chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152039 Same reporter/patient, different product/AE.;
GOT SHOT LONGER THAN 10 MONTHS AGO; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 19th November 2021).   On an unknown date, the patient did not  receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-September-2022 Reporter's comment:  The pharmacist stated that patient did not received the 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses GARDASIL (lot # K011562 and expiry date: 08-APR-2017). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
PATIENT HAD DEVELOPED PAIN AT THE INJECTION SITE. PATIENT STATED SHE DEVELOPED A LUMP THE SIDE OF A TENNIS BALL THAT WAS RED AND WARM TO TOUCH. SHE SOON DEVELOPED DIARRHEA AND DID NOT FEEL GOOD FOR THE NEXT COUPLE OF DAYS.
on February 2, 2021 I had my second shot I felt really good but the following day  I was so fatigued I had to sit down after one block just to be able to continue to my destination I felt this way all day so I am staying home today which is February 4 I didn?t want to come to work and turn around and have to go home. Mostly just fatigue, and her head felt strange. F
DEEP VEIN THROMBOSIS; NON-ST-ELEVATION MYOCARDIAL INFARCTION.; This spontaneous report received from a patient concerned a 63 year white (Not Hispanic or Latino) old female. The patient's height, and weight were not reported. The patient's past medical history included coronary artery bypass grafting (CABG), and concurrent conditions included chronic coronary artery disease (CAD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total dose administered on 23-APR-2021 for prophylactic vaccination in right arm. Concomitant medications included valsartan for unknown indication.  On 30-APR-2021, the patient developed deep vein thrombosis and was admitted in the hospital. On APR-2021, she also had developed possible non-ST-elevation myocardial infarction (NSTEMI). She was prescribed with ticagrelor (Brillinta) 60 bid and acetylsalicylic acid (Aspirin)  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from deep vein thrombosis on 30-APR-2021, and the outcome of non-st-elevation myocardial infarction. was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210502029-covid-19 vaccine ad26.cov2.s- Deep vein thrombosis  - This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0- 20210502029-covid-19 vaccine ad26.cov2.s- Non-ST-elevation myocardial infarction-. This event(s) is considered not related. 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: MEDICAL HISTORY - chronic coronary artery disease (CAD)
Flu shot. I do not know what type flu, lot #, or exact date and time. Continual arm pain at injection site from day of injection continuing for 3 months now. Getting worse instead of better. Interfering with sleep.
convuls on the same day p/vax w/DTAP, OPV, MMR, varicella dec admitted to hosp;
1st Dose: Sore and dry throat Narrative:  1st Dose: Sore and dry throat
This spontaneous report has been received from a 62 year old female company representative who was also a patient and reporting on herself. The patient's concomitant therapies included estrogens (unspecified), levothyroxine sodium (SYNTHROID), iron (unspecified) and vitamin b (unspecified). There was no information about the patient's concurrent conditions or medical history provided. The patient did not have any known drug reactions or allergies. In April 2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque forming units) subcutaneously (dose, lot # and expiration date were not reported) reconstituted with sterile diluent (DILUENT MRK) (dose,lot # and expiration date were not reported). On 10-MAY-2017, the patient had root canal. On 11-MAY-2017, the patient started breaking out into what she called one of the worst cases of shingles that she had ever seen. The patient reported that at first she had discomfort, but the pain kept getting worse. The patient also reported secondary inflammation from the shingles outbreak (onset date in May 2017). The patient started self treating the shingles outbreak with lidocaine cream and unspecified ibuprofen. On 15-MAY-2017, she visited the physician assistant and was diagnosed with shingles and was treated with unspecified tramadol three times daily and unspecified valacyclovir hydrochloride (VALTREX) in addition to the lidodocaine and ibuprofen. There were no lab diagnostic studies performed. No product quality complaint was involved. The outcome of the events of shingles and secondary inflammation was not recovered (reported as awful and the patient was in pain as of the time of this report). The relatedness between the events and ZOSTAVAX was not reported. The reporter considered the events of shingles and secondary inflammation as disabling. Additional information has been requested.
Pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History was provided by Reporter.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 22-Mar-2021, PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatments details was not provided. The primary healthcare professional advised the patient to take acetaminophen prior to second dose.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added TCR, NNI
I had no history of left shoulder pain prior to vaccinaton. Within 24 hours of vaccine administration, I had extreme pain and nearly complete immobility of left arm. Within one week, there was improvement, but still significant pain and immobility. After 6 months of treatment, including steroid injections to the shoulder and physical therapy, there is some additional improvement, but still a significant pain and loss of function of the left arm and shoulder. I am continuing with physical therapy.
Left arm soreness day 2 day 4 swelling at site, day 5/6 red round patch itchiness still slightly sore
Pt experienced numbness and partial loss of function of lower extremities approx. two weeks following fluvax. Initially a diagnosis of Guillaine Barr syndrome was made. The pt was given IV and initially improved, but then worsened to the point he was a complete paraplegie. MRI, CT scan was suggestive of spinal tumor and fracture. Also states that he had a history of hypertension, left cva and a fib. Pt was see by his PCP on 11/1 and had no complaints of weakness or any neuro sxs. He was given flu vaccination on review of electronic notes. Pt states couple days after that appt (15-18 days) back he noted he was stumbling and getting weaker in his le. He also noted some numbness in his both feet. He continued to ambulate until last week when he had to start using wheel chair due to progressive LE weakness and truncal weakness with inability to support himself. He had several falls in the past week and came to see his PCP on 11/13 for evaluation of his LE weakness. A lumber ct spine was ordered and pt returned yesterday for the follow up. He was noted to be even weaker in his LE with complete inability to get up and transfer himself as he could even two days back. Pt's provider was advised to admit him to medicine for further work up and monitoring. Pt states his weakness has not progressed any further in the past 24 hrs since the admission. He denies any UE weakness, facial weakness, dysphagia, blurred or double vision or any breathing difficulties. NO speech impairment, dizziness, palpitations. He does report numbness in his feet and some paresthesia around his trunk and no complaints of bladder bowel impairment or incontinence.
Six hours of projectile vomiting, uncontrollable chills, excruciating headache, muscle and joint pain primarily in lower extremities, fever, fatigue. It has now been 24 hours since the injection and I am still experiencing extreme head pain, muscle fatigue and weakness, nausea an extreme headache
The pt experienced nausea, and headache upon waking the following morning after Anthrax shot.
w/in 24hr of vax pt devel an inj site rxn characterized by swelling, redness, induration & warmth;pt exp muscle aches from shoulder to elbow & had stiff bending elbow & rotating shoulder;pt recovered p/5 days;this is 1 of 5 pt w/this rxn;
Starting on Thurs. April 29th @ 4:50am I had aches all over body, headache, a slight fever 98.7 (normal is 97.3), diarrhea and nauseousness. I slept off and on throughout the day as my energy level was quite low. These symptoms continued throughout the day and into the evening. at 4:50am I began taking 2 Tylenol every 6 hours.   Fri. April 30th my temperature had returned to normal and my aches and pains had to diminished slightly however I still had some diarrhea and nauseousness and my headache was constant. I continued taking Tylenol every 6 hours. My energy level was a little better but not at 100% more like 65%.  Sat. May 1st my temperature is normal and I have very few aches and pains however I still have diarrhea, some nauseousness and a constant headache. I didn't take any Tylenol however my headache was too much so I took 2  Tylenol at 2pm EDT. My energy level is at 85% today.  I am not too sure if my continued  diarrhea, some nauseousness and a constant headache are side effects from my Wed. April 28th 2nd Pfizer vaccine shot. If my diarrhea, some nauseousness and a constant headache continue throughout the weekend I need to talk to a medical profession on what I should do.
Patient came to the health department on 8/18/23 for the first in a series of 2 for his M-Pox vaccination. On 8/19/23 he stated that his left lymph node or gland was swollen to the touch and his abdomen was swollen and sensitive with diarrhea. These symptoms lasted approximately 2-3 weeks. The patient called the health department on 9/18/23 to report these events.
