chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was supposed to get the second dose on Apr272021/missed on it; wasn't feeling well; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) and MALAISE (wasn't feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) and MALAISE (wasn't feeling well). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) had resolved and MALAISE (wasn't feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
REDNESS, RING EFFECT AROUND INJECTION SITE, SWELLING, SORENESS OF ARM.
Vaccine 1030 am. I took tylenol at 1 while at work as I felt achey and started getting a headache. Come 5pm I got chills which I assume meant I was getting a fever. Once I got home I had gotten the chills so bad my body shook fairly aggressively. Checked my fever, 101. Took another tylenol 500. An hour later, I was getting more feverish. Took my temp and it was up to 103. At which point I took another tylenol given it was out of the 6 hr window for 2 pills. I stripped and had to drop my AC to 62 and another hour later it was down to 102. But from 630 pm until roughly 3am my heart rate was 115-120 and some chest tightness consistently while resting. I was up and down on fever between 101 and 102 which I took medicine for when necessary. Headache and extreme back/shoulder pain that kept me awake. Finally all broke at 3am and was seemingly fine at 5 after 2 hours of sleep. 101 fever the following 2 days and for roughly 5 days after I had spikes in my heart rate and shortness of breath just walking down the hallway.
Ipsilateral lymphadenopathy affecting L axillary, L humeral, & L pectoral lymph nodes.  Onset approx. 24 h after vaccine administered.  Duration 5 days.
Erytema / edema of both eyes with urticarial lesions noted @ back, no respiratory distress. treated with Benadryl (25 mg PO every Q X 1 with good results, no lesions noted, decrease in swelling/erythema of both eyes.
1.  Vivid dreams for about a week after first dose of vaccine. 2.  Swelling, soreness and redness at sight of injection for about three days after injection.  This cleared up.   Then about a week after injection the injection site became swollen and red again.  The swelling lasted another 3 days but has now resided.  The redness is less noticeable but the circle has grown to approximately 4 1/2 inches in length and 2 1/4 inches in width.
Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory loss.
No additional AE reported; experienced the temperature excursion was administered to a patient,; This spontaneous report was received from an office manager (also reported as healthcare business professional (HBP)) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 20-JUL-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter; lot # T035379 with expiration date 31-MAY-2022 (route of administration, anatomical location and dose number were not provided) for prophylaxis. The temperature excursion was 46.8 degrees Fahrenheit (F) for 9 hours. The digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
The medical assistant noticed that vaxneuvance syringes were not as "smooth" when giving injection to patients compared to other company's prefilled syringes/ Other company's syringes were somoother and need less efforts to give the injections; Adverse event was also filled as precaution since 2 patients received the vaccines from possibly defctive syringes; This spontaneous report was received from a company representative and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, 2 patients was vaccinated with possibly defective syringes of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot number W027250, had been verified to be a valid number; expiration date 09-JUL-2024, and upon internal validation established as the same date, administered for prophylaxis (strength, and route of administration were not provided) (poor quality product administration).   On an unknown date, a medical assistant reported that when she used pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for the first two times, she noticed that syringes were not as smooth and need less effort when giving injections to patients compared to other company's prefilled syringes (unspecified names of the other company's syringes) (syringe issue). I t was reported that the medical assistant would not compare with other pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes because it was her first time using it.  This is a non-valid case due to the lack of patient's identifiers.
suspected vaccination failure; had external twice and internal. The internal are worse than any surgery; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had external one shingle twice and internal one shingle.  The internal were worse than any surgery. The patient stated that, had he/she not the shots, internal ones could travel to any organ and would kill you. The patient's neighbor at the age of 39 years died of internal as they traveled to his lungs. The patient would not wish them on a dog. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Developed chills and a rash the worsens and become very red with heat..started on face, right side neck and inner thighs on Thurday and on Friday was worse after bath and had spread to back, and feet, upper thigh and trunk, mild itching
COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: El9264), in left arm, on 29Jul2021 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 18Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Cipro allergy" (unspecified if ongoing), notes: Known allergies: Cipro; "Cod allergy" (unspecified if ongoing), notes: Known allergies: Cod; "String Beans allergy" (unspecified if ongoing), notes: Known allergies: String Beans; "Animal Dander allergy" (unspecified if ongoing), notes: Known allergies: Animal Dander. Concomitant medication(s) included: LIOTHYRONINE SOD.; LISINOPRIL; CALCIUM; FISH OIL; VITAMIN D3; VIT B12; L-THYROXINE [LEVOTHYROXINE]. The following information was reported: IMMUNISATION (medically significant) with onset 18Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 18Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
called to observation area 10:50 - report that patient passed out, was on stretcher, reported did not fall, 'came to' in less than 1 minute.  108/68, P 70 and strong, alert and oriented.  states feels anxious about flu shots.  felt lightheaded, hot, sweaty, skin pale and warm.  at 1052 rapid response arrived.  states feeling better, had had food/fluids today.   assessed that not allergic response - vaso/vagel.  1055 sat up and feeling good, skin pink.  1100 to chair.  1115 left area walking.
Previously unvaccinated child received Tdap 8/31/17 and MMRV 9/4/17 developed thrombocytopenia and epistaxis 9/14/17. No recent illness. Currently being treated for presumed ITP.
Patient's  mom knowingly wrote down patient's incorrect DOB to read that patient was 5y.o. when really patient was only 4y.o. Patient was given first dose of Peds covid Vaccine which is only eligible for kids 5-11.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. On 03-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided). On 21-APR-2015, the patient was in the office in order to receive the second dose of GARDASIL (inappropriate schedule of the vaccine administration). No adverse effects were reported. Additional information has been requested.
At 700 pm I got very dizzy, I needed to sit down. 7:15 pm I got weak, needed to lay down. I stayed down till 8:15, weakness went away. Was still dizzy the whole time. 11:30 pm dizzy was almost gone. By 300 pm 11-19-14 felt better. Right arm hurt like someone punched me in arm since 7 pm on 11-18-14. Still hurt not as bad 11-19-14. Now if I press slight feeling.
Seizures; she had a resurgence of Covid symptoms; They get worse with stress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus", start date: 2013 (ongoing); "sick" (unspecified if ongoing), notes: She has had a cytokine reaction before when she gets sick.; "cytokine reaction" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; SUSPECTED COVID-19 (non-serious) with onset 2021, outcome "unknown", described as "she had a resurgence of Covid symptoms"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "They get worse with stress".  Mentioned that after getting the vaccine she experienced seizures. It was stated that she has never had seizures before and stated that she lost her job because of it. Still in the process of diagnosing her and finding out what was causing her seizures. Since her doses, she has had at least 1 seizure every day and get worse with stress and they come in waves. Recently she had a resurgence of Covid symptoms about 2 weeks ago and the seizures got worse then. Stated that this occurred with her first and second doses. She does not remember the exact dates she received her doses. Also reported that she experienced seizures on 23Sep2021 and she had a resurgence of Covid symptoms on Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Chills, Slight Fever, Muscle Aches, Upset Stomach - Lasted about 12-16 hours after starting (less than 48 hours after shot).
Pt experienced a local reaction to vax; 9cm X 12cm area of erythema on left thigh.
Aches; Chills; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) in the left arm on an unknown date as a single dose and also received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had a history of allergy to penicillin. The patient received buspirone15 mg (MANUFACTURER UNKNOWN) within 2 weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On an unknown date, the patient had experienced aches, chills, arm pain and fatigue. The patient did not receive any treatment for the reported events. The clinical outcome of the events aches, chills, arm pain and fatigue was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received shot in left arm at the end of her shift.  By the time she got home she was having pain and tingling in that arm.  Went to bed and when she awoke in the am she had an extreme headache her cheek and eye were swollen, she was diaphoretic and nauseated.  She took Ibuprophen at the time and still has some swelling today.
Swelling and tingling of tongue.  vaccine given around 11:55 Am.... time now is 3:48 and still have swelling and tingling
Received vaccine Monday afternoon, all day Tuesday patient reported feeling very sickly with symptoms similar to flu symptoms. She stayed in bed most of the day. Around 3pm on Tuesday (24 hours post inoculation) she began to feel better. Her arm was very sore and red with localized swelling and was hot to the touch. This persisted until today Thursday. She is going to her PCP tomorrow morning to see if she needs an antibiotic.
Radiology procedure - Bilateral carotid bruits, assess for carotid artery disease. FINDINGS: Right common carotid artery is patent. Mild plaque at the right ICA. Elevated velocity right ECA to 388 cm/sec. Right ICA peak systolic velocity 202 cm/sec. Right vertebral artery is antegrade and patent. Left common carotid is patent. Mild plaque left bulb. Peak systolic velocity left ICA is 164 cm/sec. The vertebral artery is antegrade and patent. Procedure and office visit were done within 6 weeks of receiving the COVID vaccine.
PATIENT COMPLAINED OF ARM PAIN AND STIFFNESS AFTER VACCINATION, THEN AFTER ABOUT 1 MINUTE THE PATIENT FAINTED.  HE WOKE UP ALMOST IMMEDIATELY AND WAS SEATED IN VACCINATION ROOM AND OBSERVED FOR AROUND THE NEXT 30 MINUTES. PATIENT WAS DIZZY AND COMPLAINED OF HEADACHE.
No Adverse event; administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022) and NO ADVERSE EVENT (No Adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2022: Follow-up document contains updated patient demographics, product indication and dosing details updated accordingly, narrative updated.
Pt's. left arm has 6 cm x 6.5 cm raised reddened area. Pt. C/O soreness to touch.
Pt reported that on 09/18/2006 she noted a rash or whelps across her collar bone area but more concentrated on the left side. She denies itching and states that today. 9/19/06 rash appeared to be diminishing.
This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Wrong dose for age administered: Administered 10mcg/0.2ml dose instead of 30mcg/0.3ml dose. No adverse reactions.
flu; night in early morning i had trouble sleeping after 2 am. in the morning; tired; little appetite; irritation throughout my body as if a flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 13-Aug-2022. Previously administered products included for Product used for unknown indication: Pfizer vaccine (4 shots of Pfizer vaccine) on 19-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Dec-2022, the patient experienced INFLUENZA (flu), INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu). At the time of the report, INFLUENZA (flu) was resolving and INSOMNIA (night in early morning i had trouble sleeping after 2 am. in the morning), FATIGUE (tired), DECREASED APPETITE (little appetite) and SKIN IRRITATION (irritation throughout my body as if a flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.
There is a darkened raised area on Pt's left upper arm over deltoid muscle that measures 8 MM X 5 MM. Pt. C/o dull pain when spot is touched. Also itches when lightly touched by shirt.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 10-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
localized redness, swelling, itching, pain @ site of inj;apply cool pack to site;swelling 0.5cm, redness 5cm in width;claritin given;
Patient fliniched and jerked right arm at insertion of vaccine. Unknown amount of vaccine went into deltoid. Pt was advised that she can still have second dose that is scheduled. First dose cannot be re-administered with unknown amount she did recieve today.
per pt. she got swelling, hot and painful feeling in her legs the same night she got the shot.  she had her sister drive her to the er wher they did some tests and told her to go home and take tylenol and put compression stockings on. pt. showed up again at pharmacy on 08/13/2022 to inform us that she had this reaction and to report it. per pt. she still has swelling and it still hurts.
12:35 P - was in class, returned to clinic stating she felt dizzy. BP 124/70, P100, R 28. 12:40 Taken to nurses office, lying on cot. BP 124/70, P 100, R 28. Complains of difficulty breathing and "throat tightening". 911 called. Epi 1:1000 0.5 ml given IM and 50 mg BENADRYL PO. 12:45 Squad arrived - transported to hospital. Call to mother 3-17/10: states child returned to school.