chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had to lay to sleep until the next day; allergic reaction/ like rosettes on the whole body/ like nuggets from varicella; the whole body itches a lot; body aches; feeling really bad/ felt like blue, like drugged; really sleepy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy) and MYALGIA (body aches). On 16-Jun-2021, the patient experienced HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot). On an unknown date, the patient experienced HYPERSOMNIA (had to lay to sleep until the next day). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK dosage form; ACETAMINOPHEN at a dose of UNK dosage form and IBUPROFEN at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella), PRURITUS (the whole body itches a lot) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information was not provided.
Tested positive for Covid April 11,2022. Took Paxlovid 2x150mg.  Was visiting family. Believe babysitter brought it into the home. All got sick. I had it the worst. Felt like throat closed, heavy congestion, coughing so hard had pain in the back of head. Yellow/ green snot.  Fatigued, with very  little energy.
chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. 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.
Warm to touch on the arm vaccine was administered; Rash on the arm vaccine was administered; 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 WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered) 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 29-Dec-2020, 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 WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered). At the time of the report, VACCINATION SITE WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was 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.
Case number PHEH2016US029147, is an initial spontaneous report received from a healthcare professional on 03 Nov 2016 and 09 2016 (combined report). This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a FLUVIRIN (batch number: 1618401) on an unknown date. On 13 Oct 2016, the patient experienced soreness in arm from movement that was not cleared up. The outcome of the event was reported as condition improving. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19; Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19; Extreme Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH6964) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Continuing: Yes. Concomitant medication(s) included: FINASTERIDE (ongoing); TAMSULOSIN (ongoing); QVAR taken for asthma (ongoing). Vaccination history included: BNT162b2 (first dose; lot: EK9231), administration date: 11Jan2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (second dose; lot:: EL9262), administration date: 01Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (first booster dose; lot: EW0185), administration date: 29Aug2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (second booster dose; lot: FJ9943), administration date: 04Apr2022, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 20Sep2022, outcome "not recovered", described as "Extreme Dizziness"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Narrative:  Patient developed dizziness/lightheadedness shortly after receiving first moderna covid-19 vaccine. Patient needed no intervention and was able to leave on his own.
After the injection for 3-4 days had firm area under skin at site.  Sore arm at site.  Then improved. 1 week after injection the arm at site started itching more and more, had firm half dollar size area under skin, site red.
Sore shoulder/arm for 2 days. Couldn't lift arm. Too sore to sleep well on. Better 4 days after immunization.
PATIENT WAS GIVEN 0.25 ML INJECTION. APPROPRIATE DOSE WOULD HAVE BEEN 0.5 ML INJECTION. THE 0.25 ML INJECTION IS INDICATED FOR PATIENTS 6-12 YEARS OF AGE.
Pt recvd vax 8MAy92 & on 20MAY92 pt devel a low grade fever & rash; No further details were provided;
Moderna COVID-19 Vaccine EUA I had my first dose of the Moderna Vaccine 1/14 with minor discomfort. On 1/21 area around the site felt itchy. On 1/22 morning I saw large red circle that was slightly sore and hot to the touch. On 1/22 afternoon I called for appointment.  Since none was available I went to urgent care where I was prescribed Doxycycline.  Have been taking it as prescribed and circle has been slowly fading away but is still visible.  I  thought it might have been a reaction to an insect bite, but now a friend who got the vaccine the same day I did is experiencing the same reaction.   I  would like to know if you think this is connected to the vaccine and if so could it affect the efficacy of the vaccine? I am also concerned about taking the second dose.
Information has been received from a pharmacist concerning a female patient who on unspecified dates were vaccinated with the first and second doses of GARDASIL (lot number and expiration unspecified). The patient was now going through chemotherapy for osteosarcoma. Pharmacist was not sure if osteosarcoma was a pre-existing condition for this patient prior to GARDASIL administration. Pharmacist did not have much information for this patient. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, osteosarcoma was considered to be an other important medical event. Additional information has been requested.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium.
big kind of bump; kind of raised; kind of red area all around the injection site.; arm started itching, later that day it came through and itched a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (kind of red area all around the injection site.), PRURITUS (arm started itching, later that day it came through and itched a lot), VACCINATION SITE MASS (big kind of bump) and VACCINATION SITE SWELLING (kind of raised) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Osteoporosis, ZOLPIDEM TARTRATE (AMBIEN) for Sleep difficult.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (arm started itching, later that day it came through and itched a lot). On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (kind of red area all around the injection site.), VACCINATION SITE MASS (big kind of bump) and VACCINATION SITE SWELLING (kind of raised). On 15-Mar-2021, PRURITUS (arm started itching, later that day it came through and itched a lot) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (kind of red area all around the injection site.), VACCINATION SITE MASS (big kind of bump) and VACCINATION SITE SWELLING (kind of raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not used any treatment medication for the events.
arm soreness; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm a while ago. After vaccination, the patient experienced soreness in arm, for only a few days. The patient did not consent to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR123504. This case has been linked with the case US2019122954, reported by the same reporter.
ACHED ALL OVER; SHORTNESS OF BREATH; HIGH BLOOD PRESSURE; BALANCE WAS OFF WHEN WALKING; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included brain stem stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced ached all over. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced high blood pressure. On 2021, the subject experienced balance was off when walking. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, ached all over, shortness of breath, high blood pressure, and balance was off when walking. This report was non-serious.
Perimeter redness estimate 40x40 mm around smallpox vaccination. 13 pustule satellite lesions scattered from 5 o'clock to 12 o'clock position. patient stated rubbed itching area x used non permeable band aids.
Less than 30 minutes after receiving vaccine patient reported some itchiness on right arm as well as some light-headedness and an "odd" feeling on her right side only.   Blood pressure was 126/68mmHg. Recommended water and some food if possible.  Patient's symptoms resolved on their own after patient had lunch - did not report any new or worsening symptoms roughly an hour after vaccine administered.  No medications were given to patient to treat symptoms.
PT DEVELOPED TACHYCARDIA, DIZZINESS, AND DIAPHORESIS AFTER VACCINE. MONITORED FOR A HALF HOUR IN CLINIC WITH REST AND FLUIDS BUT SYMPTOMS PERSISTED. TRANSFERRED TO ED. Patient was evaluated on at least 3 separate occasions that her ED stay. Received a liter of normal saline. She received 25 mg of IV Benadryl. Her presentation is really not consistent with an acute allergic reaction. She did have a persistent slight tachycardia here. However, reviewing her record shows that this is a recurring issue for her. It has been thought that she may have POTS. She frequently has tachycardia when looking back through her records. The patient had no air way issues, no hypotension, no urticaria. Discharged w/ instruction
Information rec'd from HCP. Post vaccine the pt subsequently developed lesions on his tonsils and mono like symptoms.
Headaches a few days after shot; 5 days after shot complained of stomach pains; feeling aches, lower back pain; and sore legs and even pain in joints. 6 days after shot feeling a little better.
Immunizations given 6/6. Child presented at hospital on 6/7 with fever, increased work on breathing. Respiratory code and death early AM 6/8. Autopsy: Increased heart size/bicuspid pulmonary valve . Myocarditis with lymphocytic infiltration.
Severe local reaction to arm SQ inj sites with resulting cellulitis. (R) AND (L).
Patient had pruritus on 03/06  and eventually hives across lower back and around waist-line; Took benedryl that evening. Hives resolved within24 hours, but still has pruritus occassionally.
Moderna COVID- 19 Vaccine EUA: One day after receiving vaccination patient presented to the emergency department with palpitations and chest discomfort. Patient states some lightheadedness and headache since receiving vaccine. Physical exam noted mildly dry mucous membranes and injection site pain. Neurological exam normal, lungs were clear, good peripheral pulses, and no rash noted. Vital signs within normal ranges except for pulse 109-120 beats per minute and blood pressure 136/79 mmHg. Patient administered intravenous fluids and lorazepam and symptoms improved. Repeat  vital signs all within normal ranges and patient discharged to home stable.
4mins post vaccination pt reported that w/ previous Pfizer vaccinations he had elevated BP lasting ~30mins.  Pt was otherwise asymptomatic. Vitals: 16:19 173/84, 94, 20, 99% -- > 16:22 172/91, 93, 20, 100% -- > 16:25 154/78 -- > 16:29 152/67, 90, 20, 100% -- > 16:38 171/68 -- > 16:50 143/64, 94, 20, 100% Pt released at 16:50 in stable condition.  Pt walked to exit w/ slow steady gait.
Case number PHEH2013US004119 is an initial spontaneous report received from a nurse on 13 Feb 2013. This case refers to a female patient of unspecified age. She was vaccinated only with the liquid CYW-135 component of MENVEO vaccine (batch number: X10133) intramuscularly on 13 Feb 2013. No adverse event was reported following this drug administration error.
I felt an nodule on my left collarbone its was moving while I moved my neck , It is not painful and pea sized I didn?t get it checked by a doctor yet
This case was reported by a healthcare professional via a representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject  experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The sales representative reported that there has been 4 cases of cellulitis at this doctor's office recently. They have increased their doses of KINRIX during this time and were questioning whether it may have been a cause. The sales representative had no additional information.
1 of 3 pts vaxed from the same lot# who exp inject site react which included redness, swelling & soreness; react lasted approx 4 days; no treatment given; pt recovered;
Heart palpitations throughout the day, particularly at night while recumbent.  Frequency can be as often as every 10 beats.
Soreness at injection site. No problems until approx. 7-10 days later. Extreme muscle pain in both shoulders extending down to elbow and left hip to back of knee. Took ibuprofen and TYLENOL to try and ease pain. Continued until 11/6 when I went to express clinic. Was told possible reaction to flu vaccine and continue with ibuprofen and TYLENOL. Pain continued so went to family doctor on 11/15 and Dr. ordered bloodwork. After results of bloodwork said possible serum sickness and prescribed MOBIC. Called Dr. office today 11/21 to tell Dr. that pain is no better. Waiting on call back at this time.
Delayed (over 2 weeks after shot) arm pain. Low grade fever (between 99F and 100F).  Fatigue, exhaustion. Runny nose.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced VOMITING (Vomiting). In 2022, VOMITING (Vomiting) had resolved.            Concomitant medication was not reported.  In January 2022, the patient experienced vomiting. In 2022, the vomiting resolved. Moderna COVID-19 Vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
My heart has been messing with me; I've been sick ever since I taken that COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot). At the time of the report, CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient kept going to emergency room. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2023: Live follow-up received: Narrative updated
Fever, headaches, myalgias, sore throat about 6 days after immunization given.
FLU LIKE SYMPTOMS; ACHES ALL OVER; FEVER (EAR TEMPERATURE 101.8 F); NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. 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 and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced aches all over. On 07-APR-2021, the subject experienced fever (ear temperature 101.8 f). On 07-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.8 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, fever (ear temperature 101.8 f), aches all over, and nausea. This report was non-serious.