chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his 8 year old son who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 25-APR-2007 "three weeks ago" the patient developed a breakthrough of chicken pox. The reported referred to it as "mild". The patient sought unspecified medical attention. The patient recovered. There was no product quality complaint. Additional information has been requested.
Intermittent dizziness, headaches, muscle pains, abdominal pain, and nausea since administered injection.
Site: Pain at Injection Site-Mild, Additional Details: Patient came in stated she wanted a mennicoccal injection but meant Varicella
Arthralgia, Fever, NauseaVomiting, Chills, Fatigue, Rigors Narrative:
Slightly lightheaded immediate afterwards.  Fine with a few minutes.  Sunday woke up stuffed up, with cough and nausea.  Felt better.  Today, face is extremely red.  Cough is present.
Day following vaccine administration. pt woke up with "Flu like sx", states N/V, severe headache. Was transported to E.R for evaluation of sx.
10/24 Resident passed out while attending service on this date, taken to the hospital CT done and diagnosed with PE of bilateral upper lobes, and right mid lobe.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001001: US-009507513-2108USA001000:
On 2/14/2022, I received my second booster of Moderna for COVID-19. On 6/3/2022, I experienced a sciatica flare-up. I have had chronic sciatica for about 5 years now, but it didn't always flare up. Since 6/3/2022, I have had continuous sciatica pain, and this is the worst it has ever been. I saw my doctor on 6/7/2022, and he ordered an MRI procedure, which was done 7/1/2022. The MRI showed one protruding vertebral disk and two areas of stenosis in the lumbar spine. I received an epidural treatment on 6/21/2022, and it did not help at all.
PATIENT REPORTED TEMPERATURE  OVER 100 DEGREES CONSISTENTLY STARTING DAY AFTER SECOND DOSE SHOT (6/02/21). DID NOT LOSE TASTE/SMELL.  OCCASIONAL HEADACHES. BODY TIRED NEXT DAY AFTER 2ND SHOT. NO SYMPTOMS AT ALL FROM 1ST SHOT. NEVER TESTED POSITIVE FOR COVID.
Patient had a positive TB test the next day. A week later, eye blinking began - repetitive/continual. Doctor referred to allergist. Multiple tics that are somewhat seasonal have continued to occur. Tics are somewhat controlled by allergy medications currently.
PT STATED PT HAD WELPS TO FACE, SKIN ITCHING, AND REDNESS.
3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021; 3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Fell on left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell on left shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Borderline diabetes, Cholesterol high and Blood pressure high.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FALL (Fell on left shoulder) (seriousness criterion medically significant). At the time of the report, FALL (Fell on left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes medication for diabetes, cholesterol and blood pressure. Treatment medication includes ice packs, took Tylenol and put her left arm in a sling.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received a flu shot and covid shot in the same arm about 1 inch apart, at the patient's request. She stated today 2/3/22 she has been experiencing a lot of pain, discomfort in her left arm since the vaccination. She stated it is painful to the touch, swollen, difficult moving her arm without pain. She stated her arm is "messed up." She was seen by her physician who provided a pain killer and told her it is swollen inside.
Information has been received from a field representative on 21-JAN-2015 concerning his daughter, an 11 year old female patient with allergy to BACTRIM. The patient's pertinent medical history included sports injuries. Concomitant therapies included unspecified nasal steroids. The patient received her first dose of GARDASIL injection (strength, dose and lot# were not reported) in NOV-2014 (reported as "two months ago") and she fainted. After the patient received her second GARDASIL dosage on 20-JAN-2015, she complained of injection site pain, and later experienced shortness of breath, nausea and facial splotchiness. The representative called and discussed the patient's symptoms with her physician, and the physician said to give ibuprofen as treatment. Since it appeared that the patient had an allergy to GARDASIL, she would probably not receive the third and final dosage. No lab diagnostics studies were performed. At the time of reporting, the patient still felt some nausea. The outcome of other events was unknown. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of cardiac arrest in a 37-year-old male patient who received BOOSTRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. Concurrent medical conditions included HIV positive. In August 2018, the patient received BOOSTRIX and PNEUMOVAX. In August 2018, 10 hrs after receiving BOOSTRIX, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). In August 2018, the outcome of the cardiac arrest was fatal. The patient died in August 2018. The reported cause of death was cardiac arrest. The reporter considered the cardiac arrest to be unrelated to BOOSTRIX. Additional information was received as follows: The reporter said that the event occurred about a week before the reporting date. Ten hours after vaccination, the patient was brought to the hospital in full cardiac arrest and he died. The reporter did not think to call GlaxoSmithKline. He did not think that either vaccine caused the death of the patient. The reporter agreed to be followed up and said the best way to contact was via email. Reported Cause(s) of Death: Cardiac arrest.
