chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant Follow up-patient demographics added, report type changed from Invalid to spontaneous. suspect product start date, suspect product expire date, lot number has been updated.
Patient became light headed, dizzy w/ nausea & vomiting.  Shock-like reactionl.  Light pulse w/ blood pressure 98/66.
This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1805025) dose was not reported, administered on 09-MAR-2021 10:22 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced vaccine was used after the vial puncture past 6 hours mark in the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was used after the vial puncture past 6 hours mark in the fridge was not reported. This report was non-serious.
Injection given on 6/30/04. Chicken pox rash started on 7/8/04. Seen in office on 7/9/04. Chicken pox rash all over.
Late period (by 1 week), heavy period, the night after my vaccine I had chills and uncontrollable shaking, cold sweats, and a difficult time regulating my temperature. This subsided with rest within 24 hours
Information has been received from a registered pharmacist concerning a 67 year old male physician patient with no pertinent medical history and no drug reactions/allergies who approximately was vaccinated with a dose of PNEUMOVAX 23 IM "2 years ago" in August 2008. There were no concomitant therapies. Within hours of the vaccination his arm and shoulder were swollen and enlarged. The patient did not require any treatment. The patient sought unspecified medical attention. There were no lab diagnostic tests performed. The symptoms resolved "in a few days 2 years ago". Follow up information has been received from the registered pharmacist indicated that the patient experienced this reaction at the physician's office. They merely called with additional questions. The patient's physician should have already reported. No further information is available.
Shingrix in August, but neglected a second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in August).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The reporter stated that we had a Shingrix vacation in August but neglected a second dose.  At the time of reporting, the reporter asked if it was still beneficial to get a second dose. Additional Supportive Information:  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case is linked to the case US2022AMR089815, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR089815:same report, other patient
Severe and extensive Zoster/Shingles reactivation, affecting T10-T12 dermatomes requiring inpatient admission for IV acyclovir
On 02/03/2001 the patient developed varicella. There were no illnesses at the time of vaccination. On 02/13/2001 the patient presented to the physician and was diagnosed with varicella with 10-40 vesicles. It was noted that the patient was afebrile and no treatment was ordered. The physician considered the patient's experience to be non-serious. Subsequently the patient recovered. No further information was available.
Swelling, redness, and itch (circular bump) at injection site. Appeared 7 days after initial injection.
Bruise started to form soon after shot in deltoid muscle. Bruise seemed to get worse over 3 days and extend toward elbow.
Breakthrough bleeding, spotting, and cramping has occured since two days after receiving first covid vaccine shot.  I am currently on day 36 and up until this point I have had no like issues with my choice of birth control.
Patient was given Moderna Bivalent Booster but was only given half the dose. Wrong dose given.
Injection site pain, chills, fever 99.9, body aches, headache, and intense fatigue began 8 hours after injection.  At 24 hours after the shot, only headache and mild fatigue remained.  At 34 hours after shot, I am beginning to feel well again.
Within 5 minutes of the vaccine given, tingling sensation down both arms, up the trunk to the back of the throat, metal taste in mouth, immediately started coughing, tickle at the back of the throat, pulse elevated at 110. O2 sats remained 95%-98%, monitored by paramedic for 20 minutes, 2 Benadryl (50mg), cough subsided, notified (primary  doctor) started on Zyrtec 4x/day, Allegra 180 mg BID, Benadryl  prn, continue this regimen for 3 days, ( improvement with cough when taking medication) Heart rate remains 80-90's, higher than baseline, instructed to start steroid dose pack on January 5th, pulse 100's, continued cough.
Heart/Chest pain, rapid heart beat, nausea, sweating, headache, tingling extremities, and face, lasted 2 weeks.
headache; chills; fever; nausea; body aches; extreme dizziness; chest pain; pain that radiates from her arm to her back and settled in the kidney area
Started having acute pain in left knee 2 days after the 2nd shot.  Having difficulty putting pressure on knee joint.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
SICK; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were 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 patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018220.
tongue swelling and itching eyes. She was given Benadryl and sent to ED for no significant improvement
Persistent cough, fever, sob. Seen at urgent care, given zpak and prednisone. Symptoms resolved after treatment.
