chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my teeth are hurting so bad; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have diabetes and hypertension" (unspecified if ongoing); "I have diabetes and hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "my teeth are hurting so bad". The event "my teeth are hurting so bad" required physician office visit. Therapeutic measures were taken as a result of toothache. Additional information: patients teeth were hurting so bad on the left side and that's the side that patient got the shot on it; lasting longer than expected; more severe because now it's numbing the side of the face all the way up to eye .       No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain at injection site lasting the last 2 days, unable to lift arm. Local rash about 8 inches in diameter
SWELLING OF THE RIGHT THIGH AND AN ERYTHEMATOUS, WARM TO TOUCH RASH, WHICH BLANCHES. Treated with Benadryl and Tylenol began to resolve 1 1/2 hrs later.
19SEP91 1234PM sz, seen in ER t103.7 R, PERL, lungs clear, resp. rate 32, HR-reg, tachycardia, abd soft, no hepatosplenomegaly/CBC, BC, LP; 2OCT91 EEG
an expired dose of ROTATEQ was accidentally administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 02-FEB-2023, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1742431, expiration date: 31-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).  It was reported that the vaccine had not undergone temperature excursion. No product quality complaint. No additional information.
breathing issues; loss of smell; loss of taste; fever; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever) and FATIGUE (extreme fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN TRIHYDRATE (AMOXYCILLIN ALMUS) and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever), FATIGUE (extreme fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PYREXIA (fever) had resolved. On 28-Feb-2021, FATIGUE (extreme fatigue) and HEADACHE (headache) had resolved. At the time of the report, RESPIRATORY DISORDER (breathing issues), ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 101 (High) 101. In April 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.
Patient inadvertently received Covid 19 vaccine adult dose (12 +) as second dose.  He should have received pediatric dose.  Next day, patient experienced fatigue, headache, arm soreness at injection site.
Swelling, redness, pain. Mother took child to MD on 4/20/10 and was given oral Benadryl and was told to take Tylenol for pain. MD also gave child VZV in the right arm during same appt.
Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Augmentin [amoxicillin sodium;clavulanate potassium], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), JOINT DISLOCATION (non-serious) all with onset 01Dec2022, outcome "not recovered" and all described as "Left arm and shoulder pain and subluxation". The events "left arm and shoulder pain and subluxation" required physician office visit and emergency room visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint dislocation.  Additional information: the patient received physical therapy as treatment. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. The medical history, concurrent conditions and allergies were not reported. On 03-OCT-2015, the patient was vaccinated with a dose of oral, ROTATEQ, (strength, dose, frequency, route and lot number were not reported), which had expired on 27-SEP-2015. No adverse effects were reported. Other suspect and concomitant therapies were not reported; and there was not product quality complaint (PQC) involved. Additional information has been requested.
Narrative:  Covid + exposure within home. Pt. presented to facility ER 5/26/2022. HPI: Patient presents to the emergency department with a 4-day history of several symptoms that began a few days after being exposed to COVID-19. He states that initially he does have a scratchy throat but that progressed to cough and shortness of breath the next day. He feels achy all over as well and had a temperature up to 99 last night. Patient has a history of congestive heart failure but feels like this shortness of breath is different. Patient denies chest pain and peripheral edema. Pt admitted to facility 5/26/2022 and treated with Albuterol and oral steroid. Pt discharged 5/29/2022.
A nurse reported that a 40 year old male inadvertently received an injection of Tetanus Toxoid Adsorbed, on 11/06/00, instead of an IM injection and that day, he developed an injection site reaction characterized by pain and swelling of his forearm. As of 11/07/00, his symptoms persisted.
No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Systemic: Seizure-Mild, Additional Details: pt has a siezure, blood pressure and pulse remained strong. bp 140/99 pulse was 62 girlfriend and parents took care of patient, asked that I not call 911. they wil contact neurologist in am
Pt received 2nd dose of pfizer vaccine. Pt stated feeling lightheaded and anxious. Pt stated he was feeling nervous and anxious before getting the shot and has a history of panic attacks in the past that last a few minutes than he's back feeling normal.  Pt was then laid on the floor with legs elevated by the reaction nurse. He then was sent to Med Ops 2 where we assessed him. Vital signs were done all WNL. Pt also given water and crackers. Pt stated was feeling better. He soon after left with mother waiting outside in the car.
Extreme fatigue; Low grade fever/Body temperature 103.9; Heart rate ranging between 120 to the 140; Chills; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10Jun2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway in childhood. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 10Jun2021, the first night of vaccination, the patient experienced low grade fever and chills. On 11Jun2021, the second day after vaccination, the patient had a temperature of 103.9 with heart rate ranging between 120 to 140. On 12Jun2021, the third day after vaccination, the patient had no fever and palpitation but experienced extreme fatigue. On 13Jun2021, the fourth day, the patient had no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 103.9 and heart rate ranging between 120 to 140 were resolved on 12Jun2021, while fatigue and chills were resolved on 13Jun2021.
presented to the ED due to shortness of breath. He tested positive for COVID on 10/13, the same day as symptom onset. Symptoms included cough productive of rust colored sputum, HA, and feeling "wheezy". He endorses feeling run down and very weak. His work of breathing became more difficult on 10/15 and he felt as though the wheezing was much worse, which prompted him to present to the ED for evaluation. Endorses subjective fevers, chest pain 2/2 coughing, diarrhea, HA, and decreased po intake. Denies nausea, vomiting, or abdominal pain. Is vaccinated against COVID.
