chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 29Aug2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and a healthcare professional. A 72-year-old female patient received the first dose of PREVNAR 13, (Lot Number: T78676, expiration date: 01Feb2020), intramuscularly in the left deltoid on 15May2018 14:30 at 0.5 ml, single (one time dose) for routine vaccination/immunization in a physician's office. The patient had no medical history and no concomitant medications. The patient previously took zoster/shingles vaccine in Dec2014 and influenza vaccine in Feb2018, both for immunization with no adverse events associated. The day after getting pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) injection, on 16May2018, she developed a rash. The rash got worse and worse to the point that she went to the Emergency Room on 26May2018 where she was under observation, but not admitted related to this event. She visited the physician's office on 29May2018. The rash was a diffuse rash, at the site of injection and all over the body, extending to the scalp and resulting in and a lot of hair loss also. The adverse events were described to be severe and considered by the physician as medically significant. The patient was probably 90% improved at time of this report. She went to a Dermatologist and was on oral steroids, steroids, creams, and anti-histamines. She had a Biopsy done. The patient had no further details on testing, treatment, or further medical interventions to provide for this report. The outcome of the events of diffuse rash and hair loss was recovering. The physician considered the adverse events to be related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "diffuse rash, at the site of injection and all over the body, extending to the scalp and resulting in and a lot of hair loss" cannot be fully excluded considering the compatible time association and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Approximately 6 hrs post immunization with IIV3 and PPSV23, the patient reported onset of sweats/chillls, T = 102 degrees F, muscle aches, low back back, headache, tremulousness, nausea, and severe pain around injection sites (upper left arm/shoulder).  Pt. self-treated with acetaminophen.  On 9/28/13, T = 100.5 degrees F; symptoms listed above continued, but to a slightly lesser extent.  On the evening of 9/29/13, symtopms had resolved except for moderate pain, redness, swelling in the left arm at the injection sites.  On 9/30/13, pt. reports a mild headache and mild pain at injections sites; redness and swelling are diminishing.
Felt sore all over; Arm was sore; Headache; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep 6955) via intramuscular route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. The patient had no allergy to medications, food, or other products. The patient received birth control medications (unspecified) within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via intramuscular route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:00, the patient's arm was sore. She had a headache and felt sore all over. Therapeutic measures were not taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events arm was sore, headache and felt sore all over were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
bilateral and upper extremities weakness, partial facial; bilateral and upper extremities weakness, partial facial; blood pressure issues; presenting neurological issues; Initial information received on 09-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 35 years old female patient who experienced bilateral and upper extremities weakness, partial facial, bilateral and upper extremities weakness, partial facial, blood pressure issues and presenting neurological issues after receiving vaccine Influenza Vaccine (Quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2023, the patient received 0.5 ml dose of suspect Influenza Vaccine (Quadrivalent) produced by unknown manufacturer, formulation: Injection of lot UT8109KA via intramuscular route in the right deltoid for immunization.  On 28-Oct-2023, the patient developed bilateral and upper extremities weakness, partial facial (muscular weakness) (facial paresis), blood pressure issues (blood pressure abnormal) and presenting neurological issues (nervous system disorder) (latency: same day) following the administration of Influenza vaccine (Quadrivalent).  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.
8.5 months salty taste, later developed metallic taste for 2 months; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "glucose intolerance" (unspecified if ongoing); "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ace inhibitor, reaction(s): "allergies: ACE inhibitor"; Terazosin, reaction(s): "allergies: Terazosin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 21Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "8.5 months salty taste, later developed metallic taste for 2 months". The event "8.5 months salty taste, later developed metallic taste for 2 months" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Covid not tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
32hrs p/vax pt became ill had fever of 102, diff breathing;was treated in ER by MD who was aware of vax dx s/sx as flu;resp tx was administered-APAP #3, Biaxan, sent home w/parents;pt in school on 30OCT95
Bump located a couple inches below the injection site; Warm bump; Red bump; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not provide patient demographics, lot number, or expiration date of vaccine. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient experienced a bump approximately five days after receiving dose one of Shingrix. The healthcare professional described bump as being located a couple inches below the injection site, 1.5 inches in diameter, warm, and red.  The outcome for bump was unknown.
Headache, chills,  body aches, fatigue, flu-like symptoms, swelling and pain at injection site
This spontaneous case reported by a consumer, describes the occurrence of vaccination site erythema (injection site was red), vaccination site pain (vaccination site tenderness) and vaccination site swelling (swollen injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included depression. Concomitant products included Lexapro (escitalopram oxalate) and bupropion for an unknown indication. On Apr 28, 2021 at 10:30 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 28, 2021, patient experienced vaccination site erythema (injection site was red), vaccination site pain (vaccination site tenderness) and vaccination site swelling (swollen injection site). The patient treated with ibuprofen, at an unspecified dose and frequency. At the time of the report, vaccination site erythema (injection site was red), vaccination site pain (vaccination site tenderness) and vaccination site swelling (swollen injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Patient developed severe nausea and vomiting 2-days post vaccine. Was unable to eat/drink. Patient went to the hospital and received treatment for dehydration and released home.
Injection site hot itchy and swollen 4 inch big raised area, worst on day 3, it got smaller on Aug 6.
patient received flublock at 3:11 at pharmacy.  Patient is a technician at this pharmacy.  At 3:20 asked if dizziness was a symptom. Pharmacist had her sit down.  At 3:25 still having problems and felt faint pharmacist had her lay on floor. complained of sore chest and tight chest and tough to get a full breath.  Called 911. at 3:31 she started coughing and clearing her throat.  emt on way but not here.  Pharmacist gave epipen injection.  at 3:32 eyes opened wider and she felt better but felt heart rate up.  felt clammy and a little cold.  3:40 emt arrived and took over assessment and treatment.  pharmacist did not fill another epi shot was needed.  she was taken to the hospital as a precaution because of the epi pen injection.  released from hospital a couple of hours later with no further complications.  diagnosis was allergic reaction but unidentified.  patient medication list was given to emt because she could not remember all she was taking and given with her permission. patient approved the call for 911 to pharmacist and approved hospital to emt
Hives , Rash, Scratchy throat, difficulty swallowing. While in Emergency department received  0.9% sodium Chloride, diphenhydraMine,  famotidine,  methylPREDNISolone sodium succinate ( 3:14 PM )  iv solution stopped at 5:22 PM   per Pfizer EUA Fact Sheet for caregivers - must include " Pfizer-BioNTech COVID-19 Vaccine EUA " on Box # 18
6 am case felt weak, by 8 am case was nauseous, increased problems with walking  (balance/gait), fever 100-101, incontinent,
More than 60 hours after vaccine, a warm, red and painful area appeared on my left arm approximately 15 cm below the injection site. Pain extends up are to shoulder and neck. But I experience no pain or redness at injection site.
Failed to refrigerate.It is still viable?; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter was patient's son/daughter. The age at vaccination was not applicable for this report. The reporter stated that, the patient picked up her shingles vaccine and failed to refrigerate it until 18 hours after pick up, which led to incorrect product storage. The reporter needed to know if it was still viable.
Diarrhea started around 4/23/2022. Progressively has gotten worse since then. After a week, I had a phone visit with Urgent care, and they told me to take Imodium and come back in a week if it wasn't better. I took Imodium for about a week. Once I stopped, diarrhea had gotten significantly worse, to the point where I can't eat any food. I called my PCP and they couldn't get me in, but got a phone appointment with a different doctor the next day, and an in person appointment with a PA-C 5 days later (5/10/2022). I'm now basically just eating white rice, bananas, and Gatorade. But no fever, no cough, still have taste and smell, and have gotten 2 negative COVID tests on rapid covid tests spaced a week apart. **Note that my epilepsy meds changed in 4/2022 -- I titrated to my current dose of 200mg am/200mg pm Vimpat, and 100mg am/200mg pm Zonegran -- the Zonegran has been messing with my appetite a lot).
This spontaneous report has been received from a medical assistant, and refers to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # M048200 with expiration date of 07-DEC-2018 (strength, dose, and route were not reported), for prophylaxis. A digital data logger notified the temperature excursions, being of -9°C to 8°C for 34 hours, and another one of -14°C to -10°C for 20 hours and 45 minutes. No previous temperature excursions were reported. No adverse effects and no product quality complaints were reported. Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DAYQUIL, start date: 16May2022, stop date: 18May2022.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication was provided within 2 weeks of vaccination. Paxlovid was given as a treatment form 17May2022 to 22May2022 for Covid-19. Investigational results reported: This is a notification generated from the gQTS system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS. AE Ref No. Unknown. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1, Lot- (CR): FH8027. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Headache, Fever, CHILLS,FATIGUE, ARM SORENESS Narrative:
Joint pain and stiffness in neck, shoulders, arms, hands, and fingers. These are some areas I have had joint pain in before when I overuse them but I had not had joint pain in my fingers or hands for some time. Tylenol helped slightly as did muscle pain relief cream. Additionally, the first shot was in my left arm and at the injection site I had swelling, redness, itchiness, and it was hot to the touch.
Vaccine exposure during breastfeeding; Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding and Gestational diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding). On 28-Aug-2021, PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided.  Patient received the second dose at around 21-AUG-2021.  Company Comment: This is a case of Maternal Exposure during breastfeeding for this 24-year-old female patient with no relevant medical history who experienced the non serious unexpected event of Paraesthesia. This event occurred after the first dose of Moderna COVID-19 Vaccine and was described as tingling in hands and feet and sensation of pins and needles in hands and feet. The exact start date was not provided, however it was reported that the event lasted for one week. Rechallenge is considered negative as the it was reported that the patient received the second vaccination, however, this event did not reoccur. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring.   This case was linked to MOD-2021-339358 (Patient Link).; Sender's Comments: This is a case of Maternal Exposure during breastfeeding for this 24-year-old female patient with no relevant medical history who experienced the non serious unexpected event of Paraesthesia. This event occurred after the first dose of Moderna COVID-19 Vaccine and was described as tingling in hands and feet and sensation of pins and needles in hands and feet. The exact start date was not provided, however it was reported that the event lasted for one week. Rechallenge is considered negative as the it was reported that the patient received the second vaccination, however, this event did not reoccur. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring.
Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered.    No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
24 hours later left arm swelled down to hand, burning in arm, burning in chest-went to ER and sent home with RX for prednisone steroid but did not take. On 12/6/09 had a fever, body achy, bruising up arm and across chest, arm felt burning sensation, lips swelled up and cracked, tongue swollen, slurred speech, went to ER and since no trouble breathing was sent home. 12/8/09 c/o watery eyes, body aches, nasal discharge, bruising faded.