Shot #1-about 2-3 hours after shot became extremely tired and had a headache. 4-5 hours after the shot chest tightness (like asthma attack coming on) lasted about 4 hours.  Tiredness and headache lasted approx. 48 hours. no treatment just rest.  Shot #2-nausious feeling about 5 mins after shot.  Headache started in middle of the night (woke me out of sleep) 29 hours after shout was tired, still nausious (couldn't eat)   and still have headache. no treatment just rest. (just had 2nd shot 29 hours ago.)
Body aches, vomiting, no appetite, 102 degree fever, swollen and red arm where injections made for over 36 hours.
Patient called 7/23/12 to report small oblong red irritating spot on left side of mid back (about 2"). Pt contacted doctor and was diagnosed with shingles.
Patient received FLUCELVAX and PREVNAR 13 at the same time, and about 5 minutes after the second vaccine the patient experienced extreme sweating, paleness, nausea, light-headedness, dizziness and feeling "yucky" as she described it.
1st ever flu shot given 12/16/03 then ITP diagnosed 1/2/04 had noticed easy bruising for about 3-4 wks around the time flu shot given.
Moderna COVID-19 Vaccine EUA Symptoms: Fever, Chills, Body ache, Headache Greatly diminished after 12 hours
Large red splotch on my arm below the injection site; Below the injection site that is a bit swollen; Below the injection site that is a bit warm; Moderate pain; This case was reported by a consumer and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced red blotches, local swelling, skin warm and pain. On an unknown date, the outcome of the red blotches was not recovered/not resolved and the outcome of the local swelling and skin warm were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the red blotches, local swelling, skin warm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shangrix and stated everything seemed to go as expected. The patient developed a large red splotch on arm below the injection site and was a bit swollen and warm.  The patient stated that, one could understand if it was on the injection site but it was not. The splotch was at 2 to 3 inches below the injection site and went from being the size of a quarter to about 3 inches in diameter at the time of reporting. The patient also stated, most of the moderate pain had receded but splotch was same.
The injection went fine, and I waited a half hour. I have had anaphylaxis before. I felt a little itchy about an hour later. After 5PM I started to have a headache, muscles aches, flu-ish symptoms. Some nausea but no vomiting. I just rested and that lasted pretty much through Saturday and Sunday. I just stayed in bed. Then Monday it was similar, but it started improving, I had been taking Benadryl that whole time but on Monday I reduced to half a dose and then I went to sleep feeling reasonably ok and then woke up at 07:00AM on Tuesday April 27 I woke up and throat was swelling. I was very disoriented and very dizzy, I felt bad and horrible. I got up and went to the bathroom and visually saw how swollen and bad it was. I then called the doctor's office and spoke to another provider who wasn't familiar with me and advised me to come in. I was getting ready to go but I felt like wet towels were around my throat I could feel it squeezing. I got in the car to go to my doctor's office and in the car, I told my husband "No this is a mistake I need more urgent care than this". My husband took me into the urgent care where they monitored my vitals and symptoms and dialed 911. They told me to wait for the EpiPen and the EMT also told me to wait. When I got to the ER I was also told to wait. I waited about an hour before they administered EpiPen, IV Benadryl and steroids. It improved quickly, and I was in the ER about 8 hours, and they kept me hydrated and let me go home that day. The time between the shot to the time I got in the ambulance I had not been exposed to or touched anything else. I was just in my house. I was unwell for a few weeks but no lasting harm.
4 DAYS AFTER INJECT OF ENGERIX-B, PT EXP SWOLLEN PHARYNX LEFT SIDE, TROUBLE SWALLOWING, SORE THROAT AND AN ALLERGIC REACTION. TREATED AMOXICILLIN AND HISMANAL. 2 DAYS AFTER TREATMENT, SYMPTOMS RESOLVED.
Constant pain in the neck, diagnosed as arthritic after MRI in 2004 showed nothing related to trauma, treatment still ongoing, as traction only temporarily relieves pain, issued a cervical device to provide self administered traction for use during periods of no health care coverage. Prescribed Celebrex to lessen the pain, however due to inadequate medical care, after release from active duty, could not afford to continue regimen. Inability to focus on tasks within a few days of the initial series, and spouse noticed almost immediately a marked loss of short term memory continuing to the present.  No treatment.
We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1718 and MA2009-1720 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
Short of breath. Chest pain and tightness, fatigued heart beating fast and hard, headache, dizzy and  lightheaded , developed cough, major shortness of breath, with any simple activity
Arm pain at injection site with 1st injection.  Headache, chills, fatigue, low grade fever and arm pain with 2he injection.  Treated with acetaminophen with good results.  Symptoms lasted approximately 24 hours.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Vomiting-Medium
Information has been received from a NP concerning a pt (age and gender not reported) who had an "MMRII titer drawn which was reported as low". The pt was vaccinated with a booster dose of MMRII (Lot # not reported). Subsequently, the pt had the "MMRII titer redrawn and it was still low".  The NP also reported that another pt had an adverse event following vaccination with MMRII (WAES # 0305USA00049) and another pt had a low titer after receiving the MMRII (WAES # 0305USA00716).  Additional information has been requested.
About 5 minutes after 2nd Varicella vaccine patient developed a firm lump with some assoc. redness and itching. No warmth or tenderness noted.
Pt recvd Hep B vax 12DEC91 c/o muscle aches x 24 hrs; recvd #2 Hep B vax 16JAN92 & c/o h/a, stomach cramps, weakness, sleeplessness, nausea & sore throat 17JAN92 & lasting through 26JAN92; pt seen by MD 24JAN92 on ATB as fever & congestion;
At approximately 1:00am the patient woke up with severe deep radiating pain in her left shoulder radiating to the entire arm and neck. The severity lasted approximately 5 days. She was unable to lift or move her left arm without severe pain. On date of this report 10/20/2017, recovery is at approximately 70% according to the patient.
Swollen lymph node under right armpit; common cold; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 28Sep2021 16:00 (Lot number: FF2588) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression", start date: 2007 (ongoing); "anxiety", start date: 2007 (ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety, start date: 2007 (ongoing); SPIRONOLACTONE taken for acne, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: 11.00, Anatomical site: R Deltoid, Route of administration: Intramuscular, Batch/lot number: 3248), administration date: 25Jan2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, Time: 15.30, Anatomical site: R Deltoid, Route of administration: Intramuscular, Batch/lot no: 9266), administration date: 15Feb2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "Swollen lymph node under right armpit"; NASOPHARYNGITIS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "common cold". Therapeutic measures were not taken as a result of lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Marked swelling, pain and redness at right thigh. Fever. Tx: Prednisone and soaks.
Sore throat, both arms hurt, sweating, body aches, fatigue. Pt states Saturday afternoon felt a little better & by Sunday was OK.
Per Nurse report approximately 2 mins after vaccine client complained of nausea, vomiting and diaphoresis. NP and EMT called for evaluation, Iniital  vital signs  103/59 Pulse 85 and 02sat 99%, repeat VS 104/61, Pulse 88 and 02sat 100%.  client left observation at 1:17pm denies any SOB, did report felt nervous initially and did not eat well this am. left site without incident
Mild version of measles/rubella, fever, malaise, body aches rash torso and URI sx's L/A
Vesicles distal to injection site where ProQuad (VZV/MMR) given arm red and swollen 8 x 11cm area - whelps - scratched - allergic reaction to VZV. Most of swelling and heat distal to injection site.
WE WERE MISINFORMED BY THE HEALTH DEPARTMENT REP THAT WE CAN ADMINISTER THE MODERNA VACCINE TO ANYONE YOUNGER THAN 18 YEARS AND WE GAVE THIS 15 YR OLD PATIENT THE MODERNA VACCINE.  HE IS DUE FOR THE SECOND DOSAGE, BUT WE WANTED TO KNOW WHAT SHOULD BE DONE? THE PATIENT HAS HAD NO REACTION TO THE VACCINE.