chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness; tingling; shooting pain in her left trapezius; nerve pain in this area, mostly on the left medial trap next to her spine; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730, expiry date unknown), intramuscular (right arm), on 12Dec2020 21:00 at single dose, for covid-19 immunization. Medical history includes unresolved dystonic reaction as of 2016 secondary to taking Lamictal (not fully resolved, currently being treated with baclofen and gabapentin). Concomitant medications in two weeks included gabapentin for unresolved dystonic; methylphenidate hydrochloride (CONCERTA); clonidine; vilazodone hydrochloride (VIIBRYD); ondansetron (ZOFRAN [ONDANSETRON]); doxycycline; and baclofen for unresolved dystonic. The patient previously took lamotrigine (LAMICTAL) and experienced dystonic reaction and allergies. The patient experienced numbness, tingling, and shooting pain in her left trapezius one day on 17Dec2020, after the first injection; and these lasted two weeks. While the numbness and tingling have resolved, the patient sometimes still experiences nerve pain in this area, mostly on the left medial trap next to her spine from 17Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The patient was recovering from the events shooting pain in her left trapezius and; nerve pain in this area, mostly on the left medial trap next to her spine. The patient recovered from the events numbness and tingling on an unspecified date. The patient had no other vaccine in four weeks. The patient had a nasal swab test post-Covid vaccination on 02Jan2021 with results of negative.
LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN'T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn't sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn't sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.
Dtap - Hib given in L thigh. Presented in office 6-7-16 w/ red papular rash. Had began around vaccine site per mom. At apt it was a red papular rash L leg. L lower abd and R calf. (+) fussy BENADRYL and Hydrocortisone cream Rx.
Right deltoid - well demarcated area of erythema, not raised, blanchable, no increased warmth, nontender, no oozing, no bleeding. Pt afebrile. Pt nontoxic in office and alert/playful/cooperative. No tx given.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Anaphylaxis symptoms: tingling, dizziness, mouth and throat swelling and chest tightness warmth.  I administered my Epipen in the car and my father drove me to the ER where I received:Benedryl, Pepcid, soul-medrol, and sodium chloride.
Information has been received from a health professional concerning an 8 year old female with no medical history, who on 02/04/1999 was vaccinated subcutaneously with a 0.5ml of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 11/26/2005, the patient experienced breakthrough varicella. She presented to the office on 11/30/2005, with two crusted lesions on her head that were itchy and red. Patient had no fever or other symptoms. No labs were done and the patient subsequently recovered on 12/01/2005. No product quality complaint was involved. Additional information has been requested.
terrible headache/head was like beating; This is a spontaneous report from a contactable consumer (patient reported for herself). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated had a COVID-19 Pfizer, Pfizer whatever called it, the Pfizer vaccine here and she didn't like the way she was feeling, she got a terrible headache since she had her head was like beating. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial case received from a consumer on 17 October 2012. A 37 year old male patient received an intramuscular injection of TYPHIM Vi, lot number not reported on 12 April 2012. The patient was also administered other unspecified travel vaccines on an unspecified date. The patient had no pre-existing medical conditions or known allergies. It was reported that the patient was not ill at the time of vaccination. Concomitant medications were not reported. The patient went on a trip about 3 weeks after vaccination in May 2012. On 19 May 2012, he experienced symptoms of diarrhea, chills, and a temperature of 104F, aches and cramps. The patient was flown back home and hospitalized on 23 May 2012 for an unspecified duration. He was subsequently diagnosed with Typhoid fever on 06 June 2012 by an infectious disease doctor. Relevant diagnostic tests, laboratory data and treatments were not reported. According to the reporter, he is currently without any symptoms and had a full recovery. Date of recovery was not reported. Documents held by sender: None.
74 year old female received the first dose of the Moderna COVID-19 vaccine Lot # 031M20A on 03/10/2021 @ 20:00. Pt reported diarrhea, muscle aches, pains, chills, and fatigue on 03/13/2021. Diarrhea resolved 03/14/2021. Pt started experiencing shortness of breath on 03/22/2021, and is still currently expereicing SOB. Pt went to Urgent Care on 03/23/2021. Pt tested (-) for COVID, was diagnosed with pneumonia, and prescribed prednisone and doxycycline. Muscle aches, pains, chills, and fatigue resolved shortly after urgent care visit ~ 03/25/2021. Pt takes lisinopril, plavix, and aspirin. Pt reports no allergies and is diagnosed with hypertension and dyslipidemia. Pt is currently experiencing shortness of breath. Pt asked if the second dose is warranted based on the reaction to the first dose. Pt was advised to consult with primary doctor about symptom management and the second dose can be delayed up to 6 weeks after the first dose if necessary, and if the doctor advises for the second dose, inform the person administering the vaccine about what resulted after the 1st dose. SPI was consulted and Dr. was notified.
