chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus  in right ear.  Constant...never goes away.; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient experienced Tinnitus in right ear, which was Constant and it never gone away. The event resulted in doctor or other healthcare professional office/clinic visit, The clinical outcome of the event Tinnitus in right ear was not resolved .  No follow-up attempts are possible. No further information is expected.
An employee at the clinic accidentally got VARIVAX in her eye; An employee at the clinic accidentally got VARIVAX in her eye; This spontaneous report as received from a nurse practitioner referring to a female employee at the clinic of unknown age. The employee pertinent medical history, concomitant drugs and allergy to drugs were not reported.  On 29-OCT-2020, an employee at the clinic accidentally got varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, lot number and expiration date were not reported) in her eye(exposure via eye contact,occupational exposure to product). It was unable to located information regarding topical or ocular exposure. The employee did flush out their eye. The caller was offered an escalation and they requested that this be listed as an urgent escalation as their clinic was unclear as to how severe a situation like this is as they have never had this occur.
Five minutes after the second injection , I became tachycardic and got HBP and had a tingling sensation throughout my whole entire  body from my head/face to my feet. Subsequently had a burning sensation in the center of my body from my chest to my private parts. Became lightheaded and almost passed out. Ambulance came and gave oxygen. Taken to E.R. for monitoring and discharged after a few hours. No explanation given as to this adverse event. PLEASE NOTE: One week after my first dose, I developed very itchy hives on both of my ankles that lasted one week. After both shots, I also developed red itchy splotches on my right arm near the injection site that lasted almost a week as well. I have pictures of everything
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medications were reported.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 18-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
Pt noticed red swelling spreading outward around site 3"x3", and red anterior deltoid swelling, PM red streaking down to axilla. This was on 3/1/03. On 3/2/03 pt woke up with entire deltoid erythema burning and itching, couldn't move shoulder lymph node the size of a golf ball under skin, rash and pain continued to spread, went to ER on 3/5/03 shoulder slightly pink, itches, painful but improving.
Two months of mild to moderate chest pain and shortness of breath. These symptoms would last approximately 10 minutes at a time, and then fade away. Symptoms occurred randomly (often in the mornings after working out) 1-2 times/day.
8 hours after receiving (3rd Dose) or booster, patient reported feeling body aches, chills, and later low grade fever.
6 month old accidently was given meningitis b; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient who was 6 month old at the time of vaccination, accidently received Meningococcal B (Bexsero), which led to inappropriate age at vaccine administered. The reporter asked what could the risk of this mistake. The reporter did not consent to follow up.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 56-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804684 was linked to the source case 201804657 due to the same reporter.
Pain in his left shoulder blade; Pain in his arm; This spontaneous case was received on 30-Sep-2023 from other non-healthcare professional (consumer) via Communications (reference number: SEQW23-02830), with additional information received on 03-Oct-2023 via Communications (being processed together) and concerned a 78-year-old, male patient.   The patient's concurent conditions included diabetes (reported as 'diabetic'). The patient's concomitant medications included unspecified diabetes medication (reported as 'a whole bunch of medication'), used for an unreported indication.  On 24-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left deltoid, dose and route of administration: not reported) for flu vaccination. The batch number reported was 370682.  On 27-Sep-2023, three days after receiving Fluad Quadrivalent, the patient began to feel mild pain in his left shoulder blade and arm. The pain progressed to quit intense. The patient described the pain as pulsating pain. The pain intensified with movement and subsided when his arm was immobilized. The pain subsided when the patient would lift arm straight in the air.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 78-year-old patient was vaccinated with Fluad Quadrivalent in the left deltoid. Three days after receiving vaccine, the patient began to feel mild pain in his left shoulder blade and arm. Causal role of Fluad Quadrivalent is assessed as possibly related for pain in arm and shoulder blade pain, based on anatomical and chronological plausibility.; Sender's Comments: A 78-year-old patient was vaccinated with Fluad Quadrivalent in the left deltoid. Three days after receiving vaccine, the patient began to feel mild pain in his left shoulder blade and arm. Causal role of Fluad Quadrivalent is assessed as possibly related for pain in arm and shoulder blade pain, based on anatomical and chronological plausibility.
Patient received Moderna for 2nd Dose versus Pfizer as first dose; This spontaneous case was reported by a  and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose) outcome was unknown.            No concomitant and treatment medications were provided  Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
Developed Bell's Palsy in right side of face.  This is the second time I have had Bell's Palsy; the first time was about 10 years ago.   The ER physician said it was very unusual to get this twice in a lifetime.  I was diagnosed with Bell's Palsy about a month after my second Pfizer Covid-19 shot and thought it could be related since this adverse event did happen during the trials.
