chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue, tiredness; achy; sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) based on information received by Pfizer (manufacturer control number: EC-2020-085416), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via intramuscular on 26Mar2021 (Batch/Lot number was not reported) as dose 2, single, first dose via intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 12Dec2020 (Batch/Lot number was not reported) and ongoing, at 18 mg for renal cell carcinoma; everolimus (EVEROLIMUS), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 5 mg daily for renal cell carcinoma. Medical history included ongoing blood pressure measurement (per patient this was present prior to start of therapy and is unchanged since starting Lenvima), MD aware, diarrhoea from an unknown date and unknown if ongoing uncontrollable diarrhea, dehydration from an unknown date and unknown if ongoing period of dehydration. The patient's concomitant medications were not reported. The patient experienced fatigue, tiredness, achy, sore arm on an unspecified date. It was reported that, patient reported that a couple of weeks ago there was a "handful of days" that patient was experiencing "uncontrollable diarrhea" which led to a period of dehydration. Patient stated that he stopped Lenvima for two days and the aforementioned side effects resolved. MD not aware. Patient reported that after start of therapy he had both his Covid-19 vaccines and stated after the vaccines he experienced fatigue, tiredness and was achy (these symptoms have resolved). As per patient, he was currently experiencing a sore arm, but he had his second COVID-19 vaccine on 03/26/2021 and the soreness was starting to improve. Unknown if MD aware. Patient stated scans done on an unspecified date in March 2021 showed "remarkable" results with the Lenvima improving his cancer. MD aware. The patient underwent lab tests and procedures which included blood pressure measurement: high. The action taken in response to the events for lenvatinib mesilate was dose not changed. The outcome of the events fatigue, tiredness, achy was reported as recovered on an unspecified date and outcome of event sore arm was reported as resolving.
Information has been received a consumer through a Merck pregnancy registry concerning herself, a 41 year old female with allergies to Sulfa and iron supplements", who on 29-Apr-2008 was vaccinated IM with the third dose of 0.5 ml GARDASIL while she was pregnant. Her LMP was 27-Jan-2008. Expected date of delivery was 02-Nov-2008. The patient visited physician's office for medical attention. Prenatal testing included ultrasound for her has been normal. The patient had received the first dose of GARDASIL on 01-Oct-2007. Follow-up information has been received from a completed questionnaire. The patient was a Caucasian  with no previous pregnancies. She also had Crohn's disease and multiple bowel excisions. Medications during her pregnancy included prenatal vitamins for routine use and REPLIVA 21/7 for anemia. She also had ZOFRAN for nausea on 13-March-2008. Ultrasound on 05-Jun-2008 was normal. On 13-Nov-2008, 41 weeks from her LMP, the patient delivered a live normal male infant weighing 6 pounds 3 ounces. The infant's Apgar score was 8/9 without congenital anomalies, complications or abnormalities. There were no complications, infections or illnesses during the patient's pregnancy and delivery. No further information is available.
It was reported that a 46 year old male patient received a Fluzone SV vaccination on 12/01/2000. Reportedly on 12/05/2000, the patient developed achy, stiff joints and some abdominal discomfort. These symptoms started on 12/05/2000 and are still continuing but the patient refused to be seen by the physician. From additional correspondence received on 02/20/2001, it was reported that the symptoms only lasted one day. Per physician, 02/13/2001, reviewed, no additional information at this time. This case is closed.
Patient received both doses of Moderna vaccine with last dose on 02/5/2021. On 2/28/2021 patient tested positive for COVID-19 as part of the weekly testing. on 3/1/2021, patient developed a headache.
COVID-19 symptoms present, Coronavirus SARS-CoV2 Nasopharyngeal/Oropharyngeal Swab positive on 4/24/2021.  Pfizer representative told me to report positive COVID-19 result to VAERS.
I pulled a vial of vaccine out if the fridge by mistake that expired 12/17/22 and another nurse administered it to the patient. While in the office, the patient did not have any side effects.
Had my Moderna booster on 17 Nov 2021. ? 9 days after the booster noticed tingling and burning in my fingers ? 10-11 days after booster had burning pain in fingers and palm and swelling of my hands. Also experienced milder burning pain in sole of both feet. ? 12 days after booster hand pain was so severe I made an emergency appointment with my doctor. ? Dr. prescribed Gabapentin 100mg. ? Today is day 14 and the Gabapentin has reduced the pain but I still have tingling in my fingers. I also had an episode of severe pain when I woke up on day 14 (today) before I took the Gabapentin. ? The pain last about 1.5 hours. Starts with burning in my palms that move to my fingers. My hands then become red and swollen and the pain intensifies to being unbearable (10 on a scale of 1-10). Rubbing hands, raising above my head and putting under cold or warm water does not relieve the pain. Before using the Gabapentin, I had to wait in intense pain for the episode to pass. There is an average of three episodes a day: in the morning when I start work (typing), mid-afternoon when I take a break and end of the evening when I am getting dinner. ? I had noticed mild finger tingling and burning about a week after my second Moderna vaccine (vaccinated on 05 May 2021) but did not think it was related. Now I believe the tingling was a milder reaction to what I am going through now. Those symptoms eventually went away. ? Gabapentin is now masking the symptoms but I am worried that this may be long term as they have gotten progressively worse two weeks after the vaccine.
My son was in the hospital and we visited him. We feel that we had come down with COVID-19 due to the hospital visit. I had a fever of 102 when we checked it and I was coughing and unable to breath. I couldn't catch my breath. I was not nauseous. I did have body aches and I felt terrible. I did get tested and was not sure if I had it however I was given PAXLOVID. After taking it right away, we started to feel back to normal. As of now I am feeling fine and I don't have any COVID-19 after symptoms. March 25th I did have an A-Fib episode however I do not suspect it being caused by COVID-19.
Fever, chills, headache, body aches, nausea, and pain at injection site ( started at 8 pm lasted until 10 am)
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. The patient's past medical history included shingles (at the age of 40 years). Previously administered products included ZOSTAVAX (at or around the age of 60 years). On 4th November 2018, the patient received the 1st dose of SHINGRIX and PNEUMONIA VACCINE. On 4th November 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness and feeling unwell. In November 2018, the patient experienced headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement. In November 2018, the outcome of the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement were recovered/resolved. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient reported she had a severe reaction to the 1st dose of SHINGRIX. The patient stated that within 3 hours of the first vaccine she was light headed, dizzy and not feeling well. She had the worst headache she had ever had, she couldn't lift her head up off the pillow, it hurt so bad. She was bed ridden for a day. She had muscle and joint aches, flu like symptoms, and her doctor had her take a flu test at urgent care that was negative. She stated that the events lasted for about 2 to 3 days. She had a pneumonia vaccine on the same day, but could not recall the location. She was referred to that manufacturer to discuss potential side effects with that product, as she wondered if the combination caused such a bad reaction. The patient stated that she was not sure if she would get the 2nd vaccine or not. The patient stated that she went back for the second dose, but the pharmacist was hesitant to give it since she had the reaction that she did to the first. She was encouraged to contact GlaxoSmithKline to determine if she should receive it. The prescribing information was reviewed for the adverse events seen with vaccination and those more prevalent with dose 2 versus dose 1 and the duration of events. The patient was emailed the prescribing information and encouraged to speak with her physician. The patient visited the emergency room. The patient stated that she reported these events to her pharmacist and thought the pharmacist had reported them to GlaxoSmithKline but was not sure. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to pneumonia vaccine.
Child needed several vaccines- DTAP/Polio, Hep A, Hep B, PCV. Kinrix inadvertently given by mistake.
Pt presented with chest pain, 4 days post vaccine, Elevated troponin noted (over 3.) 2nd troponin value climbing.  Of note, patient got the vaccine the day after returning from a trip out of state.
