chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant medication was provided by the reporter.  The patient was supposed to receive the Bivalent Booster dose but instead patient was given the Monovalent vaccine ages 6-11.  No treatment medication was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661790 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Added patient demographics. Report type and I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661790:same reporter
First 24 hours - fever TMAX of 102.3, mild diffuse rash to posterior trunk, lethargy, small area of swelling/redness around site. >24 hours - Right Arm swelling & Redness spread (shoulder down to elbow), Very Hot to the Touch, Painful, Skin Sensitivity, child denied having any "tingling" or sensation issues in hand or arm, just "hurts". 48 hours - Swelling & Redness had progressed further w/ continued pain.
headache; a slight rash; flu like soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    The patient's past medical history included Multiple myeloma. Concurrent medical conditions included Allergy (Neupogen allergy), Allergy (Biaxin allergy), Allergy (Celebrex allergy), Drug allergy (Most opioids allergy reported), Sulfonamide allergy (sulfur based drugs allergy), Allergy (Morphine allergy), Allergy (Detrol allergy), Allergy (Hydrocodone allergy) and Amoxicillin (Amoxicillin allergy).   On 20-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness). At the time of the report, HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Narrative: Patient is a 73 year old MALE admitted with fever and SOB, very weak and fatigued. Positive cough and sore throat. On baseline 3L oxygen NC. previously vaccinated with Pfizer covid-19 vaccine. 1. Covid 19 positive infection with increased requirement of baseline oxygen Remdesivir(LFTs will need to be monitored closely as he does have a history of hepatitis C.), Steroids. Beta agonists. Guaifenesin. Tessalon Perles. Incentive spirometry. COVID-19 laboratories. 2. Mild COPD exacerbation possible bronchitis Will stop his Zithromax which is prophylactic 3 times a week. Will utilize doxycycline every 12 hours. 3. Diabetes mellitus, non-insulin-dependent Hold metformin. Sliding scale insulin. HOSPITAL COURSE: The patient was admitted to the medical floor and placed under droplet isolation precautions. Patient monitored with continuous pulse oximetry and oxygen weaned as tolerated. He was started on IV remdesivir and dexamethasone per protocol, as well as levofloxacin for empiric antibiotic coverage of COPD exacerbation. Steroids increased to solumedrol due to persistently poor air movement and wheezing. Supportive medications for airway clearance including mucolytics, flutter valve, and cough suppression provided. Steroids eventually weaned to prednisone 60mg with plans for out patient taper. Patient completed course of remdesivir and empiric antibiotics during hospitalization. Blood glucose was elevated during admission related to high-dose steroids and managed with basal-bolus insulin. As sugars improved with weaning steroids, patient not continued on insulin at discharge, but given glucometer and precautions to contact PCP or return to the hospital if hyperglycemic. CONDITION AT DISCHARGE: At the time of discharge, patient was hemodynamically stable and afebrile. He was saturating 93% on his baseline 3L supplemental oxygen. He was able ambulate independently.
Patient had a painful oozing sore on the corner of her eyelid and has a red streak down her face after receiving a Shingrix shot on 11/18/20.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned 11 patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 12-JAN-2022 reporter stated that, that is how I got it. There were 25 people both vaccinated and not vaccinated and 3 people not feeling well that did not say anything and came to the christmas gathering and 13 of the 25 we ended up getting tested and positive for covid and maybe even more than 13 because a lot of them thought it was just a cold and I told them no it is covid. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213503. This case, from the same reporter is linked to 20220108630 and 20220108126.; Sender's Comments: V0:20220140548 -COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
My first 2 covid 19 vaccines were Pfizer. This was my first Moderna and it was a booster shot. I had a very high fever (104), complete exhaustion-in bed and extreme body aches and headache for 2 days after the shot.  On Dec. 30, 2021 I had such extreme dizziness that I could not stand and had to lay down and was throwing up.  The dizziness slightly improved each day but didn't go away.  I continue to have some dizziness balance problems.  I had fatigue and headaches too after the dizzy spell.
I was in the hospital for 3-4 days. There were underlying conditions that I had prior. The day after the vaccine I got dehydrated, I fainted at work. I was taken to the ER. They saw that my heart was atrial fibrillation. I was kept at the hospital for a few days. They believe that my blood pressure went too low. I did a stress test and my heart is fine. I have been feeling since the hospital back to 100%. I have a bit of a headache that is continuing. We don't know if the vaccine.
On Feb 21st started getting congested sinuses with a temperature of 102F, went to the clinic to be seen on Feb 22..
Low grade fever, chills, body aches, sore joints, itchy tingly skin .  Rash and hives at injection site
99.9 fever with headache, body ache, chills. Nauseous. Feels little bit faint.  Good appetite, good smell.
Vaccine was administered on 5/11/2021 but was expired at the time due to 30 day rule. Vaccine was received in clinic on 4/6/2021.
Developed chest tightness shortly after vaccine.  Denies shortness of breath.  Patient was taken to urgent care for evaluation, but ultimately did not need any further work-up.  Questionable if patient even needed to be taken to urgent care based on our adverse reaction algorithm for COVID vaccination, but since she was transferred there, do feel obligated to submit report.  Patient has had a history of reactions to other medications (primarily chemotherapeutic agents) that have manifested similarly to this.  Discharged in stable condition.
