chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        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.   No concomitant medications were provided. No treatment information provided.
There were no side affects after the first vaccine Lot# EK5730.   Following the second vaccine on 1/28/21 I started feeling  fatigued that evening but felt better the next morning.  The following day on the 29th around 7pm I started feeling severe nausea at first and then had severe vommiting so I called 911, they took my vitals and said they were in a safe range, I did not go to the hospital and then today around 7a.m. I started  feeling better and the nausea stopped.
I started feeling tired the day after my injections (day 2) and didn't think much of it until i got home around 6:00 pm and i was exhausted.  I couldn't even open my eyes without putting effort into it. By the next morning (day 3) i was extremely tired and it hurt in my leg muscles, butt muscles, arms and stomach.  I woke up at 2:30 PM and threw up. The next day (day 4) i had diarrhea and was still exhausted and just felt lousy.  Today is day 7 and i finally came back to work.  I still have a slight headache and nausea and stomach cramping on/off.
About 15 minutes from injection, tongue tingling, about an hour waves of nausea, eyes watering & sensitive to light, nasal drips,  about 3 hours after, felt like stinging on ankles, arms, moving to different parts of body, about 6 hours, welt & red streak on arm at injection, lips swelling, tongue swelling, and throat felt like it had something in it. Very hoarse voice. Took 2 benadryl and went to ER.
Got shivers and a fever 102F. The fever was broke by 2 Acetaminophen. 100F Fever lasted for a day and a half. I had night sweats from the first night on Wednesday which gradually receded ending on Saturday night.
On 5/20 I began to notice my arm was really itchy at the sight of injection. I thought it was a mosquito bite at first because it felt bumpy. After a few hours I noticed a big red mark all around the sight of injection. It was swollen and itchy. It was a ring but more akin to a red patch right at the sight of injection. Then around that patch was a ring.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-SEP-2014, the patient was vaccinated with improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chicken pox developed on 04/06/2002pm per mom. Examined by a physician on 04/08/2002. Rash present head to torso. Benadryl and increase fluid intake. Tylenol four hrs for fever.
Information has been received from a nurse concerning 5 to 8 female "12 year old" patients who on unspecified dates, were vaccinated with first doses of Gardasil. Subsequently, on unspecified dates, the patients experienced flu-like symptoms such as nausea and vomiting. Subsequently, the patients recovered ("symptoms passed quickly"). No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Starting at 12:55 pm, the patient reported feeling dizzy that lasted intermittently until 1:25 pm. She also reported having a fear of needles. It was recommended to call a family member, to pick up. The patient left with Familiar at 1:35 pm without dizziness. Sat 100% pulse 97.
I am having a lot of problems with vertigo; This is a spontaneous report from a contactable consumer. A 82-year-old male patient received first dose of BNT162B2 (Solution for injection, Batch/lot number was unknown), via an unspecified route of administration on 2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had experienced a lot of problems with vertigo on an unspecified date of 2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received first dose of COVID-19 Moderna vaccine on 1/28/2020.  Due to his history of allergies and asthma, he took a dose of diphenhydramine 25mg (either 1 tablet or 2 tablet - patient is unsure) prior to receiving the first dose of the vaccine. He waiting for 30 minutes of observation afterwards.  He did not have any problems other than a sore arm after the dose. The patient returned for his second dose of the COVID-19 Moderna vaccine on 2/25/2020.  He forgot to take a dose of diphenhydramine prior to coming in for his second dose of the vaccine.  He sat for the 30 minutes of observation with no issues.  He drove home and after arriving home, 1 hour after receiving the dose, he started having a strange feeling around his mouth and tongue which moved from the right to left side.  He then took two doses of diphenhydramine 25 mg.  Then he started having difficulty swallowing so went to a Prompt Care.  The staff there called an ambulance and he took an ambulance. In the ED, the physicians examined him and didn't find any issues with his throat.  They noticed his left earlobe was bright red.  They administered a high dose of steroid and observed him for 3 hours.  The patient does not know the name of the steroid or dose received.  The patient states that he felt normal again after 1.5 hours after receiving the steroid injection.  The patient was discharged back home and has not had any issues since.
NO ADVERSE REACTION REPORTED. VACCINE WAS GIVEN ON THE DAY MONOVALENT COVID VACCINE NO LONGER APPROVED BY FDA AND REPLACED BY BIVALENT VACCINE. PATIENT AND PCP WAS CONTACTED AND AWARED THAT PATIENT HAS TO WAIT 2 MONTHS BEFORE SHE CAN GET  BIVALENT BOOSTER VACCINE.
