chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medication included losartan.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.
Patient stated that she experienced excruciating immediately after immunization. She reported that she had muscle pain throughout the left arm which radiates to the shoulder, back and neck all along until two wks ago, muscle pain stopped then she started having nerve pain, which persists till date.
Patient did not get full dose of vaccine; The needle was not screwed in properly and the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 207L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine). On 26-Jan-2021, UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 207L20A with no associated AEs.; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 207L20A with no associated AEs.
3 days after receiving TDAP - intense lower abd. cramps, then became cold and very tired. Cramps lasted 24 hrs. then abd. very tender. Very tired. Headache for 1 day. Lymph nodes started to hurt.
NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and environmental allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and fatigue. This report was non-serious.
The patient developed whole body hives with the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; AZ [AZITHROMYCIN]. Past drug history included: Cephalasporins, reaction(s): "known allergies: cephalosporins"; Tetracycline, reaction(s): "known allergies: Tetracycline"; Ketamine, reaction(s): "known allergies: ketamine". Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "The patient developed whole body hives with the booster".  Additional information: The patient did not receive any other vaccine within four weeks prior to vaccination. The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was scheduled for a Hepatitis B Vaccine (2nd dose) on 4/19/22.  After administration, nursing staff realized that the patient was given the Hep B Pediatric vaccine 0.5 mL.  After informing the provider, it was determined that there would be no harm to the patient , but she will have to come in to get another Hep B Pediatric vaccine to complete the second dose.  Patient was scheduled for 4/20/22 and did receive 0.5 mL of Hep B Pediatric vaccine.
3NOV-10NOV sore throat;18NOV c/o h/a;19NOV buzzing in head, has effected hearing;21NOV to MD h/a, dizziness, heavy head;
they found that 6 patients received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received.
FLUZONE HD was administered to a patient less than 65 years old with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who was administered Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] who was less than 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received suspect Influenza Quadrival A-B High Dose HV Vaccine at dose of 0.7 ml, once (Suspension for injection in pre-filled syringe) (strength: unknown) (lot UT7718AA, exp date: 30-Jun-2023) via intramuscular route to left deltoid to patient who was less than 65 years old with no reported adverse event (Product administered to patient of inappropriate age) for influenza(Latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
I have experienced severe bronchitis around January 17, 2022 and by January 29, 2022  it has gotten worse - my breathing was affected and I was coughing really bad and having to pause in between sentences when talking just to take a breath and have to cough again. I took Ibuprofen to ease the cough but it did not work or change the severity of the cough. My breathing was still impaired as well. This has been ongoing for 4 days with no improvement until I went to the doctor and was prescribed with Steroid Tablet (Methylprednisolone) which I'm taking 4x/day and Albuterol Inhaler (3-4x/day), Cough medicine (Promethazine) 1x/day), as of today 02/03/2022 my symptoms has improved but I am still coughing (with phlegm)
Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Received Pfizer booster on Friday at 5:00pm, after work. Onset of chest pains at 10:00am the next morning. Increasing pain by 3:00pm. Went to hospital to report worsening chest pains. Blood work taken, chest x-rays taken and EKG monitoring for several hours. Blood work, x-rays and EKG showed no issues with my heart. Was finally given Nitroglycerin (3 times) and chest pain subsided somewhat. I was admitted to hospital over-night for monitoring. Released the next morning with an RX for Nitroglycerin.
light headed, shaky, sweaty, passed out, nauseous, sore arm. Lasted about 15 minutes. Went back into clinic, monitored vitals, drank, ate and laid down until event lessoned.
PATIENT DID NOT RECEIVE ANY MEDICATION IN THE SECOND NOSTRIL/ PARTIAL DOSE; partial dose; A spontaneous report has been received from a health professional. The report concerns a female patient of Unknown ethnic origin born in 2012.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route, on 17-NOV-2022.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced patient did not receive any medication in the second nostril/ partial dose (preferred term: Underdose).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     The outcome of the event was unknown.    The event was considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): patient did not receive any medication in the second nostril/ partial dose.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Information has been received from two nurses and a consumer concerning the 67 year old male with type 2 diabetes mellitus, osteoarthritis, hypertension, obesity and a history of chickenpox in childhood and no allergies who on 19-JUn-2008 was vaccinated with ZOSTAVAX 0.5ml SC (lot # 658862/1415U). Concomitant therapy included LANTUS, metformin,
Swelling under right armpit; dose number 5; dose number 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number: 1, lot number: FL397), for COVID-19 immunization; Bnt162b2 (dose number: 2, lot number: FF2589), for COVID-19 immunization; Bnt162b2 (dose number: 3, lot number: EL3247), for COVID-19 immunization; Bnt162b2 (dose number: 4, lot number: EL3247), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 29Sep2022 at 11:00, outcome "unknown" and all described as "dose number 5"; SWELLING (non-serious) with onset 30Sep2022 at 08:00, outcome "not recovered", described as "Swelling under right armpit". Therapeutic measures were not taken as a result of swelling.  Additional Information: It was reported that the patient did not have Covid prior vaccination and not tested post vaccination.
