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 23-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 23-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 relevant concomitant medications were reported. 3 administrations of 23 Jun 2023 and thawed on 10 Jun 2023. No treatment medication reported.  This case was for the 19th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Patient with a history of thalassemia and Gilbert's disease, developed severe jaundice three days after vaccination. Had mild headache and sore arm but otherwise felt well. Had labs drawn - found to have highly elevated bilirubin (23) and LFTs in the 700s. Was admitted to the hospital and had CT showing Cholelithiasis, choledocholithiasis and minimal intrahepatic biliary ductal dilatation. Left hospital and was admitted to another facility where plan was for ERCP and cholecystectomy. Ultimately unclear if at all related to the vaccination - may be coincidental.
Leg slightly swollen and pt does not want to put any pressure on her left leg at all and states her feet hurt
Patient received shot on 8/2/07. On 8/3/07 pm patient developed fever, joint pains, left arm & left axilla swelling and generalized itching .Pt took NSAIDs for the above symptoms, felt little better next day pt continued to work, as the pain was getting worse pt had been to ER on 8/5/07 where pt was advised to take NSAID & benedryl and discharged same day.
Pt has episode of vomiting and noted to be limp while asleep in bed. Parents pushed her up and pt was limp with eyes rolled back and teeth clenched. After few minutes, pt started to cry and was tired. No fever, no further episodes observed.
suspected vaccination failure/had the shot and got shingles afterwards; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The patient was the reporter's mother. Age at vaccination was not reported. The patient had received the Shingles vaccine and experienced shingles afterwards. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Patient reported a headache that began 3-4 days after vaccination. It gradually worsened over the following 7-10 days, then stopped without treatment.
Swelling of eyelids and tongue. Benadryl helps. Later in the week- rash, flushing, chills, achy joints, ache of bones, liver swelled under ribcage (visible to the eye as well), diarrhea, heart palpitations, headache, lower back ache by kidney, green sludge bowel movement after 2 1/2 days, headache. Continued all prescribed medications and increased Benadryl. Now experiencing cramping and breakthrough bleeding. Already through menopause.
Injection Site Urticaria Information has been received from a health authority (case #66259) concerning a 46 year old male with no previously reported medical history who on 19-JUN-2006 was vaccinated in the left deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (thimerosal free) (lot#653198/0957R, batch #NC60730). On 19-JUN-2006, 15 minutes after vaccination, the patient presented with a hive-like lesion on the left deltoid (injection site) and was hospitalized. Subsequently, the patient recovered. The duration of the event was not reported. Other business partner numbers include E2006-03298 and IT314-06
lump swelled up to size of boiled egg; flu like symptoms; lump developed in lower part of neck; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (lump developed in lower part of neck), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE MASS (lump swelled up to size of boiled egg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ADALIMUMAB (HUMIRA) for Skin discomfort.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (lump developed in lower part of neck), ERYTHEMA (redness) and SWELLING (swelling). On an unknown date, the patient experienced INJECTION SITE MASS (lump swelled up to size of boiled egg). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ERYTHEMA (redness) and INJECTION SITE MASS (lump swelled up to size of boiled egg) outcome was unknown and SWELLING (lump developed in lower part of neck) and SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Chills started 7 hours after the injection around 8:00pm, followed by uncontrollable shaking. Headache started at 1:00am, followed by fever of 100.8.  A few hours later, fever climbed to 102.  Experiencing body aches, lethargy and exhaustion.
Child had seizure after receiving vaccination, nausea, throwing up, Fever, Headaches
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/30/2021 INFLUENZA
Pt calls to state she has a hard 50 cent sized red area that is warm to the touch at injection site. She also complains of soreness in the arm. She was instructed to apply ice, take ibuprofen, and call if symptoms persist.
After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed around 10:30 pm I started feeling nausea, followed by vomiting twice. Throughout the night I had body aches from head to toe. Also experienced body chills which continued the next morning.
This spontaneous report as received from a nurse practitioner via company representative refers to a 5 year old female patient. The patient's current condition and medical history are not reported. On 24-APR-2014 the patient was vaccinated with PROQUAD of unknown dose, frequency and route of administration (Lot # reported as J006163, expiry date unspecified). On 07-MAY-2014, 14 days after the onset of therapy the patient broke out in a rash after vaccination. It was reported that the patient received treatment and no product quality issue is reported. The outcome of the event rash is unknown. Causality was unspecified by the reporter. Additional information has been requested.
- soreness of arm & tiredness ~6:30pm 12/23/21 -chills ~9:00pm -11pm ish (fell asleep) 12/23/21 ; 11:00 am -11:45 am 12/24/21 -headache & nausea 11:20am 12/24/21 - 5:00am 12/25/21
Extremely fatigued and exhausted. I had a dull pain in my lower abdomen and stomach area. I could not stand up out of bed, and I had to get my husband to allow me to wrap my arms around his neck to stand to go to the bathroom. I stayed in bed, and on the 3rd day, I was taken to get a CT scan at local Hospital, at the advice from our Urologist, Dr. "PRIVATE". Instead of kidney stones, they found Acute Appendicitis, and called me from the Emergency Room to return to the hospital immediately. I was taken back and prepped for a 45 minute surgery that lasted 3 hours. My appendix was actually ruptured, and the surgeon performed a cleanup in that time robotically.
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021 at 12:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) 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 36.93.  Concomitant products were not provided.  On 08-JAN-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-JAN-2021, 09 vials were moved to the clinic. On 11-JAN-2021 at 2 PM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-FEB-2021.  it was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.  This case was linked to MOD-2022-56697.