Immediately after vaccination @12:46, pt c/o headache, dizziness, "sleepy", mild sweating, and blurry vision. Pt denies chest pain, numbness of extremity. Denies any medical history nor taking any medications today. Reports he ate 1 hour ago. Speaking in full sentences, not in distress. Patient rested and laid down in the cot.  Vitals: 13:00 BP 129/83, HR 94, RR 18, Temp 98.6F, SpO2 100% -- > @13:15 129/75, 86, 16, 98.6F, 100% -- > @13:30 113/63, 75, 16, 98.5F, 100% -- > @13:47 119/68,79, 97.5F, 100% Pt symptoms resolved. Pt stable and released from the vaccination site @13:47.   Pt expirienced recurrent symptoms. Patient was in his car at the parking lot when he requested for assistance. States he was feeling light headed. He was brought back to the medical bay. Vitals were monitored every 15 minutes. He was provided water, juice and snacks.  He rested in the cot for additional 30 minutes. He reports his symptoms resolved. Negative for hypostatic hypotension. Denies lightheadedness, blurred vision or extremity numbness. He left with his wife and 2 children. Advised to seek urgent/emergency care if his symptoms come back or gets worse.
Patient received bivalent Covid-19 booster on 9/8 evening, pain set in Friday morning 9/9. She had pain in her shoulder. On Sunday 9/11, she  could not move and went to ER to seek help. ER took X-ray and informed her that she had muscle spasms on her back.  She went to her PCP during the week and was saw by NP and going through signs and symptoms was concluded maybe shoulder injury. Prescribed Pain medication, steroid pack & muscle  relaxant. not much improvement  but not getting worst. will have followup appointment next week with her PCP
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling at injection site (non-serious) on an unspecified date after use of product. The outcome of the event was unknown. The information on the batch/lot number has been requested
I experienced pain at the injection site and my whole arm but much lesser, milder than the first dose. I also had with this dose shortness of breath (I have asthma) and I would say the pain in my arm lasted for about 3 days or so. The shortness of breath was only the day of the vaccination. I used my inhaler and was fine.
Soreness in arm which radiated to shoulder and neck area. Sought treatment after 2 weeks and was given a muscle relaxer.
Low grade fever; Upset stomach; Vomited; Swelling at the injection site; Injection site is itchy; Injection site is inflamed; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 15th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2022, several hours after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site itching and injection site inflammation. In November 2022, the patient experienced low grade fever, upset stomach and vomiting. In November 2022, the outcome of the low grade fever, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site inflammation were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching, injection site inflammation, low grade fever, upset stomach and vomiting to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Fluarix Quadrivalent into left deltoid and hours later the patient experienced swelling at the injection site and reported it was itchy and inflamed. The reporter also reported that less than 2 weeks, the patient experienced a low grade fever, upset stomach and vomited. The concomitant drug included Benadryl. The reporter did not consent to follow up. No HCP consent provided. Additional Supportive Information: Concomitant medication Benadryl was only retained in narrative, as the ingredient was "NOS" which leads to report failure.
At 2 months, patient had rash at location of immunization. At 4 months with no alcohol or band aids used, patient had rash on legs where shots were given. At 6 months, patient developed rash on L thigh which spread to generalized papular urticaria.
stabbing pain in right foot; moderate to severe pain in my right ankle; This case was reported by a consumer via interactive digital media and described the occurrence of foot pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced foot pain and pain ankle. The patient was treated with morphine. On 2nd April 2022, the outcome of the foot pain was recovered/resolved. On an unknown date, the outcome of the pain ankle was not recovered/not resolved.   It was unknown if the reporter considered the foot pain and pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and went to the ER (Emergency Room Visit) with severe stabbing pain in his/her right foot.  The patient was given morphine which did help and by 2nd April 2022 the foot pain was gone, but he/she continued to had moderate to severe pain in his/her right ankle. The reporter ended chat abruptly before GlaxoSmithKline could ask for contact information. The patient did not consent to follow-up.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS Narrative:
This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (severe attack of vertigo  head was spinning), FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been) and VOMITING (She was throwing up) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 033F21A, 006B21A and 016M20A) for COVID-19 vaccination. Patient did not have COVID positive test or diagnosis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Adhesive tape allergy, Allergy to antibiotic (Amoxicillin allergy), Allergy to antibiotic (Bactrim allergy), Blood pressure high and Thyroid disorder NOS. Concomitant products included OLMESARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroid disorder NOS. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been). On 21-Sep-2022, the patient experienced VERTIGO (severe attack of vertigo , head was spinning) and VOMITING (She was throwing up). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 25 milligram. At the time of the report, VERTIGO (severe attack of vertigo , head was spinning) had resolved, FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been) had not resolved and VOMITING (She was throwing up) outcome was unknown. Patient did not have problems with any previous doses. Patient's lab data included MRI, EEG and unspecified other tests in the emergency room on 21-Sep-2022. Patient stayed in the ER for several and was sent home. Patient did not experience a similar event in the past. Patient was prescribed Meclizine 25 mg as standby medication for recurrence of vertigo.
his arm has been sore; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 15Dec2021 (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: PAIN IN EXTREMITY (non-serious) with onset 15Dec2021, outcome "not recovered", described as "his arm has been sore"; PAIN (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck".  Additional information: Clinical course: Patient states he received his vaccination on 15Dec2021, and his arm has been sore since 15Dec2021. The pain was spreading to not just where he got the vaccination, but it was starting to move from the arm to the shoulder and to the neck. He was achy and it was very painful and spreading. It was so painful it hurts to lay down in bed. Patient like to know if we have heard of this problem before. Patient like to know if he has to go to the doctor. Advised patient that Pfizer MI provides the most accurate information available, and Pfizer cannot make any treatment recommendation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10:55 summoned per secretary-someone had fainted proceeded to classroom-noted pt laying on back or the floor;eyes open, coherent;asking questions;pt fainted;BP 126/62, P80, R20;epi given;BP 128/60;P88;
diagnosed with a Deep Vein Thrombosis since the clot was in his vein/Arm starting swelling specifically in his wrist and forearm; This is a spontaneous report initially directly from a contactable consumer (the patient), and then received from a Pfizer sponsored program. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164) via an unspecified route of administration, administered in left shoulder on 20Apr2021 at age of 48-year-old at singe dose for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). No family medical history relevant to AE(s). The patient did not receive any concomitant medications (reported as "the patient did not receive other products"). No relevant tests. No prior vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration in his left shoulder on 30Mar2021 at age of 48-year-old for COVID-19 immunization and experienced no adverse event. Caller stated he was calling about the COVID 19 vaccine. Caller stated he got the second dose about 3 weeks ago and about 10 days or 11 days after the second dose (01May2021) his arm starting swelling specifically in his wrist and forearm. Caller stated he went to the emergency room and there was a blood clot found in his left arm. Caller stated he was diagnosed with a deep vein thrombosis since the clot was in his vein. Caller stated everything was going better but the emergency room doctor told him he should probably report this to Pfizer to let Pfizer know. Caller clarified that he was released from the emergency room and was never admitted to the hospital. Treatment received for the event included blood thinner. The event required a visit to emergency room, and the caller stated he went to physician office today. The outcome of the event was recovering.
Patient developed widespread numbness and tingling, legs feeling like rubber approximately 1 week after flu shot. Symptoms lasted 3 days then completely resolved.
I was very sick following the third vaccine and it started a course of me being out of work for 9 months on disability as I saw an array of specialists searching for help. I had adverse effects to the first two vaccines but my symptoms became far worse after the third one. I did not know what was wrong with me at the time but felt like I was having a heart attack and made several trips to doctors offices complaining of tachycardia, faitness, shortness of breath and adrenaline rushes. With time my symptoms became worse and not better. I evenutally collapsed in the classroom on January 25th 2022 leading to illness so severe I was barely able to get out of bed. My husband became my care provider and I was unable to work. I was diagnosed with POTS, as well as Small Fiber Neuropathy. Neither of which I had prior to the third vaccine. I also started having sever blood sugar issues and was diagnosed with hypoglycemia. I now have to wear a continuous glucose monitor, I am taking beta blockers and I have a nurse come to my home once a week to administer an IV. I have a very restrictive diet as my body can no longer tolerate carbohydrates or sugar.
pt recvd vax & devel an inj site rxn characterized by swelling, itching, erythema & warmth;
pain in side and front of left elbow (same arm as I had the vaccine in).  and down to the wrist.  Difficulty stretching or raising my arm.
Loss of appetite, followed by swelling and pain at injection site. Chills and cold extremities that evening, followed by fever and abdominal cramping,  frequent urination with intense cramping. Dizziness, fainting. Fainted and fell twice the first night and came to on the floor. Bruised knee and hip but no other apparent injury. Cramping continued the second day plus dizziness and fatigue but no further fainting or loss of consciousness. One incident of unusually hard stool followed by diarrhea. Today is day three. Pain in left arm is gone. No dizziness, but still some tenderness and occasional cramping  lower abdomen. Still somewhat fatigued but appetite has returned and I am feeling somewhat better.
Full body migrating rash that is persistent.  Treatable using steroid cream and over the counter antihistamines, but symptoms persist Unexplained heartburn for 2 months.  Treatable using over the counter heartburn medication, probiotics, and temporary diet changes
Moderate to severe inflammation; This is a spontaneous report from a contactable other HCP (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Jan2021 (Batch/Lot Number: EC3247) as 1st dose, single for covid-19 immunisation. Medical history included Auto immune disease, depression, Hypercholemia, Anemia. No Covid prior vaccination. Concomitant medication(s) included secukinumab (COSENTYX); celecoxib (CELEXA); ergocalciferol (VIT D); vitamin b complex (B COMPLEX (B50)); rosuvastatin calcium (CRESTOR). The patient was allergy to Sulfur. The patient experienced moderate to severe inflammation on 29Jan2021 17:00. Patient received: Prednisone tabs, Streoid injection, lab work, x rays. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Inflammation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response,will be promptly notified to Committees, and Investigators, as appropriate.