chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received last years flu vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00825044) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to cases 2021SA355038 and 2021SA356045 (same reporter).  This case involves a 7 year old male patient who was received last years INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA, expiry: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states that 3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a nurse, concerning a 16 year old female patient with who on 06-AUG-2007 was vaccinated with the first dose of GARASIL IM. On 10-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #654540/1209U) and on 13-FEB-2008 was vaccinated with the third dose of GARASIL (Lot # 659055/1522U). Concomitant therapy included an unspecified birth control discontinued in May-2008. On 12-MAY-2008, the patient stated that she was having hair loss on her head only. At some point, she noticed that there was a little hair regrowth. She was seen by a dermatologist, who ordered a set of labs for her, they came back normal. As of 09-SEP-2008, the patient did not recovered. There was no product quality complaint. Additional information is expected.
PT RECEIVED THE H1N1 VACCINE AT THE STATE DEPARTMENT ON STATED DATE. ON 11/14, RASH AND REDNESS ON FACE, TINGLING IN FOREARMS/HANDS, PERIORAL TINGLING. OVER NEXT FEW DAYS DEVELOP DYSESTHESIAS OF FEET, THEN PROGRESSED TO WEAKNESS. THEN FEELING UNSTEADY AND REQUIRES EFFORT TO STOP FROM FALLING. PATIENT WAS ADMITTED ON 11/23. PRIMARY CARE PROVIDER AND NEUROLOGIST SUSPECT GUILLAIN-BARRE SYNDROME. 12/04/09  Discharge summary and hospital records received for DOS 11/23/09-12/01/09.  Pt. presented with tingling in arms and legs, weakess and fatigue that gradually progessed over 2 weeks since receiving H1N1 vaccination. Neurology consult obtained. Treated with steroids and Neurontin for pain titration. Motor function improved, but paresthesias and dysesthesias persisted at time of transfer to rehabilitatave facililty. DC DX: Questionable Guillain-Barre syndrome secondary to H1N1 vaccine.
Large red blotch, large knot under the skin. Started out about the size of a quarter, has grown to the size of a baseball
Bilateral eye lid swelling and redness, tongue, itching and dry hacking cough.
My husband and I had the 2nd SHINGRIX vaccine last evening. Our arms were very tender as they were with the 1st shot. However the next day, we both felt as if we had severe flu. We had chills and then a fever. Our bodies ached as did our heads. I was sick to my stomach though my husband wasn't. We were incredibly tired. We both urinated a lot though we hadn't had a lot to drink. Unfortunately I had to attend work for presentations. I could barely function.
Patient immediately felt numbness of left arm, 2 hrs later developed a shortness of breath followed by a rash on the opposite arm. Rash resolved within hours but she continues to have shortness of breath, intermittent wheezing, body aches, and profound fatigue. Shortness of breath required oral steroid and albuterol which patient has not needed prior to this- no known hx of any lung disease. Patient so fatigued unable to go to work. - seen by me today 3/1/2021.
Initial report received from a pharmacist on 28 Dec 2010: This patient was vaccinated with MENVEO (batch number: unknown) on an unknown date. The patient was administered with MenCWY component only, without MenA conjugate component. Combined follow-up report received on 25 Jan 2011 and 31 Jan 2011: The batch number was reported as 100022. The patient was vaccinated with MENVEO on 21 Dec 2010. The patient was also on some concomitants. No known side effects occurred due to usage of wrong diluents.
pt inadvertently recv pnu imune 23 instead of PPD on;pt devel an inj site rxn characterized by redness, soreness & swelling;rxn resolved slowly over 7 days;
Fever of 102 degrees, Vomiting, Diarrhea, Cold sweats, Headache, Body Aches, Sore Arm, Inability to sleep
On 09/05/2000, the patient developed a fever and on 09/07/2000 the patient developed a rash. On 09/08/2000, the patient presented to a physician with 17 lesions on her trunk, back, neck and groin. Additional information has been requested.
Infant developed watery diarrhea, fussiness and poor appetite around 6pm on 6/10/2010.  Sometime during night, infant developed diffuse, red, raised rash over face, trunk, and extremities. Mom states infant is "hot to touch" but does not have any fever. Infant has "puffiness" of face but does not have any difficulty breathing. Infant is a paternal twin. Twin does not present with any symptoms but did receive same vaccines at same time.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with PROQUAD (lot#, dose and route not reported) that was stored improperly. No adverse effects reported. Additional information is not expected (reporter refused additional contact).
received Moderna vaccine x 2 then pfizer booster.  pain and moderate swelling of axillary lymph nodes
Patient received dose that had been in fridge for one week past manufacturer recommended 30 day storage recommendation.  Called Moderna and they confirmed that dose was still effective on date given.
I had a break through case of Covid-19 mild to moderate GI issues upset stomach diarrhea stomach pain stuffy nose sinus headache runny nose sore throat lingering cough faster heart rate, asthma type symptoms.
Circular reddened area 1 1/2 in diameter starting 8/25 (the day after the shot). No swelling or induration.
pt recvd vax & the same day exp swelling of tongue, chest discomfort & throat tightness; treated self w/DPH; No further details were provided
The Pfizer vaccine was reconstituted with sterile water instead of normal saline and administered to the patient. The patient did not report any adverse effects.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series) on 02/23/21. Patient hospitalized from 08/03/21 - 08/09/21. Below is copied from discharge summary:   Hospital course: had a ground level fall. Found to have a traumatic pneumothorax. A chest tube was placed. She worked on respiratory treatments. Past medical history significant for COPD and Covid positive. Chest tube fell out 8/5. No pneumothorax remained. she worked on pulmonary exercise and worked with therapy. Discharge to home with HHPT.
A previously diluted, used, and since expired vial of Pfizer Covid vaccine was rediluted and a dose of 0.3ml was administered. Pfizer was contacted for inappropriate administration guidance.  The patient's father was contacted and the situation explained.  At this time, the patient is not redoing this dose and will wait to receive the 2nd dose at the appropriate time.  The patient's father was advised to monitor for adverse reactions including infection at the injection site.
About 16 hours after the injection in my upper left arm, I woke up with soreness and pain at the injection site. It was not bad at first, but as the day has gone on, it has gotten worse. The injection site is now red and swollen as a bump approximately 3/4ths inch in diameter and is hot to the touch. My entire arm hurts with shooting pains from my armpit down to my fingertips. I believe my lymph nodes in my left armpit are swollen because when I put a heating pad in there, the pain lessens a bit. I also took 1 Advil when I first noticed the pain at 6 AM and 1 more Advil at 4 PM. It helped a bit with the pain this morning.
This spontaneous report as received from a nurse refers to an unspecified number of 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 PEDVAXHIB injection (dose, lot #, expiry date, anatomical location and route of administration were not specified). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Member received Typhoid vaccination in left deltoid 1/3/08 - Noticed itchy red rash on left shoulder on 1/4/08 upon awakening.  Used anti-itch cream with some results.
I have had the headache on and off; But when I get up this morning I can barely walk; My two legs are giving me like 'aches'; Yes, I had a booster shot; Yes, I had a booster shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Unknown and Expiry date: Unknown) via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced headache on and off, but when patient got up that morning can barely walk, two legs were giving like aches and patient received booster shot. The outcome of the events I have had the headache on and off, But when I get up this morning I can barely walk, My two legs are giving me like aches was not recovered.  Follow-up attempts are completed. No further information is expected.
pt was given a booster dose of Pfizer vaccine.  Currently boosters are only approved for 16+.  This pt is 14 years old and is not eligible for the vaccine currently.
4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4  - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21.  Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
Diarrhea; Bloated belly and gas pains, after 5 days still have bloating; Bloated belly and gas pains, after 5 days still have bloating; This is a spontaneous report from a contactable other healthcare professional, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. On 01May2021 at 14:30, the patient experienced diarrhea, bloated belly and gas pains, after 5 days still had bloating (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, bloated belly and gas pains, after five days still had bloating was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Chest tightness, numbness and tingling that radiates into her right arm.  Throat feels "fat. Complains that right hand is drawing up into a fist, symptoms x 1 week  Started on prednisone and flexeril EKG-SR  Checking CBC, CMP, and cardiac enzymes
The nurse (patient) got covid after her dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The nurse (patient) got Covid after her dose) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (The nurse (patient) got Covid after her dose). At the time of the report, COVID-19 (The nurse (patient) got Covid after her dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
No adverse event; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions drug reactions/allergies and concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) after temperature excursion (product storage error), 0.5 milliliter, lot #U022321 with expiration date: 15-JUL-2023, administered subcutaneously (SQ) as prophylaxis (strength was not provided). The vaccine underwent temperature excursion of 6 Fahrenheit for 30 minutes. It did not have previous temperature excursion. No additional adverse events were reported (no adverse event).
This spontaneous report as received from a certified medical assistant refers to a 2 month old patient. Healthcare worker stated that on 27-JUN-2013, VARIVAX (Merck) (lot number reported as H018014, exp. date 01-OCT-2014), 0.5 ml once, subcutaneous, that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated VARIVAX (Merck) was storage with multiple temperature excursions up to 13 F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS # 1307USA002435, 1307USA002437, 1307USA002434, 1307USA002436 via same reporter link. Additional information has been requested.
Client stated that about a week after vaccination her started developing a fever, T-Max 100, body aches, chills, and developed some cold sores.  Taking tylenol and this does bring the fever down and helps with symptoms.
Acrocyanosis without fever less than twenty-four hours after moderate induration at the site.
flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms".  Additional Information: it was having flu-like symptoms for three days following his first dose of the Pfizer vaccine. He did not have any symptoms following the second dose. AE identified on 5/7 as part of daily social media monitoring.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, nausea, low grade fever, chronic cough, labored breathing, very tired feeling.
EXPIRED PRODUCT  ADMINISTERED; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's weight was 269 pounds, and height was 70 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient health status was healthy. the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider at a private doctor's office. On an unspecified date, the patient experienced shingles. The patient was treated by healthcare provided at the private doctor's office. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 49-year-old female patient who received BOOSTRIX (batch number 33T42, expiry date 1st February 2021) for prophylaxis. On 28th November 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by an occupational health nurse at GlaxoSmithKline. The patient received the BOOSTRIX vaccine on the right arm. The patient called to report swelling, itching and redness at the injection site.
Site: Pain at Injection Site-Medium, Systemic: difficulty lifting up arm-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: numbness and tingling below elbow
Quite a bit of pain to shoulder at injection site immediately after receiving. Within a few hours was barely able to move my arm, entire upper right quadrant was still and sore. Felt extreme fatigue as day continued and overnight, as well as fever (101.9), extreme joint pain, ears ringing, headache, confusion, restlessness and absolute misery; had to miss work the following day. Have generally not been phased at all  by any immunizations in the past. Had a very very light case of chicken pox as a child. Had the ZOSTAVAX vaccine in 2015 with zero side effects. Symptoms from SHINGRIX were nearly gone in 48 hours, beyond lingering headache.