chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild pain in tongue and throat/severe sore throat; mild pain in tongue and throat; Felt pain when swallowing; He could not talk normally cannot move tongue very much; He could not talk normally cannot move tongue very much; This is a spontaneous report received from Medical Information Team. A contactable physician (parent) reported that a 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22May2021 15:00 (Lot Number: EW0178, at the age of 15-year-old) as single dose for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included loratadine (CLARITIN) taken for seasonal allergies; fluticasone propionate (FLONASE) taken for seasonal allergies. A pediatric gastroenterologist reported for his son. His son had the first dose of the Pfizer COVID-19 vaccine on 22May2021. On the next day on 23May2021, he experienced mild pain in the tongue and throat. He had no fever. The pain in the throat and tongue started on Sunday (23May2021), but it was mild and he was not concerned. His son had it on Monday (24May2021) and when he came home from school around 15:00 or 15:30, he was complaining of severe sore throat. His throat was hurting more. Severe from that time. He stayed home from school. Treated with Tylenol and Motrin. Didn't really work/helping. Pushing fluids. Felt pain when swallowing. He was not eating due to severity of the pain. Had severe pain when he tried to speak. He could not open his mouth well. Tried to keep his mouth closed. He could not talk normally cannot move tongue very much. They went to urgent care and had a strep test which came out negative on 25May2021. Reporter seriousness for pain in throat and tongue was disabling. The gastroenterologist wanted to know if his son's adverse reaction was an allergic reaction and if he should get the second dose of the vaccine. There was no prior vaccinations within 4 weeks. The outcome of the events was not recovered.
Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, in left arm on 16Jun2021 at 09:45 (Batch/Lot number: Not reported) (at the age of 15-years-old) as 2nd dose single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) for seasonal allergy. Patient had no known allergies. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular in left arm in May2021 as 1st dose single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jun2021 at 23:00, the patient experienced headache, lethargy, aches in large limbs, fever and injection site pain. Patient did not receive treatment for the events. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Patient is under neurological care due to the vaccine. Patient experienced tremors in his right hand, dizziness, off-balance, and significant arm, neck, and leg pain with weakness in his hands after receiving the Pfizer vaccine in October 2021. He still experiencing these symptoms.
Patient experiences weakness in the lower extremities causing daily activity to be difficult. Patient pushed through and continuously worked out the weak body parts until normal feeling was regained.
Pt. said the shot felt painful. She received flu shots in the past but did not have this kind of pain. There was no redness, only pain. She saw the Dr. who took an xray looking for crystals but it was clear. She was prescribed Ibu 600 mg & a MEDROL dose pack. She said the pain went from 8 out of 10 to 4 out of 10. It still aches. She ices it daily and takes Ibuprofen is she's doing strenuous activity.
The box had the incorrect expiration date written on the side.  The  vaccine expired on 10/1/21 and a dose was give on 10/5/21.  The medication had been stored properly but was expired.  We contacted the manufacturer.  The manufacturer said that the vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   We contacted the patient and they did not report any unusual or abnormal side effects.
Black and blue at injection site developed a few days after injection and is still visible.   Developed a red blotch approximately 2 inches by 2 inches beneath the injection site about 1 week after injection and is still visible.
Information has been received from a 24 year old female consumer with a history of prednisone reaction unspecified, and a history of papilloma viral infection, knee surgery 6 weeks for unspecified condition who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported) injection. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 14-FEB-2007, the patient experienced legs (from mid thigh to mid calf) felt creepy-crawling, uncomfortable especially when laying down, they don't feel like my legs after receiving the injection. The patient also reported that her arm was very sore for about 3 days after receiving the injection but that went away. At the time of reporting the creepy-crawling feeling, and limb discomfort persisted. No further information was provided at the time of reporting. Additional information has been requested. This is in follow-up to report (s) previously submittedon 3/14/2007. Additional information was received from a nurse practioner. On 19-Feb-2007, seven days after receiving the vaccination, the patient called the office and complained of pain and numbness in both legs for 5 days. The outcome of the pain and numbness was not reported. No additional information is expected.
Information has been received from a physician concerning a male who was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml (lot # not reported). After getting ZOSTAVAX (Oka/Merck), on 18-FEB-2009 the patient developed Varicella like rash. The outcome of the patient's adverse events was not reported. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Itchy throat and dizzy, observed for an hour, given 50mg PO Benadryl
This 11 year old male patient received meningococcal polysaccharide vaccine (MCV4) 0.5 mL and Tetanus, Diphtheria, and Pertussis (Tdap) vaccine 0.5 mL on 08Dec2010 in his left arm. The patient's relevant medical history includes no prior allergic reaction to MCV4 or Tdap. The patient's relevant past drug history includes no history of reactions to immunizations in the past. In the evening of 08Dec2010, the patient had tactile fever. The patient awoke on 09Dec2010 with some swelling and erythema. On 10Dec2010, significant swelling and erythema (5 cm area) around site of immunizations were present. He complained of pain and itching. The patient was treated with Benadryl and with Augmentin for possible infection. The patient's physician was notified. The patient recovered.