This medically confirmed report (initial receipt 23-Oct-2012) concerns an 18 month old male patient who did not have a relevant medical history, concomitant medications, past drug history or relevant laboratory data. On 23-Oct-2012 this infant received his first dose of AFLURIA, 0.5 mL given by intramuscular route (vastus lateral muscle). The reported batch number was P58406 with an expiry date of 27-Jun-2013. AFLURIA use was discontinued. The patient outcome is unknown. Reporter Comment: It was realized that AFLURIA is not indicated for children under 5 years of age as per the package insert.
Patient received vaccines on 2/12/2021 and 3/12/2021. He was admitted to the hospital on 7/4/2021 and passed away 7/20/2021.
brain fog memory issues, chronic headaches diffuse unremitting in nature. Aggravated by physical activity
Vaccinated with Hep-A and B on 8/13/01. The pt woke up with rash, the day after vaccination. It was a small papular rash over the body. Referred to own MD. No other symptoms.
Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; 3 hours later woke up with sweats.; Few hours after dose fatigue.; In the evening, leg weakness and achy all over.; In the evening, leg weakness and achy all over.; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 16Jan2021 09:15 AM at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient experienced few hours after dose fatigue at 02:00 PM on 16Jan2021. In the evening of 16Jan2021, the patient had leg weakness and achy all over. Next morning on 17Jan2021, splitting headache woke the patient up at 5 am. The patient took Advil as treatment for headache. 3 hours later the patient still had headache with nausea. 3 hours later she woke up with sweats. Then she started feeling better. The patient woke up this morning slight headache only and resolved on own couple hours later. No treatment was received for the events except headache. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid tested post vaccination, no known allergies. Outcome of all events was recovered.   Information on the lot/batch number has been requested.
A non-serious, spontaneous report of administration of FLUMIST to a nine-month-old male infant was received from a physician. The patient's medical history includes seizures and developmental delay. Concomitant medications included Phenobarbital and oral steroids. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments not applicable and the event is considered resolved. This case is submitted in accordance with agencies post-mareketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
This spontaneous report as received from a 21 year old (at the time of report) non pregnant female patient with no pertinent medical history and no drug reactions or allergies refers to herself. On an unknown date the patient was vaccinated with a dose of GARDASIL (# J007354, exp. date: 20-FEB-2016) injection (strength, dose and route not provided) for prevention. The patient stated she did not known which dose in series she received and stated she did receive GARDASIL in the past (dates not provided). There was no concomitant medication. The patient stated that she received a GARDASIL recall letter from her physician after she received vaccine that was involved in a recent recall of the product. The patient reported that she had arm pain and numbness that lasted more than one week. She sought medical attention - was seen in the emergency room because she was gagging and had blood in her saliva. The outcome of arm pain and numbness, gagging and blood in her saliva was reported as recovered/resolved on an unspecified date. The relatedness between vaccination with GARDASIL and events was not reported. Additional information has been requested.
a shaky feeling/still very shaky today; a loss of appetite; Low grade fever; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (a shaky feeling/still very shaky today), DECREASED APPETITE (a loss of appetite), PYREXIA (Low grade fever) and NAUSEA (nauseated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibrillation (She also mentions that she has had a fib for 10 years and her doctor told her in September that she is now in a fib all the time.).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced NERVOUSNESS (a shaky feeling/still very shaky today), DECREASED APPETITE (a loss of appetite), PYREXIA (Low grade fever) and NAUSEA (nauseated). At the time of the report, NERVOUSNESS (a shaky feeling/still very shaky today) had not resolved, DECREASED APPETITE (a loss of appetite) and NAUSEA (nauseated) outcome was unknown and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Patient stated that fever is coming down & that she is still very shaky today.  No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-385899.
Information has been received from a Licensed Vocational Nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose and route of administration were not reported). No adverse effects were reported. Follow up information has been received from the Licensed Practical Nurse (initial reported as Licensed Vocational Nurse) during a telephone call on 13-NOV-2015 concerning one of the multiple patients of unknown age and gender. On 08-JUL-2015, the patient vaccinated with the improperly stored RECOMBIVAX HB. Additional information has been requested. Patient's information, products, events and narrative were updated.
