chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No ADR, timing EROR 2nd dose given 45 days after 1st Narrative: No ADR, timing ERROR 2nd dose given 45 days after 1st
So Friday I started with chest pain it was nipple line directly on my sternum. It was like a constant pressure. Friday as well as the pressure my heart was beating hard but not fast.  I went to the ER they did EKG, labs and urine work. They came back and said I didn't have any infections and that I looked good. They said they didn't see any signs of a heart attack. They discharged me and Saturday its been the same thing. Sunday I didn't wake up with it. As I would do active things around the house I  could feel it. It would just creep up on me and every day since then its been kind of like harder to show up but not as severe as it was previously. Monday I woke up and went to work. Its pretty much the same thing all week. I wake up and feel good but then little things will happen and it will come up. If I get upset or nervous it will come back. I feel like my heart beating really forcefully when that's not normal for me. Kind of like I was recovering from a hard work. Like it was beating hard but not fast. Monday I did go to my primary doctor and he pretty much just said he was unsure of what to do with it and gave me light duty at work. He then put in a referral for me to see a cardiologist.
At 8pm on the day of vacicnation, hives on the inside of both arms, worse on the arm where the vaccination was administered. By 8am (24 hours after the shot), intense nausea, aches, pain, headache, low fever and vomiting. Symptoms persisted until 10/18/17 at 8am.
The patient developed a rectal fever of 100.8F with mild soreness at the injection site. The patient was treated with Tylenol or Motrin.
Approximately 30 hours after receiving my second dose, I developed a rash over my entire body. As of today 3/29/2021, it has minimized, but is not completely gone.
Bruise, 1.5" in diameter with a 1/2" diameter tan area at the injection site (right deltoid). The client reported that it felt like the vaccinator, 'stabbed him' and it 'bled immediately'. They were concerned with the possibility of 'nerve damage'. Arm was sore and this progressed to the feeling of a 'dead arm' such that the client needed to move the arm with their other arm. The client applies ice to the area and did not seek medical attention. At the time of the interview (1/21/21 1730) the arm was regaining full use. The client was instructed to call back if the arm did not return to normal function and to contact their PCP as well.
BEFORE ADMINISTERING VACCINATIONS, PATIENT EXPRESSED THAT SHE WAS NERVOUS.  AFTER ADMINISTERING THE VACCINES, PATIENT WAS FINE.  3-4 MINUTES LATER, THE PATIENT FELT DIZZY AND AS IF SHE WAS GOING TO FAINT, THOUGH SHE NEVER DID.
Feeling bad during menstrual period; Stomach hurts on a unusual way; Mouth has this iron taste; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included bleeding disorder. 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 vaccination. Concomitant medications included tranexamic acid (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing and unspecified hair vitamins from an unknown date and unknown if ongoing. The patient previously received desmopressin (MANUFACTURER UNKNOWN) and experienced drug allergy. It was reported that the patient felt fine after her first dose but now on 01Mar2021 at 10:00, she was feeling bad during her menstrual period. The patient's stomach hurt on an unusual way and her mouth had this iron taste like after her first COVID-19 vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events feeling bad during menstrual period, stomach hurts on an unusual way and mouth has this iron taste was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given an undiluted dose of Pfizer vaccine.  Patient is currently pregnant, due 6/25/2021 with a scheduled induction on 6/14/2021 due to gestational diabetes.  Patient has had no adverse reaction to undiluted vaccine as of 6/7/2021.  Patient has been contacted and notified of the undiluted dose given, only report is soreness at the injection site on 6/5/2021 but much better today 6/7/2021.
This spontaneous report as received from a pharmacist refers to a 61 years old female patient with none pertinent medical history and none drug reaction/allergies. The patient was vaccinated with a dose of with ZOSTAVAX (lot # (0069AE, Expiration date 03-APR-2013) 0.65ml, SQ on 13-AUG-2012. No other co-suspects were reported. Concomitant therapy included hydrochlorothiazide (HCTZ). On an unknown date in August 2012the patient experienced "injection site it is swollen and red and warm which is the size of 4 to 5 inch diameter". The patient had phoned call and visited the pharmacy. As a treatment BENADRYL was given. The outcome of patient was reported as not recovered/not resolved. Additional information is not expected.
