chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraines the following day non stop since the first dose.; Is pregnant Yes, last menstrual date 06Jul2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single and administration date 21Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 06Jul2021. The patient was 8 weeks pregnant at the time of exposure to bnt162b2. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). There were no concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 2021, outcome "unknown", described as "Is pregnant Yes, last menstrual date 06Jul2021"; MIGRAINE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "Severe migraines the following day non stop since the first dose.". The event "severe migraines the following day non stop since the first dose." was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine.  Additional Information: No Seriousness criteria-Results in death. No Seriousness criteria-Life threatening. No Seriousness criteria-Caused/prolonged hospitalization. No Seriousness criteria-Disabling/Incapacitating. No Seriousness criteria-Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient had no Allergy history. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow up attempts are possible. No further information is expected.
fatigue, weakness, myalgias, fever, chills not necessarily side effect from vax;
75 y.o. female who presents with decreased level of consciousness, was apparently found unresponsive by her relatives at home this morning and brought to the emergency room by ambulance.  She was previously hospitalized on 03/19 for sepsis.  Patient does have a history of atrial fibrillation and is on Eliquis.  Currently see has a pacemaker.  Also has a history of dementia, hypothyroidism, hypertension, diabetes, coronary artery disease and COPD.  On arrival she has a high fever.  Presentation today is very similar to prior presentation when admitted for sepsis.  Patient was given Narcan EN route to the hospital by paramedics with no change in level of consciousness.  Intubated, levaphed, airevaced to higher level of care
Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: not provided) on left arm via an unspecified route of administration on 10Mar2021 at 14:30PM as a first dose single for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food or other products. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any mediations within 2 weeks of vaccination. On 12Mar2021 the patient experienced Insomnia. The patient did not receive any other vaccines four weeks prior to the COVID vaccine. Since the vaccine, the patient did have not been tested positive for COVID-19. No therapeutic measures were taken for the events. The clinical outcome of insomnia was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
RASH 2 HOURS POST VACCINE. LATER, SAME DAY RASH ON FACE. NEXT DAY, RASH FROM HEAD TO FEET AND FACIAL EDEMA.  WENT TO THE ER AND WAS TREATED WITH SOLUMEDROL AND ZANTAC THEN DISCHARGED. RX'S FOR HOME WERE PREDNISONE, VISTARIL AND ZANTAC.
2ND DOSE RECVD ON 3-30-90. 4-12-90 EXPERCD VOMITING AND DIARRHEA. LIVER PROFILED AND SHOWED ELEVATED LIVER FUNCTION STUDIES. WBC SLIGHTLY ELEVATED. IN ER AND TREATED CONSERVATIVELY. NOW AWAITING HEP. SCREEN.
I don't know if this was due to the vaccine. 2 weeks later I started feeling pain on my right abdomen. I had shooting pains going through my body from that area. I got a rash around my breast, armpit, and back all on the right side. I went to the doctor, and he said I have shingles. I still have extreme pain throughout my body and were the rashes are.
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    No concomitant medication was reported.  It was reported patient received the error dose with instruction to re-vaccinate 2 months from the initial error doses.  This case was created for patient no. 44 out of 104 cases.  No treatment information was provided.
