chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was 7 yrs old- requiring the second dose of monovalent Pediatric Pfizer 0.2 mL with the 1.3 ml diluent for a dose of (10mcg), pt was incorrectly given monovalent pfizer for age group 6mths-<5 yrs formula with incorrect diluent of 1.3 ml (should be 2.2 ml diluent for this product) with a dose of 0.2mL. Pt did not experience any symptoms but was underdosed with the incorrect formula of pfizer for her age group.
Approx. 2 hrs after receiving vaccine, pt. reported c/o weakness, vision changes, and ligthheadedness. BP checked and 150/90's. Went to urgent care, BP rechecked 140/87, and was sent to ER. Started feeling better and BP decreased to 130/79, pt. sent home. Pt. reports having received flu shot in past without any problems or reactions.
COVID breakthrough. Patient was admitted to the hospital on 8/15/22 for unrelated reasons to COVID. He was tested for COVID on 8/26/22 for discharge to inpatient rehab and tested positive. He complained of a sore throat at that time but was otherwise asymptomatic. He was on room air until his discharge to inpatient rehab.
Case number PHEH2015US023779, is an initial spontaneous report received from a consumer (patient) on 12 Nov 2015. This report refers to a 68 years old female patient. Past medical and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173537, expiry date: not reported) intramuscularly in Sep 2015. On 30 Sep 2015, three days after the vaccination, the patient experienced diarrhea, weakness, rash that blistered and she was taken to the hospital emergency room twice. Outcome and causality of the event was not reported.
apprx 12 hours after injection my tongue  started to swell and my tongue, upper palette and below tongue were sensitive to the touch.   Sensitivity disappeared in apprx hour except for tongue was still sensitive for about another 12 hours.  I had no difficulty breathing at any time.  apprx 20 hours after injection had lower abdominal cramping and episode of diarrhea lasting about an hour.
Nurse failed to look in record and took word for it that this child was new and that we would have to start from scratch with the vaccination.  Nurse had forgotten that this child had come into the office for the same shots back in September making two of them invalid due to spacing.
Worsening of neuropathy of feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia (Patient had elevated   cholesterol), Osteoarthritis spinal (osteoarthritis  Of spine), Hypothyroidism, Aortic aneurysm and Migraine. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    This case was linked.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I did not have any symptoms right after vaccine.  I started to know afterwards I was getting short of breath.  I talked to my PCP about it, and they referred me to a pulmonologist, and they diagnosed me with CPOD.  I am currently taking an inhaler.
Seen ER provider on 12/18/21 with left arm pain and lymphadenopathy  after 3rd covid booster on 12/13/21, no prior response noted with first 2 vaccines, MD felt this was her body's immune response to vaccine and should go away on own, no neuro deficits of arm noted, prednisone 40mg po daily for 6 days ordered, follow up with provider in 1 week.
Per Agency and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and Agency instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
This spontaneous report as received from a physician via filed representative concerning an 11 year old male patient. The patient's concurrent condition included asthma. No medical history and concomitant medications were reported. On 27-JUL-2017, the patient was vaccinated with GARDASIL 9 dose 1 (dosing details, lot#, expiry date and route were unknown) for prophylaxis.  On the same day, the patient was also vaccinated with diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (reported as TDAP (tetanus, diphtheria, and pertussis) vaccine) and meningococcal vaccine (unspecified) (reported as meningitis vaccine) (dosing details, lot#, expiry date and route were unknown) both for prophylaxis. On 27-JUL-2017, when the patient was leaving the physician's office he nearly fainted (but did not faint). The patient was back into a room and rested for fifteen minutes. While in the room resting the patient's pulse and blood pressure were taken and blood pressure and pulse did drop. No treatment was given for the events. The outcome of presyncope was unknown. The outcome of blood pressure decreased and heart rate decreased was considered as recovering since reported as "vitals were better". The physician was not going to go forward with the second dose of the GARDASIL 9 until Merck contacts the physician and gives the recommendation whether to give the second shot of GARDASIL 9 or not. Causality assessment was not reported.
Six days after injection, expressed 10 cc's of bright red hemorrhage in urine.  One episode only.  After drinking two bottles of water, the urine was clear of blood.  In the two days afterward, there were no additional hemorrhagic discharges.  No fever or sickness of any kind was experienced before or after this incident.  There has never been an incident of blood in my urine.  There is no history of kidney stones or bladder infections.  No treatment, except for drinking large volumes of water, has been done since the incident.
On first vaccination - injection site sore for up to 3 days - with second vaccination - injection site sore but also felt like coming down with flu for next week.  However, flowing the first week experienced aches and pains in all joints to the point of requiring NSAIDS and muscle relaxer to combat pain,  Slept for entire night and day when off from work.  Started to become better in middle of April (approximately 15th) with aches and pain reducing and sleepiness now regulated to just 12 hours over night .
Information has been received from a pharmacist concerning two patients who within the last 30 days were vaccinated with ZOSTAVAX (Merck) (subcutaneously, 0.65ml, lot # not reported). On the same day as vaccination the patients had an infection at the injection site. The patients experienced initially redness and swelling at the injection site. The infection had been treated with 2 antimicrobial (unspecified). The pharmacist believed the infection could have been "staph" because of the 2 antimicrobial (unspecified) used and the potency of these antimicrobial (unspecified). The patients had sought medical attention via phone calls. The pharmacist considered the infections to be other important medical events. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
6 hours after getting the flu shot I Developed a fever that rose to 103 degrees. I had difficuly breathing and my heartrate was faster than normal and I was wheezing.
Felt like someone beat her up; Headache; Temperature of 103F; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F). In January 2021, DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment information was provided.  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.; Reporter'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.
Sep 29 I received the third dose of COVID-19 vaccine on the left arm. Oct 1 started to feel strong pain on the left shoulder with burning and cramps from the shoulder to the elbow and numbness from the elbow to the fingers left hand. I went to the clinic Oct 4 where I got the vaccine to report the symptoms that I'm having. After evaluation the doctor determines that I have spasm and prescribes me FLEXERIL HS. Panadol/ NEURONTIN 100mg HS/ FEXERIL does not relieve what I feel in my arm and the cramp in my left arm and the pain is worse at night.
Extreme fatigue, body aches, dizziness, light nausea  (starting an hour after and lasting still, 52 hours later),
Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 26-OCT-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 5 year old female who on 07/20/1998 was vaccinated SC in the left thigh with a first dose of varicella vaccine. On 04/02/2001, the pt developed chicken pox. The rash described as papulovesicular lesions, different sizes, mostly on trunk, less on extremities, itchy. It lasted one week.
Patient received two doses of the Moderna COVID-19 vaccine on the same day; A spontaneous report was received from a pharmacy concerning a 50 year old female patient who patient received two doses of the Moderna COVID-19 vaccine on the same day with the use of mRNA-1273.   There was no medical history provided. There were no concomitant medications provided.  On 08 Jan 2021, the patient received the first and second of two planned doses of mRNA-1273 (Batch # unknown), in her right deltoid, for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient received two doses of the Moderna COVID-19 vaccine on the same day. It was noted that there were no adverse reactions identified at the time of this report. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event of patient received two doses of the Moderna COVID-19 vaccine on the same day, was considered not provided as the patient received two doses.  The outcome for the event of injected air into vaccine was recovered/resolved at the time of this report.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of inappropriate schedule of product administration.
Three and four days after receiving the vaccine I was extrememly fatigued and weak. Today (eight days after)  the area where I got the injection is broken out in whelps and pimple like erruptions and is very itchy.  I also have a slight headache.  I never have headaches.
This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included triamterene and Bupropion XL. On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 16th June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 18th June 2018, the patient experienced eye swelling, facial swelling and skin warm. On 19th June 2018, the patient experienced itchy upper limbs. On an unknown date, the outcome of the eye swelling, itchy upper limbs, pain in arm, erythema of extremities, facial swelling and skin warm were not recovered/not resolved. The reporter considered the eye swelling, facial swelling and skin warm to be almost certainly related to SHINGRIX. The reporter considered the itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient stated that a couple of hours after receiving the injection on left arm, she experienced pain in her left arm and a big red circle on her left arm. The patient stated that the day before reporting (2 days after vaccination), when she woke up, she noticed swelling under her eyes and on her cheeks. The patient's face was warm to the touch and it looked like sunburn. The patient stated that at the day of reporting (3 days after vaccination), her left arm was itchy. The patient had denied permission to contact their physician.
my daughter felt intense pain at the injection site the rest of the day and  the pain has not subsided.  By 7pm last night, about 6 hours after the injection, she developed a high fever of 104.5, I gave her aspirin to help but the fever remained high during the night.  This morning her fever is down but she is extremely tired and I am keeping her home from school as a result.
17cm X 10cm area of swelling/redness. Vesicular rash around site appearing 8/30/2012.
Urticaria at injections site. Felt warm (site) to touch. Very fussy 5-4-10. 2 cm area erythema with tenderness right thigh.
Red rash; hot; hives are much worse; rashes in front of her legs, rashes from her knee up; Patient received the second dose of the vaccine more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse), RASH (rashes in front of her legs, rashes from her knee up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, AMLODIPINE, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE and MELATONIN (MELATONINA) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-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 RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse), RASH (rashes in front of her legs, rashes from her knee up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot), URTICARIA (hives are much worse) and RASH (rashes in front of her legs, rashes from her knee up) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking medication for blood pressure and thyroid.  On 3-February-2021 patient starts treatment with Steroids unknown dosage and stopped use on 10-February-2021.On 16-February-2021 patient starts to use antihistamines unknown dosage daily for treatment.   This case was linked to MOD-2021-017845 (Patient Link).
Received my Moderna Booster around 2:13pm on 12/22/21.  Felt tired in the evening and had some soreness at the site of injection.  Around 9pm, I noticed my nose was beginning to run and my face seemed flushed but did not feel feverish.  Woke up around 6:30am today, 12/23/21 and noticed dried mucous near nasal passages. Also my face felt strange. I then observed that my upper lip, skin below my eyes and my eyelids were swollen and red.  Spoke to a nurse practitioner on telehealth appointment briefly and was encouraged to be seen in person.  Took my normal medicine and left the house a short time later.   The doctor I saw at the urgent care said he believed this to be an allergic reaction and prescribed a steroid cream for my face, told me to take Benadryl and to use a cold compress on my face.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
3wk p/vax devel lesions on face & rest of body (approx 10 on face & 20-25 lesions on trunk);no fever;lesions weepy for 2-3 days then crusted over;2nd day devel reddened area 10-15mm in size devel on upper lt thigh near the groin. Physician believes groin rash is shingle.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little lousy), LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled), PERIPHERAL SWELLING (Her two hands began swelled up, husband had to cut her ring off) and ANKLE FRACTURE (Broken ankle) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 002C21A and 008B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Had Covid over Christmas break 2021) in 2021 and Muscle relaxant. Concurrent medical conditions included Chronic pain and Sleeplessness (Can't sleep). Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]) for Chronic pain, TIZANIDINE for Muscle relaxant, HYDROXYZINE for Sleeplessness, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], SEROTONIN, DOCUSATE SODIUM (STOOL SOFTENER), SENNA [SENNA ALEXANDRINA] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Felt a little lousy). In March 2022, the patient experienced PERIPHERAL SWELLING (Her two hands began swelled up husband had to cut her ring off). On an unknown date, the patient experienced LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled) and ANKLE FRACTURE (Broken ankle). The patient was treated with Surgery for Ankle fracture. At the time of the report, FEELING ABNORMAL (Felt a little lousy), LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled), PERIPHERAL SWELLING (Her two hands began swelled up husband had to cut her ring off) and ANKLE FRACTURE (Broken ankle) outcome was unknown. Concomitant medication information includes OTC vitamin D 1,000 Units, serotonin 3 mg at bedtime. Patient did not had problems with breathing. Treatment information includes patient took around the clock Benadryl. This case was linked to MOD-2022-510833 (Patient Link).
Pt presented to ER with chest discomfort, shortness of breath, and post op repair of PFO on 4/27.  Pt was found to be COVID positive.  Pt admitted for chest pain monitoring, but was saturating well.
headache; sinus reaction; had mild reaction; heated; site got ribbed; arm sore; lil bit swollen; little bit nausea; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus reaction), VACCINATION SITE REACTION (had mild reaction), FEELING HOT (heated), VACCINATION SITE RASH (site got ribbed) and VACCINATION SITE PAIN (arm sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SINUS DISORDER (sinus reaction), VACCINATION SITE REACTION (had mild reaction), FEELING HOT (heated), VACCINATION SITE RASH (site got ribbed), VACCINATION SITE PAIN (arm sore), VACCINATION SITE SWELLING (lil bit swollen) and NAUSEA (little bit nausea). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, SINUS DISORDER (sinus reaction), VACCINATION SITE REACTION (had mild reaction), FEELING HOT (heated), VACCINATION SITE RASH (site got ribbed), VACCINATION SITE PAIN (arm sore), VACCINATION SITE SWELLING (lil bit swollen), NAUSEA (little bit nausea) and HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.