chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen not provided), lot # W002601 and expiration date 24-JAN-2024 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion for 1 hour and 45 minutes on an unknown date; previous temperature excursions were reported.  No adverse symptoms were reported.
poison ivy; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced poison ivy and was placed on Prednisone.  She called in to ask if she needs to postpone her second dose appointment due on Friday 23Apr2021. The event outcome was unknown.    No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Bruising at the injection site that is growing larger each day, with a small red halo around the actual injection. No visit to the doctor, just keeping an eye on it. Have applied arnica cream.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Plasma cell myeloma" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR SODIUM], start date: 07Jan2022; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 15Nov2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional Information: Patient received Paxlovid anti-viral details [{product=COVID 19 Treatment with start date was 04May2022 and stop date 09May2022, other medication in 2weeks product was Zyrtec D other medication in 2weeks start date 04May2022. Adverse event: Symptoms returned today (13May2022). Runny nose, sore throat, and cough. The symptoms had been gone for a few days but I woke up at 4 am with them back and have had them since. Patient had no allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A medical assistant reported that hepatitis B vaccine recombinant (Engerix-B) was inadvertently sprayed into the eye of a 24-year-old female. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 03/25/2003, while preparing an injection of Engerix-B for administration to a pt, the pt inadvertently sprayed Engerix-B into her eye. "Just after it happened", she experienced "minor" eye redness and irritation. Her eye was flushed with water and the events resolved after 15 minutes.
Carbuncle lesions on right arm, lower abdomen and lower extremities, Onset 3 days after shot Still present 9 days later. Tx with Keflex (began today) 500mg PID X 10 days.
Pt was in clinic 9-5-08 for Tdap for nsg school.  On 9-6-08 pt went to ER - for N/V, diarrhea, slight fever & swollen lf arm & eyes - body aches - pt OK by Dr. as having viral syndrome & discharged. OK since last TD.
Immediately following the injection lip numbness and facial swelling occurred, followed by a headache and systemic itching. Benadryl, Pepcid, and Ibuprofen were administered by pharmacist. Then lymphadenopathy especially in the left axilla, neck, and left arm. Followed by joint pain and difficulty making a fist. Returned home to rest and continued taking Benadryl, Pepcid, Tylenol/ Ibuprofen from 10/7 to 10/9 in the evening then continued with scheduled Tylenol/ ibuprofen until 10/13. On 10/7 began having abnormal early heavy menstrual cycle until 10/16 as well as excessive gum bleeding and black stools. As well fatigue and dizziness upon exertion. Primary care provider was notified and seen in office on 10/13 and lab work was completed on 10/14 to rule out thrombocytopenia.
nausea 11AM, itching all over 12Noon; hives wrist & shoulders 1PM; seen by MD 4PM prescribed DPH;
Acute Inflammatory Demyelinating Polyneuropathy/Guillain-Barre Syndrome, 6-day in-patient hospital admission, IVIG for 5 days, outcome undetermined as yet. Initial symptoms include severe low back pain for a week followed by bilateral leg weakness and ascending paralysis.
had trouble breathing has not been the same since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "not recovered", described as "had trouble breathing has not been the same since".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came and stated no previous vaccines had been received.  Pfizer COVID-19 vaccine was given without incident.  After patient left, it was discovered that the patient received a Moderna COVID-19 vaccine on 1/10/2021,
Tinnitus - severe ringing in both ears since 4/12/21  buzzing, hissing sound causing difficulty in hearing and interupting   job performance.  Doctor examined my ear on 4/16/21 but saw nothing  abnormality
Patient reported the next day to the pharmacy to describe adverse event. She states about 1.5-2 hours after the shot she began to experience chest pain and tightness as well as her head feeling weird and headache. She states that she laid down and went to sleep. She reported having trouble sleeping but by the morning she was feeling completely normal. She came to the pharmacy at 2:30pm to report all this, I asked her how she was feeling today and she reported no lingering symptoms. She stated she just wanted to report the reaction but now she is fine but she was scared. I asked her if she has ever experienced a reaction to a vaccine before and she said no she gets a flu shot every year with no issue. I told her in the future if she were to experience chest pain, etc she should seek medical attention while it is happening instead of waiting until the next day. I asked when her next physician appointment is so that she can follow up and also report the reaction to them, she states she has an appointment made for 8/25/20.
