chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a patient on 20 November 2013. A female patient had received a dose of FLUZONE (lot number U11910AA, on left deltoid by intramuscular route) on 19  November 2013. Patient was allergic to penicillin. On 19 November 2013, after vaccination the patient experienced soreness in left arm. Patient stated on 20 November 2013, and experienced pain down left arm, tingling in arm and has now a feeling of numbness in arm with loss of sensation. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
Medical facility that gave a 16 year old the vaccine; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) at 16-year-old.  The patient's medical history was unknown. Concomitant medication were not reported.  On 14-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273, intramuscularly, at left deltoid (lot/batch: unknown) for prophylaxis of COVID-19 infection. No treatment information was provided.   Action taken with mRNA-1273 in response to the event "Inappropriate age at vaccine administration" was not reported.   The outcome of the event "Inappropriate age at vaccine administration" was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Breakthrough case admission after 3 vaccines  Moderna 1/25/21 Lot# 004M20A;  Moderna 2/23/21 Lot# 023M20L;  Moderna 11/2/21 Lot# 077C21B
both arms ache; back itching; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced both arms ache and back itching. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Painful to lift arm. Pain at injection site. Bled when dose one shot was given. Over four months later and I am still having pain in my arm, not just at injection site. It hurts to rotate and lift and feels like the muscles are sore all of the time. Hurts to touch injection site but not continuously. Sometimes it feels like someone has punched me in the arm. Other times it feels like I have been stung by bees. This will even hurt into my shoulder and down to my elbow.
exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 37-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Stillbirth (16 weeks 2 days due to infection) on 11-Jul-2019 and Induced abortion (Induced Abortion at 6 weeks and 6 days trisomy 17 triploid. At 10 weeks had DNC.) on 11-Feb-2020. Concurrent medical conditions included Difficulty with anesthesia (Anesthesia sensitivity) and Ex-alcohol user (2-4 drinks a month (prior use)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound antenatal screen: normal (normal) At 19 weeks and normal (normal) At 28 weeks.     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.   Treatment information was not provided.
Starting with my menstrual cycle immediately following administration of my second COVID vaccine and continuing through the present, my cycles have become progressively shorter and lighter to the point that they last no more than 3 days. My time between periods has also become less predictable. I used to have a 27 day cycle on the dot, with heavy periods lasting 5 days. I have zero family history of early menopause, and as I have tracked my cycles over the past year since vaccination and they have not returned to normal, I have become more alarmed. I have had no other health changes or anything that can explain the changes in my cycle. I decided to report after comparing notes with other women and finding that many have similar experiences. I?m not even sure this is considered reportable, but if the vaccine is causing changes to menstrual cycles, I?m concerned about the impact on my fertility, and the cdc should be made aware if this is a recurring issue.
10/7/21 About 30 minutes after vaccine administered I developed a twitch in my left eye- 30 minutes later I began to have a tingling sensation on my left cheek and jaw. I went to lay down at home and when i woke up my left arm from my elbow to my fingers was also tingling with a pins and needles feeling ( about 4- 6 hrs after vaccine) I also  noticed a heavy pressure feeling in my chest.  I went to my local hospital with my symptoms.  Hospitalized from 10/8-10/10  10/21/21 In addition to above symptoms that are still ongoing. I began experiencing on set of sudden fevers of 101.9 that would spike sporadically, constant dizziness and lightheadness, unable to stay steady on my feet, nausea/ vomiting,  extreme headache not solved with migraine meds, stiff neck on left side, and extreme fatigue- i presented to my primary care office in follow up to report the onset of these new symptoms in addition to the previous ongoing symptoms from 10/7/21
missed their 3rd dose of GARDASIL; The patient did not know if they received GARDASIL or GARDASIL 9 for the first 2 doses; No other AE; This spontaneous report was received from a pharmacist referring to a 30-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, when the patient was 15, he was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis, the patient did not remember exactly with one (product name confusion), and now, the patient reported missing his third dose (product dose omission issue). No adverse event was reported.
thrombocytopenia, petechiae, purpura; hospitalization; serial lab studies;
Synmptoms began about 2AM 8/8/2021 and today (12/22/21) I was diagnosed with trochanteric pain syndrome, left hip.  Beginning Saturday, August 7th, I experienced a lot of zapping pain throughout my body,  in joints and muscles for several days after the second dose. Less than 24 hours after receiving the second dose, I was awoken around 2am with searing pain in my left hip and buttocks. I was not experiencing  pain in those areas. prior to the shot. (19 years prior I did have an injury in that area).
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Left arm broke out in red bumps at 3pm on March 19, 2021. I took 2 Tylenol for pain in arm. On March 20, 2021, my right arm had developed small red bumps. The red bumps on my left arm disappeared but left a rash on my arm.
Swelling and pain at site-area of swelling 2 inches x 5 inches swollen, with marked erythema...reports difficulty raising arm. Went to primary physician-no f/u needed.
Severe headache, fever, body ache, chills, slight cough, nausea, loss of appetite, my hearing was going in and out, severe abdominal pain, sneezing, stuffy nose, sore on my lip, swollen arm.
Narrative: hospitalized for GI bleed subsequent to  vaccination. Very low probability that vaccine was cause.
body aches; Dizziness; Nausea; loss of appetite; chills; fatigue; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 28Jan2021 (22-year-old at the time of vaccination), as a single dose for covid-19 immunization. The patient's medical history included non-sustained ventricular tachycardia diagnosed at birth, pacemaker and defibrillator. The reporter stated that her son has a serious heart condition, pacemaker/defibrillator- first was in 6th grade, currently on his fourth and drug hypersensitivity states they monitored them both longer than the 15 minutes because they have a history of serious allergic reactions to ACE inhibitors. The patient's concomitant medications were not reported. The patient continues taking his low dose aspirin prior to the vaccine but did not take any Tylenol. On 28Jan2021, the patient experienced dizziness, nausea, loss of appetite, chills, body aches, fatigue, and itching. The outcome of all the events was recovered on 29Jan2021.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
11.5 x 11.5cm area of redness, swelling and induration which developed approximately 36-48 hours post immunization. No ffever and not determined to be cellulitis.
Pain in vulva area that began within 48 hours of vaccine.  Urgent Care visit with urine test and swab tests for infection, disease with negative results.  Ulcers on Labia were identified and urgent appointment scheduled with OBGYN within 24 hours.  Appointment with OBGYN confirmed ulcers on labia with no clear etiology (no changes in person hygiene, no sexual activity, etc).   Ulcers were checked again about two weeks later and are close to healed at this point.
she also received Prevnar (CK0838) and Rotavirus (S006050) the same time. Patient started to have severe eczema after vaccinations where her face, forehead, cheeks, chin and scalp are broken out with rashes and raw skins and won't heal. She also suddenly developed allergic reaction to all types of food I eat (I am breastfeeding) - she can no longer tolerate almost all allergens (soy, wheat, sugar, eggs, citrus). She also had behavior change 4 weeks after her shots. She stopped making eye contact, stop smiling and stop responding to sounds.
I started feeling dizzy early this morning & my body ached. I kept waking up every hour starting around 4:30 AM. My legs still feel weak & my head hurts. I called my doctor's office & was told to come in for treatment but how can I travel if I can barely stand? The woman on the phone said the doctor can't treat me unless she can see me in person & can't take my word on the symptoms.
Approx. 15 min post injection, patient verbalized dizziness, jittery and nausea. B/P 173/111. Provided water and granola bar. Reports feeling better. Patient called PCP who advised to go to Urgent Care and apt made in AM to see PCP.  Patient reported that she thought she already had HTN and was planning on seeing her PCP for this later in the month. B/P upon discharge 154/102 Pulse 87. States feeling much better. Family member here to drive to urgent care. Patient discharged in satisfactory condition. Total recovery time 50 minutes.
Patient received Flucelvax Quad on 10/15/21  but patient had already gotten  flucelvax Quad 2021 on 8/13/2021.  Duplicate shot given on 10/15/21.  Patient had no symptoms of complaints
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient (age: 65 unit not reported, not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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's relevant medical history included: "Hypertension" (unspecified if ongoing). Patient had no allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 23May2022 to 27May2022 orally for covid-19. Patient did not received any other medication within 2 weeks.    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 the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
chills, fever,muscle pains, fatigue, swollen glands, arm pain    Refused second dose.  Recovered
Patient believed he had been vaccinated against influenza prior to our visit (on Mon, 11/13/2023) We vaccinated him with Moderna Spikevax Fall 2023 COVID vaccine. He phoned us later to say that actually he was vaccinated against COVID with a Fall 2023 vaccine on 11/13/2023. Patient appears to have received two full doses of Fall 2023 COVID vaccine. There is no record of any vaccinations of patient on Monday 11/13/2023 -- all history is per patient and senior housing administration report. Patient has felt well throughout this week with no adverse side effect from double dosing of COVID vaccine.
Fever and generalized rash - onset few days after vaccination rash is measles-like.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient came in post administration and said his arm was sore at the injection site and had some pins and needles feeling in him arm since the injection, however , he said it was slowly improving.
Headache; sore throat; feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad). At the time of the report, HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided No concomitant medications were provided
Patient was given Moderna additional dose (0.5mL) instead of Moderna Booster dose (0.25mL).
I received my COVID-19 vaccine on 10/31/2022. Two nights after I had trouble sleeping. Around 11/14/2022 I felt spaced out, very itch and congested. During the day on and off I kept getting the chills dizzy and vision interruptions. Symptoms continued for about three weeks causing me to become more irritable. Went to the doctor around 12/01/2022 after taking medication.
Lethargy, generalized weakness, difficultly arousing, full body aches, fevers. Ended up needing hospitalization due to the severe weakness.
Received vaccines on 8/6/07 Proquad on Rt and IPV, DTaP on Lt. Lt upper extremity 48 hours s/p vaccine 6"x3" erythematous, indurated, warm, non-tender rash. No fever, no N/V/DRH, no LAD. +fatigue. PO intake solids.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 01-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time; Stiff injection site (left); Warm to touch; experience nerve pain; After receiving the second dose, she started to have an excruciating pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 015M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included INSULIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site). The patient was treated with MELOXICAM for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at a dose of tapered doses for a week and IBUPROFEN for Pain, at a dose of 1 dosage form twice a day. At the time of the report, PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Knot on his arm; Vaccine subcutaneously injected; A spontaneous report was received from a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced knot on his arm and vaccine subcutaneously injected.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 subcutaneously in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Jan 2021, during vaccine administration, the patient was given the vaccine subcutaneously and he later noticed a knot on his arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccine subcutaneously injected, was considered resolved on 11 Jan 2021. The outcome of the event, knot on his arm, was not reported.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of mRNA-1273 vaccine was given subcutaneously (Vaccine given subcutaneously ,Vaccine administered at inappropriate site) and event of experienced knot on his arm (lot # unknown, Expiration date-unknown). The event of experienced knot on his arm is temporarily associated with the administration of mRNA-1273 vaccine, hence a causal association cannot be excluded. The event of vaccine given subcutaneously is considered not applicable
Left arm began to ache about 1 hour after dose given then right arm began to ache similarly later same day. Pt also had upset stomach no diarrhea or nausea.