chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling began at 11:12am, one hour after injection. Tingling in both lips. Tingling continued on right side from bottom lip to chin. Tingling not severe, but quite noticeable.  Initial sensation lasted ten minutes, then continued for 4  hours slowly dissipating  and ending about 3pm.
This case was considered medically important. Follow-up information pertaining to patient demographics, additional concomitant vaccines and recovery status has been received. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 9-month-old female patient who developed pneumococcal bacteremia. The patient received the third dose on 14-Aug-2006. The patient also received the third dose of Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the third dose of Tripacel (Avesntis-Pasteur) diphtheria/tetanus toxoid/acellular pertussis vaccine) and the second dose of Ipol (Adventis-Pasteur (poliovirus vaccine inactivated) on 14-Aug-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 14-Aug-2006, Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 24-Sep-2006, the patient developed pneumococcal bacteremia (pneumococcal bacteraemia) (drug ineffective). The patient was not hospitalized. Treatment was administered at the time a blood culture was performed; the patient recovered on an unspecified date. Blood culture (results: revealed Streptococcus pneumoniae; not serotyped) was done on 25-Sep-2006. OMIC
small red dot on foot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (small red dot on foot) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (small red dot on foot). At the time of the report, ERYTHEMA (small red dot on foot) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsignificant Followup received on 26 MAY 2021, no new information
A male patient (age not provided) reported that he had received a shot which I think was MENACTRA..." before taking a trip to Nepal. The patient reported having an unusual amount of itching (site of itching not reported). When he arrived in Nepal, the patient continued to feel ill and he experienced "odd symptoms" (not specified). MENACTRA lot number, date of administration, route/site of administration, event start date (s) and recovery status were not reported.
Patient had local reaction to DTaP #5: Heat redness & firm - sm. amount of swelling, redness = 10x9cm.
Heartburn; This is a spontaneous report from a contactable nurse (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced heartburn on an unspecified date with outcome of unknown.  Information on Lot/Batch number has been requested.
Information has been received from a physician and a reporter from the physician's office concerning a 12 month old Hispanic male with no known drug allergies and no medical history who on 18-Aug-2003 was vaccinated in the left arm with a first does of varicella virus vaccine live (l;ot 3644573/0014N). On 18-Aug-2003 the patient was also vaccinated with a dose of measles virus vaccine live (+) rubella virus vaccine live (second generation). On 20-Aug-2003 the patient developed a papular rash on the left arm. It was also reported that the patient developed a rash which looked like an allergic reaction from the injection site to the elbow and petechiae. It was not a varicella-like rash. Medical attention was sought and the patient was treated with diphenhydramine (Bendaryl). The patient did not have a fever, wheezing nor itching. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
3rd dose of COVID vaccine given 3/8/22, Moderna, #084J21A; Pt in SNF; pt had a positive COVID test 10/5/22; O2 supplementation via NC as needed; poor po intake; comfort measures only; pt passed away in the SNF
Reflex syncope/fainting episode; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Reflex syncope/fainting episode) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Comirnaty (Patient had received Comirnaty primary series.). Past adverse reactions to the above products included No adverse event with Comirnaty.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYNCOPE (Reflex syncope/fainting episode). At the time of the report, SYNCOPE (Reflex syncope/fainting episode) outcome was unknown.            No concomitant product information was provided.  Treatment information was not provided.  Patient received Moderna vaccine booster on Tuesday. On Thursday evening, he experienced a fainting episode, went to emergency room and diagnosed as reflex syncope.  Company Comment: This case concerns a male subject of unknown age, with a medical history of receiving the Comirnaty vaccine primary series, who experienced the unexpected event of Syncope, diagnosed as "reflex syncope" in the emergency room. The event occurred 2 days after the booster dose of mRNA 1273 VACCINE. Rechallenge is not applicable as no additional dosing is expected to be given. The patient's medical history of receiving the Comirnaty vaccine primary series  remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per list; however, based on information available and, as per medical judgement, it is assessed as non-serious.; Sender's Comments: This case concerns a male subject of unknown age, with a medical history of receiving the Comirnaty vaccine primary series, who experienced the unexpected event of Syncope, diagnosed as "reflex syncope" in the emergency room. The event occurred 2 days after the booster dose of mRNA 1273 VACCINE. Rechallenge is not applicable as no additional dosing is expected to be given. The patient's medical history of receiving the Comirnaty vaccine primary series  remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per IME list; however, based on information available and, as per medical judgement, it is assessed as non-serious.
Student was administered FLUMIST at 1:30 pm. Student was sent back to Health Center with rash to face. Examined by PA, NAD. BENADRYL given. Parents notified observed x 30 min.
