chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itched after it faded; nausea; dizziness; developed a rash on her back and stomach/Rash moved to neck; felt flush; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 15:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS; KARIVA taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Route of Administration: Intramuscular, time: 01:00 pm), administration date: 03Apr2021, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "No known adverse events"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Mar2021, when the patient was 51 years old, for COVID-19 Immunization, reaction(s): "No known adverse events". The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 15:00, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "dizziness"; RASH (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "developed a rash on her back and stomach/Rash moved to neck"; FLUSHING (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "felt flush"; RASH PRURITIC (non-serious) with onset 15Nov2021, outcome "recovering", described as "itched after it faded". Therapeutic measures were not taken as a result of nausea, dizziness, rash, flushing.  Adverse event: 12 hours post 3rd vaccine booster, patient experienced nausea and dizziness. The nausea and dizziness subsided and then 12 hours later patient developed a rash on her back and stomach and felt flush. 3rd BNT162B2 booster received the afternoon of 13Nov2021. Early morning (02:00 AM) of 14Nov2021 experienced nausea and dizziness. Subsided a few hours later on 14Nov2021 mid-afternoon, a rash formed on stomach/back which itched as it faded. Rash moved to neck on 15Nov2021 which itched after it faded. After all rashes faded, no other known event occurred. No known adverse events occurred with the first 2 dosed (dose 1 and 2). Other medications in two weeks: Birth control, vitamin D supplement and multivitamin supplement. Known allergies: None. Other medical history: None. Patient did not receive any other vaccine in four weeks.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a nurse refers to a 4 male patients of unknown age. No concurrent condition or medical history was reported. The patients were vaccinated with improperly stored GARDASIL (lot # K011562, Exp. 08-APR-2017, dose and route of administration not provided) from 29-JUL-2015 through 04-AUG-2015 (Incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. Product quality issue was not involved. This is one of the two reprots from the same reporter. Additional information has been requested.
Reaction: On 06/14/2018 (2 days later) developed: rash with redness/swelling, tenderness, hot to the touch, approximately 3.5 x 7. No abnormal oral temperature, drainage, or difficulty breathing or moving. Duration: 3 days Medications Taken: ALEVE.
Patient reports (R) shoulder pain starting on same day as vaccines given. Dr examined - stated not related to vaccines. Refer to ortho for Rotator cuff evaluation.
Pleuritic chest pain started 11 days following vaccinations and hemoptysis 13 days following vaccinations, with markedly elevated D-dimer. Right lower lobe segmental and sub-segmental pulmonary emboli and pulmonary infarction with pleural effusion diagnosed by contrast CT. Enoxaparin 1 mg/kg SQ q12 X 2 dosed followed by standard dose apixaban loading doses and therapy. Full symptomatic recovery after 1-2 weeks.
16 y/o M with history of environmental allergies here c/o L upper arm/clavicle swelling that he is concerned is related to the vaccines, Flu and MCV4 that he received yesterday in clinic. He denies any immediate reaction. He participated in football practice yesterday after school. He states that it was a "walk-through practice" without any contact and denies any hits, falls, or direct trauma/injury. He states that when he got home around 7 pm, he noticed swelling, discomfort, and numbness to L deltoid. He reports that his Mom gave him a pain pill (Tylenol arthritis 8 hours) and symptoms improved. Today at school, approximately 2 hours ago, he started to feel the swelling to L deltoid and then noticed swelling to the L sternoclavicular joint. He reports pain with ROM of L arm. He took one tab of Claritin around 10 am and then took another Tylenol arthritis around 11:18 am. He reports improvement in symptoms since taking the medication.
"Moderna COVID-19 Vaccine EUA" Initial mild pain in lower left calf lasting 3 days. Described as "pulled muscle feeling." Dissipated after 3 days. Then, mild, left sided middle back pain that progressively worsened over 3-4 days. Pain eventually felt across entire front and back of chest. Shortness of breath worsened. Difficulty pulling air into lungs and pushing it out. After a total of 5 days from onset of back pain, emergency room visit required.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The pertinent medical history and concomitant medication was not reported. Since an unknown date in 2015 (reported as since 10-JUN-2015) the patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB (lot: K007263 and Expiry: 09-JUN-2016; Lot: L013377 and Expiry: 29-OCT-2016; Lot: L016959 and Expiry: 12-MAR-2018) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Caller said she had all four Pfizer shots, including the booster/taking Paxlovid; Caller said she had all four Pfizer shots, including the booster/taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Not Known). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller said she had all four Pfizer shots, including the booster/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
90 YEARS OLD:   1st Dose of Pfizer Vaccine did NOT produce any side effects that I am aware of.   However, the 2nd Dose of Pfizer Vaccine produced side effects about 3 hours after the injection.  Reactions were arm sore, tiredness, body ache, headache; no diarrhea, temp not taken - went to bed and slept.  These side effects continuing February 6 and February 7.   February 7 taking Tylenol to help with aches and pains.  This report was written on February 7 at 1:30 pm with side effects continuing.
