chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist consultant and described the occurrence of swelling arm in an adult female subject who was vaccinated with Engerix B for prophylaxis. On an unspecified date the subject received the third dose of Engerix B (1 ml, unknown). It was noted that no blood was aspirated prior to vaccination. At an unspecified time after vaccination with Engerix B, the subject experienced swelling of the arm and a rash. It was not specified whether the events were systemic or localized. The subject was evaluated in the emergency department and was diagnosed with a hematoma. At the time of reporting the outcome of the events were unspecified.
At approximately 12:45pm on 4/27/2021, patient received his first dose of Covid19 (Moderna) vaccine, given by Pharmacist on duty. During the 15 minute observation period following the vaccine, the patient's father asked the pharmacist to check his blood pressure.  While the pharmacist was checking his blood pressure (approximately 2-3 minutes following the vaccination), she notices the patient was starting to look pale and shut and squint his eyes as if he was having trouble focusing his vision.  The pharmacist questioned the patient to make sure he felt ok, and the patient said his vision was going black and he was  getting dizzy and lightheaded.  The pharmacist moved nearby objects out of the way to prepare to lay the patient on the ground. When returning to the patient, he was staring blankly, hunched over, unresponsive, no pulse felt on a 5 second check, and had rheum dripping from nose and eyes. At 12:50pm the pharmacist instructed technician to call 911. Patient was lowered to the floor in the supine position where he remained unresponsive and no pulse could be felt on a 10 second check, but chest rise could not be evaluated as patient started to have convulsions.  Convulsions ceased after approximately 15 seconds and patient started groaning and moving his head and said he could hear but he couldn't open his eyes yet. Patient remained supine and the Pharmacist continued to carry on conversation with patient until EMS arrived at 12:57pm to evaluate patient. EMS attributed  the instance to syncope related to the vaccine.  The patient denied ambulatory care to the hospital for any further evaluation. Patient denied history of fainting expect for ?one unprovoked episode at his grandmother's house when he thinks his blood sugar got too low.?
Client stated to student nurse very anxious about shots. After receiving vaccine became very light headed. Paramedics on scene and evaluated client.  EMS report done. Client's  B/P low after vaccine 60/40 after 30min of eval B/P went up 102/60. Client signed AMA with paramedics.
vomiting; a severe migraine headache for 5-7 days; chills; fever; vertigo; slept all day long; she also had a full leg charlie horse; Nausea; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The next day on 07Apr2021, the patient vomited at least 30 times, had a severe migraine headache for 5-7 days as well as chills, fever, vertigo and slept all day long. She also had a full leg charlie horse. When she spoke to her HCP about the vaccine, they suggested getting the second dose and enduring the side effects is better than dying of covid and wrote prescriptions for migraines and nausea. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Product origin unknown; incomplete series of vaccination; Literature Report:   Information has been received from the authors of a literature, titled as stated above, referring to a female patient of unknown age. The patient was postpartum and was enrolled in the initial postpartum human papillomavirus (HPV) vaccination program that was limited to a single county. Her concurrent condition, medical history and concomitant medication were not provided.  On an unknown date previously, the patient was vaccinated with unspecified HPV vaccine (strength, route, dose, frequency, lot number and expiration date were not reported) for prophylaxis (product origin unknown). It was reported that the partially vaccinated patient did not receive additional needed dose on postpartum ward (incomplete course of vaccination).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature (link # 2101USA001836).; Sender's Comments:  US-009507513-2101USA001836:
Severe eczema on my hands; have fully developed Dishydrotic Eczema; have been absolutely miserable; the never ending itching/fissures on my hands; the never ending itching/fissures on my hands; I have just started to begin injections every 2 weeks to help with the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 at 12:00 as dose 2, single (Lot number: FE3592) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FE3183, Prev dose lot unknown: False, Prev dose administration date: 20Aug2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 20Aug2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "I have just started to begin injections every 2 weeks to help with the pain"; HAND DERMATITIS (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "Severe eczema on my hands"; FEELING ABNORMAL (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have been absolutely miserable"; DYSHIDROTIC ECZEMA (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have fully developed Dishydrotic Eczema"; PRURITUS (non-serious), SKIN FISSURES (non-serious) all with onset 20Sep2021 at 12:00, outcome "not recovered" and all described as "the never ending itching/fissures on my hands". The events "severe eczema on my hands", "have fully developed dishydrotic eczema", "have been absolutely miserable", "the never ending itching/fissures on my hands" and "i have just started to begin injections every 2 weeks to help with the pain" required physician office visit. Therapeutic measures were taken as a result of hand dermatitis, dyshidrotic eczema, feeling abnormal, pruritus, skin fissures, pain.  Additional information: No covid prior and post vaccination and known allergies was penicillin. No vaccine in four week and other medication in two weeks.Clobetasol, Triamcinolone, Opzelura, Dupixent used as treatment drug. He used every possible steroid and cream available. He had been absolutely miserable since getting these vaccines and he have been living a nightmare with the never ending itching/fissures on my hands. He had just started to begin injections every 2 weeks to help with the pain, fissures and itching on my hands.  Follow-up attempts are completed. No further information is expected.
Sleep walking/drove while I was sleeping; This spontaneous case was reported by a patient and describes the occurrence of SOMNAMBULISM (Sleep walking/drove while I was sleeping) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNAMBULISM (Sleep walking/drove while I was sleeping). At the time of the report, SOMNAMBULISM (Sleep walking/drove while I was sleeping) outcome was unknown.            No concomitant drug reported.  Patient received, 1st booster shot.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-560020 (Patient Link).
10/14/03 at end of day, arm began to be pink around injection site. Child received TD and IPV earlier in day. By the 16th, arm was very red and parents requested school nurse to examine. School nurse referred child to physician. Child was seen in ER 10/17/03 and was subsequently hospitalized and treated with Rocephin for cellulitis to arm. The hospital record received on 1/22/04 confirms diagnosis of cellulitis.
I have developed tinnitus in both of my ears.   I have never experienced this before.   I have received second dose and the tinnitus has continued.
Positive test for Covid-19; pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), FATIGUE (Fatigue) and COVID-19 (Positive test for Covid-19) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE] and VITAMIN D3 for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced PAIN (pain) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced COVID-19 (Positive test for Covid-19). On 08-Jan-2021, PAIN (pain) and FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Positive test for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID arm-large red, swollen welt at injection site that began about a week later. The welt was itchy and tender. Lasted 3 days.
Rash (about 2 inches) on the injection site; Fatigue; Upper left arm was little sore; Little nausea; A spontaneous report was received from consumer, concerning herself, a 76-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and noticed a rash (about 2 inches) on the injection site, she also felt fatigue, upper left arm was a little sore and had little nausea.  The patient's medical history and concomitant medication were not reported.  On 13-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly on the upper left arm for prophylaxis of COVID-19 infection.   On 26-Jan-2021, 14 days after administration of vaccine, patient accidently noticed a rash (about 2 inches) at the injection site and she also felt fatigue. The upper left arm was a little sore and she had a little nausea.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event rash (about 2 inches) on the injection site, she also felt fatigue, upper left arm was a little sore and had little nausea was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 76-year-old female who experienced nonserious expected events of vaccination site pain, vaccination site rash, fatigue, and nausea.  The events occurred 14 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
Sore arm; Chills; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
no additional adverse events; patient received VAQTA pediatric dose instead of adult dose; This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 21-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021092 with expiration date on 18-MAY-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect dose administered). No adverse event was reported.
Right leg - front of right leg became number, top of foot numb, unable to raise foot while walking, dragging right foot while walking, unable to lift right foot when walking. 3months
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender who on 07-APR-2014 the patient was vaccinated with MMR II lot # 0649AE, subcutaneous that had expired on 27-MAR-2014. No adverse event reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 10:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 61 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Nov2021 at 11:30 as dose 3 (booster), single (Lot number: 33026BD), in right arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Apr2021 at 14:00 as dose 1, single (Lot number: EP7533), in left arm and on 07May2021 at 12:00 as dose 2, single (Lot number: EW0169), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Brain lesions (not MS)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Velocef, reaction(s): "Known allergies: Velocef"; Ergotamine, reaction(s): "Known allergies: Ergotamine"; Dexamethasone, reaction(s): "Known allergies: Dexamethasone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: initial positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received nirmatrelvir, ritonavir (PAXLOVID, lot number: GJ5186) from 15Sep2023 to 18Sep2023 as treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Fever/chills 9p, 1a, 8a, 12p, 4p, 8p- treated with Tylenol extra strength , arm soreness at injection site, body aches, treated with Tylenol extra strength
#Asymptomatic COVID-19 Infection -Patient has been COVID-19 positive since 12/2020 but denies any fever/chills, cough, shortness of breath, and does not require any oxygen supplementation
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot# M002419, expiry date: 12-JAN-2018) (lot# L032182, expiry date: 25-AUG-2017) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Severe HA day after dose 1 of Janssen covid vaccine. Felt good over following week. Developed shortness of breath, chest pain. Dizziness and near syncopal episodes daily for past week.
revaccination with different covid-19 vaccine; interchange of vaccine products; back pain; sore arm; fatigue; headache; muscle ache; itchy eyes/right eye was itchy/both eyes are itching; eyelid is swollen; This spontaneous case was reported by a patient and describes the occurrence of EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching), SWELLING OF EYELID (eyelid is swollen), COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and BACK PAIN (back pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7149B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had not event COVID + test or diagnosis. The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: pfizer (1st dose (She had very mild side effects with Pfizer doses. She might have had fatigue and headache)), pfizer (booster dose (no side effects from the booster dose)) and pfizer (2nd dose (She had very mild side effects with Pfizer doses. She might have had fatigue and headache)). Past adverse reactions to the above products included Adverse event with pfizer and pfizer; and No adverse event with pfizer. Concurrent medical conditions included Allergy to antibiotic (Allergies: trimethoprim).    On 13-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced BACK PAIN (back pain), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache). In September 2022, the patient experienced EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching) and SWELLING OF EYELID (eyelid is swollen). On an unknown date, the patient experienced COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On 13-Sep-2022, BACK PAIN (back pain), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) had resolved. At the time of the report, EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching) and SWELLING OF EYELID (eyelid is swollen) had not resolved and COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            No concomitant medications were reported.  The patient had not experienced a similar event in the past.  It was reported that the patient called eye doctor, who said it's probably a reaction to the vaccine. That's why the patient looked online and read that it was not recommended to take Benadryl, but hoped Benadryl will help with the itching eyes.
24 hours after varicella immunization, presented with pallor, grunting, fever, and sepsis-like picture.  Discharge Summary received on 10/09/2003 states sepsis.
Cough x 2 days, low-grade fever x 2 days, right ear drainage, yellowish bilateral drainage clear to eyes x 2 days. Acute OM, acute RAD, no rash at injection site and no redness.
Fever up to 102, headache, body aches and pains, muscle soreness and stiffness, joint pain, tiredness but not able to sleep.
Soreness at injection site, fatigue the day following the injection, malaise the day following the injection. No treatment. Feel normal the second day after the injection.
Pt developed high pitched inconsolable crying, lastin up to 6 hrs despite administration of acetaminophen.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# L041204, expiration date: 20-OCT-2017, subcutaneously. No adverse effects were reported. Additional information has been requested.
Red bumps started 3 days ago and spreading.  Complain of itchiness.
I received my second (booster) injection of Shingrix 50mcg inj(im)sngdse VL 10pk in the morning of 7/9/20. I got the first dose in early February 2020. My arm got more sore than with other shots, but it was not bad. I woke up some time between 11 pm and 12 midnight, and was not feeling well. I felt like I had a fever and I had chills. I felt bad throughout the night and was not able to sleep much. I am reporting this the next morning, and I feel run down, tired, and my arm is still sore. The chills and fever seem to have subsided. I feel the need to rest today.
Pt had fever over 39 degrees c. Fussy unconsolable, restless sleep, redness at injection site.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION BREAKTHROUGH; MULTIPLE SCLEROSIS FLARE-UP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: MS (multiple sclerosis). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced multiple sclerosis flare-up (shakiness, and dizziness). On 26-DEC-2021, the patient experienced suspected covid-19 infection (breakthrough) and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from multiple sclerosis flare-up(shakiness, and dizziness), suspected covid-19 infection(breakthrough) and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213710.; Sender's Comments: V0: 20220141626-JANSSEN COVID-19 VACCINE Ad26.COV2.S- multiple sclerosis flare-up -This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE   20220141626-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.