chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his son who on unspecified dates was vaccinated with three 0.5 mL doses of COMVAX right after he was born while still in the hospital and "3 more doses later on". The lot numbers was provided as lot# 653272/0011F, 655548/1243F, and 655551/1244F. The consumer did not specified if these were the ones given to his son when he was in the hospital or if they were the ones given after he got out. The consumer did not specify what hospital his son was in and did not say how long he was there after having been born. Since then, his son had developed autism. It was unknown if medical attention was sought. At the time of the report, the patient's status was unknown. Upon internal review, autism was determined to be an other important medical event. No further information is available.
25 year old male here. A couple days after the first dose of Pfizer, I experienced this discomfort in my left side of my chest (not near the center of my chest, more right in front of my left armpit). Thought nothing of it. Couple days later it started to feel painful. So, 5 days after the first shot, I finally went to the ER and they did all the tests (blood work, EKG, chest x-ray, etc) and it came back normal. The doctor said I might have a pulled muscle or something and to treat it like a sprained ankle (couple weeks recovery). It's now been over a year since the first shot and I have developed severe side effects from the vaccine including chest pain, testicular pain, muscle spasms, headaches, nerve pain, tingling, and muscles shaking. All symptoms have developed over a year long span since vaccination. It began with left side chest pain then I developed all symptoms as weeks went forward since vaccination. I wake up everyday in pain now and this event has changed my entire life. I previously was healthy before the vaccine. I have been to many doctors who are unsure of what?s causing my symptoms but some think that due to me having Covid right before the injection might be why my body isn?t responding well and the reason for my lingering symptoms.
Cold symptoms; feeling of generally unwell; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment details were reported.
Awoke late, lethargic, complaints of feeling light headed, AMS, substantial decreased strength in BLE, generalized weakness, transported to ER by paramedics, HTN, CVA ruled out.
1st dose AZ, 2nd dose Moderna; extremely dizzy; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (1st dose AZ, 2nd dose Moderna) and DIZZINESS (extremely dizzy) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (1st dose AZ, 2nd dose Moderna) and DIZZINESS (extremely dizzy). At the time of the report, OFF LABEL USE (1st dose AZ, 2nd dose Moderna) had resolved and DIZZINESS (extremely dizzy) outcome was unknown.            Concomitant medications were not provided.  Co-suspect product included non-company product for an unknown indication. Patient reportedly received AZ vaccine for the first dose.  No treatment information was provided.
Patient was given Pfizer Covid 19 10mcg/0.2ml dose tris-sucrose for patients age 5-11 in error instead of the 6month-4year dose. Parent denies any side effects as of 7-8-22 at 10:11am and will monitor child for any future side effects that may develop.
arm is swollen and sore; arm is swollen and sore; This is a spontaneous report from a contactable consumer (patient) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) on an unspecified date at single dose  in arm for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included ibuprofen. The patient stated that on an unknown date following her vaccination, her arm was swollen and sore.The outcome of the events was unknown. Patient also asked for additional information about taking ibuprofen prior to getting the covid vaccine; she took ibuprofen before having the vaccine and now worried that she may have decreased the effectiveness. Asking how much it will be affected by taking ibuprofen. No follow-up attempts are possible; information about lot/batch number cannot be obtained.No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ELECTRICAL PULSES IN LEFT CALF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced electrical pulses in left calf. The action taken with covid-19 vaccine was not applicable. The outcome of electrical pulses in left calf was not reported. This report was non-serious.
7 days following injection hives developed, awoke on day 8 wit h redness and swelling around injection site.
Patient was given Hep A 20 days too soon. Shot was given on 5-7-18, but shot was not due until 5-27-18.
Fever, lethargic, loss of appetite, redness and sore below the vaccination site on left arm.
Around 7 minutes after administration patient started to look like he was having headache. My technician asked if he was doing ok and he replied "no." I then went out and asked what symptoms he was having. He said he was having headache, dizziness, and didn't feel well. I then stayed with him to monitor him, at which point his arms fell, I was able to lay him on the ground with an associates help without his head hitting the ground. Code white was called and store management came to the scene. Patient regained consciousness, remained on the ground for a few minutes and then said he wanted to sit up. We helped him into a chair, a few moments later, he lost consciousness again. We then laid the patient down one more time and the instore officer requested a squad.  Patient was monitored until they arrived and took over.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
intial light headedness. spotty vision and fatigue.  Patient felt like they were going to faint.  Vitals were taken and patient had elevated HR, and 90% O2.  Resolved in 60 seconds from initial response.  Patient was observed for 30 minutes post vaccination
Suffered multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age and gender. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related. Herpes zoster was considered as disability by the reporter.
Patient was experiencing throat swelling, facial flushing, headache, chest tightness, and nausea. Patient states that the injection site is still hard and warm to the touch.
