chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      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.   No concomitant and treatment medications were reported.  Vial moved to fridge on 01-DEC-2021. Total duration of the excursion refrigerated temperature for maximum 4 hours.
Information has been received from a RN concerning a pt who on 09Aug05 was vaccinated SC with a 0.5ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 09Aug05, the pt possibly had a reaction to the vaccine. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested.
BLOOD CLOT IN LEGS; This spontaneous report received from a patient by a Business partner on 22-NOV-2021 was received on 23-NOV-2021 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in legs and then patient was prescribed with medication. Patient was treated with xarelto (rivaroxaban) for blood clot in legs . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211155221-COVID-19 VACCINE AD26.COV2.S-Blood clots in legs. 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).
Fatigue began evening of 1/22/21, then on 1/23/21 had temp of 99.7, headache, chills, body aches (felt like the flu).
change in body temperature; chills; First dose on 09 Apr 2021 and second dose on 02 May 2021; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FEELING OF BODY TEMPERATURE CHANGE (change in body temperature), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021). On 03-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (change in body temperature) and CHILLS (chills). On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), FEELING OF BODY TEMPERATURE CHANGE (change in body temperature) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-432983, MOD-2021-433509 (Patient Link).
symptoms of shortness of breath, dizziness and weakness 5-6 days after vaccination.  complete heart block
Lymph nodes on the left side swelled up; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the right  arm on 09Apr2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes, sleep apnea and COVID-19. Concomitant medications were not reported. The patient had known allergy to horse serum/tetanus, The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left  arm on 16Mar2021 at 10:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation.  The patient previously took Alka-Seltzer plus cold medicine, MSG for an unknown indication and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 the patient experienced lymph nodes on the left side swelled up. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lymph nodes on the left side swelled up was recovering at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Patient noticed circular, red rash. Advised to go to primary care MD. Received 10 day course of KEFLEX 500mg (4x daily).
Red rash and bump present on R arm in area of vaccination site, pt has had some erythema that has persisted and skin itching/irritation for the last 3 months
Patient began feeling dizzy approximately 1 minute after receiving 0.5cc influenza vaccine. She then felt nausea and light headed. Placed patient in more reclining position with legs up. Gave water, cool cloth and blanket. Patient remained alert and conscious. Fully recovered within 20 minutes. FU phone call 10/17/2001, patient reports no problems.
This spontaneous report was received from a medical assistant (who was also a nurse) and refers to 2 patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L040458, expiration date 04-FEB-2018 (dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
CAN'T SWALLOW PILLS; FEVER; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and can't swallow pills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and can't swallow pills was not reported. This report was non-serious.
Severe rash on both arms and right side of chest and left side of back and buttocks and down left leg. had it for 7 weeks before i went to doctor.intense itching,felt like fiber glass poking into my skin and had to scratch it till it bled.when i did scratch it welted up and felt like an orange peel.doctor prscribed PREDNISONE and ZYRTEC. i felt better within a day.i wish i hadn't waited so long to seek help.
Information has been received from a 24 year old female consumer with no known drug reactions or allergies and nausea who on 13-OCT-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MACROBID and OTC nausea medicine. The consumer reported that on 20-OCT-2010, in the clinic were she works, she took a pregnancy test and she found that she was pregnant. It was reported that the consumer LMP was "3 weeks to a month" before, on approximately 13-SEP-2009 and the estimated date of delivery (EDD) is 20-JUN-2010. The consumer reported that on an unspecified date she had an ultrasound performed and it was found that the baby will need to have "open heart surgery when she is born" because the baby's "Tetralogy Fallot" condition. The consumer also reported that on unspecified dates, she had been in and out of the hospital (hospital unknown) due to her bleeding and that she had been passing out. It was noted that the patient had been seeing a number of specialist that performed several tests (results not provided) in regards to the baby's condition. At the time of the report, the patient's outcome was unknown. Fallot tetralogy was considered a congenital anomaly. The baby's experience has been captured in WAES 1004USA01925B1. Additional information has been requested.
pt devel high pitched, irritable & unconsolable cry 2-3 hrs p/vax recvd; did not stop crying for 2 days; fever started 6JUN92 & up to 104; APAP given but inadequate; MD instructed mom to give cold alcohol baths; appetite poor;
Patient mother called on 09/29/2022 to office stating the patient was complaining of right arm pain for a few days. It is very painful to touch and painful with ROM. Mom could not verify if there was any redness or swelling.  Vaccine given on 09/22/2022. Will take to walk in to be examined
Within 2-4 minutes post vax, the child developed whelps and redness over entire face; was given 25 mg of Benadryl by mouth and whelp resolved within 20-25 minutes.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On unknown dates the patient was vaccinated with the first two doses of ROTATEQ (lot number, dose, route and indication were not reported) and at the time of report the patient was in the office to receive a third dose of ROTARIX (it was also reported as manufacturer unspecified) and patient may be given ROTARIX instead of ROTATEQ for the third dose in rotavirus vaccines series. No adverse effect reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
16-Year-Old Vaccinated; A spontaneous report (United States) was received from health care professional(nurse) concerning 16 years-old, male patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake;    The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 [Batch Number: Unknown] intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, a 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
My period started 2 weeks earlier than expected. My periods are always the same time each month. My period started 4 days after receiving the first dose.
