chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The product was administered to a patient after being improperly stored.; This spontaneous report has been received from a prescriber nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, vaccination scheme frequency and anatomical location were not reported; lot number U008180, that was verified to be a valid lot number with an expiration date reported and established as 12-MAR-2023) for prophylaxis (product storage error). The aforementioned administered dose underwent a temperature excursion as follows: 13 (units not provided) for 297 days. There was no previous temperature excursion. No other adverse event was reported (no adverse event).  The report was considered to be non-valid due to lack of the patient's identifiers.  Follow up information was received on 24-JUN-2022 from the prescriber nurse.  The reporter informed that she is attempting to return forms, but her fax machine does not work and she was looking for an alternate route to send them. Additional information will be mailed.  Follow up information was received from the prescriber nurse on 06-JUL-2022. The patient was a 14-years-old female.  On 08-OCT-2021, the patient received dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular Injection, lot # T013205, expiration date established as 03-DEC-2021, administered intramuscularly in right deltoid; Hepatitis B vaccine manufacturer: GlaxoSmithKline, lot # 5295P, administered intramuscularly in right deltoid; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) manufacturer: GlaxoSmithKline, lot # AMVA438A, administered intramuscularly in left deltoid; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), manufacturer: GlaxoSmithKline, lot # 57C57, administered intramuscularly in right deltoid; all for prophylaxis. On 17-NOV-2021 the patient was administered an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously in right arm. The patient had no significant response to the vaccination.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient who was vaccinated with a diluent of the vaccine PENTACEL lot C5592AA, via oral route in unknown administration site on 08-Oct-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccination involved PREVNAR and rotavirus. It is a actual medication case error due to Product preparation error. It was reported that the patient was vaccinated with the PENTACEL Diluent instead of the PENTACEL itself. 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.
Symptoms:  local erythema, induration at the injection site within 24 hours; followed by the progression of the erythema to include the entire dorsal surface the the left arm;  patient was diagnosed with cellulitis and begun on keflex 500 mg po QID this evening by a local emergency room
Severe reaction; pretty svere nerve pain; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), HERPES ZOSTER (Shingles) and NEURALGIA (pretty svere nerve pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013D720A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe reaction) and NEURALGIA (pretty svere nerve pain). At the time of the report, VACCINATION COMPLICATION (Severe reaction), HERPES ZOSTER (Shingles) and NEURALGIA (pretty svere nerve pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant product is not provided Treatment included Valacyclovir
patient came and spoke to pharmacist on duty and said that she had a reaction for the fluzone hd. She said that she felt like she had a lump in the throat. head was tingling that night when she was going to bed. felt heart was racing and felt like she had fever but she did not have fever. got chills. She was fine the next morning
One day post vax pt developed early cellulitis characterized by swelling and redness from his left thigh to his knee with mild bruising. Pt was treated with Duricef and warm soaks.
Patient stated his arm was numb for 1 full day after getting vaccine and interfered with normal mobility on the left arm but completely subsided after 24 hours.
ill; pain in my chest; flu like illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu, for Immunization, reaction(s): "allergic to the flu shot". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in my chest"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like illness".  Additional information: It was stated by patient: "I got the Pfizer covid vaccine and became severely ill for three days. I had a strong pain in my chest and then I have continued getting a strange flu like illness about every couple weeks. I never had these symptoms before. I am allergic to the flu shot and I'm wondering if that has anything to do with my sickness."  The lot number for bnt162b2 was not provided and will be requested during follow up.
C/o local itching after receiving inj in (L) deltoid. Denies any difficulty breathing. Approx 3 inch area of redness around inj site. No hives noted. Ice pack placed at site for approx 15 min. Child cont to deny any systemic symptom and stated itching has stopped. Area around inj cont to be red but no hives or swelling noted. Released to class with instructions to return if difficulty breathing, itching or other symptoms occur.
Started with just a very sore arm. Swelling of axillary lymph nodes. Woke up and blood pressure dropped (fainting). Then felt extremely hot and feverish (no actual fever).mild constant dizziness accompanied with nausea.
