chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given an expired Tenivac to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old male patient and it was reported that an expired Tenivac to a patient with no reported adverse event , and the case involves a vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant was used   On 29-Jul-2022, the patient received a  dose of 0.5 ml  of  suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, (frequency: once) ( lot: U6669AA ; expiry date: 15-May-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that on 29-Jul-2002,   an expired Tenivac was given to a patient with no reported adverse event (expired product administered) (latency: same day)  Action taken : not applicable.  Outcome: unknown  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 in the guidelines. 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.
Narrative:  72 yo male with PMHx of metastatic colon cancer, asthma, migraine, GERD, DDD died at home in home hospice care on 12/10/2021. Pt had received covid vaccines on 2/9/21 & 3/12/21. This death due to cancer, not related to covid vaccines.
FLUZONE HD QIV vaccine was administered to a 25 year old patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 25 years old male patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2023, the 25 year old patient was administered a standard dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown formulation) at a dose of 0.7mL once (lot UT8079DA, expiry date- 30-JUN-2024) via intramuscular route in the right arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Caller asked guidance on this.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient came in for her second Pfizer vaccine. Patient was given Moderna Covid-19 vaccine.
Soreness in her arm; pain; Feeling abnormal; Joint pain; overweight; stiffness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain) and OVERWEIGHT (overweight) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in October 2020 and Knee replacement.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) 15 milligram. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain), OVERWEIGHT (overweight) and MUSCULOSKELETAL STIFFNESS (stiffness). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), FEELING ABNORMAL (Feeling abnormal) and OVERWEIGHT (overweight) had not resolved, PAIN (pain) had resolved, ARTHRALGIA (Joint pain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.        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.   Concomitant and Treatment medications were not provided by reporter.   Reporter did not allow further contact
On multiple unspecified dates, unspecified patients were administered improperly stored ROTA TEQ or PEDV AXHIB; No additional AE details provided; This spontaneous report has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender.  The patients' concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On multiple and unspecified dates, the patients were vaccinated with the following improperly stored vaccines: - Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) formulation not reported but defaulted to oral liquid, Lot # S040076, expiration date 15-JUN-2021 for prophylaxis (dosage regimen was not reported).   - Haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) formulation not reported but defaulted to intramuscular injection, Lot # S023218, expiration date 04-MAR-2022 for prophylaxis (dosage regimen was not reported).    The storage temperature was reported to had been at 8.9 C for 30 minutes.  No additional adverse events details were provided.  There was digital data logger involved and no previous temperature excursion was reported.  This is a non valid case due to lack of patients' identifiers.
Patient was vaccinated for COVID as of July 2021. Patient presented to ED and is diagnosed with COVID infection leading to hospitalization. Pregnant female about 39 weeks gestation an is current asymptomatic
Adverse Event: This writer was informed by vaccinator (LPN) that guest had concerns of being vaccinated by vaccinator, LPN, with a previously used Vanish Point syringe. The vaccinator informed patient that the syringe was empty and he would like to re-vaccinate him.  Intervention: The needle retracts into the syringe and the needle would not be able for another injection. Patient states that he felt the needle as it was injected into his arm.  Patient states that he was told by the vaccinator (LPN) that the syringe was empty. Guest?s asked the vaccinator ?why would you not check the syringe before sticking me?? The vaccinator stated ?I am sorry, I usually do, but I could tell by the way the syringe plunger felt as I was pushing it, to administer the vaccine that it was empty.    Outcomes: This writer assessed and educated guest and explained to him that it was more than likely not ? that he was injected with a previously used syringe. The Vanish Point needle and syringe system retracts once it has been activated/engaged. He felt the needle as it entered his Left Deltoid. Guest agreed to re-injection of the Pfizer Vaccine in his Right Deltoid.  Dr. called and the above information provided to him. He advises that if the guest would like he would call Emergency Room so that the guest could be further assessed and offered prophylaxis protocol if indicated.  Guest and his daughter were informed of this offer and decided that they would go for this assessment and services.  Received a call from Dr. (ER) and informed him of the above information. Called guest on 5/19/2021 for follow-up and his daughter reports that guest has had no untoward effects.