I waited 15 minutes and I was leaving and I called a friend when I was walking out and almost immediately as I was driving out, I felt like there were feathers coming down my back and down my leg. And then immediately felt extremely tired - from 1-10 it was a 10. I went grocery shopping and when I got in the store, I started feeling sick like when you get the feeling you are going to vomit; feeling nauseous and it seemed like it was intensifying as I shopped. I was trying hard not to throw up.  I started feeling like I wanted to shake but I wasn't shaking. I got to my mom's house and I ran and vomited. I still felt tired and my mom told me I looked sick and I laid down on her couch. I felt sick for two or three or four days - felt really sick for awhile. Then anxiety set in and I thought I might have COVID and I raced to my doctor and she wasn't there and I went to Health Department and I called the CDC and the CDC assured me it was fine and it was a side affect and reassured me and relieved my anxiety. I had a headache started in the front of my head and I felt like I had the flu but symptoms that I hadn't experienced before - it was a different kind of headache, nausea, etc, then I had ever felt. I called my doctor for an appt on 13th but no treatment.
THE PATIENT CAME BY TO REPORT AN ADVERSE RXN TO HER COVID VACCINE ON 07/29/2021...HER ARM WAS SWOLLEN AND RED AT THE INJECTION SITE BUT SHE WAS NOT DISTRESSED OR IN ANY OBVIOUS PAIN. SHE ASKED TO HAVE THE RXN REPORTED
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 2:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:20 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.09 for batch number 014M20A and 83.16 batch number 019B21A .  No concomitant medications were reported.  Batch number 014M20A administered on 27-Feb-2021 with temperature 35 from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 019B21A administered on 27-Mar-2021 with temperature 33 at 09:00 AM, 35 at 11.00 AM, 12.00 PM, 01.00 PM and 02.00 PM, 24 at 03.00 PM and 04.00PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Broke out in hives, ER gave me Epi and Benadryl immediately. Symptoms began to resolve almost immediately.
Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.
Parent reported on 11/29/2021 patient developed swollen lips ten hours after receiving the second COVID 19 vaccination on 11/27/2021. Parent stated patient was treated with Benadryl and the lip swelling did decrease and by Monday  29th when nurse spoke with parent, patient was completely fine per parent.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 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. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 10th patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663016:Patient 1 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-663014:Patient 19 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662881:Patient 2 US-MODERNATX, INC.-MOD-2022-662866:Patient 10 US-MODERNATX, INC.-MOD-2022-662861:
@ home, about 1-1 1/2hr p/vax mom noticed the baby's eye swollen along w/tongue swollen, rash all over body;baby trouble breathing;mom proceeded to ER;
ADMINISTRATION ERROR: PATIENT WAS ELIGIBLE FOR BIVALENT COVID VACCINE BUT WAS ADMINISTERED NON-BIVALENT COVID VACCINE, FACILITY, HCPOA/PATIENT AND PRIMARY DOCTOR ARE BEING INFORMED. WILL FOLLOW UP TO SEE IF PATIENT/HCPOA/DOCTOR WANTS BIVALENT BOOSTER ADMINISTERED IN 2 MONTHS
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On 24-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N012489, expiration date 17-OCT-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse events were reported. Sender's Comments: US-009507513-1708USA011793.
pt recv vax 20MAR96 & 15NOV97 pt devel chickenpox;
Approximately 24 hours after the injection, I developed a swollen lymph node near my collar bone on the same side as my injection (left arm). The swelling is about the size of a golf ball and is very painful to the touch and when not touched at all. It is now 4 full days after the injection and this symptom has not subsided.
Patient received first dose of the Moderna Covid-19 vaccine series. Patient is under recommended age of administration. No adverse reactions noted onsite after vaccination.
atrial flutter and Afib, total blockage of vein graft to heart(diagonalSVG), heart cath unsuccessful in Columbia, graft reopened in April, 2021.  Off and on Afib since reopening, two cardioversions and ablation Nov-Dec 2021-Jan 2022.