chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) for prophylaxis which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 56 year old female patient. On 20-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complaint) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
Severe redness, swelling, heat in entire upper arm.  Soreness and immobility in same arm.  Headache, fever of 102 degrees lasting for 2 days.  Body aches lasting 2 days.
Patient received SHINGRIX vaccine 5/21/18 and broke out in rash on full torso, chest, neck, arms on 5/22/18.
Patient received Novavax vaccine around 11:05am. He was waiting in the waiting area for 15 minutes when about 5 minutes into receiving the vaccine his eyes became glossy. His wife alerted us to his condition. I went out to investigate and noticed that his eyes were glossy. I asked him a couple of questions and he did not respond. I called 911 and the paramedics were dispatched. He then became sweaty all over. The paramedics arrived and checked out his vitals. He was alert when they arrived and his blood pressure was low. All other vitals were ok. The paramedics left. We filled out an incident report and the patient left on his own accord with his wife.
got sweaty, pale and felt faint immediately following injection of her Moderna COVID-19 vaccination, which required additional monitoring.   Prior to the injection- patient reported an allergy to lidocaine and when writer inquired about the reaction- she reported getting sweaty and feeling faint when she received a local injection.
We believe patient contracted chicken pox from her sister, who was recently vaccinated with the live vaccine.  Patient has previously been vaccinated, and no one else in her school or that we know has chicken pox.  She has suffered a mild rash on her scalp and trunk, consistent with a child who was previously vaccinated.  We are reporting this because of the low incidence of reports of contracting illness following the live chicken pox vaccine.
Got a pretty strong nose bleed from both nostrils; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 16:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 24Apr2021 at 22:30 (also reported as 22:00), 30 hours after the injection, the patient got a pretty strong nose bleed from both nostrils. And then again 47 hours after injection. The event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measure was not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pretty strong nose bleed from both nostrils was unknown at the time of this vaccination.  No follow-up attempts are needed. No further information is expected.
Vomiting and itchy throat progressing to an anaphylatic reaction that required 6 epi pens and 2 hours of albuterol eventually requiring intubation
Chest is very sore and painful; Cant lift things with left arm; Left breast is very sore and painful; Lymph nodes underneath left arm is very sore and painful; Very sore and painful radiating down my left arm; After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful) and PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (History of breast cancer.) and Surgical procedure (History of breast cancer surgery.). Concurrent medical conditions included Dyspepsia and Cholesterol. Concomitant products included LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, OMEPRAZOLE for Digestion impaired, VITAMIN D3, CALCIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm). The patient was treated with IBUPROFEN at a dose of 800 mg and HYDROCORTISONE ACETATE (HYDROCORTISONE ACE) at a dose of 250 mg. At the time of the report, CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
on day 2 patient felt chills, body aches, headache, and lymph node swelling under left armpit that grew to about 1/3 size of tennis ball . The patient stated the lymph node swelling went down/resolved within a few days following .  She reports having similar lymph node swelling such as this in  the past .
flu lowered resistance as shingles shot was wearing off; flu lowered resistance as shingles shot was wearing off; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza and immune system disorder. On an unknown date, the outcome of the influenza and immune system disorder were unknown.   It was unknown if the reporter considered the influenza and immune system disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-Aug-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient stated that the flu lowered patient's resistance just as his/her shingles shot was wearing off. As it was reported that no one told patient needed another shot in 5 years, so patient felt very lucky to experience no pain. Additional Supportive Information: Follow-up would not possible as no contact details were available.
I developed shingles 20 days after I received the first Pfizer shot. It began on April 15 as a few spots on my mid back which looked like pimples. The next day the rash had spread and I thought I had gotten bit by a spider. The following day the rash was inflamed and the pain was excruciating. The next day I was diagnosed with shingles.
No adverse event; Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022) and NO ADVERSE EVENT (No adverse event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022).    Concomitant medication details not reported by the reporter. Vial size was unknown. NDC number reported as 80777027399. HCP was not sure that the vial was initially stored in the refrigerator. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731749 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731749:Same Reporter
Dizziness, Headache, NauseaVomiting, Red/swollen below injection site x 12 days. No vomitting 1/4/21 Went to employee health. No treatment-will follow up w/PCP
MOM CALLED HEALTH DEPARTMENT AND LEFT MESSAGE FOR RETURN PHONE CALL ON 9-6-18.  RETURNED PHONE CALL AND SPOKE TO MOM. MOM STATES CHILD RECEIVED GARDASIL 9 VACCINE ON 8-24-18 AND BEGAN HAVING HIVES AND ITHCING ALL OVER ON 8-31-18. MOM STATES SHE HAS GIVEN CHILD BENADRYL AND CLARITIN AND THAT THIS DID HELP. INSTRUCTED MOM OF IMPORTANCE OF FOLLOWING UP WITH CHILD'S REGULAR MD, DR. MOM TO TAKE TEEN TO NEAREST EMERGENCY ROOM IF SHE DEVELOPS ANY SIGNS AND SYMPTOMS OF DISTRESS.