Legs are aching and hurting so bad I can barely walk until I stand for at least 10 minutes. I cannot sleep my legs hurt so bad, I have tried ibuprophen, tylenol, and now gabapentin. Gabapentin works the best butI still wake up with pain.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
patient was administered an expired dose of Tenivac with no reported adverse event; Initial information received on 28-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Adult and unknown gender patient who was administered an expired dose of Tenivac(DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength, dose, route: unknown) lot number not reported, expiration date: 15-May-2022, in an unknown administration site as immunization.  On 28-JUN-2022 the patient was administered an expired dose of tenivac with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Caller was wanting to know if the patient would need to be revaccinated. Caller stated she did not have any of the patients information or any further details of event.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered an expired dose of Tenivac with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was administered an expired dose of tenivac with no reported adverse 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.
Pain at injection site; Body ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
Foster mother stated child developed low grade fever to 100 next 24 hours after DTaP; C/o sore muscles; Redness and swelling at site. Pt seen in ER; Area circled with pen was 3-4 cm, irregular, border; Was red, hard, painful; I saw  72 hours later when it was normal skin in the area, No swelling or redness.
Neck pain; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   On 23rd March 2019, the patient received the 1st dose of Shingrix. On 23rd March 2019, immediately after receiving Shingrix, the patient experienced neck pain and influenza-like symptoms. On 24th March 2019, the outcome of the neck pain was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the neck pain and influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced neck pain which lasted for 24 hours. The patient also had flu like symptoms which lasted for 4-5 days.
Pt received vaccine on 03/17/2021.  Pt's wife stated that pt never felt well after receiving the vaccine.  Per hospital notes, pt lost his balance and fell at home approximately 12 hours prior to admission.  By report, he laid on the floor for around 12 hours before emergency services were activated and he was brought to the ED.  Primary diagnosis was  a closed left hip fracture with other hospital problems of the fall at home, bradycardia, coronary artery disease, hypokalemia, protein calorie malnutrition, type 2 myocardial infarction and essential hypertension.
Gave patient Fluad, patient is not +65 years of age. Informed patient about encounter, patient reported no ADR when phone called happened.
No additional AE; Both live vaccines (PROQUAD and VARIVAX) were given together on 07-AUG-20.; This spontaneous report as received from a medical assistant, referring to a 12-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliters (ml) (lot number R033653 has been verified to be valid, expiration date reported and validated as 20-NOV-2020) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 ml (lot number S021732 has been verified to be valid, expiration date reported and validated as 10-JAN-2021) (strength, vaccination scheme frequency, route of administration, and anatomical location were not reported for both suspect vaccines) as prophylaxis (inappropriate schedule of product administration). There were no temperature excursions reported. No adverse events were reported.
Information has been received from a registered nurse referring to a 13 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose was unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hospitalized for acute respiratory distress on non invasive ventilation. Acute on chronic respiratory failure. COPD exacerbation.
Left upper arm 5cm x 10 cm of erythema, and warmth, non tender to palpation cool compress and ibuprofen or TYLENOL.
This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (a little bit sore arm). On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Negative igG antibody test). At the time of the report, ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody with IgG and the result was negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were provided. Treatment products were not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.
Woke with severe Body Aches , chills  and fatigue  Two days later shoulder pain, rash  at swollen site.
No adverse effects reported; Dose inadvertently administered post expiry/ Nurse states patient inadvertently received a unspecified pediatric dose of VAQTA that had expired.; Information has been received from a nurse referring to an 18 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies,concurrent condition and concomitant medication were not provided.   On 11-JUL-2019 the patient inadvertently received a unspecified pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 unit unknown (lot # R012988, expiration date 30-MAY-2019) intramuscularly for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) had expired (expired product administered). No adverse effects were reported.
