chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist, concerning a 72 years old male patient. The patient had no medical history, drug reactions or allergies. On unspecified date in 2011, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # reported as 0365AA, expiration date 09-JUN-2012, 0.65 ml once, administered per subcutaneous route. The patient was not with concomitant medications. The pharmacist reported that in October of 2016, reported as "this week", the patient had a bad case of shingles. The pharmacist stated that the patient sought medical attention with an unspecified provider on unspecified date and he was diagnosed with shingles. The patient received an unknown treatment. The pharmacist was offered the VZVID packet fax and declined to receive this because it had been over 5 years since the vaccine was given and did not feel there was a need for isolate testing. The outcome of shingles was reported as not recovered. The causal relationship between ZOSTAVAX and shingles was not reported. No overdose or product quality complaint (PQC) was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was not sure if SHINGRIX was related to the rash. The patient declined to provide any other information.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder; pt recvd a booster dose of Engerix-B on 19SEP90; HBSAB was pos on 29NOV90 & hence resolved;
Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, received PCP clearance to receive COVID-19 vaccine. Patient given Pfizer vaccine # 1 (lot # EN6201). Approximately 12 minutes into 30 minute wait she began to report that she had a "sore/scratchy" throat and took Benadryl 50 mg PO (patients own supply). Patient took medication on her own and was given permission to take by NP. Patient was assessed by NP with breath sounds CTAB, no wheezing or stridor. No visible swelling of the lips, tongue or face. No rash. VS: B/P 124/73, HR 110, SaO2 100% on RA. During assessment she began to clear her throat and therefore was taken to Facility for further evaluation and monitoring.  At Facility, pt was monitored for about 30 minutes. Pt admitted to be anxious about the vaccine. Pt received no medications from Facility. Pt instructed to use diphenhydramine Q6-8 hrs PRN. Pt was discharged to home.
This case was reported by a health professional to a sales rep and described the occurrence of an injection site reaction in a 5 yr old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On an unspecified date, the pt received the fifth dose of Infanrix in the left arm (lot DTPA630B2). At an unspecified time following the admin of Infanrix, the pt experienced an injection site reaction. The pt weas seen at the physician's office. The outcome of the event is unk. The health professional considered the event to probably be related to vaccination with Infanrix.
patient eas administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 17-DEC-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S013711 with expiration date on 01-NOV-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  There was a previous temperature excursion from -14 to -10 degrees Celsius (C) (-10.9 C) for 15 minutes. Then, administered doses of vaccine experienced a temperature excursion from -14 to -10 C (-11.8 C) for 1 hour 30 minutes. Digital data logger was involved.
A medical assistant reported that a 4 year old child received an injection of Acel-Immune on 01/12/2000 and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
April 7, 2021 - 1st dose.  April 15, 2021 - cough, heart palpitations.  April 22, 2021 tested negative for COVID.  Took OTC cough/cold medicine.  Coughing eased up a bit, heart palpitations continued.  June 15, 2021 - Primary care doctor EKG and chest x-ray.  EKG showed extra beats,  x-ray showed interstitial coarseness possible COPD.  Referred to Cardiologist and Pulmonary Dr.  June 24, 2021 -  Cardiologist - EKG, heart monitor, echocardiogram - all acceptable range.    Pulmonary doctor - August 10, 2021 -  chest x-ray and breathing test - no COPD, no treatment required.  Coughing and heart palpitations every now and then.  Have increased vitamin C, D3
Patient states on Saturday that she had swelling in the arm she received her flu shot (on Thursday) that spread down to her elbow. She said her skin was red and hot to the touch and reported a burning sensation. She removed her Bandaid from the vaccine that morning. The pharmacist on duty recommended she go to urgent care for potential cellulitis or delayed reaction. Pharmacist instructed her to take Benadryl and ice pack for swelling since she did not want to go to urgent care Saturday night.   On Sunday, patient came to pharmacy to pick up antibiotic from urgent care. Provider diagnosed cellulitis. Patient was instructed to go to hospital if condition worsened. Patient stated that the provider did not think the vaccine was the cause but was instructed to follow up with PCP on Wednesday.
Patient did not describe any adverse events; the patient received a dose that was beyond the beyond use date of 3/3/23.
left ring finger swelling; left lower extremity pain; tightness; swelling; decreased range of motion in finger; decreased strength in finger; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling) and MOBILITY DECREASED (decreased range of motion in finger) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling), MOBILITY DECREASED (decreased range of motion in finger) and MUSCULAR WEAKNESS (decreased strength in finger). At the time of the report, PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling), MOBILITY DECREASED (decreased range of motion in finger) and MUSCULAR WEAKNESS (decreased strength in finger) outcome was unknown. Not Provided   Treatment information was provided i.e., steroids     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Site: Swelling at Injection Site-Medium, Additional Details: Patient called pharmacy a week after immunization stating arm was swollen at the area of the injection site - recommended Benadryl and is symptoms worsen or different symptoms arise seek medical attention right away
15-20min p/vax pt devel coughing, watering from eye & nose, sneezing, abd pain;vital signs were stable;had mild wheezing in chest;given epi & albuterol;sx subsided;
SORE ARM; LOW GRADE FEVER; EXHAUSTION; PERSISTENT INTERMITTENT HEADACHE; This spontaneous report received from a patient via a company representative concerned a 63 year old male. 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/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, low grade fever, exhaustion, and persistent intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and the outcome of exhaustion, persistent intermittent headache and sore arm was not reported. This report was non-serious.
