chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd Engerix-B 24 hrs later had upper abdo cramps, excessive flatulence, diarrhea, chills, nausea that lasted for approx 6 hrs; following day had 2 episodes of upper abdo cramping; no temp;
PATIENT STARTED TO DEVELOP A RASH ALL OVER HER BODY INCLUDING HER FACE AND NECK. PATIENT DIDN'T COMPLAIN OF SHORTNESS OF BREATH. THE RASH DEVELOPED WITHIN 10 MINUTES OF THE INJECTION
01/01/22 presents to EC ED for "urinary frequency and incontinence" "multiple falls". PMHx of "CHF".
Very drawn energy/weak; back of their leg hurts; Not able to eat; feel dizzy; Body aches; Feeling heavy; nauseous; Vomits; Tired; low grade fever; their jaw locked; This spontaneous case was reported by a consumer and describes the occurrence of TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat) and DIZZINESS (feel dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced TRISMUS (their jaw locked). On an unknown date, the patient experienced ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever). At the time of the report, TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever) outcome was unknown.            Concomitant medication was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded. On 05-Aug-2021: Non-significant follow up updated
Arm at injection site and around it sore for over 48 hours, still after 24 hours, and probably worse after first 24 hours. I just took acetaminophen 500mg, and it was fine.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced developed a ball rash after getting the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of developed a ball rash after getting the jab was not reported. This report was non-serious.
Patient has a history of pulmonary embolisms poat 5 years. Tgere was no type of screening for this. Patient is currently hospitalized for Pulmonary Embolisms
She reported tachycardia (pulse 150), dizziness and lightheadedness five minutes post vaccination. She then started to develop a red rash to her trunk, and throat swelling. Epinephrine administered and EMS called. Symptoms resolved post EPI.
pt recv vax 16JUN95 & pt devel chickenpox w/greater than 100 lesions;
Sterile abscess, redness right arm extending to elbow, warm to touch, tense edema. Tx Benadryl, 1/2 tsp bid, cool soaks, Prelone 15mg/3ml bid x 3 days.
Approximately 3 hours after shot I had a metallic taste in my mouth Approximately 12 hours after shot I had severe chills, headache,nausea, very tired, dizziness (I fell), brain fog Approximately 24 hours after shot symptoms subsided EXCEPT sick to my stomach, nausea and tiredness  I have received 2 shots, 3 boosters and every time I am sick from the shots!!!!!!!!!!!
Short Term Memory loss is evident since receiving the vaccine.  I have never had short or long term memory loss prior to the vaccine.  I have been monitoring this since receiving the vaccine and it is persistent on a daily basis.
85 y.o male pt came for the covid booster vaccine. pt was A&Ox3, responsive, in wheelchair, attended by home attendant and sister. pt reported no symptoms of cold, flu, fever. no prior reaction to vaccines. after the administration, pt was moved to a waiting area for 15 mins observation time. 15 mins into the vaccine administration, pt started feeling cold and chills. VS=151/65 (L arm, sitting position), O2=95%, HR=88, BS=106 mg/dL.  Pt was observed by PA as well and it was decided to send him to the ER for further monitoring. Hx of CAD, stents.
Welts that itch on left side. Began on L leg on (01/25) and continued to travel up left side. As of (02/07) on L arm and concentrated around injection site. Still present, have pictures of all if needed.
Patient became diaphoretic reported feeling weird and was going to pass out. RRT called. Patient transferred to ED.
This spontaneous report was received from nurse referring to a 25-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-SEP-2018, the patient was vaccinated with her first dose of GARDASIL 9 intramuscularly (lot # N035032 and expiration date 24-SEP-2020) (dose and frequency not reported) for prophylaxis. On 02-OCT-2018, the patient received her second dose of GARDASIL 9 (lot # N035957 and expiration date 10-OCT-2020) (dose, frequency, route not reported). No adverse effect reported.
arm redness; welts; Fever; This spontaneous case was reported by a consumer and describes the occurrence of   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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
administered an expired dose of the vaccine with no reported AE; Initial information received on 03-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who had administered an expired dose of the vaccine with no reported ae after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-May-2023, the patient received a dose 2 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection lot U7211AA, 14-MAR-2023 via intramuscular route in the left deltoid for immunisation.  On 03-May-2023 the patient developed a non-serious event administered an expired dose of the vaccine with no reported ae (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event administered an expired dose of the vaccine with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Left arm outer aspect, erythema, induration 13cm x 8cm. Tx: Benadryl, Tylenol.