This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On unspecified date, patient had swollen lips and facial swelling. The events resulted in emergency room visit. She did not go for 2nd dose. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
No additional AE details available; have been stored outside of recommended range have been administered to patients; This spontaneous report has been received from the office manager referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent.  On an unknown date in 2022, reported as between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number U039722, expiration date: 15-DEC-2023, as prophylaxis (vaccination scheme, dose, anatomical location and route of administration were not provided) following a temperature excursion of 6 up to 14 Fahrenheit degrees (F) for 0 hours 50 minutes 0 seconds; 14 up to 46 Fahrenheit degrees (F) (15F) for 0 hours 30 minutes 0 seconds, which occured on 28-JUN-2022 (product storage error). There was stated that no previous temperature excursion occurred. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000470: US-009507513-2207USA000552: US-009507513-2207USA000553: US-009507513-2207USA000561: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
2 weeks after flu shot was given, pt had horrible (L) sided eye/forehead pressure and pain. Almost a week later moved to (R) side. Went to MD - XR showed fluid behind sinuses. Took amoxicillin - then had CT - clear. Had to go to eye doctor - he diagnosed episcleritis. Said it could have come from the flu shot.
Patient complains of migratory pain moving from deltoid to trapezius area; pain with motion, no nodule, no redness, some arm weakness, pain and soreness reported from MD office to Infection Control Director today, 3/31/11 @ 1:00PM
No adverse effects; administered in error to a nine month old patient; patient was supposed to be given the hepatitis B vaccine by GSK (Engerix B) but instead was administered GARDASIL 9 (R017624 3/17/2021) in error; This spontaneous report was received from a licensed practical nurse and refers to a 9-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 13-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R017624, expiration date: 17-MAR-2021 (exact dose, site and route of administration were not reported) for prophylaxis. The nurse reported the patient was supposed to be given hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) but instead was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in error. No adverse effects were reported.
This spontaneous report was received from a Licensed Practical Nurse concerning to a 17 weeks old male patient. On 22-OCT-2012, the patient was vaccinated with the first dose, of 0.2 ml ROTATEQ (lot not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Severe Hives Started from her waist and spread all over the body; Itching All over the Body; Allergic Reaction; Sore Injection Site; Could Not Lift the Right Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site), HYPOKINESIA (Could Not Lift the Right Arm), URTICARIA (Severe Hives Started from her waist and spread all over the body), PRURITUS (Itching All over the Body) and HYPERSENSITIVITY (Allergic Reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site) and HYPOKINESIA (Could Not Lift the Right Arm). On 21-Mar-2021, the patient experienced URTICARIA (Severe Hives Started from her waist and spread all over the body), PRURITUS (Itching All over the Body) and HYPERSENSITIVITY (Allergic Reaction). On 15-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) and HYPOKINESIA (Could Not Lift the Right Arm) had resolved. On 23-Mar-2021, URTICARIA (Severe Hives Started from her waist and spread all over the body) and PRURITUS (Itching All over the Body) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment Corticosteroid cream and HCP suggested to take Diphenhydramine and Ranitidine the night before the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information received on 18 May 2021 contains non-significant information
Local reaction at site-redness, swelling that extended 2 inches above injection site to knee area. Mother states begin to occur on 1/29/2010-took to clinic. Mother states provider at clinic unfamiliar with vaccines for children-called another provider who recommended compresses, massages and antibiotic. Antibiotic was declined mother stated. Mother states condition currently gone. Mother states child has pneumonia like symptoms.
On 2/24/2021 on arm felt itchy  and red  on the 2/25/2021 it hurt and had a rash,   on 2/26 and 27 painful' 2/28 and 2/29 very painful, looked on CDC web site for info took antihistamine and Tylenol,     Tylenol didn't help the pain so I took Advil.   Today March Its better not as much pain and swelling has gone down some    I I am reading that it is COVID arm
10 days after varicella vaccine administration, the pt broke out with vesicular lesions on face and chest.
Patient became dizzy and had ringing in her ears after getting her shot.  She stayed in the pharmacy and laid down for 10 minutes or so then she was fine.
Hepatitis B vaccine #2 given 9/18/08 around noon.  Arrived in Employee Health at 7:30 am 9/19/08 with large raised rash to all parts of body.  States has never had an allergic reaction to anything before.
(OMIC). Received flu vaccine at approximately 7:30am in leg. 8:15 am developed a scratchy throat, itching of both eyes and numbness of upper lip. As time elapsed, eyes became very reddened and developed prevalent drainage from both eyes. Symptoms persisted for approximately 6-7 hours. The person took Benadryl symptoms abated.
Neuropathy, Bell?s palsy, parasthesias, abnormal lumbar puncture with elevated IGG, migraines, MECFS, Malar rash, neuro issues with respiratory breathing issues and swallowing, muscle impairment issues, vision issues  Multiple labs, ER visits.