chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; JOINT PAIN; NOT FEELING REGULAR; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (NOT FEELING REGULAR), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (JOINT PAIN) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced FEELING ABNORMAL (NOT FEELING REGULAR) and ARTHRALGIA (JOINT PAIN). At the time of the report, FEELING ABNORMAL (NOT FEELING REGULAR) had resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and ARTHRALGIA (JOINT PAIN) had not resolved.            Concomitant medication was not reported. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Began with symptoms of a pulled groin, after a week went to the doctor.  Gave me meloxicam and told to have no exercise for two weeks, then within a week had same symptoms on right groin.  Next both shoulders, elbows, knees, all painful.  Blood work showed nothing extraordinary.  Extreme pain Tuesday, May 4.  Appointment to go back tomorrow, May 6 for another type of blood test.  Doctor felt I should report symptoms.
Completed Covid 19 Vaccine Series on 01/25/2021, now has Covid 19
3-14-23 Two Hours after vaccine given complaints of muscle aches and fever - unable to sleep after taking Tylenol so she took (3/16) Lunesta at 8am. She came to the clinic with spouse, BP decreased, eyes dilated, very drowsy, Refused ER via ambulance. Spouse to take her to ER via personal car. LD soreness but no swelling or redness. Only tenderness. Slight bluish discoloration around injection sight noted.
Pt presented with rash present on neck and anterior chest at approximately 3:55 PM. Called MD. Physician instructed to give pt the chleranin tablets in Epi kit. At 4 PM save pt tabs to take. Explained to pt that it was antihistamine could present drowsiness. Call if respiratory problems occur.
Blood glucose spiked to-300 then plunged to-55 Uber the course of-1.5 hrs; Slight nausea; Some sweating for-40 minutes.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982), via an unspecified route of administration in left arm on 03Feb2021 at 08:45 AM as 1ST DOSE, SINGLE for covid-19 immunization (67 years old when vaccinated). The patient medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 04Feb2021, at 03:30 PM, patient experienced, blood glucose spiked to-300, then plunged to -55 Uber the course of-1.5 hrs. Slight nausea and some sweating for-40 minutes. The patient underwent lab tests and procedures which included blood glucose: spiked to 300, blood glucose: then plunged to 55. The patient did not receive treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
11/5 Fever started around 2 hours after vacination rose to 103 that evening. Administered Motrin. Called Doctor office next morning nurse said to continue to administer motrin. Fever continued, crying at night took to Dr office on 11/11 was diagnosed with an ear infection. Amoxicillin was prescribed. Fever continued Went to Dr office on 11/14 Ear infection worse switched to Cefzil. Fever continues on 11/15
headache; fatigued; shortness of breath; very thirsty; clammy; my eyes were very dry; heart palpitations; feeling similar to heart burn; feeling of heat (not quite burning) in upper arm; tingling of throat and tongue; tingling of throat and tongue; mild shivers; feel of coldness on my chest; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional (patient).  A 33-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in left arm on 11Mar2021 01:45 PM (at the age of 33 years old) as dose 1, single for COVID-19 immunization. Medical history included cardiac murmur (has never effected) , childhood asthma (outgrown) , gastrointestinal pain (sporadic and painful upset colon) psoriasis with beginning stages arthritis (not yet diagnosed as psoriatic arthritis),  variant (methylenetetrahydrofolate reductase gene mutation), pre-hypertensive. I am on no medications. The patient's concomitant medications were not reported. Patient is not allergic. Patient was not tested positive for post vaccination and not had COVID prior to vaccination. Patient did not receive any other vaccine in last 4 weeks and any other medication in last 2 weeks. On 11Mar2021 the patient experienced starting to get a headache at 15:45 (2 hours later), tingling of throat and tongue at 13:50, mild shivers at 13:50, feel of coldness on her chest at 13:50, feeling of heat in upper arm at 13:55, heart palpitations at 14:00 (15 minutes), feeling similar to heart burn at 14:00 (15 minutes), patient eyes were very dry at 14:45 (1 hr), fatigued at 15:45 (2 hours later), shortness of breath at 15:45 (2 hours later), very thirsty at 15:45 (2 hours later), clammy at 15:45 (2 hours later), warm clammy palms, elbows, and armpits (10 minutes). It was reported that patient had effort required to swallow saliva (clear my throat), NO difficulty breathing The patient did not receive any treatment for adverse events and outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I21.4 ACUTE NON ST ELEVATION MI 4/25/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (after the vial puncture time limit) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 052E21A) for COVID-19 immunization. No medical history reported. On Sep 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 15, 2021, patient administered expired product (after the vial puncture time limit). On Sep 15, 2021, administered expired product (after  the vial puncture time limit) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-378769 (patient link).
