chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad case of hives; its just annoying and really itchy; its just annoying and really itchy; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EL3302; Expiration Date: May2021), (age at time of vaccination was 71 years) dose 1 intramuscularly, administered in Deltoid Left on 21Jan2021 07:30 as single dose and dose 2 (Batch/Lot Number was EN6201, Expiration Date: not reported) intramuscularly, administered in Deltoid Left on 16Feb2021 07:30 as single for covid-19 immunization. Patient had some allergies not provide any further details. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. Patient did not receive any prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. She knows the vaccine was a while ago but she wants to know if there have been people reporting any kind of delayed reaction to the Covid vaccine. She now has a bad case of hives, which is new for her. She mentions she is going to see her doctor next week. If the hives are still there, she will see her doctor. She doesn't think its worth going to the ER. The hives  are pretty bad on her left shoulder, and she has spots on her back and her trunk/body, kind of on her side. She adds they are itchy. She mentions she has been taking Benadryl and putting steroid cream/anti-itch cream on it. She confirms the hives have stayed the same. No further details provided. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  urticaria. The case will be reassessed once new information is available. 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
Client reports having itchiness from mid facial cheek area to elbow on left side where she received vaccine.  Client states onset @ 2-3  minutes after receiving vaccine, lasting 15-20  minutes prior to resolving without intervention, no medications given.  Client reports she was observed in observation area for 30 minutes then left home.  Client denies and shortness of breath, chest tightness, trouble swallowing.  Client denies this happening with any other vaccine.  Client denies medical conditions, reports allergy to oranges.  Client reports she followed up with primary care provider, advised to receive second dose.
Pt with erythema & edema & warmth at site of injection (L) upper arm.
Patient reports intense itching developed over entire body onset at 1130am 10/22/12, denies any rash, skin irritation or any other symptoms. Itching continues on 10/23/12. BENADRYL taken on 10/22/12 at 6pm and 10pm; and on 10/23/12 taken at 11am.
flared patient's genital herpes, psoriasis & molluscum; caused outbreaks.
Information has been received from a pharmacist concerning a 30 year old female patient who on 08-OCT-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). After receiving VARIVAX the patient developed chicken pox and possible ocular lesions. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a pharmacist who indicated that the patient had been hospitalized with ocular lesions. The pharmacist reported that they obtained samples from the ocular lesions which were sent for viral testing. The patient was still hospitalized because they were trying to determine the etiology of the infection, diagnose the patient and determine what the patient's treatment plan would be. It was also mentioned that the patient had skin lesions which had already healed. Additional information has been requested.
Inconsolable crying, restlessness and aggitated. Saw physician on 6/1/00 and was prescribed ibuprofen and Benadryl.
Onset of ocular flashes in both eyes, mostly noticeable at night. On 2/22/2022 had an abrupt onset of floaters in both eyes, this occurring at the same time. This prompted an ER visit suggested by my PCP and subsequent visits to an ophthalmologist. Diagnosed as vitreal detachment.
Pt presents to show RN and PCP his pneumonia vaccine injection site. Site is red, swollen, tender....Area is outlined and pt is instructed to RTC on Monday to evaluate for progress. PGN - Nurse (Clinic). Symptoms: Rash.
Severe pain left arm at site of injection radiating down arm to hand and up arm to neck.  Pain in linear distribution, worsened by moving arm or touching certain spots.  Maximum severity 2 hours after injection.  Has persisted with only slight improvement.
Right hand numb/weak. Was using incorrect words during conversation-knew what wanted to say but unable to make words come out. Lasted short time and then completely resolved.
Bells Palsy 20 days after vaccination.  Vacination left arm Bells Palsy Left side of face
fever 105.2; pt was inconsolable, had vacant stare w/wailing monotone voice; no sz activity noted; temp dec & pt returned to nl p/30-45 mins;
Approx 1 1/2 hours after receiving Td vaccine, pt reports swollen lips, puffy eyelids, hives on thighs, feet and arms. She took 2 Benadryl and was symptom-free by 9 AM the next day. She did not consult a physician.
