chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 2-month-old male with no medical history or allergies who on 20-SEP-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq.  There was no concomitant therapy.  The physician reported that on 21-SEP-2007, the patient developed diarrhea.  On 25-SEP-2007, the patient's diarrhea resolved.  on 28-SEP-2007, the patient experienced abdominal pain and distress.  The patient was seen in the physician's office on that same day.  No other symptoms were reported.  No laboratory/diagnostic tests were performed.  At the time of this report, the patient's abdominal pain and distress persisted.  Additional information has been requested.
Headache, Fever, NauseaVomiting, Chills, fatigue, no change in breast feeding good supply Narrative:  Other Relevant History:
When I was going to bed, Friday night I had stomach pain but no nausea or diarrhea and my joints ached. I woke up in the middle of the night and took my temperature which was 100.   The next day my fever was 101 even though I took two doses of Tylenol. The stomach pain and fever continued the next day and night until Sunday morning when I woke up with no pain or fever, just feeling very tired.  Today, Monday I feel back to normal.
Noted increased temp in afternoon (uncertain of time); At 8PM T 104 (R), Tylenol & bathed in warm H20; Took to ER @ 10PM, @ ER temp 100.9, MD examined child then was D/C to home. T WNL 17Jan91 in afternoon
approximately 10 days after injection, my upper left arm became red, hot and bumpy.  Following, I developed a very severe headache off and on for 3-4 days.  All settled down after about 5 days.
MY DAUGHTER RECIEVED POLIO, HEP B, & DPT SHOT (ALL IN ONE) IN MORNING (10 AM).  THAT EVENING @7:30 SHE WOKE FROM NAP MOANING AND TREMBLING.  LAID HER ON COUCH TO CHECK HER AND HER HANDS AND LEGS WERE PURPLE. THE NEIGHBOR, A ER NURSE CHECKED HER AND SAID AIRWAY CLEAR AND HEART A LITTLE FAST.  CALLED 911.  WHILE WAITING AT @ 8PM SHE VOMITED FORMULA. @8:30 WE WENT TO ER, SHE STARTED LOOKING BETTER AND ACTING BETTER.  AT ER SHE HAD 102 TEMP THEY GAVE HER TYLENOL.  BY THEN SHE WAS ACTING NORMAL AGAIN.  COLOR NORMAL ALSO.
Vaccination administered 3/12/2021 @ 1213, left deltoid (Johnson and Johnson lot 1805020)  While in recovery area at 1243, patient stands from her chair and states that "I feel funny, and I have to walk".  RN asks patient to elaborate on reasons why she is needing to ambulate and encourages patient to sit for assessment.  She states, "No, I really don't want to sit, I feel like I need to walk.  I have a tingling down the back of my neck, it really feels warm actually hot, I think if you take my vitals it will only make it worse".  RN again requests that patient sit and allow for vital signs to be taken, patient refuses, and asks for water.  RN provides a bottle of water for patient and she says that she would like to stay in recovery a little longer.  Patient ambulates in area for (with RN observation) and verbalizes that she is feeling a little better with walking.  Again, upon visual examination no changes noted in patient skin on neck or sholders.   At 1248 patient agrees to sit, but again refuses additional assessment.   By 1247, patient states that she is feeling better, denies dizziness and states that heat in neck has decreased.  Patient reports having similar reaction after taking Compazine. By 1250, patient verbally expresses that she is ready to depart clinic.  Advised to seek medical attention after departure if necessary, with increase or significant change in symptoms. Patient verbalizes understanding.  Ambulates from clinic alone at 1251.
07/28/2017 patient was in office for routine 2moWECH. Patient was given vaccines at the end of visit.  PENTACEL and Rotavirus. The PENTACEL was given incorrectly. Only the ACTHIB was given with the sterile diluent solution not the DTAP/IPV solution.  Patient only received the ACTHIB portion of the vaccine with the sterile diluent solution.  DTAP/IPV not given.
Narrative:  71 YO M w/ PMHx of T2DM reports feeling very weak and  disorientated ~12 hours after second COVID-19 vaccine. Patient recalls it was as if his "brain and muscles weren't communicating." Patient had trouble walking and had to crawl up the stairs at sometimes. Patient denies myalgias/fever/cough/pain. Sx resolved without treatment within the following 3 next days.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 12-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Pt recvd vax 11SEP92 & on 12SEP92 & exp flu-like sx consisting of fever, malise, achiness & tiredness; No further details were provided;
My throat felt like it was closing up.  It was very scary, but it lasted only about five minutes or so, and then I was fine.  I did not experience any further adverse effects after that.
