chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; fatigue; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 58-years-old) as a single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, 21:00, the patient experienced chills, fatigue, fever, vomiting and diarrhea. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fatigue, fever, vomiting and diarrhea was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FATIGUE AND SORENESS AT INJECTION SITE FOR 3 DAYS Narrative:  CONTINES WAKING UP SWEATING AND C/O NASAL CONGESTION THAT STARTED ON 22JAN
Paralysis for 2 days.  Unable to use either arm, barely able to bear weight or walk.  Had to be fed,  given water, and helped to go to the bathroom.
I went into urgent care and thought I had a bladder infection. They performed both a blood and urine test. The urine test was negative for infection, but the blood test came back with extremely elevated PSA levels. I was prescribed antibiotics with an urgent referral to a urologist. I saw a urologist that scheduled a biopsy in a weak to see if I have prostate cancer.
Sore injection site; fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the right arm) on 25Feb2021 15:00 (at the age of 52-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date.    The patient's concomitant medications were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient has no other medications in two weeks. On 25Feb2021, the patient experienced sore injection site and fatigue. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache; This is a spontaneous report from a contactable consumer (patient). A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in arm left (upper muscle) in Jan2021 (25Jan2021 or 26Jan2021 after 20:00) (Batch/Lot number: unknown) (at the age of 88-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included pacemaker from 2010 and ongoing, congestive heart failure, cord wrapped around his neck (he was born with cord wrapped around his neck, what they called a blue baby), heart medicine, prediabetes (a couple of doctors thought he might have prediabetes but he does not think so) and he has something, not diverticulosis but something like that he does not remember. There was no family medical history relevant to adverse event. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for cardiac disorder from an unspecified start date and ongoing, and unknown product green capsule 190mg taken for cardiac disorder. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. On 28Jan2021, the patient experienced headache. This morning he woke with a slight headache; he took a shower, took his other heart medication and Bystolic; headache was fine for a while; then it started up after lunch; now it is not a raging headache; but it starts in the back of the head right behind his left ear up to the top of, crown of his head. The patient was not sure about the vaccine administration date, 25Jan2021 or 26Jan2021, but his second dose was scheduled for 16Feb2021. He wondered if he can take some Tylenol or something for the headache. The adverse event did not require a visit to emergency room or physician office. The patient was not hospitalized. Outcome of the event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
1/22/2023-Brought in EMS, presents to ED, had been found unresponsive at bottom of stairs. HR in 60, while obtaning CT dropped to 30's, 1 amp Atropine given. Temp-85.8, BP 194/91.Covid + test. Intubated. CT- LArge intraparenchymal Hemmorhage R cerebral hemisphere, centered R temporal and occipital lobes .2x5.9 cm. 1.9cm r to L midline shift. Evidence of impending transtentorial herniation and brainstem deviation to the left. CXR-small desnity upper left lung, atelectasis. Admit to trauma, acute hypoxic resp failure s/t fall, intraparencymal hemorrhage. WBC 18.4 1/23/2023- Vent-AC VC 400/14/100 Fio2/5 Peep. Comfort care patient has been made DNR. Sepsis d/t Covid leukocytosis 18.4, lactic acidosis 2.4. 1/23/2023-Levophed to keep MAP above 65  WBC 13.2. ABG 7.353/43.4/24.1 on 100% Fio2 AC VC vent. 1/24/2023-Terminal exubation @1257.
C/O feeling weak and felt like her throat was closing almost immediately after receiving vaccine.  Patient was evaluated by ED. No evidence of anaphylaxis.  Treated and released without.
achiness; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and VACCINATION SITE PAIN in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, MULTIVITAMINUM, VITAMIN D, FISH OIL, METOPROLOL, and MAGNESIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN and VACCINATION SITE PAIN. At the time of the report, PAIN and VACCINATION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-377059, MOD-2021-377060 (Patient Link).
This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced localized erythema and localized feeling of warmth. On an unknown date, the outcome of the localized erythema and localized feeling of warmth were unknown. The reporter considered the localized erythema and localized feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced large, red and hot local adverse event on the upper left arm and the patient thought it was related to SHINGRIX. The reporter was agree to follow up from GlaxoSmithKline.
