chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number 3; Pain at injection site; Swelling at injection site; Muscle aches; Joint aches; This is a spontaneous report from a contactable reporter (consumer or other non-hcp).   An adult female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 09:30 (Lot number: FH8027) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: intramuscular), administration date: 16Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: intramuscular), administration date: 06Apr2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 09:30, outcome "unknown", described as "Dose number 3"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Pain at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Swelling at injection site"; MYALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Muscle aches"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Joint aches". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, myalgia and arthralgia. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
faint and nearly passed out; faint and nearly passed out; dose number=3; bleeding quite a lot (blood dripping down arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Lot number: FS8757) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM; VYVANSE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19, prev dose brand=Pfizer, Batch/Lot No: EW0168), administration date: 06May2021, when the patient was 23 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, Batch/Lot No: ER8731), administration date: 15Apr2021, when the patient was 23 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Nov2021 12:00, outcome "unknown", described as "dose number=3"; HAEMORRHAGE (medically significant) with onset 30Nov2021 12:00, outcome "recovered" (30Nov2021), described as "bleeding quite a lot (blood dripping down arm)"; PRESYNCOPE (medically significant), SYNCOPE (medically significant) all with onset 30Nov2021 12:05, outcome "recovered" (30Nov2021 12:20) and all described as "faint and nearly passed out". Therapeutic measures were not taken as a result of haemorrhage, presyncope, syncope. Clinical course: No known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Immediately following the vaccination, I started bleeding quite a lot (blood dripping down arm) and it took a while (1 minute) to stop the bleeding. About 5 minutes later, I became faint and nearly passed out. I recovered in about 15 minutes.   No follow-up attempts are possible. No further information is expected.
Information has been received from the authors in a published literature article. This case concerns a 33 year old female patient pregnant with progressive hypogammaglobulinemia restricted to pregnancy starting, otitis media recurrent, sinusitis recurrent and pharyngitis streptococcal recurrent. The patient has a history of 5 previous pregnancies and 4 live birth(s). Protective titers Diphtheria, Haemophilus influenza, Mumps, Measles and Rubella. However, Tetanus titer was non protective and 1/14 antipneumococcal titers protective. On an unknown date, the patient was vaccinated with PNEUMOVAX23 for prophylaxis, and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDaP) (dose, frequency, route and lot# were unknown for both). The last menstrual period date (LMP) and end due date (EDD) were unknown. The pregnancy outcome and the fetal outcome were not provided. She was seen one and half years later, for prenatal counseling for her 4th pregnancy. Her immune evaluation included demonstrated protection to tetanus, Diphtheria and Streptococcal pneumoniae.
(R) arm swelled to 16 x 10 cm, very red & warm to the touch. Came to to office for assessment. Treated with Antihistamines.
w/in 24hrs p/vax was given the anterior half of the thigh was red, swollen & warm; a firm area approx 3cm surrounded the inj site which remains as of this date; thigh swelling resolved w/in 72hrs; ice, APAP & DPH were administered
Headache, NauseaVomiting, Left arm pain the evening of the Vaccination followed by Nausea and HA
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unspecified dates, the patients received improperly stored doses of GARDASIL (route, strength, lot#, expiration dates and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Starting the day after my arm was super painful where I couldn't move my arm. The end of August the pain started getting worse and now my ankles are starting to get stiff and sore.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced fever and rash, the fever subsided within 3 days.
Sinusitis; Injection site warmth; Hives; Redness; Swelling; extreme Itching; Swollen lymph nodes; Fatigue; Dysphagia; Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives) and DYSPHAGIA (Dysphagia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), DYSPHAGIA (Dysphagia), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (extreme Itching). On 10-Mar-2021, the patient experienced SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), URTICARIA (Hives), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form and HYDROCORTISONE at a dose of UNK dosage form. On 04-Mar-2021, DYSPHAGIA (Dysphagia) had resolved. At the time of the report, SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (extreme Itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.
Within 4 hours had redness, swelling greater than 5 inches in diameter on right thigh at site of immunizations. Baby very fussy/screaming. No fever, Taken to ER, Area iced every 3 hours x 20 minutes  & Tylenol.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021 the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Injection site is hot, swollen 4" long swollen 1 1/2" wide. At injection site and itchy at site of subcutaneous dose of ZOSTAVAX not FLUZONE.
ALLERGIC REACTION; This spontaneous report received from a patient concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction. This report was non-serious.
Patient admitted to the hospital on 3/29/2021, within 6 weeks of receiving COVID vaccination.
dose was partially administered; the needle detached from the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy. On 28-AUG-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: dose was partially administered) and needle issue (Verbatim: the needle detached from the syringe).  The outcome of the accidental underdose and needle issue were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was a pharmacy Intern who stated that while administering a dose of Arexvy to a patient, the needle detached from the syringe and the dose was partially administered which led to needle issue and accidental underdose. According to the reporter, the issue was not related with the product or the reconstitution process. The reporter consented to follow up.
a neurological sensation in her body; Initial information received on 02-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional.  This case involves an unknown age female patient who experienced a neurological sensation in her body (neurological symptom) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious a neurological sensation in her body (neurological symptom) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event (a neurological sensation in her body).  On an unknown date, the patient recovered from neurological symptom.  There will be no information available on the batch number for this case.
