chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My resting heart rate was 56 whole year of 2020 and until Feb 2021. Well check done with primary care doctor on 01/28/2021 and TSH levels were normal. Feb 11th received first does of Pfizer-BioNTech Vaccine and staring feb 22nd my resting heart rate started to increase in the 60's. (see timeline below). On May 1st my heart rate was in the 90's and I felt light headed and I had high blood pressure. I visited. May 3rd Doctor found thyroid enlarged and lab work was conducted. Diagnosed with Graves disease  Feb 14-20: Average Resting Heart rate 56 Feb 21-27: Average Resting Heart rate 61 Feb 28-March 6: Average Resting Heart rate 64 March 7-March13: Average Resting Heart rate 63 March 14-March20: Average Resting Heart rate 68 March 21-27: Average Resting Heart rate 70 March 28-Apr3:  Average Resting Heart rate  68 April 4-Apr10: Average Resting Heart rate 76 April11-17: Average Resting Heart rate 77 (max83) April18-24: Average Resting Heart rate 78(max 83)
Temp has risen up to 100 F; A spontaneous report was received from a female patient of unknown age concerning herself  who received Moderna's COVID-19 vaccine and experienced that her temp had risen to 100 F.  The patient's medical history is unknown. Products known to have been used by the patient are also unknown.   On 29 Dec 2020, the patient received a dose of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the dose, the patient reported that her temp had risen to 100 F (Fever). Information was not provided about the treatment.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I suffered from acute Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 (Batch/Lot Number: EW0177) (at age of 34 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications the patient received within 2 weeks of vaccination included vitamin C gummies. The patient suffered from acute idiopathic thrombocytopenic purpura on 18May2021 19:00. At the end of the 18th, patient noticed spots on arms and legs, about the size of the average mole. Later, gums bled and patient had blood blisters in mouth, from 1 to 3 after rinsing with listerine. The next day, he noticed more spots on feet and lower legs, similar to freckles. By the end of the day, his gums were bleeding unprovoked and he had hematuria. The bleeding continued and he went to the ER the following day and was informed that his platelet count dropped to 0. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Number of days of hospitalization was 3 days. Treatment received for the adverse events included Intravenous Immunoglobulin and steroids. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information on Lot/Batch number is available; Further information has been requested.
Patient experienced temporary memory loss 2 days after vaccination given ( by afternoon/evening of day 2 ). Patient states, she is still experiencing some forgetfulness one week after the initial incident, however to a lesser extent.
joints ached; exhausted; was tired the day of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was tired the day of the vaccine), ARTHRALGIA (joints ached) and FATIGUE (exhausted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (was tired the day of the vaccine). On 11-Mar-2021, the patient experienced ARTHRALGIA (joints ached) and FATIGUE (exhausted). At the time of the report, FATIGUE (was tired the day of the vaccine) and FATIGUE (exhausted) outcome was unknown and ARTHRALGIA (joints ached) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant information was reported.  No treatment information was reported.   This case was linked to MOD-2021-075161 (Patient Link).
4 hours after receiving Flu immunization, pt kept coughing for 10 days, went to ER 10/22/17, pt received azithromycin and hydrocodone for possible sinus infection. Went back 10/23/17 for albuterol and prednisone. PERCOCET Rx for painful cough and did chest Xray.
Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one bout of vomiting. After a two hour nap felt better although still fatigued and a little off.  Next day still fatigued and off but virtigo disappeared.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (injection site warmth and erythema experienced after 1st dose received in May 2018, refer case US2018143673). Concurrent medical conditions included fibromyalgia. Concomitant products included denosumab (Prolia). On 5th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient received vaccine in her left arm and experienced the injection site reactions. Only partial information was provided. The patient had to disconnect for an appointment.
Received DTAP, Hib 08/28/2005 Rash started 09/29/2005. Patient took Benadryl , pt also had swelling, patient was at this time take amoxicillin for otitis media until 09/30/2005, child was diagnosed with serum sickness.
rash at injection site; redness of the injection site; itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site), VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine since 06-Oct-2020. Past adverse reactions to the above products included Injection site reaction with flu vaccine.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site). On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site), VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-FEB-2021. Action taken updated and event outcome updated.
