chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial fibrillation; Hard to breathe; A spontaneous report was received from a consumer (patient's wife), regarding a 37 years-old white male patient, unknown ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, atrial fibrillation, uncomfortable (discomfort), and hard to breathe (dyspnoea).  Current medical conditions reported as controlled atrial fibrillation and cardiomyopathy. Past medical history includes atrial fibrillation diagnosis (May 2018) and stroke (May2018/hospitalized). Weight reported as 180 lbs.The patient's medication allergy included albuterol inhaler. Concomitant medications reported included are rivaroxaban, levetiracetam, bisoprolol and flecainide.  On 15 JAN 2021, one day prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 029L20A), at a dose of 0.5 ml, intramuscular in the left arm for the prophylaxis of COVID-19 infection.  The consumer reported that the patient became uncomfortable and it was hard to breathe on 16 JAN 2021. On 17 JAN 2021, in the morning, the patient went into atrial fibrillation. The patient received treatment medication with a double dose of flecainide and went back into normal sinus rhythm about 2 hours later. On 18 JAN 2021, in the morning, the patient had a second occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 21 JAN 2021, the patient again developed atrial fibrillation third occurrence, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 27 JAN 2021, the patient had a fourth occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. These adverse events were reported to his physician. The consumer stated that she can be further contacted if the safety department follows up for any additional information.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, atrial fibrillation, uncomfortable, and hard to breathe, were reported as not recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The patient's medical history of atrial fibrillation and cardiomyopathy remains a confounding factor. Further information has been requested.
A 16-year-old patient was inadvertently administered the Moderna vaccine with a booster dose (0.25 mL). The vaccine is approved for patients over 18 years of age. At the moment, the patient has not reported any adverse effect from the administration of the vaccine. Pfizer will be administered as a second dose, as recommended for young people 12 years and older.
On 07/31/2022 I was or felt heavy and tired on 08/01/2022 I had a headache and started coughing on 08/02/2022 I took a COVID19 test which resulted in positive. I had a severe illness, fever, body pain, coughing and remained at home in bed for a week.
Patient received vaccine and was monitored for 15 minutes, about 10 minutes in during monitoring patient reported tongue "swelling" and funny feeling/tingling. No dyspnea, chest pain, wheezing, lip swelling or change in vital signs. Patient was treated with 50 mg Benadryl and monitored for 1 hour until 1030. Patient's symptoms did not change after Benadryl, did not improve or worsen. Patient provided with contingency to call our office with any changes, continue Benadryl as needed and ultimately follow up with Emergency care as needed.
Burning and stinging in head as soon as I woke up the day after getting the vaccine. Feels like my brain is being pricked by needles. It?s been 4 hours and hasn?t stopped yet.
Developed the following conditions in Feb 2010. They began after he had his initial anthrax immunization and continued while received 2 more. He feels illnesses are caused by the anthrax immunization. Daily headaches that can occur one to several times a day. Vertigo with nausea that can occur one to several times a day. Anxiety attacks that cause knife-like pain in anterior, right and left chest pain (sharp with pressure), accompanied by SOB that occur 1 to several times daily. IBS with diarrhea. Fibromyalgia. Thrombocytopenia.
MD had no problems until 1 wk p/vax when arm became swollen, cool to touch & blue from shoulder to hand; was seen in ER 8DEC & 9DEC due to inc swelling & pain; venogram revealed clot in ax vein; hospitalized 14DEC to 19DEC92;
After shot 1 and 2 a rash appeared on abdomen around belly button area/flared up again 5-6 days after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 13:00 (Lot number: Ew0172) at the age of 17 years as dose 1, single and administered in arm left, administration date 17Aug2021 13:00 (Lot number: Fc3182) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; ACCUTANE; ESTARYLLA. The following information was reported: RASH (non-serious) with onset 01Aug2021 12:00, outcome "not recovered", described as "After shot 1 and 2 a rash appeared on abdomen around belly button area/flared up again 5-6 days after 2nd dose". Therapeutic measures were not taken as a result of rash.  Additional information: After shot 1 and 2 a rash appeared on abdomen around belly button area. It faded after a week but flared up again 5-6 days after 2nd dose. Patient was not have Covid prior to vaccination and not tested for Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (same reporter). This case involves 76 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Initial misuse report received from a healthcare professional (nurse) on 06 March 2014. A 35-months-old patient (2 years 11 months) had inadvertently administered a dose of 0.5 ml of FLUZONE instead of the 0.25 ml. No adverse event was reported. List of documents held by sender: none
Patient had redness, pain, and swelling the size of a baseball at the injection site.  She went to the ER due to continued symptoms 2 days after the injection.  The clinician who treated her at the ER observed that the injection had been in the subcutaneous tissue rather than the muscle, causing a hematoma, per the patient's report to the pharmacy.  The doctor prescribed acetaminophen, ice, and cephalexin as treatment.  The patient reports she did not take the cephalexin because her symptoms were improving  before she could fill the prescription the next day.
Pt had fever 2 days later and area of arm where she had r'ced PNEUMOVAX was red and sore.
Severe shoulder and arm pain on affected side. Decreased ROM. Tender to palpation. Cannot use arm due to pain.
Nodule returned, but the size of a pea; Fever went to 102 degrees Fahrenheit; Lump completely disappeard, (Vaccine) targeted that lump; Had "all the side effects"; Achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), NODULE (Nodule returned, but the size of a pea), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 047821A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule (A Subcutaneous nodule on the bottom of her butt).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump). On an unknown date, the patient experienced NODULE (Nodule returned, but the size of a pea). At the time of the report, VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) outcome was unknown, NODULE (Nodule returned, but the size of a pea) had not resolved and PYREXIA (Fever went to 102 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.         No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-372399 (Patient Link).
Rapid heart rate (atrial flutter), chest pain with elevated troponin, fever, fatigue, shortness of breath, lightheadedness
Patient started to fill dizzy, light headache,  shortness of breath and swollen throat 10- 15 minutes after given vaccine. Epi pen was given.  EMS were called, gave patient Benadryl and fluid. Patient was taken to the nearest hospital
vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022; 10 patients were administered with an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 3:27 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022).    Concomitant drugs were not reported.  It was reported that the vial was stored in refrigerator on 25-Apr-2022 and vial did not undergo any temperature excursion. Dose or volume of dose 1 and 2 were reported as 0.5 and 0.25 for dose 3.  Treatment medications were not provided.   This case was linked to MOD-2022-558779, MOD-2022-558776 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Follow-up received include new reporter, patient demographics, lab data, suspect product information, vaccination time and narrative updated.
Much worse on second vaccine then first. I didn?t take my adaptogens on second shot until third day. First injection site started hurting along with second site on other arm
Left axillary swelling and tenderness; seen by PMD; given antibiotics; swelling resolved.
headache; very achy; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 29th May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On 30th May 2019, the patient experienced headache. On an unknown date, the outcome of the influenza-like symptoms, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she received Shingrix the day before reporting and same evening she started feeling achy after dinner and on the date of reporting she has a headache and was very achy. The patient felt like she has the flu.  The reporter did not consent to follow up.
Fever reaching 105 degrees (24 hours post vaccination). Severe chills and shaking. Throat tightening - subsided and needed no further treatment. Severe body aches. All symptoms started approx. 4 hours post vaccination and intensified every hour until about 48 hours post vaccine and then fever decreased and body aches diminished slightly. Treated with extra strength TYLENOL. Called her MD - no treatment needed such as ER or Hospitalization.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
pain in and under left shoulder/blade; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date/time: 09Apr2021, Time(24 hr): 21:00, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EW0150), administration date: 09Apr2021, when the patient was 51-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Date/time: 30Apr2021, Time(24 hr): 20:45, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EW0169), administration date: 30Apr2021, when the patient was 51-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3(BOOSTER), SINGLE, Date/time: 21Nov2021, Time(24 hr): 14:30, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: FH8030), administration date: 21Nov2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "pain in and under left shoulder/blade".  Additional information: Pain in and under left shoulder/blade, was sudden onset. Made me concerned it could be something else. Can't remember how long it lasted.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201349553 same patient, different dose and event;
pt recv vax 2JAN96 & the next day devel an inj site rxn characterized by induration & redness;
09:15 AM Patient had a syncope episode immediately right after the vaccine was administered. Patient skin color looked pale and he took a while to catch his breath right after the syncope episode occurred. PA was notified and she examined the patient and after 22 minutes the patient was doing better and was released. T 98.4 F (tympanic) P 121 bpm (finger clip, sitting), O2 Sat: 97% (room air) Glucose Level: 75 Test done at 0942 mg/dl.
Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. Information about medical history and concurrent condition were not reported. On 10-JUL-2017, the patient was vaccinated with one dose of ZOSTAVAX injection (Batch# M009777 (which is not valid lot number for zoster vaccine live) with expiration date of 04-MAR-2018), 0.65 ml, subcutaneously for prophylaxis reconstituted with sterile diluent (lot# M044950 with expiration date of 30-MAY-2019), instead of VARIVAX. No adverse effects were reported.
Client reported tongue sensation and rapid palpitations to EMT. Patient was alert and oriented to person, place, and time. Pt was moved to gravity chair by self-ambulation. Pt denied Chest pain, Shortness of breath, nausea and vomiting, and dizziness. Tongue and airway was assessed by EMT  and RN. Airway was clear and patent upon assessment. Vital signs 1116: 132/82 HR 100 02 100%. 1123 33129/82 HR 84 02 99% 1150 124/84 HR 88 02 99% 1153. Pt reported feeling nervous. Pt was given oral Benadryl at 11:23am 50mg self-administered. Pt vitals were assessed after administration of Benadryl and remained stable. Client reported no allergies. Client reported history of Hypothyroidism and reported she had not taken medication in the morning. Pt reports eating before coming to vaccination site.  Client consented in staying an additional 30mins for observation. Client remained stable throughout observation and stated she felt better. She was given instructions with follow up with her primary health care provider. Emergency precautions were given if symptoms worsened. Client verbalized understanding. Client left site in no apparent distress.
Pt. received GARDASIL #2 at 8:30 this AM. She returned with severe pain & swelling of the entire right arm. The shot was given in the (R) deltoid. Most of her pain & swelling however was in the (R) forearm. She was very sensitive to touch, (+) paresthesias. She was referred to the ER for concern of compartment syndrome.
Tetanus shot. Red, sore. Bump 3 to 4 inch in diameter-lasting about 2wks and still have a bump about dime size. NO pain , no redness. Hep B shot, sore, redness, bruise, about 3wks. still have knot size of a pen size. Not sore not painful.
A sales representative reported that a 4 month old male received Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 02/22/00. Immediately, post vax, Acel-Imune, he developed swelling at the injection site. He was treated with Benadryl and the swelling resolved after 5 to 7 minutes. This is 1 of 2 pts from this facility who experienced this event following receipt of Acel-Imune, lot 466023.
Patient stated that she had swelling on the arm where she received the vaccine. It was swollen and warm to the touch. The swelling almost spread to the whole arm. She went to the urgent care and had a scan. Practitioners claimed that it was infected and gave her 2 antibiotics.
she has felt achy all over; nauseated; she is having malaise; she is feeling "pretty sick"; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 83 years old female patient who felt achy all over (pain); nauseated (nausea); she was having malaise; she was feeling pretty sick (malaise), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Polymyalgia rheumatica.  No concomitant medication were reported.  On 05-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the left arm for prophylactic vaccination.  On 08-Oct-2020, the patient felt achy all over (pain); nauseated (nausea); she was having malaise; she was feeling pretty sick (malaise) 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was pain, nausea, malaise.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAY-2014, the unspecified number of patients were vaccinated with ZOSTAVAX, subcutaneous (lot number, dose number and dose not provided). The pharmacist reported that ZOSTAVAX vaccine reached a -9C. No adverse effects were reported. At the time of the report, the outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.