First shot made me very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: First shot made me very ill). The outcome of the illness was not reported.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient had 1st shot and made the patient very ill. The patient was not able to get the second one. Follow-up not possible as no contact details provided.
numbness @ the site of inj but no restriction of motion, mom states didn't know child still had numbness of arm until came today to get vax;child appears normal;
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm, nausea and diarrhea. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
red rash at injection site and on most of upper torso. severe allergy symptoms;  nonstop runny nose and frequent sneezing (though may be unrelated to the vaccine due to cat allergies); arm muscle tiredness/soreness. Next day after this (2/16), also developed swelling around injection site where rash is.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 4:11 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 63.10.  Concomitant medication of the patient was not reported.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature of 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 29-Sep-2021 and 05-Oct-2021 and beyond use date for the vials was reported as 29-Oct-2021 and 04-Nov-2021. The vaccines moved to clinic on 27-Oct-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
March 6, 2013 - patient states rash all over my body that worsen over two days. Fever 99.1 smallpox site is red and inflamed with rash.
coagulation; IgM was at 94.5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). Other Case identifier(s): 2022NVX-US-000003731.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 14Mar2021, for Covid-19 immunization; Bnt162b2 (Dose 2, after the first series the IgM went to 58), for Covid-19 immunization, reaction(s): "IgM went to 58"; Bnt162b2 (Dose 3 (Booster)), for Covid-19 immunization. The following information was reported: COAGULOPATHY (non-serious), outcome "unknown", described as "coagulation"; BLOOD IMMUNOGLOBULIN M INCREASED (non-serious), outcome "unknown", described as "IgM was at 94.5". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 05Oct2022, it was reported that a patient started treatment on 14Mar2021 with Pfizer BioNTech Covid-19 vaccine at an unspecified dose/frequency for Covid-19 immunization. It was reported the patient experienced the following: after the first series the IgM went to 58, and after the 4th booster the IgM was at 94.5 and they reported it should be around 10. They reported the mRNA was causing coagulation.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive on 22-Jul-2021.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants were reported. No treatment medication was reported.
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of illness (did not feel well) and product dose omission issue (did not get 2nd dose on scheduled date) and vaccine exposure during pregnancy in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A) for COVID-19 immunization. No medical history reported. On Mar 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, patient experienced illness (did not feel well), product dose omission issue (did not get 2nd dose on scheduled date) and vaccine exposure during pregnancy. At the time of the report, illness (did not feel well) and product dose omission issue (did not get 2nd dose on scheduled date) outcome: unknown; and vaccine  exposure during pregnancy resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant products and treatment information not provided.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported.  Patient allergies to medications, food and other products were unknown. It was unknown if the patient had ever tested COVID positive and had experienced similar events in the past. The patient had received Moderna COVID-19 (dose 1) as full dose. The event does not caused patient to seek medical care. The symptoms were improved.  No treatment information was reported.   This case was linked to MOD-2022-547667, MOD-2022-547671 (Patient Link).
large hard lump at injection site, red the size of a 1/2 dollar swollen, neck pain with headache and chills
progressive nerve issue, caused issues with arm; caused issues with the use of my right arm.; This case was reported by a consumer via call center representative and described the occurrence of neurological disorder nos in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neurological disorder nos and arm discomfort. On an unknown date, the outcome of the neurological disorder nos and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the neurological disorder nos and arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's Comments: The reporter reported that patient facing a progressive nerve issue and caused issues with the use of his/her right arm. The reporter wanted to know what could been done to fix it. The patient had seen 5 different physicians regarding the matter and none could identify it. The reporter hoping you had, and could steer me to a cure or corrective action.
APROXIMATELY 40HRS AFTER RECIEVING FLUMIST VACCINATION, PATIENT WOKE UP WITH SORE THROAT AND SWOLLEN TONGUE. APROX. 12 HRS LATER TONGUE INCREASED SWELLING AND THROAT WAS ALSO NOW SWELLING. TOOK 50MG BENADRYL BREATHING WAS EASIER AND CALMED OTHER SYMPTOMS AS WELL. NEXT DAY UPON AWAKING TONGUE STILL SWOLLEN THROAT SCRATCHY. THAT EVENING INCREASED SWELLING OF TONGUE AND THROAT ACCOMPANIED BY GAGGING, TOOK 50MG OF BENADRYL AND WENT TO E.D. WAS PRESCRIBED 20MG PREDNISONE FOR 5 DAYS.  9/17/09 Received ER medical records of 9/14/2009. FINAL DX: possible allergic reaction Records reveal patient experienced swollen tongue & throat, feeling weird.  Initially resolved w/Benadryl but recurred & worsened w/gagging & anxiety.  Tx w/additional Benadryl & steroids.  D/C to home on continued meds w/PCP f/u.
This spontaneous report was received from a pharmacist referring to a 12 month old infant of an unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # and expiry date were not reported) instead of VARIVAX. No adverse effects were reported.
Beyond 35 days for 2nd dose; The swelling as its throbbing; skin is being stretched; Sore throat; Coughing; Difficulty swallowing; Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and DYSPHAGIA (Difficulty swallowing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). At the time of the report, PAIN (The swelling as its throbbing), SKIN TIGHTNESS (skin is being stretched), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), DYSPHAGIA (Difficulty swallowing) and LYMPHADENOPATHY (Arm pit swollen as size of softball or baseball/massive tumor looking / sticking out like ball sticked to arm/getting bigger and bigger by hour) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved.            Treatment medication was not provided.  Concomitant medication was not provided.  Patient was worried and panicking while patient called to report the events.