Case 2 -- Local reddened area of 3-4 inches in dia. Red, hot, swollen & oozing.
Rare type of cancer; Blood titer had 'gone a little bit berserk' with a blood titer of '3000' / Caller reports most recent ''blood shingles titers" 3060; Paralyzed/glued to floor; This spontaneous report was received from a nurse concerning to herself, who was a female patient of unknown age. No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided.         On an unspecified date in 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and  expiration date were not provided) on recommendation from two oncologists, one internist, and one allergist.  On an unspecified date in 2007, within 8 days of receiving the mentioned vaccine,  the patient became 'paralyzed/glued to floor' which had happened in 15 to 20 minutes intervals. At event time, blood titer was determined by healthcare professional (HCP) to be 4.3 (unspecified units).              In Autumn 2020 (reported as ''last fall''), HCP drew blood at which time blood titer had 'gone a little bit berserk' with a blood titer of '3000' (unspecified units) (viral titre increased).  On an unspecified date (reported as ''most recent''), a blood shingles titers' result of 3060 (unspecified units) was reported (per caller, normal would be 160 (unspecified units) (viral titre increased).  On an unspecified date, patient experienced a rare type of cancer (neoplasm malignant). It was reported that, on an unknown date, patient was being treated with an unknown medication from an unknown manufacturer and patient was seeing a specialist for rare cancer treatment.  It was also reported that, HCP had recommended patient receive unknown COVID-19 vaccine on unknown, future date.   At the time of the report, the outcome of neoplasm malignant, viral titre increased and paralysis was unknown.  The causal relationship between all the events and zoster vaccine live (ZOSTAVAX) was not reported.  Upon internal review, neoplasm malignant and paralysis were considered serious due to medically significant criteria.
Parents told me today at a sibling's visit that ~2 weeks after patient received her Varivax she developed a fever and what looked like chicken pox lesions at the site of injection, and ~2 weeks after that multiple contacts (cousins, church nursery) broke out with chicken pox.
The day after the shot, I became itchy all over, eventually developing what doctor diagnosed as psoriasis. He prescribed a steroid cream for affected areas. Still use the cream when needed.
extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week, heart palpitations on and off for 3 weeks and then wound up in emergency room and to hospital by ambulance for overnight (chest pains) which after they did lung, abdomen scans and eco cardiogram and ekg was diagnosed as inflammation of chest cavity
Rush of a metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Rush of a metallic taste in mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Rush of a metallic taste in mouth). At the time of the report, DYSGEUSIA (Rush of a metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications were provided. The patient only had an egg and spinach that morning.
Patient had inflammatory response with swelling, edema requiring outpatient steroids.  She developed cold right foot and had a popliteal artery occlusion. She was admitted to an outside facility who attempted thrombectomy to popliteal artery in the right leg but were unsuccessful complicated by fasciotomies and lysis which was also unsuccessful.  She was transferred to the Hospital with complete occlusion of right popliteal artery despite multiple interventions and malperfusion to right leg for ~ 4 days.  She required an above the knee amputation on the right.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm felt really bad for a couple of days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm felt really bad for a couple of days). At the time of the report, pain in extremity (arm felt really bad for a couple of days) resolved. No concomitant medication use or treatment of events provided. This case linked to MOD-2021-132115 (patient link).
This spontaneous report as received from a registered nurse refers to a patients of unknown age. ZOSTAVAX which were improperly stored were administered to patients over the "past year" (lot#, strength, dosage and route unknown). No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
eye felt irritated and burned; eye puffed up and was red; eye was red; felt a little cruddy; arm hurts; headache; A spontaneous report was received from a consumer concerning a 69-years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, arm hurts, felt a little cruddy, normal side effects, puffed up and was red.  The patient's medical history was not provided. Concomitant medications reported were  for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) headache. arm hurts, felt a little cruddy, normal side effects. On 11 Feb 2021, the patient experienced the events, eye puffed up and was red.  Treatment details included Didn't take anything.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event,felt a little cruddy was considered resolved on 9 Feb 2021.The outcome of events ,normal side effects was considered resolved on 11 Feb 2021.The outcome of events,puffed up eye  was considered resolved on 11 Feb 2021. The outcome of events, headache, arm hurts, eye felt irritated and burned and red eyes were unknown.
Information has been received from a Registered Pharmacist (R. Ph.) concerning a 96 year old female who was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) on an unspecified date. Concomitant therapy included a dose of flu shot (manufacture unknown). Subsequently the patient developed GUILLAIN-BARRE syndrome and was hospitalized. At the time of reporting the patient was in the hospital for this AE. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Received ADACEL @ 10:30 am - within 10 hours child c/o severe H/A, dizziness and nausea, and chills. BP - orthostatic hypotension - unable to stand or sit for more than 15-30 seconds - c/o increase H/A generalized weakness. Transported 911 to Hospital.
Person was vaccinated with a 5/8 inch needle instead of the standard 1 inch needle