chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Tenderness in arm; Whole body hurting; This is a spontaneous report from a contactable consumer (mother) reported for a 14-year-old male patient. A 14-year-old male patient received unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on 12Sep2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient mother was looking on the website at the symptoms that could occur. Patient age at the onset of events was 14-year-old. She stated that he does have chills. She saw tenderness in the arm as a side effect, which he does have. However, also, his whole body was hurting. She wants to know if that was normal. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Narrative: Issue Title: Frozen Influenza Vaccine Date of Report: October 14, 2022. (October 26, 2022) Brief Statement of Issue and Status: On October 13, 2022, At the completion of the vaccination clinic conducted throughout the day of October 13, the pharmacy Chief, who received the remaining flu vaccines noticed that some (39) of the vaccines were frozen and / or partially frozen. The pharmacy Chief questioned the nurse who returned the vaccine and nurse verified that yes throughout the day it was noticed that some of the vaccines were frozen or partially frozen. The pharmacy Chief confirmed  that per the manufacturers recommendation the flu vaccine is to be discarded if frozen. Actions, Progress and Resolution Date: On, October 14, 2022, at 10:00 the Flu Workgroup along with Risk management, to include VISN and National Risk Management met to discuss the event. During the meeting it was found that approximately 182 patients who received flu vaccinations on 10/12/2022 and 10/13/2022 may have received either a previously frozen or partially frozen flu vaccine. The Assistant Chief of Pharmacy contacted the manufacture (Seqiris) of the flu vaccine, who confirmed that if the flu vaccine becomes frozen it should be discarded. The flu workgroup has rectified the system issues of how and why the flu vaccines became frozen and have taken preventative measures to ensure this does not occur again on campus or at any of our facilities. A Root Cause Analysis (RCA) will be chartered to review system issues. A Safety Forum will be conducted related to this event. This will potentially lead to a large-scale disclosure. October 26, 2022 - Update: This incident was reviewed by the Facility Central Office Clinical Episode Review Team (CERT) on October 14, 2022, which determined that large-scale disclosure is not indicated at this time. As such, all 182 patients (now confirmed) will be called to perform clinical disclosure, discussing the concerns of the efficacy of the vaccination, risk/benefits, and recommendations for additional vaccination. Patients unable to be reached after three call attempts will receive a certified letter for disclosure. The clinical disclosure will be documented within records. The Root Cause Analysis found the cause to be vaccines lying directly on the ice packs inside the cooler. This has not been corrected by placing bubble wrap between the vaccine and the ice pack to prevent the vaccine from freezing. A temperature log has been developed to ensure the coolers remain within the appropriate range.
Booster Dose; the booster dose he received had undergone a temperature excursion; the booster dose he received had undergone a temperature excursion; fever 102.6; so sick; general aching; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1: Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2: Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster Dose"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "the booster dose he received had undergone a temperature excursion"; PYREXIA (non-serious), outcome "recovered", described as "fever 102.6"; ILLNESS (non-serious), outcome "recovered", described as "so sick"; PAIN (non-serious), outcome "recovered", described as "general aching". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller's husband received booster dose and had fever the next day of 102.6F, didn't want to drink, caller states she had never seen him so sick. Caller states that a month later called to notify husband that the booster dose he received had undergone a temperature excursion, but no details of the temperature excursion were given to the patient. Caller was seeking guidance on whether husband's booster dose was valid or whether he should have antibody titers drawn to determine need for additional booster dose. The reporter calling on behalf of her husband who mentioned when her husband got the Booster Dose of the Pfizer BioNTech Covid 19 Vaccine, he was administered an expired dose and she also mentioned he had bad reactions after getting that dose. Caller clarifies that vaccine was not expired, their fridge was working off and on and it was discovered a few days after 28Oct2021. Caller states they got this information last month. Caller states the temperature was not in the right range. Caller states at this point, they don't know how long it was out of range. Caller states the patient had a fever of 102.6 and he was very sick. Caller states she never saw him for 40 years getting sick with any shot. Caller states he also had general aching. Caller states he has gotten better and recovered. Caller states she doesn't know if he has to get the booster shot again. Caller states she feels left in the dark and she has been trying to search online about Pfizer and Moderna vaccines that were kept at the wrong temperatures in the fridge but can't find anything. Treatment information was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of "rash all over her body" has been received from a consumer concerning a 24-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal on 28-Oct-2009. On the morning of 29-Oct-2009, the patient had developed a rash all over her body. The consumer was taking her daughter to the physician. The reporter stated the rash had not resolved.
OVER ALL BODY WEAKNESS, MUSCEL WEAKNESS, IMBALANCE WHILE STANDING, SWEATING LOT , BUT NO FEVER, WEEKNESS STARTED AT FEET AND TRAVELED TO HIP,NOT SLEEP 24/7,UNCONTROLLED DIABETES SINCE THEN
swollen lymph nodes on right breast; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes on right breast) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 032M204) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on right breast). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes on right breast) outcome was unknown. Not Provided          This case was linked to MOD-2021-048471 (E2B Linked Report).; Sender's Comments:  MOD-2021-048471:1st dose
The patient received improperly stored vaccine at an unspecified date; This spontaneous information has been received from a physician regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin(PROQUAD) injection for prophylaxis, (lot number S003865 with expiration date in 08-AUG-2020) (route of administration, strength and anatomical location were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at a temperature of 32.5 degrees Fahrenheit (°F) for the time frame of 8 hours. There was no previous temperature excursion and the call was because of a data logger.
My daughter had the FLUMIST on last Wed 9/23/08 at 4:30 pm about 2 hours later she started complaining of aching and headache. Got up on Thursday 9/24/08 morning and called doctors office they told me to bring was diagnosed with a sinus infection. The symptoms got worse called doctor back she called her in TYLENOL 3 and it barely took the headaches and aching away. Friday 9/25/08 she cried for hours she was hurting so had she then had a stomach plus all other symptoms and she felt like she had to throw up she was hot then cold so we took her to the emergency room and the doctor there diagnosed her with having adverse side effects from the FLUMIST. He put her on LORTAB and ZOFRAN. Saturday 9/2/608 she was still hurting stomach and headache. The LORTAB just numbed the pain but did not make it go away. Took her back to the emergency room on Saturday 9/27/08 this time to a different hospital. They ran blood work did a contrast MRI of her head all the way to her abdomen and everything came back normal. He said it must be some adverse reactions to the FLUMIST. He advised to let you know and see if you had any suggestions for the relieve of symptoms and see if you have had other cases. Please let me know. I am desperate. Thanks. 10/27/08-ED records received for DOS 9/26/08-left without being seen. ED visit 9/27/08-C/O headaches, stomach ache and aches all over began 45 minutes after Flumist. PCP diagnosed symptoms as allergic reaction to FLumist.
Mother reported that her son developed hives. She states he had them the next morning after receiving his immunizations. She states the hives come and go and he had a total of 4 at one time. The baby has no other symptoms.
Left ear decreased hearing acuity, loud shah sound (tinnitus). Had ENT testing but no treatment
Person under 18 years old got a Moderna Covid-19 Vaccine. Moderna is not approved for folks under 18 years of age.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 07-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Covid-19 infection, and wanted to receive the second dose of Shignrix; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19. The patient was treated with immunoglobulins nos (Immunoglobulin). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.   Additional details provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The pharmacist reported that the patient recently received an immunoglobulin as a therapy for Covid-19 infection. The patient wanted to receive the 2nd dose of Shignrix. No further information available. The reporter consented to follow up via email. Note: This case was conservatively considered valid as it was unknown if Shingrix 1st dose was administered before or after Covid-19 infection.
local rxn-rt deltoid red, edematous, warm to touch approx 50 by 30mm in diameter;
Vomiting, dizziness, diarrhea, blood sugars high.  Went into cardiac arrest January 23, 2021
Dizziness, HYPOtension,  blurred vision Narrative:  Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
No adverse outcomes or side effect were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 13-JUN-2023 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration was not provided) (product storage error and no adverse event). The product was stored at 10.8 degrees Fahrenheit (F) for 8 hours, 23 minutes and 0 seconds with a supported temperature excursion stability evaluation.
Abnormal bleeding from gums the same day of the vaccine and the day after the vaccine. Before that, had fever and chills. Stiffness on left side of the neck. (Vaccine was on left arm) Strange flavor in the mouth lasted two weeks. Still feel mouth irritated.
pt recv vax;devel a flu like syndrome which included a weak feeling w/ HA,dizziness & hot & cold feeling;took acetaminophen;exp aching,bones & tightness in chest,as with a chest cold;awoke following day feeling fine;
Patient developed an itchy maculovesicular rash, not thought to be an allergic reaction. Patient had eczema as a child. Also complained of neck pain and stiff neck. Attempts to gather more information were unsuccessful.
