chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of child was fussy has been received from a health professional concerning a 35-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST on 14-Sep-2010. On 14-Sep-2010 at 4:00 AM the patient woke up and was fussy. The patient did not have a fever or any other symptoms and did not require medical attention. The event was ongoing.
1 Welt/hive (redness, hot, itching, some raised area in center). Mild scratchy throat but unable to tell if from thirst from 45 min drive with no fluids or from vaccine. Observed for 30 min instead of standard 15.  Given bottled water to drink.  Released to work. Symptoms lasted about an hour from vaccination.
booster dose of 0.25 mL, instead of the 0.5 mL third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose). On 17-Dec-2021, ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is immunocompromised and needs the third dose. Concomitant medication was not provided. Treatment information was not provided.
Patient informed me at the time of the second dose that starting around 4 weeks after his primary vaccination with Shingrix he began to have a rash on both arms that spread to both hands. Was given Ketoconazole from his primary's office 6/26/23, a Prednisone taper 6/27/23, went to the ER and given another Prednisone taper 8/16/23, back to his primary care provider 8/18 and given more Prednisone. Cetirizine and Triamcinolone added 8/28/23 from primary care.
After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.; After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "type 1 Diabetic" (unspecified if ongoing), notes: ?More than 25 years??. The patient's concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), LABORATORY TEST INTERFERENCE (non-serious), outcome "recovered" and all described as "After receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-.".  Additional Information: It was reported that, the patient experienced after receiving shot #2 of the vaccine patients fast acting insulin (humalog) effective time was significantly increased from time of administration formerly 30 minutes went to 6 hours+/-. This persisted for approximately 6 months following the vaccine administration then subsequently returned to normal levels. This was not noticed following the first administration of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chills, sweats, fever like symptoms with headache and muscle fatigue starting at 2:30am at night and lasting all night. Symptoms became mild for the next 24 hours but lasted till next morning in a more mild fashion.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As a nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 10-Sep-2016 at a temperature of 8 degree Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Client received 2nd A vaccine at 9:35a.m. No complaints made. 9:40 a.m. during conversation about the H1N1 vaccine client suddenly fell forward from the chair and curled up in a stiff fetal position. He opened his eyes within a 15 second period and asked: Quote "was I sleeping? Did I bite my tongue? I am ok." This happened before. He showed scars on his face and head to prove. Refused 911 call. B/P 106/65. P86. Resp. 20. He left after sitting awhile stating he was ok.  10/06/09 9:35 Client in clinic to receive a vaccine.  No complaints made. VIS given and explained H1Ni pamphlet given and discussed 2nd A vaccine given IM Lt Deltoid.  9:40 Discussion about the H1N1 vaccine was in progress when the client just suddenly shook and started bending forward & falling off the chair.  I tried to prevent him hitting his head by tugging & pulling on his shirt (he is very "tall Big person). He went down on the floor and was curled up in a stiff fetal position. He opened his eyes with 15 seconds and asked "quote" What happened was I sleeping? Did I bite my tongue, is it bleeding? This has happened before. I am ok" On examination client's skin was very clammy his tongue (at the end) was bitten and there a slight bruise in the top of his right ear. Client again said that this episode has happened before. He shows a scar on his face just above and between his eyes and one on his head sustained from this type of episode. Blood pressure was 106/65, pulse rate 86 and resp 20 shortly after the episode. He sat for a while and conversed then he said he was OK and left. he said he had not eaten, so he was encouraged to stop and have something to eat. Twice I tried to contact him by phone but no answer. Message left for him to return call. 10-07-09 Client returned call stating that he was ok and thanks for the concern.
Sore Throat, Headache, Fever, Body Aches & Pains, Dizziness, Nausea.  Treated symptoms with OTC Flu medications.  Symptoms lasted for 2 days.
A few hours after receiving the vaccine my heart started racing. Normally I could get it down by either walking around, coughing, or taking deep breaths. When I saw that wasn't working I took a beta blocker called Metoprolol Tartrate 25mg tablet. That still didn't work so I set up a video appointment with a doctor. It was going over 1 hour that my heart was racing so she told me to go to the ER. When I went to the ER they moved me to a room to try a procedure to stop my heart from racing. They got me something to blow into then they pulled my legs up to try and get blood up to my heart. That wasn't working so then they administered an adenosine injection through IV. When they checked my heart I didn't have irregular heart beats. My heart rate was between 159 and 169 BPM but it was regular. I followed up with a cardiologist on April 11, 2022. The doctor advised to continue taking the same course of beta blockers. They said if my heart starts racing more frequently then I have other procedures that can be done. Right now we will just be monitoring my heart while I'm taking the beta blockers.
Patient reported fever (102 degrees), headache, body ache, sweaty, cold approximately 8 hours after injection symptoms resolved but now complains of rash/soreness at injection site. Site appears erythematous.
Client c/o feverish feeling, chills, body aches and (R) axilla swelling the size of a tennis ball 24 hours past receiving influenza IIV4 shot. States the feelings of fever, body aches and chills resolved in 48 hours. The (R) arm axilla swelling. Resolved in 7 days. Client called her doctor, and he recommended TYLENOL PRN and warm compress.
