chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received 29 April 2008 from a health care professional. This report (2008-01336) and case numbers 2008-01334 and 2008-01335 case from the same satellite location. A 12-month-old patient (gender not reported) developed a black dot at the injection site after receiving a left thigh injection of IPOL, lot number Z0547 and a left thigh injection of DAPTACEL, lot number C2650AA on 13 June 2007 during their two month well visit. The patient returned to their physician's office for their four month well visit on 16 August 2007, at which time the physician noticed a black dot on the patient's left thigh. The patient subsequently received a left thigh injection of IPOL, lot number Z0812 on 16 August 2007. When the patient returned two months later for their six month well visit (date not provided), the physician noticed the appearance of a second black dot on the child's left thigh. Both black dots had been present at that time. The recovery status of the patient was unknown at the time of the report. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. 19/May/2008: Corrective version created for the purpose of amending the lot number on the DAPTACEL product screen to C2650A (previously entered as C2605A). The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01338 (IPOL) and 2008-01339 (Fluzone).
An Episode of aura; This spontaneous case was reported by a consumer and describes the occurrence of AURA (An Episode of aura) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029AZ1A) for COVID-19 vaccination.     The patient's past medical history included Aura (He has 25-30year history of visual aura resulting temporary loss of peripheral vision for 10-15min.), Myocardial infarction in 2017 and Stent placement (Patient had 2 stents inserted.) in 2017. Concurrent medical conditions included Allergy to chemicals (Niacin allergy), Gout (condition under control with medication) since 12-Jan-2008, Hypothyroidism (condition under control with medication) since 12-Jan-2019, Blood pressure high (condition under control with medication) since 12-Jan-2008, High cholesterol (condition under control with medication) since 12-Jan-2008 and Non-smoker. Concomitant products included FOSINOPRIL from 12-Jan-2008 to an unknown date and METOPROLOL from 17-Feb-2017 to an unknown date for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) from 12-Jan-2008 to an unknown date for Cholesterol, COLECALCIFEROL (VIT D3) from 12-Jan-2008 to an unknown date for Deficiency vitamin, ALLOPURINOL from 12-Jan-2019 to an unknown date for Gout, LEVOTHYROXINE SODIUM (SYNTHROID) from 12-Jan-2019 to an unknown date for Hypothyroidism, ACETYLSALICYLIC ACID (ASPIRIN LOW) from 17-Feb-2019 to 25-Mar-2021 for an unknown indication.   On 11-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced AURA (An Episode of aura). At the time of the report, AURA (An Episode of aura) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/80 Patient stated that his blood pressure averages 130/80.. On an unknown date, Low density lipoprotein: 50 Patient stated that his LDL averages 50..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has taken low dose of Aspirin as blood thinners.  Patient had experienced an episode of aura which was brief and was not concerned with it  after receiving his first dose.  Patient stated that he had history of visual aura from 25-30 years which results in temporary loss of peripheral vision for 10-15 min and that these incidents occur no more than twice annually and have not been deemed worthy of treatment by medical practitioners given their frequency and hence no medication was prescribed.  Patient stated that he did not drink or smoke and was also not overweight. He stated that he maintained a healthy diet and takes on an average 10,000 steps daily. He had also passed a stress test, echo cardiogram and carotid ultrasound within six  months prior to the incident and that he was not ideal stroke candidate.   This case was linked to MOD-2021-419397 (Patient Link).
Case number PHEH2014US007559 is an initial spontaneous report received from a nurse on 15 Apr 2014: This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M13015) intramuscularly on 14 Apr 2014. This vaccine had reached 22 degree Celsius approximately five hours and four minutes and was subsequently administered. No adverse event was reported following this administration error (incorrect storage of drug).
rt upper arm became reddened, blotchy w/in 15-20" p/vax;
This spontaneous prospective pregnancy report was received from a physician assistant refers to a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with MMR II (dose, route and lot # not reported) on an unspecified date. It was reported that the patient became pregnant after receiving MMR II in the past. The patient was pregnant for 25 weeks at the time of reporting. The patient's LMP is 09-APR-2012 and EDD date is 14-JAN-2013. The patient's rubella titer came back low in a recent blood test. At the time of reporting, the patient had not recovered. The patient sought medical attention by seeing the physician assistant. Additional information has been requested.
