chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in left hand which minimized to numbness in pinkie finger of left hand; had a nose bleed; Numbness in pinkie finger is continuing; This is a spontaneous report from a contactable consumer (patient herself).   A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered in left arm on 25Feb2021 06:45 (age at vaccination: 65-years) as dose number unknown, single for Covid-19 immunisation. Patient was not pregnant at the time of vaccination. Facility type vaccine was hospital. Patient was not diagnosed with covid prior to vaccination. She was not tested for covid since vaccination. Patients medical history included hashimotos and known allergies: sulfa from an unspecified date and unknown if ongoing. Past drug event included known allergies due to clindamycin, amoxicillin and sulfa from an unspecified date and unknown if ongoing. Concomitant medications reported were lisinopril and armour thyroid start and stop date unknown, taken for unspecified indication, administered in two weeks of vaccination. Patient was not administered any other vaccines within four weeks. On Friday, 26Feb2021 06:30 AM, patient woke up with numbness in left hand which minimized to numbness in pinkie finger of left hand. On Saturday about 2:30 p.m. she had a nose bleed which was a rare occurrence for her. The numbness in pinkie finger was continuing. No treatment regimen was given as a result of the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Pt seen at 1:00 PM on 5/6/03, received DTaP #1, Hib #1, IPV #1, Hep B #2, Prevnar #1. Per mom, pt began having breathing difficulty. At 7:00 PM, taken to ER, began to improve about 2:00 PM.
Pateint was given vaccine on 5/18/2021, soon after her injection, she passed out in the lobby.  Code Blue was called.  After medical team arrived, her HR= 48; BP= 89/56; O2= 100% on 3L and she responded to verbal commands.  Hx of needle phobia.   Not sure whether her Syncope was secondary to Vasovagal vs. J&J Vaccine vs. Seizures, therefore, we called EMS to take her for further evaluation.
Pt. called PCP office, stated she hand a sore arm and a small area of erythema after receiving the Moderna vaccine. Now it has increased to 3-4 inches and is warm to touch at the injection site. Pt. was informed to take Benadryl, ibuprofen and apply  cool compresses
bad headache; nausea; vomiting; back pain; 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 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Year ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021, outcome "not recovered", described as "bad headache"; NAUSEA (non-serious) with onset 28Mar2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 28Mar2021, outcome "not recovered", described as "vomiting"; BACK PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "back pain".  No follow-up attempts are possible. No further information is expected.
Do not believe related to vaccination but was advised to report by the CDC program. I started getting Hives on Jan 26. They are persisting even today. I had 3 separate bouts of facial angioedema starting in mid-February. My PCP and and allergist do not know what the cause is. They did stop my lisinopril that I have been on for at least 4-5 years in case the angioedema was related to that.  I had a positive ANA titer of 1:320 and have an appointment with a rheumatologist on 4/28
Information has been received from a nurse practitioner concerning a 13 year old female with rheumatoid arthritis and no known drug reactions/allergies and a history of passing out who on 14-AUG-2008 was vaccinated intramuscularly in left arm with the 0.5ml first dose of GARDASIL. The patient also was vaccinated in her right arm with a dose of MENACTRA. Concomitant therapy included nabumetone (RELAFEN) and ranitidine HCL (ZANTAC). The patient passed out after administration of the vaccine while in the office. On the same day, the patient recovered. Medical attention was sought in the physician's office. Additional information has been requested.
This spontaneous report was received from Physician Assistant (PA) concerning a 17 year old male. Medical history and concomitant medications were not specified. On 26-AUG-2016 and 26-OCT-2016, the male received his first and second GARDASIL 9 vaccinations, respectively. The PA reported that the male received his third vaccination of GARDASIL 9 too early. He received the third vaccination on 09-JAN-2017 intramuscularly (lot # M033583; expiration 14-APR-2019). The patient did not report any adverse effects. Additional information has been requested.
Intake nurse recvd tc from mom stating c/o fine red rash over entire body; pt is miserable; pt recvd APAP; not eating, taking fluids only; Seem weak & sleeps alot; feels warm; 10FEB92 mom said rash lasted 7 days;
feeling freezing cold; feeling like inside of the body is in fire, and coming out through my back; teeth's were shattering.; chills; headache; nausea; sweating; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BURNING SENSATION (burning sensation), FEELING COLD (feeling freezing cold), FEELING ABNORMAL (feeling like inside of the body is in fire, and coming out through my back) and CHILLS (teeth's were shattering.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient has history of Lupus Diagnosis.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (burning sensation). On 07-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), FEELING COLD (feeling freezing cold), FEELING ABNORMAL (feeling like inside of the body is in fire, and coming out through my back), CHILLS (teeth's were shattering.), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERHIDROSIS (sweating), BURNING SENSATION (burning sensation), FEELING COLD (feeling freezing cold), FEELING ABNORMAL (feeling like inside of the body is in fire, and coming out through my back), CHILLS (teeth's were shattering.), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included patient took 2 to 3 Advil medications.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included carcinoma brain. On 25th June 2018, the patient received the 1st dose of SHINGRIX 1 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever and overdose. On an unknown date, the outcome of the pain, influenza-like symptoms, fever and overdose were unknown. It was unknown if the reporter considered the pain, influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. After receiving SHINGRIX, the patient developed aches, low grade fever and flu like symptoms. Also the  patient received 1.0 ml dose of SHINGRIX, instead of 0.5 ml, which led to overdose. This case has been linked with case US2018151969 (wife's case), reported by same reporter.
Patient states they cannot fully lift their arm if their palm is facing down. They have more range of motion with their palm up. Symptoms have lasted 2+ weeks.
I got the vaccine then I went to get my treatment because I was having pain and it helped for a few days then it worsened. I thought they would get better with the injection, but they got worse than they were. I don't know if there is an interaction between the inject. But usually, it reduces the pain, but it didn't provide relief this time.
had the vaccine yesterday and then in that, in a way that felt like; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "had the vaccine yesterday and then in that, in a way that felt like".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After about 30 minutes I experience swelling and tingling to my tongue. I also experienced some dizziness.   The swelling and tingling dissipated after about 4 hours, and I took some 20mg PO Pepcid and 10mg Loratidine to see if it would help.  After 6-8 hours the swelling and tingling to my tongue was gone. I reported this to my provider Manaku MD, and she recommended it was fine to get my second vaccine, and she would give me a methylprednisone taper pack for the next vaccine. She states she questions if I have an allergy to polyethylene glycol which I did not believe I did? Unsure of where the reaction could have stemmed from.
Body aches, joint pain in knees, fatigue, soreness at injection site, swollen lymph node in underarm on left side, delayed period by at least 10 days...still waiting for it to start
I tested positive for COVID 9/8/21 and have developed an uncommon symptom of COVID which is intense burning sensation in nostrils
Vaccine had expired on 4/3/22. Moderna was contacted and since vaccine had been frozen up until date of administration, it was deemed viable and redosing was not needed.
Getting his booster; He feels tired; Headache; His body is not normal after the booster and he is not concentrating right; 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 54 year-old male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EN6204), administration date: 11Mar2021, for COVID-19 immunization, reaction(s): "received his series, first and second dose and after 3 months, he tested positive for COVID"; Bnt162b2 (Dose:02, Lot number; EP7534), administration date: 01Apr2021, for COVID-19 immunization, reaction(s): "received his series, first and second dose and after 3 months, he tested positive for COVID". The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Getting his booster"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "He feels tired"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; DISTURBANCE IN ATTENTION (non-serious) with onset Oct2021, outcome "unknown", described as "His body is not normal after the booster and he is not concentrating right".  He received his series, first and second dose and after 3 months, he tested positive for COVID. His first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug, and then he got his booster dose on 21Oct. He said after receiving his booster dose, he feels tired and have a headache. He said his body is not normal after the booster and he is not concentrating right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Delayed reporting   Received vaccination at 1500 on Dec 21, 2020, within 1 hour of vaccination experienced headache and took Tylenol at 2200 had an auditory hallucinations, itching, redness, swelling numbness to the injection site for up to 7 days. Raised hard area at the injection site  up to 14 days. Also experienced hives, fatigue, heart palpitations within the first 24 hours after vaccination. Next day reported symptoms to leadership and coworkers  On Jan 11, 2021 reported for second dose, was referred to provider based on my previous symptoms from initial dose. LTC  advised against receiving the second dose or any other covid-19 vaccinations.
Patient c/o chest pain and SOB approximately 1 hour post vaccination. Called clinic and instructed to call 911 to be transported to ED for treatment.
MDV Polio (Ipol) was exposed to a temperature excursion and may have been given to a patient, no adverse event; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA137200, 2019SA139565 and 2019SA139569 (same reporter).  This case involves a male patient of an unknown age who received vaccine IPV (VERO) [IPOL] lot P1A171M, expiry date: 24-Apr-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine MDV Polio (Ipol) that was exposed to a previously reported temperature excursion and may have been given to 3 patients.  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient with shingles. On 09-DEC-2013 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, with valid lot # J011212 (expiry date 29-AUG-2014). No concomitant medication was reported. On 10-DEC-2013 the patient called the pharmacy to reported she had a large, 2 inch in diameter, "reddened area" around the injection site. The injection site was a little itchy as well. No rash was presented. The outcome was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
I woke up with adore throat; fever; arm swelling; sore arm; rash at site; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 4 days after receiving Shingrix, the patient experienced throat irritation. In March 2020, the patient experienced pain in arm, injection site rash, fatigue, fever and swelling arm. On an unknown date, the outcome of the pain in arm, injection site rash, fatigue, fever and swelling arm were unknown and the outcome of the throat irritation was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, fatigue, throat irritation, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient arms swelled up, a rash, slight fever, reaching a 100 Fahrenheit, got swabbed, not for corona. The patient reported had regular side effects, sore arm, rash at site and tired.  But this morning (day of reporting) woke up with adore throat.  The reporter wanted to know could it be another effect, or should he/she contact primary care physician.
The Maderna booster gave me severe bronchitis, neurological disorder head ache and fatigue. Then 15 days later I tested positive with covid and had repeated symptoms.
Heart racing and high anxieties for a week; Heart racing and high anxieties for a week; dizzy; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032229) for COVID-19 prophylaxis.     Allergic to Radiation Therapy- hives after several treatments. Had cancer twice.  The patient's past medical history included Tetanus and Hives. Previously administered products included for Product used for unknown indication: Flu vaccine on 11-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Cancer, Allergy to intravenous contrast media (Allergic to CAT contrast which caused similar reactions), Allergy to vaccine (Tetanus shots) and Drug allergy (Blood pressure medications).    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 03-Nov-2023, the patient experienced PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Dizziness, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy) had not resolved.            Concomitant medication was not reported.  The patient had heart racing and high anxieties. The patient also faced dizzy on 9th day. It was unknown if the patient had any additional symptoms or events.
Have muscle pain throughout his body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Have muscle pain throughout his body) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes, Stroke, Neuropathic pain and Heart disorder (Heart situation). Concomitant products included NORTRIPTYLINE and PREGABALIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Have muscle pain throughout his body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in March 2021 for Muscle pain, at an unspecified dose and frequency. In March 2021, MYALGIA (Have muscle pain throughout his body) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient experienced muscle pain throughout his body for four to five days.   This case was linked to MOD-2021-418135 (Patient Link).
No additional AE reported; One dose of ROTATEQ was administered to the patient on 3 MAY 2022, after the excursion occured.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's concomitant medications, pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.  On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (ml) for prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number 1742421 has been verified to be valid, expiration date reported and established as 07-DEC-2022).   It was reported that the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion of 33.6 Fahrenheit degrees (F) during a time frame of 7 hours and 45 minutes (product storage error). Moreover, there was a previous temperature excursion of 48 Fahrenheit degrees (F) for 30 minutes. No additional adverse event was reported (no adverse event).
Mild tinnitus that began the day following vaccination. I have never previously experienced ringing of the ears nor any other sort of ear injury or hearing issues. It has remained relatively constant since the onset.
Situation: Patient requests from MA  full dose of Moderna. He insisted that he had doctor?s note stating that he was to receive full dose of 0.5 mL, for fourth dose/booster.  Background: MA requests full dose of Moderna from nursing station,  0.5 mL fourth dose.  Assessment: RN  gave Vanessa Bautista full dose and 0.5mL is administered for patient. During our end of day  audit  we find that the dose should have been 0.25 mL because it was his fourth dose.  Recommendation: Ensure team has clear understanding on dosing information, ensure everyone has correct visuals to assist them with doses/vaccine
Resident Received expired modern vaccine, expired on 10/13/2021. No ASE noted.
Red arm around injection site. Lump around injection site. Itchy skin around injection site.
pt recvd vax; devel flu like sxs w/ extreme d & h/a on same day as vax;
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she was shaking like a druggy), HEART RATE DECREASED (heart rate at 44), FATIGUE (wiped out) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (she was shaking like a druggy), FATIGUE (wiped out) and HEADACHE (headache). On 21-Mar-2021, the patient experienced HEART RATE DECREASED (heart rate at 44). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 19-Mar-2021, TREMOR (she was shaking like a druggy) and FATIGUE (wiped out) had resolved. On 21-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, HEART RATE DECREASED (heart rate at 44) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
pt noticed chills afternoon of 20th;on awakening on the morning of the 22nd pt had a painful, swollen rt eye, aching eye & face & eruptions on face lasting 4-5 days;seen by MD dx shingles;
Severe nausea. Fainting, loss of consciousness for several minutes, unresponsive, required 911 call. Severe calf muscle cramp of right leg.