chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated heart rate at 140 post vaccination (5 mins). Tingling to extremities, some diaphoresis. HR stayed elevated at 140 for 30 minutes, went to 120 for 1 hours, then 109 after 2 full hours. She was sent home with instructions to go to ED if she becomes symptomatic, symptoms explained.
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 11-OCT-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
pt recv vax & pt devel lesions across multiple dermatomes, scalp, etc;cult from a vesicular lesion was positive for varicella;
This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2015, the patents were administered doses of GARDASIL lot numbers:  K007828, expiration date 02-MAR-2017; K010215, expiration date 05-MAY-2017; K010574, expiration date 08-APR-2017; K011562, expiration date 08-APR-2017; H021861, expiration date 09-OCT-2015 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sleep a great deal extra for four weeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleep a great deal extra for four weeks) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Sleep a great deal extra for four weeks). At the time of the report, HYPERSOMNIA (Sleep a great deal extra for four weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
chills; pain where the shot was; Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine.; Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN6200) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number / Expiry Date: EL9265 or EL9263,, Anatomical site of injection: Left arm), administration date: 28Jan2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "tiredness", "pain where the shot was", "Chills". The following information was reported: PAIN (non-serious), FATIGUE (non-serious) all with onset 24Feb2021, outcome "unknown" and all described as "Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine."; CHILLS (non-serious) with onset 25Feb2021, outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "unknown", described as "pain where the shot was".  No follow-up attempts are possible. No further information is expected.
5 minutes post vaccine administration patient became cold, clammy, pale, and unresponsive.  Patient placed on 100% NRB and 0.3mg EPI given IM. Vital signs stable, patient transferred to Emergency Department and discharged home at 2240.
Patient received the second dose of Meningococcal vaccine too early, she should have received it when she was 16 years old. She did not have any adverse reactions to the vaccine. Clinic called patients father and informed him of the error, patient and father acknowledged and expressed understanding.
numbness/tingling in arms/legs that progressed to acute GBS w/total body paralysis requiring intubation;tx w/IVIg;pt has regained some upper body strength, excluding distal upper extremitIes, still on vent; anticipate resolution of sx
Sore throat; Extreme tiredness; Bone and body aches; Headache; Back pain; Cough; Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches) and HEADACHE (Headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Pt developed seizure 5/26/02 about 8:30 PM with post-ictal state also fever 102F range that suddenly increased. First seizure. No known F Hx (pt is adopted). Labs all WNL. 6/3/02, pt seen in office with rash otherwise reaction to MMR and continuing fever 100F range.
This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010570, 1405USA010571 by the same reporter link. Additional information has been requested.
TOOK THREE DOSES ON CONSECUTIVE DAYS; This case (PVX2019-2177) was received form a pharmacist on 27-Aug-2019. It described a 59-year-old male consumer, who "took three doses on consecutive days" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take doses of Vivotif according to the schedule. The doses were taken on day 1, 2, 3, and 5. The last dose was taken on 26-Aug-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses on consecutive days" was considered as not applicable.
My baby broke out in terrible looking hives, and he was taken to hospital emergency room, and was given a steroid dose of 5ml and a referral to a pediatrician.
Sore arm, similar to a tetnus shot.  Lasted around 36 hours.
As a Type 1 Diabetic, I had to double my fast acting insulin the first 24 hours after the vaccination. Similar to a cortisone injection. Other than that, I had quite a bit of soreness at the injection site but no other symptoms.
24 hrs p/vax pt had ax temp 104; had been given APAP q 4 hrs & had it 3 hrs prev to fever 104; 36 hrs p/vax pt had ax t105; appetite poor during this period; no other sx;
Left arm/hand numb and tingling for at least 12 hours.   103 degree fever Migraine Aches all over - unable to sleep
Injection site cellulitis, localized edema, shoulder pain, pain upon movement, painful L arm, injection site edema, injection site pain. Injection site reaction. Initial report received on  November 2008 from a physician. A 54 year old female patient with no concurrent illnesses, no known allergies, and who has past medical history of migraines, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2753AA) on 14 October 2008. The patient was taking concomitant medications of LOWESTRIN FE and "Oivel" .12 mg at the time of the vaccination; however the indication for these medications were not provided. Two days post vaccination, the patient experienced edema at the injection site on the left arm. The site was 12 cm in diameter and the arm was sore to touch and sore with movement. The patient was evaluated by a physician in 04 November 2008 and diagnosed with possible cellulitis and treated with MEDROL dose pack and "anti-inflammatories". At the time of this report, the patient had not recovered. Follow-up information was received 01 December 2008 from a health care professional. The reported clarified that the patient had been receiving LOESTRIN 1/20 (previously reported as LOWESTRIN FE 120) concomitantly as perimenopausal birth control. The extent of cellulitis extended 10-12 cm in diameter from the injection site at the center. There had also been swelling throughout the entire shoulder, generalized pain in the shoulder and at the injection site and itching. Corrective treatments consisted of a MEDROL dose pack. Testing had not been performed to confirm the cellulitis. The reported stated that the patient had not been vaccinated at their office therefore they were unsure if the vaccine vial had been tested, or if any other patients had experienced any adverse events. According to the reporter, the patient recovered from the event and had been doing well.
Breakthrough case admission after 2 vaccines  Moderna 3/25/21 Lot# 046A21A;  Moderna 4/22/21 Lot# 006C21A
Pt. states that 24 hours after receving vaccine that he started to feel bad he got dizzy then lethargic ran into a door went to fire department and they check his b/p it was 200/120 then pt went home. Did not go to ER or Doctor. Pt came back 1 wk. later for 2nd vaccine went over reaction with nurse supervisor pt. state that he need vaccine for job gave 2nd vaccine. Then pt come in for 3rd vaccine 2 wks. later states he did ok had some nausea and vomiting about 24 hours later but did not feel bad like he did after the first vaccine. Pt. comes into office 24 hours later after recieveing 3rd vaccine states had chills, hot flashes, dizzness. b/p 140/90 HR 80 instructed to take benadryl call MD if needed instructed not to ever take rabies vaccine booster.
PT RECEIVED MMRV-PROQUAD TO RIGHT THIGH-SQ- PATIENT LATER CAME BACK  3 DAYS LATER WITH REDNESS, TENDERNESS, HARD AREA AT INJECTION SITE. TREATED WITH HYDROCORTISONE CREAM-
SHORTLY AFTER RECEIVING VACCINE, PATIENT BECAME SWEATY AND UNRESPONSIVE (DID NOT FALL OR LOSE TOTAL CONCIOUSNESS). PATIENT HAD NUMBNESS IN LEFT ARM THAT LASTED APPROX. HALF AN HOUR. CONTACTED EMS IMMEDIATELY AND THEY RESPONDED WITHIN 15 MINUTES AND TREATED THE PATIENT AT THE PHARMACY.  PATIENT SIGNED RELEASE FORM AND WALKED OUT ON HIS OWN WITHOUT ASSISTANCE.  ADVISED PATIENT TO CONTACT HIS PRIMARY CARE PHYSICIAN PRIOR TO SECOND DOSE.
Presented to office on 3/7/22 with father for complaint of that 24 hours after receiving the MenB booster last Wednesday (6 days ago) father found him lying prone on the ground with his head to side; hardly responsive/ not very coherent (he could give dad a thumbs up though) and in a puddle of  his own drool; his eyes were rolled up. No abnormal body or extremity movements. He later became more responsive and went to the pool to rinse his face off of snot; he felt hot- temp 99.6F at that time; father thought this behavior was strange. Father wasn't sure if he was overreacting to not doing homework. Mother normally helps him and she has been away. Today, patient says  he remembers the episode and it was because of a "mental breakdown" due to an "overload of work"  However, father is now bringing him to medical attention because since then has continued to be lethargic, no appetite, doesn't want to drink, laying in bed and sometimes can't sit up.   He is weak. Uses his arms to lift/move his leg to get out of the car. Speaking slowly and seemingly confused. Mental status is not consistent with his baseline.   Patient referred to ED.
