chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with headache,chills,sweating, body aches, tremors, weakness, sore throat,cough, tiredness,tingling in extremeties, and nausea. Day 2 add on fever 101, strong cough, runny nose,wheezing, Day 3 add loss of taste, loss of appetite with other side effects. Day 4 some side effects were less but new ones were sores in mouth, nose,sores ,sores on lips. Day 5 same as day 4
pt had elevated temp for 7 days following vax every time APAP wore off; APAP given every 4 hrs; temp highest was 103 on 2nd & 3rd days post vax; To MD 10JUL92 given Advil rx;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L040054 with expiration date of 26-DEC-2017, lot # M018810 with expiration date of 28-MAY-2018, lot # M031557 with expiration date of 07-APR-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 36 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005915:
Narrative: Pt is a 89y.o. male who died on 02/04/2021 w/ h/o Alzheimer's disease, ACD, HLD, HTN, hypothyroid, BPH. Pt received Moderna Covid-19 Vaccination 1/2 on 01/20/2021. Pt admitted for full care by hospice on 02/01/2021 d/t Alzheimer's. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
5"x4" red, indurated, site tender area right anterior thigh at site of DTaP-Hib injection. No adenopathy, illness, fever or temp. Child acts well.
Bilateral swollen eye lids and bruising. Started when I woke up the morning after the vaccine. Mildly itchy, and sore. Swelling went down within 8 hours, bruising went away next day.  The following day the skin on my eye lids were very dry, craking/flaking , sore and itching. Applied lotion and resolved on its own.
Pt recvd 3rd DTP on 21JUN91 had low grade fever & next day devel infantile spasms;
Follow up information received; no new safety information. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a health care professional regarding a 27 year old female nurse who experienced an accidental exposure on 24Aug04. The pt's concurrent illness includes allergy to penicillin. Indication, dose and dates of Prevnar therapy were not provided. Concomitant therapy included vitamins. On 24Aug04, a 27 year old female nurse experienced an accidental exposure when some Prevnar came off of the needle and inadvertently splashed into her left eye. The reporter, another nurse in the same facility, indicated that the affected nurse was using the safety needle and she believes that no more than one drop would have entered the eye. Initially, the nurse's left eye was stinging; she flushed the eye with cold water for approx ten minutes. The reporter indicated that the nurse eye felt better but appeared irritated and red. Per the reporter she will continue to flush her eye for ten more minutes. No additional information was available at the time of this report.
Pt received dose 1 of 2 Moderna. Pt has a history of hives with influenza vaccine. Encouraged patient to wait in clinic lobby for 30 minutes after immunization was administered. At 20 minute wait time, pt developed hives on chest, abdominal pain, and sensation of "lump in throat". EMS activated, IV started, and 0.3mg epinephrine/ 50mg Benadryl/ 20mg famotidine administered.
Delayed Reaction, 2 weeks a Rash formed on inital Arm and also on opposite arm then lower back and upper thighs Skin Flaked off and was persisten rash for 5 weeks .  The Doctor indicated that they had many reports of this reaction over the same period of time. Moderna Case # and case worker said that they did not initially test for Delayed Reactions and now are beginning to get numerous inquiries and reporting about delayed reactions.
Transverse Myelitis Numbness from  T2 to feet, Lhermitte's sign. Tinnitus and diminished hearing. Abnormal MRI. Hospitalized for 5 days, evaluated, and treated with IV steroids.
Headache; Swelling in my arm; Some fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "Swelling in my arm"; FATIGUE (non-serious), outcome "recovered", described as "Some fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives; totally clears the skin and Irritation skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and SKIN IRRITATION (totally clears the skin and Irritation skin) 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.    In April 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 URTICARIA (Hives) and SKIN IRRITATION (totally clears the skin and Irritation skin). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown and SKIN IRRITATION (totally clears the skin and Irritation skin) had resolved. Not Provided      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 Concomitant use were reported
This spontaneous prospective pregnancy report as received from an 18 years old female consumer reporting on herself. The consumer's history of previous pregnancies and live births were not known. The consumer was vaccinated with a dose of MMR II (Lot # and dose not reported) subcutaneous on 22-JUN-2012 while pregnant. On an unspecified date the patient performed a pregnancy test. The patient's last menstrual period was on 06-JUN-2012 and her estimated delivery date would be on 13-MAR-2013. The patient called the doctor to seek medical attention. No treatment was given. Outcome was reported as not recovered. Follow up information has been received (report type unknown) which reported that they were unable to provide information requested, because they never administered an MMR vaccine on this patient. Information was requested to verify. Additional information is not expected.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 84 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Delayed urticaria- began 3 weeks after vaccine, still ongoing at the time of this report (6 weeks)
Patient called stating she had pain in her arm since getting the flu shot 2 weeks ago and that pain is getting worse.