injection site inflammation upon wakening the next morning was better by day three however began itching on day four and slightly irritated by day six was seriously inflamed borders were marked before bed and upon wakening day seven, had enlarged past borders  area morning of day seven is 3.5 inches across and 2 inches long, very red, raised and hot to the touch with occasional itching
Pericardial Effusion, Pulmonary Effusion, Kidney Failure (likely due to treatment, not vaccine)
Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 24-SEP-2007 was vaccinated with the first 0.5 ml IM dose of GARDASIL. There was no concomitant medication. In December 2007, the patient experienced blackout episodes and petit mal seizures. On 06-DEC-2007 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL, and on 07-AUG-2008 the patient received the third GARDASIL. Some time in 2008, the patient experienced grand mal seizures and had been hospitalized multiple times (details of hospitalizations not provided). The patient had been subsequently evaluated by an unspecified neurologist who had prescribed an unspecified anti-seizure medication. Neurological tests were performed with normal results. At the time of this report, the patient's blackout episodes, petit mal seizures and grand mal seizures persisted. Blackout episodes, petit mal seizures and grand mal seizures were also considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information has been requested.  3/9/09 Received hospital records for multiple ER & admits: 3/20/2008 FINAL DX: syncopal episode vs anxiety attack Records reveal patient experienced brief episode of syncope while getting ready to travel to hospital for eye surgery she was very nervous about.  Exam in ER revealed chewing movement of mouth/lips, shaking of LUE but was awake & alert.  Tx w/anti anxiety med, improved & d/c to home.  4/20/2008 FINAL DX: syncope r/o seizure Records reveal patient experienced sudden LOC & fell to ground striking head.  Out for approx 5 min w/jerking/seizure activity for short time.  Exam in ER was WNL.  Remained stable, d/c to home & referred to Neuro.  10/9/2008 Final DX: postictal state, probable seizure PTA; hypokalemia Records reveal patient experienced HA, facial redness & passed out.  Remained stable, d/c to home w/PCP f/u.  PMH: congenital heart disease w/open heart surgery, lazy eye w/eye surgery, petit mal seizures x approx 6 mo.  2/18-2/19/2009 FINAL DX: No d/c summary dictated. Neuro states recurrent petit mal seizure Records reveal patient admitted by Neuro s/p petit mal seizure activity while at school w/inattention & shaking of RUE.  ER exam was WNL.  Meds adjusted  2/24-2/25/2009 FINAL DX: no d/c summary dictated.  Neuro states recurrent seizure activity, suspect to be petit mal in type, localized & partial.  Exam revealed tonic clinic activity of LUE intermittently.  Meds changed, d/c to home w/neuro f/u.
On an unknown date, the vaccinee received his third injection of Lymerix. An unspecified time post immunization, he developed arthralgias, a positive ANA titer and a skin lesion "suggestive of lupus." Treatment and outcome of the events were not provided. Possible lupus is considered medically serious. The follow up describes discoid lupus in a 66 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included hyperlipidemia. There was no history of gout, psoriasis, Crohn's disease, or Lyme disease. There was no family history of rheumatoid arthritis or lupus. Concurrent medications included Zocor. The vaccinee received injections of LYMErix on 6/2/99 (lot 120F9), 7/1/99 (lot 123G9), and 8/4/00 (lot 146A9). On 9/18/00, approximately six weeks after receiving the third injecton of LYMErix, the vaccinee presented to the vaccine provider with arthralgias and myalgias of the hands, forearms, forefeet, and hindfeet. Simvastatin therapy was discontinued. In January 2001, the vaccinee developed a photosensitive rash on his face and upper extremity and was referred to a dermatologist. Antinuclear antibody titer was negative. The dermatologist performed a skin biopsy: the results were consistant wiht discoid lupus. In September 2001, the dermatologist prescribed Flaquenil 200mg once daily, then 200mg twice daily. The vaccinee was seen by the reporting rheumatologist on 11/7/01. No warm or swollen joints were noted on examination. No joint fluid was obtained for analysis. Lab analyses revealed erythrocyte sedimentation rate 32mm/hr, ANA titer 1:8 with a speckled pattern, and positive Sjogren's SSA and SSB antibodies. Rheumatoid factor on an unspecified date was normal. The rheumatologist stated that the clinical and serologic constellation now consistant with undifferentiated connective tissue disease. As of 3/26/02, the events were ongoing. The rheumatolgoist considered the events to be moderate in intensity. He considered LYMErix to be a possible trigger for the undifferentiated connective tissue disease.