Local discomfort in (R) arm - applied ice. Felt hard lump at site. No fever. Discomfort when raising arm. Resolved after 6 days.
Second dose past 36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose past 36 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Medical history was not provided.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose past 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose past 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided
The patient called today 4/9/21 to report severe unusual adverse reaction to the Janssen Covid19 vaccine.  She received her vaccine on 3/11/21.  Beginning on 3/19/21 she reported red and swollen lymph nodes with pustules on the left side near the armpit.  She nodes are still swollen and there are bumps but no pustules at this time.  Beginning on 3/24/21 she noticed a spot on her ridcage resembling Shingles, but it was a single pustule.  On 3/25/21 she noticed that the bottom of her feet started peeling and stinging. The skin seems to be sloughing off.  She made an appointment with her dermatologist for today, 4/9/21 but it has been rescheduled to 4/12/21.  The patient reports that she has history of chronic shingles and multiple autoimmune disorders. She takes daily antiviral therapy (valacyclovir).
Headache & Myalgia Narrative:  Patient received vaccine 3/9/21 with symptoms beginning 3/10/21 around 5am. Reported symptoms included headache, body aches, and stiff neck/sore throat. Reporter recommended patient to follow up with PCP. Reportedly used Advil, allergy medicines, and roll-on pain medicine.
A non-serious spontaneous report of administration during pregnancy was received from a health professional concerning a 16-year-old female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 27-Oct-2011, the patient received FLUMIST. On 28-Oct-2011, the patient found out that she is pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
suspected vaccination failure; have a light case of them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for herself. The age at vaccination was not reported. The patient and her husband, both received Shingles vaccine. After receiving Shingles vaccine, the patient still got light case of shingles. The reporter suggested that, never thought we were 100 percent safe. But she still agreed to get the vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR175888, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175888:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: "Chronic migraine" (unspecified if ongoing); "RLS" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient used Paxlovid (anti-viral) from 06May2023 to 10May2023 for the treatment of COVID-19  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
3 days following vaccination, patient reports feeling weakness, fatigue and ringing in the right ear.  symptoms lasted for 3-4 days, then resolved 3-4 days.  Approximately 1 week after the vaccine, fatigue and weakness returned, along with back pain. Pt reports sleeping 16 hours, awake for 2, sleeping again for 12 hours.  Upon awakening patient reports severe back pain, to which he admits to taking too much tylenol which resulted in upset stomach, but did relieve the back pain.  Symptoms were on a 3-4 days on, 3-4 days off type schedule for approx 3 weeks.  Patient reported complete symptom resolution at time of second injection appointment, but elected not to have the second injection.
Given MMR + Varicella and KINRIX: Developed itchy rash - first noted on face and upper extremities - when arrived home 2 hr. later noted also lower extremity itchy rash - truncal area spared (did.
5 mins after shot (red, blotchy 1.5 cm urticarial on leg), 10 mins after shot (hives on stomach, thigh wasn't worse), diarrhea.  Benedryl given in office.
Itchy red rash with bumps on the left elbow, left side of abdomen and underwear line.
Excessive aching especially when using his arm. He can raise arm above ahead but arm is still tender at rest even on June 9, 2021. He said it "hurts like hell" when he picks anything up. When he gets up in AM, he says it really hurts him and after about 1 to 1.5 hours after waking up the arm feelings okay.
Moderate- Severe chills, body aches, joint aches, loss of appetite and mild fever x 24 hours. "Covid arm" on R arm below vaccine site, started on day 3, swollen lymph node in sub clavicular node, same side as vaccine, starting on on day 3.  On day 3-4 my teeth were very sensitive to the cold.