Information has been received from a Registered Nurse concerning a 54 year old female patient with no pertinent medical history and no drug reactions or allergies who on 27-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot number: 670187/0895AA, expiration date 12-NOV-2012), 0.5 ml into the right arm. The registered nurse did not known if this was the first time this patient received PNEUMOVAX 23. Concomitant vaccine included FLUVIRIN into the left arm. The patient experienced severe right arm pain for 4 days after receiving PNEUMOVAX 23, and reported to the registered nurse that her arm felt like "dead weight". Also, it was reported that the patient was unable to "go to work". No lab test was performed. The patient sought medical attention by a phone call. At time of the report, the patient was recovering. Severe right arm pain and her arm felt like "dead weight" were considered to be disabling by the Registered Nurse. The nurse requested a lot check. A lot check for lot 670187/0895AA was requested. This is one of several reports received from the same source. Additional information has been requested.
today feel sickly; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an Adult patient (unknown gender and age) who today feel sickly, after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date in Dec-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; route, dose, formulation: unknown) in unknown administration site for Immunisation.  On 07-Jan-2022 the patient developed a non-serious "today feel sickly (malaise)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The following potential adverse event has been found on a public post. Author/Reporter Name:  Author/Reporter Location: Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Got mine 3 weeks ago today feel sickly gonna stay in bed".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was Not Applicable.  It was not reported if the patient received a corrective treatment for the event (today feel sickly).  At time of reporting, the outcome was Unknown for the event today feel sickly.
Vaccinated approximately 10:30 AM on 05/02/2011 at school.  Child reported to nurse that right arm area swollen and itchy approx 1 hr later.  Ice pack applied to right deltoid area, no itch or rash noted to any other area other than right deltoid.  No SOB or swallowing problems.  Mother informed.  Grandmother arrived to school with Tylenol and Benadryl which was taken about 11:45 AM and child attended school lunch with ice pack.  Principal informed.
he experienced sprain after his first dose; This is a spontaneous report received from a contactable consumer (patient himself) via Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sprain after his first dose on an unspecified date. Patient asked if he could take Tylenol since he experienced sprain after his first dose. Outcome of event was unknown.  Information on about lot/batch number has been requested.
Prolonged Fever, Tmax 104.9 for 5 days after vaccination. (Doing well this morning 9/20/16).
5/9/06 at 19:30 PM, T 101.3, lightheaded, nasal congestion, sore throat and decreased appetite. Nasal congestion persist today.
acute labyrinthitis; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 04-JAN-2022.The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around February 2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly, after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered acute labyrinthitis. As direct and proximate results of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX), also the patient experienced mental and emotional distress due to resulting physical limitations and seriousness his conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zoster Vaccine Live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX) wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of acute labyrinthitis was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The event acute labyrinthitis was considered to be disabling by the reporter.
Symptoms started with pain in arm where vacc was administered. As the day/evening progressed, patient started to get a severe headache, neck ache, back ache, dizzy, sensitive to light/noise, sharp abdominal pain, shortness of breath this has continued for over a week. She went to the ER 2twice, both times treated with a migraine and sent home. Exactly one week from receiving vacc, fam dr agreed something was wrong with patient, spoke with a neurologist who advised to get her to the hospital immediately.  There she was on morphine for a week straight, received MRI's, CAT scans with and without contrast, xrays, ultrasounds, spinal tap, HIDA scan tons of lab work.... she also became non responsive at one point and dr's couldnt explain how or why it happened.  She was discharged with heavy narcotics and only a diagnosis of mononucleosis. They also thought she had pneumonia, Lyme disease, West Nile which all turned out to be false positives. At one point they were getting ready to remove her gallbladder but did further tests to realize it wasn't necessary. She's been back to the ER since this visit, just 2 wks ago, with shortness of breath and major chest pain... all xrays, labs, CAT scan and HQ scan turned out good, all organs appear fine. Dr discharged her with no diagnosis as he couldn't figure out what caused the pain. He sugg she follow up with 2 other specialists which we have appointments for 1 and trying to get the other one scheduled. Each day is different pain, never knowing what is going to happen with her :(  She no longer can do most active things, sports/workout etc... all from Gardasil vaccine :(
Sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737836 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For brother case (Same reporter) US-MODERNATX, INC.-MOD-2023-737836:2nd sister case
Scared; Big swelling on the left arm; little knot on the collar bone; Nervous; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Big swelling on the left arm), MASS (little knot on the collar bone), NERVOUSNESS (Nervous) and FEELING ABNORMAL (Scared) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PERIPHERAL SWELLING (Big swelling on the left arm), MASS (little knot on the collar bone) and NERVOUSNESS (Nervous). On an unknown date, the patient experienced FEELING ABNORMAL (Scared). At the time of the report, PERIPHERAL SWELLING (Big swelling on the left arm), MASS (little knot on the collar bone), NERVOUSNESS (Nervous) and FEELING ABNORMAL (Scared) outcome was unknown.        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.   No concomitant medication included.  No treatment medication included.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Abrysvo vaccine leaked everywhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Abrysvo vaccine leaked everywhere".  The reporter considered "abrysvo vaccine leaked everywhere" not related to rsv vaccine prot.subunit pref 2v. Causality for "abrysvo vaccine leaked everywhere" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".   Patient reported no adverse reactions.