104 fever; pneumonia in lungs; so sick; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves a (unknown demographic) patient who experienced 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included COVID-19 (Coronavirus disease 2019) with last year & body pushed it out like a common cold.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Pneumonia event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  Relevant laboratory test results included: Body temperature - On an unknown date: 104  An unknown corrective treatment was received for the events.  The event outcome was unknown for the events.  Lot number had been requested.; Sender's Comments: This case concerns a (unknown demographic) patient who experienced pyrexia, pneumonia and illness (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is past medical history included COVID-19 (Coronavirus disease 2019)  was reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Loss of feeling and range of motion in left foot along with phantom pins and needles pain in both legs. Shortness of breath, unable to climb stairs Strange bruising on legs and feet Lethargic, lack of energy Cognitive issues Low testosterone high estrogen discovered in 2023 Symptoms persistent until mid 2023 after addressing hormone levels and taking Nitric Oxide supplements.  Symptoms still exist but less pronounced.
Individual developed "gello" heavy legs and "foggy" heavy head,  occurred 2-3 (4:00pm)hours after injection.  no symptoms till than.  lasted 2 hours (5:30) then legs were better and head heaviness lasted till 830 pm  symptoms improve but today 1/6/2021 still has some fatigue, chest congestion and headache.  Did find out she had exposure on Friday 1/1/2021 will get testing for Covid 19 today
SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced sore arm at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site on 25-MAR-2021. This report was non-serious.
reports a diagnosis of myelofibrosis; reports a diagnosis of  / low platelets; postherpetic neuralgia; shingles; This case was reported by a consumer via call center representative and described the occurrence of myelofibrosis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myelofibrosis (serious criteria GSK medically significant), platelets decreased, post herpetic neuralgia and shingles. Shingrix was discontinued. On an unknown date, the outcome of the myelofibrosis, platelets decreased, post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the myelofibrosis, platelets decreased, post herpetic neuralgia and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. Approximately two and a half years ago, the patient received 1st dose of Shingrix vaccine and approximately one and a half months after receiving the 1st dose, she experienced shingles and post herpetic neuralgia. The patient chose not to obtain the 2nd dose and she had consulted with her healthcare professional regarding whether or not she should proceed with receiving the 2nd dose.  The patient reported a diagnosis of myelofibrosis and low platelets and it was unclear whether this was diagnosed prior to or following the Shingrix vaccine. The patient reported she called GlaxoSmithKline and the CDC (Center for disease control) and reported her experience with Shingrix. While there were many details provided about her experience with the vaccine, the patient elected to remain anonymous and not share information for follow-up. The reporter did not consent to follow-up.
NAUSEA, ANOREXIA, HYPERGLYCEMIA, COUGH, ENDED UP TESTING POSITIVE FOR COVID-19, UTI, PNEUMONIA
On day 8 after receiving the first jab, began to experience tiny itchy bumps all around the inj site. Approximately 3 inches wide. I had only severe arm pain for the 8 days prior. On day 9 after the itchy rash occurred, I began to get swelling 4 inches wide/long around injection site and the skin turned hot pink. I?m currently on day 9, today.
Arm soreness, abnormal fatigue, the next day (3/30) I had chills, muscle aches, fever, chills, night sweat, slept all day, lost appetite, threw up once.  Next day (3/31), was much better, but had muscle aches all over my body that were so sore, they woke me up.  Also took a nap.  ON 4/1, I am feeling much better.  Injection site is slightly tender, slightly tired still, but definitely on the mend.
Leg swelling and shortness of breath.  Developed DVT in left leg. Nearly occlusive thrombus from proximal SFV to calf veins.  Also Bilateral emboli extending to both lung bases, lingular segment and RML.  Hospitalization for 2 nights for IV Heprin, then oral Xarelto for outpatient treatment
Mother called the doctor and reported that the baby cried in a "high pitch" for a few hours post vaccine.
The patient reported that he had a burning sensation on the front part of his tongue, a chemical taste in his mouth, feeling achy, and he lost his taste the same day he received the first dose of his vaccine.  He said that most of the side effects resolved by the next day.  The burning sensation on his tongue has persisted during the month.
Immediately after getting the shot within 2 minutes I started feeling very flushed and very warm. I did not have difficulty breathing so they sent me home, I took my jacket off and I had a rash from my neck, across my collar bone, across my chest and my back. My neck felt super tight so I ended up going to urgent care they did blood work and they said it must have been a swollen lymph node. They sent me to the hospital and they did an ultrasound, and it came back as nonconclusive, I also had like the more traditional symptoms, head aches, stomach ache. By the time I had the ultrasound it had already been a month. the normal symptoms went away after the week,  but the tightness in my neck persisted for the whole month. They did the ultrasound and blood work and the official diagnosis was a lymphatic reaction. I was really just having difficulty swallowing and laying flat. After urgent care and had the us I followed up with my PCP and she prescribed some steroids. It took about 2 months to fully settle back down and for the inflammation to go away. Because I had trouble swallowing solid foods I lost about 20 pounds.