A few minutes after the injection the patient reported a heart rate of 100 bpm being reported on her active watch.  A few minutes later her heart rate had returned to her normal range.  Patient did not feel dizzy or light headed and wanted to go home  Patient was advised to consult an allergist for a recommendation to receive or not receive the second Moderna COVID vaccine.
Headache, malaise, diarrhea. Injection site was inflamed and indurated in an area of 5cm x 10cm, and painful. This site reaction lasted 3.5 days and is not yet resolved.
CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA,  RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,
PATIENT WAS  GIVEN JANSSEN COVID-19 VACCINE AND SHE IS 17 Y.O.. APPROVED AGE FOR JANSSEN IS 18+
Patient received first dose of vaccine.  Experienced light headedness, feeling stuffy, and trouble breathing.  Patient was transported to emergency room for evaluation.  Patient was observed but did not require treatment or intervention.
Pt came in and upper left arm very red, induration and warm from 2 inch below shoulder line to below elbow and around most of circumference.
A report has been received from a Health Professional concerning a 26 year old, male subject, who had been receiving nasal FLUMIST, 2 doses. FLUMIST started on 17-SEP-2013. It was reported that the patient was administered two full doses of FLUMIST, one in each nostril on 17-SEP-2013. The outcome of the event of two full doses of FLUMIST, one in each nostril is unknown. The report was considered to be non-serious.
Side effects started with very painful left arm in muscles and joints and feeling drained of energy. Also had a fever of just under 100 F by oral thermometer. Later the first evening, muscle and joint aches spread to the rest of my upper body and headache started. Also had sinus congestion. Tried to sleep but could not get into a comfortable position and had fever dreams when I could drift off. Took 500mg Tylenol in the middle of the night and it didn't seem to help. Nauseous the following morning, no vomiting or diarrhea. Very painful aches in joints and muscles the next day including neck, upper back, jaw, shoulders, elbows, and knuckles. Couldn't focus. Slept most of that day. Sunday I started feeling better around 10am, but still had muscle fatigue. Pain in shoulders, neck, elbows, and knuckles came back around 9pm and could not find a comfortable position to sleep even with taking 1000mg Tylenol. Monday I had less joint pain but maintained muscle pain and had muscle cramps in my thighs and calves. Today I feel like I have no energy and am still having problems concentrating and remembering details from work meetings from last week.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. The vial did not undergo any temperature excursions. It was reported that the patient had no adverse event (AE) as a result of this misadministration and was monitored. Some of the vaccines were administered on 05-Nov-2021 and some on 12-Nov-2021. No treatment information was reported.
Patient presented in clinic with rapid heart beat, trouble breathing, and chest pain.  B/P 108/64, HR was 140-150 and hard to palpate. At this time EMS was called. IV was started at 10:45 NACL per PA. Patient was transported to ER via EMS. EMS ran HR in ambulance in parking lot and provided strip to clinic PA HR was 216. Patient was immediately transported to ER for treatment. 10/28/2009 ED records from 9/23/2009. Patient presented with c/o's weakness, chest pain, palpitations and SOB. Labs and Dx studies normal, patient released no Tx noted.
2 days post vaccine I got tingling and loss of feeling in my toes. This persisted, but I was able to walk. On Sept. 9, 2021. I got paralysis in my legs and was seen in the emergency room. Follow-ups with a neurologist and a multitude of tests later, the only etiology appears to be "having my immune system challenged" with the vaccine. Currently I am in PT with vestibular equilibrium loss remaining. My speech, word recall, walking ability/gait and balance has returned.
Pt. developed symptoms night of injection. Pt felt "hot"-diaphoretic-like he was going to pass out. Rested in bed x 2 days-generally did not feel well, headache, neck pain, stiff neck but full mobility. Chest pain, intermittent.
No additional adverse effect reported; patient received improperly stored PROQUAD on 5/19/2020 which was administered via unspecified route; This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-MAY-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, via unspecified route of administration (vaccination scheme and anatomical location were not reported; lot number was reported as S006019, which was confirmed to be invalid upon internal verification, with expiration date reported as 27-FEB-2021) as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored. No additional adverse effects reported.  The vaccine experienced a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.4F) for 15 minutes. There was a previous temperature excursion between 6F to 14F (11.1F) for 15 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001240: US-009507513-2007USA001370: US-009507513-2007USA001612: US-009507513-2007USA001668:
Patient received both doses of Pfizer COVID vaccine (1st dose on 2/24/21 (lot #EN6203) and 2nd dose on 3/19/21 (lot #ER2613).  She developed difficulty breathing and tested positive for COVID on 4/8/21. She was brought the ED  on 4/9/21 and was admitted to the hospital. Infectious Diseases was consulted and has been following patient during her hospitalization. COVID treatment may be started if patient's family decides that they want aggressive treatment versus pursuing comfort care due to patient's multiple medical issues.