chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate age at vaccine administration; A spontaneous report was received from a Dentist (healthcare professional)  concerning a 16 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-jan-2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  No Treatment information has been provided.   Action taken with mRNA-1273 in response to the events was unknown/ not reported.   The outcome, vaccine administered to a 16-year old male, was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administered for mRNA-1273 with no associated AEs.
He had only a sore arm after each shot; After 2nd vaccine he had COVID Disease in JUN2022; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (He had only a sore arm after each shot) and COVID-19 (After 2nd vaccine he had COVID Disease in JUN2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 025B21A, 033F21A and 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (After 2nd vaccine he had COVID Disease in JUN2022). On an unknown date, the patient experienced VACCINATION SITE PAIN (He had only a sore arm after each shot). At the time of the report, VACCINATION SITE PAIN (He had only a sore arm after each shot) and COVID-19 (After 2nd vaccine he had COVID Disease in JUN2022) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was calling to report that he received 5 Moderna COVID-19 shots. After second vaccine he had COVID Disease in Jun-2022.  Shot one was first Primary Monovalent Dose. Shot two was second Primary Monovalent Dose. Shot three was first Monovalent Booster Dose. Shot four was second Monovalent Booster Dose. Shot five was Bivalent Booster.  The patient had only a sore arm after each shot.  Treatment information was not provided.   This case was linked to MOD-2022-692728 (Patient Link).
Information has been received from a health professional concerning a 23 year old female who on 19-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659655/1486U) in the morning. In the evening of 19-MAR-2008 the patient experienced a fever, nausea, vomiting and diarrhea. The patient's mother called the physician's office and she was told to eat a diet of bananas, rice, applesauce and toast in additional to a dietary restriction of milk. The patient's fever, nausea, vomiting and diarrhea persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  In follow up information it was reported that patient called on 20-MAR-2008 morning and complained of diarrhea, vomiting and nausea throughout the night and into morning of 20-MAR-2008.  She was adviced no milk products, IMMODIUM for diarrhea and to keep hydrated with bananas, rice, (rice cereal), applesause  and toast (B. P. A. T.).  Patient called back to an only  gave of the reaction.  It seemed she was quite confused by the phone.  The outcome was unknown.  Additional information is not expected.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 225 pounds, and height was 66 inches. The patient's concurrent conditions included endometrial cancer, penicillin allergy. The patient had no daily medication. The patient was on chemotherapy before and after receiving the vaccine. The patient stated that garlic caused her to be ill and nauseated. The patient experienced drug allergy when treated with codeine, hydrocodone bitartrate/paracetamol, and oxycodone hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021, the patient tested negative for antibody test (confirmed immunological vaccine failure) which she described as blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191551.; Sender's Comments: V0:20210860335 -covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE (CHEMOTHERAPY)  SPECIAL SITUATIONS
The patient was screened and was found to have multiple medical allergies but no allergies to any of the components to the Janssen vaccine.  As a precaution, the nurses advised a 30 minute observation.  She received the vaccine without complication and then was being observed and they called me over and the paramedics were also with the patient.  About 17 minutes into observation, the patient started developing chest pressure (4/10), lightheadedness, and nausea.  No shortness of breath, stridor, diaphoresis, back pain, abdominal pain, vomiting, neurologic changes, and any signs or symptoms of anaphylaxis.  She was very anxious.  Further history revealed that the patient had been discharged from the hospital 6 week prior.  She initially went in for an abdominal laproscopic surgery and woke up to having 32 staples closing an abdominal incision.  They had to change from a laproscopic approach to an open abdomen approach due to complications.  She ended up with sepsis and a colostomy and was hospitalized for 2 weeks getting antibiotics.  She lives by herself and was overwhelmed before coming into the clinic for her vaccine.   The paramedics did a 12-lead ECG that showed sinus rhythm.  Vital signs and blood glucose were within normal limits.  The paramedics recommended that she go to the hospital to be checked out but she was very resistant and was tearful because she was traumatized from her previous hospitalization.  After some time, the paramedics convinced her to go to the hospital.  The paramedics hung around the emergency department and then came back once they found out that she was fine.
About 4 hours after the injection I began experiencing arm pain. In the middle of the night the muscle aches, headache, and nausea started. The whole next day I hardly left my bed due to extreme fatigue. The injection site was hard to the touch and so swollen you could visibly see a lump on my deltoid. My highest temperature taken was 100.8 and I had chills. I had a cough and could not take a full breath without coughing. I was congested. Later on in the day I had diarrhea. The following day I continued to have fatigue, muscle aches, headache, chills, and cough. I also had a rash on the area around the injection site that spread up to my shoulder, neck, and chest. The fatigue has continued until now, which is 50.5 hours after injection. I took ibuprofen 400-800 mg at a time 4 times throughout yesterday and today with little effect. I also took an antihistamine 4 times.
short episodes of apnea, violent shaking for several minutes, these all occured 7 hrs p/vax; also had severe crying for approx 2 1/2 hrs, during apnea pt went very limp, vomitted forcefully several times;
PATIENT EXPERIENCED PAIN, ITCHING, REDNESS AND SWELLING AT THE INJECTION SITE. NO TREATMENT OBTAINED YET.
