chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (mild symptoms) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (mild symptoms). At the time of the report, ADVERSE EVENT (mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment and No Concomitant Medication was provided.   Requested the follow-up forms be mailed and declined email/fax capability. Mailing address provided   This case was linked to MOD-2021-022514 (Patient Link).
Tachycardia, pulse got up to 167. Had 2 bags of IV fluids and did come down to 130. 3 days of tightness in chest and pulse ranging from 58-167.
Received 3rd dose of Moderna. (Booster shot) Body aches, chills, headaches, double and triple vision, woozy, disoriented, light headed, coughed green mucous, pain in injection site.
chills, fever (up  to 101.5), and headache starting 6 hours after injection and lasting for 30 hours.
Narrative: COVID infection following COVID vaccine series 01/19, MODERNA, dose #1  02/16, MODERNA, dose #2 09/03 COVID swab, result: detected 09/03 pt cc: exposure: unknown 09/24 COVID swab, result: not detected
Sustained fever of 99.5-101 beginning at 1am,  around  17 hours after my shot. I began taking 1 Tylenol and 1 ibuprofen beginning at 8pm last night every 3 hours. My fever persists through the meds. I?m pouring in sweat sitting by a fan and eating ice chips after taking a cold shower. I can?t control the fever. I feel nauseous and like I?m going to pass out
Redness, swelling, pain, itching at the vaccine site left thigh (where KINRIX was given) very large reaction covering almost entire front of thigh.
30min p/vax pt very warm-very red face & neck w/hive like areas;no diff breathing or swallowing;BP 200/80-heart rate 84, resp 24;face appeared puffy;sent to ER tx w/med;exp sensitivity to cold w/hands swelling up;
sleeping more than ever before; vertigo; Brain fog; tired all the time/fatigus; dizziness; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (sleeping more than ever before), VERTIGO (vertigo), BRAIN FOG (Brain fog), FATIGUE (tired all the time/fatigus) and DIZZINESS (dizziness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 002C21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Seasonal allergy (No medicines taken).   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, 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 HYPERSOMNIA (sleeping more than ever before), VERTIGO (vertigo), BRAIN FOG (Brain fog), FATIGUE (tired all the time/fatigus) and DIZZINESS (dizziness). At the time of the report, HYPERSOMNIA (sleeping more than ever before) and BRAIN FOG (Brain fog) outcome was unknown and VERTIGO (vertigo), FATIGUE (tired all the time/fatigus) and DIZZINESS (dizziness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had Covid in Nov-2020 right around Thanksgiving. He did not go to a physician nor got tested but he had all the symptoms. He stayed home for more than a week and recovered. During the next year he had to take the vaccine. After the 1st or 2nd dose, it made him have all the symptoms again only this time it was less severe but the fatigue he experienced was the same. He had never been the same again, with brain fog and dizziness. He feels tired all the time and has been sleeping more than ever before. He can't get his motor running and he does not know why. He also states that he has vertigo and the time he was calling he feels really tired. He had MRI results were unknow and was given medicines for dizziness, but he seems not to be getting anywhere with it. His doctor does not know what was happening with him. He clarified that after the 2nd dose he felt the tiredness, brain fog and dizziness but the rest of the symptoms (symptoms he felt when he had the Covid) came after the 1st dose.  Company Comment This spontaneous case concerns an adult male patient with medical history of COVID-19 in 2020. And seasonal allergies who experienced the unexpected events of hypersomnia (AESI), vertigo, brain fog and other expected events in the context of a dose of mRNA-1273 vaccine. Primary schedule vaccination was administrated in appropriate schedule with the mentioned vaccine, After the 2nd dose he felt the tiredness, brain fog and dizziness but the rest of the symptoms (symptoms he felt when he had the Covid) came after the 1st dose. The medical history of COVID-19 is a contributor for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a physician via Pfizer (manufacturer report # 2016260779) regarding a female of currently 82 years old. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # were not reported) for prophylaxis. Other suspect include unspecified nonsteroidal anti-inflammatory drug administered on an unknown date for unspecified indication. On an unknown date the patient experienced drug allergies to ZOSTAVAX and nonsteroidal anti-inflammatory drug. Outcome of the event was not reported. Causality of the event with ZOSTAVAX and nonsteroidal anti-inflammatory drug was considered to be related.
