chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After recieving the immunizations Yellow Fever, IPV, and TWIN RIX the recruit 30 minutes later went back to his squad bay. As he arrived he began to have difficulty breathing with chest tightness. EMS was called and administered meds to reduce both of those symptoms. On the way to the ER they found a rash on the left side of his chest wall. His diagnosis upon dicharge was Pneumonia.
back pain; foot pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "back pain"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "foot pain".  Is the Reporter a Healthcare Professional (HCP) was Unknown. Yea the Reporter's contact information available to you or a sub-contracted party. Is the Reporter the prescribing HCP wasUnknown  Suspect product(s): COVID-19 Vaccine   Additional information:  Interpreter/(language withheld)- swap from first time caller is consumer calling about side effects after receiving the first vaccine on 06Apr she has back pain and foot pain. Read social media. Due to long hold time. Will fax to Pfizer from an agency. For AE.  Medical Information Were not unaddressed medical questions referred or forwarded to Medical Information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th January 2022, the patient received the 2nd dose of Shingles vaccine. On 15th January 2022, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had the second shot the morning of the day of reporting and wanted to know if he/she should use heat or ice for the pain. The follow-up would not be possible as no contact details were available.
RIGHT BICEP RED/ITCHY STARTED ON 1/5/21. INJECTION GIVEN ON 1/4/21. PT STATED FELT LIKE FIRE ANTS WERE BITING HER ARM
After receiving the first vaccine for Moderna on January 10, 2021 I developed symptoms the next morning of January 11, 2021. I awoke to stiffness, swelling, red and painful joints of the hands, wrists, knees, hips and ankles. My left side including hip and leg developed pain and discomfort that has continued for 3 months. The stiffness, redness and swelling is worse in the mornings and has not improved with medication. I have been treated with methylprednisone, gabapentin and flexeril.
pt recv vax & sx of allergic rxn (immed) began 45min p/vax; pt exp hives on face, head & neck & itching which lasted 1hr;sx p/the first hr were filmy sticky eyes & dizziness lasting several hr;
Information has been received from a licensed practical nurse concerning an 8 year old male with no known allergies or pertinent medical history who on 02-OCT-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On approximately 05-APR-2007, the patient experienced chickenpox. Unspecified medical attention was sought, there were no lab tests performed. The patient was treated with oatmeal baths and Caladryl. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Fever, chills, malaise, headache, body ache , soreness at injection site.  Started approx 10 hours after injection.
On the second day, I had to drive to get the car serviced. When I got home I was very dizzy, got out of the car took 12 steps backward I was so dizzy it did not end in a fall.. I went into my house and tried to eat and it turned my stomach just to look at food. I lay down and slept until 10 am the next day. Now when I get up in the morning I am too dizzy to walk to the bathroom. I must wait 5 minutes before getting on my feet.
Ringing in ears same day as vaccine was adminstratedJoint pain, headache, dizziness, chills, fever, soreness at injection site and nausea. (Dizziness and nausea lasted 3 days) All the symptoms have gone away EXCEPT FOR TINNITUS IN BOTH EARS.
The patient's age at time of vaccination was 17. The age limit for COVID vaccine is 18 and above. We have spoken with the patient and confirmed that he has not experienced any adverse effects as a result from this unusual occurrence.
Chills; Fever; Fatigue; Weakness; This is a spontaneous report from a non-contactable consumer, the patient.  A 71-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 14:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included polycythemia vera. Concomitant medications were not reported. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM), levofloxacin (LEVAQUIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 11Mar2021 at 16:00, the patient experienced chills, fever, fatigue and weakness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab test on 14Mar2021 which included polymerase chain reaction (PCR) test via nasal swab and the test result was negative. The patient did not receive any treatment for the events chills, fever, fatigue and weakness. The clinical outcomes of the events chills, fever, fatigue and weakness were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
1. Fever 0.8 degrees above normal, no treatment, resolved by morning. 2. Burning itchy rash on scalp and back of neck, treated with 12.5 mg benedryl, resolved by morning. 3. diarrhea, mild, no treatment, ongoing at this time (6pm 5/22/21)
PT HAD RASH ON CHEST ONLY AND BREAST AREA NOT ON INJECTION SITE OR ANYWHERE ELSE/ NO ITCHING /NO BREATHING PROBLEMS /SAID SHE DIDNT KNOW IF IT WAS FROM INJECTION SINCE IMMUNIZATION WAS 2 DAYS PRIOR.
