chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe sciatic pain; Unable to move; Felt like her sciatic nerve was inflamed; This spontaneous case was reported by a nurse and describes the occurrence of SCIATICA (Severe sciatic pain), HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed) 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.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SCIATICA (Severe sciatic pain), HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, SCIATICA (Severe sciatic pain) had not resolved and HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed) outcome was unknown. Not Provided      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.   concomitant medications were not provided.  Treatment for the event included  kept putting ice, cold compress, heat.
Prominent level 1 left auxiliary lymph nodes are identified.  Follow up 12 weeks There are six lymph nodes identified in the left axilla. Lymph node labeled #4 demonstrates uniform cortical thickening up to 3.5 mm, likely decreased since 12/09/2021 MRI. The remaining lymph nodes have thin cortices and preserved fatty hila. IMPRESSION: Left axillary lymph node labeled #3 is borderline enlarged and probably benign. The lymph node is likely decreased in size s/p Covid vaccine injection into the left arm. Recommend follow up ultrasound in 2 months at time of scheduled mammogram (May 2022). A unilateral ultrasound of the left breast is recommended in 2 months.  Ultra sound guided biopsy was performed  Reactive/hyperplastic lymph node. 4 months later still enlarged lymph nodes  *Also acquired shingles possibly from the 2nd vaccine given on 4/08/21 Still suffering residual effects from this as well
This spontaneous report as received from a healthcare worker who refers to unspecified group of patients of unknown age and gender. On an unknown date in 2014 (exact date was not reported), the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency and lot #: not provided) that were exposed to supported temperature excursions also reported as "temperatures of 10F for a cumulative time of 8 hours" in "May and August 2014". No adverse effect has been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a physician concerning a patient who in 2009 was vaccinated with PNEUMOVAX 23 (lot number not provided). Subsequently the patient had a severe pneumonia with a very high white blood cell count. The patient sought unspecified medical attention. At time of the report, the patient's outcome was unknown. Severe pneumonia with a very high white blood cell count was considered to be disabling. Additional information has been requested.
3rd dose given to a 18 weeks-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 18-week-old male patient who received Hepatitis B vaccine for prophylaxis.   On 10th September 2009, the patient received the 3rd dose of Hepatitis B vaccine. On 10th September 2009, unknown after receiving Hepatitis B vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional Information: GSK Receipt Date: 6-JAN-2023 Reporter's Comment: At the time of reporting, the patient age was 13 years old. The medical assistant reported that the patient received third dose of Hepatitis B vaccine when he was 18 weeks old. The reporter wished to know if the patient required a booster shot and if the third dose was valid. Very basic information was given by the reporter. The reporter had no information about the previous vaccines nor patient other than age and sex. The reporter did not consent to follow up. Additional Supportive Information: The patient received the third dose of Hepatitis B vaccine at 18 weeks, which led to inappropriate schedule of vaccine administered. Conservatively inappropriate schedule of vaccine administered event was captured as there was no information regarding previous vaccination.
Initial report received from a nurse in the USA on 17-OCT-2005. A patient (gender and age not reported) complained of a metallic taste after receiving the injection of Fluzone. Route, site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow-up information received on 24-MAR-2006 from a health care provider. The event onset was OCT-2005. Per the reporter, the patient had recovered from the event, and there is no additional information available. Additional information is not expected. Same reporter in case 2005-02132.
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, anatomical location, route of administration, lot # and expiry date were not provided), as prescribed and/or administered by the healthcare provider at physician's office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Aweful chest pains after 2nd covid shot shortness of breath and racing heart when even standing from a chair. Just not able to do anything like before these shots, I used to walk miles, clean the house enjoy life... Now I can't.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:11 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 55.87 for dose administered on 03-Apr-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Symptoms:Redness, swelling, numbness itching.  Started 1/14/21 at 4:00pm  Treatment: monitoring while taking Benadryl and ibuprofen.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via Other Manufacturer concerned a 63 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received first dose with covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 15-MAR-2021 for covid-19 prophylaxis.  On an unspecified date, the patient experienced COVID-19 virus test positive (dose number in series 1). The patient was recovering from COVID-19 virus test positive. The patient received second dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 3), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-NOV-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use. Age at time of vaccination 63 years old.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220838534.
Started to have back and went to the doctor got a ultrasound on stomach Monday June 21st. Tuesday got a call saying he needed to be seen by specialty. He had a 6cm aorta in his stomach. They went to see the doctor that morning and he is going to have surgery so it doesn't bust but first he needs to get a CT scan to see what the damage is. Surgery will be done next week after the CT scan is done.
