chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-FEB-2014, the patient was vaccinated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  02-APR-2015, the patient was treated  for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report from a contactable Pharmacist. The Pharmacist reported similar events on 2 patients. This is case 2nd of 2 cases. A patient of unspecified age (after age 65, unit not provided), ethnicity and gender received PREVNAR 13 (Lot # R28321, Expiry Date 01Mar2018, NDC # 0005197102, UPC # 300051971022) intramuscular at 0.5 ml single on an unspecified date for an immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe reactions on their arms which were described like cellulitis type reactions on an unspecified date with outcome of unknown. The reporter was wondering if they should continue to use the rest of the products from that LOT or if it should be quarantined. Sender's Comments: Based on the information currently available, a contributory role of the suspect vaccine may not be fully excluded towards the occurrence of "severe reactions on arms described like cellulitis type reactions". 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. Linked Report(s) : US-PFIZER INC-2017087907 Same reporter/drug/AE, different patient.
fever, chills, vomiting, muscle pain, dizziness.  Started on 4/12 about 5-6 hours after vaccination.  lasted through night. Patient still with some symptoms in am.  have n ot yet been to see physician
high pulse rate for 4 days, pulse rate was 118, resting 100 which gradually came down.
vaccine was administered greater than 12 hours post first vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 08Feb2022 at 9:32am in vaccination room with an average room temp of 74 degrees F. No concomitant medication were reported. No treatment information were provided.
SYmptoms:  Rash & UrticariaPruritus  Treatment: Diphenhydramine 25 mg once ,hydrocortisone 1 application GM ONCE one application to injection site
Muscle and joint pain after second shot. Put on diclofenac, topiramate,methoccarbamol,tylenol, and predinsone. Only prednisone works. Still having problems
Developed numbness and tingling starting in her toes 8 days after vaccination. Symptoms progressed to involve paraesthesia of her arms as well and eventual motor discoordination in her arms and legs. 15 days after vaccination 6/3, was evaluated in out patient clinic and sent home with steroids. Presented again to ER next day 6/4, and was admitted to inpatient neurology and later diagnosed with AIDP/GBS. Received IVIG x7days with stabilization of neurological symptoms. Now has possible autoimmune hepatitis that is being worked up.
AFTER THE VACCINE HAD BEEN DRAWN UP IN A SYRINGE AND PUT BACK IN THE REFRIGERATOR. THE SYRINGE HAD SURPASSED THE 2 HOUR STABILITY WINDOW; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a male 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced after the vaccine had been drawn up in a syringe and put back in the refrigerator. The syringe had surpassed the 2 hour stability window, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and after the vaccine had been drawn up in a syringe and put back in the refrigerator. The syringe had surpassed the 2 hour stability window was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000218398.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/8/2022 CARDIOGENIC SHOCK J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/4/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 4/4/2022 CARDIOGENIC SHOCK R57.9 SHOCK, UNSPECIFIED 4/4/2022 CARDIOGENIC SHOCK
I was 9 weeks and 2 days pregnant with my first pregnancy (no history of miscarriages) when I received my first dose of the Moderna vaccine on 1/9/2021. I had a routine appointment with my OB-GYN the day prior, 1/8/2021, during which they completed a routine ultrasound. At that time, the ultra sound was completely normal with a healthy fetus and heart rate, and my due date was estimated to be 8/13/2021. Also at that time, I was advised by my OB-GYN to get the COVID vaccine, when offered to me, given my higher risk of contracting COVID due to my job as a healthcare worker with direct patient contact, and my higher risk for more severe illness if I contracted COVID due to pregnancy. I received the vaccine the next day with no immediate adverse reactions/events aside from some considerable arm soreness at the site of the vaccine and fatigue. Then 2 weeks and 6 days later I had another routine appointment with my OB-GYN (1/29/2021) at which point in time I was 12 weeks and 1 day pregnant. During this visit they conducted a second routine ultrasound. From this ultra sound they identified multiple abnormalities including an increased nuchal translucency of 3.5 mm, absent nasal bone, and presence of fluid around the fetus?s abdomen. These abnormalities were concerning for a chromosomal/genetic abnormality. Given these concerns I had labs drawn for maternal carrier screening (the Panorama and the Horizon 274), and I was referred to maternal fetal medicine for further imaging and testing. The results of the lab work took approximately 2 weeks to receive, but they came back normal without increased risk identified for any of the chromosomal/genetic conditions tested. I was seen by a high risk doctor and a genetic counselor within the maternal fetal medicine department on 2/2/2021. At this appointment I had a third ultrasound completed which confirmed the presence of an increased nuchal translucency now 4.3mm, and also found the presence of a cystic hygroma. These findings were again consistent with concerns for a chromosomal, genetic or other anatomical/structural condition and as such I had a chorionic villus sampling done that same day to assess the DNA of the fetus. These results also came back all normal without concern for any of the chromosomal or genetic conditions tested. I then had a follow up appointment and ultrasound with the maternal fetal medicine department on 2/19/2021, at which point I was 15 weeks and 1 day pregnant. This early anatomical scan revealed even more concerning findings with the fetus?s humerus measuring in the 1st percentile for gestational age and the fetus?s femur measuring in the 3rd percentile for gestational age. Per consultation with our genetic counselor this was indicative or some severe condition; however, it was not clear exactly what condition. Given the severity of the findings it was recommended to terminate the pregnancy. As such I had to undergo a dilation and evacuation procedure on 2/24/2021. We are currently still awaiting results of further genetic testing (exome testing), the results of which can take 2-3 months from the time of sending out the labs (sent out around 2/24/2021).
Full body hive rash not at the injection site. Below arm pits, inner thighs and continued to spread all over my body for about 6 days until I started conssitently taking Claratin in the AM and Benadryl in the PM. Still today, get little hives that pop up with brushing of the skin
Low grade fever starting around 11 hours after injection rising to 102 by 13 hours after.  Back to low grade by morning.  Swollen and tender gland in armpit starting about 36 hours after injection.
In the evening on the day of her second shot patient was dizzy and vomiting.  Had fever, chills like bad flu and was sick on Friday as well with nausea and dizziness.  The nausea and dizziness lasted 8 days for this patient and she finally started to feel better the following weekend.
fever, chills, myalgias - took 4 ibuprofens - lasted less than 24 hr
Muscle soreness day of injection. Next afternoon arm a bit puffy, red, warm, stinging and prickly.
Vaccination site induration; Vaccination site erythema; Fatigue; NAUSEATED; Threw up 1 or 2 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Immune suppressive therapy for double lung transplant.).    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 VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times). At the time of the report, VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative negative (Negative) Negative.         No concomitant and treatment medications were reported. Patient has stated that she does not to fill out any forms or give her mail as she is in a study and looking after her issues.   This case was linked to MOD-2021-019772 (Patient Link).
patient stated arm did not work on 10/8/19, in the pharmacy the right arm had what looked like a rash to the underside of arm
8pm same day, fever, chills, muscle aches. 04feb21: fever chills,headache,muscle aches. 05feb21: only swelling and pain in left armpit lymph node region
Patient reported muscle weakness in arms and lower extremities for a day. He stated it has improved since then.
Extreme fatigue, Headache, Rash at injection site, Muscle/joint pain
Information has been received from the healthcare worker who reported that on 23-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II/(lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The is one of several reports received from the same reporter. Additional information has been requested.
COVID Arm 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm 2nd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory infection (one month ago), Carcinoma liver (Two years ago that required surgery of her liver and gallbladder) and Cancer surgery (Surgery of her liver and gallbladder for Liver cancer). Concurrent medical conditions included Shellfish allergy, Fruit allergy (Strawberries), Fruit allergy (Peach), Fruit allergy (Mango), Fruit allergy (Dragon fruit), Allergy to antibiotic (any antibiotic cillins), Drug allergy (Codeine), Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Flagyl), Drug allergy (Fentanyl), Drug allergy (Morphine), Drug allergy (Acetaminophen) and Brain damage (Permanent, three years ago and caused her not to be able to remember things). Concomitant products included LISINOPRIL and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (COVID Arm 2nd dose). At the time of the report, VACCINATION SITE REACTION (COVID Arm 2nd dose) outcome was unknown.            No treatment information was provided. Patient stated that she had never experienced symptoms like the events. There was no history of COVID-19 infection and myocarditis/Pericarditis.   This case was linked to MOD-2021-403801, MOD-2021-403816 (Patient Link).
fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 4th of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: Qj5342) at the age of 72 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: Fm0698) 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 had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  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 including Paxlovid from 06Sep2023 to 11Sep2023.
Light headed 30 minutes after shot and slight headache.  Following day; extreme fatigue, fever, chills, shortness of breath. Had Covid-19 virus December 17, 2020.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 22-MAY-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (strength, lot#, dosage, frequency and route unspecified) (incorrect product storage). The temperature excursion for GARDASIL was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 6OCT93 & next day both legs swollen & aching; sore throat, cough & fever developed; sx persisted for 3 days; @ time of report, pt still experienceing aches in legs, cough & fever on & off; called but not seen in ER;
Pt mother reports noticing the reaction to arm the day after injection 11/8/19 around 7 pm. Pt was seen at local ER around 8pm. ER notes document a 3" red round circle at site of flu vaccine injection and pt was c/o itching. Pt mother reports that the red area was hot to touch.
At first it was normal discomfort but as the days went on, the pain got worse. It started as a sharp repetitive stabbing pain at the injection site and it had a burning sensation in my arm. That lasted for a while off and on and this morning I woke up and it was aching pain in my arm and it hurts to move and touch.
frequent urination at night; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: POLLAKIURIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "frequent urination at night". The event "frequent urination at night" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no other vaccine in four weeks, No COVID prior vaccination and no COVID tested post vaccination. I received my last booster on 10Jan2022 and soon after started having frequent urination at night. I saw a doctor 2/3 weeks after and all my tests turned out negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201166582 same reporter/patient/product/different dose/event in time;
On 03/22/21, 2 days after receiving vaccine, I experienced a severe headache from 1:30pm to 11:30pm. Tylenol did not really help.   I awoke from sleep on 03/23/21 at 2am with chest tightness and left arm numbness. Symptoms subsided after 10 minutes, but I awoke again 4am with same symptoms.    Symptoms subsided after several minutes.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-APR-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Private handed LVN an unopened Pediatric Pfizer vaccine, it had the orange cap still on it, she told the LVN here is the Pediatric Pfizer vaccine with orange cap. The vial hadn't been diluted. The LVN gave 0.2 ml dose of undiluted vaccine to patient. A second LVN gave the 2nd dose from that vial to patients sibling. When the 2nd LVN was getting ready to pre-draw a third dose for the next patient, she then note that vial seemed more concentrated she asked 1st LVN about vial if it had been diluted it was then that the first LVN realized that it still had the cap on it and that it hadn't yet been diluted. Patient had already left the clinic. RN was notified as was the Pediatric Infectious Disease MD on call.
fatigue, muscle pain,  chills, nauseas ,and vomiting, and fever, pain at the injection site
tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.