Received Pfizer COVID vaccine 12/23/20 and 1/13/2021.  On 4/16/2021 developed body aches, cough, headache, nasal congestion, and sore throat.  Tested positive for COVID.
Rash at injection site; rash around both ankles, and a little up from the ankles on both legs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 87 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Oct2022, outcome "unknown", described as "Rash at injection site"; RASH (non-serious) with onset Oct2022, outcome "unknown", described as "rash around both ankles, and a little up from the ankles on both legs.". Additional information: Patient reported that he got the latest booster shot a week ago. It was the Pfizer Covid 19 vaccine, the newest one, but he was unsure if it was the bivalent. He had a rash, and still has a little rash at the injection site. He also has a rash around both ankles, and a little up from the ankles on both legs. He asked if this was a common thing, and if there was something he could put on it to make the rash go away.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sneezing; Runny nose; My head is turning; I just feel so annoying; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient experienced sneezing, runny nose, stated head was turning and felt so annoying. Patient wants to know if sneezing or runny noses were part of side effects. Shot was like 2 days ago, 3 days ago. Patient don't know either have cold or COVID and was not sure whether to go and get tested. Patient second shot was scheduled on 10Apr. The outcome of all the events was unknown.  No follow-up attempts are needed. Lot/Batch number cannot be requested. No further information is expected.
This spontaneous report of expired product administered was received from a registered nurse and refers to a patient of unknown age and gender who on 28-JAN-2015 was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), 0.5 ml, intramuscular. Dose supported. No adverse experience was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
3 days after 1st vaccine experienced excruciating shoulder/elbow joint pain.  Unable to comb hair and much difficulty getting dressed.  2 days after 2nd vaccine experienced severe wrist/finger joint pain.  On a scale of 1-10, pain was a 12.
SWELLING ON RIGHT SIDE OF FACE; SWOLLEN TONSIL; PAINFUL SWALLOWING; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included filler on face, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient has no known allergies or history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced swelling on right side of face. On 14-APR-2021, the subject experienced swollen tonsil. On 14-APR-2021, the subject experienced painful swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling on right side of face, and the outcome of swollen tonsil and painful swallowing was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 63 year old male patient with no pertinent medical history and no known drug allergies/drug reactions who on 12-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously. Concomitant therapy included niacin. It was reported that on 15-JAN-2009 the patient experienced a generalized rash on his torso after being vaccinated with ZOSTAVAX. It was reported that the rash was described as itchy and raised. The patient was seen at the practice. The lot # 662389/1325X was previously reported as a lot # for ZOSTAVAX. This lot # has been validated and it was a lot # for VARIVAX. Additional information has been requested.
Exhaustion, weak balance, foggy brain within 24 hrs. of vaccination.  Neck pain (right side) within 1st week.
Started with slight itchy rash on Feb 27 on right side of face. Became more itchy and spread on Feb 28.  Face swollen to almost eye shut by Mar 1, very itchy and weepy. Rash also visible on neck and front of torso.               Visited doctors office on Mar 1 at 1:00pm. Received prescription for Prednizone 20mg, to be taken over 10 days.  Seems to be working, swelling is down and not as severely itching. Still very visable and dry crust forming on face.
Patient was fully vaccinated. 8/11/21 fatigue, cough and congestion. Tested positive for covid on 8/12/21
Information has been received from a physician concerning a 56 year old female who on 18 Oct 2006 at 4:15 pm was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 651400/0618F) (0.5ml), intramuscularly in the right deltoid. Concomitant therapy that day and time included a dose of influenza virus vaccine (lot 69898), intramuscularly in the left deltoid. There was no illness at the time of vaccination. Subsequently, a few hours after receiving the injection the patient was complaining of pain. The patient was unable to move her right arm where the injection was given. It was also reported that on 19 Oct 2006 at 8:00 am the patient's right arm extremely sore unable to move, decreased range of motion. Subsequently, the patient recovered. It was noted that the patient had no adverse events following prior vaccination. The reporter considered the patients experience to be disabling. Additional information has been requested.
child recieved flumist intranasally, followed by ipv (im) in left arm and mmr (sq) in right arm. Child seemed fine, dressed and ran out into waiting room to get stickers. bent over to look at stickers,clutched abdomen and began crying loudly complaining of stomachache. mom took him back into exam room where he continued crying and gripping his chest/abdomen.  i was called into room about 5 minutes after symptoms began. he was nauseous and in obvious significant pain, crying and holding mid epigastric area.  bp 110/64 (baseline for him) pulse ox 99% and heart rate 108.  He had two emeses, non-bilious,no blood. No diarrhea. afebrile. lungs clear. no hives. given zyrtec 15 mg and orapred 22mg with some coaxing. symptoms resoved in about 45 minutes and child was back to baseline in about an hour after symptoms began.  He has no known food or medication allergies.  he had mmr and ipv without adverse events in the past.  On october 27, 2006 he was seen in the office with painless swelling and erythema distal to injection site after recieving the aventis influenza vaccine lot #u2212aa  on 10/25/06.  this was deemed to be a local reaction to the vaccine.
Patient received Mono - Valent Pfizer BNT vaccine instead of newer bivalent vaccine, No other adverse outcome
She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days; Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation, reaction(s): "fatigue", "She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days/sore arms". The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 09Mar2021, outcome "unknown", described as "Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days".  Additional information: The caller stated after receiving her dose on Tuesday, the nurse vaccinating her said, "Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slept all day long; Body aches; Chills; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.