Suspected Covid Break through. Hospitalization from 7-25 till 8-3. Dc Home in stable condition
Administered diluted covid vaccine booster that was sitting at room temperature for 7 days. Brought patient back and readministered booster
3 days, post vax, noticed swelling/puffiness of forearms and swollen lymph node on the right armpit. Pt took Benadryl 25mg X 2 and swelling has decreased daily as has the size of the swollen lymph node.
Head pressure; Ears hurting; Eyes were hurting; Sinus infection; A spontaneous report was received from a nurse, who is a 58-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head pressure, eyes and ears hurting and feeling like sinus infection.  The patient's medical history included sinus infection. Concomitant medications were not reported.  On 04 Jan 2021, the patient received their first dose of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced head pressure, eyes and ears hurting and feeling like sinus infection.  Treatment for the events included azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, head pressure, eyes and ears hurting and feeling like sinus infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient woke up at 2am the morning after her second Moderna shot with little swollen  and hurting lips . The swelling got worse until 6am when it was very swollen and hurting a lot. It slowly subsided until she was able to come into the pharmacy to show me. By 10am it was only a little swollen and did not hurt anymore.
Vaccine adverse event report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st 12/30/21dose Lot# 2nd dose 01/19/21,lot# Diagnosed covid positive:07/23/21 Symptom onset:07/18/21 Exposure:unknown Symptoms:Cough, fatigue,muscle ache,runny nose.
headache 1 hr after fatigue after 24 hours numbness in left arm after 24 hours fever after 24 hours dizziness after 24 hours
following vax pt was warm & was given APAP-t103.9 mom called clinic & was advised bring pt in if fever persisted; pt stopped crawling, would stare, eye crossed, growth was delayed;
p/vax pt came down w/measles;was very sick, skin is still shedding;mom encouraged to have all further vaccines at MD office;
No reaction at all; First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 prophylaxis.     The patient's past medical history included Gout flare (Moderate) from 20-Feb-2021 to 13-Mar-2021. Concurrent medical conditions included Wood dust allergy, Grass allergy, Pollen allergy, Allergy to animal dander (Cat dander), Dust allergy, Gout (greatly exacerbated gout flare) since 2010, Asthma since 1980, Psoriasis since 1950, Kidney function abnormal (Reduced kidney function) since 1970, Osteo arthritis knees (increased left knee pain) since 2000 and Inflammation. Concomitant products included APIUM GRAVEOLENS SEED, BROMELAINS, CURCUMA LONGA ROOT, POTASSIUM CITRATE, PRUNUS SEROTINA FRUIT (GO OUT PLEX) for Gout flare, ZYFLAMEND for Inflammation, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for Probiotic therapy, VITAMIN B COMPLEX for Vitamin B complex supplementation, VITAMIN D3 for Vitamin D supplementation.   On 25-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30). On an unknown date, the patient experienced NO ADVERSE EVENT (No reaction at all). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No reaction at all) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30).    The patient received both doses in left upper arm.  The patient never diagnosed with/tested positive for COVID-19.  No treatment information was provided.   This case was linked to MOD-2021-032238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received. Updated event verbatim for no adverse event as no reaction at all.
Raynaud's Phenomenon, numbness and tingling on my entire left side 1 week after my 2nd shot.
patient became diaphoretic and dizzy, mild nausea hands went tingling and numb.  pt was moved to well ventilated area and recovered quickly.  regained color and dizziness diminished.
Information has been received through a manufacturer pregnancy registry from a female consumer who on 3/20/02 was vaccinated with one dose of varicella virus vaccine live. The pt started her menstrual cycle the following day on 3/21/02. Since then, the pt found out she was pregnant. Unspecified medical attention sought. Follow-up info from a nurse on 3/28/03 revealed that the pt had "several issues" and opted for termination of the pregnancy. Additional info has been requested. Reported on 04/22/2003: "On 05/02/2002 at six weeks gestation, a pregnancy termination was performed at a different facility.  It was unknown if the products of conception were examined and it was unknown if the fetus was normal.  No other medications were used during this pregnancy.  It was unknown if the patient was tested for varicella antibodies before vaccination with varicella virus vaccine live.  It was unknown if the patient had a local reaction at the vaccination site, varicella symptoms post vaccination or herpes zoster symptoms post vaccination.  The patient had 9 previous pregnancies including 2 full term births, a miscarriage during the first trimester and no pre-term births.  There were no birth defects in any previous pregnancy.  Additional information is not expected.
Breakthrough case admission after 2 vaccines Pfizer 4/1/21 Lot# EW0150;  Pfizer 4/22/21 Lot# EW0170
Information has been received from a 61 year old white female postmenopausal patient with osteoporosis, an allergy to PCN and reactive airways disease, who on Nov 01 2004 at 4:00pm was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alendronate sodium for the treatment of osteoporosis and estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) for post menopausal treatment. The patient was not ill at the time of vaccination. On Nov 02 2004 at 3:00 pm, the patient developed extrem fatigue, chills and her right deltoid area was erythematous, edematous, painful and very tender to light touch. the fatigue persisted for three days, the erythema and painful right deltoid lasted six days. it was noted that the patient recovered on Nov 04 2004. It was noted that the patient had experienced a disseminated rash at age 11 month from a first dose of smallpox vaccine. No additional information is expected.
welting in my face; burns; stings; didn't need to take anything to be able to go to the bathroom.; white spot very notable on my face, right were the sting is; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welting in my face), SKIN BURNING SENSATION (burns), PAIN (stings), THERAPEUTIC RESPONSE UNEXPECTED (didn't need to take anything to be able to go to the bathroom.) and RASH (white spot very notable on my face, right were the sting is) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Constipation (Severe).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced URTICARIA (welting in my face), SKIN BURNING SENSATION (burns), PAIN (stings), THERAPEUTIC RESPONSE UNEXPECTED (didn't need to take anything to be able to go to the bathroom.) and RASH (white spot very notable on my face, right were the sting is). At the time of the report, URTICARIA (welting in my face), SKIN BURNING SENSATION (burns), PAIN (stings) and RASH (white spot very notable on my face, right were the sting is) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (didn't need to take anything to be able to go to the bathroom.) outcome was unknown.            Concomitant products included unspecified medications. Treatment information was unknown.  The white spot on face was about the size of the pusher of an ink pen.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL (strength, dose and route unknown) and received a dose of GARDASIL 9 (strength, dose and route unknown) on 02-OCT-2015 in the office, which would be the second dose for the patient in the HPV series (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
COVID Arm, Swelling, redness, pain, ichyness surrounding the injection site.
This spontaneous report was received from a physician refers to a 14 year old female patient. No medical history or concurrent conditions were reported. On 06-JUN-2013, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular route, (lot# H020005; Exp. Date: 08-AUG-2015). No co-suspect or concomitant therapies were reported. On 06-JUN-2013, reported as one hour after she received the first dose, the patient experienced blurred vision, a fever greater than 102 F, lethargy and racing heart. The symptoms lasted 24 hours and then resolved. The patient took ADVIL to control the fever. On 12-SEP-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscular route, (lot # J006850: Exp. Date: 31-MAR-2016). On 12-SEP-2013, reported as one hour after she received the second dose, the patient again experienced blurred vision, a fever greater than 102 F, lethargy and racing heart. The symptoms only lasted a few hours and then resolved. Lab diagnostics studies were not performed. There was no intervention to prevent serious criteria. At the time of the report, the outcome of all events was reported as recovered. The causal relationship between the events and GARDASIL was unknown. Additional information has been requested.
Initial report received from a healthcare professional on 05 NOVEMBER 2014. A 66-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE QIV, batch number - UI205AB and expire date - 30 JUNE 2015, intramuscularly in left deltoid on 04 NOVEMBER 2014. The patient had no illness at time of vaccination and was sensitive to vaccines, took BENADRYL prior to administration. On 05 NOVEMBER 2014, one day after vaccination, the patient experienced erythema at the left deltoid, her skin is flushed in the upper torso to her face, neck and face are reddened and it is moving down to her arms and temperature was 99.4 F.  Patient required ER/doctor visit. Laboratory investigation and corrective treatment was not reported. At the time of this report the patient was not recovered from event. Document held by sender: none. Follow-up information received from a health care professional on 30 JAN 2015. Patient's vaccination within 4 weeks prior was reported as none. At the time of this report, the outcome of the events was reported as recovered on an unspecified date. List of documents held by sender: none.
606 doses were given after expiration date; Vaccine was kept in refrigerator on 29-Oct-2021 but expiration date provided by Moderna was 13-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 29-Oct-2021 but expiration date provided by Moderna was 13-Oct-2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 29-Oct-2021 but expiration date provided by Moderna was 13-Oct-2021). On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 29-Oct-2021 but expiration date provided by Moderna was 13-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event. No treatment medications were provided.
Has numbness; back problems; 1st blister; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLISTER (non-serious) with onset 09Feb2021, outcome "not recovered", described as "1st blister"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Has numbness"; BACK DISORDER (non-serious), outcome "unknown", described as "back problems". Therapeutic measures were taken as a result of blister.  Additional information: The patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6198), received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) and also received BNT162b2 (BNT162B2), on 17May2022 as dose 4(booster), single (Lot number: FM7553) for covid-19 immunisation. The patient also received BNT162B2, BNT162B2 OMI BA.4-5, on 27Oct2022 as dose 5 (booster), single (Lot number: GH9697) for covid-19 immunisation. It was reported that first time got blister and thought might had bumped up against oven door open and thought hit the rail but was a blister so didn't have any concern, thought odd. Had numbness and back problems so really didn't really felt like burn. Stop date of adverse event was reported as not ongoing, but just a dark circle, the blister popped. The blister was being treating with antibiotic ointment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282427 same patient and event, different dose/drug;