Redness, pain, swelling given Prednisone and BENADRYL.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient stated her eyes were extremely swollen post vaccine and she is currently still recovering (Day 3). She has been taking benadryl and the swelling around both eyes has slowly gone down. Her eye sight is not effected, but she was very concerned.
MUSCULAR PAIN IN LEFT BICEPT X 5 DAYS PAIN LEVEL 4/10, PAIN ALSO WHEN LIFTING ARM. MILD RASH ON ARM W/PINK INFLAMATION ELBOW TO SHOULDER (ITCHINESS) CALLED PHARMACIST AT PHARMACY SHE RECOMMENDED ICE PACKS AND BENADRYL. I TOOK A BENADRYL ON 7/17 AND 7/19. AND USED ICE PACKS SEVERAL TIMES A DAY FOR 4 DAYS. -ALL SIDE EFFECTS HAVE STOPPED BY 6TH DAY -(7/22) - PAIN & RASH WERE NOT PRESENTED AFTER THE 1ST INJECTION (DOSE).
Fever, Diarrhea, NauseaVomiting. arm pain Narrative:
On 10/10/2000 the patient developed a papular rash on her face, arms and neck. It was noted that the patient has no history of wild type varicella. Follow up information from a physician indicated that approximately one week later the patient recovered. No further information is available.
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.
A spontaneous report was received from a consumer concerning a male patient of unknown age, who experienced dizziness, nausea, diarrhea and weakness.   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) for prophylaxis of COVID-19 infection.   The patient left a voicemail inquiring what to take for the side effects he was experiencing. Per patient, he was experiencing dizziness, nausea/diarrhea, and reported being "real, real weak." Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events is not applicable.   The outcome of the events, dizziness, nausea, diarrhea, and weakness were not reported.   The reporter did not provide causality for the events, dizziness, nausea, diarrhea, and weakness were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
no adverse event; administered after temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, concurrent condition and drug reactions/allergies were not reported.  On 25-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml subcutaneously (SQ) for prophylaxis (lot # U022321, expiration date: 15-JUL-2023; strength was not provided) after a temperature excursion (temperature: 6 Fahrenheit (F); time frame: 30 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
I missed my 2nd vaccine passed 42 days...can i still get the 2nd; 2nd vaccine passed 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days...can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days) in a patient of an unknown age and gender who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days...can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days..can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
at time of shot felt like shooting pain down arm, over time  it felt like pain throughout upper arm, difficult to lift past shoulder without pain
Fatigue;  Fever (101}  muscle leg aches,  headache, loss of appetite
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single and on 12May2023 as dose 5 (booster), single at the age of 32 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included: Paxlovid from 12Sep2023 to 16Sep2023.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Rash with itch, mild pain, slight swelling, tightness- developed  11 days later.
Adverse effect after the booster. Intense inflammation of the hand, arm, elbow and shoulder as never before experienced.
A mother reported that her 7-month-old son received his second dose of Prevnar along with DTaP (manufacturer unknown), Haemophilus Influenza B (manufacturer unknown), and Hepatitis  B (manufacturer unknown) and Hepatitis B (manufacturer unknown) vaccines on 20-Jul-2001. Subsequently, the infant experienced a "small" allergic reaction which the reporter did not describe. No further information was available at the date of this report.
I was unable to sleep and began to feel significantly overheated by 10 or 11pm the night of my vaccination. To give a sense of the extent of the disturbance, I ended up standing outside for 10 minutes without shoes or socks in the cold night air (~45°F) to cool off, but remained shiftless the rest of the night and was unable to remain asleep for a full sleep cycle until early morning (4 or 5am). I did not take my temperature at any point but did not appear to have a significantly warm forehead. The next morning I woke up with a very sore left shoulder and arm (i.e. the site of my vaccination) and general muscular stiffness in my back. Raising my arm increases the soreness significantly. I have no concerns about my reactions, but they were significant for a first Pfizer COVID shot so I am reporting to provide information to VAERS.
The next day after my vaccine, I began to have a high fever, sore arms just for the day after. I took Tylenol to help with the fever and Ibuprofen as well in order to get the fever to break. After that, I had a low grade headache and body aches. Symptoms have completely subsided after about a week.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (6 glasses of wine/week). Concurrent medical conditions included Meniere's disease (Recent change: Intermittent Vertigo issues and Loss of hearing.) since 15-Jun-2018. Concomitant products included CISAPRIDE (PLEXUS [CISAPRIDE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CALCIUM for Pregnancy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 01-Jul-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Ultrasound scan: normal.     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.   Treatment medications were not provided.
Pt reports next day arm sore and unable to lift arm. She took NSAIDs and rested it and it seemed not to help. She seen our clinic provider who dx it as nerve pain and was given more NSAIDs. She still is having problem lifting arm and is painful.
Pt received FLUZONE HD & said shot was painful. She then received ZOSTAVAX & said she "didn't feel well" & asked for water. She said she felt faint & I administered a smelling salt. She still felt faint & she lay down on floor. Her blood pressure was 127/58. She felt better after several minutes.
reported all over body hives, swelling at vaccine site and slight swelling at the mouth around lips
Varicella vaccine was given in left anterior thigh. Immediately following the vaccine the patients leg appeared very red with welts measuring about 2 inches. no systemic signs. Observed patient for 30 mins in office and applied cold compress for 8 minutes.