chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna bivalent booster shots were stored beyond the storage condition/ vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator.; No adverse event; Patient received the Bivalent booster dose on 15Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna bivalent booster shots were stored beyond the storage condition/ vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator.), EXPIRED PRODUCT ADMINISTERED (Patient received the Bivalent booster dose on 15Feb2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Bivalent booster dose on 15Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent booster shots were stored beyond the storage condition/ vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna bivalent booster shots were stored beyond the storage condition/ vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator.), EXPIRED PRODUCT ADMINISTERED (Patient received the Bivalent booster dose on 15Feb2023) 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 PRODUCT STORAGE ERROR (Moderna bivalent booster shots were stored beyond the storage condition/ vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator.) and EXPIRED PRODUCT ADMINISTERED (Patient received the Bivalent booster dose on 15Feb2023).    Concomitant product information was not provided by the reporter.  Suspect dosage text was reported as Initial Booster. It was reported that the vaccine was stored 35 days in the refrigerator. The vaccine was not disposed after 30 days storage period in the refrigerator. No adverse events were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712238 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712238:patient administered on 15Feb2023
Devleoped fever of 106 in 24 hours, vomiting, body aches.
screaming, T105 x4 days, then variable temp elevations for over 1mon;prostrate sleep, photosensitivity, sound sensitivity, not moving around or smiling x several wk;4th day to ER-encephalitis,  residual problems,diarrhea, congestion;Annual follow-up dated 02/15/01 states the pt has a slight neurological deficits predicted to be lifelong.
Mouth pain with tingling and numbness in the tongue, neck pain, dizziness, low grade fever
Suicide attempt, behavioral health admission. This visit was within 6 weeks of receiving the COVID vaccine.
Tiredness; pain in joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: 3013513A) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "bipolar" (unspecified if ongoing), notes: Diagnosed 7 years ag. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0177, Expiration date: Unknown , Route of administration: Unknown), administration date: 18May2021, when the patient was 39-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE , Lot number: EW0196, Expiration date: Unknown , Route of administration: Unknown), administration date: 08Jun2021, when the patient was 39-year-old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in joints".  Additional information: Patient was tired for a while back. He was not happy enough walking and going to the beach. It was first the tiredness and then came the joint pain. Patient's joint pain started almost a year ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401449 same reporter/product, different patient/dose/event;
Moderna COVID-19 Vaccine EUA - 48 hours after my first shot I had a full body breakout of severe hives. I went to the ER and they immediately gave me an IV with doses of Epi,  epinephrine, steroid, benedryl and zyrtec. Then i received a prescription for benedry and zyrtec that I took for the next week.
Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 13Mar2021 00:45, the patient experienced heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath.  As a result of the events, a visit was made to the doctor or other healthcare professional office/clinic with the patient's heart rate, blood pressure and oxygen (level) were checked. As of 14Mar2021, the clinical outcomes of the heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath were resolved on an unspecified date in Mar2021.  The expiration date of the lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of ZOSTAVAX (lot # L029485 with expiration date of 06-NOV-2016; lot # L035286 with expiration date of 15-DEC-2016 and lot # L039094 with expiration date of 08-JAN-2017, dose, frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that (incorrect product storage). Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6 hrs post inject, red, swollen around inject site x 24 hrs w/residual 3cm sz indurated area as of 14MAY93; 48 hrs post inject fever 102, irritable, crying, not sleeping well, dec appetite; unconsolable;
Information has been received from a health professional concerning a 75 year old female with cataracts and allergies to penicillin, aspirin, and ALTACE who on 10-MAY-2007 at 10:30 AM was vaccinated with a dose of Zostavax (Oka/Merck).  It was noted that the patient was being seen on the day of vaccination for a pre-operative physical for cataract surgery.  On 12-MAY-2007, the patient experienced "itching, redness, hot to touch, and a wheal."  No diagnostic laboratory tests were performed.  The patient recovered on an unspecified date.  No further information is expected.