Parents described high pitch cry for approximately 12 hours would fall asleep exhausted for a while and woke up screaming. Difficult to console. Also refused to eat and unable to sleep that night of receiving the vaccines, would wake up screaming off and on. Pt had low grade fever temp 100 for about 12 hours also.
Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
pt recv vax 19OCT98 & 20OCT98 430PM began itching, had hives in evening;no angioedema;21OCT98 came to clinic 1205PM mild itching & red welt, rt inner arm;DPH given;
noticed where the injection was it  is red, welt, seems to be going away and feels hot.; hurting a little; Fatigue; Her temp was 99 or 98; muscle was hurting; felt hot right there; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunization and experienced pain. On an unspecified date after second dose of vaccination, patient noticed that where the injection was given it was reddish and kind of like a welt. It seems to be going away. It had been hurting a little. It felt hot right there. Patient asked if it was a side effect and if she need to go doctor. On the paperwork it said redness at the injection site. It was on the bottom like a circle where she got injected. She still has the Band-Aid on there. There was some soreness. Yesterday there was fatigue. Her temp was 99 or 98 yesterday. She took Tylenol and by this morning or by 10PM last night she was feeling well. She thinks she would be able to see if it was a welt. The circle looks like it is going away. She doesn't know to put ice on it. Patient felt more of a pain from the 2nd shot than the first shot, the muscle was hurting. Redness was going away, it's like a circle. Patient massaged it out and now it was not as dark. Outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 4 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The age at vaccination was not reported but could be 62 or 63 years. The patient experienced flu like symptoms after vaccination. No additional detail were provided on flu like symptoms. The reporter consented to follow up.
Janssen COVID-19 Vaccine EUA @ 10:30 am 3/11/2021 Begining at 8 pm, I got chills (shivering and shaking uncontrolably) for over an hour, then a fever of 103 less than an hour after the chills started.  I took Ibuprophen and was able to fall asleep. Woke to a fever of just 99. Feeling better the next morning.
Pt received vaccination to right deltoid on 11/18/08.  Presented to primary care clinic on 11/19/08 with c/o pain, edema to right arm, warm to the touch, pain upon touch, chills and area was pinkish-red in color.  Assessed by physician assistant who concluded cellulitis-like reaction to the vaccine.  Advised pt that it is a self-limiting process, no treatment is necessary.  Advised pt to apply warm compresses if needed.  Pt RTC on 11/21/08 with the same symptoms but location shifted, pt to get a US to r/o DVT vs cellulitis vs ADR to vaccine. Pt to f/up with US results 12/1/08.
Approximately 103 degree fever in 53 year old excessive sleep, chills, headache, aches, etc. Second day fever was closer to ~101+ Fever did not break for 3 days It took 5 days to feel back to original state
Case number PHEH2016US023793, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml, intramuscular on 13 Sep 2016. On 13 Sep 2016, 02 patients vaccinated with FLUAD that were not 65 years or older. No adverse event was reported following this medication error. The case was assessed as non-serious by the pharmacist.
pain in the arm; sweating all day; stomach ache; flu like symptoms; dizzy; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy). At the time of the report, PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Within 3 hours of administration, client had a sore deltoid. This progressed to being extremely painful and her range of motion was very limited. Could not lift arm to head level. Took Advil. Next day slightly improved with pain, still limited ROM. More ADVIL and heat to area. RN saw her next day 6/10 for TST read. No mention of her arm.
Rash on the injected arm after second dose and  later traveled to the right arm; Fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and  later traveled to the right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever after second dose). On an unknown date, the patient experienced RASH (Rash on the injected arm after second dose and  later traveled to the right arm). At the time of the report, PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and  later traveled to the right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative.         No concomitant medication reported. No treatment medication reported. Expiration  Date of both dose  was unknown . Patient took second dose on  AUG  2021 .
Per client family, client had a heart attack (cardiac event) on 12/18/2022. Client hospitalized and being transitioned to hospice care.
Five minutes after receiving vaccine was at pharmacy when had chest pain, like pinching on chest and was a bit out of breath. Went back to doctor's office and was given a Nexium - although patient comments that it was not acid reflux and lay down for 20 minutes. Felt better after 1 hour over the weekend pinching will come back every once in a while. Recovered by Monday.
Information has been received from a nurse practitioner (NP), with a company representative, concerning a 19 year old male patient, with no pertinent medical history, who was vaccinated on an unspecified date, with a dose, 0.5ml. of Gardasil (Lot # not provided). There was no concomitant medication. Subsequently the patient was diagnosed with an infraclavicular swollen lymph nodes. The NP added that no treatment was required, and the event resolved on it's own (date and duration not specified). No further information is expected.
2-3 d after received vaccination significant local reaction - erythema, swelling & tenderness at site of injection at deltoid & extending toward elbow lasted > 10d.
1/27 afternoon -Foggy, forgot what she was doing . 1/27 evening -full body shaking. Felt she could not grasp with right hand. Right eye pain, throbbing.1/29 Loose stool. 1/30  Loose stool , nausea,shaking, lethargy. 1/31 - felt better. Right hand grasp still felt off.
Intense arm pain and finger numbness, neck pain/stiffness on left side. Severe nausea and dizziness, vomiting/dry heaving. Headache, fever (102)
Her left arm swells and is very painful. It hurts when she moves her arm since the night she received the shot.
Patient received Moderna Bivalent booster as the second dose of his primary COVID-19 vaccine.  Plan for patient to receive monovalent Moderna vaccine in 8 weeks.
It was reported that pt exp severe lt back pain & muscle spasm 24hr post inj in lt arm;MD also indicated that this pt is very muscular but pt denied any heavy labor or workouts p/receiving the Td shots;
Soreness at injection site  Body aches  Fever  Chills Fatigue  Sore throat
Dead on the bed with his legs dangling off one side of the bed; Complained about an upset stomach; A spontaneous report was received from a nurse concerning a 70-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history included hypertension and diabetes. No concomitant medications were provided.  On 20 Feb 2021, Saturday, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 21 Feb 2021, Sunday 9:36 AM the patient's experienced an upset stomach and attributed it to dinner last night and later on 22 Feb 2021, Monday he was found dead on the bed with his legs dangling off one side of the bed. The cause of death was unknown.  Treatment information for event upset stomach included half a spoon of an Indian thing.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event upset stomach was fatal and patient died on 21 Feb 2021.; Reporter's Comments: This is a 70-year-old, male patient, who received Moderna's COVID-19 vaccine and history of risk factors for CAD such as hypertension and diabetes, was found dead 2 days after vaccination. Very limited information regarding this events has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Unknown cause of death
Presented with SOB/cough; CXR: Patchy infiltrates within the lung bases bilaterally; Tx with zithromax, rocephin, remdesivir, decadron; initially increased FIO2 to 6LPM but back down to 3 LPM at discharge;
Information has been received from a health professional concerning an 18 week old female who on 02-JAN-2007 was vaccinated with an oral dose of Rotateq (lot # 654422/0607F). There was no concomitant medication . Subsequently the patient developed gastroenteritis. On 25-FEB-2007 the patient had a positive rotavirus test. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Given DTaP, Hep A, and flu vaccine 10/23/2006. On 10/24/06, developed hives on arms and hands swollen. Not sure if from vaccine.
Narrative:  Patient placed on Hospice and passed away due to complications of metastatic bladder cancer. Death not suspected to be related to administration of COVID-19 vaccine