Rash started as a small circle on left arm in am on 1/14 by 430 pm the rash was on both arms, stomach, chest, left foot and right leg 2 weeks after shot, went to urgent care prescribed prednisone and antihistamine.   Took medication for 9 days. Rash went away on arms, stomach, and chest in 2 days of starting  medication but it took almost 9 days before rash on foot and leg cleared up.
I have ringing in my ear  I had a bad pain in my head also  I had to go to the emergency room
mild, cold-like symptoms; 5 out of 368 employees who have tested positive with breakthrough COVID infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID infection) and NASOPHARYNGITIS (mild, cold-like symptoms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID infection). On an unknown date, the patient experienced NASOPHARYNGITIS (mild, cold-like symptoms). At the time of the report, COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID infection) and NASOPHARYNGITIS (mild, cold-like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-270623, MOD-2021-270620 (Patient Link).
Indentation at the injection site with a purple center, that is very sensitive to touch. Client has had and X-ray and CT scan of the right thigh, both were normal. Client is receiving physical therapy to help desensitizes the area.
Swelling and pain on right thigh, post injection. Had a fever X 2 days. Use warm compresses.
Pt presents to clinic after her vaccination last Thursday (1/20/22). Pt had positive COVID-19 one month prior to booster shot. For one week she has had fevers greater than 100 degrees F, muscle aches, body pains, chest pain and palpitations with skin infection surrounding injection site. She presented to the hospital 1/22/22 for chest pain and tightness where she was given an X-ray, EKG, and blood work, all returning negative. She was told vaccine injection site was too low and may not have been injected into muscle correctly. She was discharged on Clindamycin for local injection site infection.
Sever headach; Body hurts all over; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sever headach) and MYALGIA (Body hurts all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection.    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 HEADACHE (Sever headach) and MYALGIA (Body hurts all over). At the time of the report, HEADACHE (Sever headach) and MYALGIA (Body hurts all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. On an unknown date, Body temperature: 98.2 (normal) Temperature 98.2. Reportedly, this was patient's 3rd shot.
onset of yellow eyes & fever (103) was admitted to hosp x 1 day for lab work; dx NONE;
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was previously discharged on 1/11/21 on home hospice after two recent hospitalizations. Day leading up to death on 2/6/2021 included decline in status with refusing food and medications
Swelling at injection site. Size of 2 quarters. The swelling area is hot and painful when touched.
red, warm rash 4 by 3 inches on left humoral region; counseled to ice as needed and follow up with physician and pharmacy if worsens
75 yo patient developed itching following Pneumococcal PCV 13 (PREVNAR 13) 0.5ml IM in Right Deltoid. Manufacturer: Wyeth Lot # M13067 Exp: 04/2017. The site was swollen with redness and warm to the touch.
acute disseminated encephalomyelitis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) (seriousness criterion medically significant). At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy brain: revealed nonspecific meningoencephalitis.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Healthy patient presented with acute fever, confusion, and later progressive weakness after receiving the first dose of the mRNA-1273 (Moderna) severe acute respiratory syndrome coronavirus 2 vaccine. Considering the progressive deterioration of the patient, despite being on multiple immunosuppressive agents, a brain biopsy was obtained, which revealed nonspecific meningoencephalitis.  In this case, author highlighted the need for a regulatory framework to assist clinicians and patients with coverage of treatment for acute disseminated encephalomyelitis. The use of intravenous immunoglobulin in conjunction with glucocorticoids seems to be an effective treatment option.  Company Comment: This is a literature non-study case concerning a 69-year-old or 52 year old (the information is discrepant in the source document) male patient with no reported medical history, who experienced the serious (medically significant) unexpected event acute disseminated encephalomyelitis.  The event occurred after receiving the first dose of mRNA-1273 vaccine (vaccination and event dates were not reported). The patient presented with acute fever, confusion, and later progressive weakness after receiving the first dose of the mRNA-1273 (Moderna) severe acute respiratory syndrome coronavirus 2 vaccine. Considering the progressive deterioration of the patient, despite being on multiple immunosuppressive agents, a brain biopsy was obtained, which revealed nonspecific meningoencephalitis.  Relevant diagnostic tests included Biopsy of brain that revealed nonspecific meningoencephalitis. No concomitant and treatment medication were reported for the event. At the time of the report, the event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Presented to hospital w/ 2 day history of diarrhea and worsening weakness. AKI and elevated trop on admission. Covid positive on admission. Covid-19 infection  diarrhea predominant w/o acute respiratory failure, hypoxic on pneumonia
Mother describes patient experiencing facial swelling the following morning. She was seen in the urgent care center. Pt did not have any issues with her airway. No treatment was provided.