Initial misuse report received from a healthcare professional on 16 OCT 2013. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The 06 month old patient inadvertently received a dose of TYPHIM VI on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient felt dizzy/light-headed within 1-2 minutes of receiving his 2nd dose of Moderna vaccine on 4/18/21 at ~12:30pm. Patient stood up from the waiting area, walked approximately 20 feet to the pharmacy window to request assistance where he fainted and hit his head on the counter ledge. He has a raised bump (approximately 2 inches wide) on his right temple above his eyebrow. Patient remained conscious, received water/juice/granola bar & was monitored by the RPh for an additional 30-40 minutes.
Start with ichy arms within a day. Rash . . From elbows down.I thought it was my eczema. But after a few days little red blisters started to appear. So I used eczema medication anti-itch medication and allergy pills. As soon as I can get one spot under control more blisters would appear. Until I currently have more blisters and cannot control them I went to the doctors. I am now on prednisone. Need to consult dermatologist. I do not plan on having second shot!
The following day after getting vaccines, patient was napping and became dystonic, was unable to catch her breath for about 30 seconds to a minute and then started foaming from the mouth. During the episode, I rolled her to her side and suctioned her mouth with a bulb syringe. She was mildly interactive after event but was extremely sleepy. We took her to the hospital where she was observed. A FSBS was completed that was normal, vitals were within normal limits the entire stay, and an EEG was completed that was normal. She was diagnosed with Sandifer syndrome.
IN MY FIRST VACCINE WITH MODERNA I START A MENUSTRAL CYCLE IT BEGAN VERY HEAVY THEN I STARTED PASSING HUGE AMOUNTS OF BLOOD CLOTS. I BLEED FOR 25 DAYS AND CLOTTED. I BECAME ANIEMIC AS WELL. THE SECOND VACCINE WAS 10/15/2021 AND ON 10/17/2021 I STARTED WAS NOT SCHEDULED TO START A MENUSTRAL CYCLE AGAIN AND I AM BLEEDING AND CLOTTING.
Information has been received from a consumer concerning his approximately 20 weeks old (also reported as "5 months" old) son with no pertinent medical history and no drug allergy or reaction who "three months ago", on approximately 29-MAY-2011 (also reported as "at 2 months" old) and in July (also reported as "at 4 months") was vaccinated with the first and the second doses of ROTATEQ (Lot number not reported). There was no concomitant medication. "Four weeks ago", on approximately 01-AUG-2011 the patient had broken out in hives all at once in the morning. The patient sought unspecified medical attention. The consumer stated they had consulted an allergist and they would be following up with their healthcare provider to address the situation. The patient was not given treatment. Scratch test was performed without result. The consumer reported that the adverse events was improved after stopping therapy and the ROTATEQ would not be reintroduced. At the time of the report, the patient had not recovered. Additional information has been requested.
pt seen because of intermittent, inconsolable crying since pertussis vax on Friday; apparently, p/that vax pt was fussy w/shrill cry from which could not be calm; lasted through most of the afternon & evening; irritability; t37.5;
This spontaneous report as received from a medical assistant refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported). The reporter was unsure which lot numbers were administered so she provided two lot numbers that were possibly involved: L006385 with expiration date 25-FEB-2017 and L025207 with expiration date 27-JUL-2017. There was no symptoms reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 40 hours. Data logger was involved. Additional information has been requested.
IT STARTED WITH EXTREME ARM PAIN THEN EXTREME NAUSEA DIZZINESS FAST HEART RATE HEADACHE VOMITING DIARRHEA STIFF AND SORE NECK HOT AND COLD FLASHES I LEFT WORK AND WENT STRAIGHT HOME TO BED I DID NOT START FEELING BETTER FOR 5 DAYS.
The first couple of days I felt tired, had a headache with runny nose and sneezing. After a couple of days, I became very congested in my nose and about a week later it went down into my chest. I experienced bad ear pain in my left ear. I thought I had an ear infection. I never had a fever. I tested myself on July 16, 2022, and it was positive. I was out of town, so I did virtual appointments, and I also went in to have someone look at my ear. After 3 weeks I went to the emergency room. I followed up with my ENT doctor and they indicated that they did not see anything. I went to the walk in on July 21, 2022, and I went to a local emergency room on the 27th. I was having pressure in my chest. I went to the ENT on August 22, 2022. I also had swelling on my left parotid gland lymph node area. I went to see a cardiologist on August 11, 2022, and it was normal. I do not feel that this is related to the vaccination. I think the ear pain, swelling in the lymph node, some coughing and irritation in the trigeminal nerve. I took cough syrup for the congestion, and I was prescribed a rescue inhaler which I used twice. I took MUCINEX for the cough. I felt better with coughing by the 10th or 11th of August. It took about 3 or 4 weeks to completely.  I am still getting headaches but not like when I was extremely sick.
1 day after receiving the flu shot my son had flu like symptoms, low grade fever, runny nose, irratable.  He also seems to have a lot of balance problems and is extemely irratable.
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with ROTATEQ (lot #, dose, route not reported), which were exposed to 31F over at least 10 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at that time of report. This is one of several reports received from the same source.
After receiving the vaccine, I wasn't feeling well. Three days after receiving the vaccine, my legs got really weak. I tried to stand but I was not able to stand because my legs could not support.  I did not think to call my doctor, I wasn't sure if I should call him about this or wait to see what happened.  Two weeks later after receiving the second vaccine, I was bending over, pain started radiating throughout my back. I still have muscle weakness in my legs and back.
Approx 20 min after receiving flu injection began to feel increased pressure in head and feeling "off". Ringing in ears/head began. Injection given 9/28/09. Saw ENT 3 weeks later.
allergic reaction; site where they injected me caused pain; my body had some aches; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction 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 allergic reaction, injection site pain and general body pain. On an unknown date, the outcome of the allergic reaction, injection site pain and general body pain were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain and general body pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingle vaccination and the site where they injected her caused pain and her body had some aches, it was an allergic reaction to the vaccine. The reporter did not consent to follow-up to her and her prescribing healthcare professional.
FEW MINUTES AFTER VACCINE ADMINISTRATION PATIENT STARTED SAYING HE WAS DIZZY AND SLEEPY. PHARMACIST ATTENTED THE PATIENT, PARENT WANTED TO CALL EMS SO WE DID. IN THE MEAN WHILE PATIENT, ASKED PATIENT IF HE WAS FELING SICK AND WANTED TO THROW UP OR ITCHING OR SHORTNESS OF BREATH OF ANYTHING ABNORMAL, HE JUST KEPT SAYING HE WAS SLEEPY. EMS ARRIVED WITHIN 10 MINUTES CHECKED THE PATIENT AND SAID HE WAS DOING ABSOLUTELY FINE.
Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
CC:  shakiness made pt felt as though pt was about to faint or blackout but didn't actually happen.  per nurse report, it was how pt felt but didn't actually happen so pt was fine when the nurse checked back again after an hour later.
fever & swollen lymph nodes lt side of neck-pain swelling & redness @ inj site (LD) w/in 24hr of vax;22MAY96 parent states all sx resolved x/still has swollen lymph nodes
Information has been received from a female office manager concerning herself who was vaccinated intramuscularly with all three doses of GARDASIL (lot#s not reported). Subsequently the patient developed cervical cancer. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the office manager concerning her 19 year old daughter (previous reported as the office manager herself) who on 11-OCT-2007 was vaccinated with the first dose of GARDASIL (lot#658100/0525U). The patient did not receive any concomitant vaccinations at that time. On 12-NOV-2007, the patient received the second dose of GARDASIL (lot#658100/0525U). The patient did not receive any concomitant vaccinations at that time. On 17-MAR-2008, the patient received the third dose of GARDASIL (lot# 659180/1785U). The patient was not sexually active at the time that she received the GARDASIL vaccinations. August 2008, the patient had a Pap smear and the results were normal. At the time of the patient's second Pap smear, in September 2009, the patient had been sexually active for a short time. The Pap smear results revealed low grade squamous intraepithelial lesions (SIL) and positive for Human papilloma virus (HPV), high risk and cervical intra epithelial neoplasm (CIN 1). The patient had a biopsy (date not reported) and the results were consistent with previous Pap smear results. On 09-AUG-2010, the patient had a loop electrosurgical excision procedure (LEEP), with no complications. The patient was scheduled for a Pap smear in November 2010. Upon internal review, cervical cancer was considered to be an other important medical event. Additional information has been requested.
nausea, vomiting, weakness and malaise, diffuse body rash presented to ER with rash, platelets 94 and right upper lobe pneumonia tested negative in ER for COVID
Moderna COVID?19 Vaccine EUA  30 minutes post injection: itchy rash on back of hands, flushed face. Resolved with 2 benadryl approx 5 hours post: rash returned. Resolved with 2 more benadryl 2-3 days post: severe anxiety and hypervigilance 4-5 days post: fatigue, chills, body aches 8 days post: injection site turned red
The morning after she got her second vaccination (2/3/2021), she was unresponsive.  She was then taken to the hospital, by ambulance. They did multiple tests, Blood work, urine sample, CT scans, and had no results. Then they transferred her to get an MRI at hospital, and then went back to original hospital. MRI confirmed she had a stroke and multiple TIAs (mini strokes). Then she was admitted and slept all day on 2/4/2021, finally awoke on 2/5/2021. She stayed in the hospital about a week, and then was transferred to a nursing home/ rehab facility - Facility on 2/10/2021. She was there until March 3rd, 20 days after being admitted. She was then released to go home on 3/3/2021. She has now recovered since then. She is having home health coming to her house, but is no longer going to be there starting June 1st.
Within hours of receiving vaccination, pt developed shingles. She came to clinic to report on 5/12/2017. The area was from her shoulder to elbow.
Patient reported back to the pharmacy on 8.22.19 to complain she has been experience muscle soreness and stiffness in the neck, shoulder, and arm areas for the past 3 weeks. Patient is not able to completely lift up left arm. She also was initiated on Metoprolol around the same time and was unsure if the pain could be attributed to the shot, medication, or combination of both.