Admitted to PICU with acute onset encephalitis.  He  had Tdap and Meninococcal vaccines for school on July 12, 2021,  5 days post vaccination he became febrile. fever occurred in evening and spontaneously resolved.  Mom noticed 3 days prior to presentation that he was walking funny and was confused.  Patient had temperature of 100.8 degrees on Tuesday night and then 100.3 degrees last night.  She said he had episodes of tremoring and therefore took him to neighborhood Hospital for evaluation.  While he was there he had episode of Urinary incontinence. Patient does not have any history of seizures and no family history of seizures.
Pt developed a 7 x 6 cm erythematous, swollen, firm local reactions to the left deltoid following dose #4 of Anthrax. No systemic symptoms yet. Follow up information received 09/18/02 states, "Low testosterone production due to brain lesion on the hypo thalmus gland, fatigue, mild muscle soreness". Hypothalmus lesion stable.  Pt on hormone replacement (testosterone) with good results.  Still c/o sever soreness in muscles, very painful feet, stiffness after sitting.   Pt. recalls golf-ball size swelling + itching at injection site after doses 1+2 of ANTHRAX and worse after dose #3.  Began to experience fatigue + loss of libido.  After dose #4 pt's local symptoms more severe in spite of prophylactic BENADRYL PO.  Grapefruit-size "lump" in arm, itchiness + rash in arms and legs.  Open lesions in some areas of arms and legs.  Fatigue + decrease libido more severe.  Consulted with PCP + low testosterone levels noted. MRI revealed hypothalonic lesion.  This was monitored for 3-4 months of requent MRI.  Lesion was stable + pt started hormone therapy.  Meanwhile muscle pain severe + CPK elevated to 920.  Numbness , neurological tests + blood tests were (-) including EMG.  CPK did return to normal, but muscle pain unchanged.  Family member notes pt. had short-term memory loss after doses #3+4 of ANTHRAX.  This abated however + pt was not aware of it.  Other tests incl.  lumber puncture (-).  Trial of PREDNISONE did not help symptoms.
pt received vaccine at 1340, mom noticed hives at 1415, returned to clinic, seen by md at 1515, benadryl given at 1515, pt observed until 1600, reddness and elevation lessened, no further hives noted
he ended up in the hospital with Paracydis/The side effect listed should be:  Pericarditis; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, after the 2nd dose the patient ended up in the hospital with pericarditis which was supposedly a common side effect of the vaccine. The patient wanted to know what Pfizer recommends and if this should be reported. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recv vax @ clinic @ 515PM;pt was pale,lethargic&had a rectal temp of 103.2;pt was cyanotic around mouth;p/02 color improved;pt had good capillary refill in nail beds;
After each one became hot; Tachycardic; Lightheaded; Rather weak-feeling starting approx. 10 minutes after the injection; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20a) for COVID-19 vaccination.     No allergies.  Patient never had COVID positive test or diagnosis.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection). In March 2021, FEELING HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported.  No vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Approximately 10 mins after second dose, patient became hot, tachycardic then lightheaded and rather weak-feeling and lasted for approximately 30 mins. AE did not cause patient to seek medical care and patient did not experience a similar event in the past. No treatment medications were provided. This case was linked to MOD-2022-566610, MOD-2022-566670 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live significant follow up-Reporter details, patients details and dose information were added.
Pt recvd 1st dose of Hep B vax 09NOV89 & later exp malaise & lethargy.24 hrs later sx resolved.Pt recvd 2nd vax 15DEC89 & felt tired & weak.
