chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; A patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial./Due to staff confusion over which of the bivalent vaccine to use, pt was incorrectly given a "booster" or yellow label/pi; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial./Due to staff confusion over which of the bivalent vaccine to use, pt was incorrectly given a "booster" or yellow label/pi) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 18-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial./Due to staff confusion over which of the bivalent vaccine to use, pt was incorrectly given a "booster" or yellow label/pi). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial./Due to staff confusion over which of the bivalent vaccine to use, pt was incorrectly given a "booster" or yellow label/pi) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial./Due to staff confusion over which of the bivalent vaccine to use, pt was incorrectly given a "booster" or yellow label/pi).    No concomitant medications were reported.  It was reported that the patient who has received no previous Moderna vaccines did receive a 0.2mL dose of the Moderna Bivalent from the Pink cap vial. No side effects were reported by parents. Due to staff confusion over which of the bivalent vaccine to use, patient was incorrectly given a "booster" or yellow label/pink top vial as a first dose. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2023: Live Significant follow-up appended: Patient details updated, Event details updated, Suspect product details updated and Case narrative updated.
Patient started coughing, had a runny nose, and watery bloodshot eyes as we were leaving the doctor's office.  We got to the car and we knew something was not right with him, drinking water was not calming his cough.  Patient had an allergic reaction to a walnut about a year prior, and it started this way.  We went back into the doctor's office, and a nurse brought us into a room and brought in Benadryl immediately.  Patient's face was now red/flushed.  The nurses and doctor we had just seen came in and looked him over, and listened to his breathing.  Patient's pediatrician said she could hear some faint wheezing when he breathed deeply.  They observed patient for approximately 20 - 30 minutes, the coughing and runny nose had calmed and slowed down, but Dr patient was not recovering enough from the Benadryl and she made the decision to administer an Epipen and call an ambulance to transport us to the ER.  At the hospital, patient was given more Benadryl, a steroid and Pepcid.  We were in the hospital for observation for approx. 5 hours before being discharged.  Patient is currently taking a 4-day steroid and has not had any more reactions so far.
stomach cramps; diarrhea; no energy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), FATIGUE (fatigue), DIARRHOEA (diarrhea) and ASTHENIA (no energy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), FATIGUE (fatigue), DIARRHOEA (diarrhea) and ASTHENIA (no energy). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), FATIGUE (fatigue), DIARRHOEA (diarrhea) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approx. 10-20 mins after receiving the vaccine he was walking out of the office and passed out. He was taken by ambulance to hospital. He received an EKG that showed a conduction delay but nothing else. Since the vaccine he has experienced severe dizziness and shortness of breath apon standing and has been now diagnosed with a Dyautonomia Disorder POTS (Postural Orthostatic Tachycardia Syndrome). A support group of parents I am in there is a parent in that group that her son started to have all the same symptoms and has been diagnosed with the same disorder since his flu shot.
did not receive second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
4 days after receiving varicella vaccine developed varicella on chest dont know yet if its going to be worst.5 postules so far.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 16:30 as dose 1, single (Lot number: EN6203), in right arm, on 01Apr2021 at 16:00 as dose 2, single (Lot number: EN6198), in right arm, on 09Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 301458A), in right arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no other medication in 2weeks. Past drug history included: Allergic to bactrim, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The event "covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative, notes: Tested negative on fourth day of medication; (30Jul2022) Negative, notes: continued to test negative days 5-8; (31Jul2022) Negative, notes: continued to test negative days 5-8; (01Aug2022) Negative, notes: continued to test negative days 5-8; (02Aug2022) Negative, notes: continued to test negative days 5-8; (03Aug2022) Positive, notes: then tested positive on day nine; (08Aug2022) Positive, notes: testing positive on day 14. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 25Jul2022 to 30Jul2022.
Severe swelling immediately, size of tennis ball, tightness in my throat, itching at injection site, very hot to touch, dizziness, mild tachycardia.
