chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, body aches, joint pain, fever, malaise. Site reaction- redness, pain, swelling, itching.
Patient started with extreme irritability after receiving her first DAPT-IPV-HIB, PREVNAR, and rotavirus vaccines. Sx's started the night of the administration and had a current jelly stool  the next day - Ultrasound showed intussusception.
Woke 12 hours after receiving vaccine with extreme joint/body aches, weakness.  Felt as if I had major case of Flu.  After 12 hours started to improve but was unable to really function all day.  Following morning I was back to normal.  This happened with my second shot lasting only 12 hours; 3rd shot (booster but was full dose) was sick for 36 hours then fine.  I asked for Pfizer for 4th booster but was advised to stay with Moderna.
missed 2nd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was supposed to get the second dose of the vaccine on 21-May-21. No concomitant drugs were reported. No treatment medications were reported.
Pt received her 12 month set of immunizations on 08/03/04, was fine afebrile until fever of 105.4 began on 08/06/04 without any other symptoms present. Taken to ER on 08/07/04 for lab work and IV rehydration. Mild conjunctivitis also began on 08/07/04.  Fever lasted from 08/06/04-08/09/04.  Follow up appointment with PCP on 08/09 revealed ear infection that was not there during ER visit on 08/07.
fever followed by severe pain and stiffness left knee followed by severe pain in bilateral shoulders and stiffness of bilateral shoulders
Insomnia after 2nd dose; Sore arm after 2nd dose; Headache after 2nd dose; Fatigue after 2nd dose; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included COLCHICINE for an unknown indication.    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, the patient experienced INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose). At the time of the report, INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose) outcome was unknown. Not Provided          The concomitant medication was provided as anti depressant.  The treatment information was not provided.  The action taken with mRNA 1273 with the events were considered as not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080625 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080625:1st dose vaccine
Felt soreness at injection site; Felt soreness at injection site and inside the under arm (armpit); Booster dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Nov2021 (Lot number: 320305D) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 02), for Covid-19 immunization; Bnt162b2 (Dose 01), for Covid-19 immunization; Flu vaccine vii (Anatomical site of injection: Right arm.). The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "Booster dose"; INJECTION SITE PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "Felt soreness at injection site"; AXILLARY PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "Felt soreness at injection site and inside the under arm (armpit)". The event "booster dose" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of injection site pain, axillary pain.  No follow-up attempts are possible. No further information is expected.
Customer 30 seconds -1 minute after administration of the vaccine became unresponsive, and had facial twitching and overall body clenched down for 15 seconds--seizure like. Customer woke and assisted customer to ground, he reported lightheadedness, customer was pale. Customer was fasting. Customer reports within 5 minutes on the floor that he felt better. Assisted customer into sitting position and observed for 20 more minutes. customer reports being 100% at time of departure. Customer with his father.
body ache; chills; dizzy; arm was a little sore; Joint pain; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2022 11:00 (Lot number: FJ5682) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high Diagnosed years ago; "allergic to penicillin" (unspecified if ongoing), notes: allergic to penicillin. Concomitant medication(s) included: NORVASC. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2022, outcome "recovered" (24Mar2022), described as "dizzy"; PAIN (non-serious) with onset 26Mar2022 07:00, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 26Mar2022 07:00, outcome "unknown", described as "chills"; ARTHRALGIA (non-serious) with onset Mar2022, outcome "unknown", described as "Joint pain"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2022, outcome "recovered" (23Mar2022), described as "arm was a little sore". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible. No further information is expected.
The pt received Hep A&B, and Typhoid in the morning and at 14:15 received Yellow Fever, MMR and TD. Roughly 1 hour later, the pt developed sore throat, generalized itching, hives, swelling of nose and congestion, and cough. Symptoms relieved with Benadryl.
Information has been received from a CMA concerning an 85 year old female with high lipids, hypothyroid, osteopenia, fatigue syndrome, lower extremity edema, insomnia and an allergy to sulfa medications who on 9/2/03 at a well visit was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (643785/0872M). The pt was well at the time of vaccination. On 9/4/03, two days post vaccination, the pt felt sick and her left arm was swollen and red, with a circumference of 16cm wide and 18 by 5cm long with increasing pain. She was diagnosed with cellultiis. She was treated with three doses of Keflex. On 9/5/03 the pt was seen in the physician's office and stated that she was feeling better and was recovering. Treatment was continued with Keflex 500mg 4 times daily and Benadryl 25mg 4 times daily. Subsequently, the pt has since recovered. It was noted that the pt had only been with this practice since her first visit on 10/3/00 and the reporter was not sure if this was the pt's first vaccination with pneumococcal 23v polysaccharide vaccine or not. No product quality complaint was involved. Upon internal review, cellulitis and felt sick were determined to be other important medical events (OMIC). Additional info has been requested. Follow up on 12/19/03: "Information has been received from a certified medical assistant and a physician concerning an 85 year old white retired female with high lipids, hypothyroid, osteopenia, fatigue syndrome, lower extremity edema, insomnia and an allergy to sulfa medications who on 09/02/03 at a "well visit" was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 643785/0872M).  Concomitant therapy included levothyroxine Na, aspirin, garlic extract, calcium and multivitamins.  There was no illness at the time of vaccination.  ON 09/03/03, the pt felt sick and her left arm was swollen and red, with a circumference of 16cm wide and 18 by 5 cm long with increasing pain.  She was diagnosed with cellulitis.  She was treated with three doses of cephalexin.  On 09/05/03 the pt was seen in the physician's office and stated that she was feeling better and was recovering.  Treatment was continued for 3 days with cephalexin, 500mg 4 times daily and diphenhydramine 25mg 4 times daily.  The pt's symptoms worsened.  After 3 days with cephalexin the pt went to the ER.  She was switched to dicloxacillin QID for an unknown duration.  On 09/10/03 the pt recovered.  It was noted that the pt had only been with this practive since her first visit on 10/03/00 and the reporter was not sure if this was the pt's first vaccination with pneumococcal 23v polysaccharide or not.  No product quality complaint was involved.  Upon internal review, cellulitis and felt sick were determined to be other important medical events (OMIC).  No further information is expected.  It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed injection site cellulitis (WAES # 0311USA01583)."
COVID arm  reaction, was diagnosed as cellulitis; A spontaneous report was received from a healthcare professional concerning a female patient who developed "covid arm" reaction, diagnosed as cellulitis/PT: cellulitis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received dose of mRNA-1273 (Lot #, route of administration, and injection site unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient had "covid arm" reaction, went to the emergency room (ER) and was diagnosed as cellulitis and treated that way.   Treatment details were unknown.  Action taken with mRNA-1273 was not provided.  The outcome of event "covid arm" reaction, diagnosed as cellulitis was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of cellulitis in the arm occurring with unknown latency after the first dose of mRNA-1273. Treatment for cellulitis. Outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration on 7-may-2021. Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-364498.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: metastatic breast cancer, and other pre-existing medical conditions included: Patient was non-pregnant at the time of vaccination. The patient previously experienced drug allergy when treated with rifaximine. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, 1 total, dose number 1, administered on 17-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, dose number 2, administered on 21-NOV-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. Concomitant medications included letrozole, and palbociclib. The patient received paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: UNKNOWN) dose was not reported, administered from 01-MAY-2022 to 05-MAY-2022 for treatment of COVID-19. On an unspecified date in 2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 2). Patient was getting better, including fainter and fainter positive rapid test, then had a flare up and strong positive rapid test 7 days after completing Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000234202.; Sender's Comments: V0: 20220607763-covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
1524- whole body shakey, HR-140's, feels anxious, 02 sat 99%RA, b/p 172/98. Within 10 min of vaccine she states heart started beating fast, felt warm ,warmness went away. 1532 cont shakey Hr-114, 1541 repeat little dizzy and shakiness increased, b/p 158/82, hr-119, 02 sat 99%. 1550-Pt reports she is starting to feel better hr-107, 02 sat 98% ra. 1600 reports head clear now, no dizziness, HR-95, 0s sat 98%ra, 1615 b/p 148/80, hr-95, 02 sat 100%. Pt notified son and brother of reaction. Instructed to f/u with md as needed
Note: pt had vaccine administered at an outside facility; she thinks on 5/21 but not certain of the exact date. Reported 2-3 days later, had localized pain and swelling at injection site. On 6/2, reported she had worsening pain ("like a bee sting,") swelling, and discoloration. Saw me for this concern in my office on 6/3 at which point she had minimal discoloration and no swelling, but site was still very tender to touch. I am reporting this because it is a local site reaction that occurred/persisted later than the expected timeline of 1-2 days after vaccination.
Fifteen minutes after injection, I experienced pain in my left chest. It migrated to the center of my chest and could be felt on both front and back. Pain was a dull, squeezing ache that could be mitigated by placing hand over the pain and leaning forward. Pain level was 2. The pain migrated to left shoulder and up left side of neck. Vital signs were normal.  A few dry coughs caused medical personnel to offer water, which was declined. The pain was similar to the pain I experienced after drinking contrast medium (now considered an allergic reaction) but without breathing difficulties. The pain went away after an hour and half. Nurses suggested emergency medical care, which I declined.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/15/2021 and 02/05/2021. They presented to emergency department on 09/17/2021 for low oxygen and tested positive for COVID-19 on 09/18/2021. They were admitted to hospital 09/17/2021. During hospitalization, it was found that they were having multiple co-occurring conditions and issues. They were found to have had an acute embolic cerebral vascular accident, be in A-Fib, have a non-ST elevation myocardial infarction, have COVID-19 pneumonia,  and to have a large right upper lobe mass with surrounding smaller satellite nodules. It was speculated that these lung masses were cancerous, but the individual declined any further treatments or diagnostic procedures. They opted to pursue palliative care and were discharged to hospice on 09/24/2021, in what was described as "declining condition." The hospice facility is not specified in clinical notes, but it is likely they were discharged to the nursing home at which they were a resident. They died on 09/30/2021.
Information has been received from a physician concerning a 69-year-old male with a history of lymphoma that is in remission and no known drug allergies, who on 29-JAN-2008 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  It was reported that the patient's siblings had experienced shingles so the patient's primary physician recommended the vaccination.  "A few days later," on approximately 01-Feb-2008, the patient had a circular, red rash on his right lower abdomen.  The affected area grew in size.  There were no vesicles, but the area was sensitive and hot "as if there are nerves coming to the surface".  The patient sought medical attention in the office.  There were no laboratory or diagnostic tests performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ with lot number K011663 and expiry date-24-MAY-2016 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.
On 11/18/2022 pt became tired and dizzy at home.  Nurse wife triaged Pt and found pt to have pulse of 24.  Also had SOB and skin gray in color.  Medics called.  Found pt to have 3rd degree heart block.  Transported to ED.  Resolved to 2nd degree then 1st degree heartblock with minimal intervention.  Pt was admitted.  Pacemaker placed on 11/21/22.  Issue has not been resolved as time VAERS is filed and pt is still admitted to hospital.    Pt. also had STRONG reaction to 4th Moderna shot with chills, sweating, nauseated less than 2 hours after receiving 4th shot earlier in 2022.  VAERS report was filed for reaction to 4th shot.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 10-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, EXP 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
At 11pm, I started shaking and feeling dizzy.  By 1am I had a headache that prevented me from sleeping, along with shivering.  The next day, until after 4pm the headache was worst at this time then all symptoms subsided by 6pm
Pt described being "unable to talk coherently", "difficulty walking", these s/s lasted 1 1/2 to 2 hrs fever, soreness of arm @ inject site; This report was recvd 21MAY91 when pt returned for 2nd Typhoid which was not administered;
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at Care Center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Treated for type B influenza despite having flu shot Sept 31/2020.  Treating redness all over since shot with benadryl watching food intake and vitamin intake. Worst break out lasting about 2.5 hours severe with shaking, sweating  nausea and discomfort, high blood pressure and dizziness.  Benadryl didn't seem to help within 30 mins.  Had rash still all evening on arms and face
1/25/21 10p chills 1/26/21 6a fever 101° 1/26/21 8a muscle aches 1/26/21 11a fatigue
After receiving the Men B vaccine patient became pale and passed out.  Patient woke up after about 20 sec in a panic asking for her mom.  Nurse brought in a CNP to check over the patient.  Patient was asked to lie down with her feet elevated and was given OJ with graham crackers.  After about 10 min the CNP rechecked the patient before sending them home.
low grade fevers, dry heaves, myalgias.  Patient treated with acetaminophen and IV fluids
Information has been received from a 68 year old male patient (also reported as female) reporting on himself. The patient's pertinent medical history was not informed. Concurrent conditions included anxiety. On 16-NOV-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), to prevent shingles. Concomitant therapies were not informed. On 16-NOV-2016, the patient experienced a little tingly feeling at the site of the injection and a minor headache. The outcome of tingly feeling at the site of the injection and a minor headache was unknown at the time of the report. The causal relationship between ZOSTAVAX and the events was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not allow to contact him or his physician.