Over an hour later patient was at lunch when she developed a flushed feeling, felt a little dizzy. Went to the bathroom and saw her eyes bloodshot red, chest red and flushed. She notified other healthcare worker and was signed in immediately to see physician. No sob but felt pressure on her chest and felt jittery inside her body. She frequently was clearing her throat which her fellow associates said she was not doing prior to injection. Was treated with NS bolus and medications and was discharged home. Doctor wants her to stay out of work tomorrow.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-OCT-2014 the patient was vaccinated with a second dose of PNEUMOVAX23 (dose, route, lot # and expiration date were not provided). The first dose was received approximately 1 year prior (in approximately 2013). No adverse experience reported.  Additional information has been requested.
sore throat; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported. The reporter stated that the symptoms only lasted for a day or two and were not as bad as his symptoms from second dose.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M040412 and expiration date on 30-JUN-2019 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA011335: US-009507513-1706USA002268: US-009507513-1706USA002266: US-009507513-1706USA002267.
It's not really a cold, it's a congestion. It's like a allergy in my nasal nose; I developed this drainage and cough, it is like an allergy; I developed this drainage and cough, it is like an allergy; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Lot Number: EL9261; Expiration Date: 31May2021) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient got developed that drainage and cough, which was like an allergy. The patient asked that the caused event was due to vaccination. The patient also experienced an allergy in his/her nasal nose and then that caused him/her to do some coughing. The outcome of all the events was unknown.  Additional Context: Over the call both the patient (husband) and the reporter (wife) were available. Reporter stated, "I was actually going to put my husband on. It is really his question. We both had the Pfizer COVID-19 vaccine about 2 weeks ago. And coincidently, he felt fine and everything still does feel fine but something odd is going on with his toes. And I know there is something called COVID toes and we looked it up online, that's sort of what it looks like, a mild case but not extreme. But really our question is related to, could this be a side effect from the vaccine. I will put him on." Reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Reporter was provided with the contact# for Pfizer Medical Information. When requested for permission to probe questions for a safety report, patient stated, "I'm not sure what questions I'm answering. What am I answering? What questions are you talking about?" When informed that the questions would be related to demographic details, medical history, patient stated, "This is taking way too long. I'll have to call back. I have the number and the option. I will call back in a later date."  No follow up attempts are possible. No further information is expected.
breast cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown", described as "breast cancer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 69 y.o. female patient of MD.   Report on admission: Patient is a 69 y.o. female presenting from home with c/o 69-year-old female with a history of COPD presents emergency department with shortness of breath for 1 week.  Shortness of breath definitely worsened despite taking her inhaler at home.  Patient was admitted in November for same and was in the ICU on BiPAP.  Patient also reports COVID-positive end of December Husband at bedside reports at the trach location there is airway stenosis which is inoperable.   Hospital course as below.  Cardiology and pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged to SNF in stable condition.  Patient will need close monitoring of vital signs.   1.  COVID PNA: -pulm followed -COVID +12/26, positive again on 1/7/2023 -CT chest with very low lung volumes, bilateral groundglass infiltrates reflecting pulmonary edema versus pneumonia -isolation completed 1/18/23  2.  Asthma: -pulm consulted  3.  Acute hypoxic respiratory failure: -Likely in setting of above -Wean oxygen as able  4.  Sepsis trigger: -1/7 blood cultures no growth to date  5.  Type 2 diabetes, hyperglycemia/hypoglycemia: -In setting of steroids -A1c 7.5 -Sliding scale insulin, adjust home meds  6.  UTI: -Urine culture positive for enterococcus faecalis -abx completed   7. Tachycardia: -cardio consulted
First event was a headache that occurred 12 hours after injection.  Next was a complaint of pressure inside of the neck, chest and stomach along with extreme swelling in the cheek and jaw on the side of the injection. Extreme fatigue, ankle joint pain. Returned to the doctor 24 hours after injection and was re-examined.  Stomach and neck pain was experienced when doctor pressed on these parts.  Extreme arm swelling and hot red rash the size of a large grapefruit occurred at 32 hours after injection.
Approximately 3 hours after patient received the flu shot, experienced severe dizziness and nausea with vomiting. The dizziness was so bad that felt as if patient were drunk and had vertigo. The "world was spinning" whether patient was standing, sitting or laying down. Had very severe nausea for several hour accompanied by vomiting. The effects were not as severe the following day. Was just very exhausted and woozy feeling for 2 days. Patient has never had a reaction to a flu shot previously.