Swelling at the inject site, it is approximately the size of a golf ball. Very Sore, had some burning sensations the first night. It is still swollen and sore.
injection site hot to the touch; injection site swelling; injection site itching profusely; Heartburn; sore; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), PAIN (sore), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DYSPEPSIA (Heartburn) and PAIN (sore). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely). At the time of the report, DYSPEPSIA (Heartburn), PAIN (sore), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  Treatment for the event included Tylenol (paracetamol).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hard time sleeping; Didnt feel good; Feeling sick; Arm started hurting, right arm also started hurting; Feeling very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting) and FATIGUE (Feeling very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A 028L20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, FOLIC ACID, VITAMIN B12 NOS, POTASSIUM, ELDERBERRY [SAMBUCUS NIGRA], GARLIC [ALLIUM SATIVUM], TURMERIC [CURCUMA LONGA RHIZOME], CALCIUM, MAGNESIUM, LACTULOSE and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), HEADACHE (Headache) and CHILLS (Chills). 20-Mar-2021, the patient experienced FATIGUE (Feeling very tired). The patient was treated with TRAMADOL at an unspecified dose and frequency and Manual therapy (cold packs on arm) for Pain in extremity. At the time of the report, INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), FATIGUE (Feeling very tired), HEADACHE (Headache) and CHILLS (Chills) was resolving.            This case was linked to US-MODERNATX, INC.-MOD-2021-054246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054246:patient link, 1st dose case
I was having some upper respiratory issues and slight chills and body aches. I went to urgent care the next day and they tested me for COVID-19, Influenza A and B, and SARS and the Influenza A came back positive. I was given TAMIFLU and was on that for five days which helped after a couple days.
This is a spontaneous report from a contactable physician. A 18-year-old female patient received TRUMENBA (lot # J29203, Exp date JUN2016 NDC# 100000008535) via an unspecified route of administration in left deltoid, on 01JUL2015 at 11:00 AM. The patient had no significant medical history. Concomitant medications included ORTHO TRI-CYCLEN, oral at 35 ug daily. The patient experienced fever of 100.1, vomiting and significant redness at injection site on 02JUL2015. Fever of 100.1 and vomiting recovered on 03JUL2015, outcome of significant redness at injection site was unknown.
At 10am on 11/21, she came to the pharmacy showing a 6 inch red rash at the injection site. She had a fever, dizziness and muscle pain. She went to the ER.
Patient experiences blurred vision, hot, dizziness at the observation area after the vaccination.  Her pupils were dilated and her lip was pale.  She felt better after zip of water and felt normal after few minutes.
No additional AE; VARIVAX has since been administered to one patient. Excursion occurred overnight on 24OCT2023; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, historical drugs, and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 24-OCT-2023, overnight, a varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W021741 was verified to be valid, expiration date reported and confirmed as 10-JUL-2024), suffered a temperature excursion of 14 degree Fahrenheit (F) to 46 F (17.8F), during a time frame of 11 hours 18 minutes 0 seconds; it did not had previous temperature excursions. On 25-OCT-2023, after the reporter was provided stability information for the product (as reported), the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W021741, expiration date 10-JUL-2024) (exact dose, route of administration, and anatomical location were not provided) (Product storage error).   No additional adverse event (AE) was reported.
Information has been received from a nurse, via a company representative, concerning a 13 year old female patient who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, IM of HPV. The nurse reported that the patient had developed vaginal bleeding that had "varied from light to heavy and has been continuous since the date of administration." The nurse reported that the patient had been referred to an OBGYN for further evaluation. At the time of this report, the patient had not recovered. Additional information has been requested.
Tachycardia, shortness of breath, chest pain, dizziness, weakness.  Reported to ED at 9:20 pm, temp 100F, pulse=120, RR=20, BP=140/89, pulse ox=98%.  Patient off work until 10/14/13.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No adverse events reported. No temperature excursion of the product was reported. The vial was first was placed in refrigerator on 4-Nov-2021. No treatment medications were reported.
Pain in the shoulders; Eyes are swollen; Headaches; Cannot open eyes in the morning; Blurry eyes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Laser therapy.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes). At the time of the report, ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079251 (E2B Linked Report).   Reporter did not allow further contact
There is muscle pain going into my lymph nodes and breast tissue; There is muscle pain going into my lymph nodes and breast tissue; There is muscle pain going into my lymph nodes and breast tissue; This is a spontaneous report from a contactable consumer, the patient A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 11Jun2021 at 15:30(at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, penicillin allergy, and COVID-19. Concomitant medication was not reported. The patient previously received meningococcal vaccine (MANUFACTURER UNKNOWN) on 28May2021 for immunisation within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Jun2021 at 23:45 the patient experienced muscle pain going into her lymph nodes and breast tissue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event muscle pain going into lymph nodes and breast tissue was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient developed right sided facial weakness within one week that progressed to bifacial weakness (greater on L than R), numbness in hands and feet, and severe weakness in lower extremities (2/5 proximal muscle weakness).  Symptoms were consistent with Acute Inflammatory Demyelinating Polyradiculoneuropathy.
Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes; No adverse event; possible temperature excursion, patients received this vaccine; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (possible temperature excursion, patients received this vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Due to freezer issue on March 8th,2023, possible TE, lowest Temperature -22.2 C, High -13.6 C, for over 10 minutes).    No concomitant drug was reported. It was reported that bivalent, due to freezer issue on 08-Mar-2023, possible temperature excursion, lowest Temperature -22.2 degree Celsius, High -13.6 degree Celsius, for over 10 minutes. Two patients received that vaccine. The patient received first bivalent dose. No reactions reported. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717480:Same reporter, mother case
Pt. received 2 Anthrax shots while approx. 1 month along in her pregnancy.She is due 3/31/00.