chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Tdap booster vaccine and 1 hr later developed severe itching (L) arm & low back, dorsal torso, but no rash. Urticaria pruritus. Loratadine 10 mg once, diphenhydramine 25 mg once.
Verbalized hx of syncope with vaccines. Vaccines administered with pt in semifowlers position. After 15 minutes, pt attempted to sit up. Became dizzy and lost consciousness for 30-60 seconds. Fell off treatment table. Diaphoretic. Slurred speech. Confused.
Altered mental status and generalized weakness. Chronically ill appearing, rhonchi at bases bilateral. From nursing home.
Patient received vaccine without incident & was instructed to sit in the waiting area for observation. 7 mins after her vaccine, pharmacy  technician alerted me, Provider  that Patient was pale and slumped over in her chair. Patient fainted and fell into rn arms and I called 911. EMS arrived about 15 mins after the call and assessed patient vitals. They found her BP to be low and recommended that she be taken to the hospital for observation. patient refused to be taken and signed a waiver.
The worst started four hours after the vaccine and lasted ten hours, then I slept awhile, and the next day it was still effecting me but to a lesser degree and by the following day no symptoms. My first dose knocked me out for three days (chills, tired, headaches) the second dose was four days of the same.  This booster although over much quicker, it's was a little scary, and touch and go that first night not knowing if my breathing was going to be effected since it was my arm was swollen, and felt it in my neck and in my eye on that side. I feel it's important to be vaccinated being in healthcare, but I'm concerned about the next one. Perhaps an alternative vaccine, or something I can do on my end, or think about retirement.
tingling in her mouth; tingling throughout her whole body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in her mouth) and PARAESTHESIA (tingling throughout her whole body) 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.    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 PARAESTHESIA ORAL (tingling in her mouth) and PARAESTHESIA (tingling throughout her whole body). At the time of the report, PARAESTHESIA ORAL (tingling in her mouth) and PARAESTHESIA (tingling throughout her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
head to toe rash x 5 weeks head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (hospitalization), outcome "unknown", described as "head to toe rash x 5 weeks head to toe". The event "head to toe rash x 5 weeks head to toe" required emergency room visit. Additional information: Patient was having a head to toe rash x 5 weeks. Reporter has talked to a few friends who possibly have had rashes associated with the Pfizer Covid vaccine. He also was seen in a hospital ER and the doctor suggested the possibility. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
my resting heart rate has also elevated; Serious pain in my arm; high sensitivity in hands; Vision a bit off; Fatigued; Unable to do anything; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work. On an unknown date, the outcome of the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work were unknown.   It was unknown if the reporter considered the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix on sunday 17th November 2019 and till the time of reporting still had side effects. After vaccination, the patient had serious pain in arm and high sensitivity in hands. The patient washed the hands with cold water and felt the coldness more pronounced. The patient's vision was bit off and was very fatigue. The patient asked, was this typical 4 days later. The patient stated that, was in great shape and work out daily including running. After vaccination, the patient had been completely unable to do anything. The patient asked that, the heart rate was elevated, was that common due to pain or injection or both.
My scapular region was in pain almost every night. I would come home in pain after work every night. On 5/14/2013 I received my second dose. On June 16, I admitted myself to the emergency room. After many tests and many doctors I have finally been diagnosed. I spent a week at a facility. They did an array of tests to rule out the final diagnosis of vaccine induced brachial plexopathy. On July 25th, 2013 it was the official diagnosis from Dr. post vaccination-induced brachial plexopathy.
Immune issues; Cerebral palsy; Down syndrome; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (disability), outcome "unknown", described as "Immune issues"; CEREBRAL PALSY (medically significant), outcome "unknown"; TRISOMY 21 (disability), outcome "unknown", described as "Down syndrome". Therapeutic measures were taken as a result of cerebral palsy, trisomy 21. Additional information: the patient's mother called in on behalf of the patient seeking assistance with the Pfizer-BioNTech COVID-19 Vaccine. During the call caller stated." He's disabled and has a bunch of immune issues.. He's 28 he has down syndrome and cerebral palsy.. He's in a wheel chair.. and he has a bunch of different health conditions."  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided,a causal association between reported events and suspect BNT162B2 cannot be excluded. This 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 identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swollen lymph node under left armpit; Swollen lymph node under left armpit causing soreness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 18Jul2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 27Jun2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Jul2021 at 04:00, the patient experienced swollen lymph node under left armpit which caused soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node under left armpit which caused soreness was unknown at the time of this report.
