chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first moderna vaccine on 3/22/2021. Since it has passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first moderna vaccine on 3/22/2021. Since it has passed) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first moderna vaccine on 3/22/2021. Since it has passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first moderna vaccine on 3/22/2021. Since it has passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
turning worst/starting to turn red; left toe was swollen; Sore/(left toe) a lot of pain; Felt like he had the flu; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left toe was swollen), PAIN IN EXTREMITY (Sore/(left toe) a lot of pain), INFLUENZA LIKE ILLNESS (Felt like he had the flu), HEADACHE (Headache) and ERYTHEMA (turning worst/starting to turn red) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Gout (Patient have a history of gout.).   On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu) and HEADACHE (Headache). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore/(left toe) a lot of pain). On 13-Feb-2021, the patient experienced SWELLING (left toe was swollen). On an unknown date, the patient experienced ERYTHEMA (turning worst/starting to turn red). At the time of the report, SWELLING (left toe was swollen), PAIN IN EXTREMITY (Sore/(left toe) a lot of pain) and ERYTHEMA (turning worst/starting to turn red) outcome was unknown and INFLUENZA LIKE ILLNESS (Felt like he had the flu) and HEADACHE (Headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Tylenol.
Recently afterwards the side of his tongue went numb; my daughter's dad have been losing our taste.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2, solution for injection), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "Recently afterwards the side of his tongue went numb"; AGEUSIA (non-serious), outcome "unknown", described as "my daughter's dad have been losing our taste.". Therapeutic measures were not taken as a result of hypoaesthesia oral, ageusia.  Additional information: This is the second case out of the 2 cases. Reporter stated, "Can you send me a package. Patient had a miscarriage from the Pfizer. Patient have a baby of 6 weeks old (Further clarification was unknown) and I just got the Pfizer and I think that's the cause of it. Do you need to send me some packet (Further clarification was unknown) or something to fill out or what you want me to do.  Patient had the miscarriage." When confirmed the name of the vaccine as Pfizer COVID-19 vaccine, Reporter stated, "Yeah,  got the vaccination, Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series and then patient had a miscarriage of 6 weeks old on 17Jul and then me and my daughter's dad have been losing our taste. Are we going to get that back. Patient have all paper work and stuff, if you guys need that kind of stuff (Further clarification was unknown, hence checked as initial report). When paraphrased the concern, Reporter stated, "Will me and my daughter's dad get our taste back We are off eventually the vaccination so we can taste again. We are losing our taste from the Pfizer vaccination. When will the taste come back to our mouth? Me and my daughter's dad." Reporter was provided with the contact# for Pfizer Medical Information Department.   Follow-up attempts completed. No further information is expected.
There is the dural venous sinus thrombosis extending from the lateral left transverse sinus into the jugular bulb.
On  10/3 - patient noted to have a red, raised/inflamed , firm, warm area at injection site (R deltoid) as well as bruise.  At the date of this report (10/10/2019) patient still remains with area
breakout of herpes simplex; Activation of sinus; Eye inflammation; 4 big cold sores on her lips; Fever; Chills; Fatigue; pounding headache/now dull and not pounding; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (breakout of herpes simplex), SINUS DISORDER (Activation of sinus), EYE INFLAMMATION (Eye inflammation), ORAL HERPES (4 big cold sores on her lips) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes. Concomitant products included LISINOPRIL, Hydochlorothiazide, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HERPES SIMPLEX (breakout of herpes simplex), SINUS DISORDER (Activation of sinus), EYE INFLAMMATION (Eye inflammation), ORAL HERPES (4 big cold sores on her lips), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (pounding headache/now dull and not pounding). On 26-Feb-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, HERPES SIMPLEX (breakout of herpes simplex), ORAL HERPES (4 big cold sores on her lips) and PYREXIA (Fever) had resolved. At the time of the report, SINUS DISORDER (Activation of sinus), EYE INFLAMMATION (Eye inflammation) and HEADACHE (pounding headache/now dull and not pounding) outcome was unknown.            No treatment related information has been reported.
Hives covering body. Angioedema (eyes, mild on hands and feet, briefly lips). Leg weakness for 48 hours.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Aug2021 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: re-testing positive 11 days after initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 14Jun2022 to 19Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. On 25Jun2022, the patient experienced rebound covid with re-testing positive 11 days after initial infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse(patient).  The 43-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration by injection in the right deltoid on 21Dec2020 at single dose to protect herself from getting COVID.  Medical history included ongoing chronic sinusitis , ongoing seasonal allergy.  Concomitant medication included ongoing cephalosporin for Chronic sinusitis from 29Dec2020 which was the only thing new that she has been taking, but she had taken it in the past many times, ongoing cetirizine hydrochloride(ZYRTEC) for seasonal allergies, ongoing fluticasone propionate (FLONASE) for seasonal allergies which had been taking this for years.  She got her first dose of the COVID vaccine last Monday, the Monday before Christmas on 21Dec2020. Yesterday(30Dec2020), in the exact spot that she received it, she was getting itching, redness, and swelling. She read and was told that that could happen, she just thought it would be sooner rather than 9 days later. She was calling to get this reported. Otherwise, she is fine. She had been using antihistamines and cortisone cream as treatments. She had been taking cetirizine hydrochloride for years. She normally took at night, but because of her arm she took it this morning.Last night(30Dec2020) she also put ice to the are as it felt hot.  Outcome of events was not recovered. Events(itching, redness, and swelling) were assessed as non-serious.
A few days after my injection, around the injection site, I have a baseball size very apparent red mark that is sore to the touch and this is 9 days after my injection that it's still here and getting worse. I would like to send a picture, if possible.
PER PT AND FAMILY  WEAKNESS/ confusion  N/V/D   POST 2ND WVACCINE X 1 DAY  UNABLE TO HOLD ANYTHING DOWN, difficult walking and remembering date
Severe persistent joint pain on right arm extending down to right hip 24hrs after injection was administered.
Received flu vaccination same day. Nausea, stomach issues, fatigue, WBC is high.
Case previously recorded as MA2009-4291. Initial case report received from a pediatrician on 04 NOV 2009. A 9 month-old male patient was vaccinated with 0.5 ml FLUVIRIN 2009/2010 (batch no. 100813, expiration date 01 FEB 2010) i.m. on 30 OCT 2009, an off-label indication. No adverse event was reported. NA09-007607.
Information has been received from an approximately 25 year old female registered nurse who in approximately 1993 was vaccinated with a dose of hepatitis B virus vaccine. Concomitant vaccination included a dose of MMR (second generation). The reporter stated that she has been suffering from fibromyaglia since approximately 1993 and that the symptoms began within the same time period as when she received hepatitis B virus vaccine and MMR (second generation) The reporter noted that she needed the vaccines as a precaution for working in the hospital. Unspecified medical attention was sought. The reporter is trying to get her records from employee health and has been investigating her fibromyalgia. It was noted that a product quality complaint was not involved. Upon internal review, fibromyalgia was considered to be an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 7/3/2003 adds no new info.
Patient developed facial swelling and a hardened rash at the site. Patient mentioned that she kept needing to swallow because fluid kept coming up and her throat felt funny. We gave her Benadryl. Not sure if her facial rash/bumps was due to the vaccine.
Felt great @ post injection.  9pm took 2 Melatonin & drank small cup hot Sleepy Time tea..  Went to bed.  At 11:30 pm still not asleep.  Restless & uncomfortable.  1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping.  Felt like I had the flu.  Got out of bed & sat in recliner with quilt over me.  After a bit started feeling a little better.  Went back to bed @ 3 am.  Still had a rough time getting back to sleep.  Very uncomfortable.  Got up @ 5am.  Still have intense total-body aches, neck pain, headache, fever 100.1      Drinking a lot of water.  Took 2 / 500mg Acetaminophen
pt recv vax & exp fatigue, tiredness, joint pain 3-5 day p/vax lasting 1mo;
The first thing that happened was the pain that spread across my arm it looked like I was bit by a mosquito I took benadryl my entire upper arm was swollen, Sunday I projectile vomitted out of no where without any indication of being nauseous, I had a lot of fatigue I was coughing intermittently I thought it was my asthma but I also had severe neck pain I could barely hold my head up and I was sent to the urgent care where I was monitored. I had hives in random parts of my body including my face.  My body was sore and I had to take off of work because I couldn't sit up. That following Thursday I was completely fine  there was nothing wrong with me. Thursday I had an appt and explained everything to my Dr which she monitored me and said it was an immune response
Patient received PFIZER vaccinations on: 12/31/2020 and 01/21/2021 Patient tested positive for COVID-19 on 4/1/2021
left arm red (injection site); left arm itchy (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm red (injection site)) and INJECTION SITE PRURITUS (left arm itchy (injection site)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (left arm red (injection site)) and INJECTION SITE PRURITUS (left arm itchy (injection site)). At the time of the report, VACCINATION SITE ERYTHEMA (left arm red (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. It is reported that patient is taking (glifotes 5ml) for diabetes type 2 and for treating high blood pressure.
fever; Body ache; chills; Felt tired; diarrhea; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and DIARRHOEA (diarrhea) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 21-Apr-2021, PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, COVID-19: Positive.     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.   Caller advised patient also taking Berry Syrup.    This case was linked INC.-MOD-2021-100778 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-100778:wife's case crosslinked
87-year-old female,  vaccinated with Pfizer x2 doses on 2/2021, with a past medical history of Afib, dementia, HTN, HLD, CKD, gout, and anemia presented to the ED with cough, SOB, sputum production,  x 4 days, presented to the ED with worsening fatigue and SOB.  Daughter is the historian.  She reports brother was sick Sunday and then 3 days later patient developed intermittent headaches, shortness of breath, and fatigue  First vaccine 1/25/2021
Heart attack, 100 % blockage in artery, stent implant required. Class 1 FAA medical give every 6 months for over 10 years and no limitations. No history of heart desease or high blood pressure.