Drug Ineffective; COVID-19; vertigo; unable to walk; extreme fatigue; light sensitivity; noise sensitivity; nonstop migraines; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER9733) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (disability) with onset 04Apr2021, outcome "not recovered", described as "extreme fatigue"; PHOTOPHOBIA (disability) with onset 04Apr2021, outcome "not recovered", described as "light sensitivity"; NAUSEA (disability) with onset 04Apr2021, outcome "not recovered"; HYPERACUSIS (disability) with onset 04Apr2021, outcome "not recovered", described as "noise sensitivity"; MIGRAINE (disability) with onset 04Apr2021, outcome "not recovered", described as "nonstop migraines"; GAIT INABILITY (disability) with onset 04Apr2021, outcome "not recovered", described as "unable to walk"; VERTIGO (disability) with onset 04Apr2021, outcome "not recovered"; COVID-19 (disability, medically significant) with onset 01Jan2022, outcome "not recovered"; DRUG INEFFECTIVE (disability, medically significant) with onset 01Jan2022, outcome "not recovered". The events "vertigo", "unable to walk", "extreme fatigue", "light sensitivity", "noise sensitivity", "nonstop migraines" and "nausea" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive. Therapeutic measures were taken as a result of vertigo, gait inability, fatigue, photophobia, hyperacusis, migraine, nausea which includes Specialists, care of concierge doc. Clinical course: Patient reports that fatigue was ongoing and that becomes extreme after any strenuous activity; periodic vertigo; loud noises cause vertigo and nausea. Patient did not experienced COVID prior vaccination. Patient  tested COVID positive post vaccination. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and received treatment.
Difficulty breathing, sore throat, hoarseness, cough, red water eyes, flushed and hot face, generalized body aches - difficulty breathing and cough subsided after 3 hrs - remaining symptoms lasted 9+ hours.
Developed swelling, soreness, and tenderness in the left arm pit area.; Developed swelling, soreness, and tenderness in the left arm pit area.; Developed swelling, soreness, and tenderness in the left arm pit area.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: FD7218) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1, Lot No: ER8733, Location: Arm Left), administration date: 24Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot No: EW0164, Location: Arm Left), administration date: 14Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), TENDERNESS (non-serious) all with onset 30Dec2021, outcome "not recovered" and all described as "Developed swelling, soreness, and tenderness in the left arm pit area.". The event "developed swelling, soreness, and tenderness in the left arm pit area.", "developed swelling, soreness, and tenderness in the left arm pit area." and "developed swelling, soreness, and tenderness in the left arm pit area." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of axillary pain, swelling, tenderness. Additional Information: Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.   No follow-up attempts are possible. No further information is expected.
Mother was standing at the window to pay vaccine and child was by her side. She claims his legs buckled and he leaned on the counter and she helped him to the floor. Nurses were called. B/P 119/81 - Pulse 73 at 8:55AM - Pt was alert and oriented. B/P at 9am 116/72 P=68 C/O lightheadedness only monitored for 45 minutes. Advised mother to F/U with MD due to epilepsy DX.
This child became limp when leaned into bushes and unconscious on 8/13/01. On 8/19/01, she was found unresponsive and that was X 6-8 hours. EEG showed a spike in right temporal area. These events were felt to be afebrile seizures.
Flu symptoms; This case was reported by a physician via call center representative and described the occurrence of flu symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were reported as follows: No lot number or expiration date of the vaccine was provided. The patient did not consent to follow up.
Swelling at top of throat; Big welts size of quarters/hives; Red spotty rash across body; ears are red and burning; ears are burning; fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning) and EAR DISCOMFORT (ears are burning) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 045B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Tetracycline).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours) outcome was unknown.            No concomitant medications provided.   This case was linked to MOD-2022-438492, MOD-2022-438766 (Patient Link).
very tired, chills and fever of 103.8.  Took an Alieve this AM to try and get fever down.
Varicella vaccine breakthrough. Developed rash on torso and arms on 3/31/2006. Diagnosed by Dr with atypical varicella in our office on 4/11/06. 2 clusters of papules with central vesicles. Some crusted and scabbed. Afebrile. less than 50 lesions.
Headache, sore arm - 2nd day  Headache - 3rd day  Fever (101.5), chills, body aches, mood swings, fatigue- 4th day Fever (100.5) chills, body aches, fatigue- 5th day Rash all over body, fever (101.7), body aches, fatigue, mood swings - 6th day Rash, soreness in legs - 7th day
10min p/vax lightheaded, faint, pale, sweats for 10min;next morning subcutaneous swelling @ inj site size of baseball which lasted 3 days;
n adult patient was adminsitered with the pediatric monovalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine).    No relevant concomitant medications were reported. No treatment medication reported.
Pain in left side by the base of the ribs and a headache; Pain in left side by the base of the ribs and a headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17May2021 13:45 (Lot number: EW0185) at the age of 15 years as dose 1, single and intramuscular, administered in deltoid right, administration date 07Jun2021 (Lot number: EW0177) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; PROZAC; VITAMIN D [VITAMIN D NOS]. Past drug history included: Opioids, reaction(s): "known allergies: Opioids". The following information was reported: HEADACHE (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 17May2021 14:45, outcome "recovering" and all described as "Pain in left side by the base of the ribs and a headache". Therapeutic measures were not taken as a result of headache, musculoskeletal chest pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Initial report received on 02 November 2007 from a health care professional. A 60-year-old male patient had received an injection of Fluzone SV, lot number unknown, route and site of administration unknown, on 02 November 2007 at 10:00 am. Approximately 90 minutes post-vaccination, the patient was admitted to the hospital with a glucose of 22. The patient had reportedly exercised that morning and not eaten breakfast. He was admitted for 24 hours, his glucose level was stabilized, and he was discharged. The patient had a past history of unknown allergies. He had a family history but no personal history of diabetes. Illness at the time of vaccination and other medications were unknown. Recovery status was not reported.
day after vaccine started to have sweats, body ache, headache, fever. Self resolved after 24 hours.  Did not report until 12/23/20 at 10:40.   vaccine recipient  completing RL
Hives on right arm, Face and neck feel strange, almost numb, tingly, tight, comes and goes Headache Fatigue
feeling nausea and dizzy  Had patient lay down on cot, vital signs monitored, all stable
No additional AE reported; VARIVAX had a temperature excursion and was administered to the patient; This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 21-MAY-2021, varicella virus vaccine live (oka/merck) (VARIVAX) was involved on a temperature excursion of 7F for 21 hours and 57 minutes and, on an unspecified date a excursion of 6 degree Fahrenheit (°F) yo 14 °F for 429 hours.   Subsequently, on 26-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # T029535 and expiration date on 01-SEP-2022 (route of administration and strength were not provided) for prophylaxis. The vaccine was exposed to a temperature of 9F, during a 17 hours and 53 minute timeframe. The call was made du to a data logger. No additional adverse events reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Fever 100.3 F Chills Myalgia Tiredness Muscle pain
Patient passed out a few minutes after receiving vaccine. She woke up a few seconds later was very pale, sweating and confused. Blood sugar was 50.
left deltoid pain, worse with movement; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (left deltoid pain, worse with movement) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (left deltoid pain, worse with movement). At the time of the report, INJECTION SITE PAIN (left deltoid pain, worse with movement) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Side effects last from the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects last from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects last from the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects last from the 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 product use was provided by the reporter. No treatment medication was provided.
Developed muscular pains throughout body and it did not go away. Sought advice from doctor in July, was diagnosed with PMR and prescribed prednisone, which I have been taking continuously since.
Fever, Severe Chills, Headache, fatigue, body aches and pain everywhere started at approximately  05:30 AM 12/17/21 lasting  for one hour and possibly continuing. Patient resting at present 7:40 AM. Will continue to monitor for anaphylaxis or worsening reaction,  Pfizer  2nd Dose given  03/30/21. Severe fatigue, lethargy, fever, chills, body aches and pains everywhere, anaphylaxis. Patient extremely anxious with booster administered 12/16/21
Patient called pharmacy 9/23/2017 and reported that her arm was swollen after receiving 3 shots several days prior. She also reports that she "feels like she took a downer". She denies having hives, shortness of breath or swelling anywhere else, suggesting that reaction appears to be localized to injection site. She also denies that swollen arm is larger than other, unaffected, arm. Suggested patient treat localized reaction with topical steroid cream to reduce swelling or take Benadryl if sigs of allergic reaction manifest.
Patient came in complaining of redness, knot around injections site, location was about the size of a baseball and warm to the touch. She said it had been aching for 2 days and she felt terrible the day after, no energy, overall sick, but is feeling better today.
Within 15-minutes of being vaccinated patient reports numbness and tingling to right side of check and upper gum-line, and numbness in part of upper lip, along with dry cough. Symptoms persisted about 2 hours. No treatment initiated. Patient denied wheezing, hives, shortness of breath, or dizziness. *ACTUAL VACCINE ADMINISTERED:  [Afluria IIV4 PFS]      Vaccine Manufacturer: [Seqirus, Inc.], Lot YF36305
Experienced 102 fever 24 hours post dose, 48-72 hours extremely painful and swollen left lymph node--still experiencing this, extreme fatigue.
10AUG98 mom reported pt had 5 or 6 tiny bruised in a line above where got hepatitis vax;mom noticed them yesterday morning on top of pt lt shoulder;
Patient was 17 when vaccine was administered (authorized for 18 and older). No adverse events reported.
Injection site is red, swollen, sore to the touch, and has a lump   Moderna COVID-19 Vaccine EUA
Patient went to MD office with redness and pain in arm. MD diagnosed an infection. MD prescribed cephalexin 250mg.