Symptoms/signs: Joint Pain/Swelling, Flu-like symptoms, Fatigue and Malaise, 3 Skin Rashes, Headaches - Migraines, Eye/Sight problems, Tingling - Face, Numbness - Face, Dizziness, Confusion / Disorientation, Short-term Memory Deficit, Pain in left Clavicle and Shoulder - recurrent, Neck Pain with Fatigue with Headache, Aggravated Sleep Disturbance, Arthalgia, Myalgia, Diagnosed Lyme Disease, Bells Palsy, Possible Cardiac problem, Aggravated Major Depressive Disorder?, Aggravated Anxiety and Panic Disorder? Vagus Nerve Implant (VNS)? Time Course: Diagnosed 6/24/2003 - I became disabled 4/1/2001 via.  Treatment:  Zithromax 500/mg daily, Rocephin 2 grams Shot, Electrocardiogram. Initial Consult with Neuro-Ophthalmology - need to schedule visual field test
Headache, Myalgia, Arthralgia, Phlebitis & UrticariaPruritus Narrative:
This spontaneous report was received from a medical assistant refers to a 34 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIBAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. This case is linked to the case 1511USA014539 and 1511USA011479 (same reporter link). Additional information has been requested.
sweating; fever; body aches; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "sweating"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperhidrosis, pyrexia, pain. Additional information: Patient experienced adverse events same day after received dose 2. S/S-Covid-like symptoms-fever, body aches, sweating. Resolved with OTC meds and rest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, (leg, neck, and back pain) fever 103, tachycardic, Redness and Swelling in Right upper arm around injection site.
Narrative: COVID infection following COVID vaccine series 12/29/2020 , Pfizer, dose #1 01/19/2021 Pfizer, dose #2 08/23 COVID swab, result: detected 08/21 pt cc: cough, dyspnea, fatigue exposure: unknown 08/23 pt admit to medicine cc: General fatigue and shortness of breath dx: Acute hypoxic respiratory failure LOS: 5 days 08/23 CTA PE impression: Negative study for acute pulmonary embolism. Multifocal pneumonia, with the largest opacity in the RIGHT lower lobe. Recommend PA and lateral chest radiographs in 6-8 weeks after appropriate treatment to document resolution. 08/23 CXR impression: No acute pulmonary finding. 08/25 FIBRINOGEN result: 491 08/25DDIMER result: 0.99 08/25 ESR result: 41 08/26 FIBRINOGEN result: 378 08/26 DDIMER result: 0.6 08/26 ESR result: 30 08/27 FIBRINOGEN result: 326 08/27 DDIMER result: 1.56 08/27 ESR result: 21 09/05 pt traveled and was readmitted to a non-Facility hospital LOS: unknown 09/09 COVID-19 ANTIGEN(BINAX) result: not detected 09/09 ESR result: 7 09/09 CTA PE impression: No pulmonary embolus. Since prior CT dated 8/23/2021, some worsening of multifocal airspace and groundglass opacities, consistent with known viral pneumonia, again most pronounced in the right lower lobe. 09/09 BNP result: 106.3 09/09 procalcitonin result: <0.05 09/09 pt admit to cc: General fatigue and shortness of breath dx: COVID Pneumonia LOS: 1 day 09/10 FIBRINOGEN result: 250 09/10 DDIMER result: 1.41 09/10 ESR result: 10
Pt. did a home pregnancy test on 3/17/10 and states it was positive. She had an MMR on 3/12/10 where she indicated she was not pregnant, states LMP was 2/23/10-but was "mistaken" and it was 2/16/10.
Fever, chills, nausea, vomiting, severe headache, neck and body pain
Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab); Flare Ups Twice a Week; Pain In Joints And Skin; Pain In Joints And Skin; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4451143-00 (AbbVie).  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1154441), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab)"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Flare Ups Twice a Week"; ARTHRALGIA (non-serious), PAIN OF SKIN (non-serious), outcome "not recovered" and all described as "Pain In Joints And Skin". The action taken for adalimumab was unknown. Clinical course: An adult male with events of non-serious Flare Ups Twice a Week, Pain In Joints And Skin And Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab). There was no reported medical history.  On unknown dates, the patient experienced flare ups twice a week, pain in joints and skin and medication not relieving the pain in joints and skin. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(Adalimumab) The reporter's causality for the event(s) of Flare Ups Twice a Week, Pain In Joints And Skin unknown onset and Pain In Joints And Skin Unknown Onset With Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Medication Not Relieving The Pain In Joints And Skin was not provided.  The reporter considered "medication not relieving the pain in joints and skin with humira (adalimumab)", "flare ups twice a week" and "pain in joints and skin" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  condition aggravated, arthralgia, skin pain, condition aggravated and drug ineffective    cannot be excluded.