chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flushing; arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site). On 24-Feb-2021, HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved.            No concomitant product use was reported.   No treatment information was provided   This case was linked to MOD-2021-021490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: TCR received on 25-FEB-2021. Updated patient identifiers. Added new events
After the first vaccine, patient stated she had chest and throat tightness for 7 days.  After the second vaccine, 5 minutes later, patient stated she had severe dizziness, shortness of breath, fainted, shaking, elevated blood pressure to 161/70, passed out.  A facility called 911 for the patient.  Patient was taken to the emergency room and treated with Ativan and meclizine.  2 EKGs and CXR in ER were normal.  Patient spend 1 night in the hospital.  The next day, all symptoms returned.  Patient was treated with benadryl, zofran, and meclizine.  Patient is still taking meclizine for dizziness.  Patient was treated as an outpatient with oral steroids.  2 weeks later, patient is still havng symptoms, but milder.
Around 32 hours after receiving the injection, I began getting minor child and body aches which lasted for around 8 hours before subsiding.
I experienced muscle aches all over, my left arm where injection site located, was very sore. Had a low grade temperature of 99.7 (my temp is usually 97.1-97.3)and had really bad chills.
Administered past expiration. Moved from freezer to fridge 10/7/2021 with 30-min expiration on 11/6/2021. Verified no repeat dose needed with manufacturer.
Patient began c/o itchiness all over body. Pt was given a dose of Benadryl at 3:26pm. Pt states she began to improve around 3:35pm. Pt left at 3:40pm stating her itchiness as resolved.
Pt vaccinated with DT/OPV developed convulsions. Mother states child had hx of convulsions due to auto accident. Had not had convulsions since AUG89. Was taken off meds same day vac given.  Restarted Phenobarb.
spontaneous bleeding (resulting in emergency c section); sick with flu; vaccine exposure during pregnancy; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a serious spontaneous bleeding (resulting in emergency c section) (haemorrhage in pregnancy) (unknown latency) following the administration of INFLUENZA VACCINE.   On an unknown date the patient developed non-serious events of sick with flu (influenza) (unknown latency) and vaccine exposure during pregnancy (exposure during pregnancy) (latency same day) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (vaccine exposure during pregnancy, sick with flu) and emergency c section for haemorrhage in pregnancy  At time of reporting, the outcome was Unknown for all events   Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown.  Seriousness criteria- medically significant for haemorrhage in pregnancy; Sender's Comments: Sanofi company comment dated 2-JAN-2023: This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE. Additional information regarding condition at the time of vaccination, past vaccination history, lab investigation, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
Rash all over her body; itchy around shoulders; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over her body) and PRURITUS (itchy around shoulders) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Rash all over her body) and PRURITUS (itchy around shoulders). At the time of the report, RASH (Rash all over her body) and PRURITUS (itchy around shoulders) outcome was unknown.        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.   No treatment information was provided.
Member related "shot of fire" immediately after administration. Presented to center 10/6/2021 with pain, redness, swelling, warmth. Provider noted a 7x7cm red, swollen, tender R deltoid. 10/5/2021 - Member took 2 OTC benadryl and Tylenol. 10/6/2021 - Member presented and was administered Zyrtec 10mg PO, 650mg Tylenol PO and Ice Pack. Educated to follow up later in the day at facility if not any better and was scheduled for a follow up in facility for 10/7/2021. Per provider on 10/6/2021, after member had above meds and ice applied for 10 mins, less redness and warmth. Educated to notify her personal physician about occurrence.
STARTING TWO DAYS AFTER VACCINATION, TENDERNESS AT INJECTION SITE. AFTER A COUPLE OF DAYS, THE PAIN RADIATED FROM SHOULDERS DOWN TO MIDDLE OF THE LEFT HAND AND EXTENDED THROUGH THE PECTORAL AREA AS WELL AS THE BACK.  UNABLE TO LIFT ARM ABOVE THE SHOULDER/HEAD REGION. DESCRIBED AS AN INTENSE BURNING SENSATION.
Pt vaccinated with Influenza developed sore throat, runny nose, head cold, eyes blood shot, coughing, fever, headache & hoarse voice.
11:30 called for patient c/o  palpitation which had improved and now having dizziness with  spinning  patient had fluid, and juice - had breakfast this morning at 9:30 am  BP- 104/77/ HR- 88 SAT 97  Patient not improving  12:15 pm - c/o headache on the right fontal and crying  patient called spouse to come pick her up - patient symptoms worsening and patient wants to go to the  ER 911 called  patient left for ER  doctors community hospital - spoke with Dr. who accepted patient  Call made to spouse multiple times went to the voice mail  Repeat was at 12:13 pm  bp 125/93, hr 85, sao 99
chest tightness (within 10 minutes), trouble swallowing (within 10 minutes), dizzy (within 3 minutes), fuzziness leading to blacking out (within 5 minutes), thumb tingling/partial numbness (within 2 minutes), tightness in neck and jaw (within 10 minutes), headache (within 10 minutes),  - nausea, extreme tiredness, confusion (all about 3 hours later)
patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before; patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before; This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before) and INTERCHANGE OF VACCINE PRODUCTS (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before) and INTERCHANGE OF VACCINE PRODUCTS (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before). At the time of the report, EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before) and INTERCHANGE OF VACCINE PRODUCTS (patient received a dose of the Moderna vaccine after receiving 2 doses of Pfizer before) 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.   No Concomitant medications were reported. No treatment medications were reported. The patient then stated that "her doctor told her that the Pfizer vaccine is not that good and that she should receive the Moderna vaccine instead.
Received quad vaccine - influenza/pneumococcal shingle/whooping cough on 1/31/14 - 4:00 PM. Admitted to hospital 11:00 AM. Symptom - confused/slurry speech/200+ blood pressure - originally thought being a stroke - re-evaluated as brain seizure.
One day post vax, the pt developed aches and chills for 24 hours, that self resolved. The pt reportedly recovered from this experience. From additional correspondence received on 07/25/2000, the route and site the vaccination was administered was provided. No further info is anticipated for this repost. This case is closed.
soreness in the arm,very sore; couldn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm,very sore) and INSOMNIA (couldn't sleep well) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm,very sore) and INSOMNIA (couldn't sleep well). At the time of the report, PAIN IN EXTREMITY (soreness in the arm,very sore) and INSOMNIA (couldn't sleep well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Info was received consumer wants the form to be mail to her address no  new information was added
I received the second dose on 19Nov2021 and I did not receive a cycle in December; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 (Lot number: 330268D) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Asthama" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE taken for asthma; CHELATED IRON taken for anaemia. Vaccination history included: Bnt162b2 (Dose 1, Batch/ Lot Number: FF2589, Anatomical site of administration: Right Arm), administration date: 23Oct2021, when the patient was 32 years old, for covid 19 immunization, reaction(s): "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine", "I experienced irregular period afterwards my first dose", "cycles are irregular, I have more bleeding", "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "I received the second dose on 19Nov2021 and I did not receive a cycle in December"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea. No follow-up attempts are possible. No further information is expected.
4.5 inch indurated, with slight swelling and warm to touch on left deltoid area. Child did not complain of pain.
extreme fatigue, muscle aches, extreme chills and shivering, night sweats. Treatment included taking OTC Acetaminophen, and Ibuprofen. Symptoms lasted from onset to conclusion about 36 hours with varying levels of intensity. The most intense were within 24 hours.
0.5ML GIVEN FOR BOOSTER INSTEAD OF 0.25ML...NO KNOWN ADVERSE EVENT AT THIS TIME
Flu; Dry heaves; Violent chills; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), RETCHING (Dry heaves), CHILLS (Violent chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA (Flu), RETCHING (Dry heaves), VOMITING (Vomiting) and PYREXIA (Fever). 31-Mar-2021, the patient experienced CHILLS (Violent chills). On 31-Mar-2021, RETCHING (Dry heaves), CHILLS (Violent chills) and VOMITING (Vomiting) had resolved with sequelae. On 03-Apr-2021, INFLUENZA (Flu) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal PCR.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
PATIENT HAD PFIZER VACCINE ON 02/26/2021 and  03/27/2021, AND TESTED POSITIVE TO COVID.
Eight days after the shot, I developed itching at the site of injection. Today - day 9 - it is painful (mild), warm, and firm to the touch at the region surrounding the injection.
most likely unrelated but pt died of SIDS; pt exposed to HIV; born premature 30 wks gestation;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. On 20-NOV-2012, the patient was vaccinated with a dose of expired ZOSTAVAX (lot # 671144/1269AA, expiry: 05-NOV-2012). No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Approximately 30 minutes after injection, while driving to work.  My vision became blurry and felt extremely weak.  I arrived at my office very pale, weak, and very blurry vision, develop fever of 100.1.  Symptoms lasted 12-18 hours
Patient presented to the ED on 4/23/2021 for confusion. She received her second vaccination dose on 4/29/2021. Patient presented to the ED on 5/2/2021 and was subsequently hospitalized for closed fracture of femur. These visits are within 6 weeks of receiving COVID vaccination.
Redness at Injection Site; soreness at the injection site; Soreness to Kidneys; Sharp Stabbing Pain in his Head/Headache; body aches/stabbing pain; had a third dose of Shingrix on July 13th; first dose of Shingrix in 2018 / second dose of Shingrix on July 25th 2019; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 13th July 2020, the patient received the 3rd dose of Shingrix. On 25th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced injection site erythema, injection site pain, renal pain, headache, general body pain and extra dose administered. On an unknown date, the outcome of the injection site erythema, injection site pain, renal pain and headache were recovered/resolved and the outcome of the general body pain, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, renal pain, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered and had redness and soreness at the injection site, along with soreness to his kidneys, and a sharp, stabbing pain in his head and body aches.  The reporter wanted to know if he would had any effects from taking a third dose of Shingrix.   The patient provided a Medical Disclaimer for the caller and information from the PI and content and provided the caller with the MI number to give to his HCP to have him call our MI department.   The did not know why he waited to have his second dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Headache, Sedation, Myalgia, Fever, chills Narrative:
Patient given Varicella instead of MMR as requested. Patient has complaint of red, itchy sore arm.
soreness and swelling from site to wrist then developed pain in pelvis and legs md told her to take aleve
Three days after receiving the vaccine, patient had a sore throat, severe headache, and pain in both legs. The patient had shortness of breath. The patient did contact her doctor. The patient was prescribed Ibuprofen for pain, and given a B-12 shot. Patient did not need to be hospitalized but has not recovered. Doctor is monitoring patient's condition. Follow-up: Severe legs pain and weakness. Left leg was swollen, radiated to left arm, weakness in left arm. She was put on oxygen. Oxygen level dropped. Had chest pains, shortness of breath, she is hoarse. She had paralysis in left leg- hospitalized. It began with sore throat and headache 3 days after injection. On the 4th day my legs started hurting severely and I could not stand hardly 10 min without getting tired and weak. I then got hoarse and started having breathing problems. I had contacted my Dr. and he told me sounded like I was having a reaction to the shot.
Bruise at the injection site; Irritation at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received updates event outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen on injection side, itchiness and pain on arm, take TYLENOL or ibuprofen, use ice packs but not directly 2-3 times a day for 5-10 minutes. Patient's symptoms went away within the next 2-3 days.
At the 10 minute mark of the shot clock, the pt came up to the front desk to state he was feeling light headed and "weird". Pt was advised to sit and upon turning the patient lost his balance and fell backward to the ground.  Pt was advised to remain down for evaluation, but stated he was fine and sat up to move himself over to the chair.  Dr.  was called immed.BP: 65/33, HR: 69, SpO2: 100% and a manual BP: 68/40. He stated he did not hit his head or lose consciousness.  Stated he broke the fall by falling on his right arm. His right elbow had a small abrasion, denied pain, and had PMS in all extremities.  Pt added when he turned he lost his vision, but doesn't feel he hit his head, and shared he began sweating