chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the arm I got the vaccine in the muscle pain disappeared; the arm I got the vaccine in the muscle pain disappeared; arm muscle hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single dose for covid-19 immunisation. Relevant medical history included: "Muscle pain" (unspecified if ongoing), notes: As of two weeks ago my muscles in the back of my thighs, buttock cause me so much pain I actually ordered a walker because I need more than a cane for this pain. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "the arm I got the vaccine in the muscle pain disappeared"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm muscle hurts".  Information about lot/batch number cannot be obtained. No further information expected.
Since October Hair Loss January 27 bleeding (mensural).  Have not had a cycle in 20 years
Patient is Immunocompromised.  Received 1st booster dose (4th dose) too soon after 3rd dose.  Was given 3rd dose on 4/28/22 then inadvertently given 1st booster on 5/20/22.  Pt. reports no side effects from dose given on 5/20/22
ErythemaMultiform itching, soreness, heat to touch Narrative:  Itching, redness, heat, soreness at injection site. Has hx of arm paralysis from flu vaccine, also hx of hives and angioedema. None of these s/s reported at this time. S/S resolved.  Other Relevant History:
None. Pt should have received .5 ml of Flu vaccine but was given .25 ml by mistake. (Pt turned 3 years old on 12/3/06)
Enlarging redness, heat and pain/swelling in Left UE since Monday. No underlying/active skin issues; has distant h/o molloscum in h.s. Reports 3" of redness and itch presented in LUE w/n several hours of the injection. Since then the area of redness has enlarged, itch resolved, now painful, enlarging, and firm/hot to the touch.  Rapid onset of redness and itch within hours of typhoid and pneumoccal vaccines given on 12/2/19; itching has since resolved and patient has developed a large, enlarging red indurated painful patch on L UE w/o any systemic sx or sign of anaphylaxis. Sx could represent an immediate type localized hypersensitivity reaction, a strong inflammatory rxn to one or both of the vaccines, and/or a secondary bacterial cellulitis. No purulence, fluctuance or known MRSA exposure. We discussed empiric coverage w/ abx that could cover MRSA and MSSA, individually and together. Will start tx to cover MSSA. Patient expresses agreement w/ above treatment plan, and all questions are answered to the patient's apparent satisfaction.   DICLOXACILLIN SODIUM 500 MG CAPS; 1 CAPSULE EVERY 6 HOURS; 5 DAYS; QTY 20 CAPSULE; 0 REFILLS (New) Rx Issued via Electronic (Network)
Post vax, pt became irritable, fussy and began vomiting. Pt would not take solids or liquid food. Pt fell asleep and would not awaken or arouse. Pt seen in ER that evening. Pt seen at physicians office the following day and was sleepy but awake and playful.
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife who reported for her husband. The age at vaccination was not reported. The patient's wife reported that, the patients experienced some side effects after receiving the dose of Shingrix. The reporter wanted to know should he go to his primary care.
Child's (L) knee swelled up to grapefruit size - v - painful. In ER on 10/17/10; to rheumatologist on 10/19/10 - diagnosed with probable juvenile rheumatoid arthritis.
PATIENT HAS HAD HISTORY OF FAINTING IN THE PAST FROM MEDICAL PROCEDURES, INCLUDING VACCINATIONS. PATIENT SEEMED OK AFTER VACCINE, WAS ADVISED TO SIT FOR A WHILE, BEFORE COMING BACK TO PHARMACY/WORK (PT IS A PHARMACY TECHNICIAN) SHE RETURNED AFTER ABOUT 5 MINUTES, AND SEEMED OK. WAS TALKING AND SMILING, AND THEN ABOUT 5 MINUTES LATER SAID SHE WAS FEELING WOOZY. SHE WAS ADVISED TO SIT DOWN AGAIN, BUT WHILE SHE WAS IN PROCESS OF SITTING DOWN, SHE PASSED OUT VERY BRIEFLY... JUST FOR A FEW SECONDS. A SECOND PHARMACY TECHNICIAN CAUGHT HER ON HER WAY DOWN, AVOIDING ANY INJURY TO VACCINATED TECHNICIAN.
Administered the Moderna COVID 19 vaccine after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided    Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Added contact information
Patient had a vasovagal reaction 5-10mins after administration and had LOC for a good 5-7secs.
Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told to increase Lasix to 40 mg daily for 4 days. Swelling became worse over next 2 days and patient became short of breath and on 03/02/2021 she went to Hospital and had a CT scan of chest which showed a pulmonary embolus  and  a bilateral lower extremity ultrasound which showed a right femoral DVT and popliteal occlusive thrombus and a posterior tibial and peroneal vein occlusive thrombus. She was started on Lovenox  and admitted to the hospital . she was discharged on 03/05/2021 and had a right femoral thrombectomy as an outpatient on 03/ 08 2021 with complete resolution . She was discharged home on Lovenox and later switched to Eliqus. She is home and doing well at time ofreport.
Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. On unknown dates unspecified number of improperly stored GARDASIL 9 (lot# M011117, expiration date 07-DEC-2017 was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one several reports received from the same source. Additional information not expected as there is no consent to contact the physician.
4/11/22 patient called to report lingering occasional right shoulder pain.  No swelling and not painful to the touch, but every now and then he will feel pain when he is pushing or pulling something or moving his arm in a certain way.  Started a few days to a week or 2 after pfizer booster shot (not exactly sure when he noticed it, but it wasn't the same day as the shot).  Patient said he put ice on it and tried different types of pain relievers.  He mentioned it at the doctor's office during an office visit and his nurse said that the same exact thing happened to her.
This spontaneous report was received from a physician concerning a 53 year old male patient. The patient's concurrent conditions included LGL T cell leukemia and chronic neutropenia. The patient's historical drugs and medical history were not reported. On 04-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for vaccination (prophylaxis). The patient's concomitant medication included hydrochlorothiazide. On the same date, the patient developed joint pain, rigors and possible cellulitis at the injection site. On an unspecified date in May 2017, the patient was admitted to a hospital where he was treated with unspecified antibiotics. No lab diagnostics studies were performed. On an unspecified date, the patient sought medical attention. At the time of reporting, the status of the patient was unresolved. The causal relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
fatigue began later in the evening of 12/29/2020, Headache began 12/30/2020 worsened throughout the day and "flu like symptoms",  12/31/2020 continued with fatigue, redness and knot at site of injection.  1/1/2021 itching at site, redness with a ring appearance around injection site.  Had ED visit for symptoms 1/1/2021, given Benadryl and an antibiotic.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was administered booster shot from the vial which was expired on 3-Apr-2022. No side effects were reported.  No treatment information was provided.
Rapid heartbeat; Chills; Sore arm; My entire left arm was sore; low blood pressure and my blood pressure was 81/51; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 14:20 (Batch/Lot Number: EN6198; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date , gastrointestinal disorder from an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for anticoagulant therapy, start and stop date were not reported.  The patient experienced rapid heartbeat, chills, sore arm, His entire left arm was sore, low blood pressure and his blood pressure was 81/51.  The patient underwent lab tests and procedures which included blood pressure measurement: low on blood pressure measurement: 81/51 on heart rate: 60 heart rate: rapid  83. Therapeutic measures were taken as a result of rapid heartbeat with Diltiazem. The outcome of the events was unknown.  Additional Context: Consumer stated "I am calling I had the Pfizer vaccine on 05Mar2021 and I have a heart condition and I am calling to report a side effect that occurred about 11 hours, I became aware about a side effect of rapid heartbeat for about 11 hours, it was during the night. Is this the number where I can (incomplete sentence). I wanted to know if this is a common adverse event, side effect?"  When confirmed the consumer wanted to report the side effects, consumer stated, "Yes I wanted to report the side effect, I have atrial fibrillation and I take medication for that and 11 hours after my first vaccine I had rapid heartbeat even though I had medicine (Unspecified Medication) in my blood stream. I take medicine 24/7 to control, to prevent rapid heartbeat. Usually my heart rate would be, and this was during the night I woke up and it was my pulse was 83 and that is very rapid for me especially since I am under the influence of the heart medicine (Unspecified Medication) to keep it down. Usually that time at night my heart rate would be about 60 and I had to take additional heart pills during for about 12 hours (further clarification unknown)." When informed the role of Pfizer Drug Safety, consumer stated, "But you don't, do you have any feedback or response from all this massive inoculation as to whether this is the, it was not a sudden fast heart rate and it was not sudden because I am under the medication 24/7." Consumer was informed about Pfizer Medical Information and offered the number. Consumer was provided with the number of Pfizer Medical Information # and was requested to select option 3, timings as and 8 am to 11 pm Monday to Sunday as per (EST). Email: Consumer stated, "I don't, the device is broken."   No follow-up attempts are Possible. No further information is expected
Patient woke up with an itchy red rash on her left arm and torso on 10/2/20. She stated this was the first day it ha started since she had gotten the vaccination and that she had not changed any personal care products that would have left her with a rash. I instructed her to take an antihistamine and use OTC hydrocortisone and ice to relieve itching. She stated she was going to call her dermatologist to see if they would see her because the itching was bothering her.
No further adverse effect reported.; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 24-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S014947, expiration date: 10-DEC-2020; dose details and route were unknown) for prophylaxis (product storage error).           The vaccine was stored below 36 degrees Fahrenheit (34 degrees Fahrenheit) for 27 minutes. There were no previous temperature excursions. The digital data logger was involved. No further adverse effect reported.
