chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe joint pain; burning sensation; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: ARTHRALGIA (non-serious), outcome "unknown", described as "Severe joint pain"; BURNING SENSATION (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". The events "severe joint pain", "burning sensation" and "headache" required physician office visit.  Additional information: The Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if  the patient been tested for COVID-19 since the vaccination. It was unknown if the patient had any known allergies. It was unknown if patient had any other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset unknown). The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 10-AUG-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as geniculate herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, geniculate herpes zoster was determined to be medically significant. Additional information has been requested.
Systemic: acne like rash on scalp-Mild, Additional Details: Patient complained about getting acne on his scalp which has only occurred after receiving vaccine.
Proteinuria about 0.5g/L. Hematuria about 200 ery/uL. Fever of 100.5F oral. Malaise. Patient has had similar proteinuria and hematuria in response to viral infections (influenza) before but it had resolved and not been seen in the last year prior to the vaccination. Suspected mild IgA nephropathy but not confirmed. Fever and malaise resolved in 36 hours. Hematuria resolved in about 4 days and proteinuria in about 6 days. No treatment other than tylenol for fever.
FEET BLEED; WOUNDS ON HANDS; THIN SKIN; BLISTERS EASILY/BLISTERS ON FEET; WOUNDS ON HANDS TOOK VERY LONG TIME TO HEAL; This spontaneous report received from a patient via another pharmaceutical company concerned an elderly male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: exposure to covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total, first dose was administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The age at time of vaccination was 66 years old. The patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa, and moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced feet bleed, wounds on hands, thin skin, blisters easily/blisters on feet, and wounds on hands took very long time to heal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from blisters easily/blisters on feet, and the outcome of feet bleed, wounds on hands, thin skin and wounds on hands took very long time to heal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220713416-COVID-19 VACCINE AD26.COV2.S-feet bleed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient was dosed with pediatric 5 - 11 years old covid vaccine.  As patient was 15 years old patient should have been dosed with the 12  and older vaccine.  Per CDC dosing error guidance no further action was taken.  Patient was dosed with appropriate second dose of Covid 19 on 02/18/2022.
Severe sepsis secondary to Covid pneumonia: Patient made nice recovery with the completion of convalescent plasma and remdesivir. Patient will complete 5 more days of oral dexamethasone.
stated that she is half dead; stated that the symptoms that she is feeling are terrible; stated that she is not sleeping; stated that she is not eating; stated that her body is electrified; stated that there is something in the chemical that is not agreeing to her; had a very bad reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "stated that she is half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated that the symptoms that she is feeling are terrible"; INSOMNIA (non-serious), outcome "unknown", described as "stated that she is not sleeping"; EATING DISORDER (non-serious), outcome "unknown", described as "stated that she is not eating"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "stated that her body is electrified"; PRODUCT FORMULATION ISSUE (non-serious), outcome "unknown", described as "stated that there is something in the chemical that is not agreeing to her"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "had a very bad reaction". Reason for no lot number of Pfizer Covid vaccine: Complainant hung up abruptly/transfer incomplete.  Clinical course: Warm transfer from agent (name Withheld) Pfizer (name withheld), no CEP provided has a caller who had a very bad reaction to the Pfizer Covid vaccine. Stated that she is half dead. Wanted to speak with someone who knows what they are doing. Stated that she is recording the call. Stated that they were racially profiling and discriminating her. Stated that Pfizer called her. Stated that she is a joke to them. Stated that the nurse (Name withheld) hung up. Stated that the symptoms that she is feeling are terrible, is not sleeping, is not eating and her is body electrified. Stated that there is something in the chemical that is not agreeing to her. Stated that she is pissed off at Pfizer that called at 8:00am for a survey. Stated that they are not offering people anything. Caller rambling on. Unable to speak due to caller rambling on. Unable to clarify details. Caller started to use profanity. Caller told agent  to be quiet so that she can tell how bad the situation is.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given expired vaccine. Vaccine expiration date 09/30/2022. Vaccine administered on 10/20/2022. No adverse effects reported so far
Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shrimp. The patient did not receive any medications within two weeks of vaccination. 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 06Apr2021 at 16:00, the day after the vaccination, the patient experienced fever, chills and body aches and wanted to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN) on 06Apr2021. The clinical outcome of the events fever, chills and body aches were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This was a vaccine error not an adverse event.  The immunization was given after the 12 hour window after puncturing the vial.  Moderna was contacted and after a long delay it was communicated that the only issue was a lack of preservative.
Little bit of a sore arm; Jaw felt like it was locked; Tightness in the jaw; Jaw started to ache, she thought that it was probably joint pain; Difficulty eating; Intense nausea; Head felt kuke she was hit with a bat / a little bit headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain) and FEEDING DISORDER (Difficulty eating) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoedema (Left arm) in 2002 and BRCA2 gene mutation in 2009. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2009, BRCA2 gene mutation assay: positive (Positive) Positive. On an unknown date, Cardiac stress test: normal (normal) Normal.     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.   This case was linked to MOD-2021-276557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: updated reporter details, patient demographics, New event and lab data added
feeling lightheaded; I started feeling like I lost a lot of energy.; I feel like I've had a couple of times when my chest hurts; Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021); This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I feel like I've had a couple of times when my chest hurts), ASTHENIA (I started feeling like I lost a lot of energy.), DIZZINESS (feeling lightheaded) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0181 and EW0180) for COVID-19 vaccination.     Family history included Skin cancer (The patient's father died of skin cancer.) and Aneurysm cerebral (The patient's mother had an aneurysm in her brain & she died from it.).   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)). On 04-Jul-2021, the patient experienced CHEST PAIN (I feel like I've had a couple of times when my chest hurts). On 20-Jul-2021, the patient experienced ASTHENIA (I started feeling like I lost a lot of energy.). On an unknown date, the patient experienced DIZZINESS (feeling lightheaded). On 20-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)) had resolved. At the time of the report, CHEST PAIN (I feel like I've had a couple of times when my chest hurts), ASTHENIA (I started feeling like I lost a lot of energy.) and DIZZINESS (feeling lightheaded) outcome was unknown.            The consumer stated that he received first dose of the Moderna COVID-19 vaccine on 02 June 2021 and did not have any side effects. No concomitant product use was provided by the reporter.   No treatment medications were reported.
SWELLING OF FACE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. 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. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of face. This report was non-serious.
less arm pain; pain on his hamstrings; swollen right hand; right shoulder pain; severe pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis. The following information was reported: IMMUNISATION (non-serious) with onset 27Sep2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "less arm pain"; MYALGIA (non-serious), outcome "unknown", described as "pain on his hamstrings"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen right hand"; ARTHRALGIA (non-serious), outcome "unknown", described as "right shoulder pain"; PAIN (non-serious), outcome "not recovered", described as "severe pain".  Additional information: It was reported that prior to vaccination, patient was on neuro medication and had no issues before, he was very strong and can ride a bike in 10 miles once a week. Reporter stated that he spoke to his HCP and was prescribed with Meloxicam 75mg (generic) medication for Rheumatoid Arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received TD, MMR and PPD on 4/26/01 without incident, about 3 days later developed extremities myalgia and arthralgia over R side of body, as well as in L elbow, leg and hip. Also became very fatigued about 5/3/01, condition had worsened to the point where pt had pain everywhere plus a rash over body and felt febrile. No temp documented. Husband states brought pt to MCHO where saw nurse who referred to PMD for further evaluation. On 5/7/01 pt went to doctor on duty (DOD) on N Main st. Told that could be reaction to, given Allegra and told to use with tylenol for arthralgia. On 5/14/01 was to see a FP doctor who did exam and lab test. Told the condition could be related to stress. Today pt c/o scattered pain over mainly trunk. Also says left side of mouth hurts when eating/swallowing and feels generalized fatigue .
A reddened and hard welt has formed, where the shot was administered; A reddened and hard welt has formed where the shot was administered; administered a vaccination intradermally when it's supposed to be intramuscular; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age not reported) who experienced reddened and hard welt has formed, where the shot was administered, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  The patient was postpartum  On 19-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intradermal route in unknown administration site.  On an unknown date, the patient developed a non-serious a reddened and hard welt has formed where the shot was administered (vaccination site erythema and vaccination site urticaria) with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of inappropriate route of vaccination.  Final diagnosis was vaccination site urticaria and vaccination site erythema.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for vaccination site urticaria and vaccination site erythema.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
One of them is paralyzed; sickness; neurological symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PARALYSIS (medically significant) with onset 2021, outcome "unknown", described as "One of them is paralyzed"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sickness"; NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological symptoms".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Benadryl was given. Blood pressure was 144/88.  Patient was observed for 1 hour. Following 1 hour, she went to her office and planned to go home. Patient was later called to identify if symptoms were still occurring, but did not answer. Voicemail was left.
pt recvd vax;following vax, it was noted that the lot's expiration date had passed;there were no problems;
Pt was given Hep-B vaccine. Mother called about 1/2 hour later, said that pt had red rash. Pt brought back to office and checked by doctor and was given Benadryl 50 mg IM and Aristocort Forte 40 mg IM and observed. No difficulty or anything.
Anaphylactic reaction: full body rash; Anaphylactic reaction: full body rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 69-year-old on 22Feb2021 (lot number: EL9267, expiration date unknown), at single dose for COVID-19 immunization. Medical history included cardiac disease, triple bypass operation, diabetes, thyroid, high blood pressure, known allergies: penicillin. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 01Mar2021 the patient experienced anaphylactic reaction: full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. The COVID was not tested post vaccination. The patient received treatment for the events, included unspecified medications. The outcome of the events was not recovered.
5 min after the immunizations the patient reported to feel dizzy, faint and was visibly pale and shaky.   I sat the patient down gave him Snapple to drink, called 911 and observed him until Ems came in. He had also asked for water which was provided as well.
pt recv vax & exp nausea & h/a w/in 15-20min of vax;nausea subsided w/in 1-2hr;h/a subsided w/in 5-6hr;
Patient refers having some type of rash or severe pruritus all over chest area. Patient reports started 24 hours after vaccine administration (2nd dose) MODERNA. Patient did not see a doctor and took Benadryl the rash lasted 6 days. Patient reports about a month and half ago it happened again in the same area with the same intensity but less days (don't know how many) and it was after sun exposure.
WAS ACCIDENTALY GIVEN MMRV INSTEAD OF JUST MMR, CHILD RECIEVED 2 DOSES OF VARICELLA TODAY