chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, 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 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  No treatment drug was reported.   The case corresponds to 8th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:
Exposure to vaccine during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE (PULMICORT), LEVOTHYROXINE SODIUM (SYNTHROID), BUDESONIDE and LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 30-Dec-2020, MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2020, Ultrasound scan: anatomy scan-wm (Inconclusive) Anatomy scan-WM. On 15-Oct-2020, Ultrasound scan: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   27-SEP-2020, Pregnancy test was Positive.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: This follow-up was received by safety on 09-APR-2021 which reported dose 2 details (date of administration, route of administration and anatomical location), lab test details (Ultrasound), date of LMP, date of conception, best doctor details, ethnicity and race.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
5 minutes after receiving vaccine patient started getting nauseous. Reports waves of nausea every couple of minutes.
Case number PHEH2014US024364, is an initial spontaneous report received from a nurse on 21 JAN 2014, with a follow-up report received from the nurse on 19 JAN 2015. This report refers to a 81 year old female patient. Historical condition and concomitant medication were not reported. her past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: MAR 2015) intramuscularly in right deltoid at a dose of 0.5 ml on 06 NOV 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes.  No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 JAN 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, SORE THROAT Narrative:
APRROXIAMETLTY 1 WEEK AFTER PT RECIEVED THE 2ND VACCINE SHE DEVELOPED GENERALIZED SWELLING WITH A 11 POUND WEIGHT GAIN.  HAS BEEN C/O EXTREME FATIGUE.
12/25/21: Pt admitted with increasing SOB. Progressive worsening non-productive cough. onset of symptoms was 12/24 and diagnosed with covid 12/25. Decadron 6mg IV daily. Pt required increase supplemental o2 from 2 to 3L at night. currently at 2L with o2 sats in upper 90's. given albuterol prn, pulmicort BID, combivent QID.  12/26-28: continue therapy and wean o2 to home o2 as tolerated.  12/29: Pt discharged. Pt only required NC assistance o2 at 1L and deemed stable. Discharged with dexamethasone 6mg tablets once daily (duration not written)
Initial report received from healthcare professional on 12 June 2013. A 17-year-old female patient, received first dose of YF-VAX (lot number: UH597AA, route and site of administration was not reported) on 04 June 2013. The patient's medical history included heart raced to ZYRTEC administration and had stomach cramping with chicken and eggs. The patient had no illness at time of vaccination and had not received any vaccines within 4 weeks of 04 June 2013. Concomitant drugs were not reported. On 10 June 2013, 6 days after vaccination, the patient had developed cold symptoms, sore throat and redness 2 cm, slightly raised area at the injections site. Laboratory investigations/ details and corrective treatments were not reported. On an unspecified date, the patient had recovered from events. List of documents held by sender: none.
About 3 days after vaccines I experienced  pain in right hand between thumb and forefinger.  Fourth day after vaccine started experiencing joint pain in left hip and left knee. 23 days later, Nov 29, I still have both in both areas.
Patient reports periodic pains in the arms she received the vaccine. The pains are not constant, but rather very sharp and quick and come and go at random times. She said she has experienced it every day since receiving the vaccine.
This spontaneous report was received from a physician via company representative, concerning a 4 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in October 2017 (reported as "6 months ago"), the patient was vaccinated with a dose of ROTATEQ, orally, for prevention of rotavirus (lot number and expiration date were not reported). On the same day, the patient received a dose of PEDIARIX and one of PREVNAR 13, for an unknown indication (route of administration, anatomical location, lot numbers and expiration dates were not reported). On an unknown date in 2017 (reported as "8 days" after receiving the vaccines), the patient began to experience inconsolable crying and bloody stools. The physician reported that the patient was diagnosed with intussusception, which resolved without treatment by the next day. It was unknown by the reporter if lab diagnostics or studies were performed. The reporter did not assess the causal relationship between the suspect vaccines and the event. Upon internal review, intussusception was considered to be medically significant.
Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA010537: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Blood sugar shooting up between 200-250; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received his dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730, Expiry Date: Unknown), via an unspecified route of administration in Left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history included type 2 diabetes/diabetic which was diagnosed more than 10 years ago. There was no family medical history. There were no concomitant medications. The patient previously had influenza vaccine (FLU VACCINE VII, reported as flu vaccination) for vaccination and had no reaction. The patient received COVID-19 vaccine on 16Dec2020 between 10:00 and 10:15. His blood sugar was usually between 100 and 150. Now his blood sugar was shooting up between 200-250 in Dec2020. He took his blood sugar every day and realized it was going up. He was taking medication every day. He wanted to know if any other diabetic patients reported and increase in blood sugar after receiving COVID-19 vaccine. There were no additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination facility was hospital. The outcome of the event was unknown.
Patient got first dose of pfizer on 5/28/21 and 4 minutes after vaccine, started to feel dizzy. Patient did not faint or lose consciousness. Her mother was with her the whole time as well as myself. She felt fine after a few minutes, we gave her orange juice and candy and she was ok.
In September of 2021, I received my second dose of the Covid 19 Moderna Vaccine. I received this vaccine via my left arm. Following this shot, I did experience common side effects including fatigue and head aches immediately. Following my common side effects lifting after a few days, I noticed there continued to be a presence and "fullness" in my left ear. I monitored this, but continued to live my daily live. Then 12 days after my vaccine shot, I had my first episode of vertigo. I have never had vertigo in my life, but this episode lasted for about 5 minutes.   Following this first episode, I began experiencing mild to sever vertigo episode, tinnitus and temporary hearing loss. After my first episode, I went to multiple Ear, Nose and Throat doctors, general physicians and other specialists. These symptoms have not left after multiple months and I am continuing to work with Dr. on my treatment and a therapist for the mental hardship.   I do have a very long medical log of symptoms, dates and test that I am happy to share with  the CDC for research records. Although, I do believe these symptoms are directly from the Covid 19 vaccine.
Patient passed out at clinic - he has a history of anxiety and did not take meds before the shot because he was concerned about an interaction. The patient received his shot, sat down and fell out of the chair. He landed face first on the ground and hit his head on the corner of a post. He was rolled over and feet elevated. He came around quickly. He had a mark on his head. 911 was called on the scene to evaluate his head injury. Patient declined transport to the hospital and returned home. He was instructed to call 911 or report to hospital if he did not feel well tonight.
I missed my scheduled 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
This case was reported by a healthcare professional and described the occurrence of arm discomfort in a 67-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included PNEUMOVAX 23 (Merck) given on 7 December 2011. Concurrent medications included aspirin and multivitamins. On 7 December 2011 at 15:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right deltoid. On 7 December 2011, less than one day after vaccination with BOOSTRIX, the subject experienced arm discomfort and arm weakness. At the time of reporting the events were unresolved. It was reported that the subject was due for a doctor's visit soon and an assessment would be made at that time.