Patient had numbness and tingling in the right arm, fingers didn't work, tingliness lasted for 6 hours.
Dramatic drop in %SpO2: from a range of 94 - 97, to 88 - 89, with occasional drops to 87. I checked it because I found, even on waking, that I needed to make an effort to breathe more deeply - which did make enough of a difference. In a setting where it would have been available, I am sure I would have received O2. I also had a fever of up to 101.3, and felt "rotten", but not dire. In 2017, I had some sort of incident - I was traveling at the time, and it was never "determined"  - that may have been a "scatter" pulmonary embolism - where the clot breaks apart before distributing into the lung. Initially, I did have quite low %SpO2 readings, but over the years that has improved. But these readings were even lower than I had ever seen. I have two oximeters, to, um, verify each other, so I am reasonably confident of their readings. I have a background in physics so I have some experience with instrumentation.  This situation continued for perhaps 6 hours, then the fever slowly went down and the %SpO2 increased to 90 ? 91, which was ?manageable?, then slowly higher. It is still lower than it had been, but feels normal enough.    Since this dramatic drop in %SpO2 seemed a part of COVID-19 symptoms, I thought this might be significant, and that is why I am reporting it.
Pregnant; This case was received via an unknown source (no reference has been entered for a health authority) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 004M20A) for COVID-19 vaccination.     Patient medication history was not provided by the reporter.  Concomitant products included PRENATAL + DHA for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: ultrasound done two times as a part of pregnancy..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A report has been received from Health Professional concerning a 32 year old, Male subject, who had been receiving Nasal FLUMIST quadrivalent, 2 doses. FLUMIST quadrivalent started on 17-Sep-2013. It was reported that the patient was administered two full doses of FLUMIST quadrivalent, one in each nostril on 17-Sep-2013. The outcome of the event of two full doses of FLUMIST quadrivalent, one in each nostril is unknown. the report was considered to be non-serious.
Low grade fever on 2.24.21, severe pain in the left skin dermatome under the left nipple, redness size of 3x2 inches with several small blisters under the left nipple, area is very sensitive to touch by clothing Tramadol 3 times a day The redness is not getting larger, but the pain is not abating
Information has been received from a health professional concerning a female, who on 06Aug96 was vaccinated with a dose of varicella virus live (lot 617001/0246D). Subsequently the pt experienced chickenpox. The pt's sister also experienced chickenpox following vaccination with varicella virus vaccine live (WAES0602USA05492). Additional information has been requested.
Swelling at injection site  pain at injection site  Fever  Chills Nausea Trouble sleeping Muscle aches  Fatigue  Headache
The patient described shortness of breath and a feeling of not getting enough oxygen starting 9 hours after the vaccination.  He states this  occurred when he tried to lie down on his side.  He states he woke up the next morning feeling exhausted.  He also stated that his heart was "pounding" all night long, however he stated when he checked his pulse it was normal.   He states that his symptoms resolved after 4 days, and has no issues now.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced shingles in December 2017). Concurrent medical conditions included sulfonamide allergy. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th March 2018, 2 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, rash and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash and pain in arm were recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, rash and pain in arm to be probably related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The patient's concomitant medications included blood pressure medicine and thyroid medicine. At 16:00 hours, the patient received SHINGRIX in left deltoid. The patient developed a swelling, rash and pain around the injection site, which radiated to the whole arm.