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with an incorrect stored dose of GARDASIL 9 lot # M034780 with expiration date on 15-APR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hour and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Pt was seen in our office on 9/30/13 at 900 AM bug bites pt did not have a fever at that time was give the flu vaccine. At 4:30 pt developed a fever and had a febrile seizure at 5pm. Went to ER. Told to give TYLENOL/MOTRIN Q 4hrs. Had another febrile seizure at 3am. Seen in our office today at 10am fever was 98.7.
Skin rash severe Skin disorder, joint pain, night sweat. HBP, Headache.
Started to fall, 4 times. Took to emergency room. In course of 4 days.
Patient, age 5, received vaccinations on 8/20/07. That night he complained his arm hurt and his parents gave Tylenol. The next morning, 8/21/07, his mother noticed his arm was red and swollen. He had a slight fever and the redness seemed to be spreading from his left shoulder to elbow. Child was brought back to the health department and advised to see their doctor. The mother provided a phone number for the health department to do a follow up call however both that # and the one given at the time of service are invalid. No contact has been made.
I received the Moderna Bivalent booster for COVID-19 on 10/3/2022. On 12/9/2022, I began to feel a tightness in the throat during the evening. On 12/10/2022, the throat tightness intensified, plus I began to experience nasal congestion and pressure. There was also some nasal discharge, and I developed a cough. I suspected that I had COVID-19, because my husband had recently tested positive. I took a home antigen test on 12/10/2022 and got a positive result. Even though my symptoms were mild, I decided to have a telehealth visit with a doctor, just in case the symptoms worsened. During my telehealth visit on 12/11/2022, we discussed my symptoms, my weight, my pet dander allergies, and other comorbidities and their possible effect on the COVID-19. She prescribed me azelastine nasal spray and Paxlovid. The azelastine was prescribed to help with the sinus congestion and to lower the risk of developing a sinus infection. I began the medications the evening of 12/11/2022. On 12/13/2022 and 12/14/2022, my symptoms lessened. On 12/16/2022, I was less tired. On 12/17/2022, I tested negative. Things went well until 12/23/2022, when I developed a runny nose, nasal congestion, and a cough. I took another test and got a positive result on 12/24/2022; it was a rebound. I tested negative again on 12/29/2022 or 12/30/2022, but at the time of this writing, I still have a lingering cough. There's not much congestion to cough up or to clear, but it's annoying. I also lost my sense of smell on the evening of 12/24/2022, but I regained it on 12/31/2022.
He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), via an unspecified route of administration on 07Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he received the first dose on 07Aug2021 and today (date unspecified) he was supposed to have the second dose. On an unspecified date in Aug2021, after getting the first dose, the patient had tested positive for Covid. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Twelve hours after IM injection in LD with 0.5cc Pneumovax, Lot 485F soreness at injection site noted.  By 24 hours after injection, the UNDERSIDE of left arm from elbow to axilla was sore, red, warm, and swollen. Saw MD  around 2PM on Sat, 11/04/06; was started on Keflex. Returned to clinic Monday 11/06/2006. Area was larger, but less redness. Using Keflex, anti-inflammatories, elevation, and heat to area.
1st Day after vaccine - arm soreness, sluggish feeling 2nd Day after vaccine - flushed/warm feeling in face
a 2 year old female was given an expired dose of Daptacel with no adverse event; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a healthcare professional.   This case involves a 2 years old female patient who was given an expired 0.5ml dose (fourth dose in series) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5020AA, Expiration Date: 16-May-2019 via intramuscular route in the left thigh on 01-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  The outcome of event was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Within 5 hours of getting second Shingrix shot patient felt palpitations, intermittent dizziness, a few sensations that she couldn't breathe but these quickly passed.  Patients blood pressure was 76/53 with a HR of 187 when first felt palpitations. Seven minutes later BP 124/59, HR 90.  The following day patient had a BP of 92/60, HR 89. After this, vitals remained stable.
Immediately and after  the next 5 mins for at least 3 hours Arm pain, Nausea, Burst of adrenaline/energy