This spontaneous report has been received from a registered nurse and referred to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (strength, dose, and frequency were not reported; lot number M007125 with an expiration date 06-OCT-2017) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011313: US-009507513-1705USA015159: US-009507513-1705USA015157:
I was diagnosed with acute bronchitis and probable pneumonia on Monday, November 7. I do not believe this illness is related to my COVID booster. However, I received a call that asked me to complete this form.
Swollen and itchy fingers, achiness, chills, profuse sweating, headache, sore at shot sites, vomiting, drowsiness, collapsed, unable to walk.
PATIENT PRESENTED TO OUR CLINIC WITH A LETTER STATING HE NEEDED VARICELLA.  VACCINE WAS GIVEN AND THEN ADMINISTRATOR FOUND DOCUMENTATION OF PATIENT RECEIVING SECOND VARICELLA ON 4/3/09.  PATIENT HAD NO ADVERSE REACTIONS FROM VACCINE.
Upper left arm black/ blue sore 5 days.. Lymph Nodes very swollen left under arm very sore.
Vaccine had an exp. date of 09/19/2021 and was given on 09/21/2021.
Pain/Arm was sore; Chills; Fatigue; Arm was uncomfortable; symptoms woke her up at night; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain (1st dose received on an unknown date and experienced pain, refere case US2020187890).   On 17th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, chills, fatigue, limb discomfort and sleep disturbance. The patient was treated with IBUPROFEN. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in extremity, chills, fatigue, limb discomfort and sleep disturbance were unknown.   It was unknown if the reporter considered the pain in extremity, chills, fatigue, limb discomfort and sleep disturbance to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced pain, chills and continue to feel fatigue. She stated that symptoms were worse also woke her at night. She took two ibuprofen to feel relief. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187890:same reporter, different dose
There was no actual adverse event reported, the immunization was administered during a recall of a lot number that had a shorted expiration date.  It was later stated by an agency that the vaccine was still safe to use, the patient did not need to repeat series, and we did not need to notify the patient....but we are submitting this for record purposes only.
The patient reports the development of a lump near the injection site about a week after receiving the vaccine. The lump continues 3 weeks after vaccination. She reports no burning, discoloration, or burning sensations. The patient reports unrelated blood work to have been done during this time which showed nothing abnormal. The patient plans to monitor and will mention it to her doctor at her wellness visit next week.
I felt immense pain in my arm and back, more than during the first two shots. (I did have painful reactions to the first two shots, but this was much worse.) My  lymph nodes in my right armpit, near my right collarbone, and on the right side of my neck were swollen. I felt extreme fatigue. Overall, I felt flu-like symptoms. Then, two days after the shot, I started to develop tightness in my lungs, a slight cough, and difficulty taking a deep breath. The flu like symptoms eased in the following days, but the new symptoms in my lungs got worse. Finally, four days after the shot, I coughed blood in the phlegm I had coughed up, so I went to urgent care. They were concerned about a potential blood clot in my lungs, so they sent me to ER. The ER doctor confirmed there was no blood clot through a CT scan, but I had elevated Troponin T levels, so they were concerned about my heart. My EKG and echocardiogram were clear, so the doctors don't think the vaccine affected my heart. The final diagnosis was pneumonia. The doctor thought that my body was run-down from the booster shot and susceptible to getting sick with pneumonia.
Heart attach and cardiac arrest, on a ventilator for a week, excruciating pain through out the body
2 days after the vaccine he started having a pretty intense headache up to 8/10 for about 2 weeks until a few days at which it started to improve and is now around a 2 on 10/15/2002. The headache was initially in the back of the head and down the neck, now is in the front of the head. Denies any other neurological symptoms, no blurry vision, no weakness, slurred speech, did have full body fatigue for 1 week post vaccine.
Pt inadvertently given the Pfizer 5-11 yo vaccine.  Should have received Pfizer 6m-4yr vaccine.  No treatment provided.  CDC website reviewed with mother, education provided "If the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be assessed on a case-by-case basis."
Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration in the left arm on 07Jan2021 at 15:45 (at the age of 51-years-old) as a single dose, for COVID-19 vaccination. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 10:00 PM, the patient experienced swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar. The events were reported as non-serious and continued 2 weeks after the first injection. The patient did not receive any treatment for the events. The clinical outcome of swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt recvd vax & p/wnd inject had rt leg pins & needles, paresthesias of  legs, earache & back pain was seen by MD; sx unresolved;