She complained her leg was hurting and showed us her leg. The shot site was swollen and red. She said it was itchy and hurting. We elevated her leg and rubbed around the site and put ice on it
Pt presented to ED on 11/15/09 complaining of pain and weakness in extremities over the last two weeks.  She had received her H1N1 vaccine approx. 3 weeks before presenting.  She was admitted to the hospital for ascending weakness. Remains hospitalized.   11/23/2009 and 12/4/09 - Hospital records and discharge summaries received. Service dates 11/15/09 to 11/21/09. Discharge Diagnoses Include: Paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Patient presents having noted pain and weakness in extremities. Left side weaker than right. Weakness occurs primarily at night, pain worse after rest. Numbness feet and fingers. Mild headache. Single episode of bladder incontinence. Tingling sensation lower extremities. Unsteady gait. Concerns regarding Guillian-Barre Syndrome. "Popping" sensation in muscles. Developed respiratory distress and anxiety. Pleuritic chest pain. Fever.   01/05/2010 PCP Medical records received. Service dates 11/14/09 to 12/15/09. Assessment: Presumed GBS. Patient presents with pain and weakness in extremities. Crawling sensation in extremities. Loss of bladder control. Hospitalized. Follow-up visits. Using walker. Short of breath. Continued difficulty with activities of daily life.
07 month old female patient administered expired dose of Pentacel, no AE; Initial information received on 11-May-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient (reported that 7 months, 1 week, and 3 days) who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Past vaccination included PEDIARIX.  Medical history, medical treatment and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 04-May-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ163AA and expiry date: 03-May-2021) (Frequency once) via an  intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the caller stated that PENTACEL was administered to a patient 1 day after the expiration date. The caller would like to know what the protocol is for this issue. Caller asking how to proceed if an expired Pentacel was given to a patient.  At the time of report 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 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.
Information has been received from a registered nurse concerning an elderly male (age not reported) who on 02-JUL-2007 was vaccinated with a second dose of PNEUMOVAX 23 (lot # 655290/0959F) 0.5 ml IM.  No other vaccines were given on that date.  On 02-JUL-2007, a few hours after being vaccinated, the patient experienced soreness at the arm.  Medical attention was sought.  There was no swelling or redness.  The patient rated his pain a 9 out of 10 on the pain scale by that evening.  The nurse was very concerned about the patient because of his pain rating especially since he has prior immunizations and was in the army.  Follow-up information was received from the registered nurse via a phone call.  The patient was seen on 04-JUL-2007 and he was feeling better, but he drove the other day and said his arm was sore again so the pain was not completely gone.  No further information is available.
DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.
Pain in upper arm around injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8713) via an unspecified route of administration in the left arm on 13Apr2021 at 16:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021 at 17:30, the patient experienced pain in upper arm around injection site. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in upper arm around injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Child received routine vaccinations on 4/4/01. Seen in ER on 4/6/01 with symmetrical dry rashes on the outer aspects of lower extremities; fever (98.8F on Tylenol); and listlessness.
This spontaneous prospective pregnancy report as received from a consumer refers to her 27 year old daughter. On an unknown date, "several years ago", the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The consumer reported that "recently", the patient became pregnant. The patient underwent an urine and bloodwork pregnancy tests that were positive. The LMP and EDD were not known. The patient was recently diagnosed with HVP. The patient was experiencing a heavy discharge with a distinct odor accompanied with a slight fever, burning when urinating, extreme tiredness and nausea. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pain in her jaw; numbness on her left face; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 2nd dose schedule on 21Apr2021. Patient asked if she could take the 2nd dose vaccine because she experienced a reaction after the 1st dose (pain in her jaw and numbness on her left face). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She received her covid vaccine around 1700.  She had a reaction that we monitored in the observation room for approximately 40 minutes.  She was not feeling better so we took her to the ED for monitoring.  She was discharged from the ED after an hour and a half.  No intervention was needed.  Her symptoms were feeling flushed/ anxious/ shaky, injection arm felt hot (was cool to the touch), HR was 117, BP was 143/96, which is high for her.  We are recommending she reach out to her PCP prior to scheduling her second dose.
24 hrs after vaccine pt right arm had 8 1/2 x 5 erythema, no fever.
local rxn 2cm red, 4cm hard area; devel p/24hr & fever 101+
Patient reports feeling slight lightheadedness and dizzy, flushed, (but no sweating) for a few seconds post vaccination.  Patient was seen and cleared by EMS (BP 118/81, HR: 72).   Instructed patient to call PCP,  911, or go to the nearest emergency room for any further issues.