DULL HEADACHE; INJECTION SITE ARM PAIN; FATIGUE; ACHY; DIZZY; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced injection site arm pain. On 09-APR-2021, the subject experienced felt fatigued. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine  was not applicable. The patient recovered from achy, dizzy, injection site arm pain, and felt fatigued on APR-2021, and had not recovered from dull headache. This report was non-serious.
Got vaccine on May 11, exactly 2 weeks later on 25 of May out of nowhere while sitting in my car my heart started to race, vision became blurry, it felt like i was going to pass out. First two months were the worst - i could not go to work, i could not go to the store, even for a short walk around the house. Symptoms are - dizziness, feeling of pressure in my head, tinnitus, insomnia, heart palpitations, panic attacks (that iv never experienced before getting this vaccine), vision in my left eye was blurry (it resolved in 2 moths), indigestion, anxiety (again i have never experienced such thing). Its been 6 months now - last month i was somewhat ok (this symptoms come and go in waves), but they came back beginning of the last week. This experience is horrible - its hell on earth.
pt recv vax 2DEC97 & mom states on 4DEC pt c/o stomach pain & began vomiting & diarrhea & temp was up & down;highest reading 102;mom states sx of stomach pain & diarrhea have cont through today 9DEC97;pt stools are white, pale w/dark circle
expiratory and inspiratory wheezing lasting 30 minutes.  Observed; no treatment necessary as wheezing resolved on its own with no additional symptoms developing
Hives, nausea, rash 1 day after vaccine.  Mild transaminitis and rechecked 8/12/21 and increasing LFTs as below.  hepatitis.  Seen at ED and LFTs increasing so transferred to Hospital and admitted. LFTs improved and patient able to be discharged home. COVID antibodies IgG were checked given recent COVID + infection on July 1, 2021 and IgG was positive.
Wegener's granulomatosis; after the second dose that the symptoms got worst; Pressure on the chest/pressure like feeling off and on continuously; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) (seriousness criterion medically significant), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 3900 (abnormal) abnormal. In 2021, Heart rate: 100 (High) High.         It was reported that the patient got electrocardiogram (ECG) and blood work done, the results for which were not provided. No treatment information was provided.  No relevant concomitant medications were reported. Company Comment: 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.   This case was linked to MOD-2021-265463 (Patient Link).
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILL-DEFINED DISORDER (medically significant), outcome "unknown", described as "a cousin dying from it".  Clinical information: Reporter stated they have a cousin dying from it and they want to know why. Caller declined to provide any information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via GSK market research programs and described the occurrence of sickness in a 75-year-old female patient who received Flu Seasonal TIV. Concomitant products included ADVAIR. On an unknown date, the patient received Flu Seasonal TIV at an unkonwn dose. On an unknown date, an unknown time after receiving Flu Seasonal TIV, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Flu seasonal TIV. Additional information was provided: The patient was ill for 2 days. She stayed in bed and drank plenty of fluids and in 2 days felt fine.
I did not have an adverse reaction to the vaccine. I tested for COVID19 on 01/23/2023. I had a horrible, constant cough. No congestion and no fever. I contacted my doctor and got the prescription PAXLOVID. I tolerated the medication without any complications. As of today, I still have a cough and fatigue, but I am feeling better.
Patient felt tingling in throat and swelling of tongue.  First vaccine of Pfizer given. Patient given epipen and felt some relief. Called 911 and she was taken to ER with AMR.
Tightness in right calf, got worse, to ER for ultrasound.  Diagnosis was blood clot.  Now on blood thinners.  Cause unknown. Began a few weeks after vaccination. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.
I now have excessive fatigue and extremely cold natured. I now wear a hoodie or light jacket even when indoors.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: Rotating his arm he is having some issue. Lifting up a certain height there is pain. Uncomfortable to raise arm above shoulder. Patient is really tired.
red, swollen in area of immun, warm to touch, pt stated swelling started 9SEP97;
Patient died within 48 hours of being given flu vaccine. Cause of death CHF and bronchitis. Patient sick with chest congestion prior to vaccine per niece. Hospitalized 11/18/04. Previous history of CHF.
Information has been received from a 26 year old male patient, referring to himself. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. In 2005 or 2006 when the patient was about 12 year old, the patient was vaccinated with first dose of GARDASIL (3 dose regimen, route was reported as "in the arm", strength, lot #, expiration date unknown) for prophylaxis (reported as "for HPV protection"). On an unknown date, the patient's current partner was recently diagnosed with Human Papillomavirus type 16. The patient said he was certain he was exposed to Human Papillomavirus (HPV) 16 within the past 8 months. The patient said he planned to "get checked" for Human Papillomavirus (HPV) by a physician as a precaution. No treatment was given for the events. No lab diagnostics or studies were performed for the events. The patient had not sought medical attention.
pt vaxed & 2 days later had a fever of 103-104 w/no other sx; hospitalized 5 days @ time of this report; meningitis r/o;
Patient received the PNEUMOVAX 23 vaccination on Saturday afternoon July 22, 2017.  The following account was given over the phone on 7/25/17 by the patient. She states that she bled from the vaccination site for 3 hours after the vaccination but not heavily. On Sunday morning she states that she could not raise her arm or brush her hair. She was in pain. She used Tylenol to treat the pain. On Monday she went to work. She states this was the worst day; the pain was so great that she was crying, felt like she "wanted to cut my arm off", and considered going to the emergency department for treatment. She was unable to move her arm and had no function in that arm. She works at a clinic and a nurse observed that her whole arm looked red and there was swelling at injection site although not officially seen. She described the pain further as throbbing and agonizing. She also stated that the pain was felt under her arm, breast, shoulder (top and back) and went down into her fingers. She used Tylenol and ice packs to treat the pain. Today, she says she has a call into her provider and hopes to see her tomorrow. The pain is slightly less today (7/25/17) but is still painful, and hard to lift arm and can't lift anything heavy.
Received Shingrix (GSK) Series I, Lot 7KG39, exp 2/17/2024, NDC#058160082311 at the Hosp on 1/31/23. Six hours later - experienced nausea, abdominal pain, chills, fever. 12 hours later - insomnia, body aches. 24-hrs later- the beginning of itchy hives on thighs. 36 hrs later hives spread from thighs torso, arms, neck, scalp and body aches continues. I notified the facility of the reaction. They recommended to go to ER. I thought more prudent to just take a Benadryl. It's now a little more than 48 Hrs, the hives are still itching, the spread seems to have stopped. I do still have a headache.
Insomnia, headache, menstrual like cramps/squishy poop, fever (101.7 from forehead thermometer), swollen lymph node(s) under arm, one instance of dizziness (saw spots/ arms legs tingling), nausea, and started an unexpected 3rd menstrual period (see report from shot # 1) just 2 weeks after the last one.  Called doctor who said it should all pass.  As of today, everything seems fine except the swollen lymph node(s) under the arm are decreased but not yet gone.  We are not sure what will happen with the disruptions to the menstrual cycle.
Rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0102A1A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia. Concomitant products included METOPROLOL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat). At the time of the report, HEART RATE INCREASED (Rapid heartbeat) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Initial misuse report received from health care professional on 30  October 2013. A dose of FLUZONE ID administered on 30 patients over 65-years of age. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Started experiencing stiffness in her mouth, that lasted 25 minutes; Trouble breathing, that lasted 2 to 3 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes). On 02-Apr-2021, MUSCULOSKELETAL STIFFNESS (Started experiencing stiffness in her mouth, that lasted 25 minutes) and DYSPNOEA (Trouble breathing, that lasted 2 to 3 minutes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Heart rate: 77 heart beats per minute (normal) 70-77 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Thyroid medication. Patient prescribed an Antihistaminic pill for events. On 02-Apr-2021, oxygen levels were fine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Live follow up was received on 15-Jun-2021 and contains no new information
Severe arm pain and flu-like symptoms began about 8 hours after injection. Flu-like symptoms went away after ~3 days but the injection site was extremely sore for ~5 days and it was almost 2 weeks after the injection before the arm felt normal again.