arm hurt for 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for 4-5 days) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical medical condition nor concomitant medication was reported.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurt for 4-5 days). On 15-Mar-2021, PAIN IN EXTREMITY (arm hurt for 4-5 days) had resolved. more details was not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
12/22/2021 vaccination at 12:45PM. At about 1:45PM, I started to experience Gastroesophageal reflux disease (GERD) and asthma. Cerebral palsy, either side. More of a pin-point pain. GERD usually comes with relief with burping vs soreness with my fibromyalgia. The shortness of breath wasn't that often, not that dramatic. Pretty in line with what I have experienced in the past. 12/23/2021 Called PCM; too busy. Referred to nurse hotline in early morning. Advice, 'Keep ice on vaccination site, heat and ice. Treat myself like I had COVID, like my body had been exposed. Take it easy, not worry about it. Any doubts, go to urgent care or ER. It has been a couple of days and I don't feel that there is an issue.
pain, tenderness of left arm since 01/15/2021. Rash with swelling and hardness in three areas appeared on 01/18/2021. The 3 rash areas and hardness became one on 01/21/2021. Severe itching of area at night. Big rash with hardness persists today.
vomiting; chills; swollen stomach; Stomach cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL9264) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "low immune system" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: Received on 30Jan2021, lot EL9262, expiration 31May2021. Dosage 0.3 ml.), administration date: 30Jan2021, when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Feb2021, outcome "not recovered", described as "Stomach cramps"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; CHILLS (non-serious), outcome "unknown", described as "chills"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "swollen stomach". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Results of tests on 01Mar2021, test: COVID-19 PCR test, result: negative.  No follow-up attempts are possible. No further information is expected.
Immediately after vaccine pt c/o severe headache, dizziness, tongue tingling. No hives or local reaction. No trouble swallowing. Resolved without rx after about 2 mins.
9pm My throat felt it was swollen and I had a very hard time breathing. Took short, quick breaths. Lasted for 5-10 minutes that it went away. Had chills & pressure on my chest. Took a BENADRYL. Felt better in the AM. (This was my first flu shot ever).
BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches and fever was not reported. This report was non-serious.
pre-syncope/lightheadedness that was not positional/orthostatic eg was present while sitting
18-year-old healthy man received his second Pfizer COVID-19 vaccine on Sunday, may 16th.  He had generalized muscle aches and mild flu-like symptoms which were not unexpected on Monday the 17th.  On the 18th, he reported dyspnea on exertion, some chest tightness, and his throat felt like it was "closing".  He also had tender anterior cervical lymph nodes and a fever to 100.8 °F.  He came into the ER for further evaluation. After evaluated by cardiology, given his stability, felt appropriate for discharge with immediate outpatient follow-up.
Severe headache and body aches. Swelling at injection site sore arm for the injection could not move the arm. Fever with tachycardia episodes. Severe nausea with vomiting. Inability to digest food or consume food without Nausea
The day of the shot, my arm was sore but then the next day, the soreness was gone and no other side effects appeared until a week after.  8 Days after receiving the vaccine, a small welt grew at the injection site. It was itchy and warm to the touch. The next day, the welt wasn't as hard, but still present and itchy at times.
Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose with neuropathy; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received (COVID 19 PFIZER), dose 2 intramuscular, administered in right arm on 13Apr2021 17:00 as single dose for COVID-19 immunization. Medical history included type 2 (DM) diabetes mellitus, obesity, vitamin D deficiency and was diagnosed with COVID-19 prior to vaccination; all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient previously received 1st dose of (COVID 19 PFIZER), intramuscular, administered in left arm on 23Mar2021 05:00 PM  for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced transient (bilateral) b/l lower extremities (LE) edema 2d after 2nd dose with neuropathy. Outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken were NSAID and muscle relaxant. Since the vaccination, the patient has not been tested for COVID-19.
I have a lymph node on my left side of my neck that is swollen and painful. ( near the clavicle)
Increased Heart rate, discomfort in left forearm for short periods of time, Fatigue, Anxiety, light headedness / clouded mind, sometimes vertigo like symptoms for a briefs period
Arm sore; Arm was very itching; Fatigue; Redness at the injection site in an area about 4 inches in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm was very itching), VACCINATION SITE ERYTHEMA (Redness at the injection site in an area about 4 inches in the shoulder) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site in an area about 4 inches in the shoulder). On 21-Jan-2021, the patient experienced FATIGUE (Fatigue). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore) and PRURITUS (Arm was very itching). On 06-Feb-2021, PRURITUS (Arm was very itching) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm sore), VACCINATION SITE ERYTHEMA (Redness at the injection site in an area about 4 inches in the shoulder) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included bandage over the zone to avoid touching it.
Patient got dizziness and shaking. Patient was given gatorade, hershey kisses, and water. About 15 minutes later, he felt better and was able to walk out of the pharmacy.
MOTHER BROUGHT BABY IN FOR SHOTS TODAY (11/5/07) AND STATES THAT 5 OR 6 DAYS AFTER THE LAST VISIT (8/2/07)BABY HAD SEVERE DIARRHEA THAT LASTED X 6 DAYS.  DIARRHEA WAS WATERY, YELLOWISH IN COLOR AND HAD A "ROTAVIRUS SMELL"
Myocarditis , Chest pain, Shortness of breath, pounding heart, high fever  Monitored for worsen symptoms and Acetaminophen 1 gram every 6 hours
Patient was in the hall getting his vitals done, at this time the T.L checked right arm of this patient as it was passed on that the patient had some redness and swelling from the right deltoid all the way to the elbow on the right arm. After looking to make sure which vaccinations were given in the right and left arms as he received one in each arm, checked with the medication nurse, what the other vaccine was it was the Pneumo vaccine in the right arm not the flu vaccine causing the problems, ordered Ibuprofen for pain and swelling, and asked that we put a note in for the pharmacist of the reaction from the pneumo vaccine. Patient has not had any voiced concerns this evening except being a little anxious, he denies any suicidal or homicidal ideations, denies any N/V/D or any hallucinations, patient has stated that he has never had any problems with the flu vaccine before.
4/13/21 Numbness and tingling in feet, moved up legs.  Cramping and deep muscle pain with shooting pains up thighs.   4/20/21 went to urgent care as cramping very severe with rapid heart rate.  Tachycardia, EKG normal.  Labs CBC, BMP, CK normal. 4/25/21 Heart 160, went to ER.  Tachycardia, SVT.  CT with contrast normal, labs normal.  Discharged to cardiology follow-up.    4/30/21 Cardiology appointment.  Wearing MCOT monitor 2 weeks 3/5/21 Neurology: EMG normal
muscle at the injection site became very sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle at the injection site became very sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     no medical history was reported by reporter.  The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (muscle at the injection site became very sore). At the time of the report, MYALGIA (muscle at the injection site became very sore) 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.   patient reports that he had his 1st dose of the Moderna Covid-19 vaccine on 01Apr2021 through their local county health department.  On the night of the vaccination, his muscle at the injection site became very sore. Consent to follow up obtained. patient wants to know if he can apple Bio freeze to the injection area. no concomitant medication was provided. AE contact Information Updated  in Followup document . Caller is returning call / email from Safety.  Contact information updated.  Patient stated that they were unable to reply to original email with completed form from Safety.  It was returned undeliverable.  Please resend email.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non Significant follow up - Event and Narrative updated On 11-Jun-2021: Initial Additional-1 : To confirm
This spontaneous report was received from a registered nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available. Sender's Comments: US-009507513-1612USA008999: US-009507513-1612USA009001: US-009507513-1610USA002776.
After I gave the vaccine to patient within few minutes  patient start feeling closing out the esophagus and it was swallowed. I gave patient epipen and called 911
Abnormal skin reaction on both hands- rash, red, itchy, already several days, still on going.
No additional AE; Nurse calling because expired oral vaccine administered to patient.; This spontaneous report was received from a nurse (conflicting information, also reported as "MD") referring to a 4-month-old male patient. It was reported that the patient did not have any medical history, concomitant therapies neither any known drug allergies.  On 20-JUL-2020, the patient was vaccinated with one expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution (strength, number of doses, and vaccination scheme frequency were not reported; lot number R026541 has been verified to be a valid, expiration date reported and validated as 11-JUL-2020) as prevention of rotavirus (expired product administered). The nurse stated that the patient did not seek medical attention, no laboratory tests were performed and no received treatment for the event. Additionally, it was reported that, there was no temperature excursion with this vaccine and that the other vaccines had been removed from inventory. No adverse effects were reported.