My 1st Covid-19 vax was on Saturday 02/13/2021. On Friday 02/26/2021 I had pain in my right ankle and foot and thought it was possibly just another bruise. Saturday evening 02/26/2021 I realised it was a blood vessel popping out. On Tuesday 03/02/2021 I had an ultrasound and it was diagnosed as a "superficial thrombosis". It goes from the inside of my right foot to the top of the foot. Then it can be seen on the inside of my ankle, skip a spot, and is again visible on the inside of my calf. It ends mid-calf on my right leg.
APPROXIMATELY 1600, BEGAN HAVING PAIN INSTANTLY AFTER RECEIVING SHOT TO HER L DELTOID. AT THAT TIME AND ON THROUGH PAIN WAS SO BAD THAT SHE CRIED.  CONTINUES TO HAVE PAIN WHEN SHE REACHES BEHIND HER, RAISES ARM, PICKS UP ANYTHING HEAVY, CAN NOT CARRY HER PURSE ON THE L ARM. WITH MOVEMENTS PAIN WILL SHOOT DOWN TO HER ELBOW. THE PAIN CONTINUES TO AWAKEN HER FROM SLEEP, THEN SHE CAN NO LONGER LIE IN BED, HAS TO SLEEP IN RECLINER.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of M-M-R II (dose, frequency, route and expiration were unknown, lot # M020073) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006063.
I was light headed and my face was hot, I was there my 15 min. then walk out and stop at a restroom I look at my face and was red and slightly swollen , I came home and took another benadryl 25mg and my face was good again
Has gotten diarrhea and because of fatigue, is sleeping harder and causing a sort of sleepwalking.  Mistaking other objects as the toilet.
24 hours after FLUZONE Quad, mother called and described area of injection to be red and swollen covering 6" x 5". I recommended BENADRYL 25mg 2 up to 4 times a day and to draw with a marker/pen the outer edges of affected area and to see Dr if area enlarges or other symptoms arise. 11/15/15- swelling decreased, red area increased- may see Dr.
67 year old patient stated her last name and she had never received a COVID19 vaccine  and did not have a Vaccine Card.  Record confirmed no history of COVID19 vaccination.  Provided patient education and administered #1  primary COVID19 vaccine to RD.  When entering vaccine data discovered patient record under the name that indicated patient had completed COVID 19 primary series and received one booster on 10/12/22.  Advised patient and her husband of the error.  He stated she gets confused.  Advised pt return in two months for bivalent booster and that he accompany her for future health care visits.  He agreed.  Notified supervisor of error and completed VAERS report
Numbness and tingling and left leg and foot approximately 6 hours after the vaccine. Joint pain in both knees approximately 12 hours after the vaccine making it difficult to descend stairs. Over the next several weeks joint pain increased to include both hands, wrist, elbows, shoulders, ankles and feet. The pain has increased, mobility and ability to do everyday tasks is greatly impaired.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reaction and concomitant medications were reported. On an unknown date, multiple unspecified patients were inadvertently vaccinated with VARIVAX (dosing details, lot # and expiry date were not reported). It was reported that the vaccines were exposed (excursion 1) to the temperature of -4.2C during a time frame of 1 hour 6 minutes. It was reported that the  vaccines were exposed (excursion 2) to the temperature of -2C during a time frame of 2 hours 20 minutes. No previous temperature excursion was reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Additional information has been requested.
pt vax;  devel pain, erythema of site.  exam revealed circumferential erythema, warm to touch, mildly indurated.  Tx w/ cold compress & Cephalexin.
Whole body Bone hurt; whole body muscle bone hurt; This spontaneous case was reported by a nurse and describes the occurrence of BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 002a21a) for COVID-19 vaccination.     Patient did not have a history of the following medical conditions such as Anaphylaxis, Asthma,  Hypersensitivity reactions, Hay fever, hives or urticaria.    On 24-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt). At the time of the report, BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's weight was reported as 210. Lab test such as Body temperature, Heart rate , Respiratory rate and blood pressure measurement was not done. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2022-555946, MOD-2022-556083 (Patient Link).
discomfort in inner right ear; redness and itching in injection site; headache; redness and itching in injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (discomfort in inner right ear), VACCINATION SITE PRURITUS (redness and itching in injection site), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness and itching in injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced EAR DISCOMFORT (discomfort in inner right ear), VACCINATION SITE PRURITUS (redness and itching in injection site), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness and itching in injection site). At the time of the report, EAR DISCOMFORT (discomfort in inner right ear), VACCINATION SITE PRURITUS (redness and itching in injection site), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness and itching in injection site) outcome was unknown.            No concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-MAY-2021 Contains Reporter/patient contact information updated upon returning call from safety. On 07-May-2021: Follow up received on 07-MAY-2021 Contains Reporter/patient contact information updated upon returning call from safety, no new information provided.
Patient reported adverse reaction to right arm after receiving pneumonia vaccine on 6/16/18. Per patient, she developed arm stiffness, warm and pain initiating at injection site on same day following injection. Patient seeked care at ER where she was diagnosed with cellulitis and received 2 rounds of IV ABX and oral ABX concurrently.
Pulmonary embolism/ Pain behind his leg; PAIN BEHIND HIS LEG; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (patient received dose 1 of monovalent Moderna COVID-19 vaccine, lot: 002A21A) on 26-Feb-2021, Moderna covid-19 vaccine (patient received dose 2 of monovalent Moderna COVID-19 vaccine, lot: 045A21A.) on 01-Apr-2021, Moderna covid-19 vaccine (patient received dose 3 of monovalent Moderna COVID-19 vaccine, lot: 939905..) on 27-Oct-2021, Moderna covid-19 vaccine (patient received dose 4 of monovalent Moderna COVID-19 vaccine and lot: 066K21A.) on 02-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 25-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) (seriousness criteria hospitalization and medically significant) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) outcome was unknown.            No concomitant drug was reported.   No treatment drug was reported. Company comment- This is a regulatory authority case concerning a 72-year-old male patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI pulmonary embolism along with the unexpected and serious (hospitalization) event pain in extremity. It was reported that after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a 5th dose of COVID vaccine schedule the patient had pain behind his leg, was hospitalized, and had a pulmonary embolism. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Received vaccine 04/11/2022, I did not have any trouble that day. On 04/26/2022 I started  having active diarrhea.  I have diarrhea 3 to 4 times a day.  I have had testing done from blood work, parasites, etc and everything is negative. I am scheduled to have a colonscopy on 07/18/2022 for further testing.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in arm) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness in arm). At the time of the report, MYALGIA (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Following my 2 dose of the Phizer Covid Vaccine I experienced a temperature of 101.0 spiking over the course of 2 days, sever body shaking, dizziness, weakness, and cold sweats. These symptoms lasted for approx. 2 1/2 days.  3-4 days following my severe symptoms I was extremely sore in my neck muscles and fatigued. My balance felt "off".
Behavioral problems resembling Autism spectrum, namely repetitive activities, lack of social skills, speech delay, toe walking, hand flapping. Problems persisting despite speech & occupational therapies (some improvement in speech noticed). Currently, planning to treat through dietary intervention & chelation.
Projectile vomiting; Vomited prior to swallowing the complete dose; This case was reported by a nurse via call center representative and described the occurrence of vomiting projectile in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KN3J4, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th February 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 9th February 2022, immediately after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced vomiting projectile and incomplete dose administered. On 9th February 2022, the outcome of the vomiting projectile was recovered/resolved. On an unknown date, the outcome of the incomplete dose administered was unknown.   It was unknown if the reporter considered the vomiting projectile to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was given the dose of Rotarix vaccine by Medication Technician, and he projectile vomited prior to swallowing the complete dose, which led to incomplete dose administered. The reporter stated that, they believed the patiet might have been overfed and the patient did not appear to be ill. Till the time of reporting, the patient had not been re-dosed. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Pain, redness, swelling, nausea, faintness, tightness, knot in arm size of ball, fever!
Fever,  chills, headache, injection site is red and warm 3 days later and extreme fatigue. Wanted to report swollen lymph nodes  under left armpit with significant pain
Right Arm Hot Hurting in & around the Bicep Muscle. Large Round Ring Oblong Ring Approximately  6 x 9. It is hot to the touch, & pain in my elbow, & shoulder joint, Pain also going down my tight arm to my hand. Not  getting any better, taking Tylenol for pain, helps some. I thought it would be getting better, but is about the same.