chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 76 year old male patient with Chronic obstructive pulmonary disease (COPD), asthma, hypertension and rheumatoid arthritis who in 2002 was vaccinated with a dose of PNEUMOVAX 23 (Dose, route and Lot# Not reported) and on 12-08-2010 the patient received a booster of PNEUMOVAX 23 (Dose, route and Lot# Not reported). The physician stated that "around 11-DEC-2010" a few days after of PNEUMOVAX 23 booster administered, the patient experienced cellulitis. The area this presented on the patient's skin was traced with a marker. The physician also stated that on 13-DEC-2010 the patient was seen and the cellulitis had started to recede, KEFLEX was given as treatment for the event. At the time of the report the patient improved the cellulitis on therapy. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
First period on 9/11/21. Bled for 2 days. Then 15 days later started her next period. Doesn't remember how many days she bled. Got COVID vaccine dose 1 on 11/13/2021. 11/18/21 - bled for 2 days. 12/15/21 - started with heavy menstrual bleeding  - soaking a pad every 1-2 hours. Have had difficulty getting the bleeding to stop despite high dose OCP.  Evaluated by labs for bleeding disorders - labs normal, hematology evaluated and agreed no sign of underlying bleeding disorder. Normal pelvic ultrasound but with endometrial thickening. Awaiting input from GYN on next steps at this point.   No hospitalization required. Normal vitals. No anemia on labs.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 4:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 4:22 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 12-FEB-2022 16:22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had received the booster dose.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and lot number was no longer possessed.  No treatment medications were reported.
Extreme pain in entire left arm (arm where administered. Low grade fever of 101.  Extreme pain in the muscles of entire body especially neck for three days.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients were vaccinated with unspecified doses in series of GARDASIL lot # K010215, expiry date 05-MAY-2017 (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) on 06-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician's assistant reported that on 08-DEC-2012, the patient had injection site reaction consisting of redness, tender, warmth and indurations form shoulder down to the wrist. The patient was treated with INVANZ IV. The patient was evaluated at the urgent care clinic "over the weekend". A complete blood county, C-reactive protein and sedimentation rate test were performed (results not provided). The outcome of injection site reaction, from shoulder down to the wrist, warmth, tender and redness was unknown. The relatedness for injection site reaction, indurations from shoulder down to the wrist, tender and redness was unknown for PNEUMOVAX23. Additional information has been requested.
Pt. received Varicella vaccine 11-29-16. Within 24 hrs. vaccine became itchy, red "erythematous non-indurated area on upper right arm with TTP, no warmth of area" per Dr.
Soreness in the arm; dizzy; feels like everything is spinning around and stops, and then starts again; arm pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), VERTIGO (feels like everything is spinning around and stops, and then starts again), VACCINATION SITE PAIN (arm pain at the injection site) and MYALGIA (Soreness in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia and Osteoporosis. Concomitant products included ATORVASTATIN, LORAZEPAM, ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain at the injection site). On 03-Feb-2021, the patient experienced DIZZINESS (dizzy) and VERTIGO (feels like everything is spinning around and stops, and then starts again). On an unknown date, the patient experienced MYALGIA (Soreness in the arm). At the time of the report, DIZZINESS (dizzy), VERTIGO (feels like everything is spinning around and stops, and then starts again) and VACCINATION SITE PAIN (arm pain at the injection site) had resolved and MYALGIA (Soreness in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medication, osteoporosis injection in every 6 month and lucartamide for unknown indication. No treatment details were added.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received contains patient's address details. On 19-Jul-2021: Follow up received. Updated new non serious event as sore arm.
Coma; This case was reported by a consumer via call center representative and described the occurrence of coma in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced coma (serious criteria GSK medically significant). On an unknown date, the outcome of the coma was unknown.   The reporter considered the coma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was considered as adult as per vaccine indication. The patient experience the symptoms (exact symptoms or patient identifiers not provided) but were in a coma due to Shingrix. This case has been linked with case US2019201127, reported by the same reporter.
Started period 6 days after getting vaccine. last day of previous period was the day I received the booster; Off label use; Booster/ Dose received: 3; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant  female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Oct2021, the patient started period 6 days after getting vaccine. The last day of previous period was the day she received the booster. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started period 6 days after getting vaccine, last day of previous period was the day received the booster was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
It war reported, "Employee was given TD 0.1 ml intradermally instead of intended Tubersol. Upon reporting for reading of Mantoux, employee was found to have large area of erythema and 26mm induration. Reader felt this may be due to incorrect med administration." Reportedly the pt recovered from this experience.
After being vaccinated, patient fainted and hit her head on the counter. Pt was able to be aroused and mother was advised to take pt to redimed to check out head. While mother was checking out pt fainted a second time. EMS was contacted and pt was transported to local hospital.
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
My arm was very painful & very red. Had pains in my arm for 4 weeks. I tried allergy pills - no help. Called pharmacy & was told, no one else had this problem.
I got the shingles shot twice. Both times I got the shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shot and got the shingles. The reporter stated that, shingles were one of the many side effets from the covid shot and this was the reason why the patient's doctor advised not to take the covid shot. For tolerance to the 2nd dose of shingles vaccine refer linked case US2021AMR139344, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139344:Same reporter
Died four days after receiving vaccines for us apparent reasons. Autopsy pending. COD ruled as asphyxia, manner of death natural as per autopsy report
Headache, Neck ache, then Fever 3/13/2021 10:30 evening headache started thru the night, Sunday 03/14/2021 fever started thru out the day until Monday morning 03/15/2021 then slight headache again
PATIENT WAS GIVEN 0.25ML OUT OF MODERNA BOOSTER VIAL INSTEAD OF 0.5ML
The day after I got my first Pfizer shot I have the same similar dry cough; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. The patient previously took Lisinopril for reported indication high blood pressure and experienced dry cough. On an unspecified date, the patient reported event described as the day after got first Pfizer shot had the same similar dry cough. Where the patient experienced cough post dose 1 vaccination. The patient mentioned that she had her first Pfizer shot on 14th and then on the 8th she was supposed to get her second shot but she had. Patient got a dry cough, had first Pfizer shot (unspecified vaccine) on 14th and then on the 8th was supposed to get second shot but had, have had high blood pressure and had when first got on high blood pressure medicine, had Lisinopril which caused the dry cough and dealt with that for 3 months and then they switched medicines. Since the day after got first Pfizer shot have the same similar dry cough. Patient asked whether in Pfizer vaccination, was there any ingredients similar to what would be in Lisinopril. The outcome of the event dry cough was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 17-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included FLUARIX QUADRIVALENT and Hep A vaccine. On 6th October 2017, the patient received BEXSERO .5 ml. On 11th October 2017, 5 days after receiving BEXSERO, the patient experienced injection site warmth, injection site itching and injection site tenderness. On an unknown date, the outcome of the injection site warmth, injection site itching and injection site tenderness were unknown. The reporter considered the injection site warmth, injection site itching and injection site tenderness to be possibly related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. On 6th October 2017, the patient received a dose of FLUARIX QUADRIVALENT (batch number: 572KT, expiry date: 25th May 2018) in right deltoid and Hepatitis A vaccine (non GSK, batch number: N005796, expiry date: 26th May 2018) in left deltoid. The patient received a dose of BEXSERO at 4:30 in left deltoid. It was reported that the left arm was itchy and warm to the touch. The area measured at greater than 10 cc with tenderness. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.
pt states that he developed a pain in his abdomen.  He woke light headed, nauseated, had diarrhea and gastro intestinal issues but does not have fever.  PCP called the VA  today and was told to call us to make report and FU w/ them tomorrow if he isnt feeling any better.
Started getting a headache, dizzy, nausea about an hour after vaccination.  Approximately 30 minutes later, started getting hives around ankles and wrists.  Increased heart rate and palpatations.  Hives starting on right side of neck behind ear, starting around 2pm on 11/13/2009.  Took Benadryl to help with itching but with no positive results.
hives; sore arm; This is a spontaneous report from a contactable consumer (patient herself).  A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0177), via an unspecified route of administration, administered in Arm Left on 17May2021 at 12:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism and allergy from gluten, penicillin, dust and mold. Concomitant medications included levothyroxine sodium (TIROSINT) taken for hypothyroidism. The patient previously took penicillin and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives and sore arm on an unspecified date. Patient reported that it was unclear if hives was from his external and food allergies or the shot. Patient started taking antihistamines prior to Dose 2 and the hives cleared up. Therapeutic measures were taken as a result of hives and sore arm and patient was on Claritan. The outcome of the events was reported as not recovered.  Follow-up attempts were needed. Information on Lot/Batch number was available, additional in-formation has been requested
Clinic visit on 3/19 reported feeling very fatigued the following 48 hrs after COVID vaccination then symptoms continued to progress over last 4-5 days. Reported headache, body aches, chills, decreased appetite, fatigue, nausea, fever, mild cough. Treated with Cipro pending urine culture. Presented to ER 3/20 for positive blood cultures, admitted to hospital, treated with Gentamicin and Zosyn discharged home 3/24.
Severe sepsis with septic shock. Oral surgery was consulted 03/14/2022 and recommended teeth extraction (#22 and #28). He went for extraction on 03/19/2022 when PLTs >50,000.  Apixaban was resumed.Per recommendation, patient's PICC was replaced prior to discharging, unasyn IV and flagyl PO until 03/28/2022.  He is scheduled to follow up as an outpatient. He developed wounds on his buttocks and Wound Care/Ostomy Service saw him weekly. Treated with saline, gauze and mepilex. He will follow up with doctors as an outpatient.  Patient was stable and on oxygen (4L) at time of discharge to SNF. Hospital admission within 6 weeks of receiving the COVID vaccine.
facial flushing, lip/ear numbness, SOB Narrative:  Pt received first dose of COVID-19 vaccine (Pfizer) on 4/2/2021. Within 10 mins, reports facial flushing, sensation of SOB, nausea, and lip/ear numbness. No hives noted. Patient given famotidine 20mg at time of sx. Monitored pt for 1 hour. Pt reports hx of anxiety regarding the immunization and extensive anxiety hx in general. ID consult placed, ID physician felt sx likely related to anxiety.
Daughter shows signs of long term effects.  Birth date 7/22/17 birth weight 6lbs 15oz. Pregnancy was healthy and normal
This spontaneous report as received from a consumer refers to a male patient of unknown age. In September 2014 (exact date unspecified) the patient was vaccinated with the first dose and in October 2014 (exact date unspecified) the patient was vaccinated with the second dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) that were exposed to out of range temperatures before they were administered. No adverse effects were reported. Additional information is not expected because there is no contact information to do a follow-up with.
h/a severe flu & sinus infection, ear plugged; APAP extra strength w/o relief; MD ordered Ceclor for sinus infection & Erythrmycin 24FEB93; pt recovered;
Woke up with headache, nausea, body aches, and muscle pain from injection site up through left side of neck. I'm even a little light headed.
This spontaneous report as received from a pharmacist refers to a 34 years old patient. The patient was inadvertently administered with ZOSTAVAX (subcutaneously, Lot #, dose unspecified) on 19-NOV-2012. No adverse effects reported. No treatment information was reported. The outcome was unknown. Additional information is not expected.
Temp > 100.6, small localized vessicular rash at site of injection 10 days after, also with fluid filled blisters s/p injection as well.
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization.  No adverse events reported after vaccine administration.
Immediately after vaccination, there was a small amount of bleeding followed by swelling and bruising at injection site
Myopericarditis following COVID-19 Booster Dose; This is a literature report for the following literature source(s).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "unknown", described as "Myopericarditis following COVID-19 Booster Dose". The event "myopericarditis following covid-19 booster dose" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: diffuse st changes; left ventricular end-diastolic pressure: 55 %; troponin: less than 0.01.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Soon after my first  dose of the Covid vaccine I broke out with reoccurring HSV-2. My best friend also had the same experience after both doses, although she broke out with both cold sores and genital. We both use Valtrex for outbreaks and it did not seem to work as well as normal. I actually thought the first outbreak was over and another sore started wailed taking the valtrex . This happened to my friend as well. We are still both fighting the outbreaks.  The outbreaks are more severe than usual.  I just had my second dose yesterday and already feel nerve pain and new sore beginning.