dizziness, nausea  taking meclizine . Still experiencing dizziness as of 1/12/2021.
getting bells palsy after the first Pfizer injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-017831.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "getting bells palsy after the first Pfizer injection". The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) Unknown results, notes: chest x-ray to make sure they did not have pneumonia; Computerised tomogram: (unspecified date) Unknown results, notes: did not show any blood clots; Oxygen saturation: (unspecified date) Low, notes: still low in the 80's; SARS-CoV-2 test: (Nov2020) Positive, notes: had covid 19 back in Nov2020.  Clinical course: Caller said they initially took 2 Pfizer doses and 1 Pfizer booster. Caller reports getting bells palsy after the first Pfizer injection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200945535 same patient/drug/AE, different dose number;
Temp 104 the roc after vaccines runny nose, crying. 07/31/06 fever until Wed approx 36 hours, received Motrin.
Patient was nervous and teary eyed in the vaccination booth, prior to administrating.  She is a minor so her Father accompanied her.  We were in the booth for a few minutes where I was trying to get her to relax and breathe.  Her father was there the entire time. I gave the Pfizer vaccine and she stated "that was it?"  She seemed ok upon leaving the booth.  Her and her Father sat in the observation area directly in front of the pharmacy. About 5 minutes passed when her Father tapped on the window.  Went out to check on the patient and she was pale and little disoriented.  She ended up throwing up as well. We gave her a bag so she wouldn't have to stand up and could stay near her father, to prevent a fall. ?We gave her a cold compress and a water and had her stay for 30 minutes.  By the time she left, she had her color back and was able to say that she was feeling much better.  Her father was not surprised that she had a reaction like this and stated that she usually has form of reaction like to vaccines.  She was ok by the time she left and they both stated they'd be back for the second vaccine.
Patient stated that he developed shingles just a couple weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago). At the time of the report, HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago) outcome was unknown.            Reporter did not allow further contact
Patient described pain at the injection and arm immobility. It improved significantly by day 6 after receiving vaccine. Patient reported that most of the issue has resolved on day 7.
Vaccinated well child 4/26/02. On 5/14/02, presented with petechie and ecchymosis. Evaluated by hematology course 5/14/02 - 9/10/02. Required platelets transfusions. Bone marrow depletion. No dyspnsia.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Elevated pulse rate - Itchy, runny eyes, gagging cough, sore throat, muscle aches, headache, dizziness, blurred vision, and chest tightness
vial was initially stored in the refrigerator on 11-Apr-2022; administered with vaccine exposed in room temp for 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine exposed in room temp for ~24 hours) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose EW0175) on 30-Apr-2021, Pfizer (2nd dose EW0183) on 21-May-2021 and Pfizer (1st booster dose 33030BD) on 23-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 29-Apr-2022 at 9:12 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022 at 9:12 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (adminstered with vaccine exposed in room temp for ~24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adminstered with vaccine exposed in room temp for ~24 hours) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. Administered Moderna Covid-19 vaccine in a prefilled syringe which has been exposed to room temperature for ~24 hours. There were no temperature excursions. No treatment were given.
She got her vaccine, she had no reaction that day at all, kind of laid around with no energy.   She went to the ER on 5/2/21 due to her eyes, and then she continued to have problems with her eyes and went to the ER again on 5/12/21 she was completely broke out with little raised bumps, all over her body, her neck, her chest, back, legs, stomach, arms.  Very itchy and her face and her eyes are staying real red and puffy.  She gave her the prednisone and Pepsin and Benadryl, which she took for the entire course which did not help.  Then I went this past Wednesday 5/19/21 to an UC and they gave her Cephalexin which she takes every 8 hours, and still trying to take Benadryl, but it's not helping her.  She still continues with all of the rashes, and went and boat oatmeal bar soap and oatmeal bath trying to get rid of the rash, but that is not really working either.  She even has sores in her head that are oozing, and was told to use baby shampoo which has not helped.  She still continues and cannot get relief from the itching.  She eyes are so bad and itching that she has to put cold compresses on them.  She says that her skin looks like she has been burnt real bad, especially her eyes and face.  She said that you can see the red bumps on her arms, and most of her body which is very noticeable.   The UC suggested that she needed to see a dermatologist.  She feels that she needs to be tested to see what she is allergic to.    She continues with the same symptoms, has soreness around her eyes, and has not had any improvement with the antibiotics either.  The skin of her eyes are so sore and says it looks like somebody  has hit her hard and the skin is dry to touch.   She bought some Vaseline to see if that would help the area as well, and would like something done as it is almost a month and nothing has helped.