190 patients (9 different lot numbers) received a vaccine past the beyond; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond).    Concomitant medication was not reported.  It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received vaccine past the beyond used by date. Treatment medication was not reported.  This case contains information for the 146th of 190 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient passed out for a few moments but was responsive very quickly.  Paramedics came and took her to the ER
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 80 year female who received 0.5 ml of FLUZONE HIGH DOSE (batch number UJ047AB, expiry date 28-MAY-2019, route of administration were not reported) in left deltoid on an unspecified date. It was a case of actual medication error as Syringe issue and Underdose due to she states that a little went in and then the rest "exploded" out both sides of the syringe. It was reported that pharmacist notes that there are 2 cracks in the syringe. She states that one crack is "right above white box with NDC number in it", the second is "to the left on the box that has the lot number and expiration date. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
PATIENT RECEIVED VACCINATIONS AND SAT IN CHAIR FOR 5-10 MINUTES. PATIENT STATED FELT FINE. PATIENT WALKING TO WAITING ROOM FELT DIZZY. LAID PATIENT FLAT ON FLOOR. PATIENT IMMEDIATELY FELT BETTER. BP 94/69. PATIENT LAID ON FLOOR FOR 5 MINUTES AND SAT UP. BP 116/85. PATIENT STOOD UP BP 114/74. WALKED PATIENT TO CAR. NOTIFIED PATIENT IF DIZZINESS COMES BACK TO LAY DOWN AND IF GETS ANY WORSE GO TO ER.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable consumer (patient). This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date and unspecified time after receiving the first dose, the patient tested positive for COVID-19. The clinical outcome of testing positive for COVID-19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
1st dose 57 days ago; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago) had resolved.        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 concomitant medication taken by the patient. No treatment information was provided
30DEC97 12MN devel n/v, h/a, diarrhea;pt instructed to notify PMD;sx d/t viral illness;felt tired for a couple day & p/sx subsided;
Initial report received from a health care professional on 09 Nov 2010: This child patient was vaccinated with MENVEO (batch number: unknown) with unknown dose intramuscularly on unspecified date. On 05 Nov 2010, the patient's arm swelled from injection site down to elbow after administration of MENVEO. The patient's affected area was red, swollen and hot to touch. Final outcome of the patient and causality was not reported.
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot# M041513 with expiration date: 11-OCT-2018, lot# N002203 with expiration date: 19-JAN-2019 and lot# M033906 with expiration date 20-JAN-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not reported). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 54 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009056: US-009507513-1707USA009057.
patient was given PCV-23 after having been given PCV-23 10 months prior patient developed severe arm pain, mild weakness and erythema distal to injection site
pt was fine the day of the vaccine administration. patient awoke the next day with localized swelling to the site of the vaccine and hives to his abdomen and back. Thigh was itchy. NO difficulty breathing or swallowing.
Patient reported to the pharmacy 4 days after receiving his second dose of Shingrix stating that he had loss of strength in his left hand, Patient states that it is warm to the touch, and that he cannot touch his pinky to his thumb. Upon looking at the patient's hand it is quite swollen compared to the other hand, particularly at the thumb. Patient reports that does hurt, but it is not unbearable pain.
Started that evening I had sore arms and my Lymph node area on my left side under my armpit and my left leg where not swollen but they were incredible painful like super sensitive and the next day I was having a headache and feeling very tired and still tender on the Lymph area. My whole arm was sore.
Soreness/redness of injection site. Fainting, Headache, Runny Nose, Stiff neck, Muscle aches intense, Hoarseness, Paleness, Weakness, Dizziness, Behavior changes, extreme shoulder and leg pains.
Headache developed by 2 PM on 10-22-02.Progressively feeling worse and developed stomacheache with diarrhea by that evening. Missed the subsequent 2 days of work with diarrhea a couple times per day and headache that persisted, pressure in ears, sinus, tightness in throat, no SOB. Use of Albuterol inhaler relieved some of tightness in throat and sinus pressure.
Patient given 3rd dose of SHINGRIX; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 31st October 2023) for prophylaxis.   On 29th October 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 29th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received Shingrix vaccine. The reporter stated that this was her 3rd dose which was an extra dose. The patient did not experienced side effects. The reporter wanted to know more information on what to do next. The reporter did not consent to follow up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Pt contacted pharmacy on 1/31 and stated that his arm has been sore since date of vaccination. RPh on duty suggested that patient contact MD to discuss and have evaluated.
