chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA left deltoid 2021/12/17 14:45 Patient woke up feeling cold and shaking uncontrollably at 23:30 with severe headache and arthralgia. Nausea started about 00:00. Neck and cheeks were cold and she covered all but her nose and mouth to maintain body heat. Chills lasted about 1 hour until her head finally warmed up. ~01:00 she fell into fitful sleep ~01:30 she woke up hot and sweating with worsening severe headache and neckache while generalized arthralgia continued and started drinking in resonse to extreme thirst  Pacing for several hours worsened nausea but somewhat relieved head and body aches Patient took an ibuprofen to relieve pain ~04:00, paced for another 30 minutes, and went to bed 05:00 and slept until 07:30 08:30 when taking a shower, she noticed injection site in left deltoid was enlarged, and hot and tender to touch ~09:30 started feeling cold and started shaking again with generalized body aches most severe in head and and spine with other joints (especially knees) also sore ~10:30 hot and sweating while generalized head and body aches persisted ~11:00 noticed mild difficulty breathing ~12:30 felt like fever broke and headache subsided slightly ~13:00 noticed increased difficulty breathing ~18:00 took another ibuprofen 200 mg following several rounds of chills and sweats ~19:30 noticed improved ability to breathe and somewhat diminished headache with ongoing body aches, especially spine and knees (other appendicular joint pain had largely resolved)
Information has been received from a physician concerning a female who on approximately 18-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil. After receiving the vaccine, the patient vomited and fainted. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician and a healthcare professional concerning a 14 year old female with no pertinent medical history who on 21-JUN-2007 at 2:30 pm was vaccinated intramuscularly in the left arm with a 0.5 ml dose of the GARDASIL (Lot # 657737/0522U) concomitantly with a subcutaneously administered VARIVAX (Oka/Merck) (MSD) (Lot # "0674U") in the left arm. At 2:35 pm on 21-JUN-2007, the patient experienced a "syncope episode-patient passed out, became dizzy then vomited all over". It was also reported that the patient was kept for a while due to decreased blood pressure for observation and to bring vitals back up where they should have been and to make sure the patient was feeling better. The patient recovered on 21-JUN-2007. Additional information is not expected.
Headache Tues 8/14/12 & fever. 5:30 seizure Wed (went uncon.) 8/15/12. Was ambulance / air to another location then to hospital in another city by air.
Neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Neuropathy". The event "neuropathy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received povidone-iodine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11May2021 at 17:00, in a 24-hour period, the patient went from feeling completely healthy/normal, to extremely ill, then back to healthy to normal. Within an hour of when the patient first started feeling ill, she felt cold and began to experience chills and shaking, then her feet felt numb from feeling so cold. Her body and head felt achy. The patient had a fever of 100 that quickly rose to 104 during this same hour.  The patient heart rate was also much higher than normal. After taking ibuprofen (MOTRIN), drinking water, and resting, the chills stopped and fever dropped to 100. On 12May2021, the next morning, the patient fever had broken (experienced night sweats), body aches were gone, the headache still lingered slightly. From the moment the patient symptoms started, she felt progressively worse, until a few hours later when she started feeling progressively better. The entire process of feeling ill to feeling ok was incredibly fast. The patient had never experienced anything like it before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events except night sweats and included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling completely healthy to normal, to extremely ill, then back to healthy to normal was resolved on an unknown date in May2021. The clinical outcome of the event began to experience chills and shaking was resolved on 11May2021. The clinical outcome of the event body felt achy/body aches was resolved on 12May2021, after the duration of one day. The clinical outcome of the events began to experience chills and shaking, feet felt numb from feeling so cold, head felt achy/ headache still lingered slightly, fever of 100 that quickly rose to 104 during this same hour, heart rate was also much higher than normal, night sweats were resolving, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a female patient who was vaccinated IM with a 0.5 ml "recent" dose of HPV vaccine (yeast).  Subsequently the patient called the practice and reported swelling in both arms and she wanted to be seen by the physician.  No further information was provided.  Additional information has been requested.
Edema in the left shoulder and stiffness. Pain the shoulder and arm that lasted for several weeks , along with numbness and tingling in the arm and fingers. I also had decreased range of motion due to pain in the shoulder after the injection for several weeks.
