chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; Sore arm; Slight body aches; muscle aches; Chills; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 13:30 (Lot number: FH8028) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Many fruits" (unspecified if ongoing), notes: Known allergies: Many fruits (e.g., apples, pears, cherries). Concomitant medication(s) included: ALPRAZOLAM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 03Mar2021, Prev dose administrator route: Intramuscular), administration date: 03Mar2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 23Mar2021, Prev dose administrator route: Intramuscular), administration date: 23Mar2021, when the patient was 38 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Pain at injection site"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Sore arm"; PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovering", described as "Slight body aches"; MYALGIA (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "muscle aches"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Chills". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, pain, myalgia, chills.  Additional information: Patient had no illness at time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The events did not result in hospitalization or any other seriousness criteria. Morning after receiving shot, wake up with the reported events, they lasted about 1 day and then fully recovered. No longing effects. No relevant tests were performed with respect to the events.  Follow-up attempts are completed. No further information is expected.
Approximately 4 hours after my vaccine, I left work and had a beer (pretty typical for me to have a beer or glass of wine a few times per week.)  After just one beer, I completely blacked out. I did not pass out or fall asleep, but I have no memory of anything else after that first beer. I did not drink anymore after that and it took approximately 4 hours to return to "normal."  This has never happened to me before and the only difference was that I had had that vaccine that day.
Information has been received from a registered nurse concerning an 11 year old male with no allergies or medical history who on 1/3/97 was vaccinated with a dose of varicella virus vaccine live (lot # 618233/0781D). There was no concomitant medication. On 3/18/04, the patient experienced a rash on the trunk, face, and arms. Unspecified medical attention was sought and he was treated with calamine (+) camphor (+) pramoxine hydrochloride bath and acyclovir. A product quality complaint was not involved. Additional information has been requested.
This non-serious spontaneous case, initially received on 17-Sep-2018 reported by other non-health professional and concerns a female pregnant patient of unspecified age. On an unspecified date, the pregnant patient received influenza vaccine, (dose, batch number, route of administration, anatomical location, manufacturer, trade name was not reported).
She started feeling bad with chills and fever and stayed in bed the day after receiving the vaccine. The rash started on her chest almost 24 hours post vaccination (around 5PM). She woke up in the middle of the night to find the rash had rapidly spread up to her neck and down to her knees (not on face). It did not ever itch or burn. After seeing a doctor, he/she said it looked like hives. The rash resolved by Sunday (5 days post vaccination). She says only since it has gone away has her skin been itchy.
I received the vaccine on August 9 at 6 p.m. After about an hour I began to feel some dizziness but bearable I went to bed around 9 pm and about 2:30 am I woke up with the fingers of the ends of my hands like stiff was relieved when I woke up. About mid-morning; the next day I began to feel some weakness in my legs but I could walk. That weakness has remained me until today, it is annoying, I feel heavy feet and arms a little ,sometimes worse and general , I have not been able to go to work like this.Today 08/23/21 I am still with the same symptoms and I am seeking for medical help.
He had bad sinus; He lost his appetite.; It felt just like a viral infection.; About 4 hours later, he had headache.; He had fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.), HEADACHE (About 4 hours later, he had headache.) and FATIGUE (He had fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.), HEADACHE (About 4 hours later, he had headache.) and FATIGUE (He had fatigue). The patient was treated with CHLORPHENAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD AND SINUS PLUS) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.) and HEADACHE (About 4 hours later, he had headache.) outcome was unknown and FATIGUE (He had fatigue) had not resolved.        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.   Concomitant medication includes Blood pressure medication.   The reporter stated the symptoms were all the like having virus but exaggerated.
Erythema multiforme, generalized hives, target lesions painful feet and ankle.
Stiffness, pain upon touch on first evening; then  add redness & swelling on the next day below injection site; then add itching  from Day 3 thru today, day 7.
DURING ADMINISTRATION, RN NOTED 70 % OF THE VACINE LEAKED OUT BY THE LEUER TAPER. PT WAS GIVEN 0.3 ML OF PFIZER IN THE RIGHT DELTOID.
