chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sensation of losing consciousness.; Next morning on 14Sep in the morning, caused dizziness; Body temperature spiked to 103F in 12 hrs of vaccination; Experienced distorted dreams through the night.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 13Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 49 years for covid-19 immunization at a Clinic/Administration facility. The patient's relevant medical history included: "Undergoing treatment for chronic lymphocytic leukaemia" (unspecified if ongoing), notes: Undergoing treatment for chronic, lymphocytic leukaemia. Concomitant medication(s) included: IBRUTINIB, stop date: 24Aug2022; VALACYCLOVIR [VALACICLOVIR], stop date: 01Sep2022. Vaccination history included: Covid-19 vaccine (Dose: 01, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 02, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 03, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Sep2022, outcome "recovered" (2022), described as "Body temperature spiked to 103F in 12 hrs of vaccination"; ABNORMAL DREAMS (non-serious) with onset 13Sep2022, outcome "recovered" (2022), described as "Experienced distorted dreams through the night."; DIZZINESS (non-serious) with onset 14Sep2022, outcome "recovered" (2022), described as "Next morning on 14Sep in the morning, caused dizziness"; CONSCIOUSNESS FLUCTUATING (medically significant) with onset 14Sep2022, outcome "recovered" (2022), described as "sensation of losing consciousness.". The patient underwent the following laboratory tests and procedures: Body temperature: (13Sep2022) 103 Fahrenheit, notes: Body temperature spiked to 103F in 12 hrs of vaccination.  No follow-up attempts are possible. No further information is expected.
I was very anxious for a few days as I literally could not move my shoulder for 3 days even if I tried?it was as if my right arm was paralyzed.  When I went to bed that Friday evening I was experiencing pain...then when I awoke Saturday morning my shoulder was in a  paralyzed state. I never knew something like this was remotely even possible from receiving a vaccine?any vaccine.  The x-rays confirmed that my shoulder was not injured.
This case was reported by a consumer and described the occurrence of severe diarrhea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of FLULAVAL (details unknown). On unspecified date, two weeks after vaccination with FLULAVAL, the subject experienced severe diarrhea and vomiting. At the time of reporting the outcome of the events was unspecified. No other information was provided.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave a single pediatric dose of Moderna Covid-19 Vaccine, Bivalent BUD) and NO ADVERSE EVENT (No Adverse Event) in a 5-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave a single pediatric dose of Moderna Covid-19 Vaccine, Bivalent BUD).    No concomitant medications were reported. No treatment medications were reported.
Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight; Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 14-year-old female patient received 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 21Jun2022, outcome "unknown" and all described as "Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: She tested positive for Covid tonight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller stated his 14 year old daughter is double vaccinated with the Pfizer Covid 19 vaccine but not boosted. The patient tested positive for Covid tonight and developed symptoms at afternoon of nausea, fever, and headache so reporter tested for patient. Reporter understands Paxlovid should not be crushed, however asked if there is any additional information on crushing the medication. Patient hasn't learned how to swallow pills yet.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Itchiness/rash on random areas of body at random times of the day after second Pfizer vaccine dose on 09/07/2021
My arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 14:15 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iodine contrast media allergy" (unspecified if ongoing), notes: known allergies- Iodine with contrast; "Lung cancer" (unspecified if ongoing). Concomitant medication(s) included: SLYND. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arm was sore".  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Her arm was sore with both shots which she know was a normal side effect. The treatment for the adverse events arm was sore with first dose was not provided.   No follow-up attempts are possible. No further information is expected.
Patient had received 1st dose moderna on 12/17/2021. Patient then decided to receive pfizer 05/23/2022 because he did not like the side effects of the moderna. Patient came into clinic and received another pfizer 6/13/2021. Pateint received this booster dose too early. Patient is to return to clinic in 4 months for booster.
swollen feet; knees are swollen; My cheeks has swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient itself).A 73-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiry Date: Unknown) via intramuscular in left arm on 26Apr2021 at 09:10 (at the age of 73-year-old) as dose 1, single COVID-19 immunization. Medical history included High Blood Pressure. The patient's concomitant medications were reported as yes. Consumer stated, got first shot of Pfizer this morning at 9:10 this Monday morning and after 6 PM at dinner and consumer realized that cheeks has swollen. Consumer not in pain first shot was there beside and have been out over a day. Consumer came home an hour ago and at dinner and noticed got shoes off, noticed feet was swollen, both of feet are swollen, the right foot was swollen, and the left foot was swollen and then those knees was swollen. Consumer stated for concomitant medications as yes, taking a lot of medications. On an unspecified date, patient experienced swollen feet, knees are swollen, my cheeks has swollen. The patient was not received any treatment for events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
fever 98.9, body aches and (difficulty breathing) ! almost went to ER but didn't. the next day my chest started hurting. this day two after my reaction
Information has been received from a 64 year old female with thyroid disorder, a history of shingles two years ago and no allergies/drug reactions who in October 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot no and route not reported). Concomitant medication included "lavaxol" (unspecified). In December 2008, the patient was diagnosed with multiple myeloma cancer. The patient reported she started chemotherapy treatment (unspecified) in February 2009 and had about 14 vials of blood taken and other test done as well. Then right before her stem cell transplant she had her immune system wipe out. The patient reported that on 11-JUN-2009 she had a Stem cell transplant in a clinic and was hospitalized for 14 days. The consumer reported that for a couple of weeks when she came home she did not feel to good, but at the time of the report she was feeling and doing well. On unspecified dates a blood work and a lung function test were performed (results not provided). The consumer reported that she does not believe that multiple myeloma cancer was caused by ZOSTAVAX (Merck). No additional information is expected.
One day post vax, this pt experienced a low-grade fever and extremely sore arm and neck. Three days post vax, the pt began having cold like symptoms (runny nose, congestion, fatigue). From additional information received on 11/24/98, it was reported that the pt recovered from this experience.
Information has been received from a physician concerning two patients who were vaccinated with GARDASIL (route, site and lot number not reported). Subsequently the patients experienced contact dermatitis from the GARDASIL band-aids. The skin affected was the shape of the band-aids. There was no additional information at that time. Further information was received from the office manager. It was reported that "several girls" mentioned that the band aids "should not be used." The patient information was not recorded at the time, and therefore, the office had no way of knowing "who made the comments."
Was sick for 2 days and then it disappeared; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick for 2 days and then it disappeared) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick for 2 days and then it disappeared). At the time of the report, ILLNESS (Was sick for 2 days and then it disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-225993.
Within 24 hrs child had fever, vomiting and hives. Child taking Benadryl.
Report received from a Merck sales representative concerning her sister-in-law's mother on 21-APR-2010. The female, in her 60's, received an unspecified flu vaccine (manufacturer unspecified) on 12-JAN-2010. There was no concomitant therapy or pertinent medical history. On 15-JAN-2010, the female developed numbness of her right foot which progressed to an inability to walk. The patient sought medical attention. She was hospitalized and has a urinary catheter due to inability to pass her urine. Lumbar puncture and other unspecified studies were performed (not further specified, results unknown). The patient had not recovered. The events were reported as disabling. This case was reported as serious due to patient hospitalisation. Additional information has been requested. This case was originally report to Merck & Co, Inc (case# 1004USA03475).
Pt recvd vax 27JAN93 & on 25FEB93 pt devel weakness in knees & muscles aches & pains, exp in calves; No further details were provided;
Narrative: Patient reported redness, warmth, swelling, and tenderness to left  deltoid where he received his second Covid vaccination on 4/28/2021. He denied  having any reaction to the initial Covid vaccine and feels the site redness and  swelling is inproving. He denies fever, chills, or limitation in the arm. Patient  encouraged to apply ice 20 minutes on at a time throughout the day as needed to  help with swelling, redness, and discomfort. Patient encouraged to notify staff is  symptoms persist or worsen
very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy). At the time of the report, PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Batch/lot number: EL3246, expiry: unknown), via an unspecified route of administration on 30Dec2020 at single dose (once by injection in the left shoulder) for COVID-19 immunization (Healthcare worker). Medical history was reported as none. There were no concomitant medications. On 01Jan2021, it was reported that the patient experienced shoulder pain, whole body was hurting, and nausea.  Patient asked, after getting the vaccine, if one was able to get COVID, she clarified that she meant after the first dose of the vaccine. She got the typical symptoms and side effects after she got the first dose, like shoulder pain. She is curious if you can still get COVID after the first dose. She is sure you are better off after the second one, but was curious about after the first one. The patient was taking COVID Vaccine because she is a Healthcare worker. Patient is a medical assistant. It was also reported that her shoulder pain was more prominent than her body. She works in the field and people are getting COVID after the first dose of the vaccine. She is concerned on if she could still get it or not. She gets the second dose on 20Jan2021. The outcome of the event once by injection in the left shoulder/Shoulder pain was recovered on 04Jan2021, whole body was hurting was recovered on 02Jan2021, and nausea was recovered on 01Jan2021.
The patient was at the center for half an hour after received vaccination, he did not have any symptoms and left, half an hour later mother called because the patient developed a hive in the site of the injection, we brought back the patient to the center and administer Benadryl  (25 mg) IM in his left Gluteus. The patient is Ok, with no other symptoms, no fever, no rash and he is alert.
DEVELOPED FLU LIKE SYMPTOMS NEXT DAY AFTER GETTING VACCINATION, ON 11-2 GOT A ZPAK AND COUGH SYRUP, ON 11-18 GOT NAUSEA TABLETS.
pt developed a pustule on inner lower eyelid OS about 7 days after receiving the vaccine; pt was cultured and started on viroptic drops.
At dose#2 visit patient reported facial redness and peeling for 1 week onset 72 hours after Pfizer dose#1. She denied symptoms of severe allergy including urticaria or other rash, angioedema, throat swelling, respiratory symptoms, presyncope. Rash resolved with antihistamines after 1 week.
A non-serious spontaneous report of administration of FLUMIST to a pregnant female was received from a registered nurse concerning an adult female. Neither relevant medical history/obstetrical history nor concomitant medications have been reported for this patient. On 03-Nov-2010, the patient received FLUMIST for an unknown indication. There was no adverse event associated with this medication error. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
MELT DOWN; SHIRT WRINGING WET; ALLERGIC REACTION; BODY CHILLS ON/OFF; BURNING/CHERRY RED LEGS AND WHOLE BODY BURNING; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning/cherry red legs and whole body burning. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced body chills on/off. Laboratory data included: Audiogram (NR: not provided) Negative, and Blood test (NR: not provided) Everything came back negative. On 09-APR-2021 17:00, the subject experienced allergic reaction. On 15-APR-2021, the subject experienced melt down. On 15-APR-2021, the subject experienced shirt wringing wet. On 17-APR-2021, treatment medications included: pregabalin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from allergic reaction, burning/cherry red legs and whole body burning, body chills on/off, abdominal pain, melt down, and shirt wringing wet. This report was non-serious.
To whom it may concern, the evening of the shot and the days that followed I had a high fever, chills, was sweating a lot, pain in my muscles, legs, etc.  This all passed, and it wasn?t until yesterday 4-17-21 that I began to experience bizarre symptoms (not congruent to the above).  My left arm is extremely tingly, almost as if it?s asleep. As of this evening (4/18/21 around 7:30 PM), I am also experiencing this tingly sensation on the left of my face as well. It feels like pins and needles, and is very bizarre.  I?m extremely confident in saying it?s in direct correlation to the shot.  Please advise.
Breakthrough case admission after 4 vaccines Moderna 3/11/21 Lot# 023M20A;  Moderna 4/11/21 Lot# 018B21A;  Moderna 12/3/21 Lot# 013F21A;  Moderna 4/9/22 Lot# 083J21A
Headache, Myalgia, Arthralgia, Fatigue, chills, swollen glands (neck)  Narrative:
Caused Long COVID Symptoms to occur. I fully recovered from COVID by end of November 2020. I was vaccinated in Spring 2021.   First symptom of anxiety, tachycardia (resting heart rate of 120-130), headaches, nerve pain on side/chest, and alcohol intolerance  occurred early June 2021. More than 6 months after recovery, but approximately 6 weeks after full vaccination.  No previous history of this. Resulted in 2 trips to the ER.   Primary doctor prescribed medication (on an as needed basis) to assist with anxiety attacks. Also, suggested to increase electrolyte intake to help with symptoms.  Symptoms seemed to be more managed and under control by December 2021, but still flair up on occasion.  I would say I am 90% better at this time, but still rely on medications and electrolytes not previously prescribed/used before vaccination. I also still have alcohol intolerance.
This spontaneous report was received from a nurse via company representative regarding an unknown age female patient. The patient's medical history included seasonal allergies. No other pertinent concurrent conditions, concomitant medications were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prevention of HPV (strength, frequency, lot#, expiration date and route of administration were not reported). On an unknown date, the patient experienced fever (pyrexia), chills, nausea, vomiting and body aches (pain) for 2 days. The patient was told to take ibuprofen at home. The outcome of the events were not reported. The causal relationship between GARDASIL 9 and the event was not reported. No product quality complain was present.
Patient experienced chills overnight the evening after receiving the vaccine.  She reported that she did not have a fever. The next morning the chills went away but patient reported that she was sore all over and complained about muscle soreness.
Client reported feeling lightheaded and dizzy at 0940. V/S 140/80 pulse 71 and oxygen saturation 97% on room air.
rxn to flu shot given on 15OCT97;16OCT97 fever, bumps @ inj site & itching;blisters back of throat;MD dx as a rxn to the vax;
No further details available; Caller reporting temperature excursion. Caller reports AE as product was administered; This spontaneous report was received from a registered nurse and refers to a 15-year-old patient of unknown gender.  There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 15-DEC-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S037503 and expiration date since it makes match with the autopopulated expiration date 20-NOV-2020), 0.5 milliliter (route of administration and anatomical location were not reported ) for prophylaxis.         It was reported, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was stored at temperature excursion. The temperature excursion was 0.38 degrees Celsius for a time frame of four hours and 45 minutes, and 11.09 degrees Celsius for 1 hour and 30 minutes, as recorded by a data logger. There was no previous temperature excursion. No further details available.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2012USA012971: US-009507513-2012USA012900: