chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chills; Fatigue; Lethargic; Nausea; soreness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.  On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Apr-2021, the patient experienced LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea). On 04-Apr-2021, TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea) had resolved. At the time of the report, LETHARGY (Lethargic) outcome was unknown.            No concomitant medications were provided No treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Headache (30 min s/a administration), sore- stiff sensation from injection site to L occipital region. Malaise, chills, fever up 102 degrees. s/p 4 hours of administration, weakness palpitations (106 BPM @1355 hrs).
I am getting like a rash on my chest, it burns and it itches a lot, like both; I am getting like a rash on my chest, it burns and it itches a lot, like both; I am getting like a rash on my chest, it burns and it itches a lot, like both; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: SA7484), dose 1 intramuscularly administered in left arm on 01Aug2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin taken for diabetes. No prior vaccinations within 4 weeks. On an unspecified date in Aug2021, the patient was getting like a rash on her chest, it burns and it itches a lot, like both. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
severe arm pain in the arm that he got the injection/ left arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 029A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm). At the time of the report, VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.  It was reported that patient still has the pain even though it is 2 months out
Headache, Fever, Swelling/enduration/redness/warmth at injection site
Night 1: dizziness, poor balance, broken sleep Day after Night 1: dizziness, poor balance, mild headache Night 2: very heavy night sweat Days1 through 7: constipation, poor appetite, low food intake
101 fever; joint pain; injection site pain normal with the moderna booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster). At the time of the report, PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) The result was 101 with no units reported..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not reported.
Extreme pain all over body, nausea, vomiting, dizziness, headache, stomach ache, tingling/numbness of left arm
Patient received his Anthrax dose (6th) on 18 September and the following day complained of malaise, subjective fever ("feeling hot"), and noted pain/swelling at the vaccination site. He denies rhinoconjunctival, generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, neurologic, and CV symptoms. He notes a single loose stool. Today he feels the vaccinate site is improving and currently only complains of mild itching at the site. He denies prior adverse vaccine reactions.
This case was reported by a pharmacist and described the occurrence of fever in a 77-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date unknown) for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were reported as follows: The reporter described that patient had aches, pains, and fever following SHINGRIX vaccine to the severity that she was reluctant to get 2nd dose. The patient was telling others around her not to get the vaccine. The reporter agreed to be followed up. This case was linked with case US2018GSK190866, reported by same reporter.
quite painful, arm is still very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 24-MAR-2023, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: quite painful, arm is still very painful). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient interactive digital media. The patient had shingles once long ago and did not remember it being that bad.  The patient got the shingles shot on the day of reporting and the shot itself was quite painful and now, 8 hours later, patient's arm was still very painful. The patient was not sure if he/she had got the shot and he/she knew the pain would be so bad. The follow-up could not be possible as no contact details were available.
Extreme muscle fatigue in legs and arms. Difficulty walking and using arms for more than a few minutes at a time.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2016 the patient was inoculated with ZOSTAVAX (lot# and route unk.) vaccine by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injures and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Pt. was denoted while at work passed out in employee bathroom and she hit her head. It was also denoted she had a rash over 1/3 of her body.  She told the charge nurse that she didnt know what happen she was just getting ready to sit down to use the restroom and she blacked out.  Originally thought it was blood pressure related but her blood pressure was within normal limits.  Reactions are she passed out and rash.  She informed charge nurse she was going to see her primary on 06/16/2021.
Pt receiving first flu shot; during 15 minute observation time, pt c/o numbness and tingling, and feeling faint.  VS BP 118/78, P 84  Observed longer for potential further symptoms, but had none.
I had a sore throat, low-grade fever, I wasn't feeling good. Mom had tested positive for COVID-19, I went in to get PCR COVID-19 test, it did come back positive. I was prescribed the PAXLOVID, that I started that day. It took me couple of days to start feeling better. Even after taking the five-day regimen, I felt a bit off but I am now feeling better.
Patient had a potential allergic reaction to the vaccine. She felt a scratchiness in her throat after vaccination that would not go away. After waiting a few minutes, we administered an epi-pen to the patient. Symptoms went away. Patient refused 911 and left the pharmacy after administration.