Narrative:  74 yo M with AMS following day after receiving zoster recombinant vaccine. Has dysarthria at baseline but sx worsened to AMS following vaccine. Imporved while admitted. Sx improved within 4 days of event.
Client was vaccinated with Pfizer vaccines for Covid in beginning and end of June, 2021.  Mother not exactly sure of dates but states it was beginning and end of June.  Client was tested on 10/1 because she had contact with + family member.  She tested PCR + on 10/1 and is asymptomatic.
Severe stiffness, pain developed in neck, bilateral shoulders, arms, hips, legs, ankles including muscles associated with those areas. Increasing g in severity to the point of being unable to move.  This followed a right shoulder rotator cuff tear on 05/23/2021. Shoulder surgery scheduled for 07/02/2021 which was cancelled the day of surgery due to my severe autoimmune type symptoms. Emergency MRI showed negative to pinched cervical spine. Treatment was in ER of 60 mg Prednisone and follow up with rheumatologist Dr. is now evaluating my care and making recommendations to see how I respond.
1hr p/vax lt side from top of head to foot went numb @ 1 1/2hr then throbbing & aching;next day felt ill;2/13/99 devel T101.1 fever & cough & saw MD;told not to have Td again;
A non-serious spontaneous report of administration of expired product was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
When I got the shot, a few hours later, I felt like my neck was being squeezed and my ear was pinned to my shoulder. I felt like I was in a complete spasm to my right side. I did take medicine and used heat but did not get relief. I did go to the ER that following day in the afternoon. They gave me a Toradol Shot and oral Percocet, Zofran and a IV KETAMINE drip. I was discharged later that evening to follow up with my PCP and a spine specialist. I have been following up with them since and I still experience severe spine and hand arthritis, and nerve numbness in my fingers.
drowsiness, fatigue, abnormal vision, cutaneious hypersensitivity Narrative:
Severe body aches, chills, headache Lasted for about 12 hours (9 am-9pm)
almost exactly 12 hours after vaccination, patient threw up twice (4am and 6am) she had no temperature, had not been around anyone else that was sick, did not get any other people that she was in contact with sick and the same people who ate the same dinner as her that night did not get sick.  After she woke up around 8am the next day, she acted perfectly norman and not ill at all. Per follow-up: Per mother of pt., child woke up at 5 AM and threw up once. Had no other problems -afebrile, no c/o nausea or food poisoning. Mother convinced Hep B vaccine was cause of child throwing up.
swelling at injection site; Fever; Fatigue; Shoulder pain; This case was reported by a consumer and described the occurrence of injection site swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, fever, fatigue and shoulder pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site swelling, fever, fatigue and shoulder pain were unknown.   The reporter considered the injection site swelling, fever, fatigue and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient complained of fever, fatigue, shoulder pain, and swelling at injection site. The patient spoke to pharmacist who advised to take Tylenol to manage and rest. The reporter consented to follow up.
given expired Quadracel to a 4 year old; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a four years old patient (gender not reported) who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Exp. Date Jun-2019 ) (lot number, dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
4/3 had a low grade fever 100.5.  Achy, lethargic.  Arm at site was very tender.   4/4, all symptoms appear to be gone.
Patient was vaccinated at 2:45pm with Polio and Menactra in the right deltoid and Gardisil 9 in the left arm. When given the Gardasil last he immediately tensed up, and went into a vasovagal episode.  Another person and I lowered him to the ground safely placed an pillow under his head and gave him cold wash cloths for he forehead. We called for help immediately and Dr. came in to evaluate. Shortly after episode patient asked where he was and states he was tired, dizzy, sweating, his whole body felt numb, and felt as though he fell asleep for a quick nap. Dr. checked his blood pressure, and did a full body examination along with listening for bowel sounds, extremity movement, along with checking for level of consciousness. One he was improving we placed him back in a chair with a pillow behind his head, and we gave him some water and Gatorade. We monitored patient for at least 30 minutes post incident. Dr. evaluated and accompanied him out to his car. Parents and patient stated that this has never happened before but siblings and father has had this happen before to them.
