chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the first dose Moderna  she was  a little scared but she was ok.  She got her shot and was told to stay around for 15 minutes, she starting walking with her mom, when she told her mom she  felt dizzy, then she passed out unto her mom's arms,  her mom put her on the floor, did not heart her head.   Mom helped her to get up and came back to the pharmacy, sat her down again.   We called 911 for help, patient  asked for water, while her mom went to get her some water, pharmacist was watching her when she had a short convulsion for  about 2 to 3 seconds, she stretched her body to the  back.   When 911 came, she had already recovered her color,  her vitals where ok, she was breathing normal.  Patient refused to get on the ambulance, signed her release and left.  Emergency personel advised her to follow up with her doctor.
Pt reports she developed swelling and tenderness underneath left arm 10/7/21 around 8 pm.
Soreness in arm at site of injection; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 14:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. There were no medical history. No other medications in two weeks and other vaccine in four weeks were reported. No known allergies. The patient experienced soreness in arm at site of injection on 22Feb2021 20:30. The patient didn't received treatment for event. No covid prior vaccination. The patient wasn't covid tested post vaccination. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Abnormally heavy and clotting period. Using more than one pd and tampon an hour due to heavy flow. Menstruation has never been like this before. Period still going and just as heavy as day 1 and 2; called obgyn reported symptoms and was told to monitor symptoms keep updated and report abnormal period here.
Pt received a pediatric dose of Pfizer.  Pt is 12 yo and should have received the adult dose.  Medical Director, Dr. , notified of occurrence.  Dr. advised that no further treatment recommended per CDC guidelines.
My brother also experienced the same thing with me and we went together got the vaccine at the same place and he also came down with Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "My brother also experienced the same thing with me and we went together got the vaccine at the same place and he also came down with Insomnia".  Additional information: COVID-19 Vaccine was a Pfizer product. This was the second case out of the 2 cases. Consumer started to experience insomnia, the last two times when Pfizer vaccine was taken. Consumer could not sleep, so went to see a psychiatrist to get medication to sleep. Then, after taking medication for like 3 months Consumer started back to get partial sleep. Now, Consumer went to take booster yesterday, and surprisingly again could not sleep the whole night again. So, consumer's  brother had already went the last time to the same site at the same time and he also came with the similar sleeping problem. All three was Pfizer, consumer did not take any other brand. Consumer further stated that second time, had to go 3 weeks later to take it (Pfizer COVID-19 Vaccine) again and finally could not sleep, the whole night and was awake. So, had to get a medication to sleep but now yesterday consumer went to take the Booster and it happened again and then could not sleep. Consumer does not know what this report was going to do just 'with another area'. Consumer was informed that this report will eventually help other patient receiving the Vaccine. Consumer confirmed that the brother also received the Pfizer COVID-19 vaccine at the same day and experienced the same event Insomnia. Consumer do not have any information about the product details (LOT# & Expiration date) of Pfizer Covid-19 Vaccine. They have concluded that this was the vaccine but then they had the benefit of doubt. May be some other factors that was causing this but then yesterday after consumer took it again and could not sleep and decided to make the call to see if the vaccine is interfering with the sleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
730 left arm soon after that she began to feel nauseous headache dizziness weakness generalized she has history of 2 years ago of a stroke secondary to a PFO treated she is on long-term anticoagulation she still having some episodes of dizziness and generalized headache no vomiting no blurred vision no numbness of arms or legs weakness of arms or legs feels like she is having gait disturbances because the symptoms she presented to ICC no fever she had some chills No blurring of vision no double vision no visual field defects She is on long-term anticoagulation She has had no CVA after her stroke 2   Patient is a 30-year-old female with a past medical history of DM2, lupus, CVA in 2019 due to embolism, HTN.  Patient presents to emergency department with complaint of right face, arm, leg numbness and weakness.  Patient reports concern as she got her COVID-19 vaccine at 730 this morning and immediately after felt nauseous and dizzy and then developed numbness tingling to right side of her face, and weakness to right arm and leg thereafter.  She does have history of CVA, patient reports no residual deficits from that event.  Denies fever, chills, shortness of breath, chest pain or palpitations   Initial ED work-up included laboratory studies which resulted with, sodium 135, glucose 326. Imaging studies included CT head which was unremarkable, CTA head and neck unremarkable as well.  Vitals on admission, temp 98.5, HR 89, RR 16, BP 124/79, SPO2 100% on room air.
101y.o. year old female with history of mild asthma, hypertension and dementia.  She lives at home with 24-hour day caregivers.  She is fully vaccinated for COVID. She developed a nonproductive cough and appeared to be more lethargic, slept a lot on 10/3 10/4, she also had a low-grade fever on 10/4. Son, who is a retired pediatrician, did a home COVID test which was positive.  They checked her pulse ox and at some point in time her saturation was 87%, however, the son is not sure if the pulse oximeter was functioning properly, plus the patient has painted nails which may have interfered with the pulse oximeter.  They called her primary care physician and they were advised to come to the hospital. In the emergency department she did not have a fever, her white count was noted to be 14, repeated white count is 9.4.  Initially her creatinine was elevated at 1.2, after hydration it is down to 1.08.  COVID test was positive.  Chest x-ray showed mild basilar atelectasis. Patient also suffered a skin tear on her left forearm, she has a visiting nurse who changes her dressings at home, the wound does not appear to be infected. ID is consulted in regards to COVID. History was obtained from the son at bedside, as the patient has dementia and is unable to provide meaningful information.
mom called clinic 1030AM 29JUL93 stating pt had 3 seizures starting 730PM pt not seen in ER given APAP & cool bath- fluids; seen by DM dx febrosis-ducts immunization given;
Assessment and Plan Patient is a 82 y.o. female patient of DO with history of asthma essential hypertension chronic pain dyslipidemia bilateral lower extremity presented with altered mental status   Acute metabolic Encephalopathy (resolved) Covid-19 Virus Infection Date of onset of symptoms: 12/9/2022 Symptoms present on admission: Altered mental status and fatigue Date of covid positive test: 12/10/2022 Imaging: Chest x-ray negative for pneumonia Oxygen requirements on admission: Room air Current oxygen requirements: None Medical therapy: Paxlovid started 12/12 (age, asthma history) to complete 5 day total course Consultants following: ID econsult Anticipated special isolation end date: 12/19/2022   Acute Cystitis Pyuria, ESBL E coli Dosed with fosfomycin 12/13   Asthma, unspecified On albuterol as needed (at home) Oxygen supplementation as needed Not in acute exacerbation   Essential hypertension Continue home medications (amlodipine, lopressor)   GERD PPI   Dyslipidemia On pravastatin at home, resumed   Chronic pain Continue home narcotics  Peripheral vascular disease DVT (unclear occurrence) On Eliquis aspirin and statin at home Venous duplex 9/2022 negative Changed to lovenox 12/12 when Paxlovid started to avoid/minimize interactions Hold Eliquis until 12/17/22 and continue lovenox until 12/17/22
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA304593 (same reporter). This case involves a 34 years old patient (gender was not reported) who developed a boil at the injection site, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious boil at the injection site (furuncle) 3-4 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. Final diagnosis was developed a boil at the injection site. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for developed a boil at the injection site. List of documents held by sender: none.
Administered 6/11/03, examined 6/13/03. 9 x 7cm red and slightly swollen warm spot on left anterior thigh (site of vaccine).
Body ache, head to toe; Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Body ache, head to toe) and discomfort (Verbatim: Discomfort).  The outcome of the general body pain was recovered/resolved and the outcome of the discomfort was recovered/resolved (duration 1 day).   It was unknown if the reporter considered the general body pain and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient got a Shingles vaccine recently, and beforehand, he/she was unaware there would be two shots involved.  After, the patient got his/her second dose (two months after the first dose), the next day his/her entire body ached from head to toe.  The following day patient felt great, and he/she stated that, at any rate, he/she was certain that one day of utter discomfort was well worth not suffering from shingles for two months. The follow up would not possible as no contact details were available.
got sick after both shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick after both shots). At the time of the report, ILLNESS (got sick after both shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.     Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075858, US-MODERNATX, INC.-MOD-2021-075230, US-MODERNATX, INC.-MOD-2021-075415 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075858:case created for second dose for unknown male patient US-MODERNATX, INC.-MOD-2021-075230:Cross linked case US-MODERNATX, INC.-MOD-2021-075415:Cross linked case
Headache, Myalgia, Tachycardia,  Dyspnea, fatigue, injection site pain  Narrative:
Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe). At the time of the report, PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu like symptoms) to be related. No further causality assessment was provided for PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe).    No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of product dispensing error and influenza like illness was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
i have like a bruise under both breasts; it doesn´t hurt, but there was itching; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (i have like a bruise under both breasts) and PRURITUS (it doesn´t hurt, but there was itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced CONTUSION (i have like a bruise under both breasts) and PRURITUS (it doesn´t hurt, but there was itching). The patient was treated with HYDROCORTISONE on 20-May-2021 for Itching, at an unspecified dose and frequency. At the time of the report, CONTUSION (i have like a bruise under both breasts) and PRURITUS (it doesn´t hurt, but there was itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
8 days after my vaccine, the injection site started itching; swelled up; became red; hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3262), dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 09:15 as dose 1, single for COVID-19 immunization (at the age of 39-year-old). Medical history included known allergies: Compazine, Reglan, and Phenergan. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), zinc and elderberry [sambucus nigra]. No other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 05Feb2021 15:00, 8 days after his vaccine, the injection site started itching, swelled up, became red and hot to the touch. The patient was treated with Benadryl as a therapeutic measure of all the events. On an unspecified date, the patient recovered from all the events.  Follow-up attempts completed. No further information expected.
Approximately 3 hours after influenza vaccine, patient reported nausea, body aches, chills. Symptoms last 24 hours then resolved.
12 hours after injection right arm bruising; 36 hours after injection woke up dizzy, nauseated, didn't feel well.  Within minutes of uprising, shortness of breath, heart palpitations, and tachycardia, heart rate driving was 144 beats per minute, severe diarrhea uncontrollable.  Went to ER, ekg performed, CXR, blood taken, C.T., of lungs with contrast, D dimer was positive, Potassium was 3 and given a potassium drink.  Saw PCP and was placed on 40 mg of Prescribed potassium meds.  blood drawn every two weeks, weaned to 20 mg daily after approximately 1 month, weaned off meds end of March.  Placed on high potassium diet.
Did not want to bear weight on left lower extremity for 24 hrs. Still favoring left leg, but walking well after 24 hours.
Patient was admitted due to feeling jittery, with history of seizure, possible non-compliance. Dose of Keppra increased, chest imaging negative for pneumonia.
Very early menstrual cycle (about 10 days earlier than normal). Stronger cramps, heavy flow. Cramps, pain, discomfort.
Extremely heavy menstrual period. Period is on time but I am soaking completely through a regular use tampon in ~3-4 hours when one would usually last me 6-8 hours.
A consumer reported that her 71 year old father received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine on 1/10/02. The pt experienced muscle aches for 3 weeks, post vax. No additional information was available as of the date of this report.  The FOLLOW- UP letter sent to consumer with addresas from initial report was returned undelieverable.
Experienced severe pain in upper arm/shoulder (left arm) about 3-5 days after injection-I am still experiencing pain and limited range of motion 3 months later. I am currently seeking medical help.
I have developed mild sporadic tremors in my hands and in my neck/head. I haven't received any treatment.
On 3/28, I began a menstrual cycle. This was my second one for the month. This lasted until 4/20. I had a hormonal IUD that came out over the course of the menstrual cycle. In 01/2020, I had surgery in regards to my endometriosis and things were normal until this. Between the orilissa and the IUD with help with maintaining a normal cycle so this was very abnormal. I went to the doctor who did an ultrasound. The ultrasound showed uterine polyps that were not there back on February and that my IUD was out of place.  I had anemia from such a heavy menstrual cycle. The fatigue had gotten worse. The joint pain continued as well but was on the back burner with respect to the fatigue and menstrual cycle.
About 20 hours after receiving immunizations, at about 8:30 AM; at home the baby started tonic / clonic movements lasting about 25 minutes according to family. the eyes staring and unresponsive. At the ER 3 hours later the events reappear. Follow-up received on 4/26/01 states that the baby has died.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Diarrhea; Joint pain; Chills; This is a spontaneous report received from a contactable consumer. A 82-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 28Feb2021 at 13:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. The patient had medical history included diabetes, high blood pressure and stroke. It was not sure if the patient had allergies to medications, food, or other products. It was not sure whether any concomitant medications was taken by the patient. 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date of Feb2021 (at the age of 82-year-old) at 13:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Mar2021, at 02:00, the patient experienced joint pain and chills. On 03Mar2021, two days later patient developed diarrhea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of joint pain, chills and diarrhea was recovered on an unknown date at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
1-2 minutes after last immunization approximately 5 sec LOC, pale, diaphoretic, nauseous recovered completely 10 min.
Received 1st does of Moderna on 5/19/21.   After receiving a second dose of Moderna on 8/3/21; patient reported  that she had facial paralysis 2 weeks after 1st dose of vaccine.    Stated that she still has residual effects from facial paralysis; unable to close right eye completely and does have some blurred vision at times.   Advised to follow  up with  provider or ER if symptoms do not resolve or if condition worsens.