I started of with typical fever, body aches, and fever. That started about 12 hours after shot that last about 48hours. About 72 hours I developed a cough I couldn't sleep, it was a dry cough, it was painful. I went to the med clinic they ran test and prescribed me antibiotics and sent me home. The antibiotics did nothing for me . My cough persisted for 7 to 12 days.
first dose arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (first dose arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E or F 21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, VITAMIN 15 for an unknown indication.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (first dose arm pain). On 22-Aug-2021, MYALGIA (first dose arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used by the patient included multivitamins and cardiac medication. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-322348 (Patient Link).
A non-serious Spontaneous report of administration of FLUMIST to a 61-year-old female was received from an office manager. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Hospitalized 7/19/22-7/25/22. weakness, thrombocytopenia, sore throat, nasal congestion and cough, hypoxia, O2 supplementation, respiratory failure, PNA, acute MI.
Pericarditis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Pericarditis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN on 25-May-2021 for Pericarditis, at an unspecified dose and frequency. On 27-May-2021, PERICARDITIS (Pericarditis) had resolved.            Concomitant product use was not provided. The patient experienced chest pain on 25 May 2021, went to the ER , and was diagnosed with pericarditis; stayed in the ER for 3 hours and was prescribed Ibuprofen. No history of heart related problem was reported by the patient.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Cellulitis 4X6 inch area of redness 2 days after VARIVAX. Augmentin 875 mg -125mg - 1 tab Q 12 X 10d.
Client had Pfizer vaccines for COVID-19 July and August 2021. Developed symptoms on 12/13/2021: chills, nasal congestion, cough and headache.  PCR+ on 12/16/2021.
The day of the vaccine I had the return of the dry cough, which I previously with COVID-19.   I also had mild chest pains.  I had fatigue and felt sleepy.  Within the first 24 hours of the vaccine, I had burning in the eyes.  Within the next week I had more fatigue and sleepiness. Within a few weeks I had a more intermediate cough.  The cough was not every day but every few days.  About a month after the vaccine, I have had a cough every day.  The worsening of other conditions, in late February into March, I had worsening of restless legs.  I also had increased of my asthma symptoms which I had to increase my medication for the asthma.  I had chest tightness until April 10th.  On April 29th, I had increased fatigue and montenect jerk of my arm and legs.  After a week or so of those symptoms, I saw my Rheumatologist she put me on a steroid of 6 days.  The abnormal fatigues and fatigue improved after I started the steroid.  I still have a little fatigue and intermediate dry cough.  Also, with had a symptom of monocular diplopia, the doctor I saw thinks that was to the increased dry eye symptom.  I think the symptoms have increase my autoimmune system to flare up.  I still have to use the inhaler also more than I use too.
A 32 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:30 (Lot Number: EW0170) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. The patient medical history was not reported. Concomitant medications included amoxicillin, daily multivitamin, probiotic supplement. The patient previously received the first dose  at arm left on 30Mar2021 14:00  as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling, reddened skin, and itchiness at vaccination site, low- grade fever for 36 hours, slight cough, headaches, extreme tiredness, brain fog from 19Apr2021 19:00. No treatment received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Outcome of the events was reported as recovering.    No follow-up attempts are needed. No further information is expected.
Myalgia, Arthralgia, inj site soreness, chills, body aches, joint pain Narrative:
Chest pain, short of breath.   Morphine, sublingual Nitro, IV Nitro drip & Heparin drip
Miscarriage. Date of start of "last period" 11/9/21. Conception between 11/18-11/24. Vaccination 12/2/21. Positive pregnancy test 12/6/21. Spotting. Blood test 12/14 (HCG 402). Blood test 12/16 (HCG 515). Blood test 12/20 (HCG 553). Ultrasound 12/22 "Tiny sac in uterus, empty". Blood test 12/23 (HCG decreasing). 12/24 spotting begins and bleeding continues through 12/29/2021.
Approximately 5 months subsequent to receiving one dose of varicella virus vaccine live the pt developed scattered pink papules with slight vesicle formation in groin at axilla. The pt was presented to a pediatrician and was diagnosed with varicella.
HAD PAIN WHEN RECEIVED. PAIN, 35X57 MM BORDER OF REDNESS, SWELLING, HOT TO TOUCH.
At 8:00 PM I began having chills and a headache.  I checked my temperature and it was 100F.  By 8:30 I went to bed and coughed a lot.  I became nauseous and had dry heaves.  My left arm was sore. I was extremely thirsty. I spent the night going to the bathroom and it became harder to do because I had excruciating pain in my lower back.  I could barely walk.  My Afib seemed to be acting up and I had strong chest pain and was out of breadth. This kept me up all night.  By morning, I tried to get up but was unable to do so.  I finally fell asleep around 1:30 p.m. and woke up a t 6:00 pm. To my relief, most of the symptoms had subsided and I could get up and walk arund.
Information has been received from a nurse concerning a 12 to 15 month old male who in 2009 was vaccinated with a 0.5 ml dose of VARIVAX (Merck). Concomitant therapy included a dose of VAQTA (manufacturer unspecified). Recently, about a week after receiving VARIVAX (Merck), the patient developed a full case of chicken pox. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information is not expected.
I started getting symptoms of diarrhea, fatigue, headache, cough, and sore throat. The fatigue continued and then I also started getting shortness of breath on exertion. I took an at home COVID-19 test which was positive. A couple of days later, I did a rapid and PCR test that was negative at the doctors office.
The morning of 9/14, patient arm was swollen, had a red mark at injection site, was sore, warm to touch and itchy. Patient using Benadryl and Ivarest (poison ivy cream) for itching. Aleve for pain.
Left upper arm hot, swollen, and tender.  Entire surface circumference 3 inch in length.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose number unknown, single (Lot number: Fm8028) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic hypersomnia" (unspecified if ongoing); "intracranial cavernous angioma" (unspecified if ongoing), notes: Intracranial cavernous angioma. Concomitant medication(s) included: ADDERALL taken for hypersomnia, start date: 01Nov2021. Past drug history included: Cechlor, reaction(s): "known allergies: Cechlor", notes: known allergies: Cechlor. Known allergies included cephalosporin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". It was reported that when she first came down with covid, she was sleeping all the time anyway, so she didn't take it. On day 3 of Paxlovid, she felt better and took it just one of the two adderall doses. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) came down. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=09May2022, treatment stop date=12May2022, lot number=GA1513.
Patient was given a Monovalent Moderna Vaccine on 4/21/23. The vaccine was no longer recommended for use on 4/19/2023. Dr. notified and recommended for patient to come in 2 months for Bivalent dose. Patient notified and vernalized understating.
she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021.  No follow-up activities are needed. No further information is expected.
7 days after the first dose I developed what I believe to be "Moderna Arm" based on my research. I had a red circle on my arm and it  burned for 3 days. The redness spread throughout my body and was on my face as well. It was easily treated with Benedryl. The red circle went away after a week. I get my second shot next week.
Approximately 24 hours after 2nd shot, patient couldn't breath good. He was admitted to hospital where patient reported to go into kidney failure and having pneumonia. He had an extended stay for 2 weeks in the ICU there. Patient does not remember treating physician,  This was all patient reported.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 43-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination site pain (experienced soreness at the injection site), axillary pain (pain under her left arm/pain in armpit) and breast pain (pain to the left-side of breast), with outcome of unknown. Additional information: Patient received the Pfizer COVID-19 vaccine on May 18, 2021. About 6-8 hours after the vaccination, she experienced soreness at the injection site, pain under her left arm and pain to the left-side of her breast. She asked if breast pain was normal. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Skin irritation circling around the back of my neck from ear to ear , inclusive of top of neck down to the top of my shoulder. Post-nasal drip with swollen eyes.
Pt. lost consciousness within 1 min of HPV injection for 2-3 seconds. Pt was monitored in exam room for 30 mins - vitals taken then repeat in 20 mins & documented in pts EHR.
MMRV immunization was given intra-muscular instead of subcutaneous. No adverse reactions at this time.
Patient stated that her injection site became very painful and warm.  Patient then stated that her entire body became warm & that was the last thing she remember.  Patient witnessed falling out of chair onto the floor.  Patient was easily aroused.  Patient did hit her head of the floor and abrasion was noted on her forehead.  Patient was assessed and vital signs were as follows:  Oxygen saturation-96%, pulse rate-66, BP-141/82.
muscle pain in both legs, worse at sleeping and first in the morning.  Improves during the day but still aches equally in both legs at major muscles.    Especially painful after exercising or exertion prior day.   No treatment yet but ceased statin drug to see if any change.  3 weeks in and no change in pain level.