Bruising on the arm/ bruise spread to under arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on the arm/ bruise spread to under 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (Bruising on the arm/ bruise spread to under arm). At the time of the report, CONTUSION (Bruising on the arm/ bruise spread to under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had bruising on the arm since 10-Mar-2021 and on 14-Mar-2021 it started spreading to his under arm. No treatment information was provided.
I was so miserable; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I was so miserable) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I was so miserable). At the time of the report, FEELING ABNORMAL (I was so miserable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details provided for this event.
Intensive headache  muscle pain  joint pain  chills  nausea and vomiting  fever  loss of appetite
Vision not clear; Pounding of chest; throat felt contracted; A report was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced vision not clear, pounding of chest, and throat felt contracted.  The patient's medical history, as provided by the reporter, included asthma and hypoglycemia. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, 15 minutes following vaccine administration, the subject's vision became unclear, and she described everything seeming hazy and smoky. Her throat then began to feet contracted and her chest was pounding. The patient was transported to the emergency room (ER) via an ambulance. Her electrocardiogram (EKG) result was normal, while blood pressure and blood sugar results were increased. She remained in the ER overnight but was not admitted. Her vision returned to normal 5 pm the same day. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, vision not clear, was considered resolved on 30 Dec 2020. The outcome of the events, pounding of chest, and throat felt contracted were unknown.   The reporter did not provide an assessment for the events, vision not clear, pounding of chest, and throat felt contracted.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The Patient's medical history of asthma and hypoglycemia remains as confounders.
After about 15-30 minutes of receiving flublok the patients injection site and area around bandage began itching and turning red. The itchiness and redness then began radiating to the shoulder and back and became very intense. She took 2 benadryl capsules and used a cold compress. After approximately 30-45 minutes the itching and redness subsided. After 2 hours the symptoms were completely subsided.
Irregular menstrual cycle. Typical cycle for me is 24-26 days with 4 days of bleeding. Following my vaccination, my cycle was only 19 days long and bleeding lasted for 14 days (7/16/2021-7/29/2021).
Vaccine adm. at 1020am.  Immediately after injection of this immunization, pt began hyperventilating and limbs began to shake, eyes rolled back in her head & she lost consciousness.  Pt revived immediately with 0.3mm ammonia inhalant & once alert helped to supine position, given apple juice & crackers.  Ice pack applied to neck & head.  BP 114/76 & pulse 60 & RR 18.  15 min after injection pt was sitting at time of injection & no injury occurred.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 38 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Syncope, muscle pain, daily seizures, paralysis, muscle twitching. Tests normal (video EEG, MRI, CT scan, X-rays, tilt table test, heart monitors, EKG, stress test, pulmonary function test).
TOOK 2 UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 29-Aug-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201908-000701 (PVX2019-2217; wife) and PVX201908-000702 (PVX2019-2218; husband) were created and cross-linked in the database.  This case (PVX2019-2218) describes a male consumer who "took 2 unrefrigerated doses" (PT: Product storage error), during therapy with Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 27-Aug-2019 and 29-Aug-2019, respectively. The lot number was either 3003280 or 3003282.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201908-000701:
This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246), via an unspecified route of administration on 18Jan2021 at 09:00 (at the age of 49-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure and tachycardia. The patient does not have allergies to medications, food, or other products. The vaccination was administered to the patient in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. The patient's historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) on an unspecified date. Concomitant medications were not reported. On 18Jan2021 at 15:00 (reported as six hours after the shot), the patient experienced a headache. On 18Jan2021 at 21:00 (reported as twelve hours post shot) the patient experienced chills. The patient did not receive any treatment for the events. The clinical outcomes of headache and chills were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
warm; itchy; injection site a rash from elbow to shoulder; sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (injection site a rash from elbow to shoulder), AXILLARY PAIN (sore arm) and FATIGUE (felt tired) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Feb-2021, the patient experienced AXILLARY PAIN (sore arm) and FATIGUE (felt tired). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (injection site a rash from elbow to shoulder).   At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (injection site a rash from elbow to shoulder), AXILLARY PAIN (sore arm) and FATIGUE (felt tired) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It is reported that patient made a healing cream with steroid cream. Concomitant product use was not provided by the reporter.