I became paralyzed from the waist down. I had MRI's, I had a lumbar puncture, they did exploratory surgery inside my stomach. They put a scope down my throat. I have a appointment with the neurologist. I have also seen an infectious disease doctor.
This spontaneous report was received from a medical assistant referring to a 29 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2008, the patient was vaccinated with hepatitis B vaccine (manufacturer unspecified) (dose number, dose, frequency, lot number, expiration date, frequency and route were not reported). Concomitant medications were not provided. On an unknown date, the patient experienced pyrexia and rash but she did not seek medical attention at that time and no treatment was given for the adverse events. No product quality complaint (PQC) was involved. At the time of the report, the outcome of pyrexia and rash was reported as recovered on an unspecified date. Additional information is not expected as no contact permission was provided.
fast heartbeat within 4 and 5 weeks after administration of menactra; Initial information received on 06-Oct-2022 regarding an unsolicited non-valid serious case received from other health professional.  This case is linked to case 2022SA413588.  This case involves Adolescent female patient who experienced fast heartbeat within 4 and 5 weeks after administration of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (dose, strength, formulation, and lot number: unknown, expiry date: 22-Apr-2023) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency: approximately after 4-5 weeks), the patient developed a serious event of fast heartbeat within 4 and 5 weeks after administration of menactra (heart rate increased).  Nurse says that she considered the incident to be serious because she had to call 911.  Feels this was a serious event since her daughter is still experiencing rapid heart rate and sees a pediatric cardiologist and had her heart monitored for 14 days. She wants it noted the event didn't happen while she was receiving the vaccine.   Action taken : not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: Not recovered/not resolved  Seriousness criteria: medically significant.    Additional information was received on 25-Oct-2022 from other health professional: Patient gender and age group was added and case was upgraded to valid case, event seriousness was updated to serious and narrative was amended accordingly.; Sender's Comments: Sanofi Company Comment dated 01-Nov-2022: This case involves Adolescent female patient who experienced fast heartbeat within 4 and 5 weeks after administration of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. However, the patient's vaccination history, medical history, tolerance, concomitant medications, allergic history and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed individually assessed.
Client's employment called stating she had a rash, hives and the roof of her mouth was numb.  They thought she had taken benadryl earlier in the day.  Encouraged client to report to the closed ER for further evaluation and treatment.
SEVERE vertigo for 3 weeks; Extreme vomiting; headache; blurry vision; dizzy - couldn't walk; dizzy - couldn't walk; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 60-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: ew0153), via an unspecified route in the left arm on 19Apr2021 at 11:00 (age at vaccination: 60-year-old), as a single dose for covid-19 immunization. Medical history included known allergies to penicillin and high blood pressure. Concomitant medications included lisinopril 10mg. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: er8727), via an unspecified route in the right arm on 29Mar2021 at 11:00, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 21Apr2021 at 02:00, patient experienced severe vertigo for 3 weeks, extreme vomiting, headache, blurry vision, dizzy - couldn't walk for a couple weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroids, anti-vertigo, anti-nausea and antibiotics. The clinical outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
no adverse event; patient received an expired dose of varivax; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (S02469 invalid lot, but expiration date reported as 17-MAR-2022). On 01-MAY-2020, the patient was vaccinated with expired doses of varicella virus vaccine live (oka/merck)(VARIVAX) with a lot # R011809 and expiration date:23-APR-2020 (strength and dose were not reported) via subcutaneous route for prophylaxis (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.
