chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site is about 1/8 inch in size and is all red/Injection site is starting to turn red; the patient can't walk or talk or communicate with him; the patient can't walk or talk or communicate with him; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 12Mar2021 13:00 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 70 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Stroke", start date: 2017 (unspecified if ongoing), notes: had 4 strokes about 4 years ago; "Grand mal seizure", start date: 2017 (unspecified if ongoing), notes: 9-10 grand mal seizures; began the same time when she had strokes; not had a seizure for over a year; "Diabetes" (ongoing), notes: diagnosed with diabetes at least 20 years ago; monitors the patient's blood sugar four times per day; "High cholesterol" (ongoing), notes: diagnosed with high cholesterol probably also more than 20 years ago; "Acid reflux" (ongoing), notes: diagnosed with acid reflux more than 20 years ago; "Hiatal hernia" (ongoing), notes: diagnosed with around the same time she was diagnosed with acid reflux more than 20 years ago. Concomitant medication(s) included: BABY ASPIRIN taken for blood cholesterol increased (ongoing); BASAGLAR taken for diabetes mellitus (ongoing); NOVOLOG taken for diabetes mellitus (ongoing); METOPROLOL (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); VALPROIC ACID taken for seizure, start date: 2017 (ongoing); PHENYTOIN taken for seizure, start date: 2017 (ongoing); LISINOPRIL taken for gastrooesophageal reflux disease, start date: 2018 (ongoing). Past drug history included: Losartan. Vaccination history included: Smallpox injection. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 18Mar2021, outcome "unknown", described as "injection site is about 1/8 inch in size and is all red/Injection site is starting to turn red"; GAIT INABILITY (non-serious), SPEECH DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "the patient can't walk or talk or communicate with him". Additional information: The patient weighed "130" about a year ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. BNT162B2 was injected right below where the patient received a smallpox injection. The patient started taking Baby Aspirin, Basaglar, Novolog, Metoprolol, and Atorvastatin more than 10 years ago. The events did not result in an emergency room visit. The patient was scheduled to be brought to the doctor on 19Mar2021 due to redness at injection site.  No follow-up attempts are possible. No further information is expected.
Tested positive for COVID 19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID 19 after 1st dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID 19 after 1st dose). On 06-Apr-2021, COVID-19 (Tested positive for COVID 19 after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: (Positive) Covid-19 tested positive. On 06-Apr-2021, SARS-CoV-2 test: (Negative) Covid-19 tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.No treatment information was provided.
pt exposed to sibling w/herpes zoster who in 10/97 recv 1st dose varivax  & in 4/98 pt devel ``a few vesicles' addl info recv mom rpt to ofc pt had broken out w/chickenpox
@ 1PM on day of vax t102, vomited x 3; that evening fever 102-103 given APAP; PC to ER 2OCT fever, fussy all day, high pitched screaming; 3OCT AM PC to MD advised to see MD; t105 took to ER & told vax rxn to inc APAP dose;
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, strength and injection site were not reported) subcutaneous. On an unknown date the patient experienced shingles. The patient transmitted shingles to his wife after he received ZOSTAVAX. The outcome and action taken was not provided. This is one of several reports received from the same source with Patient/Partner link to case 1308USA008550. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. An 89-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration in the arm on 21Jan2015. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2015 the patient experienced a lot of redness in the area and a large portion of the upper arm was red. The patient was still experienced the reported events at the time of this report. Causality assessment was not provided.
Redness in left posterior upper arm measuring 8 x 5 cm, soreness, itching, warm to touch, aching in left elbow.
Papular, erythematous rash on both thighs, worse on (R) rash very itchy.
Patient described feeling "cloudy". The "cloudy" feeling improved after 15 minutes and then a headache developed. Event occurred during 15 minute observation period and patient has transportation alternatives available (if needed).
She developed signs of a CVA on or about May 6 following her vaccination series.   In the hospital she was found to have a Cerebral Venous sinus thrombosis.  She underwent intralumenal clot removal and was put on anti-coagulants.  Her post operative course was complicated by further intracranial bleeding or clotting depending on how her coagulation status went.  She slowly succumbed to these and was put on hospice after a week and sent home and passed away soon after.
red blotchy skin over DTP inject site then p/receiving MMR developed raised wheal 5cm red 10 cm area; DPH given 930AM p/examined pt BP 80/60 P90 R28 clear lungs;  arm still has swelling;
Pfizer-BioNTech COVID-19 Vaccine EUA Pt received 1st dose vaccine 2/17/2021, 2nd dose vaccine 3/10/2021.  Had been on warfarin since 2015, unclear if pt had been taking atorvastatin (last refill was 2019 according to Dr, Adult Primary Care clinic). Pt was last seen normal by his wife at approximately 1030am, out in the yard.  She went out at approximately 1130 am and found him down on the ground.  Pt was brought in by paramedic to ER.   IN ER, score =22, aphasic, R hemiplegic, CT scan of head showed large parenchymal hematoma in L basal ganglia with small SAH plus 2 mm L to F subfalcine midline shift.    Pt was intubated in ER for airway protection after an episode of vomiting. In ER, pt was given - Vitamin K 10 mg IV x1, Levetiracetam 1500 mg IV x1, Nicardipine infusion, 4-factor PCC (KCentra) 3500 unitsx1, Sodium chloride 3% infusion, pantoprazole 40 mg IV x1, Ondansetron 4 mg IVx1.  After intubation, pt also received propofol infusion, and admitted to CCU.   3/15 Repeat CT head showed expansion of hematoma associated with midline shift. 3/16-3/17 transfer to hospital was arranged, pt remained unresponsive. 3/18-3/19 comfort care
Client  had  first dose of Moderna at 3:16pm.  At 3:20pm client alerted observation area nurse that she felt a strange feeling on her lips PHN was alerted and at 3:21pm client reports mouth and tongue "feel weird" and that she has a history of high blood pressure and COPD and takes Lisinopril and spirivia and albuterol.  Client reports feeling tongue swelling up. Take vitals blood pressure: 200/102, pulse: 94 and oxygen: 98%. PHN called 911 at 3:23pm.  Vitals taken again at 3:29pm blood pressure: 185/90, pulse:97 and oxygen:97%. Fire arrived at 3:31pm to assume care. At 3:40pm client left facility on a gurney.
mom states pt hwas sore rt arm, unable to elevate above chest area; also reddened & swollen in rt arm pit area; was seen by MD instructed to take childrens Advil for pain;
itchy red spot on arm; itchy rash spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy red spot on arm) and RASH PRURITIC (itchy rash spot on arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. not provided and not provided) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (itchy rash spot on arm). On 03-Mar-2021, the patient experienced RASH PRURITIC (itchy red spot on arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy red spot on arm) and RASH PRURITIC (itchy rash spot on arm) outcome was unknown.            No concomitant medications provided  Treatment medicine include Benadryl  Action taken with mRNA-1273 in response to the event was not applicable.
PATIENT PRESENTED TODAY 67/1/19 WITH A LITTLE RASH IN HER RIGHT ARM, ACCORDING TO HER STARTED YESTERDAY. NO SWELLING, NO ITCHING
My husband has a severe rash all over his body. It's mainly in his hair, neck, shoulder, back, and legs. He is constantly scratching. That's his biggest compliant. He is tired a lot. Heart pounding and racing. He gets dizzy. He's lost weight (30 lbs).  It's getting worse.
On the 26th of November I had a little of a cough.  I went on the 28th of November that I went and had a tooth pulled.  That evening I heard from my daughter that they had tested positive.  My husband and I both went to the doctor on the 29th of November and tested positive. My doctor prescribed Paxlovid.  It felt like a head cold bronchitis cough.
some reactions; 98-99 range by 6 o'clock; woke up Saturday morning not feeling so good; body aches most of the day; 102 degrees; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up Saturday morning not feeling so good), INJECTION SITE REACTION (some reactions), PYREXIA (98-99 range by 6 o'clock), PYREXIA (102 degrees) and MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced PYREXIA (102 degrees) and MYALGIA (body aches). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (woke up Saturday morning not feeling so good), PYREXIA (98-99 range by 6 o'clock) and MYALGIA (body aches most of the day). On an unknown date, the patient experienced INJECTION SITE REACTION (some reactions). On 26-Oct-2021, FEELING ABNORMAL (woke up Saturday morning not feeling so good), PYREXIA (98-99 range by 6 o'clock) and MYALGIA (body aches most of the day) had resolved. At the time of the report, INJECTION SITE REACTION (some reactions) outcome was unknown and PYREXIA (102 degrees) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 102 (High) 102 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Followup received on 26-oct-2021 and contains significant information includes dose details,events were added. On 27-Oct-2021: The Follow up document was received and contains Non significant information: Updated Contact Information
About 5 days after vaccination index finger on that arm c/forefinger began to tingle with pins and needles feeling. Now has aching in + up of arm and forearm and muscle twitching has this constant feeling.
I have dealt with COP for many year and never have I developed a blood clots in my lungs. I recently got sick and j was schedules to have my knee replaced when all a sudden I couldn't breathe. They discovered that I had two blood clots in my lungs and cover shot is the only that I can come up with as to why I'm now developing blood clots in my lungs
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-NOV-2104 the patient was vaccinated with a dose of expired ZOSTAVAX (lot number not provided) (strength, dose, frequency and route not provided). The dose of ZOSTAVAX expired on an unspecified date in July 2014. No adverse effect reported. Additional information has been requested.
Heavy vaginal bleeding X 3 days beginning approx 3/27/2021, around 3 days post 1st covid vaccine.  Previously no menstrual bleeding or spotting for 7 months since starting on tamoxifen.  Bleeding was bright red, and significantly heavier than normal menstruation.
Both vaccines were given in left deltoid at Clinic.  Significant swelling, tenderness, erythema 2 days later, with Temp 102 when seen at Urgent Care Clinic.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JAN-2013 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As 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.
Information has been received from a physician concerning a female patient with allergies and no known drug reactions/allergies who on 10-APR-2006 was vaccinated with a first SQ dose of VARIVAX (Merck) (Lot # 646671/0628R). On 26-MAY-2006 the patient was vaccinated with a second SQ dose of VARIVAX (Merck) (Lot # 646671/0628R). Concomitant therapy included ORTHO TRI-CYCLEN LO, ZYRTEC and NASONEX. It was reported that the patient had not seroconverted. No breakthrough disease was noted. The patient sought medical attention by an office visit. On November 2009 a Varicella Zoster antibody IgG level test was performed and the result was non-reactive. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Fatigue; Little bit of fever; Little bit of cough; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Little bit of fever) and COUGH (Little bit of cough) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Little bit of fever) and COUGH (Little bit of cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), PYREXIA (Little bit of fever) and COUGH (Little bit of cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 15:00 (Lot number: EN6203) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid", start date: 2019 (unspecified if ongoing), notes: about 2 years ago. Concomitant medication(s) included: LEVOTHYROXINE SODIUM taken for thyroid disorder, start date: 2019. Vaccination history included: Bnt162b2 (Lot Number /Expiry Date: EN5318 / not provided, Route: injection, Anatomical Location: left arm, Dose no. : 1), administration date: 08Feb2021, when the patient was 74 years old, for COVID-19 Immunization; Flu vaccine (before 4 weeks prior to this vaccine), for immunisation.The following information was reported: HEADACHE (non-serious) with onset 01Mar2021, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 01Mar2021, outcome "recovering", described as "Tiredness"; VACCINATION SITE SWELLING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Swelling at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient did not receive additional vaccines on same date of the vaccine. The patient had no relevant family medical history. The events did not result to emergency or physician's office visit. No follow-up attempts are possible. No further information is expected.
CLENCHED JAW; LUMP AT INJECTION SITE; MIGRAINE; ARM PAIN; HEADACHE; THROBBING/INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced clenched jaw, lump at injection site, migraine, arm pain, headache, and throbbing/injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, had not recovered from arm pain, and the outcome of clenched jaw, headache, throbbing/injection site pain and lump at injection site was not reported. This report was non-serious.
I felt like the whole room and bed were spinning and moving like in an earthquake.; a little lightheaded; This is a spontaneous report from a non-contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), via an unspecified route of administration on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at the Clinic facility. Patient age at vaccination was 88 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included high blood pressure, and Hashimoto's Disease. Concomitant medications included levothyroxine sodium (SYNTHYROID), fenofibrate, lisinopril, colecalciferol (VITAMIN D). On 27Jan2021 at 06:00 AM upon waking up the morning after the shot, before getting out of bed, the patient felt like the whole room and bed were spinning and moving like in an earthquake. She stayed in bed for about 15 minutes, then sat up on the edge of the bed. She was still a little lightheaded so waited a few more minutes and then the feeling went away. The patient reported this has never happened to her before. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Woke up feeling really achy, hurting all over, cold, shivers, migraine
12/22/2004 pt states she feels warm, c/o palpitations and chest heaviness, beginning approximately 2-3 hours after flu vaccination. Apical rate 90, irreg. Resp's=18 unlabored. Color pink, warm, dry, afebrile. Enc f/u with Urgent Care or personal MD; or emergency Dept. Declined follow up with MD. 12/24/04 follow up with pt, no further symptoms, resolved.
Pt recvd 1st dose of vax on 8SEP92 & 21SEP92 recvd 2nd dose of vax & exp some muscle discomfort; 21SEP92 pt exp tiredness, felt bad & exp sore arm @ the inject site;
Covid rebound; Covid rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "atherosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Positive, notes: Positive antigen test 15Apr2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: Covid rebound. Positive antigen test 15Apr2023. Cough and congestion  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.