chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in his ear / fluttery feeling and sounds in his ear; Still not feeling great; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (Got a tetanus shot two weeks after the first dose).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches). At the time of the report, TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
My tongue swelled and got numb. I had taken a Benadryl 15 minutes prior to the shot. I couldn?t feel it for a couple of hours.  I took strong antihistamines for 48 hours every 4-6 hours. I also had a sore arm. Second dose lot number 030M20A. I took a very strong antihistamine prior to vaccine.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Patient was on chronic medications. No treatment medication was provided.   This case was linked to MOD-2021-398880 (Parent-Child Link).   See case MOD-2021-398880 for details regarding the child case.
Developed chest pain, malaise and SOB in mid May seen in ER , MI ruled out, saw cardiologist and had cath which was negative,  continued symptoms, seen in ER again and  finally found to have pulmonary emboli.
Mild to moderate headache started 1-2 days after receiving Pfizer COVID19 vaccine. Almost daily mild headache since.  Confounding factors including poor sleep hygiene, excessive caffeine use, and decreased fluid intake.
At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor headache, a slight sore throat, and  minor eye pain like they were dry. Though i I felt terrible, the most concerning side effect was that my skin felt like it was extremely raw in patches all over my body where if my sheets lightly touched one of those ?patches?, it would be very painful. However, there was no rash or discoloration from what I could tell. I also had strange painful sensations at the ends of my toes but were different in quality relative to the hypersensitive/raw painful sensations on my skin. The adverse events kept me awake for hours but when I finally got to sleep and woke up the next morning.  I only had chills, weakness, and acheyness which were much less in severity than those early morning hours. It is now 4:45 pm and the only adverse effect I am still feeling is the fatigue. Also, I forgot to mention it on the medication portion but I had taken 400 mg of ibuprofen about 15 minutes before receiving that second dose.
cold w/runny nose, congested lungs & fever (102 x 2 days) began about 29MAR & lasted 3-4 days; devel fine raised rash around ears 3APR; seen by MD 9APR & had neg strep test; started amoxicillin; as of 12APR93 afebriel, lt rash cont, ornery;
Tiredness, body ache, headache, slight fever, cheat pain on right side, body chills.
PROQUAD vaccine was one day expired. Pt was notified and will be revaccinated. Incident reported to Merck as well.
The pt experienced fatigue swollen hands, wrist and feet pain, low grade fever, night sweats, difficulty breathing, neck pain, hand tremor, bloodshot eyes, pleuritis, Treated with Doxycycline for 10 days prednisone, Prevacid, Voltaren and Ultram). the pt also experienced chest pain, and a restrictive feeling in throat.
Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic.  She returned 2 hours later with anxiety, hyperventilation and paresthesia.  Vital signs showed improvement before symptoms resolved.
After getting the shot my arm started swelling up around the injection/Second day swelled more around the arm /On the 8th day after injection my arm swelled up around the injection again; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; was hot to the touch; hard hot to the touch; This is a spontaneous report from a contactable Other-HCP (patient). A 25-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at arm right on 31Dec2020 13:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included Asthma allergies attention deficit hyperactivity disorder. There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "After getting the shot my arm started swelling up around the injection. It got extremely red and it hurt and itched. Second day swelled more around the arm and was hot to the touch. 3 day it went away. On the 8th day after injection my arm swelled up around the injection again. Itches and hard hot to the touch". Adverse event start date provided as 01Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was unknown.  Information on Lot/Batch has been requested.
Could not use my arm for 4 days, had cold sweats, and ultimately, after reaching menopause at age 45, began with hot flashes in my 65 degree bedroom since the second vaccine.  Unsure if this is a life long thing now.  Item 21 does not allow collaboration or explanation of a "question" of a life long result.
The pt experienced bruising that developed approximately 3 weeks post vax. Diagnosis of idiopathic thrombocytic purpura.
An initial report was received in the USA from another manufacturer HQWYE0613625FEB05 on 7/5/05. It was reported that a 2 year old male child, was found to have autism that was dx'd in May, 2004. That manufacturer received this report from the pt's relative. He received IPOL, lot numbers, sites and routes not reported, on 8/24/01 and 12/19/02. Exact latency, concomitant medications and past medical history were not provided. The pt has not recovered.
Arm got sore; Headache; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. Caller also reported information for her husband who is the patient in report 2 of 2.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 06Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced minor side effects after vaccination. On 06Jun2021, the patient arm got sore on night. On an unspecified date in Jun2021, the patient experienced headache, tiredness and muscle pain. She thought these were just normal symptoms and called to ask if she can take Ibuprofen to see if she could knock this headache and muscle pain out. The outcome for the events was unknown.   Information on the lot/batch number has been requested
Paitent had redness and hardness at site of injection. We told to ice for 15 minutes and use analgesic if could tolerate.
Sore Left Arm, High Fever Controlable, Chills, Headache, Body Aches, Fatigue
Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023; No Adverse Event; patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-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-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) 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 (patients administered doses after the BUD) and PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023).    This case contains information for the 5th of 6 adult patients described by the reporter.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Follow-up received in which batch number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
She started getting sore throat & horrible cough approximately 4 hours after vaccine, called MD they said to just rest probably from shot. she called me I told her take Benadryl b/c her face was swelling / lips swelling. She took outdated 10/3 then 10/4 9:00 AM took good date feeling much better after 2:00 10/5/19 speaking w/ pt as of 2:00pm 10/5/19 pt is feeling much better. No doctor office visit or any other things needed. Pt just took Benadryl & slept.
like the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced aches like the flu.
He completed the series of COVID vaccines in June 2021. He was admitted to another hospital due to COVID pneumonia from 8/9/21-8/13/22 and readmitted with fluid overload from 9/5/21-9/9/21. He came to the Hospital on 9/9/21, complained of SOB. He was tested COVID positive on 9/9/21, and he was given diuretics for CHF. His condition was improved, and he was discharged home on 9/13/21.
Initial report received on 27 October 2009 from a healthcare professional. A 13 year old female patient with no previous history of pregnancies and a "negative" medical history received MENACTRA (lot number U2925AA) and BOOSTRIX (manufacturer GSK, lot number AC52B045BA) on 16 September 2009. On 27 October 2009, the reporter discovered that the patient was 29 weeks pregnant. At the time of vaccination, the patient was 24 weeks pregnant. Date of last menstrual period and estimated date of confinement were not reported. Information regarding tobacco, alcohol, and recreational drug use were unknown. At the time of the report, the patient had not experienced any adverse events following vaccinations on 16 September 2009. Follow-up information was received from a healthcare professional on 28 December 2009. The reporter noted that the patient was unaware of her pregnancy, and did not access prenatal care until 29.4 weeks gestation. On 08 October 2009 she underwent an ultrasound, which showed normal fetal anatomy, normal AFI (13.73 cm), and normal placenta (grade 0). All labs were normal, except for hematocrit (29.4) and hemoglobin (9.3). The patient was diagnosed with severe anemia. No additional information was reported.
2 days after vaccination a large area of erythema around 2 inches in diameter at injection site. Just posterior to this were 2 1 cm urticaril lesions. Very prurtic. Also with runny nose, cough, but not sure if related although it occurred within 22 hours of vaccination.
Within 10 minutes of receiving the vaccines, she fainted for 1-2 minute - loss of consciousness. Placed on the floor. For 40 minutes continued to not feel well and remained groggy. 911 summoned and took her to hospital ER. Given IV hydration over 2 hours and was discharged home in good condition. No sequelae since the incident. (called patient on several occasions).
Pain spread in muscle flesh, in ring form away from  right arm injection site, down arm to elbow, across and down upper right side chest, and down back side similar to chest. A dull ache remains in upper right side of body 3-months later.
Swollen finger; Redness on stomach; Tiredness,fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache). The patient was treated with OXYCODONE for Pain, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache) outcome was unknown.            Concomitant drugs include thyroid medication , and Hormone cream.  Treatment medications include ANTI NAUSEA medication.
a patient received the Moderna vaccines only 2 weeks apart.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.). On 23-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter
Arm was sore. I started taking Advil the evening of 5-4-21. The next morning, I woke up with chills and weakness. I was unable to lift arm to shoulder without discomfort. I took more Advil. I had a 101.5 fever. I actually felt worse than I did when I had COVID back on 12-10-20. I spent the next 4 hours in bed. I got up at 11:00 am and went to the couch to lie down for most of the day. I started feeling slightly better around 5:00 pm. I had dinner and laid around. I went to bed at 10:00 pm. Everything lasted a period of 23 hours. I'm feeling back normal today.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-DEC-2015 at 08:30, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.3 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient during routine observation a flag for 30 minutes began to feel sweaty, hot flash sensation and began tohyperventilate. Patient was identified by observation staff as follows:  Awake x3, no chest pain, slight SOB, increased work of breathing without rales, rhonchi or wheeze.  Pulses strong, capillary refill at 2 seconds, warm and dry. Patient is hyperventilation state without carpal spasms.  Patient placed on pulse ox at 98% room air, pulse 88 and BP 174/84.  No rash or hives, - supportive treatment - Refused additional treatment
A report was received from a health care professional on 12/11/03 concerning approximately 10 children between the ages of 6 months and 3 years who inadvertently received Fluvirin between the dates of 12/8/03 and 12/10/03. Between the dates of 12/8/03 and 12/10/03, approximately 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
We had a MA that drawn IPV for patient when patient was suppose to receive HPV9 - it was given by mistake. Patient was contacted by provider. He had no symptoms or signs.
Pt describes small red itchy bumps on different parts of his body which appeared 3 days after immun. has gotten better over following 2 days.
Patient is 17 and not approved to receive the Moderna COVID vaccine.  Monitored for s/s of adverse reaction on site.  Followed up with parents as well.
Havrix expired vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 29th August 2022, the patient received Havrix. On 29th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's comment: The reporter stated that an expired dose of Havrix vaccine was administered to the patient. The reporter did not consent to follow-up. The reporter declined permission to create an account at in database. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Initial unsolicited report received from a Nurse on 11 November 2015. This case involves an adult female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV (Dose, route and site of administration, dose in series, batch number were not reported) on 4 November 2015. The patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were not reported. The patient's Concomitant medications were not reported. On 4 November 2015, same day after vaccination, the patient developed a rash on chest, neck and on 9 November 2015, 5 days after vaccination patient experienced bilateral tingling in feet. The patient required ER/doctor visit. The patient's laboratory data was not reported. The patient's corrective treatment includes Medrol dose pack and Claritin. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Given injection 12/28 at 2:36. Extreme arm soreness immediately. That night I noticed random bruising all over my body. Next day I had a major headache all day. Today, woke up with a major headache, full body aches, joint aches, chest pain, heart palpitations, and extreme fatigue.
I had a horrible headache from the first vaccine. I took the second one and my headache increased and I had ringing in both ears. On the 10th day after my second vaccine, I had a lump in my armpit, you could see the lump travel from wrist to armpit .I also got dizzy. My face, chin, left arm and feet on left side went numb, it was all the way up my body. I never passed out. The numbness on left side lasted for 2 days. It went away about mysteriously as it came. It appeared that I had a stroke. I had 9 more instances like that over the next 6 weeks.
This patient was exposed to his sibling with the chicken pox on 03/31/01, 30 - 40 lesions on his trunk, extremities and mouth. Afebrile.
had screeching cry, starting @ 5PM on 25JUN93 lasted util 130AM went to sleep; woke up 9AM & played well started having intermittent staring spells lasting 2 minutes each & lasted for 2 days period;
Big hive at shot site with 3 smaller hives in area.  Area is very hot and extremely itchy.  It's been this way since 2am on Friday 2/19/21.  I take Benadryl at night and cortizone and ice on it during the day.  As of Monday, 2/22/21 it is still the same.
Low grade fever reaching 103 at highest - lasted for 5 days followed by extreme fussiness that still persists- called nurse who thinks it is a reaction gave infant Tylenol to reduce fever.
While administering the vaccine,  the Medical Assistant states she did not fully clear the syringe when she pulled the needle back out of the patient, resulting in the vaccine to spill/spray out. Based on the event, it was discussed with Provider and Pharmacist and it was recommended to revaccinate the patient in one week to assure she receives the full dose for her 1st dose of Moderna vaccine. Vaccination from 9/7/2021 was determined to be invalid and removed from WIR. Patient returned to clinic on 9/14/2021 to receive the revaccination of her 1st dose. Patient is scheduled for her 2nd dose of Moderna on 10/12/2021.