Appetite decreased the same week as COVID #2 vaccine received in July.  That vaccine received at a facility separate from our office, so no known lot info, route, etc.  Increasing symptoms being experienced since then.  Energy levels decreased.  Morning nausea and sometimes vomiting.  Decreased eating due to concern for nausea and/or vomiting being induced.  Nearly 20 pound weight loss since last visit in February until August acute visit.  Father feels strongly that this all was prompted by COVID #2 vaccine.  Lab tests normal.  Ultrasound normal.  GI and Psychology referrals and showed improvement over 6 weeks with stable weight to gaining a few pounds, less nausea and vomiting.  On omeprazole which has seemed to help.
Patient received the Hep A and varicella vaccinations on 4/26 and developed urticarial lesions on bilateral anterior and posterior thighs, anterior trunk, and bilateral anterior and posterior arms on 4/27. She has not been scratching the lesions. MOC denies that patient has had any edema. Pt's sister has had a fever recently. Pt has not had a rash like this after vaccines before. She has an area on her thigh at that became hard at the injection site after a vaccine in the past.
Patient was tired and slept for two days after vaccine.  Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds.  On Day 4 she did vomit.   After second shot, she complained of constipation and aching on over.  She vomited twice.
This case was reporter by a physician and described the occurence of upper arm swelling in a 6-year old male who received Hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The physician submitted this report directly to VAERS (212627).  The pt's medical history, concurrent conditions, and concurrent medications were not reported.  On 11/13/2003, the pt received the second dose of Hepatitis B vaccine to the arm and later the same day experienced swelling of the upper arm "from the shoulder to the elbow."  The event resolved the next day.  The reporter considered the event to be related to vaccination with Engerix-B.
On the 8th day January 26, 2021 following the vaccine my upper left arm at injection site started itching. On January 28 I noticed a red rash in a 2 circle  at injection site. The area is swollen and warm to the touch. On January 28 I saw a nurse at the Health Dept. She said they have been seeing this following the Moderna vaccine and told me to put cool compresses on it and hydrocortisone cream for the itching. Also told me to take a Benadryl in the evening. Said it should get better in a few days. However today, January 29 it had gotten worse with the red rash area increasing in size and it is still swollen and itches.
pt recv vax &  4 days p/vax, a FANA (inflammatory) screen was performed;the resulting levels were extremely elevated;
vomiting, diarrhea, n/v, metallic taste in mouth, syncope, weakness, anorexia, abdominal cramping Drinking warm ginger-ale, dried cheerios, sips of water with some relief. Recommended Mylanta to help soothe stomach.  4/23-symptoms lasted 1 week; feels improved. Still fatigues easily.
pt recv vax in OCT93 & in FEB94 pt exp loss of taste & smell;CT scans & MRI were reportedly neg;pt stated that a specialist told her has olfactory nerve damage r/t flu shot;
started having nausea and vomiting that cont until went to the ER on 6/18/11 passed out in the ER and couldn't remember what treatment recieved felt better then on afternoon of 6/19/11 became nauseated and started vomiting again was sent home and plans to see pcp on 6/22/11
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxin, reaction(s): "Known allergies: naproxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2022 to 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Blood in stool, diarrhea, dehydration, dizziness, chills, fatigue
Pt devel inject site rxn with soreness at the inject site. This is 1 of 8 employees of this facility to devel inject site rxn following receipt  of vax with lot# 4978139.
Patient registered to receive Moderna at one end of the table but she received Pfizer at the other end of the table.   It was confirmed by nurse and student that she was asked what she was getting prior to administration.
a person had 2 Moderna shots and that they got the Pfizer booster and made them sick; a person had 2 Moderna shots and that they got the Pfizer booster and made them sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shots (Dose 1), for COVID-19 Immunization; Moderna shots (Dose 2), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "a person had 2 Moderna shots and that they got the Pfizer booster and made them sick".  Additional information: I over heard that a person had 2 Moderna shots and that they got the Pfizer booster and made them sick   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history was provided by reporter. On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine). On 09-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine) had 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 medications were provided. No treatment medications were provided.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L015046 and expiration date 29-APR-2017, subcutaneously (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had an unspecified temperature excursion, reported as more than 14 Fahrenheit (F) and less than 46 F with a time frame of 40 minutes. No previous temperature excursions were reported and a digital data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.