chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Feb-2022 at 10:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022 at 10:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. Pharmacist is not aware of any other adverse event complaints. The vial was initially stored in the refrigerator on 07-Feb-2022. The vial had no temperature excursions.   This case was linked to MOD-2022-487948, MOD-2022-487957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Follow up received contains no new information.
Soreness at injection site onset 9/29/21, persists through the time of this report (11:00M 10/1/21).  Fever up to 100.8* F on 9/30/21 (the day after the injection), resolved by 5:00AM on 10/1/21.  Chills starting 9/29/21 7:30PM, resolved by 1:00PM on 09/30/21.  Body aches, resolved by 10:00AM on 10/1/21.
Headache after few mins. of Covid vaccination; followed by severe body aches & soreness at injection site. Took Tylenol & ice pack applied to injection site; helped  reduced pain. Feeling better now.
Hives and itching all over my body. No change to diet, laundry detergent nothing  .
Initial report received from a patient who is also a health care professional. A 49-year-old female patient with a medical history of allergies to shellfish and rubber accelerator, had received an intramuscular injection of FLUZONE, lot number UH181AA, on 06 October 2010. One day later, on 07 October 2010, the patient's face was red, flushed, and warm to the touch. Her left eye was swollen and she had rare hives on the back of her neck and her left wrist. She was treated with BENADRYL and a MEDROL pack. The patient reported that she reacts similarly to various cleaning agents and that her reaction may possibly have been related to a cleaning agent she had used. The patient's recovery status was not reported. Follow-up information was received on 29 October 2010 from a patient who is also a health care professional. The patient received the FLUZONE injection in the left deltoid muscle. She had been previously tested and she did not have an egg allergy. She was treated with a MEDROL dose pack and all symptoms were resolved within 24 hours (date not reported). List of documents held by sender: none.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported.  On 18-Mar-2022 at 3:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 3:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine administration time was reported as 15:35:33. No treatment medications were reported.
Pt states received flu and pneumonia shot 11/25/03. Pt states "it hurt during administration." Pt states arm "hasn't been right since." Pt said called HD and spoke with unidentified nurse.
Patient arrived at our clinic requesting his second dose of Moderna vaccine.  This clinic was only open to the residents at this house. He lost his CDC card, but said that his first dose was at this site a few weeks ago.  We were the only agency that offered a vaccination clinic at this site, and it was 4 weeks prior.  So we proceeded to vaccinate him.  At the end of his observation, his wife came in and told us he was crazy and has an awful memory.  She claimed this was his 3rd shot.  I inquired for my supervisor to look into health records to see how many doses he received.  Turns out he was vaccinated on Feb 4, March 4, and April 30th.  So it turns out he received a 4th dose of Moderna vaccine today at our clinic.  No symptoms were observed in observation.
It started with a headache and scratchy throat one morning. The next days following, I had a runny nose and cough. I completed an at-home COVID-19 antigen test because of my symptoms on 05/15/2022, and it came back positive. I called my doctor's office, and she informed me for my symptoms to take Mucinex and take my Albuterol nebulizer treatments. Currently, I'm still exhibiting a deep cough and runny nose still of my COVID-19 symptoms.
Routine blood work drawn after her first covid vaccine and found her White count to be low; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from company(manufacturer control number: US-company-USASL2021039875). This case was split from master case 2021292945 for a female patient took COVID-19 vaccine and experienced white blood cell count decreased.  This non-serious solicited report (USASL2021039875) was reported to the company on 11Mar2021 by a consumer from a commercial program (PSP00046b). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), on an unknown date in 2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis from 2018 to an unspecified stop date. On 05Mar2021, after first dose COVID-19 vaccine, after a routine blood work drawn after her first COVID vaccine and found her white count to be low, while receiving Enbrel with Reusable Autoinjector. The patient began Enbrel with Reusable Autoinjector on an unknown date in 2018. Subsequently, the patient's physician advised her to held Enbrel for one week which was schedule on 11Mar2021. Additionally, the physician also advised to do not receive second dose of COVID-19 vaccine. No treatment information was received. The outcome of the event white blood cell count decreased was reported as unknown.   Follow up has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up(PRD/SRD 26Mar2021): The following information was received from the company: COVID-19 VACCINE was not specifically reported as suspect.
c/o chills-pale, skin w/d-afeb;BP 138/98;no rash;no swelling;no diff breathing;
Left shoulder pain, weakness in shoulder and upper arm, limited range of motion.  Gradually improved over several months but still not 100% and still have pain.
