professional and consumer via Agency - 00782322].  This case involves 72 years old male patient who was accidentally vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ512AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid, for prophylactic vaccination.  It was reported "Nurse Manager states that the last year's stock of FLUZONE HIGH DOSE QUADRIVALENT did not get pulled and as a result a nurse accidentally gave an expired FLUZONE HIGH DOSE QUADRIVALENT to a patient in error. She asks if the dose was valid or if it needs to be readministered".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Caller has "IBS and diverticulitis and gets nausea from it".; itching in the throat; coughing; she gets it on and off due to the weather/pollen; she gets it on and off due to the weather/pollen; Caller has "IBS and diverticulitis and gets nausea from it".; Caller has "IBS and diverticulitis and gets nausea from it".; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age (reported as age: 79 unit: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history included colonoscopy on an unspecified date in 2021. The patient's concomitant medications were not reported. Patient wanted to know if its ok to take the second dose of the Pfizer Covid vaccine today (09Apr2021). She was experiencing itching in the throat and coughing on an unknown date which was also reported that "it stated last night and she gets it on and off due to the weather/pollen". Patient had a colonoscopy done on the last Wednesday, on an unspecified date 2021 (unknown results). Patient has "IBS and diverticulitis and gets nausea from it" since an unknown date. Patient stated it's not unusual for her to get this. Patient wanted to know if she cancels her appointment, how long she has to take her second dose. The outcome of the events reported was unknown.   Information on the lot/batch number has been requested.
Severe dizziness and nausea.  It woke me up at @ 5:30 am.  I almost fell and was so sick to my stomach.  This lasted for 9 hours!!!  I had to hold on the walls when had to go to the bathroom.  I was by myself and feared falling.  I had to put a bucket next to me because I felt like throwing up.  I couldn't move my head, eyes anything with out severe dizziness and nausea.  Finally after 9 hours it started to ease off, but took another 15 hours for me not to stumble periodically.  I am 10 days out now and still can't turn my head too quickly, or put it too far back when washing my hair, or moving my eyes to fast, I still have a few minutes of dizziness which makes me nauseous for several minutes.  Still at night when I lay down, it feels like my head is spinning!  I have heard about people with vertigo and how debilitating it is... and I now understand.  I fear this  dizziness and nausea will not go away!!!!   It now feels like I am car sick several times a day.
This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced red around injection site, injection site lump, injection site warmth (described as "increased warmth" at injection site), injection site tenderness. In September 2013, within days after vaccination with FLUARIX Quadrivalent, the subject experienced low grade fever, diaphoresis (described as "sweating on face") and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX Quadrivalent. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX Quadrivalent (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX Quadrivalent. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far".
Headaches beginning 9/2/16 and increasing intensity/severity as of 9/6/16.
I had a rash develop on my neck, armpits, upper torso, and lower back about 30 hours after receiving the 2nd dose of the vaccine. It went away about 2 days later. I took Zyrtec which helped to diminish the rash. I was also extremely light headed, dizzy, and fatigued (could not be upright or awake for more than an hour at a time) for 4.5 days following the vaccine.
On 8/15 pt vomited one time. Then, on 8/17 at 02:00 AM pt developed a fever, which lasted almost 24 hours and went up to 102 degrees. When fever broke, mother noticed a rash which first developed on child's face and torso, and then spread to her back, diaper area and legs. At the same time, the injection site where the pt had received her MMR injection became red and inflamed. Mother describes child acting as though she was in pain with decreased appetite and increased whining. Mother states the rash lasted until 8/21/16, and child's behavior was back to normal on 8/23/2016. Only treatment provided was Tylenol, which did relieve the fever and provided relief from pain as well. Mother researched measles online and said rash appeared similar to what she saw in online images, however she did not seek medical attention.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 04/10/2021. Patient w/PMHx of HTN, DM2 and CAD presented to the ED on 11/25/2021 via EMS for altered mental status. Hypoxic at 74% on room air, admitted for acute hypoxemic respiratory failure 2/2 Covid-19 Pneumonia. Tx'd w/remdesivir, Baricitinib, steroids and Airvo. Patient expired on 12/3/2021.
IF HE LEAN AGAINST THE WALL HE BRUISE THERE (EASY BRUISING); PUT ON A LITTLE BIT OF WEIGHT; PAINFUL AT THE INJECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 63 year old white male of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: failed back surgery, and little sinusitis (but that could be from dust), and concurrent conditions included: chronic pain, colitis (for 15 years), and alcohol user (only when on vacation), and other pre-existing medical conditions included: The patient had no known allergies. The patient had been off to work and retired from 14 to 15 months and he used to walk a lot. The patient had never had covid. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 1 administered on 5-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 2 administered on 18-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (dose number in series 2).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 3 administered to left arm on 03-JUN-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (dose number in series 3). Age at time of vaccination 63 years old. Concomitant medications included cefradine (Vicodin) and fentanyl for pain management. On an unspecified date, the patient experienced only side effect following vaccination was if he lean against the wall, he bruise there (easy bruising) and he was confident and happy with the vaccine. The patient used naproxen drug as treatment medication for bruising. He stopped taking drug and currently not bruising (dose number in series 2). The patient had put on a little bit of weight, and experienced painful at the injection site (dose number in series 2). The patient recovered from if he lean against the wall he bruise there (easy bruising), and the outcome of put on a little bit of weight, painful at the injection and off label dosing frequency was not reported. This report was non-serious.
Patient said she had a four inch raised area at site of injection. She also developed rash with blister on the opposite arm.
Parent called office on 1/24/22 stating that the patient developed a light pink area around the injection site on 1/22/22. Over the weekend it increased in redness, "puffiness", was warm to the touch, became the size of a grapefruit and was painful. At the time of the phone call to office, the swelling had decreased, but still with redness and some pain. Parent was advised to apply cold compress and use Advil/Tylenol as needed
Swelling, erythema, tenderness right thigh. The discharge summary states cellulitis.
This is a spontaneous report from a contactable pharmacist via sales representative reporting for himself. This 40-year-old male patient of unknown race/ethnicity received PREVNAR 13 on an unknown date at 0.5 ml single to prevent pneumococcal pneumonia. Medical history included pneumonia three times in the past 5 years. Concomitant medications were not provided. In May2017, about 3 weeks before this report the patient had left arm pain for a week, fever over 101 F for a day and flu like symptoms. Outcome of fever was recovered in May2017. Outcome of the other events was recovered on an unspecified date in 2017.
he got sick with chills; he got sick with chills; a burning up fever; body pain; shortness of breath; His legs are on fire/His head is on fire.; his body is hurting all over including his chest; He feels miserable.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. Relevant medical history included: "insulin dependent diabetic" (unspecified if ongoing), notes: insulin dependent diabetic; "60% blockage already on his heart" (unspecified if ongoing), notes: 60% blockage already on his heart; "he had Covid before" (unspecified if ongoing), notes: he had Covid before; "Kidneys are shot" (unspecified if ongoing), notes: Kidneys are shot; "The caller had the antibody infusion" (unspecified if ongoing), notes: The caller had the antibody infusion so he had to wait 90 days to get the vaccine. The patient took concomitant medications. The following information was reported: CHILLS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "he got sick with chills"; PYREXIA (non-serious), outcome "unknown", described as "a burning up fever"; PAIN (non-serious), outcome "unknown", described as "body pain"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; BURNING SENSATION (non-serious), outcome "unknown", described as "His legs are on fire/His head is on fire. "; CHEST PAIN (non-serious), outcome "unknown", described as "his body is hurting all over including his chest"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He feels miserable. ".  Additional Information: The patient was on blood thinners, and they still gave the vaccine to him. He is waiting for his arm to heal up to start dialysis treatment. Description of Product Complaint: The reporter on the line reporting that after getting the Pfizer COVID-19 vaccine he got sick with chills, a burning up fever, his body is hurting all over including his chest, and he is having shortness of breath. It sounds like the vaccine gave him Covid, and he had Covid before. The caller had the antibody infusion, so he had to wait 90 days to get the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
On days that it is worst all his toes are red; Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning; One of his toes is purple; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning), SKIN DISCOLOURATION (One of his toes is purple) and ERYTHEMA (On days that it is worst all his toes are red) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 prophylaxis.     Patient had no allergies nor diseases.     On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning) and SKIN DISCOLOURATION (One of his toes is purple). On an unknown date, the patient experienced ERYTHEMA (On days that it is worst all his toes are red). At the time of the report, PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning) and SKIN DISCOLOURATION (One of his toes is purple) had not resolved and ERYTHEMA (On days that it is worst all his toes are red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Patient had itchy burning skin at any place in the body randomly. It happen mostly on feet, and it can be in other place of body at the same time. It was getting worse as it started itching then progress to itching and burning. One of patient's toes turned purple. On worst days, all toes turned red. Patient's feet felt like walking on hot coals.  No treatment medication was reported.