Worsening tinnitus noted immediately after booster dose of Moderna.  In retrospect, onset of tinnitus initial onset of tinnitus had been after primary series of Moderna vaccine 1/21, however the association was not apparent until the booster dose.
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician's office concerning a 16 year old female patient who feels like fainting, nausea with most vaccines and fear of needles who on 26-JUN-2007 at 10:30 AM who was vaccinated in to right arm with a first dose of GARDASIL. Concomitant therapy includes MMR. The patient went home and felt like she was going to faint but she never fainted after receiving her first dose of GARDASIL. The office also reported that the patient slept for a "really long time". The patient sought unspecified medical attention. The patient recovered. Additional information has been requested. In follow up it was indicated that patient had nausea and she fainted in the office. On 29-JUN-2007 the patient recovered. Additional information is not expected.
Mild coughing about a half hour after vaccination administered Mid-afternoon, achiness and chills About 7 pm, intense itching and tenderness at vaccination site Took aspirin, slept all night, some symptoms in the morning, but they were gone by about 10 am
10 minutes after receiving vaccination she became dizzy, faint, nauseated, and her blood pressure bottomed out. 10 minutes later from 100 resting hear rate her heart rate jumped to 230.
I've HAD MILD TINNITUS SINCE ABOUT 1970. About 2-3 weeks after the 2nd Covid-19 vaccination the tinnitus Increased substantially. I believe it has continued to worsen over time.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 016M20A, 027A21A and 037C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medication was provided by reporter. A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were - 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose).  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260, US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:MAster case US-MODERNATX, INC.-MOD-2023-704260:
At 10:25 patient received her 5 yr immunizations, which included Dtap, IPV, and MMR. At 10:35 patient began to complain of neck pain and abdominal pain. There was no evidence of rash, swelling, itching, or difficulty breathing at this time. The patient then got a sip of water and swallowed this without difficulty. At first the patient stated the water made her feel better, but then she began to complain of neck pain and abd pain. The patient was then placed back in her room for re-evaluation by the physician. At 10:40 the patient was re-evaluated by the physician. At this time the patient had developed redness on her legs, arms, and ears, has started complaining of itching, and still had neck pain and abdominal pain. There was no difficulty breathing or swallowing at this time. At 10:45 2 tsp of Benadryl was given by mouth vital signs at 10:52 were BP 90/50, heart rate 144. 0.2mg of epinephrine 1:1000 was given subcutaneously. By 11:00 patient stated the itching was getting better and she was feeling much better. Vital signs at 11:05 were BP 102/60, heart rate 132. At this time patient was playing in her room and did not have any complaints.
High fever, intense head pain, (sensation of pounding in head) tiredness, enlarged neck nodules.
Vasovagal syncope. After sitting for a few moments on the exam table after the immunization (none other given today), patient stood to walk out of exam room. She reported to her mother that she did not feel well and then fainted. Mother reported catching her so patient did not injure herself on the floor. She quickly recovered but had low blood pressure (normalized within 10 minutes) and normal blood sugar.
soreness in right shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2017-2018 season) for prophylaxis.   In August 2017, the patient received Fluarix Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2017-2018 season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Fluarix Quadrivalent 2017-2018 season.  Additional details were provided as follows: The age at vaccination was not reported. In this case the reporter is the pharmacist and patient also. The patient received Fluarix Quadrivalent 2017-2018 season and had intermittent soreness in right shoulder after vaccination that lasted up to 30 days. Maybe 3 other colleagues who got shot at same time reported similar. The reporter would like to request, if possible, the health care professional address for the case attached. The reporter has agreed to follow up. This case linked with US2019GSK104482, reported by same reporter.
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine.  Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more  IV fluids.  Slow recovery and observed over 5 hours. Went home.
Patient developed rash on 7/25/06 that became blistering. Seen in office. Dr. diagnosed varicella on 7/26/06.
This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Nov2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Nov2021, the patient experienced fever. The event did not result in doctors 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 fever was unknown at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.
Arrived at clinic c/o chills and body aches. Temp taken=103.6. Unable to contact guardian by phone, msg. left. Uncle was called--said he would try to contact guardian to inform of student's condition.   ~15 mins. later, temp retaken= 105.3. Ice packs applied to back and cold towel to forehead.  10:55, still no contact from guardian, 911 was called. EMTS arrived at 11:05. Took temp=104.  Child was transported to ER, treated with antipyretic, Discharged from ER.
Tension-Type Headache (12hrs post vaccine up to 48 hours) Fatigue and Lethargy (7hrs- 48hrs) Elevated Body Temperature (12-36hrs) Chills (12-36hrs)  Stomach Cramping (12-24hrs)  Nausea (24-36hrs) Body Aches (24-36hours) Insomnia (2 nights)   Night Sweats (Second night; approximately 24hrs after vaccine)   Missed time at work due to above  Symptoms improving spontaneously approximately 48hrs after vaccine. Acetaminophen 500mg as needed mildly alleviated symptoms.
ADMITTED TO HOSPITAL ON 1/20/2022 FOR ACUTE HYPOXIC RESPIRATORY FAILURE SECONDARY TO COVID-19 INFECTION. ARDS AND POSSIBLE BACTERIAL INFECTION, PNEUMONIA, PULMONARY EDEMA, ACUTE HEART FAILURE AXACERBATION, AKI ON CKD, AND RIGHT ATROPHIC KIDNEY. TRANSFERRED TO ICE AND INTUBATED ON 1/25/2022.
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0937. MD made aware.  No harm to patient or adverse reactions.
This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 28 year old female patient with none drug reactions/allergies. The patient's medical history included adenocarcinoma. On 26-DEC-2013 the patient was inadvertently vaccinated with a dose of GARDASIL, 0.5 ml, intramuscularly. There was none concomitant medications. The patient was pregnant with last menstrual period (LMP) of around 21-JUN-2013 and estimated due date (EDD) of 28-MAR-2014. To confirm pregnancy urine pregnancy test was performed on an unknown date. Initial exposure to GARDASIL was at 27 week(s), also reported that patient was around 28 weeks pregnant. The pregnancy outcome was outcome pending. There were no known drug effects. The patient sought medical attention in the office where she was given GARDASIL. Additional information has been requested.
experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (experienced 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (experienced side effects). At the time of the report, ADVERSE REACTION (experienced side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.   This case was linked to MOD21-019807 (Patient Link).
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 25-NOV-2015, the patient was vaccinated with improperly stored VARIVAX lot # L015045, dose number 1. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. received vaccine app. 1145 am 12/2 (Friday). Reports terrible joint pain, fever (no temp) trembling and headache that lasted until Sunday. Also says dehydrated.
This spontaneous report as received from a healthcare worker and a nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reprots from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 07-APR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: K010219, expiry date: 02-JUN-2015). This is one of several reports from the same reporter. Additional information has been requested.
Sore left shoulder for three months. Autoimmune response until now (3 months): fatigue, worsened psoriasis, eczema, indigestion, constipation, arthritis (sore joints) not experienced prior to vaccine.
following administration patient reports a small amount of bruising that evening and then by the next morning had a large amount of bruising from her elbow to her wrist and said it was very painful- but not a lot of bruising at site of injection.
I awoke to my left arm itching and found about a two inch red circle where I assumed the injection site had been.  This occurred on Jan. 28th which was 8 days after my first dose of Moderna. I did not find this anywhere on the list of side effects.  I had experienced a typical sore arm on the first 24 hours and also experienced some nausea on January 24th, but these were side effects reported as possible.
INJECTIONS STARTED TO COMING OUT FROM NECK AND IF DID NOT RECEIVED VACCINE WOULD BE DEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: numbness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced injections started to coming out from neck and if did not received vaccine would be dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injections started to coming out from neck and if did not received vaccine would be dead was not reported. This report was non-serious.
Pericarditis diagnosis, current treatment 3 months of colchicine, and ibuprofen.