chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anxious; Weak; Pain on his eyes, feeling them hot; Pain on his eyes, feeling them hot; Fast heartbeat; Fever; Pain at the injection site; Muscle pain; Little headache; "The wrist hurt where you put the fingers to take the blood pressure"; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot) and PALPITATIONS (Fast heartbeat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure"). On 27-Oct-2021, the patient experienced ANXIETY (Anxious). On 26-Oct-2021, ASTHENIA (Weak), FEELING HOT (Pain on his eyes, feeling them hot), EYE PAIN (Pain on his eyes, feeling them hot), PALPITATIONS (Fast heartbeat), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain), HEADACHE (Little headache) and ARTHRALGIA ("The wrist hurt where you put the fingers to take the blood pressure") had resolved. At the time of the report, ANXIETY (Anxious) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Fast heartbeat.         No treatment information was provided.  Patient received only half a dose as he was doing fine and his laboratory results were good. Patient was concerned though because, he stated yesterday feeling anxious and today he is worried if that could affect somehow the efficacy of the vaccine.   This case was linked to MOD-2021-367850 (Patient Link).
Second TDAP vaccine, last one was in 2010 at 13 years old with no issues. Began itching slightly on neck/hair line about 30 minutes after vaccine administration, but nothing severe. Broke out in hives from top of head to feet around 8:00pm that evening. I took 50mg of  Benadryl with no shortness of breath/airway involvement at that time. About 30 minutes later, my throat began to feel scratchy and full. Face, lips, and eyes also began to swell around this time. I went to the ER around 9PM due to angioedema/periorbital edema and was given decadron PO and pepcid PO. After an hour of eval, the swelling or itching had not changed significantly so the ER MD gave me 25mg IM of atarax. I was monitored for approx. 45-60 more minutes and was released home with no issues and an RX for a steroid pack, pepcid, and hydroxyzine. Rash has completely dissolved at this time with no current issues.
Onset about 18-19 hrs. after inj. pt. took BENADRYL swelling went down the inj. site was painful & swollen, area approximately 3".
Initial unsolicited report received from other health care professional on 24-JUL-2018. This case involves a five-year-old child patient, who was vaccinated with 0.5 ml dose of MENACTRA (frequency once, batch number: U5984AB, expiration date, dose and site of administration was not reported) via subcutaneous route instead of MMR vaccine on 23 Jul 2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate route of vaccination and wrong vaccine administered. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Dizziness; Pain in the lower extremities; pain in feet; legs hurt; Felt poorly; Blood pressure which was up a little but not terribly; Left arm where she got the injection was sore (localized pain); This is a spontaneous report from a contactable consumer (patient's sister). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 13Jan2021 07:45, at a single dose, for COVID-19 immunization. The patient's medical history included atrial fibrillation, hypertension, bypass in 2010, hearing is very bad on the phone, arthritis pain, headache, and blood thinner. The patient's concomitant medications included metoprolol for hypertension, quinapril for hypertension, acetylsalicylic acid (BABY ASPIRIN) for hypertension, ascorbic acid/ calcium/ minerals NOS/ retinol/ tocopheryl acetate/ vitamin B NOS/ vitamins NOS/ zinc (CENTRUM SILVER), calcium carbonate (CALTRATE), atorvastatin, warfarin as blood thinner, spironolactone, and paracetamol (TYLENOL) for arthritis pain and headache; all were ongoing. The patient received the first dose of the BNT162B2 vaccine on 13Jan2021 and had reactions to the vaccine or something else. That day, the patient's left arm where she got the injection was sore (localized pain), but that was expected, and it went away within 2 days (initially didn't report it because it was expected). Yesterday (18Jan2021), the patient experienced dizziness and pain in the lower extremities. Last night (18Jan2021; about 6 days after the injection), the patient woke up, felt poorly, and was very dizzy (feeling of dizziness), then, later on, had pain in both lower extremities. The patient took her blood pressure which was up a little but not terribly with result of 159. The patient's heart rate, temperature, and pulse oximetry were okay on 18Jan2021. She then walked to the bathroom, came back, and went back into bed. The second time she said her legs hurt but this morning she is feeling better than she was. Today (19Jan2021), the pain in feet is better, and the dizziness is gone. Pulse oximetry and temperature were okay this morning (19Jan2021). The patient was wondering if these effects could be related to the vaccine, since the dose was received 6 days ago. The patient was not sure if could possibly be related to the COVID-19 vaccine or if it was that she spent a lot of time doing paperwork on the computer yesterday (18Jan2021) and perhaps that caused some of the symptoms. The patient's sister called to ask if Pfizer has heard of any late adverse effects from the COVID-19 vaccine like this patient's, 6 days later. The patient was scheduled to get the second dose on 04Feb2021 (day 22) and her sister asked what if it's not available. The patient's sister was concerned about interval and potentially being unable to gain access to the second dose due to supply issues. The patient recovered from "Left arm where she got the injection was sore (localized pain)" on 15Jan2021; and from "Dizziness" on 19Jan2021. The patient was recovering from the other events.
mom reported 18JUL98 lt arm swollen (from shoulder down to 1/2 of upper arm), red, painful hot & hard to touch & child unable to lift arm;allergy med given twice & swelling stopped & subsided;
swelling, redness and pain at an unspecified injection site\infection at the injection site; first injection that occured on an unspecified date in 2016; This spontaneous report was received from a physician refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.  On an unknown date in 2016, the patient had her first vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. On 30-MAY-2019, the patient was vaccinated with second dose (inappropriate schedule of product administration) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis.  On 31-MAY-2019, the patient developed swelling, redness and pain at an unspecified injection site. The patient's mother took the patient to the urgent care center who sent them to the emergency room for a possible infection. The emergency room diagnosed the patient with an infection at the injection site (vaccination site infection) and started the patient on unspecified oral antibiotics. The Emergency Room told the patient's mother that the infection was a result of a "dirty clinic" using "dirty needles". The Mother reportedly spoke directly with the physician on 03-JUN-2019, about the conversation she had at the emergency room. The mother stated that, the patient did not had this reaction with the first injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). As of 3-JUN-2019, the patient is feeling much better with no redness, swelling or pain. The outcome of vaccination site infection was reported as recovered/resolved. Causality assessment of the event vaccination site infection in relation to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Had pains in her heart/horrible heart pains; I must of had some damage done to my heart; Stated that it feels tight on the left side of her chest/I felt like I been hit in the chest; Short of breath/trouble breathing; This is a spontaneous report. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient visited a doctor for routine blood work on an unspecified date. The patient stated that she was in good health and had no medical problems. She was fine while there, and when she drove about 5 minutes to the grocery and once she started walking around, she started having reported that she had pains in her heart (horrible heart pains) and that it hurt so badly and was really strong. She was also short of breath/trouble breathing. She went to her vehicle and sat there and drank water slowly. In 10 minutes, the pains went away even though she felt like she been hit in the chest. She felt like she had been punched in the chest and she went home and called the hospital. Even talking, she was still a little short of breath. The patient reported that she must had some damage done to her heart and she was scared to have the second shot. She left a message with her doctor about what had happened on Wednesday (as reported). Yesterday, she got up and felt like she punched in the chest and was short of breath. She found the facts sheet that she had been given and the number that she could call and talk to somebody. She spoke with someone and was transferred to a department and she was concerned if there was damage to her heart because the pain was gone away and she was still struggling to get a good breath and she felt tight in left side of chest on the side where she had the injection. Patient was concerned about getting second injection and felt she needs to be medically evaluated for her heart and she has insurance and will have to pay and there will be tests that she needs and does not know what percentage that she will have to pay for it. She stated that she had a severe reaction 25 minutes after the injection and she wanted it documented. Outcome of event pains in her heart/horrible heart pains was recovered on an unspecified date; and outcome of the rest of events was unknown.  Information on the lot/batch number has been requested.
Sunday afternoon had vision problems with my left eye. the left peripheral vision was wave like heat waves.  for about 20 minuets. After that, it felt like a headache in the eye. Lasted the rest of the day.  Monday to now if feels like the eye has been numbed or dilated.
Pt with fever 102(+) -> 104.3 wi 24 hours of vaccines. Mom very upset at "catch up" immunization given. I sent pt to ER for eval.
Information has been received from a pharmacist concerning an adult pregnant female who in approximately 2000 about five years ago, when she was not pregnant, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3). A recent titer did not show seroconversion. It was noted that the patient had no symptoms. Unspecified medical attention was sought. The patients outcome was unknown. A product quality complaint was not involved. Additional information has been requested.
Severe joint pain all over her body and in the back; Severe joint pain all over her body and in the back; Tiredness; Chill; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe joint pain all over her body and in the back), ARTHRALGIA (Severe joint pain all over her body and in the back), FATIGUE (Tiredness) and CHILLS (Chill) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (J&J) (1st vaccine) on 18-Jun-2021. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine (J&J).    On 20-Dec-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 BACK PAIN (Severe joint pain all over her body and in the back), ARTHRALGIA (Severe joint pain all over her body and in the back), FATIGUE (Tiredness) and CHILLS (Chill). At the time of the report, BACK PAIN (Severe joint pain all over her body and in the back) and ARTHRALGIA (Severe joint pain all over her body and in the back) outcome was unknown and FATIGUE (Tiredness) and CHILLS (Chill) had resolved.            The patient had no preexisting condition and no allergy. No concomitant medication was provided.  Patient described the symptoms inconsistent as it comes and goes. Patient stated that one day she had no pain and another pain she would have major pain.  No treatment medication was provided.
mild pain at injection site 24 hours after receiving vaccine dose; This is a spontaneous report from a contactable via a Pfizer sales representative.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced mild pain at injection site 24 hours after receiving vaccine dose in Dec2020.  Patient is healthy and within weight parameters. The outcome of the event was recovered in Dec2020.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
I am breastfeeding my infant and I had a noticeable decrease in breast milk supply beginning within 24 hours of receiving the vaccine
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. Between 24-APR-2017 and 09-MAY-2017, the patients were vaccinated with improperly stored doses M-M-R II, lot numbers M011667, exp. 08-MAR-2018 and M032485 (rHA), exp. 06-JUL-2018 for prophylaxis. This report involved a digital data logger. No adverse events reported. Temperature and duration of excursion for the vaccine were as follows: -10.8°C for 6 hrs. 15 min -14.2°C for 45 min -12.5°C for 30 min -4.4°C for 11 hrs. 50 min 17.4F for 4 hrs. 35 min. This is one of three reports received from the same source. Additional information is not expected as scheduled follow up was received.; Sender's Comments:  US-009507513-1705USA007967: US-009507513-1705USA007838:
pt recvd vax 30JUN94 & on morning of 1JUL94 pt awoke w/low grade fever (99-100) fever w/listlessness cont & 9JUL94 pt had a marked dec in appetite; eval by MD & was found to have dec platelet & WBC Count; seen by MD; react 2nd to MMR
Hives approximately 3 hours post injection.  Red, hard, warm, itchy, painful rash at injection site started the next day
I developed AFlutter (a form of Atrial Fibrillation) as a result of getting the Pfizer Booster. My first two vaccines were Moderna. According to my heart rate data that is tracked on my device, since 2018 my resting heart rate has been approximately 60bpm. I received the Pfizer booster on November 15, 2021. In mid-December 2021, my resting heart rate data increased to 70bpm.  In March & April 2022, I started to have dizzy/fainting episodes. On my first visit to an ER on 4/12/2022, I was diagnosed  with AFlutter immediately. My symptoms persisted and I had an ablation procedure on June 14, 2022 to correct the AFlutter. At my 3 week post-procedure check-up, my heart rhythm was normal again, as was my resting heart rate. On my device data, my resting heart rate has been approximately 60bpm since my ablation procedure. I have not had any additional booster vaccines since the one I had November 15, 2021.
arm soreness, arm that received the shot; fatigue; swollen lymph nodes; burning sensation in the left side of the body; chest pain; sever indigestion/severe heartburn; left side of the body just has a weird odd feeling; whole left side of the body is hot; arm started getting hot and sore again; This is a spontaneous report from a contactable consumer (patient).   A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153), dose 1 via an unspecified route of administration, administered in arm on 24Apr2021 as single for COVID-19 immunisation. The patient medical history included autoimmune illness. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness, arm that received the shot, fatigue, swollen lymph nodes, burning sensation in the left side of the body, chest pain, sever indigestion/severe heartburn, left side of the body just has a weird odd feeling, whole left side of the body is hot, and getting hot and sore again. The patient reported that she had the typical side effects like the sore arm and a little bit of fatigue. About the fifth day after she had severe heartburn and chest pain. She further reported that since the heartburn episode she felt like there was burning down her left side of the body. The arm that received the shot stopped being sore but then about 2 days ago it started getting hot and sore again but there were no bumps or swelling. On the left side of her body, she felt like it was on fire and her lymph nodes were swollen under her arm and her left side of the body just had a weird, odd feeling. She has an autoimmune disease, and she was wondering if that could be why she was having a reaction to the vaccine. The outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
Vaccine was expired by 2 days per Moderna website and was inadvertently administered.  Patient denied any abnormal symptoms or issues after receiving shot. Patient was monitored for approx. 3.5 hrs after injection due to patient being an employee of clinic that shot was administered.
After receiving my flu shot in December, I began to notice stomach pain after eating and occasional small hives. I thought it was nothing and expected it to go away in time. The stomach pain began to get worse and worse. The hives remained as well but the seemingly allergic reaction began to worsen to swelling at the mouth, uvula, and various muscles. The uvula swelling was so bad that I would choke at night. My first appointments with the doctor were in Feb 2017 to attempt to diagnose what was going on. After many other blood tests, the doctor tested me for gluten sensitivity at my request. This came back positive and celiac disease was later confirmed by endoscopy/colonoscopy on June 29, 2017. I had hoped this would solve my chronic urticaria as well. However, it did not. An allergist diagnosed me with delayed idiopathic urticaria on 22 Sept 2017. I have suffered from chronic urticaria for the last 2+ years triggered by physical stimulus of the skin including cold, heat, vibration, and pressure. In the pamphlet for the vaccine, urticaria is a known potential adverse event. The flu shot may have been the triggering agent for celiac disease as well.
On 4/22/01, temperature was 103.2F; on 4/23/01, temperature was 105.6F; on 4/24/01, temperature was 105.2F. He had over 40 chickenpox. Recovering but still a few chickenpox.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine), VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age (gravida 1) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved and VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information provided. No treatment information provided. Reporter did not allow further contact; Sender's Comments: This report refers to a case of product exposure during pregnancy for mRNA-1273 (lot # unknown) with AEs of Vaccination site warmth, Vaccination site reaction, Vaccination site pruritus, and Vaccination site erythema reported.