Patient c/o of being light headed, dizzy and feeling as if she was going to pass out. Also c/o increased heart rate. Patient placed on cot in supine position with feet elevated. 10:10a BP 120/80. Patient juice and crackers. She remained in supine position until she was feeling much better. 10:20a B/P 116/80, Pulse 72 10:45a Patient recovered and left to to home
Arm pain; Arm tingling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and tingling of extremity. On an unknown date, the outcome of the pain in arm and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and tingling of extremity to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient's husband.  The age at the vaccination was not reported. The reporter stated that patient received Shingrix vaccine and was experiencing arm pain and tingling. The reporter did not provide any further information and abandoned the call. The reporter did not consented to follow-up.
Warm rush of heat overcame my body focused in my lower abdomen.  I had an itchy, tingly feeling in my mouth-not throat.  It was approximately 8 minutes after the vaccine.  I was monitored.  BP was fine, oxygen level was fine.  My heart rate started out at 140 but quickly went down.  No medicine was needed.  Mouth feeling subsided in a minute or two.  Warm sensation in abdomen intermittently returned for several hours post vaccine.  I ultimately took Benadryl at home as a precaution.  I did notice that sensation subsided then.  I also had increased nasal discharge and slight cough the afternoon following the vaccination.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 16-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Grandmother called late pm on date of vaccination stating patient had low grade temp, extreme irritability and trembling. TYLENOL dose given. Patient started vomiting later in evening. Ran fevers 100-103 (+) 48 hours after immunization given. Recovered completely.
30 to 45 minutes post yellow fever and TYPHIM VI vaccines child developed bilateral eye redness, sensation of something stuck in throat, hives and wheezing. Vital signs BP - 125/73, Pulse 98-107, Resp. 20, O2 Sat 92-100. Pt. treated in urgent care with 500 ml IV normal saline, 25 mg BENADRYL IV, 40 mg SOLUMEDROL IV, 30 mg ranitidine IV and neb treatment with albuterol 5 mg - observed for 2 hours in UC without return of symptoms - discharged to home. On ORAPRED 1mg PO x 5 day and daily CLARITIN with BENADRYL PRN and to return to clinic if symptoms return.
Very bad headache beginning the night of the vaccine chills nausea dizziness Ibuprofen did not help with the headache.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Dose Number 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Oct2021 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single, administered in arm left, administration date 02Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 09Feb2021 (Lot number: EL3247) as dose 1, single for COVID-19 immunization. Relevant medical history included: "endometriosis" (unspecified if ongoing); "ichthyosis" (unspecified if ongoing). Concomitant medications included: MIRALAX; RESTASIS; VIVELLE [ESTRADIOL]; CAL SUP; MG [MAGNESIUM SULFATE]; PROBIOTICS. The following information was reported: IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "positive COVID-19 test with symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab; (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Sore throat started on 03Jan2022, sore throat and chills on 04Jan2022, took home test kit for Covid from pharmacy on 04Jan2022, result came up positive. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Reporter assessed case as non-serious.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment medication reported.  The vaccines was  stored in freezer, out one to two vials were taken out and placed in fridge each day as needed.
Arm soreness Flu-like symptoms; incl mild fever, aches, mild headache, fatigue
Information has been received from a physician and the mother of a 5 year old female who on 04/10/97 was vaccinated with a first dose of Varivax SC in the left thigh. The patient was concomitantly vaccinated with a second dose of Hepatitis b vaccine recombinant. There were no illnesses at the time of vaccination. The physician reported that on 01/07/02, the patient presented with a breakthrough varicella rash. The patient's mother reported that the patient subsequently recovered. No additional information is expected.
Pharm student was administering #3 pfizer booster. Upon admin the needle did not go right through the skin. His finger was on the plunger and a few drops came out of the syringe. Student administered the rest of the dose.  Notified RN staff and said that the pt received at least half of the dose. Recommendations were looked up and it states to administer another half dose immediately. Pt was notified of incident. No complaints or concerns. 0.15 mL dose administered to pt with no incidents.
Pt had numbness and tingling of his finger tips on same evening as recieving flu shot that morning. On next day, Tuesday, he started same numbnes and tingling in his toes. Pt went to family doctor on Wednesday and needed walker to assist him in walking. (Prior to this event the pt was able to ambulate without assistance of any devices, drive a car long distances and grocery shop on own) pcp- sent pt to the ER for evaluation. Pt was diagnosed as having Guillain Barre syndrome from the flu shot. By 9 pm that Wednesday evening he was not able to stand and pt had limited use of his arms. Pt was admitted to hospital. By 9am on Thursday pt had little movement and no feeling in legs. He had very little movement of his arms and was not able to lift his arms to his mouth to feed himself. By Thursday night pt was intubated and placed on ventilation support. By Friday am he was not able to move any extremities and only had movement of his head, mouth and shoulder shrugs. Immunoglobulin administration was started on Wed afternoon and continued for 5 or 6 doses (one each day). No improvement was seen. Pt subsequently developed several infectious processes-e-coli in urine, staph (not MRSA) in his sputum, and strep in his blood. Plasmaphoresis was started every other day times 5 exchanges. (Was have finished 3 exchanges up to this time with no movement of extremities seen.
Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and splotchy; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 49-years-old), as a first single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had previously experienced allergy when receiving Zithromax (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Mar2021 at 09:45, the patient's face got very red, hot and splotchy and was slightly swollen. The patient did not receive any treatment for the adverse events. The clinical outcome of face got very red, hot and splotchy and slightly swollen was recovered. No follow-up attempts are needed. No further information is expected.
Reports no reaction the first day but, on the second day she had muscle pain her right arm at injection site had a knot and swelling.  Muscle pain and swelling of arm left, the bump remained.  On 1/12/ 2021 Redness,swelling and warmth came back at injection site. Into clinic to report today 1/13/2021.  Injection site is warm to tough and red.  Right arm blotchy and itching.  Client in formed if does not clear soon to seek medical attention.
Patient contracted COVID-19 after being fully vaccinated. Runny nose and sore throat.
Following 1st dose of vax pt experienced pain @ inject site; Following 2nd dose of vax experienced prolonged pain & tenderness @ inject site;
Instead of the Flu-Mist being given 0.1 ml in each nostril the whole 0.2mL was given in one nostril.
Fever. Rash over torso & legs. Saw dr. No remedies. Except BENADRYL.
SM complaining of immediate nodule sensation to AVA site 10/20/2006 and then itching which progressed to entire body within 30 minutes with "goose bump" like rash. Rash described as skin toned colored individually maculars w/o hive like formations. Within 1-2 days c/o two quarter size flat red patches, one to anterior left thigh and second to lateral right ankle (?from scratching). No other symptoms...denied SOB, swelling, sore throat, CP or any anaphylactic symptoms. (DEERs and AHLTA vac dates conflicting. No medical records available, new record begun with transfer).
Severe pain at site, radiating down arm. Nausea, fever, malaise, LE tremors with paresth.
fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm left on 04Jan2021 08:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included asthma, obesity.  Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), macrogol 3350 (MIRALAX), montelukast sodium (SINGULAIR).  The patient previously took cefalexin (KEFLEX) and experienced Known allergies: Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 01:30 PM Intramuscular in right arm for COVID-19 immunization. The patient experienced fever, chills, weakness, rash all over the body, sob all on 04Jan2021 12:00 with outcome of recovered in Jan2021.  No treatment was received. Information on the Batch/Lot number has been requested.
Information has been received from a physician concerning a 74 year old female patient who "3 days ago", on 08-JUL-2011 was vaccinated SC with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot number not reported). The physician reported that the patient was experienced persistent and troublesome pain along her breast line and around to her back. The patient was in the physician now on 11-JUL-2011 for medical attention. At the time of the report, the patient's present status was unknown. Follow up information has been received from the physician concerning the patient with hypertension and reflux who on 29-MAR-2011 (previously reported as "08-JUL-2011") was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot number: 670383/0170AA) in left upper extremity. Concomitant therapy included losartan potassium-HCTZ (MSD) and NEXIUM. Two days following vaccination, on 31-MAR-2011 and continuing to present, the patient experienced pain and paresthesia in left lumbar 4-5 dermatomal distribution. The area of wearing bra and clothes was sensitive to touch. The touching area of wearing bra and clothes was very uncomfortable. The mammogram and neurologic check were performed and neurology consultation was pending. There was no adverse event following prior vaccination and no illness at time of vaccination. At the time of the report, the patient's present was unknown (also reported as "continuing to present"). Pain and paresthesia in left lumbar 4-5 dermatomal distribution and sensitive to touch were considered to be persistent disabling by the physician. Additional information has been requested.
As I said it really started happening after I was positive for the Covid virus in November 2022. I have begun to have stiffness in my joints, finger, back, and hips and I never have had arthritis in my joints and it is an odd feeling that comes and goes throughout the day and that is the bothersome thing for me. I have an appointment tomorrow to see what is going on.
reported aches on 12/23/20, that resolved, now with persistent arm soreness, some localized redness that has not spread, and some swelling.  Condition not worsening.  Has full ROM.
heart inflammation, heart went into atrial fibrillation again, suspected myocarditis (symptoms within short time of second shot) Observation of EKG on Apple watch showed atrial fibrillation (after four years of normal readings)
Severe arm pain; pain at the injection site, bad pain in my arm where I got the shot; can hardly raise my arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (can hardly raise my arm), PAIN IN EXTREMITY (Severe arm pain) and VACCINATION SITE PAIN (pain at the injection site, bad pain in my arm where I got the shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (can hardly raise my arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe arm pain) and VACCINATION SITE PAIN (pain at the injection site, bad pain in my arm where I got the shot). At the time of the report, INJECTED LIMB MOBILITY DECREASED (can hardly raise my arm), PAIN IN EXTREMITY (Severe arm pain) and VACCINATION SITE PAIN (pain at the injection site, bad pain in my arm where I got the shot) had not resolved.            Patient is on high blood pressure concomitant medications.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-214538 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28 JUN 2021: contains non-significant information. On 06-Jul-2021: Follow-up information received on 06-JUL-2021: Event and event outcome was updated.