Made her sick for a day; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made her sick for a day) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Peritoneal dialysis since an unknown date. Concurrent medical conditions included Diabetic and Cataract (Cataract in one eye).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Made her sick for a day) and PAIN IN EXTREMITY (Sore arm). In 2021, ILLNESS (Made her sick for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2021-415970, MOD-2021-416208 (Patient Link).
In right arm (arm with Menactra and VZV (2nd dose for him). Patient got 2-3 cm red, warm area and edematous lymph nodes near but no contagious to IZ, also fever, brief blurry vision.
Approximately 12 hours after I received my booster shot (3rd shot overall), I woke up with my heart pounding.  Up until then, my blood pressure was perfect.  I?ve been struggling to control my blood pressure since then, even having one of my medications changed.  It may not be related to the booster shot, but it seems odd that the trouble started the night (12 hours) after I got the shot.
Coughing after vaccine; 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 COUGH (Coughing after vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing after vaccine). At the time of the report, COUGH (Coughing after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Itchy and rash at injection site, fever, tender and rash has begin to spread all over the arm.
Dizziness right after shot was given. Had pt lay down for 20 minutes. Rechecked 02 sats. pulse and B/P which were all WNL.
Initial and follow-up info has been received from an RN concerning an 8 year old white female pt with no medical history who on 6/16/97 was vaccinated with a 1st dose of MMRII. On 5/21/05, at 11:30 AM, the pt developed a "varicella rash" over entire body. On 5/28/05, the pt recovered. No further info is expected.
At 3:00pm on March 20, 2019 began to feel extremely tired, slight headache and nausea then chills. Took 2 TYLENOL and laid down for several hours headache and nausea went away. Continued to feel chilled and tired. Went to bed earlier then normal. Upon awakening in the morning I felt fine.
Information has with allergies to PENICILLIN, CEPHALOSPORIN, non-steroidal anti-inflammatory drugs and silver containing compounds who on 07-AUG-2007 was vaccinated with one dose of ZOSTAVAX (Merck). Concomitant therapy included estrogens, PREMARIN, ACTONEL, SEREVENT DISKUS, DILAUDID, DOXYCYCLINE and HYDROCHLOROTHIAZIDE (manufacturer unknown). On approximately 12-APR-2009, "within the last week", the patient developed a rash on her right calf. At the time of this report, the patient had not recovered. No lab tests were done. Unspecified medical attention was sought. Additional information has been requested.
started last week feeling numbness in my right foot. Then went to my right  leg and up to my right arm and hand . Then went to the left arm. Starting to have pain in my right hand and leg.  The numbness grew daily. When i stand the numbness goes away and then when i lay down or sit down it comes back.
3 hrs after Td injection pt noted sweating and pimples on forehead-pimples gone by next morning-no fever-no redness at injection site.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FT1620) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Patient do not have any known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any medications within 2 weeks. From 15May2022 to 19May2022 patient took Covid-19 treatment of Paxlovid. Patient stated that there were no adverse effects but Covid symptoms returned after 5 days from completing the therapy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
The adverse event was a diagnosis of Shingles.   I have not previously been vaccinated for Shingles.  I did have chickenpox as a child.
Very mild headache; shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 35-years-old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 as 1st dose, single for COVID-19 immunization (at the age of 35 years). The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Feb2021, the patient experienced very mild headache and shortness of breath for about 1-2 hours. Patient did not receive any treatment for adverse events. The outcome of event was recovered on an unspecified date.    No follow up attempts are possible. No further information is expected.
expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient) had not resolved.        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 medication included.  No treatment medication included.
got .25mL of the bivalent booster instead of 0.5mL; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL).    No concomitant medication were reported.             No treatment information was provided by the reporter.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Continuous Eructation and Singultus onset within 2 hours of vaccination on 2/17, loss of appetite and lethargy with continued unabated eructation and singultus 2/18.  Patient anxiety due to worsening condition, 2/19, visit to Dr. diagnosed Mesenteric Lymphadenitis. Continuous Eructation and Singultus on 2/19-present Vomiting on 2/20. Loose Stools on 2/21