About 24hrs after vaccines, pt w/ redness, warmth and tenderness increased redness 12 cm x6 cm, and came to clinic on 3/3, started on Keflex 500 mg 1000mg bid x 10 days.
Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 21 days past expiration.
Narrative: COVID infection following COVID vaccine series 03/30, Pfizer, dose #1 04/21, Pfizer, dose #2 12/29 COVID swab, result: detected 12/26 pt cc: fever headache, fatigue, body aches, sore throat, dry cough, CP, and dyspnea. exposure: son 12/29 pt admit ED cc: fever headache, fatigue, body aches, sore throat, dry cough, CP, and dyspnea dx: COVID LOS: 1 day 12/29 CXR impression: No acute cardiopulmonary findings. 12/29 CTA PE impression: 1. Negative study for pulmonary embolism diagnostic level of the proximal segmental pulmonary arteries. 2. No pulmonary consolidation. 12/29 DDIMER; 0.82 12/29 CRP: 1.008 12/30 LACTIC ACID: 1.53 12/30 FIBRINOGEN: 423 12/31 DDIMER: 0,58 12/31 ESR: 20 12/31 CXR impression: Right lower lobe cystic lesion. Recommend chest CT for further characterization 12/31 SARS-CoV2 igG: 0.15 1/1 CXR impression: Right lower lung zone cystic lesion of unclear etiology was better seen on the prior exam of 12/31/2021. Of note, this was not seen on the CT of 12/29/2021. 1/1 CT Chest impression: 1. Chest x-ray abnormality likely correlates to small area of scarring with bronchiolectasis at the right lower lobe base. No suspicious pulmonary nodules or masses 2. Very small amount of grouped peribronchial groundglass in the ligula is most likely infectious or inflammatory. Correlate with history and consider COVID testing. 1/1 FIBRINOGEN: 387 1/1 DDIMER: 0.43 1/1 ESR: 29 1/1 Procalcitonin: <0.05
pt began crying evening of shots;inconsolable crying for 3 1/2hr, non-stop;
This spontaneous report has been received from a mother who was referring to her daughter. The patient was an approximately 17 years old, not pregnant female with unspecified allergic reaction to penicillin, which started on unspecified date in the past, and with no pertinent medical history. In January 2013, reported as sometime in 2013, the patient was vaccinated with GARDASIL (lot not reported #) first dose, intramuscular (dose, strength not reported). There were no concomitant therapies. It was reported that after the daughter was administered the vaccine she was diagnosed with Hashimoto's thyroiditis, she experienced soreness of the arm, lost twenty pounds and she was losing her hair and appetite, adverse events onset date was reported as March 2013. It was reported that the patient was being monitored and she had blood drawn every sixty to ninety days (no results provided). The patient sought medical attention by office visit on unspecified dates. The patient did not recover from the adverse events. The relatedness between the adverse event and GARDASIL was not assess by the reporter. Additional information has been requested.
Patient was administered second dose in wrong location.  Pharmacist administered  too low.  Patient had large red skin reaction about 3 inches in size.  A follow up call 2 days later and patient is felling better.  Patient works at dr office and was looked at.
cyanotic episodes-hypotonia-eye deviation; hosp peds ICU;full work up done;
Arm swollen, tender with red rash gave Zyrtec 10 PO QD, Prednisone Pack
This spontaneous report as received from a healthcare worker, refers to a 5 year old child of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that in 2010, patient received the first dose of M-M-R II, 0.5 ml, subcutaneously, and on the same date received the first dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). On 02-DEC-2013, patient received the second dose of M-M-R II, 0.5 ml, subcutaneously, and the second dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). On 13-AUG-2014, patient received the third dose of M-M-R II, 0.5 ml, subcutaneously, and the third dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). No adverse effects were reported. Additional information is not expected since the physician cannot be contacted.
This spontaneous report was received from a medical assistant and refers to a 3-year-old patient. The patient's medical history, concomitant medications and drug reactions or allergies were not reported. On 14-SEP-2016, the 20-month-old patient, was vaccinated with the first dose of M-M-R II (strength, dose, route of administration and lot # with expiration date were not reported) as prophylaxis. On 07-MAR-2018, the patient, who was at that time 38 months old, was vaccinated with the second dose of M-M-R II (strength, dose, route of administration and lot # with expiration date were not reported) as prophylaxis. No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown.
12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel.  Said she felt like she had the "flu".
Fri night- stomach pain diarrhea  Saturday till present--very sore throat and chest congestion with yellow phlegm.   NO FEVER, NO LOSS OF TASTE OR SMELL
got shingles with vaccine/Suspected Vaccination Failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles with vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case  was received from the patient via  interactive digital media. The patient stated he/she got shingles along with vaccine twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Post vax, the patient complained of erythema, induration and increased warmth at the injection site. This is the second reaction of this type from the same vial of Pneumovax vaccine. No history of reaction before. DX: Allergic reaction to Pneumovax vaccine.
1PM sx started itchy watery eyes, SOB, trouble swallowing, itchy mouth, back spasms (explosive), diarrhea;adm to hosp;cough, SOB, itchy eyes, throat closing & diff swallowing;hard to stay cognizant;cramping;nausea;
Eight days after the 2nd dose of Pfizer Covid vaccine I developed a lump in  my groin that needed surgery.  After the surgery I was told the lump was a tumor on my lymph node and was diagnosed with Follicular Lymphoma.  Since the covid vaccine in April of 2021 my lympnnodes in my neck, groin and armpits have been enlarged and changing.  Never before the covid vaccine had my lymphnodes ever been an issue.  I believe the covid vaccine is responsible for my changing lymphnodes.
Bleeding Narrative:  Employee vaccinated with Triple J on 3/18/2021. On 4/11 developed a hematoma on right inner thigh which burst on 4/12 leaving large ecchymotic areas, about 4 x 6 inches with clearer central area which was the site of the original hematoma. CBC drawn, WNL, PLT = 234.
Cant raise arm, whole arm hurts, Pain on shoulder & neck, headache since last night, stiffness on left shoulder area.
1/26/21: Fever of 102F, bad chills, body aches in almost all muscles (did not exercise), headache, mild nausea and muscle continuously twitching in one leg for a few hours.  1/27/21: Fever of 101F, chills, body ache (did not exercise), mild nausea and headache.
Widespread pruritic rash/hives. Mother called in. Pt was given liquid Benadryl. Taken to family doctor. Advised not to obtain 2nd injection unless in his office.
Swelling under the left jaw; Swelling under the left arm (size of a baseball) after first dose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling under the left jaw), VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 09-Jan-2022, the patient experienced VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose). On 10-Jan-2022, the patient experienced SWELLING FACE (Swelling under the left jaw). On 09-Jan-2022, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 14-Jan-2022, SWELLING FACE (Swelling under the left jaw) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling under the left arm (size of a baseball) after first dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment information were reported.  Patient received Monoclonal antibody on 18-Sep-2021 to treat COVID-19. Swelling under the  armpit was a little better but still swollen. Patient stated that his father had Lymph-node Cancer and was worried because under the arm there was the lymph node.
Headache, Myalgia, NauseaVomiting, short of breath, injection site pain Narrative:  shortness of breath started 2/7/21 and continued through 2/11/21 nausea, myalgia, headache resolved within 48 hours injection site pain resolved by 2/11/21  Other Relevant History:
Moderna Covid Vaccine - Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Moderna Covid Vaccine - Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Moderna Covid Vaccine - Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Moderna Covid Vaccine - Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Moderna Covid Vaccine - Covid) to be related.    Concomitant medication list was not provided. The patient's doctor prescribed Paxlovid for COVID-19 and it had an alert about milk. Caller was asking if there was a lot of milk in there. The patient saw lactose listed and did not think it would be enough to set caller off. The patient declines to report, just wanted to know if it was ok for the patient to take. The patient stated this had been hell and had 4 shots, had 2 boosters. The patient had the Moderna COVID-19 vaccine for all doses.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. The patient was scheduled to receive paxlovid as treatment. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Product quality number added.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. The patient was scheduled to receive paxlovid as treatment. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.