Headache, Tachypnea, ErythemaMultiform, Tachycardia, chills, fatigue, injection arm pain Narrative:   Other Relevant History:
patient received first vaccination on 28-Dec-2020 and then mistakenly received the second vaccination on 14-Jan-2021 (18 days apart)/no AE; Initial information received on 15-Jan-2021 regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number-00432089) and transmitted to Sanofi on 17-JAN-2021.  This case involves a 4 year-old male patient who was administered with second dose of FLUZONE QUADRIVALENT 18 days after initial dose (Inappropriate schedule of product administration).  The caller stated that this dose was 14 days before the next scheduled dose. The patient reported that the health care professional administering the vaccine did not check the chart first to see the last date of the previous Fluzone Quadrivalent.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2020 and 14-Jan-2021, the patient received 0.5 mL first and second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA and expiry date 30-Jun-2021) via intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due drug dose administration interval too short (latency was on same day).  At the time of reporting, no adverse event reported.  Product used: Used, First time product used: No, Still using product : No,  Was Device Used : Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "Supplement" (unspecified if ongoing); "Compromised immune system" (unspecified if ongoing); "APL leukemia", start date: 05Mar2020, stop date: 26Nov2020; "cancerous tumor" (unspecified if ongoing). The patient's family history included: "Parkinson's disease" (unspecified if ongoing), notes: father; "Brain stem stroke" (unspecified if ongoing), notes: mother; "Glioblastoma" (unspecified if ongoing), notes: sister. Concomitant medication(s) included: APIXABAN taken for atrial fibrillation, start date: 2018 (ongoing); METOPROLOL taken for atrial fibrillation, start date: 2018 (ongoing); CALCIUM & VITAMIN D3 taken for supplementation therapy, start date: 2018 (ongoing). Past drug history included: Cipro, reaction(s): "Nausea"; Bupropion, reaction(s): "Nausea". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
I have developed BVRO  I have no risk factors eg diabetes or hypertension so the Dr thought it could be the vaccine
Patient reports severe body aches/joint pain which she states have gotten better but still has large red area (extended hand size) on arm of injection even after a week has past since injection given. Has been instructed to watch area and come in to her primary care doctor on Monday if redness has not resolved.
Received Small Pox vaccine-developed lump and tenderness in L clavicular area.
Blurry vision, light headedness, whoozy feeling like going to pass out many days in a row and per week starting the week after booster until 3 weeks post booster. Driving and had to pull over due to dizziness and blurry vision and felt like passing out.
Pt had a sore arm. Left. Red, warm to the touch. Large area 5 to 10 cm below injection site.
Muscle aches, chills, sweating, extreme fatigue and chest tightness with shortness of breath all started within 2 hours after 2nd dose administered. Pcp contacted at the beginning of the following week. She ordered a chest xray which showed nothing and wanted updates on symptoms. Since chest tightness, shortness of breath and fatique isn't going away by Friday Aug 7, pcp ordered echocardiogram and ekg
Pt recvd flu vax 25NOV91 & exp nausea, h/a early DEC, progressive paresthesias, weakness; pt hospitalized 27DEC91; pos Hep B surface core AB;
Called local public health clinic to report adverse event because she was upset that she called pharmacy (where she received the vaccine) and was told "We don't know anything about that". Reports the morning after her vaccine she experienced itching and a rash over most of her upper torso and upper left arm. Took Benadryl for 2-3 days until resolved.
Information has been received for pregnancy Registry for Gardasil from a Certified Medical Assistant (C.M.A) concerning a 33 year old female patient who on 29-MAR-2007 was vaccinated with a first dose of Gardasil and on 26-APR-2007, received her second dose of Gardasil. The patient was discovered to be pregnant in July (date unspecified). In August there was no fetal heartbeat detected (date unspecified). The patient had a Dialation and curettage (D & C) on 18-SEP-2007 and post D & C visit on 04-OCT-2007. It was unclear if any fetal tissue was recovered and what the cause of the termination of pregnancy. No other information to report. On 04-OCT-2007 patient recovered. Upon internal review, miscarriage was determined other medical event (OME) category. Additional information has been requested.
no adverse event; a dose of V ARlV AX was administered via IM route versus subcutaneous as recommended in the Prescribing Information; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 09-JUL-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose:0.5ml, lot # T032315, expiration date 22-SEP-2022; strenght was unknown) via intramuscular (IM) route versus subcutaneous as recommended in the Prescribing Information for prophylaxis (incorrect route of product administration). No additional adverse events was reported. No product quality complaint.
Left side of top and bottom lips swelling; Left side of top and bottom lips some numbness; Bottom lip swelling; Bottom lip some numbness; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, breast cancer, heartbeats irregular and sulfa (sulfonamide) allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), propranolol hydrochloride (PROPRANOLOL) and exemestane (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the right arm on 15Mar2021 at 11:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 23:30, 12 hours after the second shot, the patient experienced bottom lip swelling and some numbness which lasted for about 36 hours. On 08Apr2021 at 23:45, 72 hours after the shot, the patient experienced a second episode of left side of top and bottom lip swelling and some numbness. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events bottom lip swelling (onset date: 05Apr2021) and some numbness (onset date: 05Apr2021) were resolved on 07Apr2021 at 11:30, while the clinical outcome of the events top and bottom lip swelling (onset date: 08Apr2021) and some numbness (onset date: 08Apr2021) were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case meets criteria for vaccine breakthrough review. SxS include fever, cough, SOB, weakness for 1 week PTA after exposure.  Tested positive 11/20.
pt states that she got very achy and had a headache so went to bed.  She woke up with chest pains and these pains would come and go and the chest tightness and heaviness was constant.  She took Tylenol and Advil but nothing seemed to help. These symptoms lasted almost 3 days.  The left side of her chest is still a little sore.
Symptoms: Extreme pain in right shoulder area starting the morning of 11/10/17 Signs: Redness at injection site Treatment from Dr. includes starting corticosteroids Unknown outcome.
Moderna Covid 19 vaccine EUA.  Adminstered to 15 year old male, no adverse event.
Parent reports pt developed paleness, lethargy. Parent became very concerned and called ambulance. Discharge summary states vomiting. msv
SORENESS AND PAIN AT SITE OF INJECTION RADIATING TO NECK AREA. PATIENT HAS DIFFICULY LIFTING ARM.
A week after, my arm, which had hurt for only one day after the shot, began to hurt a lot. There is a hard knot that has developed and a red circular area that itches
10 minutes after receiving vaccine developed right upper sternal discomfort/chest pain. Denied shortness of breath, itchy swelling of throat, hives, dizziness, headaches, or even sore arm. Ibuprofen 600 mg taken that evening and subsequent evening was ineffective relief. Deep breath causes increased pain to site. Rare occasional dry cough.
Nasal Swab Result :Positive; Nasal Swab Result :Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:00 (Lot number: FGJ527) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 01Apr2021 11:30 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 11Mar2021 12:00 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Nasal Swab Result :Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. The patient received no other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.
Dry eyes, mouth and nose almost immediately after vaccination was given. Slight sensation in left side of neck and arm
Constant high-pitched crying for 4-5 hrs; both legs turned bluish, swollen & warm for about 2 days; pt had recvd DTP in one leg & HIB in the other; It was noted by the mom that pt did not have any fever @ all;
Myalgia, NauseaVomiting, SORE ARM; FATIGUE Narrative:
Nerve pain in legs. Terrible nerve pain in arm overall; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall). At the time of the report, NEURALGIA (Nerve pain in legs. Terrible nerve pain in arm overall) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
stomach cramps around 6pm, then vomiting and cramping and aches all night, saturday vomitin, cramps and pains, nausea and fatigue and unable to eat saturday, slept all day saturday, up for a few hours then slept until sunday, felt some better nausea, unable to eat.  monday had slight nausea ate tiny bit, tuesday mild nausea and ate light foods, wednesday felt alot better byt fatigued
Patient felt her arm getting sore a couple hours after the immunization and had trouble sleeping from the pain. She woke up and felt heat radiating from the site and her arm was swollen. She went to her doctor the day after the immunization (6/19). The doctor escribed Keflex to treat and also told the patient to take oral Benadryl OTC. Apply ice and Tylenol and to notify MD if not better. Keep arm elevated.
Terrible pain in his arm, radiating down his shoulder, axilla and chest wall. Went to Urgent Care and received a shot and RX anti-inflammatory. Severe pain for days.
Patient received incorrect COVID vaccine.  Patient received Moderna vaccine when he should have received Pfizer second dose.   COVID-19 questionnaire reviewed Patient was incorrectly given the Moderna vaccine. He was observed without incident for 15 minutes thereafter. ED precautions reviewed
This spontaneous retrospective pregnancy report was received from an approximately 27 year old female patient. The patient's current conditions included allergy to morphine and CLEREGIL (reported as "Regil"). The patient had no pertinent medical history. In October 2012, the patient was vaccinated with an unidentified HPV vaccine, intramuscularly (name, strength, dose, lot number and expiration date were not provided). The patient had no concomitant medications. The patient reported, that at time of vaccination she was on her 2nd week of pregnancy. She also stated, that during her pregnancy, she felt sick the entire time. Furthermore, she had "liquid" coming from her mouth constantly. On an unspecified date, the patient sought for medical attention and she was admitted to hospital, as she was vomiting constantly. Information regarding the patient's last menstrual period (LMP) and estimated date of delivery (EDD) was not provided). On an unknown date, the patient delivered a male infant. She reported that her son, had not been able to function in a "normal child setting". Sometimes her son banged his head against the wall and had several behavioral issues since he was 1 year old (MARRS # 1610USA002863). At the time of the report, the outcome of vomiting, malaise and drooling was unknown. The outcome of exposure during pregnancy was reported as recovered. Additionally, the reporter did not provide for causality between the adverse events and vaccination with the unidentified HPV vaccine. Additional information has been requested.