Elevated heart rate about 5 mins after injection. Sat in medical area and talked to patient. Heart rate came down to normal limits within 5 mins.
Patient age 14 received dose of Moderna; Patient received first dose of Pfizer on 29-JUL-2021 and second dose of Moderna COVID 19 vaccine on 02-SEP-2021; Patient received first dose of Pfizer and second dose of Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Patient age 14 received dose of Moderna), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Pfizer on 29-JUL-2021 and second dose of Moderna COVID 19 vaccine on 02-SEP-2021) and INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose of Pfizer and second dose of Moderna COVID 19 vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of BNT162B2                                                                                              (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced OFF LABEL USE (Patient age 14 received dose of Moderna), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Pfizer on 29-JUL-2021 and second dose of Moderna COVID 19 vaccine on 02-SEP-2021) and INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose of Pfizer and second dose of Moderna COVID 19 vaccine). On 02-Sep-2021, OFF LABEL USE (Patient age 14 received dose of Moderna), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Pfizer on 29-JUL-2021 and second dose of Moderna COVID 19 vaccine on 02-SEP-2021) and INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose of Pfizer and second dose of Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  It was reported that clinic gave a pediatric patient a Moderna vaccine when patient should have been give Pfizer (as their second dose).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up document received; Updated vaccine facility information.
I was called to attend an emergency that happened during COVID Clinic.  The medical assistant reported 10year old boy was there for his routine first COVID vaccine.  5 minutes after the COVID shot, he was sweating and appeared to be in discomfort.  The Nurse practitioner was called who mentioned that pt was initially responding  to verbal command but later he had decreased responsiveness.  Help was called immediately. By the time I arrived, he was sitting on the chair and was looking to the side with up rolling of his eyes. No involuntary movements of his limbs. I immediately laid him down on the floor. He appeared very pale and was diaphoretic. Pt did not response to voice commands. Sternal rub was done couple of times for tactile stimulation, patient had minimal response/grimacing. I asked help to get his vitals Oxygen saturation, Blood pressure, Blood glucose and for Oxygen.   EMS was called.  His heart sounds were muffled on examination and the NP did not appreciate any pulse in the groin. Epipen was given by NP.  Within 60 seconds, his heart rate was pounding, he started responding to pain, his speech was slurred was confused.  Patient?s Oxygen saturation was maintained throughout at 98%, pulse 62 and blood pressure was 90/65. Blood sugar was 90mg/dl.  Upon reevaluation, pt. started responding to the questions in a slow manner, he still appeared sweaty and pale.   Paramedics arrived and we provided details about the patient. He was referred to a local Hospital for further evaluation.    After 4 hours, I Spoke with the attending at the Hospital who mentioned pt was doing well.  However, prior to discharge he got diaphoretic and was readmitted at Emergency Department for observation. IV fluids were given. CBC showed elevation of WBC. Normal CMP. Discharged home with diagnosis of syncope and advised to follow up with PCP.     Parents were asking whether patient can receive the second dose of Pfizer vaccine.  Based on the experience below, please suggest if its okay to give second Pfizer vaccine and please advice on precautions we need to take. I appreciate your input and help. Thank you.
Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 11Feb2021 as dose 2, single (Lot number: EM9809), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stated she is fat" (unspecified if ongoing), notes: Onset Date: 20-25 years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Sep2022, outcome "recovered" and all described as "Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Negative; (05Sep2022) Negative; (07Sep2022) Positive; (Sep2022) Negative, notes: Just negative COVID Test since she has taken Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She always wore a mask and had been for 2 years. She took it off 10 minutes to eat a sandwich. She thought that was where she got COVID. She was exposed on 03Sep2022. Patient took Paxlovid from 07Sep2022 to 12Sep2022 and was still pretty tired and the hoarseness was weird. Patient had a couple of rough days last week, around 07Sep2022 through 09Sep2022, but otherwise, pretty good. She was not completely recovered even though she had tested negative 3-4 times.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug, different doses/events;
Client states (L) arm became red & sore 24 hours later twice the size of (R) arm.
