chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.  No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-501575 (Patient Link).
Severe right arm pain, nausea, fever, fatigue, muscle pain, general feeling of being ill.  Started 11pm on 1/4/21 continuing through 1/5/21 evening.
Severe injection site pain Severe chills throughout night not controlled with tylenol/ibuprofen Vaginal bleeding/spotting 2 days after injection- I am breastfeeding and have not had a mensural cycle or bleeding until I received the shot. Lasted for about 12 hours on and off spotting with slight cramping Cough and Sore throat Chest congestion
couldn't sleep; Tired; Pregnant; Sore arm; Stomach crumps; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PAIN (Sore arm), ABDOMINAL PAIN UPPER (Stomach crumps), POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FISH OIL (OMEGA 3 FISH OILS), PROBIOTICS NOS, COLECALCIFEROL, MENAQUINONE-7 (VITAMIN D3 K2) and LECITHIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Feb-2021 and the estimated date of delivery was 24-Nov-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PAIN (Sore arm) and ABDOMINAL PAIN UPPER (Stomach crumps). On 01-Apr-2021, the patient experienced POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 06-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved. On 03-Apr-2021, POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach crumps) had resolved. Unknown
Blisters on the lips; Blisters inside the mouth; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB, PANTOPRAZOLE, AMLODIPINE, CITALOPRAM, MAGNESIUM and CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth). At the time of the report, LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included vitamin B3, arthritis pain killer and Pro-Air Inhaler sos for an unknown indication.
Pt was seen for her first OB appointment with Dr. Pt stated about an hour after she left the office after receiving her flu vaccine, she developed hives across her feet. Pt stated they continued to spread and this am she is covered all over her body in hives. Pt reports to itching, redness and tenderness. Pt denies shortness of breath, difficulty breathing or swelling. Pt was instructed to take oral Benadryl 25mg 1 tablet by mouth every 6 hours as needed.  Pt denies previous reactions to flu vaccines and denies any known allergies to foods or medications. Pt has an estimated due date of 4/18/2019.
Weakness, tired, sore all over, diaphragm sore, bubble head, head ache
immed p/vax pt devel rash over face, abd & lt thigh;lt thigh was swollen red & warm to touch;MD notified & pt given DPH;VS stable; pt watched for 20";pt's rash was gone p/20" s/lt leg area;mom instructed to give pt DPH
Muffled hearing,  feeling of fullness in ears which persists to this day (5/04/2021)
Arm tenderness at injection site; This is a spontaneous report from a contactable consumer.  A consumer of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 12Mar2021 at single dose for COVID-19 immunization. The patient received the first dose of vaccine on an unknown date. The patient reported arm tenderness at injection site 24 hours after immunization. Tenderness has resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Headache, Diarrhea, NauseaVomiting, chills Narrative:  1/2/21 headache nausea. 1/3/21 vomiting diarrhea chills, called in sick by 1/4 symptoms resolved.
No additional adverse events.; Caller is nurse who reported that PROQUAD was given to a 17 year old patient.; This spontaneous report was received from a registered nurse, concerning a 17-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies and concomitant medications were not provided.   On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (1 dose, valid lot number W007743 [expiration date 04-SEP-2023]) (dose, strength and route were not provided) for prophylaxis at 17 years old (product administered to patient of inappropriate age). No additional information available. No additional adverse events. No product quality complaints.
This child's parent called from New Mexico on 11/24/00, describing fever times one day (103's), headaches, and a circular rash. She was advised to be evaluated there.  The parent called back on 11/27/00 and told us the patient was diagnosed with the chicken pox by the pediatrician there.
Beginning that evening 4/28/20 child complains of increased pain in bone of right leg injection given.  Pain level rated by child an 8.  4/29/20 child complains of increases pain in leg, can't walk on leg without leg giving out the to pain.  Pain rated 10.  Doctor office contacted for advise and concern. Informed common reaction, given imstructions on how to help pain go away.  Child complains skin itches along inner thigh, itch and stinging pain.  Constipated.  Child has history of having 1 -2 BM daily, constipated now. 5/3/20 child has three tiny moles.  5/4/20 child complains of rash along waist, stinging pain, itches, sore opened, bright red.  Also child develops a breakout of tiny bumps skin colored.  Called doctor office, lft msg with answer service.  5/5/20 Follow up with doctor office, appt made same day, saw doctor over rash and skin reaction outbreak.  No mention from provider that the rash may be his immune system trying to deal with the vaccine ingredients and aluminum.  Over the last 10 days, child has had increases emotional breakdowns.  Continue to keep up with provider to assure child well taken care of and helped through.  Will continue documenting.
she has been seeing some blood when she blows her nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient verbally reported that she has been seeing some blood when she blows her nose. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; COVID Rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 026L20A), on 24Feb2021 as dose 2, single (Lot number: 011M20A) and on 26Oct2021 as dose 3 (booster), single (Lot number: 014F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "recovering", described as "COVID Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: COVID 19 Treatment, brand=Paxlovid, treatment start date=15Aug2022, treatment stop date=20Aug2022. No known allergies.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Experiencing bad leg cramps especially at night.  Has been taking Acetaminophen only in the evening.
Pt. stated that rash began on torso 7 days after receiving shingles vaccine. Pt. also complained of being itchy at site of rash. Pt. denied any HX of shingles.
Patient's father completed the consent  form and confirmed to the immunizing pharmacist on 6-10-21 during an off site Covid vaccine clinic  that the patient is 12 years old. While processing the prescription on 06-11-21  we had a rejection  from the  insurance and they confirmed that the patient's DOB was different. The  patient's Dad  was contacted again and he  said that the daughter is 11 years old and not 12 years old as he originally stated.  He did not report any adverse effect to the RPH that contacted him.
very fatigued since the vaccines about a month ago; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued since the vaccines about a month ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very fatigued since the vaccines about a month ago). At the time of the report, FATIGUE (very fatigued since the vaccines about a month ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; injected way below her deltoid and at the time of the report it had been a red hot bump; it was inadvertently administered subcutaneously; This is a spontaneous report from a contactable physician (patient). A 48-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via subcutaneous on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for birth control. The patient had the second dose of the COVID-19 vaccine yesterday (14Jan2021) and it was inadvertently administered subcutaneously. She said that the vaccine was injected way below her deltoid and at the time of the report it had been a red hot bump. She also mentioned that she had 0 symptoms and no muscle paint. She was wondering whether there were recommendations for her disposition. The patient also stated that it was subcutaneous, it was way off, it was not her deltoid at all. The outcome of the event was unknown.  Information about Lot/Batch number is requested.
Reports local site reaction x1 week, redness, warm and tender to touch, approximate 3 inches round.  Complained of feeling tired yesterday 10/10/11. Reports shooting pains, numbness and tingling in right arm that started last night.  Woke up this morning with additional warm, red irregular erythematic area on inside of right upper arm approximately 3-4 inches that is oblong in shape.  Denies fever. Referred to PCP.
Pt developed 14 cm x 14 cm erythematous, tender indurated swelling of right thigh 2 days post vax.
Vaccinator delivered incorrect vaccine. Patient was labeled, scanned, and identified as a Booster dose of Pfizer.  An error was made with the vaccinator picking the wrong syringe. Janssen syringes are 3mL, Pfizer syringes are 1mL. All Janssen syringes are labeled as well. Patient had no symptoms, No complaints, and  was given necessary information to report to VAERS in addition to this report.
1st and 2nd doses: severe joint pain, temp 103 for over 24 hours, back pain, skin tingling, vomiting, nausea, extreme exhaustion
ELBOW JOINT PAIN AND PAIN AT THE INJECTION SITE.  GETTING WORSE AS TIME GOES ON.
Extreme stomach cramping, frequent diarrhea spells, chills, slight nausea, complained of feeling very ill and very fatigued.  Took 1st capsule of Vivotif at 8:30 03/12/04.  Onset of symptoms 13:30 03/12/04. Symptoms lasted less than 24 hours on 03/13/04.  Stomach sore but other symptoms resolved.
This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the consumer was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The consumer reported that on an unknown date, she experienced injection site itching. The outcome of injection site itching was unknown. Additional information has been requested.
pt recv vax & exp laryngitis;no tx was given;event resolved;21JAN97 pt reported that voice is gone again;it has been determined that this event is not related to dose 1 or 2 of engerix-B;
I felt a little nauseous the night I received the vaccine. The next a.m. I got up went to the kitchen and blacked out falling on the floor. I was awake and got up. No injuries and took it easy the balance of the day.
Spontaneous hives, intense itching episodes, painful inflamed skin 11 days post vaccine.  I am not on day 4, with no relief of symptoms.
Burning, itching and swelling at injection site 9 days after. Called nurse and was given steroid cream. Resolved swelling and itching in 2 days. Still red 2weeks later. No other symptoms.
redness little lower that injection site looks like sunburn; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, AMLODIPINE, GLIMEPIRIDE, LOSARTAN and ROSUVASTATIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn). At the time of the report, VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn) had not resolved. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Dardinacy (for diabetes) used as a concomitant medication.  Patient was treated by ice pack.
headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) 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 reported.    This case was linked to MOD-2021-063213 (Patient Link).
3x3 cm red swollen area on the right arm at the distal immunization site.
Patient developed itching to whole body without rash. Noticed after getting COVID booster shot and has lasted about a month. She also developed bruising to bilateral thighs from scratching.  The mother of the patient developed the same symptoms and both got COVID vaccine at same time.
"Within hours," fever, aches and pains, and cough. Ring of redness around the arm starting from the injections sites. Treated by TYLENOL, fluids, and bed rest over 4 days.
Flu shot 10-2-12. Developed full body rash 10-3-12. Recovered. Got flu Sx-vomiting, rash, swelling to neck/face 10-11-12. Tx ER as is 17 wks pregnant. 23 hr. observation due to vomiting. Recovered & discharged.
COVID FOR THE THIRD TIME; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid for the third time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid for the third time was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208289.
MEMORY LOSS/ SHORT TERM MEMORY LOSS; BLURRED VISION; HEADACHES; This spontaneous report received from a patient concerned of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical conditions included: tested negative for covid (prior to the vaccine). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total administered on DEC-2020 for prophylactic vaccination. The patient had sharp memory began to get fuzzy a few months later, noticed could remember everything prior to the vaccine and everything within the last two months, but everything in between was a blur following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced memory loss/ short term memory loss, blurred vision, and headaches. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The patient memory loss was to the extent that many times patient cannot remember patient had taken medication or to the extent or even had to put alarms in phone to remember to pick up kids from school. This was like being 45 and having Alzheimer's Disease. The memory loss had been noticed by friends, family, and co-workers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory loss/ short term memory loss, and the outcome of blurred vision and headaches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220361891.