my left arm all of the sudden showed up as a bruise; left arm now is hurting me and it's tingling; left arm now is hurting me and it's tingling; my left arm is throbbing to the point that is shaking; my left arm is throbbing to the point that is shaking; My left arm goes numb it's tingling right now; going to sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at the time of vaccination was 56 years). The patient's medical history and concomitant medications was not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date dose 1, single for COVID-19 immunisation. On an unspecified date patient reported, the second shot which was like a week and a half ago, well around Monday her left arm all of the sudden showed up as a bruise, where the vaccine went in, and her left arm was hurting her and it's tingling (per caller: symptoms started a week after second vaccine). She never had a problem with her left hand, four weeks into this her left arm was throbbing to the point that was shaking. Her left arm goes numb it's tingling right now, I have to change hands with my left arm, that's a problem. She never had tingling in left arm and going to sleep all the time. She would never had this pain unless they did not inject her. Her left arm goes numb it's tingling, she had to change hands with her left arm. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna 4/1/21, 5/13/21. Positive on 7/15/22
Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Starting March 6, I noticed what looked like mosquito bites at the injection site, 4 numbs. We marked them around 5 PM and today, March 7 at 7 AM, they have swollen to 1 large mass about the size of a half dollar
pain started where shot was given still tender after six months since received shot. still bump in arm soreness tender, burning at random moments throbbing at random moments. sore when exercising and or using my arm only hurts in the area of where the shot was given
Fever, malaise , body aches, headache, foggy memory, fast heart rate lasting more then a week and progress worse each day diagnosis with sepsis in the hospital
Left hand and fingers: warm; Left hand and fingers: tingling; Left hand and fingers: numbness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Jun2021 at 00:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (aspirin) (MANUFACTURER UNKNOWN) and vitex agnus-castus (VITEX) for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 at 14:00, the patient experienced left hand and fingers: warm, tingling and numbness. Therapeutic measures were not taken as a result of the events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left hand and fingers: warm, tingling and numbness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had swollen lymph nodes under his left arm 3 days after injection was administered.  He stayed he had surgery to remove lymph nodes in June 2020.
This serious clinical study case, received from other health professional on 31-May-2018, concerning a female infant subject whose mother (age: 29, body weight: 202 lbs, height: 62.2 inches, body mass index: 36.7) enrolled in study. The patient's mother had no history of pregnancies and family history had no congenital malformations. The patient's mother had no habit of tobacco, alcohol or illicit drug use. The history of the patient's mother included hypertension and concomitant medications included VITAFOL ONE for healthy pregnancy. The last menstrual period (LMP) of the patient's mother was reported as 20-Jul-2017. On 17-Oct-2017, the patient's mother was administered with Influenza vaccine (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 12th week of pregnancy. On 17-Oct-2017, electrocardiogram (EKG) was performed and the result was normal (no major congenital malformations noted). On 24-Oct-2017, after 8 days of vaccination, the patient's mother was diagnosed with chronic hypertension. The patient's mother was treated with Labetalol (200 mg, twice daily via oral route since 08-Sep-2017) for chronic hypertension. On 24-Oct-2017, cystic fibrosis mutation analysis of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). On 25-Oct-2017, 1st trimester screen of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). The nature of pregnancy was reported as singleton. On 05-Dec-2017, the patient's mother had given the informed consent. On 20-Mar-2018, prenatal test of the patient's mother (Group B streptococcus agalactiae) was done which showed the result was normal (no major congenital malformation was noted). The estimated date of delivery (EDD) of the patient was 26-Apr-2018. In 2018, at 39.1 gestational age, the patient's mother gave birth to female infant (patient) of weight 2410 g (reported as low birth weight), length: 43.2 cm and head circumference was 34.0. Type of pregnancy was reported as caesarean. The APGAR (appearance, pulse, grimace, activity, and respiration) score at 1 minute was 7 and 5 minutes was 9. The patient had no pregnancy complications. This case was cross-linked to case 201703634 (mother case).
A week after I received Flu shot, I developed severe pain in my left groin muscle. Could hardly walk. Received muscle relaxer & prednisone seems to work, pain gone.
High Fever of 103.7.  The high fever reduced to 101.5 with one dose of children's acetaminophen.  His fever continued for 24 hours and was over by 3:00 PM on 9/18/2010.
Rt arm "extremely sore since pneumonia shot"; States "fever @ site when touched @ exactly where needle went in"; "Can't raise arm w/out excruciating pain"; "cannot hook bra"; Sleeping w/heating pad; Has not seen MD for arm; Aches X 8 hrs/dy
This report concerns a female infant who on an unspecified date was vaccinated with haemophilus B conjugate vaccine. Concomitant vaccinations included rotavirus vaccine and poliovirus vaccine. Subsequently the pt experienced diarrhea. The pt also experienced conjunctivitis, rash and fever following vaccination with hepatitis B vaccine, recombinant. This was originally reported by a physician. No further information is expected.