chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid-19 after vaccination; diagnosed with Covid-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 013A21A) 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 13-Dec-2021, the patient experienced DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination). At the time of the report, DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination) outcome was unknown.            No concomitant medications was provided by the reporter. Patient was diagnosed with COVID-19 and went to the infusion where patient received the package of stuff on 14 Dec 2021.  Company Comment: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 9 months after the first dose of mRNA-1273 vaccine administration. Drug ineffective was also captured as an additional event. Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow-up received contain No new information; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 9 months after the first dose of mRNA-1273 vaccine administration. Drug ineffective was also captured as an additional event. Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Abnormal menstrual cycle and possible miscarriage. Patient normally has regular 29 day menstrual cycle and had been trying to conceive prior to being required by employer's contractor to obtain  a COVID-19 vaccination. After receiving the first dose of the vaccine, patient's menstrual cycle began 5 days late with heavy flow, cramping, and unusual tissue discharge on the first day. 12 days of intermittent bleeding/spotting occurred despite normal period for patient lasting 5 days on average. Symptoms were reported to pharmacist on 9/12/2021 when patient returned for the 2nd dose of the vaccine. Pharmacist dismissed symptoms as stress unrelated to vaccine (though patient was not under any unusual stress) and recommended second dose of vaccine and follow up with OBGYN.. Patient reported symptoms at OBGYN annual checkup appointment. Physician recommended patient wait two menstrual cycles prior to further attempts to conceive.
dose had been administered outside of the 12 hour puncture viability window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains Dose details of suspect drug were added
No adverse event but employee had recieved dose 1 &2 of Pfizer,   booster shot should have been Pfizer also.  Moderna given by error.
15 min after shot while siting and waiting I began to have ringing in both ears and I have had it constantly  without any ceasing of symptoms.
CLIENT RECIEVED MODERNA VACCINE TODAY 03/21/210 AT 12:30PM. AFTER 415MIN HAD PASSED SHE SAW HER SKIN WAS RED AND BUMPY TO HER NECK, BACK AREAS. NO RASH TO ARMS OR LEGS. DENIES TROUBLE BREATHING OR TROUBLE SWALLOWING. STATES HAS HX OR ROSACEA. DOES NOT TAKE ANY MEDICATION FOR THE ROSACEA. MEDICATIONS TAKING CURRENTLY ARE LISTED ABOVE. DENIES ANY MEDICATION, FOOD, OR ENVIORNMENTAL ALLERGIES. WILL CONTINUE TO MONITOR CLIENT IN CLINIC FOR FURTHER REACTIONS. CLIENT AT THIS MOMENT 1:32PM IS SILL IN CLINIC, FEELING WELL WITH NO FUTHER REACTIONS. SKIN IS STILL RED AND BUMPY TO NECK AND UPPER BACK AREA. BP TAKEN AT 1:16PM WAS 126/80 P-73 R16. HAS NO OTHER MEDICAL ISSUES.
on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction or position.  he stated after vaccine administration  on 6/18/21 his arm was sore for 2 days (he stated he experienced average soreness like with any vaccine). Soreness went away completely and had no complaints, but noticed soreness again on 7/8/21 ,around area of injection site on and also sometimes when lifting or rotating arm. He stated he did lift some boxes/totes recently at home and it's possible the soreness could be from that; however, the soreness seems to be in similar area where he received the vaccine 3 weeks ago.
Itchy rash onher  injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash onher  injection arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy rash onher  injection arm). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash onher  injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not provided. The treatment medications were not provided.
At 6:30 pm on the date of injection, I became cold with chills and shivering.  Soon after, I had intense muscular pain in my upper, middle, and lower back.  My spine and rib cage also hurt immensely.  I took 1000mg of Tylenol and my usual dose of 10mg oxycodone and went to bed.  My fever was about 100.4 and rose to 101.6 within a couple hours but never went higher.  At 8:00 am, I woke up with very little pain and no fever, but did have the dry heaves for about 10 minutes.  As the day went on, the symptoms pretty much disappeared and I was eating normally with no side effects from the day before.  Within one day, September 3, I had completely gone back to my regular schedule.