Had pain and redness at site of immunization. Had flu like symptoms (chills, fever, malaise for 3 days after immunization.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Language barrier, ems and police came to help
headache the day after, sore arm (continues four days later), red rash (appeared two days later and continues on day 4)
Patient stated ?I feel oozed and fatigued?.  Patients legs were elevated. Powerade provided to patient and she was able to drink it. Paramedics in attendance, assessed patient Vitals were BP- 150/78, HR-80. After 3 minutes patient states that she felt better. Patient left facility in stable condition.
Low grade fever, Body Aches, Vomiting x2 Abdominal upset started 01/21/2021 at 2:00am
On 9/15/20 at 8 PM injection site became red,  warm to touch, painful  and itchy. On 9/16/20 6 AM had headache,dizzy, nauseated. On 9/17 6 AM had a raised,  red itchy rash from my neck down to my thighs front and back,  still red and warm at injection site. Dizziness and nausea gone. Rash lasted for 2 days.
pt recv vax 13AUG97 & 14AUG97devel stiffness/soreness of lt arm to elbow;legs felt like hundreds of pins poking tot he bone & they were cold; chills, fever, had no energy to move, stomach was queasy & felt dizzy;devel ice cream h/a;weakness
pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Pre-eclampsia (Delivered at 38 Weeks) on 22-Oct-2011 and Alcohol use (Prior Use) in May 2020. Concurrent medical conditions included Sjogren's syndrome since 01-May-2014 and Gestational diabetes since December 2020. Concomitant products included METFORMIN from December 2020 to an unknown date for Gestational diabetes, IRON from November 2020 to an unknown date and VITAMIN D [VITAMIN D NOS] from 2020 to an unknown date for Supplementation therapy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (ASPIRIN 81) from June 2020 to an unknown date.    On 24-Dec-2020 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was Feb-2021. On 24-Dec-2020 at 4:00 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        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 treatment information was provided.; Reporter's Comments: This case concerns a 32 year-old, female patient, who is pregnant and experienced an event of vaccine exposure during pregnancy after receiving her first dose of mRNA-1273 vaccine. No adverse events were reported.
This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
LIKELY VACCINE REACTION TO MMR.  PETECHIA AROUND INJECTION SITE, REDNESS, RASH TO L ARM.
only received the adjuvant component of the vaccine; only received the adjuvant component of the shingrix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Shingrix. On 29th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The reporter stated that patient only received the adjuvant component of the Shingrix vaccine on 29th June 2022 inadvertently. Additional supportive information: The patient only received adjuvant component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter consented to follow up.
covid vaccine breakthrough case  dose 1 Moderna 3/29/21  017B21A dose 2 Moderna 4/26/21  048B21A
Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 026L21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (20 years ago . No recent changes in status such as improvement or worsening.), Cholesterol (20 years ago . No recent changes in status such as improvement or worsening.) and Drug allergy (Allergic to Demerol). Concomitant products included LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.            Height of the patient was 6 feet.  The patient never had COVID  test or diagnosis or no other vaccines given within 1 month prior to Moderna COVID-19 vaccine and patient doesn't experienced any similar event in the past. The patient experienced a painful arm, but did not remember whether was left or right arm. No treatment information were reported by the reporter.   This case was linked to MOD-2022-543751, MOD-2022-543640 (Patient Link).
Swelling of the left side of the face and eye area. Red and itchy. Patient stated that it was much worst the day after vaccination but have gotten significantly better today. No reaction at injection site.
Received a letter from an RN, PHN 09/19/01, saying that this infant died on 09/01/01 with preliminary diagnosis of Sudden Infant Death Syndrome. Did not know of patient death prior to the letter. Death certificate states cause of death as "pending" and autopsy performed.
Chills, body aches, fatigue, redness and tenderness around injection site which has been increasing in size. Area hot to touch and pain rated 4/10 that radiates to R shoulder and back.
Red, hard, painful lump at vaccine site. Started 2 hours after vaccine and still tender and sore a week later. Also noticing left axillary lymph nodes swollen And tender (vaccine administered on left bicep) Left arm is also sore to lift and feels generally a little weaker. Symptoms still persist one week later.