chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Hand arthritis), SPONDYLITIS (Back arthritis), COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Hand arthritis), SPONDYLITIS (Back arthritis), COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness). At the time of the report, ARTHRITIS (Hand arthritis) and SPONDYLITIS (Back arthritis) had not resolved and COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness) had resolved. No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication information provided. Company Comment: This is a spontaneous case concerning a 48-year-old patient of unknown gender with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, Spondylitis and COVID-19, on unknown date after receiving 3 doses of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the events, clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Arthritis and Spondylitis had not resolved while the event COVID-19 had resolved. Medical history of Rheumatoid arthritis remains a risk factor for the events Arthritis and Spondylitis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 48-year-old patient of unknown gender with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, Spondylitis and COVID-19, on unknown date after receiving 3 doses of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the events, clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Arthritis and Spondylitis had not resolved while the event COVID-19 had resolved. Medical history of Rheumatoid arthritis remains a risk factor for the events Arthritis and Spondylitis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
rapid heart beat; Chest tightness; massive pressure in rectum; Weakness; Headache; heart rate lingered; asthma; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269, expiry date: not provided), via an unspecified route of administration on 9Feb2021 (Age at vaccination: 55 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included ongoing hemorrhoids. The patient Concomitant medications were not reported. On 9Feb2021, the patient experienced rapid heart beat. On an unspecified date, the patient experienced Chest tightness, massive pressure in rectum, Weakness and headache. It was reported that she received the Covid-19 vaccine on 09Feb2021. After receiving the vaccine she experienced a rapid heart beat. Her heart beat is usually 78. Her heart was fluctuating at 99-100 beats. She has asthma, predetermined. She didn't use her inhaler because she didn't know what it would do. She had chest tightness. She called because she read that severe reactions of the vaccine are increased heart rate. She is asking should she not get the second dose because of the increased heart rate? In the past she has had hemorrhoids. Since getting the vaccine she has had massive pressure in her rectum. She also experienced weakness and a headache. Is increased heart rate a severe reaction to the vaccine? She is unsure about getting the second dose. Her heart rate lingered. It was still there the next day but had decreased before it was back to normal. The lab test included test: Heart rate irregular, result: usually 78,fluctuating at 99-100 beats,increased (lingered,next day but had decreased before it was back to normal) on an unknown date. The outcome of rapid heart beat was recovered on 12Feb2021, while outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Initial misuse report received from a healthcare professional on 24 July 2013. A child was administered only the DTaP/IPV component of PENTACEL vaccine and ACT-HIB component was not administered. No adverse event was reported. Documents held by sender: none.
first dose of Shingrix series greater than 2 years ago / never returned for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient did not remember date of first dose and pharmacist unable to find it in state database. The pharmacist did not have lot number or expiration date of first dose. The reporter consented to follow up.
itching; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and SWELLING (swollen) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PRURITUS (itching) and SWELLING (swollen). At the time of the report, PRURITUS (itching) and SWELLING (swollen) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID 19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Information has been received from a health professional concerning her 7 yr old daughter who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt had a mild breakthrough of varicella. It was noted that the pt does not have any pox on her body at the present time. the pt's status was reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Anaphylactic reaction requiring medical attention.; This is a Spontaneous case report received from Pfizer Sponsored Program, from a contactable consumer (parent).   A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 09Jun2021 at 19:30 as dose 2, single for covid-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2, administered in left arm for COVID-19 immunization received on 19May2021 at 19:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination includes dentist twilight sedation. On 11Jun2021 at 12:00, the patient experienced anaphylactic reaction requiring medical attention (medically significant). Pregnazone shots, steroids shots were received as treatment for adverse event. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 13Jun2021. Therapeutic measures were taken as a result of anaphylactic reaction requiring medical attention. The adverse events resulted in Emergency room/department or urgent care. Device Date: 14Jun2021. The patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of therapy non-responder in a 17-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and HBV (ENGERIX B) for prophylaxis. Concurrent medical conditions included lung transplant (patient on list for lung transplant.). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On 30th January 2019, the patient received ENGERIX B 1 ml. On 30th January 2019, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and unknown after receiving ENGERIX B, the patient experienced underdose. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and underdose were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. Additional details were provided as follows: The patient was on list for lung transplant. The patient received a complete Hep B series as an infant. On 30th January 2019, the patient received ENGERIX B 20mcg/ml, 1 ml since, office could not verify doses given as an infant, which led to an underdose. The Anti-HBs titer was drawn and was not detectable or less than 10 mIU/ml, which led to therapy non-responder. Recommendations do not support the dose given to this patient (IDSA Clinical Practice Guidelines for vaccination of the Immunocompromised Host) state the patient should have received a 40mcg dose. The reporter did not agree to be followed up.
Acute onset shortness of breath approximately 11-12 hours post second dose of Moderna covid vaccine. EMS responded and briefly performed CPR before DNR was produced and life saving measures were discontinued.  Patient subsequently expired.
p/vax pt devel nasal stuffiness w/in 2hr;congestion & localized rxn;
my stomach is just killing me, I mean it is just upset; It just hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 14Jul2021, outcome "unknown", described as "my stomach is just killing me, I mean it is just upset"; ABDOMINAL PAIN UPPER (non-serious) with onset 14Jul2021, outcome "unknown", described as "It just hurts".  Additional information: Patient had the Pfizer shot the 14th and her stomach was just killing her, she meant it was just upset and wanted to know if that a side effect as she did not knew it that was because of the Pfizer shot or what her stomach truly upset on that day and it was been like 14, 15, 16, 17,18, 19, she meant 6 days and also stated "It just hurts, I don't know if it is you know something else is wrong with the stomach bile or it's a side effect from that."(Not further clarified). It was not clarified if lot number is FA6780 and expiration date is 14Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Directly after the vaccine, patient was flushed and nauseated. Started coughing up phlegm.
Left arm injection site area red, warm, swollen- approx. size of baseball. Tender to touch. Child with fever, n/v, or diarrhea. Pt. presented to school nurse.
Patient received influenza vaccination and while walking to waiting room patient passed out.  Patient turned pale and mother carried him back to a room.  Vitals were monitored and legs elevated.
Patient was in to see Doctor for a well visit today.   Grandmother was in with pt and advised the physician that she had not had her COVID vaccine and would like to get it today along with her 11 year wellness vaccines.  The vaccines were ordered and LPN gave her the Pfizer COVID (12 and older) vaccine along with her Tdap and Menveo.  The Pfizer COVID (12 and older) was mixed and given by LPN.  Mom called back to our clinic after pt had left and advised other staff that she had just received her COVID vaccine last week on 11-8-21.  Doctor called and discussed with mom.  Pt had in fact gotten her 1st dose Pfizer COVID (5-11 yrs) vaccine on 11-8-2021 and then received a 2nd dose on todays date.
5JUL94 mom noted area on lt upper thigh reddened about 3cm-MD dx delayed hypersensitivity DTP-HIB given together 8 days ago;
Patient provided incomplete vaccination record of COVID-19 series. Dose series was discovered post administration. Patient received a 5th dose of the Pfizer vaccine. Monitoring conducted for 15 minutes post administration with no significant signs or symptoms. Counseling was performed on common adverse events and potential for myocarditis and pericarditis. Any follow-up to be conducted by patients primary care physician.
Information has been received from an office manager regarding to a 67 years old male patient with diabetes. On 12-NOV-2012, the patient was vaccinated with, 0.5 cc dose of PNEUMOVAX23 INJ, intramuscular, (Lot number reported as H01339, expiration date 07-MAR-2014). No other co-suspects were reported. Concomitant medications included LANTUS, ALTACE, AVODART, ENABLEX, FLOMAX, glimepiride, losartan potassium (manufacturer unknown), NASACORT, NASONEX, NOVOLOG, TRICOR, VYTORIN and ZYRTEC. On an unknown date, the patient experienced swelling, tenderness and pain at the injections site. The office manager reported that all the events were better now. The patient sought medical attention, consulted office. At the time of the report, the patient was recovering from the adverse events. Additional information has been requested.
Got GBS from it (flu shot); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that her doctor said she must not get flu shots, ever again. Because the patient once got GBS from it, which would happen each time. Additional supportive information:  This case had been linked with US2023AMR017300 by same reporter for multiple patients. Follow-up would not possible as no contact details were available; Sender's Comments:  US-GSK-US2023AMR017300:Same reporter
constant coughing, tightness in throat, inflammation of eyes 2hr p/vax & lasted 24hr then resolved;
This spontaneous report as received from a physician refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot # not reported). The physician report that the patient (anonymous) experienced hair loss after receiving the GARDASIL. The patient saw a dermatologist for medical attention. The outcome of hair loss was reported as not recovered. Additional information has been requested.
Fever (101), wheezing with some respiratory distress. No history of asthma or wheezing in past.
Pt developed a warm tender lump on her (R) delt, the location of the imm, which developed within hours of the imm.
Patient felt dizzy, tired, lost sensation in hands, felt that she might pass out.  I had patient recline back in car seat take deep breaths assessed patient. Patient drank some water had granola bar since she hadn't eaten in awhile.   Vitals: Symptoms Onset SpO2: 98% Hr: 80  10min. after symptom onset SpO2%: 99% HR: 65
No adverse event; Pediatric dose was given to adults mistakenly; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    No concomitant medication information was provided. It was reported patient received the error dose with instruction to re-vaccinate 2 months from the initial error doses. Treatment information was not provided. This case is of patient 90th out 104.
Felt fine after leaving vaccine site. Went to the beach to swim and had dinner w 4 beers over a 3 hour period and still felt fine.   Got into bed feeling heavy fatigue and then had fever sweats, body aches and intense fatigue through the night. Woke up 3 hour late for my daily responsibilities in a fog and daze. Feeling foggy and dazed with light body aches and fever seems to have subsided.
The Day Of: slight headache and body aches, chills Next day: slight headache, fatigue
Severe brain fog; headache; body aches; chills; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: nuts" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: DILANTIN [PHENYTOIN SODIUM]; PHENOBARBITAL. Vaccination history included: Bnt162b2 (Dose 1, Administration time: 10:00, Anatomical location: Left arm), administration date: 05Mar2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Administration time: 10:00, Anatomical location: Left arm), administration date: 26Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021 12:15, outcome "unknown", described as "dose received: 3"; FEELING ABNORMAL (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "Severe brain fog"; HEADACHE (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 09Nov2021 14:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of feeling abnormal, headache, pain, chills.  Additional information: The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 38 years1 month. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter.
A 15 year old adolescent, developed back and side aches, 5 days, post vax. On the 6th day, she complained of painful deep breathing, sore throat, and a fever of 101F. Numerous complaints of fever, headache, leg aches, low energy, loss of appetite which lasted 5 days (8/11/01 to 8/16/01).