chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient took one Vivotif capsule in the evening on 8/28/2019.  She developed headache, dizziness, and she had blood pressure go up to 200 in 8/30/2019 in the morning.  She went to ER and was treated for comfort.  Her husband and she could not remember what she had in the hospital.  He called Pharmacy in the afternoon on 8/30/2019.  A pharmacist, asked him not to give his wife any more Vivotif and instructed him to monitor her symptoms until she could see her primary care doctor.    Her husband and she came to Pharmacy on 9/3/2019.  He said they just left her primary care doctor who asked Patient to discontinue Vivotif.  She was advised to take Tylenol for her headache and Meclizine for her dizziness.  Patient gave patient a list of facilities where patient could have her Vivotif disposed.
Pt. presents today stating " someone is following him and is out to get him." He has a history of mental health hospitalizations. He is hallucinating but asking for another COVID vaccine and flu shot. He is not able to give consent. In checking database, he got 2- Bivalent COVID vaccines, one 4/2023 and 5/2023. Evidently, when he came in May, he stated it was his first COVID vaccine. Pt. is also stating " the COVID vaccine grew my breast and caused me to sweat." Gynecomastia. Nurse Manager, spoke and assessed patient and he is referred to  Health Center.  Homeless reps at health dept. gave him some personal care items and food. 3- at home COVID test were given.
pt recv vax 26FEB96 & lab eval on 3APR96 & 10JUL96 revealed negative anti-HB s titers;pt exp rt arm pain& a big black like monkey on arm which was reported to occur following vax in FEB96;rt arm was larger than lt arm;
Severe ear ache lasting 5 days starting 2 days after injection. Swollen lymph nodes in neck. Sore throat. All lasting 5 days.
Rash arms, abdomen, chest > 72 hours.  Rash is slowly going away but still there as of 1/25. No difficulty breathing, SOB or GI upset.
mom states pt passed out approx 1hr p/vax; MD was phoned; MD stated per phone, to mom that it probably was just an allergy to something pt had eaten that day; dx lasted 30-40seconds;
4/15/10 -night/bed time. Some red spots on legs (upper thighs). By Sunday, spots were on thighs, buttocks, trunk, belly & chest. Raised slightly, red by 4/20/10 progressed to arms & face. Itchy. Sunday started BENADRYL. By Tuesday resolving -Wed (4/21) faint, less itching.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Nausea-Severe
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19  immunization. No medical history reported. On Jun 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 11, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jun 11, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021. This case linked to MOD-2021-365041 (patient link).
Patient experienced a reaction approximately 10min after vaccination, and reported a tingling sensation of the lips and tongue. Began monitoring vitals. Approximately 17min from time of vaccination, gave 50mg Benadryl PO. 39min after medication, patient reports symptoms resolved completely.
administered the vaccine intended for younger group ages 5-11 instead of the vaccine for 12 and above.
No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related.    No concomitant medications were reported.  The patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown.  No treatment medications were reported.
48 year old female presenting for evaluation of left arm and armpit pain.  Patient reports she received the Moderna COVID-19 vaccine on 1/6/2021.  Reports within the first 24 hours she developed pain to the injection site, nausea and some abdominal discomfort that resolved by the evening of 1/7/2021.  Patient reports yesterday she still noticed some soreness to the left arm (this was the arm the vaccine was injected in).  Reports she also had pain to the left armpit with some tenderness and pain extending to the breast at times.  Reports that she was wearing a sports bra at work and she had to take it off due to pain in the armpit.  Denies any fevers/chills, body aches, fatigue.  Denies any nasal congestion, sore throat, cough, loss of taste or smell, chest pain or shortness of breath.  Denies any abdominal pain, vomiting or diarrhea.  Denies any history of anaphylaxis.  Denies any history of severe reactions to vaccines.  Patient was advised this is possible side effect from vaccine but patient very concerned and wanted to be evaluated.
Change in sense of taste; had a perpetual salty taste since the day after vaccination. Has lasted so far 5 days post-vaccination
Site: Pain at Injection Site-Severe, Additional Details: pain at the shoulder region, cannot move shoulder. Can move fingers but cannot move shoulder. Mother states they have used ice, heat, and pain medications. They have not gone to visit physician but going back to college.
Vaccine administration error. Given too high. Did not go into deltoid muscle, instead caused excruciating rotator cuff pain leading to arm immobility for approx 48 hrs.  Pain continued after for approx one week, helped by ice and anti-inflammatory medication.
? Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated)
Systemic: It was ordered to not give the vaccine to patient due to previous allergy. information of type of allergy, when did it started, for how long had the reaction was not provided. note on system was posted 4/25/22. vaccine was given on 4/29/22.-Mild, Systemic: Tachycardia-Mild, Error: Wrong Vaccine/Product Administered-, Additional Details: the patient got allergic reaction from first shot. It was ordered to not give the vaccine to patient due to previous allergy. information of type of allergy, when did it started, for how long had the reaction was not provided. note on system was posted 4/25/22. vaccine was given on 4/29/22. caregiver called in reporting an adverse event and mentioning decision. no information about allergy type, when, for how long was provided.
symptoms started about 2a morning after, chills, body aches, fever high as 101.2, lowest was 99.8, no appetite, injection site a little swollen, hurt to move.  Nothing was taken, just let it run in course
Cannot bear wt on (L) leg x 72 hrs after vaccine. FROM, tender at site. Slight resistance to (L) external rotation.
ERYTHEMA, SWELLING, MYALGIA, FATIGUE,  MALAISE SYMPTOMS LASTED 24 HRS
SHINGRIX injection around 3:30 PM on 12/28/2018. Sore arm later in the evening. Pain increased and during the night arm was very hot from the shoulder to the elbow. Pain worsened and was not able to sleep. Tossing and turning. By morning I felt as if I was in a fog and could not function. Very weak and just wanted to lay down. Around 3 PM in the afternoon the fog was starting to lift and had something to eat. Never, never had an adverse reaction to ANY injection I ever had. This was a terrible experience and not sure if I should receive the 2nd injection. Have an appointment with my primary doctor to discuss this horrible experience.
Severe headache, 97.1 temp with extremely hot skin, rapid heartbeat (120 bpm). Next day felt fine with elevated heart rate. Monday, 3/22, all normal, including normal 60 bpm heart rate
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient started having dizziness when she got up to leave from the waiting room 15 minutes post vaccination, she also mentioned headache behind her right eye. She was taken to an exam room in a wheel chair as she was unsteady on her feet. She was laid down on an exam table and vitals checked. She states no previous vaccine reactions, has history of seizures and has had them with increased frequency recently. Patient was released to her friend to be driven back to work 1 hour and 27 minutes post vaccination
Health district notified by Police Dept. that a homebound resident who received first dose of Moderna on 4/26/21 and was due for second dose moderna on 5/24/21 was found deceased at home on 5/21/21.
an unusual high pitched cry; 5-6 hrs p/vax; crying screamign for 3-5hrs, large amount of redness & swelling on entire thigh;
Asthma, GBS. Nurse follow up on 05/18/04: dehydration, leg cramps, weakness in lower extremities, tightness in neck, numbness in fingers, difficulty standing.
DTap and MMR given 08/18/2005. Was seen 08/20/2005 for possible immunization reaction. Redness and tenderness to left arm 4" in length wrapping 3/4 length circumference. No tenderness, no induration. Slight itch.
This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patients of unknown age and gender, who on unspecified dates were vaccinated with a doses of PEDVAXHIB (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 13-year-old male patient who received MENVEO. Concomitant products included GARDASIL. On an unknown date, the patient received MENVEO. On an unknown date, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site irritation and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site irritation and injection site warmth were recovered/resolved. The reporter considered the injection site erythema, injection site irritation and injection site warmth to be related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient was son of nurse reporter. The patient received MENVEO on unknown arm and experienced arm redness, irritation and warmth at injection site up to 2 days after receiving vaccination. This case has been linked with case US2016146453 as reported by same reporter.
fever 38.5 erythema tender cellulitis in area of injection 1 cm diameter no fluctuant
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Flu vaccine administered at 10:15 am.....over course of afternoon low fever/joint pain/fatigue...7pm fever spiked to 102 degrees....uncontrolable chills/shaking...skin surfaces very hot to the touch....sleep at night was frequently interrupted by chills/shaking or too hot...next am very fatigued/headache/low fever
The patient is an 1 year old female. The patient is a healthy 12mo old female infant who received varicella vaccine in addition to MMR and hep B on 01 APR 2015. The MOP reports she initially had typical fever and then did fine. Ten days after receipt she developed a vesicular exanthem, initially only to her face and then yesterday to her trunk. She has approximately 10 vesicles but hundreds of small red spots to all extremities and trunk. She was seen by Dr. at clinic and dx with vaccine induced varicella. She has no known exposure to an active infection and does not attend daycare and has limited exposure to other groups. Her symptoms have now fully resolved.
Redness and heat of entire upper arm, fever of 102 F x 2 days.
Started having garbled type of speech on 10/19/2022, went to my doctor a week later and blood pressure was up. Had a CT Scan and a Ceratoid Ultrasound to rule out TIA. Doctor increase my Metoprolol dose. On 12/01/2022 had started a new injection medication of PCSK9 then 2 weeks later started having episodes of raised heart rate and shortness of breath. It had gotten so bad it woke me up at times in the night. Medication requires regular lab work, went to have lab work done in 02/2023. My doctor decided to increase my dose of Metoprolol again. Doctor had me wear a Heart Monitor for 3 days and found that I had Sinus Tachycardia with rare PVC's. Doctor ordered a Stress Test and an Echocardiogram and both showed normal. Have been extremely fatigued the entire time.
Localized reaction to LD - red, warm. Swollen - bruise noted. Encouraged to use BENADRYL.
Case number PHEH2014US012628, is an initial spontaneous report received from a nurse on 19 Jun 2014, and with a follow up report received from nurse on 21 Jul 2014. This report refers to an 11 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml into right deltoid on 10 Jun 2014. On the same day she also received booster dose of BOOSTRIX (other manufacturer, batch number: YS475) at a dose of 0.5 ml intramuscular. On 11 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. She also experienced itching. The outcome of the events was recovered on 16 Jun 2014. Causality assessment and seriousness of events was not reported. Follow up report received from nurse on 21 Jul 2014. Updated patient details, concomitant vaccine and event (itching).
Localized, indurated, erythema, swelling, 6 x 6 cm in size on (R) lateral upper arm.
Angioedema, SkinRash & CoughWheeze Narrative:  Shot #2 swelling of throat and taken to ER - treated solumedrol, Benadryl, famotidine, home on decadron. Tired. Telework nurse. 15-20 mins, itching. Worsened - tried to leave, tight in chest & neck, so came back in. Hives.  Other Relevant History:
She wouldn't breastfeed; Mother saw she was crying then turned red; Mother saw she was crying; Mother notices severe irritability; Tactile fever; She had 2 episodes of vomiting; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2407394-1. The original narrative from the sender is as follows:  Shortly after vaccines, mother noticed severe irritability. She wouldn't breastfeed. She had 2 episodes of vomiting approximately EMS hours after vaccines. Tactile fever. Mother saw she was crying then turned red, no cyanosis. Called ambulance, went to local ER, was evaluated and sent home, no testing done.  Current illness included Viral bronchiolitis.  The causal relationship between Vaxelis and the events, " "She wouldn't breastfeed", "Mother saw she was crying then turned red", "Mother saw she was crying", "Mother notices severe irritability", "Tactile fever" and "She had 2 episodes of vomiting" was not reported.  No further information is expected.
Joint stiffness and pain Flu like symptoms Back pain Stiffness impairing ambulation Fatigue General malaise Generalize weakness Burning sensation in muscles
Headache, most of the night, dizzy, joint and muscle aches, jaw pain, spiked a fever at 1:30 AM around 102, skin aches and the left arm pain. Couldn't sleep on that side. Fever is down to 100.2 at 9am.
(R) Arm, Rash, itchy and tingling feeling where the vaccine was given.
DESCRIBED RED BLISTERY RASH ON STOMACH, SMALL BLISTERS ON ARMS AND LEGS. LASTED ABOUT A WEEK. STATED TOOK B-COMPLEX TO HELP CURE IT.
Great amount of pressure at time of Pnuemo vaccination. Later in day, Lt arm very sore unable to move away from body.
Gave pt flu shot at 11:30 am Pt came back after shot arojnd 11:45am and said Back tightened up , then said had trouble breathing , told to take mask off to help breathe better, Breathing did not improve in 5 mintues called emt. They responed in at 12:05, And took gentleman to ER .
Information has been received from a registered nurse concerning a child who on 11MAY1998 was vaccinated with a dose of varicella virus vaccine live, only. There was no concomitant medication. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications, no treatment was required and patients were often not seen by the nurse, but were reported by parents as explanation of an absence. It was also noted that the child was part of six cases that took place over the last school year from 09/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 9 years of age. The nurse also reported that five other children developed mild chickenpox.
Initial report received on 06 November 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number not reported received on 28 February 2012, lot number "C3973AA-C4193AA" received on 24 April 2012 and lot number C4258AA received on 22 June 2012 (routes and sites of administration not reported). The subject developed a cough on 17 July 2012, approximately 25 days after the last dose, and paroxysmal cough on 18 July 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I'm down for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles shot and was down for 3 days. The patient had ever shot with no side effects.
Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains reporter address updated.