STROKE; This spontaneous report received from a patient via media concerned a 38 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was a dad to a 3 year old boy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 21-AUG-2022 for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke from the vaccine and still at the time of reporting patient was not able to speak or fully use limbs. It was reported as "38 year old male/dad to a 3 year old boy - stroke from the vaccine in 8/21 and I still am not able to speak or fully use limbs" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230211299- stroke.. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
pt recv vax & became pregnant (LMP 10FEB97);MD noted that pt did not administered varicella vax;APR97 8 wk p/last menstrual period pt had a 6+ week fetal pole w/o fetal heartbeat & exp a missed spontaneous abortion;
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient who was less than 65 years old (of an unknown age and gender), received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
flu; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves a patient unknown identifiers who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for immunization. Information on batch number is requested  On an unknown date the patient developed "flu" (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Received shot Friday night, Sat. OK, Sunday very tired, SUnday night, fever reaching 101.9 for several hours, body aches, chills. Fever broke during the night. Monday a little tired. A four iinch diameter red area on shot site.
Rash around her lips and chin/ having pain on that region since last night; Rash around her lips and chin/ having pain on that region since last night; This spontaneous case  was received on 24-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02277) and concerned a 62-year-old, female patient.   The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis.   On 23-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, left arm) for flu prevention. The batch number reported was P100230210, expiry date: 22-Jun-2021.   On the same day at night, after receiving Afluria Quadrivalent, the patient developed rash around her lips and chin, and she stated having pain on that region.   The patient did not receive any treatment for the events.   At the time of initial reporting on 24-Sep-2020, the patient had not recovered from the events.    The reporter did not provide causality assessment. The pharmacist thought it could be related to patient's psoriasis.  The reporter assessed the events as non-serious.  Company comment: A 62-year-old, female patient was administered Afluria Quadrivalent vaccine. On the same day at night, after receiving Afluria Quadrivalent, the patient developed facial pain and rash. The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis. Causality is assessed as possibly related for both events, due to plausible temporal relationship.; Sender's Comments: A 62-year-old, female patient was administered Afluria Quadrivalent vaccine. On the same day at night, after receiving Afluria Quadrivalent, the patient developed facial pain and rash. The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis. Causality is assessed as possibly related for both events, due to plausible temporal relationship.
staff administered 2 doses with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who experienced staff administered 2 doses with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE twice(strength, dose, formulation, route, lot number not reported) in unknown administration site for immunization.  On an unknown date the patient reported a non-serious staff administered 2 doses with no reported adverse event (extra dose administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: 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.
Began to note shortness of breath and chest tightness, some dizziness.  No treatment sought.  Rested.  Some nausea, lack of appetite.  Symptoms gradually resolved today.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild
9:00 AM 5/30: Severe vomiting, high fever, gray color, non-responsive. Went back to the clinic. They gave him juice and sent us home. He vomited again on the way home, so we took him to the walk-in clinic. He vomited again in the parking lot. That doctor told us to take him to the Emergency Room immediately, as patient was lethargic and his fever was rising. He vomited once more on the way to the E.R. The doctor there tested him for strep throat, did a chest x-ray to check for pneumonia, and checked his urine for a UTI. All came back negative. He informed us that patient had probably just been upset about receiving the vaccination, or had caught another bug and it was just coincidence that he started vomiting after the vaccine. He sent us home. Patient continue to vomit irregularly for two days, until finally we saw a naturopathic doctor who gave us some remedies to help reduce his nausea. Those helped, but patient continued to vomit once every couple day for two and a half weeks. He also had extremely low energy and lost his sense of balance for about a week following the vaccination. Prior to receiving the vaccine, he loved to swing as high and fast on the swing as possible. After receiving the vaccine, he only wanted to swing very slowly. That continued for about 6 months after the vaccination.
Iron deficiency anemia due to chronic blood loss -  He was given 80 mg IV protonix, Zofran, 2 g IV magnesium in ED. On admission, GI was consulted. Underwent EGD on 3/21 which showed reflux esophagitis, and a deeply cratered non-bleeding duodenal ulcer with visible vessel. Vessel treated with bipolar cautery. Discharged home. ED visit to hospital admission within 6 weeks of receiving hte COVID vaccine.