A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 26-Nov-2013. It was reported that consumer was administered expired FLUMIST QUADRIVALENT which started on 26-Nov-2013. The outcome of the event of Expired FLUMIST QUADRIVALENT Administered is unknown. The report was considered to be non-serious.
Information has been received from a nurse concerning an adult in 50s, who in October 2008 ("past week") received a first dose of 0.5 ml PNEUMOVAX (lot # 660718/0551X, route and injection site unknown).  It was reported that the patient had pain and burning while the injection was given.  The events resolved in a minute or two.  The patient sought unspecified medical attention;  no treatment was required.  Additional information has been requested.  This is one of 3 reports from a same source.
Pt developed fever, chills, sweats, headache, severe pain, redness and warmth at the vaccination site, posterior deltoid left arm administered subcutaneously.  This worsened over 3 days.
Developed shingles on right posterior, right testicle, between legs. Followed by fever and consistent headache which have subsided, shingles still present.  IMPORTANT: NEVER HAD CHICKEN POX Received chicken pox vaccination and booster as infant.
Patient received Pfizer vaccine on left deltoid and immediately displayed seizure like activity while sitting down. Patient eyes rolled back and was briefly unresponsive for a few seconds. EMS was notifed at this time. The patient was assisted and carried down to the matted floor and feet were elevated on a chair. Patient did become responsive and was alert and oriented but continued be dizzy. Patient did not have labored breathing or respiratory distress at this time.   Patient's vital signs were taken at 14:50: 130/71, 80hr, 95% PsO2, 18rr  The fire department arrived and transported patient to Hospital. Patient did have another seizure like activity and patient's heart rate dropped into the 40-50s. Peripheral IV on right hand was initiated and bolused.   Patient's mother, was notified of event and patient's sister who was waiting outside was brought into facility. Patient's sister who is 14 years old was later picked up by mother.
She could not get warm, she was bone cold; She slept a lot; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 0LGL20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted). At the time of the report, FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) outcome was unknown.            Patient reported that she was asthmatic at baseline.   She had COVID-19 before first dose.  No treatment medications were reported
experiencing swelling, redness and pain on the arm where she got the vaccine; experiencing swelling, redness and pain on the arm where she got the vaccine; experiencing swelling, redness and pain on the arm where she got the vaccine; 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 female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; rsv vaccine (RSV VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 06Nov2023, outcome "unknown" and all described as "experiencing swelling, redness and pain on the arm where she got the vaccine". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain.  Additional information: Caller got her dose of Abrysvo on 31Oct2023. On 06Nov2023, she started experiencing swelling, redness and pain on the arm where she got the vaccine. She mentioned she has a surgery next week, so she saw a nurse in a dermatologist and told her that it is in the same location of the muscle that starts with d where the vaccine is given. She wanted to know if this is related to the vaccine as she had none of this side effects when the vaccine was given, not even pain. Caller mentioned she was started in antibiotics just in case this was something related to getting staph infection during the shot. I am having surgery next week. If I knew this was a possible reaction, I would not be so worried because now I am worrying if it is unrelated but I cannot seem to find information from Pfizer on whether or not people can get a delayed reaction like this.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Fever of 102, night sweats, redness/swollen at injection site, soreness for several days at injection site.
Aches to mid back 12/6/05 in AM for about 2hours; general muscle aches 12/6/05 in AM for about 2 hrs; c/o shortness of breath 12/6/05 in AM for 2 minutes
Severe vertigo, nausea, faintness, clamminess, inability to focus eyes.  Lasted for several hours through the night.  I don't know if this vaccine was Tdap Adacel or Tdap (Boostrix), which is why I chose "other" above.
Injection site is a little feverish, warm; Injection site tight; Injection site itchy; Injection site is now red; Injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is a little feverish, warm), VACCINATION SITE INDURATION (Injection site tight), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is now red) and VACCINATION SITE SWELLING (Injection site raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is a little feverish, warm), VACCINATION SITE INDURATION (Injection site tight), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is now red) and VACCINATION SITE SWELLING (Injection site raised). At the time of the report, VACCINATION SITE WARMTH (Injection site is a little feverish, warm), VACCINATION SITE INDURATION (Injection site tight), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is now red) and VACCINATION SITE SWELLING (Injection site raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 days of intermittent twitching/jerking movement of arms, head and neck, epsiodes approx. 20-40 min in duration. Involved hyperventilation, improved with . Admitted 8/22-24. No meds given.
Janssen COVID-19 Vaccine EUA:  I received Janssen COVID-19 Vaccine EUA on 4/7/2021 and started having  the muscle and joint pain, stiffness, immobility around the ankles and feet about three hours or so after the injection.  This is persisting and can't stand for a more than 30 minutes without incurring additional pains and stiffness.  The stiffness is such that it feels as there is a sprained muscle or bone by the right ankle and top of the sole of left foot.