chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a consumer who was a 68 years old male patient with amoxicillin allergy, coronary artery disease and medical history of knee surgery and dental surgery. The patient was vaccinated SC with a dose of ZOSTAVAX on 26-JUL-2012. No other co-suspects were reported. Concomitant medications included aspirin, multivitamins, fish oil, fosinopril sodium and lovastatin (manufacturer unknown). On 27-JUL-2012 the patient developed welts on his rib cage while on ZOSTAVAX. The patient stated that he previously took amoxicillin and developed hives. The patient did not seek medical attention. No treatment information was reported. Cholesterol test, blood panel, urine analysis and complete blood count were performed. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
18 year old female came to hospital for chest tightness, choking sensation in the throat as well as skin rash after receiving COVID-19 vaccine.  Initially patient presented to emergency room but subsequently discharged on steroid and Benadryl.  Patient had continued episode of choking as well as chest tightness and skin rash for that patient came back to emergency room.  Patient had received total 5 doses of epi pen because of that.  Patient was admitted to medical floor initially.  Patient was given steroid, Benadryl and famotidine.  Patient had 2 episodes on medical floor where she started feeling choking and chest tightness.  Patient remained stable hemodynamically except for tachycardia.  Patient was transferred to intensive care unit for close monitoring.  D-dimer was negative, urine tox screen was negative, COVID-19 PCR was negative, EKG showed sinus tachycardia.  CT scan of neck was negative.  We had discussed that patient has remained stable hemodynamically in the intensive care unit and discharge planning was discussed and patient was getting ready to be discharged when she had another episode where after drinking soda patient started having that choking sensation, patient remained stable hemodynamically during this episode as well.  Her symptoms had improved.  She looked visibly anxious.  Patient was monitored in the ICU for few more hours and patient remained stable.  I checked back on her and she was able to eat her lunch.  She probably had a allergic reaction to more than a vaccine but subsequent episodes are thought to be secondary to anxiety attack given situation.
Initial report received from a healthcare professional on 11 September 2013. A 32-year-old female patient had received an intramuscular dose of ADACEL vaccine (lot number U4655AA) in left deltoid on 11 September 2013. The patient was pregnant at the time of vaccination. Patient's last menstrual period date was 04 July 2013 and the estimated date of delivery was reported as "10 May 2004". Laboratory tests were not reported. The patient was healthy. Medical history and concomitant medications were not reported. The patient did not receive any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow-up received on 22-Oct-2013: estimated date of delivery was updated.
Red itchy rash appeared approximately one week after vaccination. Started as a couple inches in diameter, but his since spread down towards elbow. Approximate current size is 3 inches by 5 inches.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced off label use. On 02-SEP-2021, the patient experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
(1) Red swollen arm (2) Burning down left side of body (side given) for 2 days. (3) Headache & Body Aches for 2 days (4) Patient has MS but symptoms are now gone
Per Mom was fine till evening when he developed low grade temp. back and neck pain with a "stiff feeling", which continues today.  He is able to bring chin to chest without pain, no fever today.  Also has a sore throat but no trouble breathing.
Tachycardia  (Inappropriate tachycardia), low blood pressure, heart pain
2-16-20 Developed a faint erythematous maculopapular rash on trunk and temp 100.7 degrees, presented to ED. then found to by hypothermic to 96 twice. No ther symptoms except irritable. Admitted for observation 2-16-20 to 2-17-20. Sepsis work up negative, discharged home with normal temp.
Information has been received from a medical assistant concerning unspecified patients of unknown age gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, an unspecified number of patients were administered improperly stored doses of GARDASIL 9 (lot# and expiration date, strength, dose, frequency and route were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Shingles/rash/bites or something around mid section where shingles would normally appear. Link I found on line was for rare reaction in women.
Upon completion of giving MMR vaccine, pt developed a raised wheal the size of a 50 cent piece. Around area skin was red and hot to the touch.
Symptoms of red around the injection site and fatigued from Sunday night (6/9/19) until Tuesday morning (6/11/19). No treatment necessary.
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an approximately 71 year old female patient. Information regarding medical history, concurrent conditions, and concomitant medication use was not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2009 (patient was approximately 63 years old at this time), the patient was administered ZOSTAVAX by a pharmacist (lot # and route unknown). On or about 13-APR-2017 (patient was approximately 71 years old at this time), the patient was treated by a physician at a medical group for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Worse asthma, feeling breathless. Tingling arm still after 24 hrs. Hot  feeling spine. Severe migraine  headache. Heavy painful useless right arm. Heartburn
fatigue; headache; injection site soreness; overall body/joint/muscle pain; overall body/joint/muscle pain; nausea; overall body/joint/muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 06Apr2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 16Mar2021 at 14:00(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 04:00, the patient experienced fatigue, headache, injection site soreness(vaccination site pain), overall body, joint, muscle pain and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fatigue, headache, injection site soreness, overall body, joint, muscle pain and nausea was recovered on Apr2021.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2015US000663 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 65-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 14554P) at a dose of 0.5 ml intramuscularly on 06 Nov 2014. It was reported that the patient received FLUVIRIN which reached below 36 F for 3.5 non-consecutive days and the vaccine reached 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen and thought it was a thermometer mal-function. No adverse event reported following this medication error.
This report describes joint pain in a 67 year old female who received Lyme disease vaccine recombinant OspA(Lymerix) It was received from the vaccinee and has not been verified by a physician or other healthcare professional. Reportedly, the vaccinee had no relevant medical history, received no concurrent medications, and had no known allergies. She had no history of Lyme disease and did not have gout, psoriasis, or Crohn 's disease. There was no family history of rheumatoid arthritis or lupus. The vaccinee stated that in April 1999 and in May 1999 she received her first and second injections of Lymerix respectively w/out adverse event. the vaccinee stated that in May, 2000, she received her third injection of Lymerix. Starting in April, 2001. the vaccinee experienced muscular pain in her neck, upper arms and left shoulder which radiated to her right shoulder. She also experienced swelling in her hands. She stated that her symptoms were particularly severe in the morning and after resting or riding in a car. On 04/02/02, the patient awoke with left ankle swelling "The patient's symptoms were treated with a 5 week course of rofecoxib (vioxx) in fall 2001 and a 5 week course of celecoxib (Celebrex) in winter, 2002 with no relief. As of 04/03/02, the events persisted. The adverse events "joint pain" and "joint swelling" do not meet ICW serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Localized erythema and induration at site of injection L deltoid approx 8cm diameter.
1/2021=began having jerks and dropping things occasionally 4/2021(first week of april)= Took him to Pediatrician office about jerks/falling, diagnosed with PANDAS related to history of chronic strep infections (strep test was negative and he hadn't been positive in over a year at this point.) 4/11/2021= Emergency room visit related to falling multiple times (injuring his knees and mouth) in a short time frame of less than an hour and increased jerks. He was admitted and kept overnight for a EEG. Diagnosed with Juvenile Myclonic Epilepsy. Started on Keppra. 4/29/2021= First Tonic clonic seizure (missed pm dose and seizure the next AM) 6/19/2021=Second Tonic clonic seizure. ER trip related to injuries. Bilateral jaw fractures, busted chin, multiple broken teeth, and hit head. (Missed AM dose and had PM seizure) 6/26/2021= 3rd Tonic clonic seizure (no missed dose) Keppra doubled. 7/7/2021= 4th Tonic clonic seizure(no missed dose). Lamictal added in addition to Keppra. 7/19/2021= 5th Tonic clonic seizure (no missed dose) 7/23/2021= last dose of Lamictal medication, developed a rash, fever, nausea and vomiting 7/29/2021= 6th Tonic clonic seizure 8/11/2021= Depakote added in addition to Keppra
Information has been received from a physician concerning an 8 year old male who on 30-DEC-1999, when he was 15 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Recently," in April 2007 the patient developed a breakthrough of chickenpox with approximately 25 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from a physician who reported that on 15-APR-2007 the patient was seen in the physician's office and had developed a breakthrough of chickenpox. The patient had recovered from chickenpox after 1 week. No further information is expected.
Pt was administered first series of Ixairio B on 27 Aug 2010. Pt presented to Immunizations Clinic while on a temporary duty and recieved JE-Vax on 11/15/2010. Due to the mixing of vaccines, Vaccine help hotline was called who inturn called their on-call doctor. On-call doc will return our call after doing further research.
Localized swollen-ness.  Feels like a small ball at the vaccination area.  It was red in some small spots, almost if it was a rash.  It started the day after vaccination, but 2 days after, I called her and she reported an improvement.
Approximately 24 hours after booster vaccine injection, patient started experiencing severe chest pain on the left side directly over the heart muscle.  Patient saw primary care doctor 4 days after vaccine and an EKG was done.  EKG came back abnormal and patient was diagnosed with Pericarditis.  Patient was prescribed an anti-inflammatory (colchicine 0.6mg) to take 1x/day for 3 months and ibuprofen (600 mg) to take 3x/day for 1 month.  Patient saw cardiologist 10 days after vaccine and an EKG and echocardiogram were done.  EKG came back almost normal and echocardiogram was normal.  Patient still experiencing chest pain 3 weeks after vaccine.
Fever, chills, severely swollen arm, redness and heat and injection site, swollen lymp nodes, headache, sweating   All lasting more than 3 days
Sick; Tested positive for flu/Had the flu/Cold viruses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses). At the time of the report, ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.   Patient tested positive from the flu as cold viruses were in their home and had lot of problems in the family. Patient worked in the hospital and might have bought the flu home.    Treatment medications were not reported.   This case was linked to MOD-2022-596523, MOD-2022-596527, MOD-2022-596527, MOD-2022-596527 (Patient Link).
fatigue; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:15 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Mar2021 21:30, outcome "recovering", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 21:30, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional information: Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Confusion, Headache, Myalgia, exhaustion, pain at injection site, hot flashes Narrative:  Other Relevant History:
A serious spontaneous report of seizure-like-activity and fainting has been received from a health professional concerning a child, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. After receiving FLUMIST, the patient fainted and experienced seizure-like-activity lasting a few seconds. The seizure-like-activity was noted within five minutes of receiving FLUMIST. The outcome of the events of seizure-like-activity and fainting was unknown.
had a little bit of reaction at the injection site; has grown a great deal; real itchy; got swelling; redness about a foot long; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (had a little bit of reaction at the injection site), PRURITUS (has grown a great deal) and VACCINATION SITE ERYTHEMA (redness about a foot long) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (had a little bit of reaction at the injection site), PRURITUS (has grown a great deal) and VACCINATION SITE ERYTHEMA (redness about a foot long). At the time of the report, VACCINATION SITE REACTION (had a little bit of reaction at the injection site), PRURITUS (has grown a great deal) and VACCINATION SITE ERYTHEMA (redness about a foot long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
COVID-19 infection, mild-to-moderate.  Fully vaccinated.  There have been several cases of COVID in the unit where patient is hospitalized.  On room air  experienced symptom onset overnight with HA and other symptoms including cough.
11AUG95 began being cranky & began vomiting;11AUG95 had fever of 104.5-gave APAP & Tepid baths;had episodes of crying & screaming;cont off & on throughout the weekend;15AUG95 devel a rash on face & arms;
Fever, diffuse macular rash-7 days prior to devel of sx had MMR;
I had a CT scan to evaluate known kidney stones 12/20/21. In addition to stones, the scan revealed a 3.2 cm  "left adnexal lesion" which was diagnosed as an ovarian cyst on an ultrasound on 1/20/22. I can't imagine this is related to my booster shot, but I reported it and got a call requesting follow up of this, so I am dutifully reporting it.
This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included no adverse event. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 19, 2021, patient experienced paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness). At the time of the report, paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reporter did not allow further contact.
I started having epoxides of tinnitus and high-pitched sounds and now my hearing has changed. I hear high pitched sounds that are different than tinnitus. It sounds louder to me know then they use too. The actual sounds that I hear are louder now that they use to be.
Irregular heartbeat started that same evening after receiving the flu shot (10/12/16). Was taken to the ER 10/15/16 for irregular heartbeat and admitted. Released the next day. Irregular heartbeat has continued daily. Spent most of 10/20/16 in Urgent Care having more tests. Consulting cardiologist believes that I may have had a rare reaction to the antigen in the flu shot. Had appointment with different cardiologist on 10/31/16 (would not allow me to make appointment with consulting cardiologist the day in Urgent Care due to he is an EP cardiologist) but happened to be the one on call on 10/20/16). The cardiologist can see that I'm having PAC's (type of irregular heartbeat) daily due to heart monitor and placed me on a beta blocker to keep them more calm since occurring daily.
Morning after immunizations had fever of 102 degrees Fahrenheit felt nauseated, achy. Doctor visit - Dr felt signs and symptoms were related to vaccines. S/S lasted 3 - 4 days. Dr had ordered immunizations d/t scheduled spleenectomy and gall bladder removed at end of December 2009. Surgery was performed on schedule without incident.
Injection site pain, Fatigue, Chills, Nausea, Headache, Muscle pain, Malaise , I am currently in bed. I feel terrible., I took Tylenol and Ibuprofen.
ceased to left lower extremity neuropathy; pain in big toe; Grade 2 myalgia in Left lower extremity; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at the age of 43-year-old, dose 1 intramuscular, administered in Arm Left on 21Sep2021 10:30 (Batch/Lot Number: FF8839) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cervical cancer treatment 2010, low immune system, and known allergies: Iodine Contrast. There were no concomitant medications. On 21Sep2021 12:30, the patient experienced Grade 2 myalgia in Left lower extremity for 5 minutes, ceased to left lower extremity neuropathy with pain in big toe. No treatment was received. The outcome of event myalgia was recovered on 21Sep2021 12:35 while other events were not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "left lower extremity neuropathy" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Mild Intermittent Throbbing headache that started 45mn after shot. Subside the morning of the next day, but came back in the afternoon 5pm. It's been progressively worsen over the course of the week
mom called 16MAY94 stated that pt arm broke out w/red raised bumps around inject site of HIB; no fever or pain noted; area wa approxx size of 2 fifty cents pieces according to mom;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt recovered fully and was picked up by brother.
02/22/22 presents to ED for "hypoxia, hypotension as well as confusion". PMHx of "Alzheimer dementia"