Dizziness and lightheaded constantly since getting the shot, also have had tunnel vision and a head ache
Coughing; Lethargy; Headache; Joint pain; 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 COUGH (Coughing), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   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, 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 experienced COUGH (Coughing), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain). At the time of the report, COUGH (Coughing), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   Reporter did not allow further contact
Patient was diagnosed with COVID in May 5th 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient was diagnosed with COVID in May 5th 2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 011L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Seasonal allergy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient was diagnosed with COVID in May 5th 2022). At the time of the report, COVID-19 (Patient was diagnosed with COVID in May 5th 2022) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided. Symptoms of COVID-19 include cough and fatigue and patient called their HCP to seek medical care. No treatment medication were provided. It was reported that symptoms were improved.  Company comment- This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 6 months and 12 days after receiving the third dose of mRNA-1273 vaccine.  Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 6 months and 12 days after receiving the third dose of mRNA-1273 vaccine.  Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
her lymph nodes on her clavicle swelled; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right upper arm on 26Feb2021 (also reported as 27Feb2021) 12:00 (at the age of 48 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 04Mar2021 (reported as in the morning, like 9:00 AM), the patient experienced her lymph nodes on her clavicle swelled. It was reported that she received the first dose of Pfizer COVID vaccine on 27Feb2021 (also reported as 26Feb2021) on Saturday then 5 days later, her lymph nodes on her clavicle swelled and they were still currently swollen on 10Mar2021. Patient was wondering if she should get the second dose. She has a question due to having a reaction 5 days after the vaccine. Stated that her lymph nodes in her clavicle swelled, three of them swelled. One was the size of quarter and the other two were the size of a nickel. She was supposed to get the second shot in 20Mar2021. She was wondering if she should have concern regarding getting the second shot due to event that occurred. No history of all previous immunizations with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Vaccine administered at inappropriate site; Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   Previously administered products included Zostavax.   On 15th May 2019, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. In May 2019, 4 days after receiving Shingrix and an unknown time after receiving TETANUS VACCINE, the patient experienced rash. On 15th May 2019, the patient experienced vaccine administered at inappropriate site. The patient was treated with corticosteroids, dermatological preparations (nos) (Corticosteroid Cream). On an unknown date, the outcome of the rash and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The patient received her Shingrix vaccine on the muscle area on left side of the body below the waist, which led to .. On the same day, she received Pneumonia and Tetanus vaccine. About 4 days later, she developed a rash on the top of her foot. She visited her dermatologist on 25th May 2019 and was prescribed a corticosteroid cream. Her dermatologist was not able to figure out what kind of rash it was. The reporter consented for follow up.
Two days after second dose: a big contracture of the levator scapulae muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fatty liver" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 1, Anatomical Location: Arm Left , lot number: EP7534), administration date: 23Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: MUSCLE CONTRACTURE (non-serious) with onset 15Apr2021, outcome "recovered" (Apr2021), described as "Two days after second dose: a big contracture of the levator scapulae muscle". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26May2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of muscle contracture.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medication the patient received within 2 weeks of vaccination was reported as not sure, maybe Vitamin 1 a day for women 50+, and advil. It was reported that, two days after second dose: a big contracture of the levator scapulae muscle. Next day was gone. No headache nor fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (COVID test type post vaccination: Nasal Swab, Antigen). The patient reported that her niece was skinny and no liver disease and got same reaction to vaccine. The event was reported as non-serious. Device date was reported as 30May2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623895 same reporter, vaccine and AE, different patient
Right deltoid, redness and swelling within 30 minutes of immunization.  Benadryl 6.25mg given orally.
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating  pain down arm and tingling in fingers which continues into sixth day.  Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
Broke out with chicken pox on 06/29/02- generalized -approx 500 pox. Febrile prior  & 1-2 days post 101 degree F, rash was itchy, Felt miserable, Seen MD- Dx  chickenpox secondary to chicken pox shot, MD felt this was an adverse reaction because of how many pox this child had. symptomatic tx only.
Weakness, muscle pain, arthritis type pain, muscles and bones feel weak, joint pain, reports her hips feel like they are going out of place, reports this started after receiving second covid vaccine
Persisted extreme swelling of lymph node on left side of neck below the upper jaw; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 29Oct2021 at 14:00 (Lot number: FF8841) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8731; Anatomical Location: Left arm; Administration time: 14:00), administration date: 02Apr2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0164; Anatomical Location: Left arm; Administration time: 14:00), administration date: 23Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Persisted extreme swelling of lymph node on left side of neck below the upper jaw". The event "Persisted extreme swelling of lymph node on left side of neck below the upper jaw " was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for lymphadenopathy included prescribed Augmentin Anti-biotics.
Initial information has been received from an office staff member and follow up information has been received from a nurse concerning a female patient who in approximately January 2009 was vaccinated with the first dose of GARDASIL (lot # not available). The patient became lightheaded and went to the emergency room after receiving the vaccine (approximately January 2009). The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information has been requested.  In the follow-up the nurse stated that the vaccine was ordered by a nurse practitioner. The patient was 13 year old and was vaccinated with the first dose of GARDASIL (Lot # 659055/05060X) on 22-OCT-2008. The nurse reported that within 5 minutes of receiving the vaccination, the patient became dizzy and lightheaded. The patient complained of shortness of breath. The nurse practitioner evaluated the patient and had her transported to the emergency room. The patient was evaluated in the emergency room. The patient was wheezing and was given a breathing treatment. The patient was not admitted to the hospital. The patient had recovered and the following day returned to school. The patient becoming lightheaded was considered another important medical event by the reporter because the patient went to the emergency room. Additional information is not expected.
Syncope episode with jerking movements both sides of body. Lasted 30-45 seconds. Monitored closely after 30-40 minutes.
Entire left arm swelled 2 days after recieving 3rd Gardasil injection. Recieved ibprofen and ice.
pt woke up w/hoarseness, cough & clear runny nose, temp varies from 100-103.7, 1 bump under arm, 1 bump on leg;mom reports looking like chickenpox; t100 approx 10AM;
This spontaneous report as received from a nurse refers to a 12 month old male patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection (lot # and expiration date not provided) (dose not reported). It was reported that the patient received improperly stored (Oka/Merck) VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.