chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ventricular hypokinesia; Chest pain; Hypokinesia; Malaise; This case was received via FDA VAERS (Reference number: 1342336) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VENTRICULAR HYPOKINESIA (Ventricular hypokinesia) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPOKINESIA (Hypokinesia) (seriousness criterion hospitalization) and MALAISE (Malaise) (seriousness criterion hospitalization). At the time of the report, VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, C-reactive protein: increased (High) CRP 6.3mg/dL. On 25-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, Ejection fraction: decreased (Low) LVEF 45-50%. On 25-Mar-2021, Electrocardiogram ST segment elevation: unknown (Inconclusive) near diffuse ST elevations with the exception of lead V1. On 25-Mar-2021, Red blood cell sedimentation rate: unknown (Inconclusive) ESR 20. On 25-Mar-2021, Troponin: increased (High) Troponin elevated peak 11.9 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: 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.  Further information cannot be obtained.; 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.  Further information cannot be obtained.
Major swelling of  (right) arm, hot to touch, painful to touch, itching. Visited primary care MD. Took prednisone x 5 days, and CLINDAMYCIN 300 mg BID. Cleared up after. Same arm as PNEUMOVAX shot.
4:00pm 1/17/22 body aches and headache 7:00pm 1/17/22 severe body aches and joint pain, had to lay down, and lymph node under left arm started throbbing All day 1/18/22 head ache like a migraine, joint pain, muscle aches, nausea (but no throwing up) and intense pain under left arm - stayed home from work 1/19/22  feeling lightheaded, woozy, nauseous and still tender at the injection site and under left arm.
The patient received the vaccination and immediately her arm started to swell in the injection area. I asked the patient if they felt alright and not dizzy or anything. The patient stated that they felt fine and that this has happened before several years ago. I offered BENADRYL and asked for the patient to stay for at least 15 minutes for observation. The patient did not have a severe enough reaction for EPI-PEN. The swelling dissipated after about 12 minutes. The patient left and said they still felt fine and I promised a follow up call.
Patient received Moderna Vaccine 1st dose at 17 years of age. Moderna Vaccine is approved for 18 years of age and older.
No adverse reaction. Patient received DTAP instead of TDAP. Verbally spoke with mother and patient was fine with no side effects at all.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), HYPOAESTHESIA ORAL (lips numb), MYALGIA (body aches), NAUSEA (nauseated) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No Adverse Event since an unknown date. Concomitant products included SIMVASTATIN (ZOCOR) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), HYPOAESTHESIA ORAL (lips numb), MYALGIA (body aches), NAUSEA (nauseated), CHILLS (chills) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness) outcome was unknown. Not Provided          Concomitant products included SIMVASTATIN (ZOCOR) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.  Action taken with mRNA-1273 in response to the event was not applicable.
3-30-2009 Received Hep A at approx 2pm. Developed hives approx 8p. Took BENADRYL. 3-31-09 no hives visible. C/O itching all over. SOLUMEDROL 125mg IM given.
Patient presented to clinic to receive Shingles vaccine and was administered COVID Bivalent Booster instead. Patient had already received this booster on 10/4/22 so received two bivalent boosters. Patient did experience ill feelings the day after the vaccination and did have to leave work. Resolved by the following day.
Seizure; Neurologically confused; A spontaneous report was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced a seizure and was neurologically confused (confusional state).  The patient's current conditions included epilepsy. Concomitant product use was not provided by the reporter.  On 26-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 22-FEB-2021, right before the patient was supposed to get the second dose of vaccine, she had a seizure and was hospitalized. The same day, patient was neurologically confused. The patient underwent different unknown tests including computerized tomography. On 24-FEB-2021, the patient was discharged from hospital.   No treatment information was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, seizure and confusional state were resolved/recovered; Reporter's Comments: Based on reporter's causality and the prior history of epilepsy, the events are assessed as unlikely related to mRNA-1273.
Narrative: COVID infection following completion of COVID vaccine series 01/19/21 COVID vaccine dose #1 02/16/21 COVID vaccine dose #2 07/28/21 Pt calls into CC reporting COVID positive result at Pharmacy yesterday (07/27); reports sore throat, headache, fatigue 07/29/21 PT reports improving symptoms- cough, fatigue, headache, muscle pain, runny nose, sore throat that started 07/17; rx given for acetaminophen, DM/guaifenesin, throat lozenges; met criteria for resolution as 10 days has passed since first symptoms
Patient developed a purpuric rash and vesicles on his abdominal wall after receiving the Hepatitis B vaccine.
10 minutes after receiving vaccination I felt like I was going to pass out. I had an elevated heart rate for around 3 minutes and had to do deep breathing to get it to go back to normal.
Extreme musculoskeletal pain, extreme nerve pain, fever and sweats lasting from 7pm on May 17th till 7pm May 18th then followed by extreme exhaustion and out cold asleep for 18 hours with continuing extreme exhaustion.
Reaction started with a sore arm after injection. Three weeks later pain is much worse. Pain is in upper arm and rotator cuff of shoulder. Chronic constant, difficult to use arm (left) and to sleep at night.
PAIN IN BACK & LEFT LEG  (active) SWELLING IN HANDS & FEET (resolved) WEAKNESS UNABLE TO RAISE LEFT LEG (resolved)
pt. c/o - tingling of right leg; itching of her throat.   symptoms resolved and pt. went home
pt brought to hosp with c/o increase in weakness and inability to stand; found to be positive for COVID and leukopenia; hypoxic; admitted to hospital; placed on O2 supplementation; AHRF; dexamethasone, baricitinib, pt declined remdesivir; O2 needs increased, placed on NRB and HFNC; c/o intermittent chest pain; pt went into respiratory arrest, in PEA arrest, but pt was DNR; pt died in the hospital
No additional AEs; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; This spontaneous report was received from a healthcare business professional (described also as an administrator) via a Company representative and refers to a 7-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 19-AUG-2021, the patient was mistakenly mixed up with an older female patient that had similar names and was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration, wrong patient received product). No adverse event was reported.
Fever; This is a spontaneous report from a Pfizer sponsored program  Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for Covid-19 immunisation. The patient took her second dose yesterday and caught fever today and she wanted to know if she could take Ibuprofen. The outcome of the event was unknown.  Information on the lot batch number has been requested.
This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions. On an unknown date, unspecified multiple patients were vaccinated with improperly stored PEDVAXHIB (dose, frequency, lot#, expiration date and indication not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA000855, 1709USA004997 and 1709USA004998 as same reporter link. Sender's Comments: US-009507513-1709USA000855: US-009507513-1709USA004997: US-009507513-1709USA004998.
Teratoma growth on ovary - removed on 20Jul2021; Teratoma growth on ovary - removed on 20Jul2021; Slight tightness in throat; Rapid heart rate; slight tightness in chest upon breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 15:15 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Teratoma growth on ovary - removed on 20 July 2021" (unspecified if ongoing), notes: Teratoma growth on ovary - removed on 20Jul2021; "Sulfa drugs allergy" (unspecified if ongoing); "cipro Allergy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 09Apr2021. The following information was reported: OVARIAN GERM CELL CANCER (medically significant), TERATOMA (non-serious), outcome "unknown" and all described as "Teratoma growth on ovary - removed on 20Jul2021"; THROAT TIGHTNESS (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Slight tightness in throat"; HEART RATE INCREASED (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "slight tightness in chest upon breathing". The patient underwent the following laboratory tests and procedures: culture throat: (12Jul2021) negative; (20Jul2021) negative; (11Sep2021) negative; (16Nov2021) negative. Therapeutic measures were taken as a result of ovarian germ cell cancer, teratoma. Therapeutic measures were not taken as a result of throat tightness, heart rate increased, chest discomfort. Slight tightness in throat approx. 45minutes after that seemed to go away the later Rapid heart rate and slight tightness in chest upon breathing approx 1.5 hours after. Patient received no other vaccine in four weeks. Patient had administered birth control pills in past.  No follow-up attempts are possible. No further information is expected.
Body aches; Temperature of 101.6; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Temperature of 101.6) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (Temperature of 101.6) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (Temperature of 101.6) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pyrexia: 101.6 (Inconclusive) temperature of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018097) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018097)
10/19/2005 Fluarix given to the patient. Patient reported on 10/20 that he started with severe abdominal cramps and nausea four hours after receiving the injection. C/0 severe abd cramps all night and woke at 4am with pain and around projectile vomiting and diarrhea for 15 minutes. No blood noted in fluids. Patient and wife ate the same food and she was not ill. However she did have the same type flu shot with no ill effects. At 4pm on 10/20 patient had diarrhea once again no vomiting.
first dose on 13th-may-21 and second dsoe on 6th-jun-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C121A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021 at 1:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported by patient.  Patient reported no adverse events with second dose of moderna vaccine.   This case was linked to MOD-2021-249067 (Patient Link).
Immediate dizziness the morning after my 1st shot. It is not constant. Can be triggered by tilting my head in certain positions. Laying up and down in bed and tilting recliner triggers the dizziness frequently. Going to get blood work tomorrow. Thus is almost week 5 and no relief. The dizziness is the same. No nausea. I just got over dizziness from a scuba accident that occurred in 2018. My dizziness was completely gone last fall. The dizziness is definitely different now. I am concerned this will be a long term effect that doesn't go away. It has affected my job.
Information has been received from a registered nurse concerning a patient who was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot#650087/0815P).  Subsequently the patient developed a generalized rash.  Subsequently, the patient recovered.  There was no product complaint.  It was noted that the reporter a lot check to be done on the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantines/Rejection System revealed that there was no open Quarantines registered against this lot/fill.  Additional information has been requested.
pt recvd vax & 30 days p/vax exp elevated liver function tests, swelling joints, a rash, & muscle aches;
Lymph node swelling on both sides of her neck; Really bad muscle aches; sore at the top of her neck/sore around spinal cord area on her neck; The pain went to the base of her skull around the spinal cord; burning sensation; Her head felt heavy; The pain went to the back of her neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord) and BURNING SENSATION (burning sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-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 LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck) outcome was unknown and NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken  6 days of steroids and antibiotics for head and neck effects No concomitant medications were provided
Arm swelling, redness, induration of (L) arm. Went to ER. Tx is antibiotic.
Pt. got her flu injectable vaccine in RUE on 10/27/15 and presented back to clinic with a 3 3/4 inch diameter sore of erythema, swelling. TDP = heat to RUE. Rx BENADRY and cool compress.
Fever up to 102, headache, chills, nausea, localized tenderness approximately 10 hours after vaccination. Patient took Aleve with out noticeable improvement. Seen by Provider who prescribed Motrin and if not better in 24 hours to be reevaluated.
Had swelling under left arm and twitching in both arms after first dose on 13 October. Had tightness and pain in chest starting from left arm pit area across chest. Had trouble breathing and also tingling numbness in left arm and fingers after second dose recived on 11/3.  Went to emergency room on 8 November with above symptoms, ended up leaving after 5 hours because they had not taken me in for treatment after TRIAGE. I was triaged and sent back to waiting room.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5 ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24,47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Severe shoulder pain, resulting in immobility lasting from time of injection until present (currently at 12 days and still with severe mobility limitation).
THERE HAS BEEN NO ADVERSE EVENT NOTED BY PARENT. NO ER OR URGENT CARE VISITS FOR PATIENT AFTER DATE OF VACCINE.
Pt had fasted that morning, received Tdap and MENACTRA vaccine, had ear irrigated for a foreign body and at completion of irrigation had sudden onset severe headache, dizziness, nausea, vomiting, pallor, BP 80/44. Pt transferred to ER where symptoms self resolved and felt could have been secondary to ear wash.
Severe upper arm pain that stretched to back Headache Runny Nose Itchy Throat
First 12 hours post booster ? mild discomfort at short location Second 12 hours ? chills, shakes, nausea, not thinking clearly, achiness in joints. Day 2 ? not 100% lucid.  Inflamed lymph nodes  between left collar bone and top of let shoulder.
L DELTOID AROUND VACCINE SWOLLEN AND HOT TO TOUCH; AXILLARY REGION VERY TENDER TO TOUCH, NO SUPERFICIAL AXILLARY LYMPH NODES, UNABLE TO PRESS DEEPLY DUE TO PAIN LEVEL. PAIN RADIATING TO CHEST - NIPPLE REGION.