2 hrs After injection / headache / soreness at injection site Morning after injection/ 100 degree fever / body aches / all day headache
Muscle and Bones aches. @ weeks later i had severe pain in my right leg and hip.
Covid arm: red area around injection site on day 13 post vaccine. Applied local anti-inflammatory
Patient had swelling on upper left arm and rash on arm. Warm to touch (according to patient). She came in 7 days later and swelling/redness visible, but fading. Gave BENADRYL and told her to take 1 later.
I had pain all over my body, my left arm hot, edematous, red hives, my arm was heavy, heaviness on my neck, I've been like this for 4 days and I called the pharmacy and reported it to a lawyer today. They indicated this site and to notify it.
No adverse reaction,treatment and pt stated as per phone on 11/1/2022 no problems,Had attempted to call pt on 10/27/2022 x several times and again on 10/28/2022 no answer just voicemail stating full.
Information has been received from a licensed practical nurse concerning a 55 year old female paraeducator (weight 242 pounds, height unknown) with penicillin allergy who on 2-JAN-2009 was vaccinated with a first dose of ZOSTAVAX subcutaneous, lot # 663177/1413X. The nurse stated that the patient called on 5-JAN-2009 and reported she developed blister filled pustules where the vaccine was given, denied any pain at injection site, only developed pustules. Patient recovered. Additional information is not expected.
Redness at the site of injection; Soreness at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication information provided.  No relevant treatment medication information provided.
Within minutes of vaccination, pt c/o jaw tingling and "spasm-like feeling of tongue and jaw". Pt talked w/lisp but no evident swelling of tongue/face. Pt received IV BENADRYL given within 3 minutes and Prednisone 40mg PO 20 minutes later. Pt discharged within 1 hour.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Called Clinic provider, to assist. They administered oral benadryl and suggested calling EMS, but patient declined. Husband did drive patient to emergency room. Followup unknown
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   This case was linked to MOD-2021-395985 (Patient Link).
Tinnitus, bilateral.  No treatment.  Was present as of 4/26/2021
Patient was administered HPV vaccine on 12/2/2014 at approximately 3:40 pm. As per consent form signed by mother of child, patient was not sick and NKDA. Today mother of child returned to our clinic w/complaint of headache that started this morning approximately 10:00 am-she gave her TYLENOL. Patient c/o feeling chills and RN observed tremors of lips and involuntary movements of upper extremities. Oral temp 98.3 BP 106/71 P=105. Transported to be evaluated by dr.
Injection site red; Injection site hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 31st May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The reporter has a consumer that received the Shingrix and reported that the injection site became red and hot a couple of days after receiving the vaccination. The symptoms have resolved. The reporter was unable to provide additional information because the consumer was not in pharmacy at the time of reporting.
Sore arm, severe headache, moderate nausea, low fever (100 F)
A dose of age-appropriate Moderna primary series Covid-19 vaccine was administered to this 10 year old patient on 11/18/22. It was subsequently realized that the lot of vaccine given (AR5186C) had actually expired the day before on 11/17/22. Per guidance on the CDC's website regarding such an administration error, the manufacturer was then contacted. Moderna was able to provide documentation that although the vaccine was expired on the date of administration the dose maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus.
Cold sore at bottom of nose.  I am 79 and never before had a cold sore.  Started approximately 5 days after being vaccinated.  Looks like it is starting to dry up but has not gone away yet.
Grandmother presented on 7/16/2008, states child began running fever a few days ago, then loose stools one day.  A few "bumps like mosquito bites" appeared on arms and one on face 7/14/08, which child scratched.  Three new blister-like lesions to right forearm developing today.
Initial report received from a healthcare professional on 24 February 2014. A patient, whose date of birth, age, gender, medical history and concomitant medication were not reported, had received another injection instead of ADACEL on an unspecified date, leading to wrong vaccine administration. Documents held by sender: none.
Patient reported tongue soreness and swelling of face. Her pulse was first checked about 15 minutes after administration and was 76 beats per minute. Her blood pressure was checked and found to be 162/86 with pulse of 87 at that time. Repeat blood pressure was 168/72 with pulse of 74. She says she was tingly and dizzy. She was checked by EMT and was allowed to leave after checking out ok.
covid symptoms including cough, fever, chills, headache, sore throat, bodyaches, generalized weakness and fatigue, shortness of breath beginning 11/15/21 and worsening over several days.
Severe muscle spasms, fever, fatigue, headache, tightness, soreness