chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter. No treatment medication reported by reporter.  Patient received underdose of 0.25 ml Moderna Bivalent Booster.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter (Master case)
Redness, soreness in injection area---ongoing for over 30 hours. Low grade fever (100.4  deg) for approximately 12 hours.
Information has been received from a registered pharmacist concerning a 54 years old white female patient with history of drug reaction/allergies to Sulfa and codeine, who on 21-JUL-2008 was vaccinated SC with a dose of ZOSTAVAX (Lot # 659673/0557X). Concomitant therapy included hydrocortisone. The pharmacist reported that the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient developed a large swelling and itching in a 2" X 3" area around the injection site. The patient sought medical attention, phone call. Follow-up information was received. The patient was concerned because swelling did not go down after 2 days. On application of cortisone ointment swelling went down. No further information is available.
After receiving  my 1st vaccine shot, I became ill:  Fevers (99, 101, 102 degrees); extreme body aches; head hurt when coughing; heavy breathing; trouble sleeping-loss of sleep;  loss of appetite; vaginal infection.  I took Tylenol and Motrin and drank lots of water.  Symptoms lasted for seven/eight days.
pt c/o pain @ vax site & down lt arm immed;12 days later stated pain cont & had been noting some limits in some ROM in lt arm;pt saw MD p/that time frame;
Information has been received through the Merck pregnancy registry from a certified nurse midwife concerning a 21 year old female who on 20-FEB-2007 was vaccinated with a first dose of VARIVAX.  Concomitant therapy included vitamins (unspecified).  The patient was pregnant.  The patient's LMP was 03-APR-2007.  The patient's Quad screen was abnormal; it indicated an increased risk for fetal Down 1 in 133.  Fetal biometry was measuring consistent with 16w3d.  This may have reflected a true dating discrepancy however it may have also represented symmetric IUGR.  Therefore her sonogram was moved up.  On 13-AUG-2007 the ultrasound showed: Single live IUP measuring consistent with 16w3d.  A complex cardiac defect was observed on the scan.  The normal four chamber view could not be visualized.  There was a large VSD and a large primum ASD suggesting an atrioventricular canal defect.  The LVOT appears elongated and narrow.  There is a left ventricular echogenic focus.  The aortic arch could not be visualized on the exam.  The ductal arteriosus and descending aorta appeared narrowed.  However, the pulmonary artery appeared dilated and measured 3.7mm.  Heterotaxy was observed with the fetal stomach appearing fluid filled and located on the right.  The kidneys and bowel appeared slightly echogenic and the fetal long bones appeared shortened (<3%).  The nurse reported that the multiple anomalies were not consistent with a syndrome, "little was right and the prognosis was grim".  The above Ultrasound findings and testing results were reviewed with the patient and her partner.  The reporter discussed the significantly increased risk for fetal aneuploidy based on multiple ultrasound markers and major cardiac anomaly detected, indication, risks and benefits of amniocentesis were recommended.  However, after counseling, the patient and her partner decided against further evaluation and wished to pursue termination of pregnancy.  They were aware that the evaluation was incomplete at that time and prognosis, though guarded could not fully be delineated.  The patient and her partner decided to proceed with termination without further evaluation.  On 14-AUG-2007 the patient elected for a termination of the pregnancy.  The fetus was 18 weeks by the LMP, but measured 16 weeks and was small because of the anomalies.  Karotyping was performed on both the patient and her husband and all tests were normal.  As of 26-JUN-2008 the patient was pregnant again.  (Refer to WAES#: 0807USA00561).  Additional information has been requested.
The person was not injected at the correct site for an IM injection it was injected to high on the shoulder, closer  to the acromion. Pt is having issues is moving his arm.
Day 9 started burning and itchy and red patch. Five days later day 14 double in size sore itchy and bruising around outer circle
severe diarrhea; This is a spontaneous report received from a contactable consumer (patient reported for self). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported experiencing severe diarrhea since 2 AM this morning (as reported). The consumer reported his diarrhea was currently improved. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt vaccinated with DTP/OPV developed fever 102, wheezing, asthma screaming episode for about 3 hrs. Treated with Benadryl.
Guest reported "some tightness in chest" approx. 10 mins after receiving vaccine while waiting in observation area. EMT observer continued to monitor guest and offered Benadryl, which was taken. EMT requested to take vital signs which guest declined. Observation time was increased to 30 mins. After 30 mins. guest stated "feeling better" and left on her own after RN on site checked her condition. Lead RN called guest around 3:30 pm and guest reported "feeling perfectly fine."
ADMINISTERED EXPIRED DOSE; This spontaneous report received from a health care professional concerned a 19 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 07-MAY-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administered expired dose. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired dose was not reported. This report was non-serious.
DIFFUSE RED RASH AND MAJOR  ITCHINESS . RASH IS MOSTLY FLAT, SLIGHTLY RAISED AND BLANCHES ON TRUNK. SAW MD WHO PRESCRIBED MEDROL PACK WITH INSUFFICIENT HELP. NOW ON PREDNISONE 40 MG QD. PRURITIS MUCH BETTER ALTHO RASH STILL THERE 5 WEEKS AFTER. NOT SURE IT IS CONNECTED BUTGENERALLY NOT ALLERGIC AND IT IS LATE IN LIFE TO GET FOOD ALLERGY.
Stopped breathing/death. Blood(redness ) in both eyes, (began 12/15).  2/18/09 Death certificate states COD as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head & spinal cord.
Chattering teeth; worst leg aches; worst leg aches and cramps ever; nausea; dizziness; huge headache; low grade fever; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and vitamins for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced chattering teeth, worst leg aches and cramps, nausea, dizziness, huge headache, low grade fever and diarrhoea. On an unknown date, the patient underwent body temperature measurement and result was found to be 99.6 F. No therapeutic measures were taken for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care The clinical outcome of all the events chattering teeth, worst leg aches and cramps, nausea, dizziness, huge headache, low grade fever and diarrhoea were resolving at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Vaccine given 2/24/16, left arm - deltoid. Pt seen 2/25/16 unable/unwilling to move arm. No swelling noted. Seen 2/29/16 sx much improved.
Rash on arms, abdomen, face, body itchy, hot, malaise, swelling of fingers and hands, difficult swallowing. Rx benadryl; course of Prednisone.
Death  4/18/2021 Causes of death listed on patient's death certificate: 1) Sequelae of SARS-Coronavirus 2019  Other: Rheumatoid Arthritis, Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity
allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Cyst, Obsessive-compulsive personality disorder, Knee injury (chronic knee injuries), Anterior cruciate ligament tear (ACL), Ligament tear (MCL) and Pain. Concurrent medical conditions included Allergy.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (allergy issues, cysts, OCPD, chronic knee injuries, ACL, MCL, pains cleared up) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient reported unintended benefits which she got from Moderna vaccines and booster shots. The patient also mentioned that the 1st vaccine shot and the 2nd booster were the most beneficial to her.  The patient already had a connect with her PCPs, rheumatologist and pulmonologist about her situation.  No treatment information was provided by the reporter.
Some pollen allergies like 10 days ago that caused sinus headaches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hay fever and pollen allergies and every spring she got that. Concomitant medications were not reported. The patient reported that she got the first shot on of the Pfizer COVID vaccine on 22Mar2021 and the second shot was scheduled for 16Apr2021. She stated that she had some pollen allergies like 10 days ago (On 30Mar2021) that caused sinus headaches. And 10 days ago (On 30Mar2021), she had to take antibiotics for 5 days, which ended 04Apr2021.  She wanted to know if it was okay to get the second shot. The patient stated that this was not a reaction to the vaccine, that she had been having hay fever and pollen allergies, every spring she got that. She did not think it was because of the vaccine. Event outcome was unknown.  Information on the lot/batch number has been requested.
Low grade fever; body aches; flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of low grade fever in a male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 13th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th March 2019, 1 days after receiving Shingrix, the patient experienced low grade fever, general body pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On 16th March 2019, the outcome of the low grade fever, general body pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the low grade fever, general body pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient experienced flu-like symptoms with a low grade fever and body aches. The patient self medicated with over the counter Tylenol.  The reporter did not consent to follow-up. The outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered/resolved with sequel).
PATIENT STARTED TO NOT FEEL WELL SHORTLY AFTER RECEIVING BOOSTER. HE EXPERIENCED AN EYE DROOP SO THEY WENT TO THE ER, THE ER SENT THEM TO THE EYE DOCTOR. AT THAT TIME HE STILL DIDNT FEEL WELL AND WAS ADMITTED HIM TO THE HOSPITAL. HE HAD AN MRI/MRA DONE WHEN THEY DISCOVERED THAT HIS CAROTID ARTERY HAD SPLIT AND HE HAD AN IRREGULAR HEARTBEAT AS WELL. HE IS STILL IN THE HOSPITAL AND THEY ARE WORKING TO TRANSFER HIM TO A NEARBY HOSPITAL WITH A CARDIOLOGY UNIT ON SITE.
Erythema, induration, tenderness at the site of injection. Myalgias and low grade fever.
Went into cardiac arrest on 10/29/21 had echocardiogram done and found myocardis/micardis
About one hour following vaccination,  employee had throat discomfort/itching, pruritic rash.  Was admitted to ED who noted tachycardia, hypertensive but not hypoxic.  Benadryl, pepcid and solumedrol given.  Wheezing developed.  IM epinephrine given after which symptoms rapidly resolved.  Patient monitored for 4 hours and released with 3 day course of steroids and anti-histamines.  Recommended follow up with allergist.
1st Vaccine Moderna 8/14/21 Pharmacy #3583 - Flu like symptoms the next night 24 hours later, rash at injection stie then no issues until a week later- Covid Arm- raised hot huge rash bump that went away in 3-4 days.  My menstruation cycle was due in two weeks and was a few days late.  2nd dose Moderna 9/11/21 at Pharmacy #3583 Fever that very night and swollen lymph nodes only on right side groin, armpit, ithy large rash developed and saw my Dr via telehealth call prescribed high dose steroid for three days.  My menstruation cycle the next few months September, October and November were sooner and sooner so the 28 day cycle closed down to 23 days. Then in February my cycle did not come and in March 2022 I have no been on a constant bleeding, heavy cycle, spotting and only 4-5 days here and there maybe 3 times in the last 4 months of not a lot of bleeding. I have talked to my Dr about it but no one seems to realize there is an issue with the shots and cycles this extreme. As of today June 5 2022 I am on the search for a new gyno that will listen to me and figure out how to reverse this damage.
This is a spontaneous report from a contactable consumer or other non-HCP. A 28-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced fever, headache and left foot got hot; on an unspecified date. The outcome of the events: unknown. Follow-up attempts completed. No further information expected.
No additional AEs; Caller reported expired dose of PROQUAD was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided.  On 29-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #T030479 was confirmed to be valid, expiration date: 07-MAR-2022, administered subcutaneously (anatomical location not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Pt felt faint and got dizzy, light-headed, sweaty, and confused immediately after administration of vaccine.  Pt has a history of vaccine phobia and admitted he was nervous prior to receiving the vaccine.  He also informed me after he started to have side effects that his vaccine phobia had led to him not getting a vaccine since he was 14 years old.
Lump in my left arm spreading from injection, heat and severe pain in my left arm and armpit - can't hardley move arm or close hands - fingers , severe swelling .  Fever , chills, body aches, body weakness, severe headache, back ache , severe fatigue and not being able to function.  Chest hurts and sinuses bothering me .
flu like symptoms; fever; felt really achy; This is a spontaneous report from a contactable Nurse. This Nurse reported for a male patient (reporter's son). The male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Lot Number/Batch no: unknown), dose unknown via unspecified route of administration on unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history had included Covid 19 virus in Dec2020. Concomitant medications were not reported. The patient previously took past drug ibuprofen before getting his Covid 19 vaccines. On an unspecified date, the patient experienced flu like symptoms, fever and felt really achy. It was reported that, her own experience with the Covid 19 vaccine she reports her son felt worse than she did with flu like symptoms and a fever and felt really achy. The reporter was glad her son did not have bad side effects. The patient underwent lab tests and procedures, which included Covid 19 virus was diagnosed as having Covid 1 9 positive on dec2020. She had declined to file a safety report for her son. No further information is provided or obtained. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tightness in chest; Sleepiness; Temperature; Flushed; Grogginess; Headache; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LANSOPRAZOLE (PREVACID), HYDRALAZINE, ENALAPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 03-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed), DIZZINESS (Grogginess) and HEADACHE (Headache). On 05-Mar-2021, CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) had resolved. At the time of the report, INJECTION SITE PAIN (Injection site soreness) had resolved and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: high (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the soreness included icing of the site   This case was linked to MOD-2021-036424 (Patient Link).
FOR THREE DAYS AFTER THE SHOT: EXTREME  LEFT SHOULDER AND LEFT UPPER ARM PAIN, BONE PAIN IN THAT AREA. INSOMNIA DUE TO PAIN, NAUSEATED .  ***DAY ONE AND TWO: HEART PALPITATIONS AND TAHICARDIA.  DAY TWO, FACE MUSCLE TWITCHING.  ***DAY TWO:  NASAL CONGESTION, FATIGUE , INCREASED  HEART BEAT, FEELING COLD/CHILLS, NO CIRCULATION IN EXTREMITIES. - PERIPHERAL COLDNESS.  ***DAY THREE: LYMPH NODES IN MY THROAT GOT ENLARGED AND PAINFULL, STARTED FIRST ON THE LEFT SIDE IN THE MORNING , BOTH SIDES BY 3 PM. HARD TIME SWALOWING. FEELING ABNORMAL, HEAD DISCOMFORT -LIGHT HEADED , CANT FOCUS  AND DIZZY. I FELT LIKE I AM GOING TO  FAINT. TINNITIS LATE ON DAY 3
Fever of 102F, Derma, between 11:30 PM to 2:30 AM, Chills at same frame, Sore Throat, Headache, pounding continuing from 11:30, 03/23/21 until 9:45 03/24/21, Several hours of weakness and dizziness, Injection site, Left arm, continues to be sore.