Chest pain with tachycardia  and associated shortness of breath starting the day after vaccination and lasting for 4 weeks. Treated with aspirin and NSAIDS for 1 month. Suspected myocarditis as diagnosis
As was true of the first dose I received, I had chills, upset stomach, muscle aches.  Feels like having the flu or a fever.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
felt high and giddy; felt high and giddy; tested Positive for PCP in her blood test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EUPHORIC MOOD (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "felt high and giddy"; BLOOD TEST ABNORMAL (non-serious), outcome "unknown", described as "tested Positive for PCP in her blood test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mentioned that there might be a medication that can cause a false positive result for that according to her doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Profuse sweating, bloody/mucous diarrhea/vomiting x 2 days
Approx. 2 hrs and 5 mins post Pfizer vaccination , patient had a sudden change in her mentation , she was more confused and was unable to recognize his son . He refused to get into his son's car post dialysis . Vital signs all within normal limits , no other issues .
TOOK 2 DOSES OF VIVOTIF ON THE SAME DAY; This spontaneous case report (PVX2019-2888) was received from a pharmacist on 22-Nov-2019. It described a female consumer who "took 2 doses of Vivotif on the same day" (PT: Overdose), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: On an unknown date, the consumer took two doses of Vivotif and then stopped taking Vivotif.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took 2 doses of Vivotif on the same day (Overdose). The reason for taking two doses on the same day and further details of the event is limited. Vivotif dose should be taken every other day as per CCDS. Considering the nature of the event, the causality of the event overdose is assessed as not related to Vivotif.; Sender's Comments: A patient took 2 doses of Vivotif on the same day (Overdose). The reason for taking two doses on the same day and further details of the event is limited. Vivotif dose should be taken every other day as per CCDS. Considering the nature of the event, the causality of the event overdose is assessed as not related to Vivotif.
pt recv vax 8OCT96 &  noted earache, tingling feeling lt side of face;was seen @ hosp probable Bell's Palsy seen in office 10OCT96 confirmed lt sided Bell's palsy;initial lyme test in ER was reported as negative;
Dull pain from site slowly traveled to elbow, began approx 48hrs after injection.
No Adverse event; Went to receive 2nd primary dose more than 35 days; Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days), WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days) and WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days), WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days) and WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead).    No concomitant drug was reported.  Patient received first dose (Intramuscular) on Jan-2022. Reporter stated that patient did not tell them that patient needed the second dose.  No treatment drug was reported.
Fevers, abdominal pain, diarrhea after COVID vaccine. CT a/p: Colitis with dilated appendix. Patient was sent to the emergency room for further evaluation. COVID testing was negative on 1/18 and 1/24.
Bitten & scratched by feral cat which was not captured; pt recvd RIG 1st & 2nd dose; Following 3rd dose had dyspnea & itching which was relieved by epi; inject admin in ER;
Immediate tachycardia, hypotension, severe headache, dizziness, and rash. Was then dismissed from her workplace  Hospital to go to MAIN Hospital ER for evaluation since she is an adult. Was evaluated in ER and given steroid pack and sent home. She was seen in my clinic 2 weeks later with continued complaints--though less severe. This was after her first vaccine--will not be getting the second per my recommendation.
Two hours after vaccines, got headache, nauseous, sore throat. Added fever and body aches during the night. Headache and nausea remained through first day. Abated 2nd day, but headache, nausea, sore throat returned third day. Fourth day headache combined with nausea continues. Headache is so bad that it makes me ill to turn my head.
Patients office called to report an immunization allergy. The patient was seen by her doctor in response to a 4 inch diameter raised red area near the injection site.
p/vax pt devel blisters that looked like chickenpox spreading all over body;
second dose was given two weeks later after the first dose of the Fluzone-no ae; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 18 months old patient who received second dose, two weeks later after the first dose (inappropriate schedule of product administration) of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  two weeks later after the first dose[lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of product administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Abnormal menstruation following vax. Longer & heavier menstrual bleeding. Periods usually ~7 days light to moderate. After vaccines, period was 12 days and heavier than usual 1-28-21 to 2-8-21. Next period was 20 days of extremely heavy bleeding (most I've ever had) 3-5-21 to 3-24-21. And now it has been 6.5 weeks since that period with no spotting or period.
Redness, swelling increase warmth and blisters in the center. 9 cm by 11cm  Central blister area was 4x3cm.
tinnitus/worsening tinnitus; headache; arm was a little sore; felt a little woozy for a while; This is a spontaneous report from a contactable consumer (patient) and via Pfizer-sponsored program.  A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, intramuscular injection, Batch/lot number: EL9265, expiration date unknown) via intramuscularly on 05Feb2021 (at the age of 74-year-old) as 1ST dose, single for COVID-19 immunization. Medical history included tinnitus; she stated that she already had tinnitus before receiving the vaccine. The patient concomitant medication prior to receiving the vaccine included paracetamol (TYLENOL, Lot number: SCA037, Expiry date: Jan2024) 325 mg and took 2 for back was hurting. Patient stated that she received her first dose of the Pfizer COVID-19 vaccine on Friday, 05Feb2021. She had to drive to a facility that was 35 minutes away because her local hospital ran out. Her back was hurting a couple hours before the shot so she took two Tylenol 325 mg tablets for a total of 650 mg. She then went and had her vaccine and came on home. She read some articles published by well-known news sources (not on social media), and the articles said you shouldn't take something like Tylenol before receiving the COVID-19 vaccine because it could diminish the effectiveness of the COVID-19 vaccine. She reported that she took 2 Tylenol for back, as suggested by her doctor, a couple of hours prior to receive the vaccine. She was worried now because she has heard that this may effect how well the vaccine works. Patient reported that on an unspecified date she experienced side effects after received her first dose of the Pfizer COVID-19 vaccine which included worsening tinnitus (she stated that she already had tinnitus before receiving the vaccine), headache, arm was a little sore, felt a little woozy for a while, all resolved after the first 24 hours. Patient wanted to know if it was okay that she took tylenol before the first dose. She asked at the end of the call if tinnitus was included in the side effects since she was experiencing it. Patient verified she took Tylenol, she did not take an NSAID. She did not think Tylenol would hurt. However, she was now stressed out and worried about it. She stated that she has not been to the doctor in forever, she has not been really out in a year due to COVID. No further contact information was known. The patient makes the comment she hoped she could get the next shot. That whole roll out has been a mess. No PQC present. The outcome of the event tinnitus/worsening tinnitus was unknown, and all other events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6198) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Breast CA", start date: Apr2004, stop date: 2005; "lymph node dissection", start date: 2004 (unspecified if ongoing), notes: Bil mastectomies lymph node dissection and Reconstruction. Chemotherapy x RT 2004- 2005; "chemotherapy", start date: 2004, stop date: 2005, notes: Bil mastectomies lymph node dissection and Reconstruction. Chemotherapy x RT 2004- 2005; "Depression", start date: 2010 (ongoing), notes: Pertinent details: Trintellix-20mg 8 day, Abilify- 2mg 8 day; "Osteopenia", start date: 2000 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Time: 13:00, Site and Route of injection: Left Deltoid, Route of administration: Intramuscular, Batch/ Lot number: EN9581), administration date: 03Feb2021, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Sep2021, outcome "recovered" (2022), described as "A-Fib". Therapeutic measures were taken as a result of atrial fibrillation as Cardioversion x2 2022 and cardiac ablation 2022.
Very Sever sore throat with many follicles, nasal congestion, sever muscular pain, sever dry mouth,  sleepness due to sever sore throat,
Body aches, chills and fever of 100.8 started at 1800 the day of vaccine.  By 0900, 1/21/2021 all symptoms have resolved except temp is now 101.8.
Patient presented to clinic 2 days after injection stating she had a reaction to one of the two vaccines given to her. She had severely swelling and redness to right side from shoulder to below breast. She states she has not been able to use her right arm and missed 2 days of work due to the swelling. When I tried to shake her hand she couldn't lift her right arm/hand and offered her left arm/hand as a greeting.
This spontaneous report was received from nurse practitioner concerning a 3 month old patient of unknown gender. On 21-JUN-2013, the patient was inadvertently vaccinated with a pediatric dose (0.5 milliliter) of VAQTA (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
After two weeks, I have developed an extremely sore right arm. There is about a 4x4 inflation point. I have numbness through my entire arm and I can barely lift my arm.