Information has been received from a nurse practitioner, concerning a female patient with allergy to ibuprofen, who on 03-MAY-2010, "yesterday", was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (route and dose not reported) (lot number not reported) (expiration date "10-NOV-2019"). On 04-MAY-2010, the patient presented to office with "severe pain and limited range of motion" of the left arm. It was also reported that on approximately 27-APR-2010, "a week ago", the patient received in the left arm a shot of tetanus toxoid and a shot of influenza virus A (antigen type unspecified) vaccine (H1N1). At the time of reporting, the patient had not recovered. Additional information has been requested.
Headache, Myalgia, Arthralgia & Fever Narrative:  dose1:pain;ha;myalgia;arthralgia;diarrhea-SYMPTOMS RESOLVED IN 3 DAYS dose 2:pain;ha;myalgia;arthralgia;n/v;chills;fever;fatigue
Major dementia type symptoms; A spontaneous report was received from a consumer concerning an elderly, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed some major dementia type symptoms/dementia.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 03 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the patient have been having some real major dementia type symptoms that were new for her (Onset date not provided).  Treatment for this event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, major dementia type symptoms/dementia was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's age is a risk factor and confounds causality assessment.
Dizzy, slur speech, bowel incontence 2 times, numbness and tingling in extremities, following asleep while driving or talking or just sitting still.
next day spend it bed again; felt the knee weak; lt tired and that then felt a little better; felt so weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (felt so weak). On an unknown date, the patient experienced SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (felt so weak), SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include Trinitrin-HCTV.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II, lot # K005109 and expiration date 04-APR-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Pt developed 45 mm indurated red area to thigh where vaccines were given.  Area L thigh still present although faded to brown in color.
Information has been received from a healthcare worker concerning a 25 year old female patient who on 19-AUG-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARADSIL (Lot # 660553/0070X). The healthcare worker reported that on the same day after vaccination the patient became lightheaded and almost passed out about 20 minutes. The patient had just left the office, but came in feeling lightheaded. Subsequently, the patient recovered from feeling lightheaded and passed out. Additional information has been requested.
Stomach ache, fever 100.8 degrees, Many muscles aching. Duration about 48 hours.
She developed temperature of 103 degrees, malaise, general weakness, and change in level of consciousness.  Physician ordered her to be sent to the ER
Lightheadedness; This is a spontaneous report received from a contactable consumer. This 75 year old female consumer (patient) reported for a herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm Left on 13Jan2021 14:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced lightheadedness on 02Feb2021 09:00 . The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Pt awakened 8/11/09 with hives on neck and chest "itchy". Denies resp distress. Treated with BENADRYL and MEDROL dose pack.
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/11/21. Patient was hospitalized from 09/08/21 - 09/13/21. Below is copied from discharge summary:   Patient a is with 60-year-old female with no past medical history was admitted for chief complaint of shortness of breath.  Patient reported the symptoms started four days prior to admission and reported ongoing progressive shortness of air associated with cough and fatigue.  She denied any chest pain, nausea, vomiting, diarrhea.  She reported that she was vaccinated with the single dose J&J vaccine.  In the emergency department her oxygen saturation was in the low 80s on room air.  She was placed on supplemental oxygen and admitted for further management.  She was started on remdesivir and Decadron.  She completed a five day course of remdesivir while inpatient.  She had improvement in her symptoms and was only on 1 liter of oxygen on day of discharge.  Home oxygen evaluation was done revealing the patient needed 2 liters of oxygen on exertion to maintain saturation above 88 percent.  This was set up for her prior to discharge.  She was prescribed an additional four days of p.o. Decadron to complete a 10 day course.   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
I had itching on both legs, and I saw a raised area appearing on the right leg close to 4 hours after the first shot of the Pfizer vaccine. Symptoms resolved in about 1 hour after taking antihistamine and applying hydrocortisone cream. On 6/16/21, I began to feel numbness in the back and leg at about 5 am. I went to an urgent care--no treatment. On 6/23/21 numbness in neck, face, and leg felt worse at about 2 am. I went to ER at about 3 am. No treatment. On 7/5/2021, I had itching from chest up to jaw that woke me at about 12: 55 am. I took an antihistamine and applied hydrocortisone and it relieved the symptom. 7/11/21 numbness in face about 9 pm and shoulder and arm right side at about 1:00 am 7/12/.21.
Extreme muscle aches and pains both shoulder joints and across the back of the neck. Hard to move her left arm in a circle and left.  She contacted her physician and they recommended her calling us.  Recommended taking Tylenol for the aches and pain and use ice.