This spontaneous report as received from a pharmacist concerning a 69 year old female patient with no pertinent medical history or drug reactions/allergies. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). The patient was not on concomitant therapies. Pharmacist reported the redness around the injection site was present on 29-SEP-2014 (reported as today). The pharmacist reported patient's outcome as "she's fine" in 2014. The patient did not seek medical attention or received treatment for the adverse event. No lab diagnostics test were performed. Additional information has been requested.
Developed induration and erythema at the site of the injection.  It enlarged daily.  When seen on the third day, it was approximately 10 cm diameter.  Mildly tender.  Did not interfere with activity of child.  No fever.  Advised cool compress to area.
Child previously immunized with 2 doses of VARIVAX developed varicella. Seen in office on 7/27/12.
This patient had a diagnosed ischemic stroke on 4-4-22. He could not be treated locally and was life flighted for treatment.
Information has been received from a licensed practical nurse concerning a 20 year old female, with asthma and an allergy to shellfish and iodine, who on approximately 08-JAN-2008 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. The patient was 4 weeks and 3 days pregnant when vaccinated. The patient sought medical attention. As of 01-FEB-2008, the patient was 7 weeks 6 days gestation. In follow-up, the nurse reported that the patient delivered a preterm, where the baby had some sort of "loss of amniotic fluid" and that had needed surgery. Subsequently, the patient whose estimated delivery date was 15-SEP-2008, delivered a vaginally on 06-AUG-2008 at 34 week estimated gestational age. The nurse reported that the patient was last seen in the office at her 32 week prenatal visit on 23-JUL-2008. The nurse was able to access the patient's chart information. On 05-AUG-2008, the patient had called the practice to report a significant decrease in fetal movement. She was sent to the hospital for a non-stress test (NST) and a biophysical profile (BPP) by ultrasound. The result of the BPP were that the patient scored only a 4 out of 8 and had amniotic fluid index (AFI) of 3.6, which is the diagnostic for oligohydramnios, and subsequently needed to be induced. She did not specify the results of the NST. It was also noted on the ultrasound at that time that the baby had a distended bladder with bilateral hydronephrosis and had an obstructed bladder outlet. And would require surgery after delivery. The patient was then sent to a major medical center where she delivered on 06-AUG-2008 and the baby had subsequent surgery (exact date of surgery not specified). According to the nurse, the mother was seen last week (week of 23-SEP-2008) and she was doing quite well at her postpartum visit and the baby was doing well and was at home with her. The nurse reported that she would offer the patient the informed consent sheet at her next visit. Upon internal review, premature baby, distended bladder, obstructed bladder outlet and bilateral hydronephrosis were determined to be other important medical events. Additional information is not expected.
Hospitalized less than 6 weeks after given last COVID booster.  She is admitted as inpatient on 1/12/21 for "vasovagal syncope vs. Cardiac arrest."
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to (Patient Link).
Large red  raised circle on arm... itchy rash at injection site... red hot cheeks periodically
Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister. Concomitant products included VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) had not resolved.            Treatment include Abreva topical ointment on it Action taken with mRNA-1273 in response to the events were Not Applicable
Information has been received from a physician concerning a 5 year old female who on 03 Oct 2002 was vaccinated with a dose of Varivax. Concomitant vaccine administered on the same day included a dose of DPT. On 19 Arp 2006 the patient broke out with about 100 varicella lesions. It was noted that the lesions were sparse and all over the patient's body. The patient did not develop a fever. The patient was given Benadryl for itching. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH99694) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteoarthritis" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 21Feb2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162b2, BNT162b2 omi ba.4-5  vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
itching/redness along trunk area Loratadine 10mg PO x 1 - itching resolved after dose
01/16/22 presents to ED for "OD". PMHx of "depression"
Tightening of throat, Benadryl 50 mg PO, symptoms resolved.
arm pain; 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.   Previously administered products included shingles vaccine with an associated reaction of pain in extremity (received 1st dose in October 2019, refer linked case US2023AMR067485).   In DEC-2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm pain). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was unknown.   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.   Linked case(s) involving the same patient:  US2023AMR067485   Additional Information: GSK Receipt Date: 31-Mar-2023 The reporter had the Shingrix vaccine in October 2019 and the 2nd dose in December 2019. The only issue they had was a sore arm. The reporter informed about his/her sister-in-law who had been dealing with the after affects of shingles for 2 and half years. Her shingles went into postherpetic neuralgia. The pain and anguish this woman had gone through was unbelievable.  She had shingles around her eye area and was just fortunate she did not lose her vision. She had been to countless doctors but still had the pain.  The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067485:same patient 1st dose
Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative.  Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
Patient stated on 10/19/21 that when she received her first COVID shot a couple days later, she had low blood sugar and had to go to the hospital by ambulance.
At her home, dyspnea, pulselessness, 1:30 am 10/26/21, treatment 911 per husband, CPR until relieved by medics, EKG indicated pulseless cardiac arrhythmia treated with cardio-conversion X3, intubated, transported to the Emergency Room.  Probable rhythm capable of some cardiac output.
Arm increasingly sore the evening I received the vaccine, started feeling feverish sometime after 11pm; woke up the next day (1/25)  at 8:30am feeling feverish, nauseous, full body muscle aches, intense pain in left arm (site of vaccine), developed 101.2 fever by 10am, experienced vomiting, diarrhea, intense nausea, fatigue, weakness, and muscle pain; pain increased at site of vaccine and spread to underarm and left breast (assuming swollen lymph nodes) and has been throbbing, developed headache; 1/26 fever broke around 9am and is down to 98.5, still fatigued and experiencing headache, muscle pain, swollen lymph nodes, intense underarm pain on side of vaccine, diarrhea, chills/sweating, developed swollen tonsils/irritated throat around 12pm but not feeling as weak today
Diluent given without powder; Diluent given without powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Diluent given without powder) and inappropriate dose of vaccine administered (Verbatim: Diluent given without powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 No additional adverse event details available as per health care professional. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received possible Menveo diluent without powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
COVID 19 Treatment/mild upper respiratory infection (uri) symptoms; COVID 19 Treatment/mild upper respiratory infection (uri) symptoms; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 at 09:00 as dose 1, single (Lot number: EK9231), in right arm, on 29Jan2021 at 08:00 as dose 2, single (Lot number: EL9261), in left arm, on 05Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 02May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ9944) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "recovering", described as "COVID 19 Treatment/mild upper respiratory infection (uri) symptoms"; COVID-19 (medically significant) with onset 2022, outcome "recovering", described as "COVID 19 Treatment/mild upper respiratory infection (uri) symptoms ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (07Jun2022) Negative, notes: Negative home test 2 days after completion of Paxlovid; (13Jun2022) Positive, notes: Symptoms and positive home test 8 days after completion of Paxlovid; (Jun2022) negative, notes: Development of covid symptoms after use of Paxlovid and negative test results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient started Paxlovid within 48 hours of mild upper respiratory infection (uri) symptoms with total resolution of covid symptoms within 36 hours of starting Paxlovid. Similar symptoms with Paxlovid rebound. The product Paxlovid was a COVID 19 treatment.  Paxlovid was started on 01Jun2022 and stopped on 05Jun2022.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
10/7/2022: Received both vaccines as mentioned above. 10/9/2022: Brought into emergency department (ED) for persistent hyperglycemia (blood sugar>500) despite normal dosages of insulin. IV fluids and additional subcutaneous insulin given. Chest x-ray normal, CT abdomen/pelvis done due to complaints of LLQ abdominal pain - negative for abnormality explaining the hyperglyemia. EKG normal. Negative for UTI or other signs of infection. Discharged back to assisted living facility (ALF) that night. 10/13/2022: Brought to ED for same Issue as on 10/9/2022, IV fluids given and additional Insulin given and discharged that night back to ALF.
Intestinal Cramping, fever, chills. Whole middle section of body aching. So painful I could barely get out of bed. The worst part lasted about 15 hours. I didn?t feel totally normal for a few days prior but able to function & do my normal life.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for COVID-19 immunisation; COVID-19 VACCINE (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: GABAPENTIN. Past drug history included: Ciprofloxacin, reaction: "Known allergies: Ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 24May2023 to 28May2023.   The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.
Induration, erythema 3.5 cm around, tenderness, pain entire shoulder region.  Self limited symptoms
Afternoon after am shot, mom called to report itchy rash on left arm with some swelling. Patient complained of knee and elbow pain.
Uncontrollable twitching on both the leg muscles (hamstring). Right leg: 28-Apr-2021 Left leg: 03-May-2021 Both legs: 04-May-2021