3-11-21 4:35PM HAD PFIZER AS FIRST DOSE ON 2-18-21. GOT MODERNA AS SECOND DOSE TODAY. EXPLAINED THAT THERE IS NO NEED TO REVACCINATE.  PT VERY ANXIOUS ABOUT IT - COMFORT GIVEN. A/O, W/D, RESP REG WITH EASE. 3-12-21 10AM STATES SHE IS DOING OK - NO ADVERSE REACTIONS'.
Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71673) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL).    No concomitant medication was reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient has received a primary series and one previous booster of the Moderna COVID-19 vaccines. No treatment medication was reported.
got an extremely sore arm after; runny nose; sneezing a lot; blood shot line through it.  She also experienced 2 dots on her right eyelid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her Pfizer Covid-19 vaccine at on Saturday. On an unspecified date, the patient experienced extremely sore arm after. She was told she would experience that. She also experienced a runny nose and was sneezing a lot. On Sunday, she woke up with the white part of her right eye with a blood shot line through it. She also experienced 2 dots on her right eyelid. This morning when she woke up there was a third dot on the right eyelid. Outcome of the events were unknown.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
It's the day after I got the vaccine and I've had ringing in my ears and brain zaps throughout the day. I thought that was worth reporting. Also more standard/expected ones: fatigue, stiff/painful upper arm, stiff neck. I've been drinking lots of water and sleeping.
DIABETES; HYPERTENSION; DIGESTIVE ISSUES; UNSURE" WHAT "EVERY 8  WEEKS" MEANS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, weight and ethnicity were not reported. The patient's concurrent conditions included ulcerative colitis. The patient received combination product Ustekinumab (solution for injection in pre-filled syringe, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 8 weeks, on an unspecified date in 2021 for Ulcerative colitis. Product constituent parts included. It was reported that his last dose of product was on 01-JAN-2021 and next schedule dose was 01-APR-2021. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose not reported, on an unspecified date in 2021 for prophylactic vaccination.  The patient was treated with Ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for an unspecified indication; and Ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the reporter called and stated that they are unsure what "every 8 weeks" meant from the package insert, they were concerned about dosing as February was short month, when to take the next dose and how to consider therapy start date. Later the reporter stated that the patient already having digestive issues, and recently diagnosed with Diabetes and Hypertension by their HCP. The action taken with COVID-19 VACCINE AD26.COV2.S, and Ustekinumab was not applicable. The outcome of the diabetes, digestive issues, hypertension and unsure what "every 8 weeks" means was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210401999-Ustekinumab-Diabetes. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. 20210401999-COVID-19 VACCINE AD26.COV2.S-Diabetes. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No additional AEs were reported.; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-OCT-2023, the patient received a improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #x019553, expiration date: 19-JAN-2025) administered for prophylaxis (strength, and route of administration were not provided) (Improper storage of product in use). The administered dose of the vaccine was stored at a temperature of -9.2 degrees Celsius (C), for a time frame of 1 hour and 7 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of GARDASIL 9 lot # M028323 expiration date: 26-SEP-2018. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (53.4F) for 54 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009211: US-009507513-1707USA009212.
has been suffering from migraines all his life. Since being vaccinated and boosted his migraines have stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "suffering from migraines all his life" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "has been suffering from migraines all his life. Since being vaccinated and boosted his migraines have stopped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hard time eating  OR drinking something that she can withstand; Everything tastes like rot; Everything smells like rot; Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), TASTE DISORDER (Everything tastes like rot), PAROSMIA (Everything smells like rot) and FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced DYSGEUSIA (Metallic taste). On 29-Oct-2021, the patient experienced TASTE DISORDER (Everything tastes like rot) and PAROSMIA (Everything smells like rot). On an unknown date, the patient experienced FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand). At the time of the report, DYSGEUSIA (Metallic taste), TASTE DISORDER (Everything tastes like rot), PAROSMIA (Everything smells like rot) and FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she called her doctor and she said that she doesn't deal with Moderna vaccine" also mentioned that pharmacy was also not able to help her. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD21-161833 (Patient Link).
After 48 hours site became red, hot to touch, hard, and painful. Size of redness increased by 72 hours to 8cm x 6.5cm.  CBC ordered.  Ibuprofen 800mg every 6 hours/cold packs as needed.
Pt's husband said she experienced some muscle pain, fever, headache, dizziness. Her husband said she couldn't get up the whole day.
got sick every year; Initial information regarding an unsolicited valid non-serious social media case received from consumer (patient) on 29-Nov-2020.  This case involved patient with unknown demographics who got sick (illness) when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency) after the administration of INFLUENZA VACCINE, the patient got sick every year (illness) and for the last 4 years.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; This is a spontaneous report from a contactable other healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Dec2020 16:45 (Batch/Lot Number: EH 9899) as DOSE 1, SINGLE for covid-19 immunisation. Also received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 06Jan2021 16:45 (Batch/Lot Number: EH 9899) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced dry spots started to appear on her skin ,which looks like eczema.and it continue to appear randomly as mass on 03Feb2021 with outcome of not recovered.  No follow-up attempts are required. No further information is expected.