chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose of vaccine administered after excursion; This spontaneous case was reported by an other health professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-250554 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (shivering after receiving 1st dose, see case US2018122090). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The shivering was not as bad as what the patient experienced after the 1st dose.
I experienced a headache and my left arm was sore after my Moderna second dose vaccine.  When I woke up the following day, I was puffy above my right eye then it went to my left eye. In two days my eyes were swelled up and I was very unhappy.  My eyes were also very itchy. A doctor in an urgent care, said it was a rash due to inflammation and they prescribed Prednisone x5 days and an antibiotic x 7 days.  I feel better today but have not recovered completely.
vomited just once; Extreme fatigue; Acid-Reflux; Loss of appetite; Unable to keep down spicy food; Bruise feeling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid-Reflux), DECREASED APPETITE (Loss of appetite), FEEDING DISORDER (Unable to keep down spicy food), VACCINATION SITE BRUISING (Bruise feeling on left arm) and VOMITING (vomited just once) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia, Hypertension and Thyroid disorder. Concomitant products included AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruise feeling on left arm). On 28-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid-Reflux), DECREASED APPETITE (Loss of appetite), FEEDING DISORDER (Unable to keep down spicy food) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced VOMITING (vomited just once). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) ongoing since an unknown date for Acid reflux (esophageal), at a dose of 1 dosage form and ALUMINIUM HYDROXIDE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM BICARBONATE (GAVISCON [ALUMINIUM HYDROXIDE;CALCIUM CARBONATE;SODIUM ALGINATE;SODIUM BICARBONATE]) ongoing since an unknown date for Acid reflux (esophageal), at a dose of 1 dosage form. On 22-Mar-2021, VACCINATION SITE BRUISING (Bruise feeling on left arm) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid-Reflux), DECREASED APPETITE (Loss of appetite), FEEDING DISORDER (Unable to keep down spicy food), VOMITING (vomited just once) and FATIGUE (Extreme fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-AUG-2021, updated event outcome.
Patient experienced a vasovagal reaction, loss of consciousness, sweating over the course of several minutes.
Patient experienced hives and a numb tongue several days after getting the shot. She called the pharmacy and was advised to go see the doctor and to take Benadryl in the mean time. Her breathing was at her baseline.
Eczema/rash noticed that morning, got worse over about 3/4 days, staying inflamed now. Same reaction to eating things that contain eggs.
Within 12 hours I started having a frver, severe aches, dizziness, lethargy. It was so bad I couldn't get out of bed for a whole day.
Red, warm, swollen extremity where 4th dtap given, also fever and a hoarse cough (per mother) for one night.  The redness, swelling lasted several weeks and a bruised are remains.  These clients were 23 mon. old twin brothers.  The childrens mother called public health because of lasting redness, swelling pain @ injection site.  The mother reported that her brother had a dtap reaction as a child.  The mother was instructed to follow up with PCP and determine with PCP if further vaccination  with dtap should be deferred.
This spontaneous report was received from a nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient received four doses of GARDASIL 9. The patient was supposed to received MENACTRA but the patient received a fourth dose of GARDASIL 9. On 25-SEP-2015, the patient was vaccinated with dose of GARDASIL 9 lot # L014415, 25-JUL-2017, intramuscular. On 17-NOV-2015, the patient was vaccinated with dose 2 of GARDASIL 9 lot # L028083, 03-SEP-2017, intramuscular. On 28-MAR-2016, the patient was vaccinated with dose 3 of GARDASIL 9 lot # L040164, 20-FEB-2018, intramuscular. On 09-NOV-2016, the patient was vaccinated with dose 4 of GARDASIL 9 lot # L014415, 25-JUL-2017, intramuscular. No adverse effects were reported. Additional information has been requested.
10 days after shot-developed right inguinal lymphadenopating (snores)=measuring 0.5-1cm.  Non-tender, no erythema, mutable.  11 days after shot-had high fever 102.5 degrees F; and developed rashes the following day.  (<50 lesions).
Ringing in ears, bi-laterally  Started about 7:00pm. Still happening two days later getting louder
received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the nurse reported that the patient received 1 dose of the vaccine past the 6 hour used-by time. The nurse stated that the dose of the vaccine was administered 72 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 01 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20A.  There were no reported AEs associated with this case of out of specification product use.
C/O "I feel weak, dizzy, tired, heavy headed, chest tightness" Patient reported symptoms above, also with cough, lungs ctabl 118/63 98% 69 Rapid response called patient tranfered to Evaluation Treatment Center. Under MD care.   Meds Continued:  Breo zofran, hydrochlorothiazde, robaxin, lyrica, Benadryl, Meclizine, Rotigotine for rls  Continued Medical History: arthritis in L knee, back and hips, Carpal tunnel
Information has been received from a physician concerning an 18 year old female patient with a history of abnormal pap smear and no drug reactions or allergies reported, who on 27-AUG-2009 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscular route in the left arm (lot # unknown). There was no concomitant medication. On 27-AUG-2009 the patient experienced left arm pain since receiving her first dose of GARDASIL. On 21-NOV-2009 the patient had an MRI of the left arm at an unspecified facility which revealed bone marrow edema (1x1 cm focus of marrow edema along posterior aspect of the humeral head-neck junction, centered along the posterior lateral physis, compatible with a bone contusion, multiple axillary lymph nodes measuring up to 2 x 1.2 cm of uncertain clinical significance, possible reactive; equivocal undercutting of the posterior inferior glenoid labrum at the seven o'clock position where a minor partial detachment cannot be entirely excluded). The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Pain tenderness swelling Left ankle(fasciitis) Unable to walk for one month bec of pain on stretching ankle.  Other :muscle aches , joint pains for 48 hours
Dry cough (short bursts especially during sleep and has continued for 18 days); This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at 09:30 as a single dose for COVID-19 immunization. Relevant medical history included hypertension from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination, which included unspecified high blood pressure drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 23:00, the patient experienced dry cough (short bursts especially during sleep and had continued for 18 days). The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.  Information on the batch/lot number has been requested.
-Tinnitus occurred within 24 hours of receiving second Moderna Dosage.  - Still occurring after 6 days, with no relief. Actual increasing after the 4th day.
A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.
This is not confirmed diagnosis however, part of the immediate differential diagnosis includes possible vaccine related thrombosis. Currently being worked up in the hospital for New - Onset aortic arch thrombus with thromboembolectomy to left arm.  Patient has no previous history of blood clots, no family history of blood clots and the location of blood clot is in a very unusual location.   Patient developed sudden onset symptoms of left arm arterial thrombosis that required immediate surgical embolectomy to restore blood flow to left arm.  CT scan noted large aortic arch thrombosis and transferred to Hospital for escalation of care, cardiac surgery and vascular surgery evaluation.  Hematology team consulted to begin workup for hypercoagulopathy.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The medical history, concomitant medication and concurrent condition was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9. On 09-MAY-2016, the patient experienced syncope. The patient went back to exam room for cold rags. The outcome of syncope was unknown. The patient did not seek medical attention. Additional information has been requested.
Rt leg erythema 5 1/2" x 6 1/2" Lt leg erythema 2"x 2"
Case number PHEH2014US011891 is an initial spontaneous report received from the nurse on 11 Jun 2014. This report refers to a female patient between the age of 20-30 years. Her medical history and concomitant medications were not reported. On 04 Feb 2014, she was vaccinated with MENVEO (batch number: not reported) intramuscularly at a dose of 0.5 ml. Following the vaccination, on the same day during the waiting period, she experienced sudden onset of headache. She also felt sleepy and light headed. The injection site had turned red and was about the size of a soft ball. The outcome, seriousness and causality of the events were not reported.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 27-MAR-2013 at 2:20 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 226.50 hours (also reported as 17 hours -1, 447, 2, -54 hours, 178, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Patient experienced fever night of vaccine, highest 101.0 At 0500 on 10/16 patient woke parent up stating "this night seemed so long". At 1500 on 10/16 patient was doing math homework on paper and stated numbers looked like they were getting bigger and smaller. Symptoms continued, patient stated items in surrounding area seemed to be "getting larger and smaller. Patient also stated he felt he was getting bigger and smaller.  Symptoms lasted approximately 50 minutes.  Patient was in distress (fearful) during symptoms, stated he was afraid it might happen again after symptoms resolved.
SkinRash, Rash, 8 days post shot has redness to sight, warm and slightly swollen. size 4inchX5inch pink/red area. Escorted to ER for follow up cares. Narrative: Mild cellulitis at Moderna injection site. No systemic signs Prescribed Cephalexin and told to follow up with PCP
Moderna Covid 19 Vaccine EU A  A week after the injection which was on 3/1, the injection site swelled, got red and itchy and was warm to the touch. Yesterday 3/8, there was a rash.  Today, 3/9, it remains swollen, warm and itchy.  I have used topical Benadryl on it.
Tinnitus, gradually worse as time has went on, at first was at night and now all day
Pt. got extremely lightheaded and pale. Pt stated at the point of almost passing out. Scared of needles. No trouble breathing, heart rate normal. Pt. wanted to lay down with an ice pack. Called EMS - pt. was released w/ no hospitalization.
pt recv vax 15OCT96 to rt deltoid;came to clinic 17OCT96 w/ c/o redness & warmth to rt forearm progressive x 1 days;dx w/cellulitis rt forearm;rx ATB; rechecked 18OCT96, dx w/resolving cellulitis & told to f/u PRN;
Began suffering from vertigo 12/15/21   Woke up, felt dizzy, became nauseous.  Vertigo continued until I called Dr  in April and was diagnosed.  PT appt April 19.  I have not suffered from vertigo since.  I also had a Crohns flare up in January 2022 I called my gastroenterologist and had a sigmoidoscopy Feb 2, 2022 and a colonoscopy Feb 18 2022 I am now on medication to keep under control.
Pt stated his arm became red, hot and itchy by the afternoon the day he received his vaccine. Pt evaluated 7 days later sx still visible.
Awoke feeling as if I had been hit in the neck lower back and knees-bad muscle pain. that evening developed fever 102, took Tylenol, had malaise, generalized feeling of being unwell. Muscle pain grew worse. Saturday night fever went to 104-visit Emergency room on Sunday. No evidence of any infection, had blood work, chest xray, flu test, all negative. Received fluids and this was called severe post vaccination reaction.
Week after immunization, pain at injection site. Redness around injection area, warm to touch, light swelling. Pain worsened and rash began to spread up to shoulder area.
This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS got worst after 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MULTIPLE SCLEROSIS (MS got worst after 2nd shot) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (MS got worst after 2nd shot) outcome was unknown. No concomitant medications was reported. No treatment was reported. Company Comment. This spontaneous case concerns a 63 year old female, with relevant medical history of multiple sclerosis, who experienced the unexpected, serious (medically significant) AESI Multiple Sclerosis on the same day as vaccination with a second dose of mRNA-1273. She reports that her multiple sclerosis got worse after the vaccine.  Concomitant medications, labs and treatment details were not reported. The outcome of the event is unknown. The medical history of multiple sclerosis remains a strong confounder. The benefit risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 63 year old female, with relevant medical history of multiple sclerosis, who experienced the unexpected, serious (medically significant) AESI Multiple Sclerosis on the same day as vaccination with a second dose of mRNA-1273.  She reports that her multiple sclerosis got worse after the vaccine. Concomitant medications, labs and treatment details were not reported. The outcome of the event is unknown. The medical history of multiple sclerosis remains a strong confounder. The benefit risk relationship of mRNA-1273 is not affected by this report.
I was very tired and slept for 12.5 hours and really the only symptoms I had were coughing and sneezing and a little bit of a headache. My husband brought it home from a church conference. I was prescribed a Z-PAK.
Axillary gland is swelling; Achiness; Fever; Arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), SWELLING (Axillary gland is swelling), PAIN (Achiness) and PYREXIA (Fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Achiness) and PYREXIA (Fever). On 11-Feb-2021, the patient experienced SWELLING (Axillary gland is swelling). At the time of the report, PAIN IN EXTREMITY (Arm soreness), SWELLING (Axillary gland is swelling), PAIN (Achiness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, on 11-Feb-2021, the patient noticed that his axillary gland was swollen, and has progressively been swelling.  No corrective treatment was provided.
She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to yeast).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses). At the time of the report, HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given.  No treatment medication was given.   This case was linked to MOD-2021-386595 (Patient Link).
Dizzy after first injection for 12 hours.  Dizzy and throat tightness approx 1 hour after 2nd injection.  Took inhaler with relief.  Approx 1030pm stomach gurgling, abdominal pains , diarrhea started.   11pm fever 102 started and severe shaking chills.  Fever continued until 4/15 530am despite Motrin.  4/14 early morning hours noticed face bright red like a beet and swollen.  Throat tight and cough.  Took Benedryl and Pepcid every 4 hours along with Motrin.   My primary care had no appointments, tried urgent care and they referred me to ED.  I was so sick I couldn?t sit up and go to ED.  Watched pulse ox and vitals at home.   Got a telehealth appointment 4/16 today with my doctor.  Told to continue Benedryl every 4-6 hours until all symptoms are gone.  Continue with headache, weakness, dizziness, throat tightness on and off, lack of appetite  and mild abdominal pain today.  Lost 4-5 pounds since Tuesday.
No adverse event, this was a vaccine administration error as this person was 16 years old and vaccinated with Moderna.
pt recv vax 22AUG96 & 7OCT96 pt antibody test was negative less than 0.7;
Breakthrough COVID infection. Symptoms of dyspnea, productive cough, and palpitations. Unsure of symptom onset. Positive swab collected 08/13/2022.