chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Pain at injection site; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Nausea; Body ache; Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2) (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 (manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at injection site"; AXILLARY PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "Pain in armpit as well as neck and shoulder"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional event: Description of Event:  5'1, 31 years old. After COVID booster experienced pain at injection site, in armpit as well as neck and shoulder, all lasting for more than 24 hours. Nausea, body ache, headache, chills  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 CPS (Infectious Disease), concerning a pt who was vaccinated  with Recombivax HB. Subsequently the pt experienced fulminant hepatitis B. The pt's outcome was not reported. Upon internal review, the fulminant hepatitis B was considered to be an other medical event. Additional information has been requested.
On Week 5, had 5-day course of prednisone for tendinitis.  No recrudescent lesions, very faint scar after soughing small eschar at 4 weeks.  Patient had 3 or 4 smallpox vaccinations, the last one in the military in 1985.
This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. The pharmacist was informed by a nurse, that on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number, and expiration date were not reported) administered intramuscularly (rather than subcutaneously) for prophylaxis that was reconstituted using sterile diluent (MRK) (lot number and expiration date were not provided). According to the reporter, the patient experienced an unspecified localized reaction at the injection site as well as pain in the arm where the vaccine was administered. At the time of this report, the outcome of the vaccination site reaction and vaccination site pain was unknown. The causality assessment between vaccination site reaction and vaccination site pain with ZOSTAVAX and sterile diluent (MRK) was unknown. Additional information has been requested.
Within the first hour my left arm started swelling at the site of the injection. The swelling was well past the band-aid to the point of taking off the band-aid to relieve pressure. Four hours after the vaccination I had begun to have pain in my left shoulder when trying to use my left arm/hand. This pain in my arm is still very high after 5 weeks. The pain is actually worse as I cannot play golf with extra pain in my back swing.
spontaneous coronary artery dissection, admitted 6/16/21 (please note, I don't have information on the particular vaccine that was administered
Redness, itching, tenderness around vaccination site. Arm hurt night of vaccination. Noticed redness 24 hrs later. 72 hrs red, warm, indurated area 3.5x5cm local reaction.
The night of the vaccine: body aches, intense chills, fever, night sweats, headache, insomnia The morning after: Passing out/fainting (loss of consciousness for a couple seconds), body aches, chills, headache. *Symptoms improved with sleep throughout the afternoon of the the day after. Body aches and weakness continued for about 4 days.
Edema below deltoid to about 2 inches from elbow slight red, painful x 2 days. TX cool compresses, Benadryl PO PRN.
Dizziness; Flu like symptoms; Concentration impaired; Nauseous; Muscle pain; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired). At the time of the report, DIZZINESS (Dizziness) had not resolved, NAUSEA (Nauseous) had resolved and HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired) outcome was unknown.      Concomitant medication use was not provided. Treatment information included Anti nausea medicine.
The pt was seen in the office with a painful rash on left side of face. There was a cluster of vesicles just in front of ear with a few vesicles scattered along dermatome. Diagnosed with shingles.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 57-year-old male (ethnicity and race unspecified) 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 was not reported,1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 05-MAY-2021, patient took a clinical laboratory test where it turned up negative antibodies (suspected immunological vaccination failure). On 05-MAY-2021, Laboratory data included: Antibody test (NR: not provided) as negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210536462-covid-19 vaccine ad26.cov2.s-suspected immunological vaccination 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
Patient was seated in observation area post administration of Pfizer COVID 19 Vaccination.  Patient noted a sudden onset of flushing (warm) feeling to face and chest.  Patient's feet were elevated, 50 mg Diphenhydramine PO administered per standing order and provider direction.   Patient reported recovery from flushing symptoms approximately 5 minutes after initial onset and evaluation.
Information has been received from a registered nurse concerning a 1 year old patient of unknown gender. No concurrent condition, medical history and concomitant therapies were reported. On 02-MAY-201 the patient was inadvertently administered 1 dose of (Oka/Merck) VARIVAX (lot#, dosage and route not provided) and 1 dose of (Oka-Merck) PROQUAD (lot#, dosage and route not provided) (overdose). No adverse effect were reported. It was unspecified if the patient sought any medical attention. Additional information is not expected as there was no consent to contact the nurse.
Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 at 13:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) and escitalopram oxalate (ESCITALOPRAM), both from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 at 14:15, the patient experienced arm soreness. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient blacked out while seated in waiting area after vaccine. He did not respond to multiple questions for about 5 minutes until he slowly started coming around again. EMS was called and they put him on the stretcher and raised his legs until the moved him to a seated position.
Shortness of breath; abnormal palpitations and heart racing while at rest; as well as chest pains.
Within 5 minutes of receiving HPV vaccine, patient passed out.  Was receiving MMR vaccine at the time of fainting.  But was within the time frame of HPV precautions.