Patient had a syncopal episode approximately 5 minutes after administration of the vaccines above. The patient was assisted to a lying position, aroused with verbal and tactile stimuli after 3-5 seconds. The patient was anxious prior to vaccine administration, per Mother it had been many years she had immunizations. Cool compress applied to forehead and the patient was given water and cookies, BP: 100/80 Pulse: 88 Resp: 26. The patient was monitored for approximately 15 minutes, till she verbalized she was better. Mother refused EMS transport to ER for evaluation.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 03/04/2021, 03/30/2021, and 11/01/2021. They presented to emergency department on 02/07/2022 with primary complaints of shortness of breath and cough. They tested positive for COVID-19 and were admitted to hospital (ICU) same day. The individual had stage IV metastatic lung cancer that had spread to the brain (diagnosis approx 4 months earlier) and was on palliative care at the time. They were discharged to a hospice facility on 02/11/2022. An additional COVID-19 test was positive on 02/17/2022. They died on 02/18/2022.
after receiving injection, pt. sat in chair @ about 0918 pt. fell to ground, noted having tonic clonic seizure like activity lasting about 15 seconds, pt. .placed on his side.  After about 15 seconds, pt. became arousable, awake alert and oriented, noted to have "chipped tooth" and slight bleeding in his mouth.  Pt. states has hx. of syncopal episodes after receiving injections.  Denies any history of seizures.   Team alert was called and Pt. was  taken to ED for further evaluation
Armpit began to hurt on day 6 due to swollen lymph node, rash appeared at site on day 9, itchy bumps appeared on hands and elbow on day 10.
105 fever, rash, diarrhea, severe fatigue, lethargic, pneumonia. Was finally hospitalized and treated with intravenous Rocephin.
Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better
The patient became very tired after the vaccine and the next day she had a 2 inch red band around her arm where the injection was given. It felt sore. 2 days later she has experienced diarrhea, neck tightness and the area is hot to touch.
A pharmacist reported that a 28-year old female with epilepsy and asthma, was vaccinated with her second dose of RECOMBIVAX HB vaccine IM on 18MAR93. Concomitant medications included TEGRETOL, THEO-DUR, ACTIFED, and enalapril maleate HCTZ. On the evening of 19MAR93, she had a grand mal seizure for approximately 5 minutes. The seizure was followed by  fifteen to twenty minutes of drowsiness. On 25AUG93, the patient was vaccinated with her third dose of vaccine IM. Additonal concomitant medication included MYSOLINE. On 25AUG93, the patient had a grand mal seizure that lasted for two minutes. The experiences necessitated a visit to a physicians. At the time of the report, the patient had recovered.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number M73CE, expiry date 30th June 2019) for prophylaxis. Co-suspect products included HAVRIX (batch number N37Z5, expiry date 10th November 2018) for prophylaxis. On 20th December 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) and HAVRIX (intramuscular). On 20th December 2018, not applicable after receiving FLUARIX QUADRIVALENT 2019 season and unknown after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and expired vaccine used were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT 2018-2019 season and HAVRIX. Additional details were provided as follows: The nurse, who was also working as a pharmacy technician, reported that the patient received HAVRIX in right deltoid was expired on 10th November 2018, which led to Expired vaccine used. The reporter also indicates that this patient was administered FLUARIX in right deltoid and a Sanofi vaccine right deltoid (both within the expiration dates) in the same site on the same date. The reporter stated the patient experienced raised redness in the arm of injection after receiving the injections. The agent advised caller to contact Sanofi to report the raised redness for the vaccine that was administered. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Sanofi vaccine as well.