chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01May2021 as dose 2, single (Lot number: ER8732), in left arm, on 30Oct2021 as dose 3 (booster), single (Lot number: 301SSBA), in left arm and on 30Aug2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Aug2009. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for covid again after after being treated with paxlovid and testing negative; Negative, notes: Tested positive for covid again after after being treated with paxlovid and testing negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment: Paxlovid. Treatment start and stop date: 03Mar2023 and 07Mar2023. Indication= Treatment of COVID-19. Adverse event: Tested positive for covid again after after being treated with paxlovid and testing negative. No exposure to anyone with covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107503 same patient, different drug/event;US-PFIZER INC-202300108848 same patient, different dose and event;
New sudden onset headache starting around July 7th. First dose was 5/6/21, second dose 6/3/21. Headache worsened with bending, sneezing, and bearing down. Improves with rest and laying flat. Patient experiencing vision changes, balance issues and discoordination. Exam findings included bilateral ptosis, decreased right arm swing, right lower extremity shuffling gait, bilateral occipital neuralgia. Patient was sent for MRI brain and MRV to rule out Venus sinus thrombosis.
patient complained dizziness. she was alert and calm. vital signs stable with blood pressure 110/20 heart rate 72, pulse ox 98%. patient was lying down for 20 minutes. 1:16 pm patient said she felt better and she drank apple juice. she denied any dizziness, vital sign stable. she was alert and calm and sent home with their father.
Seen 3 days ago for HiN1 injection and Pneumococcal Vaccine, RUA. Now c/o pain, swelling, and unable to move. RUA warm, painful to touch, and w/red splotchy rash. Unable to lift >30 degrees. Patient was seen last Fri Jan 29th at this clinic and she received both the H1N1 and pneumococcal vaccines in her right arm. She now c/o pain in her arm with swelling, rash, heat to the area, and difficulty moving the arm > 30 degrees. She denies fever or baody aches.
Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 13:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: sulfa drugs" (unspecified if ongoing), notes: Known allergy: sulfa drugs; "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: I had Covid-19 in March 2020 (confirmed by antibodies in May 2020); "Chronic migraine" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; TIZANIDINE; PROPANOLOL [PROPRANOLOL]; ZOLPIDEM.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Injection site pain".  Additional Information: The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 21Apr2021 at 13:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, chronic migraine, COVID-19 in Mar2020 (confirmed by antibodies in May2020) and allergy to sulfa drugs. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN), propranolol (PROPANOLOL) and zolpidem (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event vaccination site pain was resolved within a day on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1-11-2010 One hour after receiving nasal vaccine Medimmune 500832P-teacher returned stating she now felt a little dizzy and a little queasy and a little sore throat BP 120/70 Pulse 72 R-20.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT REPORTED A SORE ARM, LIKE ANY OTHER SHOT.
Moderna COVID-19 Vaccine EUA: two days after receiving  immunization patient presented hypoxic to emergency department. Hospitalized for aspiration pneumonia. Administered antimicrobials and oxygen. Discharged to home medically stable.
ROTATEQ was administered to a patient on 06/09/2022. No additional AE information. No additional AEs/no PQCs.; Medical Assistant calling in to report a temperature excursion; This spontaneous report has been received from a medical assistant, referring to a 8-weeks-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, allergies or concomitant medications were not reported.  On 09-JUN-2022, the patient was vaccinated with rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported), following a temperature excursion (product storage error). No additional AEs/no PQCs were reported (no adverse event).
C/O OF ARM NUMBNESS AFTER RECEIVING VACCINATIONS, THEN 2.5 MINUTES AFTER C/O BECOMING LIGHTHEADED AND DIZZY
Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose
Pt recv vax on 10/14/98; on 10/15/98 pt exp fever (103), weak, headache, achy, nausea
Red, slightly warm, has a lump inside left arm injection site. Comfort measures-cold compress, Tylenol.
Pfizer BioNTech COVID-19 Vaccine EUA: Moderna COVID-19 Vaccine EUA Patient received Pfizer COVID vaccine on 4/22/2021 from medical clinic per wallet card. Patient received the Moderna vaccine on 5/13/2021 from Pharmacy and 9/30/2021 from Pharmacy
HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from  a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered as prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Vaccine was administered 19 days after it was expired.  This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 17 May -2021 patient received a dose of mRNA-1273  19 days after expired  (batch 028A21A)The benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 17 May -2021 patient received a dose of mRNA-1273  19 days after expired  (batch 028A21A)The benefit-risk relationship of mRNA-1273  is not affected by this report.