Drug exposure in utero; Physiological jaundice; Hyper bilirubinemia; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of neonatal jaundice in a male neonate exposed to Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number Y53NN, expiry date 30th June 2019) in utero. The mother received the product for prophylaxis.   Co-suspect product exposures included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number Y53NN, expiry date 30th June 2019).   The parent's medical history included Family history of uncle included Down's syndrome. On a certain date, preterm delivery occured.   On 19th September 2018, the 29-year-old mother received Fluarix Quadrivalent 2018-2019 season .5 ml. On 17th October 2018, the mother received Fluarix Quadrivalent 2018-2019 season .5 ml. The mother's last menstrual period was on 6th March 2018 and estimated date of delivery was 11th December 2018. The neonate was exposed to Fluarix Quadrivalent 2018-2019 season at week 28 of gestation and during the third trimester of pregnancy. At 37 weeks and 5 days, the neonate was born via vaginal delivery and weighed 3628 grams (8lbs) at birth. APGAR scores were 9 and 9. The neonate was diagnosed with neonatal jaundice and bilirubinemia newborn. On an unknown date, the neonate experienced drug exposure in utero. The neonate was treated with ascorbic acid + ergocalciferol + retinol palmitate (Trivisol). On 4th December 2018, the outcome of the neonatal jaundice and bilirubinemia newborn were recovered/resolved. On an unknown date, the outcome of the drug exposure in utero was unknown.   It was unknown if the reporter considered the neonatal jaundice and bilirubinemia newborn to be related to Fluarix Quadrivalent 2018-2019 season and Fluarix Quadrivalent 2018-2019 season.     See case US2018190948 for details regarding the mother case.  Additional details were provided as follows: The gender of baby was male. The length was 20 and half inches. The head circumstance was 37 centimeters. On 30th November 2018, lab test for total bilirubin was performed. This case has been linked to mother case US2018190948, reported by same reporter.
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 31-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 10 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002451: US-009507513-2104USA002490: US-009507513-2104USA002491:
No adverse effects were reported by patient, but vaccine was administered 5 days after the BUD of 2/8/23.
She received her vaccination on August 06, 2022. She tested positive for COVID-19 on August 11, 2022. Her symptoms were basic cold symptoms. She had congestion and a cough. She ran a fever for one day. She seemed fine after two or three days even though she tested positive for ten days. She In mid-October, she got a respiratory virus of some sort. About five days into the virus, she had an ear infection. The main symptoms were irritability, difficulty sleeping, and a fever over 100.5. I took her to the doctor. They diagnosed the ear infection and prescribed AUGMENTIN. She missed one and a half days of daycare before she could go back. Her second ear infection was mid-November. It also followed an unknown respiratory virus with congestion and cough. We took her to the doctor after she spiked a fever of over 100.5. They diagnosed the ear infection and prescribed cefdinir. The third ear infection was early December. She had another unidentified respiratory infection with congestion and cough. She spiked a fever over 100.5. We took her to the doctor. They diagnosed the ear infection. I think they prescribed AUGMENTIN, but I can't remember. Late December, we took her to the doctor due to another fever. They diagnosed her with Flu A and another ear infection. They prescribed amoxycillin. Early January, she had congestion and complained of ear pain after difficulty sleeping. She didn't have a fever, but she had another ear infection. The prescribed AUGMENTIN. She was on the AUGMENTIN through Friday, January 20, 2023. She was fine for a full week and a couple of days before the next respiratory infection.
Received 1st vaccine 3/17/00. That night and over the next few days the injection site went very red and became swollen and tender. Also experienced a couple of transient/short term mild ear infections 3/18/00-3/30/00.
While receiving my second shot, a drop of the vaccine liquid came into contact with my arm, dripping down. I brushed it off, as well as the pharmacist. A day later the vaccination site started to hurt, which was expected but also itch. On Thursday, two days after I received my shot, my friends pointed out that my arm is in hives, red, and swollen. My arm is still in hives, and itches like crazy. It looks like an allergic reaction. I have pictures
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005797 with expiration date 21-MAR-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the third time was 48 hours with the lowest recorded temperature of 1 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the fourth time was 72 hours with the highest recorded temperature of 9 Celsius degree (the lowest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
PT RECEIVED VACCINE IN AFTERNOON, LATER THAT EVENING PT HAD FEVER OF 101 F. PT MOTHER GAVE TYLENOL AND FEVER WENT DOWN. NEXT MORNING, PT STARTED BREAKING OUT IN RASH ALL OVER BODY/FACE, MOTHER GAVE PT BENADRYL AND RASH DECREASED. NO FURTHER RASH OR FEVER SINCE INITIAL INCIDENT
PATIENT IS UNDER AGE 50 AND IS NOT IMMUNOCOMPROMISED OR TAKING ANY OTHER MEDICATIONS THAT WOULD WEAKEN HIS IMMUNE SYSTEM.
Shortness of breath and wheezing beginning the day after first dose and still present. The shortness of breath and wheezing was increased with the booster shot.
Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On 24-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route were unknown). On 12-MAR-2015, the patient was vaccinated with the second dose of GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 4 year old patient. It was reported that on 10-AUG-2011, the patient may had been vaccinate with ZOSTAVAX instead of VARIVAX. The reporter stated that she cannot read the complete lot#/expiry date on the patient's vaccination record, however she provided the product lot#/exp ad possibly "13862/expiry date: 19-JAN-2012". No product quality complaint (PQC) was reported. Additional information has been requested.
Fever 103.2 at night which resolved the next day. No rash this time.
Central 4 cm x 3.5 c in with area of erythema of 9-12 cm Redness at sight
Heart racing, palpitations upon standing from sitting position.  Heart monitor for one month (August 2021) diagnosed with Premature atrial contractions, Premature Ventricular Contractions, AFIB Paroxysmal and Palpitations.  Prescribed Eliquis 5mg 2x daily, Flecainide 50mg 1/2 tab 2xdaily.  Ordered echo and nuclear stress test.  After test symptoms still persisted meds Flecainide increased to 100mg 2x daily on October 27, 2021.  On November 17, 2021 doctor visit for continued breakthrough AFIB.  Added metoprolol 25mg 1/2 tab at bedtime.  Heart monitor for one month.  As of this date, I still have breakthrough AFIB, PVC and PAC.  Will return to doctor 12/21/2021 for results of heart monitoring.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "never had AFib until receive the 2 shots and booster". Clinical course: Patient stated know 4 friends of mine that we all four never had AFib until receive the 2 shots and booster. Patient scheduled for an abolition surgery on 20Sep2022 and 2 of patient friend have already under gone this procedure. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Voice began to get hoarse, throat felt like swelling was occurring however breathing not affected, coughing, lips began to swell and eyes watered and felt like bulging. At approximately 5 hrs later I felt flushed and muscles extremely achy and sore. After 8 hrs. I am recovering.
patient with bilateral PEs with right heart strain - reported SOB since the time of the second COVID vaccination - plan for EKOS catheter tomorrow and treatment with Eliquis
Headache, Sedation, Myalgia, Fever, NauseaVomiting, chills and fatigue. pain, redness and swelling at the  injection site.  Narrative:  Other Relevant History:
Three hours after getting shot, I started experiencing tightness and raspiness of throat, and my face feels swelled. These symptoms are still ongoing now [an hour after onset], accompanied by nausea, cough, and a runny nose.
LASTED FOR SEVERAL HOURS THEN SUBSIDEDCONTROLLED SHAKING OF HANDS AN ARMS
Fever (99.6 F) Vomiting 2 times the following morning Fatigue
macular, papular rash starting @ hairline working down to hip-temp 100 x 224hr;
Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Eh9899), via an unspecified route of administration in the left arm on19Dec2020 10:30 at a single dose for covid-19 immunization. The patient has no relevant medical history. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 19 December 2020, the patient experienced right arm pain. No treatment was given for the event. The outcome of the event was recovered. The vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Information on Lot/Batch has been requested.
Awoke @ 4am with nausea, stomach pain, headache, red/hot/rash on cheeks.  throughout morning, lightheaded/dizzy, chills,very tired.  by afternoon, stomach pain worsened and while on toilet, i passed out-hit my head and then had a head injury.    Also, extremely painful arm and site of injection
Nausea, fatigue, lightheadedness, dizziness, loss of appetite. Note that patient was pregnant upon receipt of the vaccine.
Thursday evening, patient started having itchiness/redness to bilateral hands.  No pain noted.  Friday night he had rashes on/off.  On 25 Jan, patient hasn't gotten better and decided to contact the medical group.  Patient's rash has spread from hands to forearms.  Bilateral feet with redness as well.
Fever, headache, stomach ache for almost 24 hrs redness/warmth/swelling at site. An 4 inch radius around.
Injection site soreness started the evening of the date the vaccine was given.  Inflammation about the size of an avocado was noticed 24 hours after injection.  Soreness and redness increased over the next 24 hours along with mild swelling.  The redness started to improve 48 hours after injection, and it resolved about 60 hours post injection.  No treatment was necessary.
Discovered after vaccine given was expired on 4/6/2022.  Contacted GSK Vaccine Center and it was recommended the child be revaccinated as soon as possible.
Developed tingling/numbness in hand and fingers on side of shoulder that received injection. Tingling reduced overtime to just middle, ring and pinky fingers. It persisted throughout the night and was mostly gone by the next day. However, it has reoccurred three different days since the day of the injection. It most recently re-occurred yesterday (05/25/2014) and is still persisting this morning (05/26/14) so figured it should probably be reported as a reaction.  I saw no mention of finger numbness/tingling as a possible reaction on the vaccine information sheet so had not reported it previously.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 15-JUN-2017, 22-JUN-2017, 04-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035828, expiration date 28-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 207 hours and 47 to 77 degrees Fahrenheit for 207 hours. Data logger was involved in recording of the temperature excursions. There was a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours reported.; Sender's Comments: US-009507513-1709USA004675: