chrisvoncsefalvay/vaers-outcomes huggingface dataset:
similar to a stroke/blood clot in brain; reduced mobility; massive weakness; Twitching; blood pressure high; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (similar to a stroke/blood clot in brain), MOBILITY DECREASED (reduced mobility), ASTHENIA (massive weakness), MUSCLE TWITCHING (Twitching) and BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure high) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k21A and 036A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL and PROSTATE CONTROL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (similar to a stroke/blood clot in brain) (seriousness criterion hospitalization), MOBILITY DECREASED (reduced mobility) (seriousness criterion hospitalization), ASTHENIA (massive weakness) (seriousness criterion hospitalization), MUSCLE TWITCHING (Twitching) (seriousness criterion hospitalization) and BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure high) (seriousness criterion hospitalization). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to ASTHENIA, BLOOD PRESSURE SYSTOLIC INCREASED, CEREBROVASCULAR ACCIDENT, MOBILITY DECREASED and MUSCLE TWITCHING. The patient was treated with ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 40 mg at bedtime. At the time of the report, CEREBROVASCULAR ACCIDENT (similar to a stroke/blood clot in brain), MOBILITY DECREASED (reduced mobility), ASTHENIA (massive weakness), MUSCLE TWITCHING (Twitching) and BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure high) outcome was unknown. Not Provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sudden onset swelling and pain at injection site. Strength, sensation, warmth of RUE intact. Passive range of motion intact. Mild tingling in R fingers. Recommended Tylenol, warm compress; Recommended going to ED if symptoms worsen.
Vomiting; Severe headache; This is a spontaneous report from a contactable consumer reported for self. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose in Left arm on 29Mar2021 12:00 AM (Lot number: ER8733) for COVID-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), both received within 2 weeks of vaccination. The patient experienced vomiting and Severe headache on 29Mar2021 07:00 PM, there was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Pt recvd 3 doses Hep B vax 5OCT90 & 2NOV90 & 4APR91 & w/in 1 wk of vax pt devel discoloration & swelling of the large toe w/arthralgia in knees, swelling & discomfort of fingers of both hands; also devel pain & swelling @ inject site;
Information has been received through the Merck pregnancy registry from a physician concerning an 18-year-old white female with no drug reactions/allergies and with a history of chickenpox (therefore the patient had immunity to varicella) who on 10-OCT-2006 was inadvertently vaccinated SC with a 0.5mL dose of Varivax (Lot # 654082/0916F) when she was 19 weeks pregnant. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified). Titers showed the patient had a prior immunity to varicella. It was noted that the physician ordered Varivax, and the nurse administered it. It was "just human error". Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that a the LMP=07-MAY-2006 (EDD=04-MAR-2007). On 25-JUL-2006, an ultrasound was obtained to "check dates". On 22-SEP-2006, a MSAFB was obtained, and showed "neg NTD, OS, Trils". On 18-OCT-2006, an ultrasound showed a 20.6 week male. The patient had no previous pregnancies, no full-term deliveries, and no pre-term births. There was no birth defects with any other pregnancy; no still birth or miscarriage in any previous pregnancy. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. A liveborn male infant was born on 18-FEB-2007 (weight 7 pounds 2 ounces; 38 weeks from LMP). The infant was normal. There was no complications or abnormalities. There was no complications during pregnancy. There were no complications during labor/delivery. There were no infections or illnesses during pregnancy. There were no concurrent medical conditions. There was no feature of congenital varicella zoster syndrome. Diagnostic tests during pregnancy included: "varicella zoster IgG=3.61 (positive IgG Ab=31.10); IgM=0.30 (0-0.90 Neg)". Other medication used during the pregnancy included: "PNV" and ferrous sulfate from December 2006 325mg daily for anemia. No additional information is expected.
Vaccine ok per RMA. Slight eyelid swelling noted 5/1/14 but very obvious eyelid swelling, redness above cheek bones and localized swelling and redness of (R) thigh.
headache during the day; a big bruise on her leg; This is a spontaneous report from a contactable consumer(patient).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 16:50 (Lot Number: ER8735) as single dose for covid-19 immunization.  Medical history included ongoing high blood pressure(she had this condition for the last year), ongoing acid reflux (this had been a while that she's had this, she was not sure how long), ongoing anxiety(she had this condition for a few years). Ongoing concomitant medications included citalopram taken for anxiety; omeprazole taken for acid reflux; acetylsalicylic acid (ASPIRIN (E.C.), baby aspirin) taken as blood thinner which she had been taking this off and on whenever she felt and blood pressure medication taken for hypertension. Historical vaccine included first dose of BNT162B2 at left arm, upper arm, lot: EP7533, on 24Mar2021 at 7:15pm at 59-year-old for COVID-19 immunization. There was no prior Vaccinations or events following prior vaccinations.  She declined being sick at the time of vaccination. After the second shot on 15Apr2021, she began taking aspirin because she heard about blood clots and stuff. And then she got a pedicure where they did a massage. She woke up Saturday morning(17AprR2021) and had a big bruise on her leg(not at the injection site), but she had gone the day before and got a massage so maybe the bruise was from that pedicure massage. She was not sure what caused it, she didn't hit anything, that they sometimes hit you up there, it was a deep tissue massage, under her right knee, the calf, the under side. Since 17Apr2021, she had been waking up with a headache in the morning for a few days, headache didn't start until the 17Apr2021, she was taking ibuprofen(treatment), headache has not worsened, it was a dull headache. There was no emergency room, no physician office needed. Outcome of a big bruise on her leg was recovering, of headache was unknown.  No follow-up attempts are needed. No further information is expected.
My lymph node in my left armpit is enlarged. I am contacting my doctor for further guidance.
Red, itchy rash. Small bumps over 1/2 - 3/4 of my entire body. Started in "hot zones" progressed over all body parts.
Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 episodes throughout the day since. No treatment needed. I just wanted to report just in case .
This is a literature report for the following literature source(s): "Neuropathic symptoms with SARS-CoV-2 vaccination", 2022. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing); "Sudden onset of cold sensation in legs and formication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious), BURNING SENSATION (non-serious), all with latency 3 hrs. after the suspect product(s) administration, outcome "unknown" and all described as "Lower limbs paresthesia and burning sensation". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Heart rate: Unknown results; anti AChR: Unknown results; Unknown results; Unknown results; Unknown results; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. Linked Report(s): US-PFIZER INC-202200764439 Same article/patient different drug/event.
blood in urine, neck stiffness, headache in back of head, stabbing headache, temporal pressure, visual disturbances,
Flu like symptoms / like the flu; Muscle ache; feeling lousy; felt bad / feeling bad; body aches; This is a spontaneous report from a contactable consumer (parent). This consumer reported similar events for two patients. This is the 1st of two reports. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 16Feb2021 at 12:30 (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 26Jan2021 at 09:00 (at the age of 44-years-old) for COVID-19 immunisation. On an unspecified date in Feb2021, the patient experienced flu like symptoms / like the flu, muscle ache, feeling lousy, felt bad / feeling bad, and body aches. It was reported that the patient has been on the couch and had to call out of work. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170713 Different patient, same reporter and product and similar events.
In 8/99, the pt received his first injection of Lymerix with no adverse events. In 9/99, he received the second dose of Lymerix. 3/27/00 he experienced dizziness, nausea and vomiting. He was diagnosed with demyelination of the white matter of his brain and was hospitalized.  Information received on 3/30/00 reports that symptoms are ongoing and the patient remains in the hospital.  Additional information has been requested.
Same day when I got the vaccine I started feeling hot & dizzy I asked a nurse to check my temperature and it was at 101F, I left home the next day in the morning I was low on oxygen they had to called the ambulance and they took me to the ER.  I was hospitalized since 01/5/2021- 01/17/2021 the fever continued during that time but as it right now I'm still with oxygen I also have a cough. The doctors said it affected my lungs. On February I should be getting another lung exam.
got sick for over two weeks each time I got them; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographics) reported got sick for over two weeks each time I got them (Illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick for over two weeks each time after the vaccine (Illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Edema to mid calf with maximum of 1cm indentation.  No history of previous episodes of edema.  Slowly improved daily until completely gone 3/3/21
Pt. given KINRIX and Influenza in (L) leg - no redness or swelling immediately after immunization however dad reports that evening he started to complain of pain and noted redness, swelling of (L) thigh. (R) leg has minimal rash and redness where PROQUAD was given. Pt. seen today 2-16-18 and prescribed BENADRYL, cephalexin and ibuprofen. Will recheck Monday 2-19-18.
Entire body ache, cold chills, nausea, temperature.  Did not take anything before going to bed and was very uncomfortable all night.  Took two tylenol next morning at 6:30am and felt better until 12:00 and took 2 more tylenol and felt better until 6:30 and then took two more and went to bed and woke up at 6:30am the next morning and felt fine.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 13-OCT-2017, the patient received an expired dose of VARIVAX lot # L035124, expiration date: 14-SEP-2017, one dose, subcutaneously, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effect was reported.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. Date of Refrigeration include  07-May-2021.
unauthorized age receive Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna) 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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  HCP stated that they accidentally administered 2 doses of the Moderna COVID-19 vaccine to a patient before they turned 18. Now, they are 18 years old and would like to receive a booster.  Treatment information was not provided.   This case was linked to MOD-2022-549081 (Patient Link).
pt recv vax; 01apr94 exp diplopia & devel rash over body, Koplik's spots & T 103;
Lips: tingling, numbness. Tongue: tingling. Throat closing up, itching. Voice: hoarse, shortness of breath
Extreme fatigue and a harsh cough causing headache. For 2 days.   Arm pain
Lethargy soon after immunization followed by vomiting some hours later symptoms resolved within 48 hours never had fever.
Pt had red/swollen arm that was warm to the touch. Ice was used to control swelling and PT is doing fine now 4 days post vaccination.
Redness that spread after receiving Smallpox vaccine in left arm.  Redness has continued to spread and was see by PCM on 26 Aug, and was told to report back if redness went outside the drawn circle. Pt reported back on 8/27/13 and redness had indeed gone outside the line.  Pt was walked into PCM for medication treatment.  Swollen lymph nodes in L arm.
Myocardial infarction (heart attack), very mild. No direct treatment,  but additional drugs (atorvastatin and clopidogrel) prescribed
Patients who is 17 years of age got Moderna Vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old patient, of unknown gender, who was administered Moderna's COVID-19 vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of Covid-19 infection.  It was reported that one of their patients who is 17 years of age, got Moderna Vaccine, and it was already reported to VAERS. No further information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The event of "Product administration to patient of inappropriate age" (patient who is 17 years of age and got Moderna Vaccine), was considered resolved.; Reporter's Comments: This report refers to a case of "Product administration to patient of inappropriate age" of  mRNA-1273, (lot # is unknown),  with no associated AEs reported.
I  was positive on 23Dec / We tested positive again; I  was positive on 23Dec / We tested positive again; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 60-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2022, outcome "unknown" and all described as "I  was positive on 23Dec / We tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Positive; (31Dec2022) Negative; (02Jan2023) Positive, notes: Our symptoms came back today 02Jan and we tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Hot; Intense itchiness on the injection site; Bumpy rash size of a quarter on the injection site; Swelling the size of golf ball; Red and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Intense itchiness on the injection site), VACCINATION SITE RASH (Bumpy rash size of a quarter on the injection site), VACCINATION SITE SWELLING (Swelling the size of golf ball) and VACCINATION SITE ERYTHEMA (Red and hot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Hypothyroidism (PMH includes hypothyroidism.). Concurrent medical conditions included Allergy (Denies allergies). Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Intense itchiness on the injection site), VACCINATION SITE RASH (Bumpy rash size of a quarter on the injection site), VACCINATION SITE SWELLING (Swelling the size of golf ball) and VACCINATION SITE ERYTHEMA (Red and hot). At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Intense itchiness on the injection site), VACCINATION SITE RASH (Bumpy rash size of a quarter on the injection site), VACCINATION SITE SWELLING (Swelling the size of golf ball) and VACCINATION SITE ERYTHEMA (Red and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was nor reported.   Reporter did not allow further contact
Patient fell from her chair about 15 minutes after vaccination. Patient was alert and conscious and was able to communicate with us. She asked for water cause she was thirsty before fall . Left a message for patient on voicemail to see how she was doing. Hoping to get a call back from patient. Patient refused to go to the hospital and said she was fine
My arm was extremely sore after injection in the shoulder region, felt it was just a minor reaction and it would get better.  But the soreness in my shoulder kept getting worse, with extreme pain, upon certain movements.  I took ibuprofen for the pain, but it would just ease the symptoms and not take it away.  After 3 weeks of pain I made an appointment with my physician, who felt it was due to injection being given in my rotor cuff.