chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MODERNA COVID VACCINE #3 GIVEN 12/22/21, LOT #067H21A. MODERNA COVID VACCINE #4 GIVEN 6/16/2022, LOT # UNAVAILABLE. pt readmitted to SNF on 7/12/22 after hospitalization; during hospitalization, pt tested positive for COVID on 7/1/22; pt currently on O2 supplementation via NC; DNR; comfort measures only; pt found deceased in the SNF.
I received the first vaccine injection in a series of two for the Shingles. My Fibromyalgia muscle and joint pain became increasingly worse. It got to the point where I could not get a good night's rest due to pain. After much suffering I realized that I was due for my second shingles vaccine. That is when I became aware that my pain progressed after the first injection. I am not getting the second injection and I hope this pain goes away. The two step Shingles vaccine is not for those with autoimmune disease. This is my opinion.
Headache, Myalgia, Fever, Headache, left arm pain, all over body aches, and fatigue No, but had left arm pain and fatigue with 1st vaccine  Narrative:
nauseated, swollen hands, feet & face inj time 2PM 18FEB97;
Patient developed shingles following the 3rd dose of Moderna vaccine administered about 3 weeks before the onset of symptoms.
still got the flu; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who still got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had a non-serious event of still got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
p/vax pt had fever & swelling of groin;MD stated child had a bacterial infect d/t inject;swelling of lymph nodes inj site was OK;felt the infect was d/t vax or the way it was given;given ATB;swelling going down;
12/7/06- Call from doctor reported, states patient was seen and treated for cellulitis at injection site. 12/7/06 attempted to contact patient at number listed "No longer in service". 12/11/06 call to doctor reported, states she will have patient call me. 12/12/06 Have not received call from client. Call to doctor office number 12/18/06 no call from either physician or patient for status.
Dizzy any time the patient stood up or walked around; Unable to walk for a while; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021 at 18:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 17Apr2021 at 16:00, a little less than 24 hours after receiving the first dose, the patient became dizzy any time she stood up or walked around and it was nothing serious but did make the patient unable to walk for a while. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizzy any time the patient stood up or walked around and unable to walk for a while were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 02/23, Pfizer, dose #1 03/16, Pfizer, dose #2 08/02 COVID swab, result: NOT detected 08/19 pt cc: chills, cough, diarrhea, fatigue, fever, myalgias, rhinorrhea, dyspnea exposure: unknown 10/26 COVID swab, result: detected 10/26 clinically resolved 11/01 COVID swab, result: detected 11/01 CXR impression: No acute cardiopulmonary disease. 11/01 US EXTREMITY VENOUS impression: No evidence of LEFT lower extremity DVT. 11/01 human rhinovirus: detected
I broke with Covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2022 and was forwarded to Moderna on 29-Jan-2022.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (I broke with Covid) 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.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 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 COVID-19 (I broke with Covid). At the time of the report, COVID-19 (I broke with Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient had both the vaccines in September but broke with COVID Thursday.; Sender's Comments: This spontaneous case concerns a patient of unknown age/sex with no medical history, experience the unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273. The patient was tested positive for SARS-Cov-2. The dates of first and second dose were not reported. The treatment details were not reported. At the time of reporting the outcome was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Started with chill, then body ache all over.   At night I experienced audio hallucinations.  On the second night after the vaccine,  I heard my dad calling my name and woke me up from my sleep.   It happened twice that night.  Then the following night,  I heard my daughter calling for me and woke me up from my sleep.  I went back to sleep, then I hear my dad called for me again.  On Sunday night,  it happen again.  This time, my sister calling for me.  Every time it's loud and clear.  It stop after that Sunday night.  I didn't take any treatment.
infection @ the site of inj; needed ER visit on 22APR95; drainage of abscess & ATB for 10 days; Keflex given;
runny nose, upset stomach, muscle, h/a x 24hr, flu like sx-erythema @ inj site;
Rotarix-reconstituted formulation was administered to a 4 month old via IM instead of oral; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2339G, expiry date 01-FEB-2024) for prophylaxis.   On 13-MAR-2023, the patient received Rotarix lyophilized formulation (intramuscular). On 13-MAR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Rotarix-reconstituted formulation was administered to a 4 month old via IM instead of oral). The outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 14-MAR-2023 Nurse reported that Rotarix-reconstituted formulation was administered to a 4 month old via intramuscular instead of oral. MA(medical assistant) took a syringe from the office and drew the Rotarix out if the vial and administered intramuscularly.  RN called medical information for guidance and patient was due to come back in for follow up on 18-MAR-2023. The reporter consented to follow up. Rotarix-reconstituted formulation was administered to a 4 month old via intramuscular instead of oral which led to inappropriate route of vaccination.
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. On 03-JUN-2015 the two patients missed prescribed doses of unspecified frozen vaccine which may have been (Oka/Merck) PROQUAD (lot number and expiry date unknown)(dosing regimen and frequency unknown) for an unknown indication due to improper storage. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy unknown. The relatedness of the events to the therapy with (Oka/Merck) PROQUAD was unknown. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Woke at 4:30am with a pounding headache, every muscle and bone in my body ached. I was freezing and couldn't get warm. Site of injection was very sore. I had no temperature. Got out of bed at 7:00 am and still had a pounding headache and couldn't get warm without a blanket. Throughout the day I felt better but still had the headache, (I rarely get headaches and if I do they don't last). Went to bed at 11 pm 02 /22/2021 with a headache. Woke 02/23/2021 with a slight headache. I didn't take aspirin or anything else. but may later today.
not able to get the second dose; left arm felt numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (left arm felt numb) and PRODUCT DOSE OMISSION ISSUE (not able to get the second dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE ANAESTHESIA (left arm felt numb). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to get the second dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Numbness, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ANAESTHESIA (left arm felt numb) and PRODUCT DOSE OMISSION ISSUE (not able to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
large red rash on the deltoid around the injection site for 3 days and ongoing. pain when touched/laid on.
pt exp febrile seizure the morning p/immun pt had a fever & was taken to hosp; the attending MD recommended to watch closely when future immun given;
ADVERSE EVENT: This writer received a report with patient mother concerns that she is unable to get her daughter her second dose of the Moderna Vaccine. The report indicates patient received her first dose of the Moderna vaccine on March 29, 2021. Database indicates the injection was to the Right Deltoid -  Moderna Vaccine ? Lot #008B21A. The report indicates patient's mother has difficulty in getting her daughter vaccinated because she is not 18 years of age and no one would administer the second dose of Moderna. This writer received instructions from doctor to offer patient a second dose of Moderna or Pfizer.  This writer called patient's mother on 10.16.21 with this information and she accepted as well as patient. They will come on Sunday 10.17.2021 around 4:pm for her second dose of Moderna. This writer plans on greeting guests at that time. Apologies for this incident was given to both mother and daughter. Informed Doctor. TREATMENT: Mother reports that her daughter had no adverse side effects from the first injection. Patient was vaccinated 10.17.21 at 3:32 pm with the Moderna vaccine ? 15 minutes of usual observation offered and accepted.  OUTCOMES: Patient and parent provided vaccine education and materials and no untoward effects observed.
No adverse reaction; Got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Patient received a 3rd dose of Moderna vaccine. Patient has vascular dementia and did not remember receiving  the Moderna vaccine in the past. The daughter reported after vaccination the patient had already received 2 doses of Moderna vaccine a few months ago. The patient's only complaint since vaccination is soreness at the injection site.
Possible intussusception. The patient had 2 bowl movements with bright red blood. Patient was inconsolable during the first bowel movement. The patient was afebrile and otherwise well. An ultrasound was performed and did not reveal an intussusception. However, there was concern that the intussusception had already spontaneously resolved by the time of the ultrasound.
Suspected vaccination failure; Whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that last time the patient had Tdap vaccination and expereinced whooping cough. The patient stated he or she would nover receive vaccine again. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and lab test confirming whooping cough are not reported.
70-year-old man with no significant cardiac history. He was visiting relatives for the holidays today when he developed acute onset chest discomfort.  He presented to the local ER and was found to have inferior STEMI.  He was emergently transferred directly to the Hospital.  There was noted to be a subtotal lesion in the distal right coronary artery.  The right coronary artery is a moderate caliber dominant vessel which supplies a moderate area of myocardium and is 99% stenosed in the distal segment.  The lesion was predilated with a 2.5 mm balloon, stented with a 2.5 mm drug-eluting stent, and postdilated with a 2.75 mm noncompliant balloon with multiple inflations to burst rated atmospheres.  There was excellent angiographic result with reduction in stenosis from 99% to 0% residual and continued TIMI-3 flow down the vessel. Admitted to ICU for recovery.
Received flu shot at around 9:30 am on Sept 26, 2014. Shot was given by employee in her left arm. She has been having pain ever since from shoulder to elbow and limited range of motion. Taking MOTRIN 800 mg QD to ease the pain. Pt takes the flu shot every year.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 12-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is experiencing an enlarged lymph node on the right side of her neck. This was developed the day after the vaccination. She states she had the same reaction to the flu vaccination when she got it 20 years ago. She stated she had not gotten a flu vaccination since, but wanted to get it this year due to the Covid-19 pandemic
Received Pfizer vaccines on 4/1/21, 4/22/21 tested positive for COVID by PCR on 7/29/21 Onset date 7/26/21 w/  cough, fever, chills, myalgias, congestion; known exposure to COVID
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE, start date: 01Jan2000; ZOLOFT, start date: 13Oct2021. Past drug history included: Asacol, reaction(s): "known allergies Asacol", notes: known allergies Asacol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "recovered" (01Apr2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (19Mar2022) Negative, notes: negative rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient took Paxlovid from 14Mar2022 to 19Mar2022 for COVID 19 Treatment. Details were reported for Other medication in 2weeks product. Adverse event: Started paxlovid on day 1 of symptoms (fever, fatigue, sore throat, muscle aches). Near immediate improvement in all symptoms within 24-48 hours of starting paxlovid. Had a negative rapid antigen test in last day of taking paxlovid. 48 hours after stopping paxlovid had sore throat, cough, congestion. Not severe but lasted 4-7 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 to product and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Started menstrual bleeding in the middle of the night. This bleeding was about a week and a half before my expected period. It lasted for several hours then stopped for about 12 hours. It started again much heavier after the 12 hour break. I am still bleeding, though today (day 11) is much lighter than it has been for the past week and a half. I expect/hope to be done bleeding by tomorrow if it continues to lighten.
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself.   A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on  18Dec2020 12:15 at single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced  got red rash on my neck and chest  on 18Dec2020 12:15 with outcome of recovering ,  felt lightheaded  on 18Dec2020 12:15 with outcome of recovering ,  face and ears got red and  begin to feel warm  on 18Dec2020 12:15 with outcome of recovering , then  whole body felt really weird  on 18Dec2020 12:15 with outcome of recovering ,  lips went numb  on 18Dec2020 12:15 with outcome of recovering ,  begin to lose consciousness  on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours  could barely talk or open my eyes  on 18Dec2020 12:15 with outcome of recovering , felt so weak,  could not move my body on 18Dec2020 12:15 with outcome of recovering.  The patient was hospitalized for one day for all the reported events.   The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 18Dec2020  .   The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.