Presented to ED on 6/5/22 with COVID pneumonia and symptoms for 5 days.  At that time, he was saturating well on room air with normal effort.  Chest for-ray showed right middle lobe pneumonia and he was treated with doxycycline for CAP. Paxlovid was intended but unable to be used due to renal function.  Presented to ED on 6/15/22 81y.o. M with PMH of Chronic mesenteric ischemia, hypertension, CAD status post CABG, PAD with  SMA stenosis, chronic mesenteric ischemia status post iliac artery stent bilaterally, type 2 diabetes, CKD 3 and secondary hyperparathyroidism, normocytic anemia, and HLD who presents to the ED with complaint of shortness of breath.   Admitted with acute respiratory failure 2/2 Covid
Leukocytoclastic Vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    Concurrent medical conditions included Immune thrombocytopenic purpura (potential predisposing condition to the development of vasculitis following elasomeran administration).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) was resolving. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) to be related.    No concomitant and treatment information were reported.  The case of vasculitis in this patient, although diffuse in distribution, was self-resolving.  Patient was counseled of the potential risk of worsening reaction to the second dose of the vaccine and was instructed to proceed at their own risk. He elected to receive the second vaccination dose without any further reaction or side effects. Company comment: This literature case concerns an 80-year-old male patient, with medical history of Immune thrombocytopenic purpura, who experienced the serious (due to medically significant) AESI of cutaneous vasculitis (reported as Leukocytoclastic Vasculitis), after the first dose of mRNA-1273 vaccine. The date of vaccination and the onset of the event were not properly reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. Patient´s medical history of Immune thrombocytopenic purpura remains a potential predisposing condition to the development of vasculitis. The outcome of the event was reported as resolving. The reporter considered that cutaneous reactions should be noted as potential side effects of the vaccine The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature case concerns an 80-year-old male patient, with medical history of Immune thrombocytopenic purpura, who experienced the serious (due to medically significant) AESI of cutaneous vasculitis (reported as Leukocytoclastic Vasculitis), after the first dose of mRNA-1273 vaccine. The date of vaccination and the onset of the event were not properly reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. Patient´s medical history of Immune thrombocytopenic purpura remains a potential predisposing condition to the development of vasculitis. The outcome of the event was reported as resolving. The reporter considered that cutaneous reactions should be noted as potential side effects of the vaccine The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Patient was given Pediatric dose instead of Adult dose by Error.  Supervisor contacted Moderna Manufacture and recommendations were given by writing. If a half dose volume dose of vaccine is administered to a patient recommended for the full volume, another half volume dose can be administered on the same clinic day, and the 2 dose can count as 1 full dose. This even was also notified to Medical director. Patient was also notified and second dose was given same day.
Product was Expired; Initial Report Received on 16-Jun-2022  A medical assistant reported that 28-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. Allergies were unknown.  Concomitant medications at the time of vaccination were reported as unknown.  On 31-May-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 02-Feb-2022; serial # and NDC # unavailable) in the left deltoid. The patient did not experience any adverse effects and was not pregnant at the time of the injection.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
headache, sore throat, cough, fever-highest 101, chills, body aches, nasal congestion. starting 1/18/2022
Information has been received from a registered nurse concerning a patient who was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Subsequently the patient developed fever and diarrhea. It was reported that there was blood in the patient's stool two days after the first dose. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Upon internal review, the patient's bloody stool was considered to be an other important medical event (OMIC). Additional information has been requested.
The following day I had redness at the injection site about 2/12 inches long and wide with itching and minor swelling/bump. The day following also was tired achy and felt off/headache. On Thursday symptoms went away other than the arm and a slight headache. On Saturday the redness and I ring was gone, but I started having pain in my armpit and when I moved my arm in different positions. Hand was tingling with certain positions suggesting nerve pain. Lasted 2 to 3 days and got worse before better. Was mostly gone by Tuesday. Wednesday 8 days after injections the redness, itching, and swelling in my arm returned. Same size as the day after my injection. Called the doctor to see if I need to be concerned that the redness, itchyness, and swelling returned after completely going away 4 days earlier. Also feeling tired for the past 3 to 4 days but otherwise good. Some minor discomfort/pain in collar bone around and lump node in neck but is not consistent. Comes and goes. Not sure if the nerve pain in arm was related to the vaccine, but since the redness returned it may all be related.
Drug rash, hives.  Diffuse macular papular back, groin, arms, legs
vaccinated patients were not immune by HBsAB; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 2582 adult patients of unknown gender. The patients' concurrent conditions included chronic kidney disease (CKD). The patients' medical history and concomitant medications were not specified.  On unknown dates, the patients was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients' Hepatitis B surface antibody (HBsAB) titer was equal or less than 12 mIU/ml. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patients' experience.