This is a spontaneous report from a contactable other HCP. A 4-months old infant received PREVNAR 13, 0.5 ml single dose, at 2 months on unknown date and experienced on the night that his hands and feet turned red. Follow-up (24-APR-2013): Follow-up attempts completed. No further information expected.
Dermatographia, itching, rashes. Flaring up in the evening and night.
Fever of 104F rectally and a rash all over body for 24 hrs. Went to ER for evaluation.
pt recv vax 10JUN97 & c/o chronic migraine h/a;pt reportedly never had them before;also had c/o tiredness, lethargy, muscle soreness & feeling down in the dumps;muscle soreness resolved but still is exp h/a, tiredness & lethargy;
Light headedness, sore throat, headache, body aches, high fever 104.5
Patient was scheduled to receive 2nd dose of Pfizer BioNtech Covid 19 Vaccine (ages 5-11) series. Patient was given instead the Pfizer BioNTech Covid  19 Bivalent Vaccine (ages 5-11) Booster.  Patient currently at this time does not have any reactions or symptoms.
Client states that she "passed out approx 4.5 hours after vaccination"  She states that she passed out while taking the trash out and woke up about 1 hour later.  Also, states that she has not felt well since.  Also states that when she checked her blood sugar after she woke up, it was 97.
14-16 days post injection patient experienced loss of sensation in lower left quadrant of the face. Lower jaw, teeth, etc became numb and the only sensation is tingling, burning or stinging. Pain will sporadically shoot up through the TMJ and into the temple area, especially when chewing. Ear pain develops occasionally. This has been unresolved since March 2021.
Patient hasn't received second dose (4 months since first one); Eye infection; Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE INFECTION (Eye infection), HERPES ZOSTER (Shingles) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)). In April 2021, the patient experienced EYE INFECTION (Eye infection) and HERPES ZOSTER (Shingles). At the time of the report, EYE INFECTION (Eye infection) and HERPES ZOSTER (Shingles) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Information has been received from a mother and a certified medical assistant concerning the development of a rash by a twin sister following vaccination. A 18 year old female who on 20-JUN-2008, was vaccinated with the first dose of GARDASIL. On 19-AUG-2008, was vaccinated with the second dose of GARDASIL. On 20-JUN-2008, the patient experienced rash after the first vaccination, but development or resolution was not available at the time of the report. The patient reported on 25-AUG-2008, that she developed a rash that started 10 days prior (4 days prior to the second vaccination). On 15-AUG-2008, the patient experienced 10 point erythematous rash all over her torso. At the time of reporting, the outcome was unknown. Her rash was described as similar to her twin sister's (WAES0809USA02661). Additional information has been requested. This one of several reports received from the same source.
Extremely sore and swollen injection site. I took TYLENOL about two hours after the injection. It wasn't until I went to bed about 10:00 PM, that my entire body began to ache - as if I had the flu. My face ached, my arms, legs, and back ached. Even my neck ached. I also had moderate nausea. Not enough to throw up, but extremely uncomfortable. As I was in bed sleeping, my first thought was that it must have been something that I had eaten for dinner, but I believe it was the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 01Apr2023, and treatment stop date: 05Apr2023.   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZERBION-TECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Cottonmouth; Chest pain; fast heartbeat; Night sweats; excessive sweating after walking; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038c21a) for COVID-19 vaccination.     Multiple sclerosis and possible dementia.  The patient's past medical history included Multiple sclerosis and Dementia.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On 01-Jul-2021, the patient experienced DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking). At the time of the report, DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. no treatment information is provided
No adverse event; The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.).    No concomitant or treatment medications were reported.  Patient received expired vaccine. No other adverse reactions were observed.