SWOLLEN LIPS BOTH HANDS SWOLLEN SHARP PAIN WITH DEEP BREATHS TIREDNESS COURSE TIME:  2 DAYS
Diarrhea left arm sore, diarrhea x 10 every hour . lightheaded Narrative:
One week after receiving my booster I broke out in a full body rash. It spontaneously moves around my body. It started at my scalp, to where I thought I may have lice, but it moved to my entire body. About a month later, I also started to get hives. I went to hospital, where they did a full panel, and they weren't able to find anything. They prescribed hydroxyzine 25mg, a six day course of prednisone and I am currently taking Zyrtec. I am on a waitlist to see a dermatologist.
Swelling, warmth erythema over 11 x 10 cm area on (L) thigh which was 2 cm greater in diameter than right.
Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medications were none.   The following information was reported: ARRHYTHMIA (medically significant), EXTRASYSTOLES (non-serious) all with onset 24Mar2021, outcome "recovered with sequelae" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". Therapeutic measures were not taken as a result of arrhythmia, extrasystoles. The patient subsequently received dose 2 of BNT162B2 (Lot# EP6955) on 11Apr2021.  Follow-up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Patient received dose on 8/5/23 from a vial that was punctured on 8/3/23. Patient has no symptoms to report. Stability information from Moderna states the vaccine provided the activity necessary to protect against the SARS-CoV-2.  Patient does not need an additional dose.
exhaustion; pain in legs; pain in legs, back; pain in legs, back, and back of neck; wave of malaise / feels like she was run over by a truck; nausea; skin is sensitive to the touch described as pain when husband caressed her and pain when water from shower touches skin.; feels like she has the flu but does not; headache in front of head; overall body pain; Sick; difficulty standing up in shower; feels hypersensitive; pain and suggests it may be nerve pain; This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity, Shingrix with an associated reaction of somnolence and Shingrix with an associated reaction of fatigue (1st dose received on unknown date, refer case US2020AMR224531).   On 8th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th November 2020, less than a day after receiving Shingrix, the patient experienced exhaustion, leg pain, back pain, neck pain and malaise. In November 2020, the patient experienced nausea, touch sensitivity increased, influenza like illness, headache, general body pain, sickness, difficulty in standing, hypersensitivity and nerve pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the exhaustion, leg pain, back pain, neck pain, malaise, nausea, touch sensitivity increased, influenza like illness, headache, general body pain, sickness, difficulty in standing and hypersensitivity were not recovered/not resolved and the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the exhaustion, leg pain, back pain, neck pain, malaise, nausea, touch sensitivity increased, influenza like illness, headache, general body pain, sickness, difficulty in standing, hypersensitivity and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix in left deltoid and once home was fine. The patient reported after laying down for a few minutes and all of a sudden she experienced a wave of malaise, exhaustion, and pain in legs, back and back of neck. The patient reported that her skin was sensitive to the touch described as pain when husband caressed her and pain when water from shower touches skin. The patient reported difficulty in describing pain and suggested it may be nerve pain. The patient also complained of headache in front of head, nausea and overall body pain resulting in difficulty standing up in shower. The patient felt like she had the flu but did not, felt like she was run over by a truck, felt hypersensitive, and imagined this must be what shingles felt like.  The patient was not having a rash. The patient suggested she might go to emergency room due to not having a primary care physician at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR224531:1st dose, same patient
Doctor ordered Monovalent Pfizer Covid Vaccine age 5-11. Medical Assistant gave Bivalent Pfizer Covid Vaccine age 5-11 instead.
1st dose, I experienced a rash around the injection site a week after I received the vaccine. 2nd dose, approx. 11hrs after receiving the vaccine my body got REALLY HOT, like it was on fire.  everywhere except my feet were freezing.  Simultaneously, I experienced a slight headache.  Treated with ice packs and 2 Advil (1.5hrs into the symptoms)... approximately 3hrs later woke up and the HOT sensation had subsided.  Woke up with a slight headache, but no big deal.  Took a shower, and my torso broke out into a rash (small red bumps - hive-like, slightly itchy).  Contacted my doctor... Treatment:  Triamcinolone on rash, Allegra or an allergy medicine for 1 week.
Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 years prior showed 10% stenosis. Performs regular cardiovascular exercise (Peloton).  No smoking or drug or alcohol history. Normal lipids before and after event. Normal lipid subfractions (MRI advanced profile).  Pfizer Vaccine Dose #1 received 12/31/2020. First mild angina episode 1/17/2021. Pfizer Vaccine Dose #2 received 1/21/2021. Increasing angina developed 1/22/2021 through 1/27/2021. Normal echocardiogram 1/27/2021. NSTEMI occurred 1/28/2021 at 3:30am necessitating Emergency room visit, Catheterization demonstrating a new 95% LAD stenosis and stent placed. Patient subsequent developed questionable dysautonomia (tachycardia and insomnia of unknown etiology). Currently in recovery.
Increased menstrual bleeding. Never experienced bleeding to this extreme prior to the vaccine.  Started on birth control that helped decrease the bleeding.
Got  positive test for COVID three days after the first shot; asthma got worse; allergies got worse; My breathing was difficult; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult). At the time of the report, COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.
This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient. On 23-JUN-2014 the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose, lot# not reported). On 23-JUN-2014, the patient experienced bronchospastic response after being administered with the injection (first injection of a three dose series) of GARDASIL. The outcome of bronchospastic response was unknown. Additional information has been requested.
Patient immediately felt sensation at injection site that immediately spread up towards neck and chin area which converted into numbness of the area within minutes.  Sensation was not painful.  Patient had feeling of overwhelm but disregarded both the sensation and overwhelm as anxiety of the vaccination process in general and did not report to the available medical staff. Numbness remained for  approximately 24 hours primarily in the chin and bottom lip with some loss of feeling in the upper lip.  No sign of swelling.
Started having stinging rectum pain. Moderate level pain . Moderate to high level when peeing or pooping . Lasted for 24hours . Family history of ulcerative colitis. On 9/10  had blood when wiping .
there was a sewer smell and she couldn't smell it; tender; when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her; nausea; had a headache every day for almost a whole week since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concurrent medical conditions included Diabetes, Blood pressure high and Neuropathy. Concomitant products included METFORMIN, GLIMEPIRIDE, LISINOPRIL, GABAPENTIN (NEURONTIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (there was a sewer smell and she couldn't smell it). August 2021, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 220 mg. At the time of the report, ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Patient received the covid vaccine on 12/22/2020.   c/o new onset of sore throat and bodyache on 1/4/2021.  Denies, fever, cough, any ocular or GI symptoms.  Found out today, 1/4/2021 co-worker tested positive for Covid on 12/15/2020.
Snort like cough- dry/short/repetitive hours after vaccines. Fever 100 day after vaccines and leg pain c/w injection site soreness, Urticarial rash began 7/25/ evening and ongoing. Increased fussiness since afternoon of vaccines.
Mom reported baby slept from 930AM p/receiving vax, was awakened briefly @ 6PM, took 2oz of formula then returned to sleep; sleeping very soundly mom & dad unable to rouse baby, shook pt & moved from bed;
Forget many things; Feels very sick; Memory loss; No energy; Fever 102 Fahrenheit; Headache on both sides; Received 2nd dose after recommended interval, more than 35 Days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose after recommended interval, more than 35 Days), MEMORY IMPAIRMENT (Forget many things), MALAISE (Feels very sick), AMNESIA (Memory loss) and ASTHENIA (No energy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Bronchitis NOS. Concurrent medical conditions included Allergy NOS (She has allergy to many things.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose after recommended interval, more than 35 Days). On 16-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Forget many things), MALAISE (Feels very sick), AMNESIA (Memory loss), ASTHENIA (No energy), PYREXIA (Fever 102 Fahrenheit) and HEADACHE (Headache on both sides). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose after recommended interval, more than 35 Days), MEMORY IMPAIRMENT (Forget many things), MALAISE (Feels very sick), AMNESIA (Memory loss), ASTHENIA (No energy), PYREXIA (Fever 102 Fahrenheit) and HEADACHE (Headache on both sides) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102 she had fever 102 Fahrenheit and last for 3 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included five different types of Inhalers. Concomitant medications were not provided.   This case was linked to MOD-2021-194101 (Patient Link).
Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and  dissyness and brain zaps.
p/vax pt failed to seroconvert;on unspecified date, pt titer was low 0.77;5/27/97 a second titer was negative at 0.5 9 91.1-positive);
The injection site looks bruised as if a blood vessel was nicked; There was quite a bit of blood; This is a spontaneous report from a contactable pharmacist (patient). A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose in the arm for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the 1st dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday (21Jan2021). She noticed that when the Pharmacist pulled it out of arm, there was quite a bit of blood and upon checking today (22Jan2021), the injection site looks bruised as if a blood vessel was nicked. Events outcome was unknown.  Information on the lot/batch number has been requested.