This spontaneous report as received from a certified medical assistant refers to a 65 year old male patient without pertinent medical history. The patient had no drug reactions or allergies. The patient was vaccinated with one dose of ZOSTAVAX (lot number, dose, route and indication were not reported) at an unspecified facility, on an unspecified date within the past two weeks. No other co-suspects were reported. There was no concomitant medication. The patient visited the office for medical attention on 08-FEB-2013, with a generalized varicella-like rash. There was no treatment given for adverse event. There was no laboratory diagnostics study performed. Action taken was not provided. The patient was not recovered at the time of report. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Intramuscular) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K007243 expiration date: 13-DEC-2015 and lot # L008059 expiration date: 18-DEC-2016) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complain was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014713; 1511USA014714; 1511USA014712). Additional information has been requested.
Flu like symptoms: 101-102 fever, chills, HA, and severe bone and joint aches. Tylenol 650mg alternated with Ibuprofen 600mg every 4-6hrs. Resolved 48 hours later.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old male patient who received KINRIX (batch number 5S5TJ, expiry date 19th October 2018). The patient's past medical history included milk allergy and gluten intolerance. On 30th March 2017, the patient received KINRIX. In March 2017, less than a week after receiving KINRIX, the patient experienced fever. On 30th March 2017, the patient experienced injection site erythema and dizziness. On 31st March 2017, the patient experienced appetite lost. On an unknown date, the outcome of the injection site erythema was unchanged and the outcome of the dizziness and appetite lost were recovering/resolving and the outcome of the fever was unknown. It was unknown if the reporter considered the injection site erythema, dizziness, appetite lost and fever to be related to KINRIX. Additional details were reported as follows: This case was reported by the patient's mother. On 30th March 2017, the patient began to develop redness around the injection site. The patient then began to feel dizzy in the evening on the same day. Upon awakening on the 31st March 2017, the patient was still dizzy and feverish, with a temp of 103 degrees. The patient's appetite was lost and the patient did not felt like eating. The lot number 2 in report was intentionally left blank. There was only 1 lot number (not further specified).
2 weeks after getting the 1st dose, he had a stroke; He did not get the 2nd dose because of medical problems; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 ACETYLSALICYLIC ACID (BABY ASPIRIN), TAMSULOSIN, ATORVASTATIN CALCIUM (LIPITOR) and RIVAROXABAN (XARELTO) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose because of medical problems). In February 2021, the patient experienced CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose because of medical problems) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included OTC preservision. No treatment information was reported.  Caller was a Pharmacist who has a patient debating whether or not to receive his 2nd dose of the Moderna COVID-19 vaccine. The patient received the 1st dose of the Moderna COVID-19 vaccine on 14-FEB-2021. He did not get the 2nd dose because of medical problems. Per the Pharmacist, 2 weeks after receiving the 1st dose, the patient experienced a stroke and was hospitalized. The caller did not know the details of patient's experience after the 1st dose.  It has been 5 months since the patient received his 1st dose.  This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknow) with AE reported of CVA. Based on the current available information and temporal association between the use of the product and the start date of the event, CVA, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknow) with AE reported of CVA. Based on the current available information and temporal association between the use of the product and the start date of the event, CVA, a causal relationship cannot be excluded.
Tdap after injection patient woke up with neuropathy in Left shoulder and neck-has persisted for 2 weeks with dysesthesia and numbness of Left traezius muscle area.