Redness, pain, and swelling at site. Advised to monitor, use ice, TYLENOL/ibuprofen for pain if needed.
patient fainted about 2-3 minutes after receiving the vaccine--lasted only seconds--patient was shaking and pale after recovering--patient was did state they probably should have eaten breakfast that morning and did not--his mom got him some orange juice and a poptart -- we also got him a cool/wet compress for the back of his neck--within 10 minutes his color improved-his shaking subsided and he began feeling much better. he was able to leave with his mother under his own power after 15 - 20 minutes.
OBSTRUCTIVE SLEEP APNEA ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 3/13/2023  &   2/16/2023   --- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Got my 2nd shot yesterday, my / arm is so sore!; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the patient experienced arm sore.
The day after the vaccine it became uncomfortable and more difficult to swallow.  The difficulty swallowing changed to severe neck pain and a loss of mobility in my neck.  The pain was severe for 2-3 months and included extreme muscle stiffness and crepitus that added to the pain.  I went to see various doctors, a general practitioner, a rheumatologist, and a neurologist.   I still have significant pain in my neck, although it has subsided.  I also have not had a period in the time since the vaccine, although my periods were regular before the event.
Received both a Covid-19 booster and a flu vaccination; one in each arm. The flu vaccine caused internal bleeding in my arm. By that evening the bicep and triceps muscles were swollen and very painful. By Friday, the bruising was starting to show. By Monday my arm was black along the bicep down to the elbow. (I have pictures, taken on Saturday and Monday.) The arm was warm to the touch and noticeable swollen for three days. I also felt fatigued for two days. I've had flu shots for 20 years. I've never had this kind of reaction before; I've never had any reaction. My wife had her vaccination at the same time. She had the same reaction (She'll file a separate report.)
Ear aches Headache Stiff muscle Foggy brain Chills Gaius
Had severe allergies; Got diagnosed with lupus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EN6199) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: er8730, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (disability) with onset 01Jun2021, outcome "not recovered", described as "Had severe allergies"; SYSTEMIC LUPUS ERYTHEMATOSUS (disability) with onset 01Jun2021, outcome "not recovered", described as "Got diagnosed with lupus". The events "had severe allergies" and "got diagnosed with lupus" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were taken as a result of hypersensitivity, systemic lupus erythematosus. Gabapentin, Prednisone and Antihistamine were taken as the AE treatment. There were no any other vaccine administered in last four weeks.
FALL; HURT MY KNEES; FELT LIKE I GOT HIT BY A TRUCK; BODY ACHES SO BAD; MIGRAINE; COLD SWEATS ARE INSANE/SWEATING; EXHAUSTED SO TIRED; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-AUG-2021 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 AUG-2021, the patient experienced body aches so bad. On AUG-2021, the patient experienced migraine. On AUG-2021, the patient experienced cold sweats are insane/sweating. On AUG-2021, the patient experienced exhausted so tired. On AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt like i got hit by a truck. On an unspecified date, the patient experienced fall, and hurt my knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats are insane/sweating, and the outcome of body aches so bad, migraine, exhausted so tired, fever, felt like i got hit by a truck, fall and hurt my knees was not reported. This report was non-serious.
w/in a 24hr period pt broke out w/rash on lt alt where vax given;pt had no other rxn to vax but rash;It took about 48hr for the rash to disappear;nurse stated poss thimerosal allergy;pt devel rash w/ACT HIB & HEP B @ 2mos
Fever (101), chills, body aches, severe headache, tired, sore throat
Patient complained of pain at the injection site (right deltoid), decreased range of motion to right arm, slight amount of swelling to injection site. Lasted 4-5 days.
DEVELOPED RASH ON NECK AND SHOULDERS. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 10:15AM. RASH RESOLVED BY 10:30AM
Skin rash after 24 hrs administration of FLUZONE HD and PNEUMOVAX. Redness, puffiness of skin, pain reported. Patient using BENADRYL.
Area of erythema (4"x3") at injection site on 03/24. Larger on 03/25 at DTaP. Sought medical treatment twice.
4 hours after injection: left arm stiffness, followed by lower back pain and nausea that lasted 2 days
1st vaccine redness irration at injection area a few seconds after injection. A week later arm flared  up again  in same spot. 2nd injection swollen even bigger, fever in location, feel like an insect bit me and I'm allergic to it.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, feeling hot Narrative: