chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; sore arm; Sore throat; Chills; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Aug-2016. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety and Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, NITROFURANTOIN (MACROBID [NITROFURANTOIN]) for Urinary tract infection.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 28-Aug-2021. On 05-Mar-2021, the patient experienced PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 07-Mar-2021, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     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.   Treatment information was not provided.
ACUTE NON ST ELEVATION MI 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient was given the Pfizer COVID-19 vaccine in his left arm around 1:34pm.  Patient left the immunization room and sat down in front of the pharmacy with his mother.  About 5 minutes later, the mother notified me that the patient was not feeling well and had become lightheaded and dizzy.  I immediately went out to examine the patient and as we were walking back to the immunization room the patient fainted.  His mother and I gently lowered him to the ground.  He immediately gained consciousness and after checking for any injury I went and got a yoga mat while his mother remained  by his side.  We moved him onto the yoga mat and had him lie down on his back and elevate his feet.  There was no injury and he said that he was feeling ok.  After several minutes I had him sit up slowly and remain in that position for another several minutes before standing.  He was able to stand up without assistance and walked to the bench to sit down for more monitoring.  I went back into the pharmacy but was soon notified by the patient that he felt like he might faint again.  I immediately had him lie back down on the mat.  He did not faint again and said that the fainting feeling had gone away.  Once again he stood up unassisted and I moved him into the immunization room to check his blood pressure (93/67 with a pulse of 86) and monitor him.  He said he felt better, had something to eat, and drank some water. While waiting his mother notified his pediatrician who said they would call back.  He was able to stand up and walk around without feeling dizzy or lightheaded.  His mother said they felt comfortable enough to leave.  I told them to continue to follow up with the patient's pediatrician and to ask about getting the second vaccine.  I made sure she understood that if his symptoms worsened to seek medical attention.  I followed up with the patient's mother around 7:00pm and she said that the pediatrician office called her back and said that they think he will be ok and that it might have been anxiety related to receiving the immunization.
Patient was given an extra flu vaccine this season. One on 10/13/2023 and one on 10/31/2023. Patient has not had any adverse reactions per mom. Dr. patients provider was notified and mom and dad.
Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseous and light headed. Passed out on the bathroom floor and hit my chin. Had to get stitches, fluid, and CT.
Diarrhea, headache, nausea w/out vomiting, joint pain, dizziness, fever, chills, pain at injection site.
in bed for 3 days; headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for 3 days) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 006M20A) for COVID-19 vaccination.     No medical history was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced BEDRIDDEN (in bed for 3 days) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Mar-2021, BEDRIDDEN (in bed for 3 days) and HEADACHE (headache) had resolved.            Concomitant medication information were not reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-128294 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128294:
Heat, swelling, soreness of arm at injection site. Worsening of arthritis symptoms. Arthritis pain symptoms alleviated with OTC Acetaminophen
stomach pain; Rash; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
pt recvd vax & 4 hrs pos vax exp nausea, diarrhea & fatigue;
LOSS OF HEARING, TUNNEL VISION, HOT, HEART PALPATIONS, ELEVATED HEART RATE, SWEATING
Swelling that spread to about a 4 inch by 4 inch area, redness, no pain.
After patient received the shot on 10/12/2011, she called complaining of shoulder pain in her left arm that radiated to her hand and neck and back. She continues to have pain and has been treated by dr.
This spontaneous report was received from a consumer and refers to an unspecified number of children of an unknown ages and genders. The patient' medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with M-M-R II dose, frequency, anatomical location, lot # expiration date were not reported. Concomitant medications were not provided. On an unspecified date, the children had a reaction (vaccination complication) M-M-R II and it was stated by the reported that they were on alternated vaccine schedules. The outcome of vaccination complication was unknown. Additional information has been requested.
soreness, tenderness, turning to swelling, welted, hot to touch, red spreading into a wider circle
Severe headache, muscle cramps and swelling at site. Nausea, Jaw hurts.
Approx   10 hrs after shot began to see black circle with football shape inside of circle.  Entire thing kept moving away and then coming closer.  Could not see during this event.  Tried closing eyes but was still there when I opened them.   Fell asleep approximately 20 minutes later and eyes were fine in morning.  Note that I did have eye surgery about 6 years ago and had  surgical lens implants.
dose 1 administerd on 02May2021 and dose 2 on 03May2021; A Little Soreness at Injection Site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 10:00 (Lot number: EWD162) at the age of 69 years as dose 1, single and administration date 03May2021 10:00 (Lot number: EWD162) as dose 2 single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "dose 1 administerd on 02May2021 and dose 2 on 03May2021"; VACCINATION SITE PAIN (non-serious) with onset 02May2021 11:00, outcome "recovered", described as "A Little Soreness at Injection Site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Patient was non pregnant. No other vaccine was taken in four week. Event reported was A Little Soreness at Injection Site for 12 hours or so. No Covid reported prior vaccination. No Covid tested post vaccination. No Known allergies was reported. No Other medical history was reported.  Follow-up attempts are completed. No further information is expected.
Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 04-Nov-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
cold chills; fevers between 101°-104°F; feeling like she couldn't wake up; This is a spontaneous report from a contactable consumer or other non hcp.    A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 30Aug2021 as single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose BNT162B2 via an unspecified routed of administration on 09Aug2021 Dose 1, Single for COVID-19 immunisation.  On 31Aug2021 the patient experienced cold , fever between 101-104 degree Fahrenheit, feeling like she couldn't wake up. Therapeutic measures were taken as a result of cold chills, fevers between 101 degree-104 degree Fahrenheit feeling like she couldn't wake up. The patient underwent lab tests and procedures which included body temperature as 101-104 degree Fahrenheit. The outcome of events cold, feeling like she couldn't wake up recovered on an unspecified date in 2021 and the outcome of event fever between 101 -104 degree Fahrenheit was unknown.
No actual adverse event occurred in the pharmacy.  Patient was given 0.2 ml undiluted pfizer 5-11 orange cap instead of the diluted course.  Patient and mother stayed in pharmacy area for 10-15 minutes after for standard monitoring.  Was not discovered until after patient and mother had left that wrong dosing was given.  Patient mother was advised per Pfizer to watch for systemic or local reactions.
Within the first 2 minutes I got a headache, nausea,blurry vision, redness itching and swelling from the injection site in the left deltoid down to the elbow with itching that continued down the forearm to the hand. Thirty five minutes later I got numbness and tingling in the distribution of the entire facial nerve on the left side of my face.
Moderna COVID-19 Vaccine EUA.  Extreme red rash on front and back of torso.  Was prescribed Clobetasol Propionate Cream USP, 0.05%.  Used cream at 5:00pm yesterday.  Provided immediate relief of burning and itching.  Cream to be applied twice daily until rash disappears.  Re-applied at 8:00am.  Same result.
Pt described a shingles like rash developing on her chest.  It is not painful, but is small raised bumps.
Pulsating tinnitus/can hear her heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Pulsating tinnitus/can hear her heartbeat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tetracycline). Concomitant products included SPIRONOLACTONE (SPIRONOLACTON) for Female pattern baldness, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMIN CHONDR), COLECALCIFEROL (D3), BIOTIN from 2018 to an unknown date and UBIDECARENONE (COQ-10) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (Pulsating tinnitus/can hear her heartbeat). At the time of the report, TINNITUS (Pulsating tinnitus/can hear her heartbeat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Nothing of any consequence has been found.. On an unknown date, Magnetic resonance imaging: normal (normal) Nothing of any consequence has been found..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant products included biotin tablet (2018), bone support (2020), coq-10 (30 mg) capsule (1987), selenium plus capsule at lunch (2020).  Laboratory details included, X-Rays done and reported with no results.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received contains additional details of patient demographics, medical history, lab details, suspected drug- start date and batch number, concomitant medications and event details updated.
Sore arm; Felt achy; Headache; Chills for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Felt achy), CHILLS (Chills for 24 hours) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Felt achy), CHILLS (Chills for 24 hours) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Felt achy) and HEADACHE (Headache) outcome was unknown and CHILLS (Chills for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications were not reported. The patient did not receive any treatment for the symptoms and reported as "no" for concomitant medications.
My daughter was administered the flu shot at School by the Health Department. The nurse gave it in her left arm even though she is left-handed. The evening of the flue shot I asked my daughter how it had gone. She said, "Fine, but I fell asleep and missed most of P.E." I thought it strange that the P.E. teacher would let her sleep through class so asked more questions. She said she sat down on the bleachers to tie her shoes and then "fell asleep and fell over." Her friends shook her and asked if she was okay. She said yes. Then it happened again. She said she had a headache and was very dizzy and weak. She "couldn't see very well." She told the P.E. teacher she didn't feel well. He sent her to the office alone. (It was a short walk around the corner.)  She started walking, but had to sit down and rest before actually leaving the gym. (P.E. teacher did not see her pass out, thought she just felt sick.) At the office daughter told the secretary she wasn't feeling well. Secretary told her to sit down and rest, did not ask further questions, did not know she passed out. Daughter was sent back to class right before P.E. ended (about a half hour later?)  I was never contacted by the school concerning what had happened because did not know the actual events that occurred. My daughter herself didn?t know she had fainted. She thought she had fallen asleep.
injection site pain; arm soreness; muscle aches; pains in forearms,shoulders, abdomen, quadriceps, and calves.; minor joint pain; swollen lymph nodes under both arms.; fatigue; exercise intolerance; This is a spontaneous report from a contactable physician. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9264, Expiration Date: not reported) via intramuscular, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization at the age of 29-year-old. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN5318, Expiration Date: not reported) via intramuscular, administered in left arm on 29Jan2021 as dose 1, single for COVID-19 immunization. Medical history included known allergies to tree nuts, shell fish, penicillin. Patient had covid-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient experienced some injection site pain and arm soreness, patient had no side effects for the first day. Two days after vaccinated, started debilitating muscle aches and pains in forearms, shoulders, abdomen, quadriceps, and calves. Also had some minor joint pain and swollen lymph nodes under both arms, patient noted fatigue and exercise intolerance since injection on an unspecified date. Resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test (Nasal Swab) unknown on 26Feb2021, result was pending. Patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
a female patient was administered expired Adacel vaccine; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  Adverse event was not 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.  List of documents held by sender: none.
Vaccine received Expired on 4-17-22, report to Moderna, findings from internal review of vaccine: