chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant drug information was provided.  It was reported that the HCP had administered bivalent vaccine to 4-5 adult patients beyond 30 days used by date.   No treatment drug medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687538, US-MODERNATX, INC.-MOD-2022-687539, US-MODERNATX, INC.-MOD-2022-687454, US-MODERNATX, INC.-MOD-2022-687541, US-MODERNATX, INC.-MOD-2022-687542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687541:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687454:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687539:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687542:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687538:Same reporter, Original Case : MOD-2022-687454
Patient obtained pain in her lower legs with numbness. Patient did go to her doctor and blood was taken and was told to go on bed rest.
Patient received vaccine at 14:22, waited the 30 minute observation period. Patient returned to clinic at 15:35 with reports of chest pain and c/o throat closing. She did not use her epi pen, but had it during the observation period after her injection. Nurse met patient in waiting room and escorted directly to ED. Patient was seen by ED physician and was given albuterol, solumedrol and benadryl. Was discharged home in good and improved condition at 17:33.
Moderate dizzy/light headedness 5 minutes following injection, lasting 30 minutes. Lab technician reported patient presented with pale/white lips/face, looked like patient was going to pass out. Severe headache beginning 7 hours after injection, ongoing. Moderate soreness at injection site beginning 3 hours after injection, ongoing.
improperly stored PROQUAD was administered to patient; No adverse effect reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter per subcutaneous route, lot # S002501 expiration date 23-JUL-2020.  No adverse effect was reported.  Digital Data Logger registered a temperature excursion of 18.3 Fahrenheit degrees along 8 hours and 47 minutes.
Upset stomach (very, very acid for the first day- no more).  Sore throat (still a little sore). General malaise (much better). Throat kept swelling even while taking Benadryl (still swollen but much better). Itching eyes and eyelids (no more). Itchy ears (inside) (no more). Rash like little blisters on forehead (gone now). Paled face (no more). Glassed eyes (no more). Nasal passages swelled (mostly gone). Tongue swelled (mostly gone). Inside of mouth swelled (gone). Wheezing (some). Hard time swallowing (mostly gone). Hard time breathing (mostly gone). Fever blister - secondary to acid stomach (gone).
Kind of tired; Fluttering around her heart, can't seem to stop it; This is a spontaneous report received from a contactable consumer. A 65-year-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 27-May-2021 at 15:00 hours (at 65-years old) on left arm, as dose 1, single for COVID-19 immunization.  Medical history included systemic lupus erythematosus, hypertension, asthma, rheumatoid arthritis (start date 2004 and ongoing). It was mentioned that investigation Assessment was performed. The emergency room and physician office visit were reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect was none, prior vaccinations (within 4 weeks) and events following prior vaccinations, family medical history and relevant tests were reported as none. Caller stated that she was in the hospital the week before she got that shot for bowel rupture so they had gave her something for pain, but no vaccines. Concomitant medications included acetylsalicylic acid (Aspirin) taken for rheumatoid arthritis, amlodipine besilate taken for hypertension. On 16Jun2021 the patient experienced fluttering around her heart, it could not seem to stop it (cardiac flutter) (medically significant). The patient had it every now and then with a flare. Caller stated that she does not know why it was reacting like that. She was supposed to get her second shot on 17Jun2021, but she does not think she wanted to get the second shot because she had these issues. It started yesterday and today and it had not stopped. Caller mentioned that this morning it was acting real strong and she took the Bayer aspirin, so it slowed now and it would jump every now and then. On an unknown date the patient mentioned that she was kind of tired, she could maybe later in the future get her second dose when she would feel better. The outcome of kind of tired was unknown and Heart fluttering was recovering.
One day post vax, the pt noticed 4-5 whelps about 2 inches below the site of vax. The pt came in 2 days post vax to show the health department. The pt was advised to go to her PMD. The pt was diagnosed with allergic reaction and instructed to take Benadryl. The pt also experienced itching around the mouth and ears.