No adverse event; Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.     On 10-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023).    No concomitant information was reported. It was reported that patient had no other adverse events. No treatment information was provided.
SKIN HURTS WHEN TOUCHED; TINGLING INCLUDING BACK OF HER NECK; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced skin hurts when touched. On 02-APR-2021, the subject experienced tingling including back of her neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin hurts when touched, and tingling including back of her neck. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Rapid heart beat x 3 weeks, two days after the first injection I awakened out of a deep sleep with chest pain and my heart beating out of my chest.
Child was perfectly fine before vaccine.  That evening (in the middle of the night) She became ill, fever and crying, coughing, etc.
Multiple small red and blue-ish dots on both legs. Nowhere else on body per patient's mother.
I stayed 30 min after injection because I receive allergy shots. (Grass, pollen, dust, mold) approximately 10-15 min after leaving  I experienced numbness/tingling on the right side of my face. It lasted approximately 1 hr I would say.
FEELS LIKE A FLU; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feels like a flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from feels like a flu. This report was non-serious.
Swelling at injection site immediately. Gave her a BENADRYL 25g - she said that she usually takes that for allergies. She left after swelling was getting better.
PATIENT SAYS FEVER FOR ONE WEEK, ARM WAS SWOLLEN TWICE IT'S SIZE AND COULD NOT MOVE IT.
Much redness, swelling, and pain left upper arm. Improved after 24 hrs.
This was a revaccination as #1 was given 12/5/19 and was stored at improper storage and handling at facility. The pt called and came into the clinic 2 days after the vaccine was given . She had mild redness the day after and progressed greatly today. no fever but pain in the rt deltoid. Pt did say that this did happen with the previous dose.   10cm by 15 cm erythematous patch , it is warm .  She was given Triamcinolone Acetonide 0.5% cr to  apply BID to affected area.
Headache, Arthralgia, Fever, NauseaVomiting, Site pain/swelling, Fatigue Narrative:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N007930, expiry date 08-MAR-2019) via subcutaneous route for prophylaxis. The vaccine was reconstituted with properly stored Merck sterile diluent (lot# N026288, Expiry date 08-FEB-2020). The vaccine was exposed to the temperature of -9 degree Celsius to 8 degree Celsius (-7.5 degree Celsius) for 4 hours 34 minutes. Previous temperature excursion included -14 degree Celsius to -10 degree Celsius (-12.9 degree Celsius) for 2 hours 35 minutes. A data logger was involved. No product quality complaint was present.
fever, chills, body aches and headache x 8 hours, supportive care with Tylenol, fluids and rest
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Pt developed a full body rash
Client received first Moderna vaccine inadvertently.  Client family and Rehab and Nursing Center staff unaware that client received COVID-19 Janssen vaccine on 4/6/21 (per shots database) at time Moderna vaccine was administered.
Information has been received from a nurse practitioner (N.P.) and follow up information has been received from a registered nurse (R.N.) concerning a 12 year old female with no concurrent conditions, no known drug reaction and no pertinent medical history who on 08-NOV-2010 was intramuscularly vaccinated with the first 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 08-DEC-2010 the patient experienced a seizure and was sent to ER. EEG and CT scan of head were performed with negative results reported. The patient was not admitted to hospital. On 21-JAN-2011, the patient was intramuscularly vaccinated with the second 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 24-JAN-2011 the patient experienced a seizure again. The patient was sent to ER and not admitted. On an unknown date, the patient recovered from seizure and came back to school but being followed by neurology (no contact information available). No other vaccines was given at the time of the two GARDASIL doses. Seizure was determined to be an other important medical event. No further information is available.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:54 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.25 for dose administered on 02-Mar-2021 and as 75.32 for dose administered on 30-Mar-2021  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature range of 27 to 33 Degree Fahrenheit from 09:00 AM to 12:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09:00AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 24-Apr-2021. Product moved to clinic on 30-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported