chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; lethargic; throwing up; woke up and had some phlegm and couldn't get it up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FK52A) at the age of 5 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Febrile seizure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu vaccine. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; LETHARGY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "lethargic"; VOMITING (non-serious) with onset 10Nov2021, outcome "not recovered", described as "throwing up"; PRODUCTIVE COUGH (non-serious) with onset 10Nov2021, outcome "unknown", described as "woke up and had some phlegm and couldn't get it up". Therapeutic measures were not taken as a result of illness, lethargy, vomiting, productive cough.  Additional Information: Caregiver was Calling on the behalf of her son (male, 5 and half years old) who got a pediatric Pfizer Covid19 vaccine, has been feeling very lethargic, throwing up, initially he was sick on Wednesday was fine yesterday and sick again this morning. Reporter states she is calling regarding the Pediatric Covid shot, clarified that she is referring to the Pfizer pediatric Covid shot. She states that her 5-and-a-half-year-old son got his shot Monday.  On Wednesday, he had one episode where he threw up, then he was fine. Today, he woke up at pone point and threw up and was quite a bit lethargic. He has no fever. He woke up about 6:00am and he tried to eat breakfast, which did not go over very well. He is still sleeping and has been waking up and then he threw up and fell back asleep. He threw up twice Wednesday morning and they kept him home from school. Then, by lunch time, he looked like a new kid, and he went to school Thursday. It started back up this morning.  He looks worse now. She thought on Wednesday, it was just the flu. He woke up and had some phlegm and couldn't get it up. He only had a little episode in the morning, and they thought it was congestion. Treatment was no, they were going to give him some Guaifenesin, but he looked fine Wednesday and they didn't worry.  They haven't given him anything. The Vaccination Facility Type was Pharmacy/Drug Store  No follow-up attempts are possible. No further information is expected.
About 12 days post-vax, patient developed erythema multiforme, fever and vomiting lasting 24 hours.
dry mouth after 5 days of vaccination; This is a spontaneous report received from a contactable Pharmacist. A 43-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Mar2021 as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. Prior to vaccination, was the patient did not diagnose with COVID-19. She experienced dry mouth after 5 days of vaccination on 31Mar2021 which caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: A causal relationship between BNT162B2 and the event dry mouth cannot be excluded based on temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs,  Committees, and Investigators, as appropriate .
5:30ish hot, stuffy, clammy - went outside work to remove mask to breathe a couple min 2x but by 6p diarrhea and vomiting and chills/freezing!! (just arm pain like after tetanus shot from 3a 1/21 until 5:30 1/22, though slight headache heading to work around 2:30p) Went home 9p once staff arrived. Chewed some Equate antacids and went to bed and dead tired and felt yucky all day 1/23. Missed 7a-10p shift. Tired but worked 1/24 7a-10p. Got tested 1/25 and received neg results 1/26. No fever at all, despite checking many times. Did not take any NSAIDs or anything else.
Severe nausea, vomiting, dehydration requiring IV hydration and antiemetics
Headach Low Grade Fever Injection Site Pain Muscle Pain Tiredness Feeling Unwell Loss of  Appetite
Patient was seen for a nurse visit for vaccines. Nurse A drew up the vaccines and nurse B gave the vaccines. Nurse A drew up the incorrect vaccines per mom's request. Mom had requested that the patient not get combo vaccines and instead get DTAP and IPV  seperate. Nurse A drew up a Kinrix (DTAP &IPV) and an IPV. Nurse B didn't check the vaccines that were drawn up prior to giving them. Patient was due for these vaccines, but were not given the way mom wanted them to be given and patient received an extra IPV.
Patient received shingrix dose #2 on 4.20.23. She presented to ER on 4.21.23 with complaints of headache and left arm swelling around the shingrix vaccine site. Shingrix vaccine was administered 4.20.23 around 11 am. She started having headache, nausea, left arm redness and pain around 4 pm on 4.20.23.   She denied s/s prior to vaccination.
Vital signs stable throughout - child felt light headed and dizzy approx 5 min after vaccine given. Placed supine with feet elevated. No loss of consciousness, no resp distress. Fully recovered.
8 days post vaccination soreness, 10 days post, red lesion, noticably warm to the touch,  2 inch diameter around injection site, mildly sore, no itching
Annoying headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Annoying headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Annoying headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 17-Mar-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Annoying headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
pt recvd vax & 24 hrs p/vax exp swelling, redness, & a lump @ the inject site;
Information has been received from the authors in a published literature article titled as above. OBJECTIVE: Limited data exist on human papillomavirus (HPV) vaccine (manufacturer unknown) safety during pregnancy. Although pregnancy is a contraindication, inadvertent vaccination does occur. Our objective was to evaluate whether HPV vaccination during pregnancy or peri-conception was associated with increased risks for adverse obstetric events, adverse birth outcomes or birth defects. STUDY DESIGN: We performed a retrospective, observational cohort study using administrative and healthcare data from the Vaccine Safety Datalink (VSD), a collaborative effort between the Centers for Disease Control and Prevention's Immunization Safety Office and several large health systems. The cohort consisted of insured women 11-27 years old with singleton pregnancies ending in a live birth from 01-JAN-2007 through 30-SEP-2013. Women receiving the quadrivalent HPV vaccine (4vHPV) vaccine (manufacturer unknown) during pregnancy or in the peri-conception period were classified as exposed. Controls were women with singleton pregnancies and a live birth during the same period who received 4vHPV 4-18 months prior to pregnancy start or last menstrual period (LMP). Risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth (<37 weeks' gestation), small for gestational age (SGA) birth and major structural birth defects in offspring were evaluated. Using a generalized estimating equation method we evaluated adjusted relative risks associated with receipt of 4vHPV vaccine (manufacturer unknown) during pregnancy, the peri-conception period, and risks for both periods combined. RESULTS: We identified 720 women who received the 4vHPV vaccine peri-conception (linked to MARRS# 1701USA001368) and 638 who received the vaccine during pregnancy (Drug exposure during pregnancy), compared to 8196 with distal 4vHPV exposures. Vaccination with 4vHPV was not associated with an increased risk of adverse obstetric events, birth outcomes, or major structural birth defects during any of the exposure periods as compared to controls (see table). CONCLUSION: In this cohort of insured adolescent and young adult women, inadvertent administration of the 4vHPV vaccine (manufacturer unknown) during pregnancy or peri-conception was not associated with adverse maternal or infant outcomes. This study provided needed data for providers and expectant mothers on the safety of 4vHPV vaccine, when inadvertently administered in pregnancy. This retrospective pregnancy report referred to 638 female patients (detail information as above). On unknown dates the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (lot#, strength, dosage, frequency and route unspecified) for prophylaxis during pregnancy.  The last menstrual period (LMP) and estimated due date (EDD) were not known. The outcome of Drug exposure during pregnancy was reported as recovered/resolved (details as above). Additional information has been requested.; Sender's Comments: US-009507513-1701USA001368:
Patient stated begin 24 hours after initial vaccination experienced fatigue and headache which continued to worsen resulting in inability to function and sleep continuously. Developed Diarrhea 4 days after vaccination. Begin vomiting on Monday 1-18-21. Went to Urgent Care and had a COVID test which came back Negative on 1-20-21 Will see primary care physician this Friday 1-22-21. Still experience Diarrhea, fatigue, headaches and nausea as of 1-20-21. Patient been instructed to rest, drink plenty of fluids and treat symptoms until to be seen by primary care provider
Positive COVID-19 test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID-19 test) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eye operation on 12-Apr-2021.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test: positive (Positive) 1st test. In April 2021, SARS-CoV-2 test: negative (Negative) 2nd test and positive (Positive) positive. On 28-Apr-2021, SARS-CoV-2 test: pending (Inconclusive) 3rd test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccine given at 1745. In observation at 1803 began c/o "throat closing" feeling, similar to early onset allergic reactions. Pt requested to start w/50 mg Benadryl po d/t being able to control airway and denies sob/wheezing. Benadryl given at 1805. Confirmed 95% relief of throat feeling at 15 min s/p med admin. Further c/o throat scratchiness left over and continued to monitor her for symptoms for a total of 40 mins s/p vaccine. Pt left at 1842 w/only c/o throat scratchy-1%. She will monitor for s&s tonight and seek emergency care if they reappear. 1803 p86, r16 ; 1824 bp 133/84 p70; 1835 124/84
Few hours after injection - developed 3 sm. raised hives at site - throughout next 24 hrs hives spread throughout stomach, trunk, upper thigh, buttocks - comes and goes- gave BENADRYL.
Patient denied receiving a Vaccine from a different Pharmacy,  apparently he received a Pfizer vaccine on January 27, 2021.  It was caught after the form was submitted for finalization inside with the Office staff.
Intense local reaction to subcutaneous VARIVAX vaccine, right upper extremity. 4-5 cm circular area of warmth, swelling and erythema.
states 3AM pt screaming w/t104 w/jerking of whole body; states went to ER & stayed 5 hrs until temp down; jerking lasted 30 mins; broke out in rash following day;
Within 24 of receiving the shot, I began experiencing severe headaches, nausea, fatigue, large heated welt at injection site. Headaches lasted 3 days, nausea lasted 2 days, fatigue lasted 2 days, and welt lasted a week or more. Took OTC meds for headaches and used ice for arm.
Patient stood up appox. 2 mins after injection, fainted, fell to the floor, and eyes rolled into the back of her head; this lasted 7-10 seconds, pt sat up - we monitored blood pressure for 1 hour.
Passed out; Fainted; Collapsed on the floor and injured their arm and shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SYNCOPE (Fainted) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 18-May-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainted) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported  It was reported that, within 15 minutes of receiving the dose the patient passed out and fainted. The patient collapsed on the floor and injured their arm and shoulder. The patient was seen by the doctor who confirmed no bones were broken.   No treatment medication were reported.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 26 year old female with an amoxicillin allergy and a history of genital herpes who on 19-DEC-2007 was intramuscularly vaccinated with the first 0.5 mL dose of GARADSIL (lot # 659439/1267U), on 11-MAR-2008 was intramuscularly vaccinated with the second 0.5 mL dose of GARDASIL (lot # 659182/1757U) and on 21-AUG-2008 was intramuscularly vaccinated with the third 0.5 mL dose of GARDASIL (lot # 66012/0229X). There was no concomitant medication. The patient developed a mild outbreak of her genital herpes about one day after being vaccinated with doses one and two of GARDASIL. About two weeks after her third dose of the series, the patient had a more severe outbreak that required treatment with VALTREX. The patient was seen in the office. At the time of reporting, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Hospitalized with altered mental status/encephalopathy.  COVID 19 Pneumonia
Pt received PNEUMOVAX and she developed (L) arm soreness radiating down (L) arm into thumb; arm is warm to touch, red, swollen.
I went to the doctor because I thought I had strep throat. A culture was taken and it was confirmed I had strep throat. The nurse suggested I get the Tetanus shot as it had been a long time since I had one. I said sure, not knowing it was multiple shots in one AND you are NEVER supposed to give a shot when someone is sick! I didn't know this information at the time of the shot. Immediately after the shot I felt hot and sweaty and sick. I asked to use the restroom and barely made it there. I fainted in the restroom. After I woke up I yelled for the nurse to come and help me. She walked me back to the room where I was given the shot. The doctor came back in and placed cold presses on my body to help me. After about 30 minutes I was able to stand up and walk out. I've not felt the same since that Tdap shot that day! My memory has been horrible since that day, I get dizzy very easily and constant headaches. I've had to do acupuncture and chiropractic care to help heal myself from the Tdap shot.
Given first booster of Pfizer (previously received J&J) and 30 mins after bad symptoms of Bell?s Palsy: drooping of mouth,  numbness & tingling on entire right side of face  Called ambulance, EMTs provided stroke tests and EKG all of which showed no issues. Recommended follow up at emergency room since no improvement to face. Went to emergency room where additional stroke tests were completed, also showed negative. Some facial improvement was occurring at that time so recommended monitoring it and going home to rest.   Symptoms resolved by afternoon next day.
devel h/a & palpations afternoon of 17OCT94, both became inc worse during evening, woke twice during noc severe h/a, inc palpations & vertigo, 4AM had unsteady gait from vertigo; forced fluids in AM around noon 18OCT94 sx began subsiding;
Pt recv vax on 4/8/99; on 4/10/99 pt exp chills, fever, red/swollen vax site
I had heart prepetition, Right after the vaccine I had flutter in heart for 3 Hours. Doctor believe the I was having a PAC.  August 25,2021  for delivery.
This spontaneous report was received from an employee at pharmaceutical company who came across an article on a social media news feed and refers to a female patient of unknown age. The article from News Network and was posted 29-MAY-2017.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (MMR) vaccine (manufacturer not specified). A court ruling in December 2012 the "young" patient won compensation following vaccine-related brain injury that involved MMR and resulted in autism. The outcome of the event was unknown. Causality assessment was related. Upon internal review, autism was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
sweating; chills; muscle pain; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Details regarding concomitant and treatment medications were not provided.
Symptoms: 1. Urticaria Pruritus, 2. chest and abdominal tightness, fever, fingers hurt within 12 hours.
Patient complains of pain in upper arm she doesn't know if from the injection or lifting weights/playing tennis.
HORRIBLE unbearable arm pain and chills throughout my body i would not be reporting this if the pain wasn?t this bad i feel scared and someone nervous because i can barely use my left arm where the vaccine has went in. I got the vaccine on Monday 11:20 am and then after was fine and normal then i went home and worked out at around 4:30 and after that the pain increase but it wasn?t until the Tuesday which is the day after i got my vaccine that i could not function with out ibuprophen and the second that it wore off the vaccine site was hot and the pain was radiating throughout my arm making it near impossible to do anything it is now Wednesday and the pain has gotten way worse and i am unsure of what to do other than to force myself to take Advil so i can function
1. ASTHMA ATTACK- 10 MINUTES POST VACCINATION, SUBSIDED WITHIN AN ADDITIONAL 10 MINUTES WITH USE OF EMERGENCY INHALER AND OTC ALLERGY MEDICATION. 2. ITCHING - FULL BODY ITCHING BEGAN WITHIN 1 HOUR POST VACCINATION. ITCHING WAS UNCONTROLLABLE BY EITHER OVER THE COUNTER ALLERGY MEDS OR MY REGULAR PRESCRIBED ALLERGY MEDS. NO RASH OR WHELPING. ZYRTEC DOSAGE DOUBLED BY ALLERGIST MD 48 HOURS AFTER REACTION BEGAN, NEGLIGIBLE EFFECT UPON SYMPTOMS. ITCHING REACTION LASTED FOR 72 HOURS (TUE AFTERNOON - FRI AFTERNOON) BEFORE SUBSIDING. 3. INJECTION SITE ITCHING - ITCHING AT INJECTION POINT IN ADDITION TO THE EXPECTED INJECTION SITE PAIN, REDNESS, & SWELLING. BEGAN WITHIN 1 HOUR POST VACCINATION & LASTED 72 HOURS
Swelling and redness at injection site, beginning one week after injection and lasting for several days. Still ongoing
7 day s/p vaccination sudden onset of chest pain and dyspnea, denies N/V, diaphoresis or syncopy = myopericarditis
sneezing seen by MD very sick, cough, fever, ached all over; ATB coughs now chest; bronchial trouble, improved;
subjective fever, chills, and unilateral left axillary lymphadenopathy with measured fever 100.3F
More than 35 days between first and second Moderna Covid-19 vaccine; sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between first and second Moderna Covid-19 vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between first and second Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between first and second Moderna Covid-19 vaccine) 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 concomitant medications was reported. Treatment Information was not provided by Reporter. It was reported that patient received his first vaccination at a mass vaccination site.
Had psoriasis on front lower legs and a few outbreaks on lower back.  Shortly after second Moderna, shot, psoriasis on hands, one elbow, more on back, upper legs and one ear