Right arm soreness. Had to see MD and was given Ibuprofen and cyclobenzaprine on 10/16/15 by dr.
injection site redness/swelling/pain/itching, body aches Narrative:  Employee reports experienced injection site pain/redness/swelling/itching after receiving vaccine. Unknown duration of how long symptoms persisted. Reports was taking ibuprofen (unknown dose/frequency) for 3-4 days.
Had chills and lo-grade fever for 36 hours after shot, swollen reddened injection site for up to 6 days, very achy and tired for 3 days after injection
first vaccine was on March 2nd and I tested positive for Covid on March 12.; This is a spontaneous report from a contactable consumer (patient) or other non-Health Care Professional. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6198 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 38-years-old) as single dose for Covid-19 immunization. Medical history included ongoing hypertension and started around age 16 years. The patient's concomitant medications were not reported.  The patient was not taking other products. She received her first dose of the Pfizer Covid vaccine 02Mar2021 and this past Friday 12Mar2021 she tested positive for Covid19. It was stated that her question was that she had her second dose 23Mar2021 through the county, the county approved that she could come in and get it because she would be out of quarantine by then, does Pfizer recommend getting the second vaccine on that date or waiting ninety days and starting over with the first dose again. She was experiencing fever, cough, congestion, chills, body aches, and headaches. She stated they all started on 11Mar2021 and were ongoing except the fever was gone away 14Mar2021. The rest have persisted but the body aches had improved. The patient received treatment of prescribed with Zinc and taking Mucinex and Motrin. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021 Rapid and Send Out. The outcome of event was not recovered.
Fever, chills, sweating, right neck pain, right ear and jaw pain.  Pain in thyroid area.  FATIGUE
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 20th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 47-year-old female patient who received FLUARIX (batch number 7HZ73, expiry date 30th June 2016). Concomitant products included CEFTIN, WELLBUTRIN SR and Levothyroxine. On 9th November 2015, the patient received FLUARIX (intramuscular). On 11th November 2015, 2 days after receiving FLUARIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. The reporter considered the itchy rash to be possibly related to FLUARIX. Additional details were received as follows: The reporter stated that, the patient notified the pharmacy that, 48 hours after receiving FLUARIX, she experienced an itchy rash. The itchy rash was not localized around injection site. The reporter stated that, the rash was continuing to get worse.
I experienced a sore throat, coughing, fatigue hard to wake up, chills, headaches, feeling warm but no fever. Today I still have symptoms sore throat, coughing, congestion sinus infection, still have hard time waking up in the morning. I took a Covid test and it was negative.
This spontaneous report as received from a pharmacist refers to a 81 year old female patient with glaucoma, no allergies and no pertinent medical history. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. Concomitant medication included unspecified eye drops for glaucoma. On 09-SEP-2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX 23. The patient stated that she had to leave work on 10-SEP-2014, due to the injection site being red and inflamed and her entire arm was sore and she couldn't move her arm. No treatment was given for the events. The outcome of the events was not recovered. Pharmacist was requesting a lot check on lot# K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Severe vomiting, diarrhea, chills, fever, muscle ache, headache, fatigue and sore arm at shot location. Continued nausea
Light rash on face and forearms relieved by 50 mg of Benadryl per mouth in 1 hour.  Rash occurred approximately 24 hours after injection.
This spontaneous report as received from a pharmacist refers to a 56 years old female patient. The patient was vaccinated SC with a dose of 0.65 ml ZOSTAVAX to her left deltoid on 30-AUG-2012 for prevention of shingles. No other co-suspects were reported. No concomitant medications were reported. On 30-AUG-2012 the patient experienced side effects at the injection site that included pain on a 4 out of 10 pain scale, swelling, redness, itching and hard like a ping pong ball under the skin. No treatment information was reported. It was unknown if there is any relevant laboratory data. On 02-SEP-2012 the patient's signs and symptoms on pain on a 4 out of 10 pain scale, swelling, redness, itching and hard like ping pong ball under skin had not recovered but were improving. On 02-SEP-2012 it was unknown if the patient continued to take ZOSTAVAX. Additional information is not expected.
Rash all over body. No itching, fever or difficulty breathing. Saw Doctor on 12/21/09. No treatment or testing done. Rash beginning to diminish on own. On 12/22/09 rash only present on stomach and hands.
Erythema multiforme and induration of vaccinated area, (R) arm soreness/swelling. Diphenhydramine, amoxicillin/clavulanate 875 mg BID.
Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets .  Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke.  Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.
Received flu shot at 13:00. Woke up in "middle of night" with itchy rash on chest. Also reports nausea.
This spontaneous report as received from a nurse refers to a 18 year old male patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient aged 18 years 6 months, was vaccinated with an adult - 1 ml dose of properly stored VAQTA, 50 U/1 ml, lot # reported as M034896, expiry date 26-MAY-2017 (route and site of administration were not reported). No adverse effect reported. Additional information is not expected as there was no consent for follow up.
Information has been received from a licensed practical nurse concerning a female patient, who on 11-MAR-2009 was vaccinated with the first dose of PNEUMOVAX (lot # 662785/1124X), intramuscularly. The nurse reported that on 13-MAR-2009, the patient developed cellulitis. She was treated with antibiotics and at the time of the report, the patient was recovering. The patient sought medical attention through an office visit. Additional information has been requested.
Missed second  dose/has not received her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose) had resolved.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 and reporter information has been updated
a couple of hours after the injection patient started shivering. It continued all day with increasing intensity. by 8:00 pm the patient was feeling worn out and light headed wth considerable shaking. around 2:30 am the patient woke up with a migraine. the next moring the patient was still shiviring a little. Symptoms completley faded by mid evening 12/12/20.
No additional AE reported; Medical Assistant reporting improperly stored VARIVAX was administered to a patient; This spontaneous report was received from a certified medical assistant referring to a 12-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 25-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) (1 dose) lot number U007475 and expiration date of 03-AUG-2022 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The vaccine was exposed to a temperature excursion of -10°C up to 8°C (-9.6C) for 1 hour and 0 minutes and 0 seconds, there was no previous temperature excursion. No additional adverse event was reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-MAR-2015, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 29-SEP-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included abnormal pap smear, asthma, autoimmune deficiency syndrome and hepatitis B. On 03 August 2009, at 16 weeks gestation, at 14:58 the subject received the 1st dose of HAVRIX (unknown, unknown arm). Her last menstrual period was on an unspecified date and estimated date of delivery was on 20 January 2010. The patient was exposed to HAVRIX during the 2nd trimester. Follow-up information was received on 13 April 2010 via healthcare professional. Additional medical conditions included bacterial vaginosis, candidiasis, herpes simplex virus and human immunodeficiency virus. Concurrent medications included KALETRA, TRUVADA, Azithromycin, Valaciclovir hydrochloride, Metronidazole, VENTOLIN HFA, MEPRON, Albuterol, Ferrous sulfate, Prenatal vitamins and TERAZOL. The subject was diagnosed with chronic hepatitis B prior to pregnancy; perinatal exposure to HIV with lifelong infection and AIDS diagnosis. Inconsistent adherence to antiretroviral treatment for hepatitis B and HIV during pregnancy. On 29 September 2009, at approximately 24 weeks gestation, the subject experienced an additional events of immune reconstitution syndrome and on 28 December 2009, at approximately 36 weeks and five days, oral herpes simplex virus 1 lesion. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the immune reconstitution syndrome and oral herpes simplex 1 lesion were improved. On 29 December 2009, after 36 weeks and six days gestation, the subject gave birth to a female live infant. The infant was delivered by cesarean section; weight, Apgar score and length were not provided. The neonate experienced weight loss and respiratory syncytial virus. Please see report A0801954B for details regarding the 'baby' case.