3/31/21, 0842. 54 yo M complaining of dizziness. Upon observation Pt was diaphoretic, weak, and slow. EMS evaluation performed. 12-lead.Pt was bradycardic in the 30's. IV established in L ac. Atropine administered. Pt care transferred to responding EMS unit. Pt transported to hospital.
high pitched cry followed by 5-10min apnea episode requiring o2 & paramedic response;
Case number PHEH2013US025261 is an initial report received from a pharmacist on 04 DEC 2013. This report refers to a female patient of an unknown age. The patient who was a nurse was vaccinated with FLUVIRIN (batch number: not reported, expiry date: not reported) by an another nurse intradermally on an unspecified date. As a result the injection site was red, itchy and raised. Onset date of the adverse event was not reported. Outcome of the events, seriousness and causality were not reported.
A university employee received the second vaccine in the shingles series from a pharmacist. After the dose, the employee was unable to move his/her arm. The patient observed the injection in his/her peripheral vision and it appeared that it was 2 inches above the appropriate site and at about a 45 degree angle. The patient had immediate pain and after returning home could not move his/her arm. The patient used ice and took ibuprofen. The patient could not describe the actual site more in detail but the patient visited urgent care and the provider there confirmed the site appeared to be 2 inches too high. The provider in urgent care made no interventions. The patient had improvements in his/her pain the following day.
Collapsed lungs after first shot; COVID-19 disease after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMOTHORAX (Collapsed lungs after first shot) in a 30-year-old female patient 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMOTHORAX (Collapsed lungs after first shot) (seriousness criterion medically significant) and COVID-19 (COVID-19 disease after first shot). At the time of the report, PNEUMOTHORAX (Collapsed lungs after first shot) and COVID-19 (COVID-19 disease after first shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported  No treatment information was provided.  Company comment: This case concerns a 30 year-old female patient with no reported medical history, who experienced the unexpected serious event of Pneumothorax and the non-serious AESI of COVID-19. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 30 year-old female patient with no reported medical history, who experienced the unexpected serious event of Pneumothorax and the non-serious AESI of COVID-19. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
extreme fatigue; weakness; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 14:30 (at the age of 67-year-old) single dose for COVID-19 immunisation. Medical history included A-fib, diabetes, high blood pressure, neuropathy, arthritis and sulpha drug allergies. The patient had no covid prior to vaccination. The patient reported that he had many prescriptions (not specified). On 04Feb2021, the patient extreme fatigue, weakness and shortness of breath. The event resulted in visit to the doctor and no treatment was given to the patient in response to the events. The patient was not tested for covid post vaccination. The patient had not recovered from extreme fatigue, weakness and shortness of breath at the time of the report.   No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 29-MAY-2015, the patient was vaccinated with 0.5 ml of improperly stored (Oka/Merck) VARIVAX (lot # L001334 and expiry date: 13-JAN-2017) once subcutaneously. No adverse effects were reported. No product quality complaint was reported for (Oka/Merck) VARIVAX. This is one of several reports from the same reporter. Additional information has been requested.
Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock; Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    On 07-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) had not resolved and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
10/22/09 Immediately after injection c/o dizziness - warm feeling, nausea and stomach cramping. Sx 10/22/09 symp of dizziness lasted approximately 2 mins. Warmth, nausea, cramping/stomach 10 mins. States fear of needles after injection was given and states warmth/stomach cramping 3-4 times since 6/17/09 after check up. Elevated, ice packs.
16MAY96 pt in c/o lt leg had red rash & area behind lt knee;lt knee appeared swollen;pt would not straighten leg or put any weight bearing on lt leg;keep holding leg up
Medical assistant was administering High Dose Flu shot. She got it out of the refrigerator, put the needle on the syringe, and plunged the air out. While administering the injection a piece plastic came off the syringe creating a hole, the liquid went down the patient's arm. Without full knowledge of exactly what happened, the patient left. After inspecting the syringe, the medical assistant noticed the hole. She searched the room and found the piece that had broke off. The patient will return for another dose.