Information has been received from a nurse concerning a 11 year old female who in November 2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) IM. Since November 2007, the patient had not gotten her period until recently after receiving her third dose of GARDASIL vaccine (yeast) in May of 2008. The date of the second vaccination was not provided. the patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 17-NOV-2011, patient received improperly stored VARIVAX dose 1, from batch/lot # 669601/0138AA ( expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt with fever, morbilliforem rash, cervical adenopathy 1/26/02.
Red spots at injection site, tingling and numbness and splotchy rash. Pt. was told to use ice in area at HS.
This spontaneous report as received from a nurse refers to a curently3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004451: US-009507513-1712USA012873: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878.
Vision disturbances occurred directly after the Gardasil vaccine, followed by a seizure one minute after vaccination.
p/vax pt devel fever of 39.1C w/shaking chills & an inj site rxn characterized by a swelling, redness, tenderness & warmth;tx w/DPH & APAP;
Swelling, Redness, tenderness and pain at site of injection beginning 4 hours after injection of Tdap. Resolving without treatment when seen 5 days later. Also had low grade fever and fatigue day after injection.
Onset within 24 hours of erythema, edema, tenderness at vaccine site with discoloration at injection area (black/blue circle with clustered erythematous macules) surrounded by 3x2 inch circular area of erythema and warmth. Plan to trial Motrin, elevation, and Claritin with referral to an allergist and close monitoring of symptoms.
onset optic neuritis rt eye approx 2wk post vax;visual acuity deteriorate to hand motion now improving on systemic steroids;
Pt recvd vax NOV92 & 22NOV92 pt devel pain in arm, knots in lower forearm & rt-sided abdo pain; No further details were provided;
Crazy headaches a lot of body aches and pain all over the body and fatigue nausea a lil bit of diarrhea and it lasted a day and half. Around the vaccination site was very swollen and super achy and it went away after couple of weeks.
No ADR, timing ERROR 2nd dose given 45 days after 1st dose  Narrative: No ADR, timing ERROR, 2nd dose given 45 days after 1st one
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Opioids (rash)), Drug allergy (Tamiflu) and Controlled hypertension (High Blood Pressure (controlled). No change reported; controlled.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient experienced Shortness of breath over a year ago with unknown start date. It was reported that patient concomitant medications include Unknown medications and Same medications for a long time. No treatment medications were provided.   This case was linked to MOD-2022-560263, MOD-2022-560264 (Patient Link).
Have not menstruated since getting the vaccine. Missed period 5/2/21, have not gotten since. No bleeding/spotting.  No PMS symptoms indicating I will get my period anytime soon. Almost 2 months now without period.
Sore arm, body aches, fever, chills, tiredness, headache - second dose (took acetaminophen, slept, resolved 24-36 hours after injection) Sore arm, headache, tiredness - first dose (no treatment, resolved in 24-36 hours after injection)
Had DTAP 9/27/07 - pos pertussis 9/13/10.
5 year old received DTaP on 9/23/02, began with redness on 9/24/02. Now mild swelling and tender; no fever.
pt had been in a facility and experiencing HTN and electrolyte abnormalities; began to experience hallucinations; SpO2 was in the 60s% despite O2 supplementation at 7LPM via FM; pt had a positive COVID test on 2/7/22; DNR; transitioned to comfort care with a hospice referral; pt expired in hospice
In the early morning hours following my vaccine, I woke up with an extremely high temperature which lingered for two days. The highest I believe it got was 104 degrees Fahrenheit. I also experienced a very weak bladder, deep painful muscle aches all over my body, shivering and chills, nausea and a bad headache. My injection arm was hot, sore and very painful. After 48 hours and regular doses of ibuprofen, my fever came down to 100 where it stayed between 99 and 100 for the following 24 hours. The muscle aches slowly subsided. My injection arm continued to be very sore and tender and feels inflamed and hot. Today, five days following the injection, my arm is still very sore, hard and hot.
Runny nose; fever of 101.5; Swollen glands on both sides of throat; Fatigued; 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 RHINORRHOEA (Runny nose), PYREXIA (fever of 101.5), LYMPHADENOPATHY (Swollen glands on both sides of throat) and FATIGUE (Fatigued) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), PYREXIA (fever of 101.5), LYMPHADENOPATHY (Swollen glands on both sides of throat) and FATIGUE (Fatigued). At the time of the report, RHINORRHOEA (Runny nose), PYREXIA (fever of 101.5), LYMPHADENOPATHY (Swollen glands on both sides of throat) and FATIGUE (Fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) Fever of 101.5.         Concomitant medications were not reported by reporter.  Treatment information was not provided by reporter   Reporter did not allow further contact
Administered 1.0 mL instead of 0.5 mL for vaccination dose
Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with the first "standard" dose of GARDASIL, and the second "standard" dose of GARDASIL on 28-FEB-2011. The patient was tested positive for high risk Human papilloma virus (HPV). The patient went into the office on an unspecified date for a colposcopy and sought medical attention. The result of colposcopy was unspecified. The patient was not given treatment. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
diffuse redness, erythema & swelling of entire upper arm (where shot given); no local adenopathy, no antibiotics used-cleared;
progressive decreased motor skills LE >> VE Dxd - " transverse myelitis".  7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. Assessment: Transverse myelitis, constipation, mild anemia, left empty scrotum or cryptorchism. Patient presented with bilateral lower extremity weakness. More fussy than usual, waking up during the night, not rolling over, fell over from sitting position, will not bear weight and 'crumble' to the ground. No movement lower extremities. PO intake decreased. 4-5 wet diapers. 1 small hard bowel movement last 24 hours. Patellar and Achilles reflexes 3+/5 bilaterally. Ankle clonus. Limited hand extension and weaker pincer on right. Truncal weakness. 7/22/09-ICD-9 code 341.20
Body aches, tiredness, nausea for 24hrs after injection. General tiredness and slightly sore throat for 5 days after injection
Severe local reaction to injection. As per acknowlegdement letter: Vaccine given in ED, we do not have access o this information.
Fever; Body ache; Headache; He just did not feel good; Chills; This is a spontaneous report from a contactable Consumer (Reporter's husband). A male patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on 11Aug2021, as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 on Dec2020. The patient's concomitant medications were not reported. On an unspecified date Aug2021, the patient experienced Fever, Body ache, Headache, He just did not feel good, and Chills. On an unspecified date Dec2020, the patient underwent lab tests and procedures which included Covid-19 test: Positive. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
difficulty breathing; chest tightness; feeling itchy with some chest tightness; O2 sat 70%; not feeling well; This is a spontaneous report from a contactable Nurse. A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6202), via intramuscular route of administration at arm right on 27Feb2021 14:45 (02:45 PM) (at the age of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included allergies to penicillin, iodine contrast, cephalosporins. The patient concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. It was unknown whether the patient was tested for covid post vaccination. Patient did not receive other medications in two weeks. The patient experienced difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well on 27Feb2021 14:45 (02:45 PM). Adverse event: after vaccine administration patient ambulated to the 15 minute hold location, during that time patient began to close eyes and reported not feeling well, patient husband was with her and notified staff, patient taken to private location and evaluated by nursing staff, patient barely able to state name, reported chest tightness, difficulty breathing, heart rate was 88, O2 sat 70%, administered one dose of epinephrine and administered 10L of O2 vis facemask, vital signs obtained and EMS services contacted, patient able to state name and location, reported feeling itchy with some chest tightness, continued to montior vitals until EMS services arrived. AE resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate was 88, O2 sat was 70% on 27Feb2021. The patient received epinephrine as a treatment medication and patient taken to ER (emergency room) for further evaluation for the events difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of dyspnea and other. The case will be reassessed once new information is available. 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 identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
UNABLE TO ACHIEVE OR MAINTAIN AN ERECTION; FEMINIZATION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S)(suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient was unable to achieve or maintain an erection as well as feminization (making him 5'3" and giving him small hands). The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the unable to achieve or maintain an erection and feminization was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 11-MAR-2021. Upon review, the following information was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for batch no.; Sender's Comments: v1: Version created to amend outcome in narrative. 20210324270-Covid-19 vaccine ad26.cov2.s-Erectile dysfunction. 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.
Severe case of shingles on right abdomen from spine to navel diagnosed 6/1/21. Antiviral and prednisone prescribed and completed. Could not take hydrocodone prescribed for pain.  Rash, blisters and scabs lasted 6 weeks, still have painful post herpetic neuropathy. No treatment for that.