Weak / no energy; Palpitations; Feeling tired; Headachy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak / no energy), PALPITATIONS (Palpitations), FATIGUE (Feeling tired) and HEADACHE (Headachy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ASTHENIA (Weak / no energy), PALPITATIONS (Palpitations), FATIGUE (Feeling tired) and HEADACHE (Headachy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak / no energy), PALPITATIONS (Palpitations), FATIGUE (Feeling tired) and HEADACHE (Headachy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: negative negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
right arm got tender, is still tender; does feel weird now/ describing the feeling weird symptom as feeling "just off"; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off") in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off"). At the time of the report, TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: from the follow-up document there was no new information
Vaccines were given at approximately 11:30 AM.  Mother states child had fever and seizure at home at 11:00 PM that same night. Tylenol was given by parent 1 time. Child was taken and seen at ED. Information received from ER summary states vomiting and confusion as symptoms.  msv
Fever, nausea, chills, ached, headache, rash all over 4 days
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) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INTOLERANCE (non-serious), outcome "recovering", described as "My system over reacts to the vaccine"; ECZEMA (non-serious), outcome "unknown", described as "Eczema flared". Therapeutic measures were taken as a result of drug intolerance. Additional information: Reporter stated that, her system overreacts to the vaccine. Patient used medication for that, and it has been worked for her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lymph nodes inflame in armpit on the arm side of the injection. is very inflamed and painful
ten days after shot, shingles, on face; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she few years ago had Shingles vaccine and about ten days after the Shingles shot, shingles came up on his/her face. The patient stated he/she had shingles intermittently since then. The shingles shot gave him/her shingles. The follow-up would not possible as no contact details were available. This case had been linked to the case US2021AMR224904 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224904:Same reporter
Mild fever 2/11, 2/12 & 2/13 max 100 rash maculopapular on trunk on 2/14, no itch, erythema (+).
Pt vax; next AM rose to go to bathroom & fainted.  Taken to ER.
This spontaneous report as received from a registered nurse refers to a 7 week old (11 year old at 6the time of this report) patient of unknown gender. On 12-FEB-2003, the patient was vaccinated with first dose of RECOBIVAX HB (dose, lot# and route of administration not reported), on 03-APR-2003 the patient received second dose of RECOMBIVAX HB (dose, lot # and route of administration not reported and on 12-JUN-2003 (reported as a bit early) the third dose of RECOMBIVAX HB (dose, lot # and route of administration not reported. The nurse stated that it was unknown if the child had any adverse effects since the child was living outside the reporter's country at that time. It was reported that therapy with RECOMBIVAX HB was continued.  Additional information is not expected.
This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 4-year-old female patient who received FLUARIX QUADRIVALENT (batch number TS5F3, expiry date 30th June 2017). On 19th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 13th January 2017, 116 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, fever, cough, runny nose and sore throat. On an unknown date, the outcome of the vaccination failure, influenza, fever, cough, runny nose and sore throat were unknown. It was unknown if the reporter considered the vaccination failure, influenza, fever, cough, runny nose and sore throat to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received the vaccine in her left arm. The patient underwent a throat swab test and found to be positive for influenza type A and type B. The case was considered as suspected vaccination failure since the information regarding vaccination schedule which the patient was following was unknown.
No adverse event; gave expired monovalent dose l; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051b22a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l).    Concomitant drugs were not reported. The monovalent individual vial of 5.5 ml size was stored initially in refrigerator on 20-Nov-2022 and did not underwent any temperature excursion. Treatment medications were not provided.
patient stated that his muscle swelled the night of injection.  still red 3 days later when he called pharmacy to report. has been using ice on it .
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
It started out as feeling like something was stuck in my throat, then I kept coughing, it was hard to breathe because of this. By 3:15pm it had gotten much worse so I contacted my Dr. who then had me come into the office at 4pm. She stated she couldn't tell at that time if it was a reaction or if I was already getting sick and the flu shot brought it out. She told me to take Allegra when I got home and Benadryl at night. After getting in the car, the meatball feeling stuck in my throat started to move down my chest/esophagus. I got home around 5:15pm and took Allegra. I immediately undressed to take a shower and noticed I had a rash over both of my breasts. It was bright red and warm to touch. I called the office back and left a message for the doctor. The rep said not to take any medicine until I heard back from the office. While I was waiting for the office to call me back, my chest started feeling heavier and it was uncomfortable to breath (took a lot of effort) my ribs felt sore from being moved by my lungs. I didn't hear back from the office so I called the answering service around 9:30pm and explained everything to the nurse. She contacted the doctor and called me back and said to take 2 Benadryl every 4-6 hoours as needed and that should help with the hives on my chest and the meatball type feeling in my esophagus. It is the next morning now, and I still have my symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) positive, notes: tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # L006545 with expiration date 16-NOV-2017 and lot # L006546 with expiration date 27-NOV-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. The PEDVAXHIB was also exposed to 68F for 19 hours. This is one of several reports received from the same source. Additional information has been requested.
Pt called to report that she was experiencing, "hives, a rash all over."  This rash started on Sunday, 11/16/03, twelve days post vaccine administration.  Pt states no other possible environmental factors, or lifestyle changes that might has caused this rash, she is sure that it is from the influenza vaccine.  Pt has taken the vaccine before w/o adverse effects & related no know allergies to us.  She reports that she has an app't to see her MD today.  This nurse requested pt to stop by the Health Dept. while she was in town today so I could see the rash she is experiencing, but she did not return to the office.  Outcome of MD visit unknown.
p/vax pt exp 3x3 red, indurated, sl warm area on lt upper arm;pt placed on DPH;pt was seen 4/23/98;pt reported as recovered from this exp;