Ran a fever (100 - 101) at home for day and a half. Took ibuprofen and acetaminophen intermittently as fever spiked over and over. Woke around 2:40 am on Saturday morning feeling nauseous and lightheaded. Then lost consciousness for several seconds up to a minute. Daughter called 911. Paramedics came and took me to ER where fluids were given intravenously along with morphine. White blood cell count was double (20). ER doctor thought symptoms were due to bacterial meningitis. Tried to perform spinal tap but unsuccessful. Said I was septic. Sent to downtown hospital for radiology to perform spinal tap. Once transferred, my fever was 102.3 and I was shaking with chills. Infectious Disease doctor thought maybe I didn?t have meningitis but wanted to wait and see how I progressed over the next several days. Rash developed on back. Fever subsided after two days in hospital. Severe headaches continued for several days.
Patient is a 20 year old female with no significant medical history who received yellow fever vaccine in our clinic on 12/7/17 in preparation for an upcoming trip. She had been given a prescription for oral typhoid vaccine prior to that appointment by a provider. She started the oral typhoid vaccine on 12/11/17, taking the first dose at 7 pm. She felt fine that evening. At 5 am on 12/12/17 she work up with dull pain in the epigastric region and RUQ. The pain was fairly mild and persistent on and off throughout the day. On 12/13/17 she felt fine. She took the second dose of the oral typhoid vaccine on 12/13/17, again at 7 pm. She woke up on this morning 12/14/17 with mild epigastric pain, again radiating to the RUQ. Around 11:30 am the pain got more intense, up to an 8-9/10. She had associated diarrhea (4 watery stools in 1 1/2 hours). She also felt nauseated and had the chills. She did not vomit. She took a nap and woke up in the afternoon feeling better. By the evening of 12/14/17 she felt fine. As of 12/15/17 she had had no further symptoms.
Bell?s Palsy; drooping/weakness of muscles in left side of face. Numbness started evening of the 27th and progressed to full unresponsiveness the next morning. As of 08/24/2021 some motion has been restored but not complete.
UrticariaPruritus Narrative: Approximately 10 days after the 2nd and last vaccination, awakened 4 am this morning and saw urticaria and pruritus first on the trunk then other parts of the body. for 3 hours without homemade remedies applied after skin eruption. Lesions resolved after 3 hours without treatment. Lesions remained urticarial with no ulcerations till it resolved. She will see he PCP tomorrow (she already has appointment)
swollen glands, watery eyes, runny nose, tired, dizziness, joint pain, rash-fore head , behind ears, lips trunk & arms, back 7 butt;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "paroxysmal atrial fibrillation" (unspecified if ongoing); "non-Hodgkins lymphoma", start date: 1980 (unspecified if ongoing), notes: (diagnosed and treated in 1980). The patient took concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (10Jun2022) Negative; (12Jun2022) Negative; (14Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : On 04Jun2022 patient received Anti viral Paxlovid as covid treatment. treatment stop date is 09Jun2022. patient received other medication as Metoprolol succinate via oral route. start date of Metoprolol succinate was 01oct2019. Adverse event: After completing 5 day course of Paxlovid therapy on 09Jun22, patient had 2 negative rapid antigen tests (10Jun22 and 12Jun22) and had been afebrile since 06Jun22). On 14Jun22, symptoms of nasal congestion and fatigue returned and rapid antigen test was positive. Patient advised to isolate for 5 days and wear a mask until day 10. Other medical history: paroxysmal atrial fibrillation, history of non-Hodgkin's lymphoma (diagnosed and treated in 1980)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
In monitoring parking lot, client waved down staff reporting he may have lost consciousness for around 10 minutes. Client had pale clammy skin that improved with mild activity. Client reported noticing red spots on his nose, not witnessed by monitoring staff. Client also reported have trouble drawing in deep breaths. EMS was activated and client was transported to ER for further evaluation.
chills; fatigue; headache; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved and CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
I had severe and sharp pain in my abdomen, I went to the emergency room several times. I had this pain several weeks. I had a CTS scan, blood work and couldn't find any cause of the pain. they even changed my medication nothing was helping. I had an upper endoscopy  test  and colonoscopy. The medication lessen the symptoms but they still come on and off and there is no explanation.