Weakness; Nausea; Patient received 2 doses of Fluad TIV in the same season; This spontaneous case was received on 30-Oct-2020 from a physician via Med Communications (reference number: SEQW20-04549) and concerned a 84-year-old, male patient.  The patient's concurrent conditions included severe systolic and diastolic heart failure, kidney disease, hyperlipidemia and glaucoma. The patient's concomitant medications included Baby Aspirin (acetylsalicylic acid), atorvastatin, furosemide, hydralazine (reported as hydro lysine), adjuvanted inhaler Advair diskus (fluticasone propionate, salmeterol xinafoate), albuterol (salbutamol), all for unreported indications.  On an unspecified date in Oct-2020 (reported as 06-Oct-2020 and 23-Oct-2020), the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279736 and expiry date was 04-May-2021.  On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) (explicitly coded as 'Extra dose administered') for influenza prophylaxis. The batch number reported was 279736 and expiry date was 04-May-2021.  On the same day, 20 minutes after receiving the second dose of Fluad (TIV), the patient experienced nausea and weakness.  On an unspecified date in Oct-2020, the patient recovered from the event of nausea.  At the time of initial reporting on 30-Oct-2020, the patient was recovering form the event of weakness.  The reporter did not provide a causality assessment.  The reporter assessed events of weakness and nausea as non-serious.  Company comment: On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV). On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV). On the same day, 20 minutes after receiving the second dose of vaccine, the patient experienced nausea and asthenia. Chronology is plausible. Based on provided information, causality is assessed as possibly related for both events. Extra dose administered is assessed as not related per company's conventions.; Sender's Comments: On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV). On 29-Oct-2020, the patient was vaccinated with the second dose of Fluad (TIV). On the same day, 20 minutes after receiving the second dose of vaccine, the patient experienced nausea and asthenia. Chronology is plausible. Based on provided information, causality is assessed as possibly related for both events. Extra dose administered is assessed as not related per company's conventions.
Administered a dose reconstituted with the MMR vaccine diluent; Administered a dose reconstituted with the MMR vaccine diluent; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA646, expiry date unknown) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 6th May 2022, the patient received Menveo and MMR vaccine. On 6th May 2022, unknown after receiving Menveo and MMR vaccine, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Menveo reconstituted with the MMR vaccine diluent, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.
Shortness of breath, erythema of the face, abdominal cramping, chills, tachycardia
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 11:52 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 11:52 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) on or about 24-Dec-2021. No treatment medication was reported by reporter.
The next day I was fatigued, cold, and nauseous. I had joint pains and extreme sensitivity to light.  Since the vaccine I have still been fatigued every single day. I called my doctor, and she gave me Zofran for the nausea and advised me to rest and drink fluids.
Pain in the navel Area/feels like her stomach is paralyzed; Nausea; General Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 47621A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue). On 02-Jun-2021, ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use unknown medication for blood pressure. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR was attached on 09-JUN-2021 contains updated information about events.
I been having joint pain in my hip. I went to an ortho specialist about this. They did x-rays, normal result. They said that I would need an MRI on my soft tissues. They referred me to a physical therapist.
patient received H1N1 immunization in left deltoid, felt fine, went to car and noticed swelling. Pt also noticed some redness
SWEATS AND DIZZY /VASOVAGAL- Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
Correct type of vaccine given to correct patient at correct time, but from incorrect funding source. Parent marked that child had X coverage, so vaccine was given although NP ordered vaccine from X supply. No symptoms affecting patient.
Patient states her feet started swelling instantly and she felt nauseated and also felt warm.  When her vitals were taken everything was normal.  She asked to be transported to have further observation.
feeling cold; shaking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and TREMOR (shaking) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 025D21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (Patient had Atrial fibrillation and has been under control for the last 2 years.) since 2019.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING COLD (feeling cold) and TREMOR (shaking). At the time of the report, FEELING COLD (feeling cold) and TREMOR (shaking) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-372783 (Patient Link).
CDC reports: 5 mo infant rec'd DTP/OPV 16JAN90 & 19JAN90 experienced convuls & lethargy; lumbar puncture normal.
Shortness of breath irritated by problem he's having; trouble performing normal daily functions; Weak; Tired; Bit lightheaded; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration, administered in arm left on 06Apr2021 at 15:10 (at the age of 83-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included atrial fibrillation from 1987 to an unknown date (his last episode was in 2018), ongoing chronic obstructive pulmonary disease (COPD) for about 10 years maybe 2011 and ongoing sleep apnoea syndrome. The patient family medical history included his father died of a heart attack and his mother died from dementia like alzheimer's. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for chronic obstructive pulmonary disease, start and stop date was not reported. He took albuterol whenever he was short of breath. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 16Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 07Apr2021, the patient experienced weak, tired and bit lightheaded. Shortness of breath irritated by problem he was having and trouble performing normal daily functions on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included in the emergency room blood test: normal, chest X-ray: normal and computerised tomogram: normal. It was reported that the patient underwent lab tests and procedures which included in the emergency room they did a urinalysis and took blood from him. He was sure there were 8 of the vials, and 4 of the little bottles took quite a bit of blood. He asked if they were giving someone a transfusion. They did a CAT scan of his head because they thought it might be a brain bleed. They did a chest X-ray and that was negative, he had no problem. They didn't even notice anything wrong with his COPD. Maybe they couldn't see it on an X-ray. The patient woke up in the morning at about 0900 he realized he was sick. Through the night he slept well. The patient had sleep apnea and had a CPAP on him at night with oxygen. When he woke up he felt short of breath which was unusual. When he woke up with the CPAP it almost processes it and takes care of the shortness of breath. He also had the oxygen. When he woke up he knew something was wrong. The patient took albuterol whenever he was short of breath and he had another medicine he took once a day, patient took a lot he had 13 prescriptions and then took some generic over the counter medications that doctors recommend. The outcome of the event weak and tired was recovering, bit lightheaded was not recovered, shortness of breath irritated by problem he's having and trouble performing normal daily functions was unknown.  No follow-up attempts are needed. No further information is expected.
Severe swelling left arm shoulder to hand pain in palmar surface near 5th digit . Qquil prescribed by PCP
Received immunization in (L) Deltoid. Site is swollen, hot to touch. HR is elevated (103) pt feels flushed temp 97.6 oral SOLUMEDEROL 125 mg IM @ 13:30. Ice pack to site.