chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VERY COLD WITH SHAKING FOR ABOUT TWENTY MINUTES.  FEVER AT 100.1 WHICH WAS GONE BY MORNING. THE NEXT NIGHT FEVER AT 99.1 NO OTHER PROBLEMS
Dark red bump next to injection site that increased in size from about 1 inch to 3 inches in size
Pain and soreness in arm. Patient has described as "tendonitis-like pain" starting shortly after receiving the vaccine and ongoing (until time of this report- 11/18/23)  Patient has not gone to seek treatment.
first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) had resolved.            No concomitant and treatment medication was reported by the reporter.
Rash appeared on wrist and fingers, lower stomach and thigh area itchy with rash.
Significant swelling and redness to the arm, extending from site up to shoulder and down to elbow.
Pt received a covid vaccine that was 8 hours expired.  Manufacturer is being contacted to see what the stability and recommendations are for this type of error.
A few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it.; Stomach pain; Back pain; Most joints in extreme pain; most muscles in extreme pain; extreme migraine, (could not brush hair on head due to causing extreme migraine pain); shortness of breath; fever; chills; chest pain; Urinated with extreme Frequency; unable to move left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in the left arm on 28May2021 17:30 (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination was administered was other. Medical history included asthma only from pollen, deathly allergic to Pollen, known allergies: Onions, raw carrots. The patient concomitant medication was not reported. The patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 17:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28May2021 17:30 the patient experienced a few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it, stomach pain, back pain, relived pain from some athletic injuries that were healed up in the past, but 10 times worse, most joints in extreme pain, most muscles in extreme pain, extreme migraine, (could not brush hair on head due to causing extreme migraine pain), shortness of breath, fever, chills, chest pain, the pain was the worst I have ever felt, urinated with extreme frequency, unable to move left arm. The patient underwent lab tests and procedures which included body temperature resulted 101.7 on May2021, oxygen saturation resulted 92 on May2021 O2 level at 92. The clinical outcome of the events was reported as recovered on an unspecified date in May 2021.  Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "ankylosing spondylitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: REMICADE; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (03Oct2022) Positive, notes: retested positive for Covid 4 days after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19, off label use, immunisation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash that started on abdomen and spread outward over entire body. Used Benadryl cream at home without relief and at that time went to ER where she was given Epinephrine SC. Diagnosed with allergic reaction and sent home with instruction for Benadryl 25mg PO.
Information has been received from a consumer, who reported that "his friend, a male, was diagnosed with shingles not long after receiving ZOSTAVAX", in August 2007. He had a very mild case of shingles on his lips and he recovered from it quickly. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Minutes after getting the shot, I started to feel paresthesias in different parts of my body, the first one being some burning sensation & very slight pain in a buttock which I self-injured about a year ago (when I injected myself with Toradol & Norflex and since then have had pain & some numbness). Every tingling and/or prickling sensation I felt lasted only very few seconds, it was on different parts of my body (specially arms & calfs), and the whole episode lasted only a few minutes.  Could this have been possible, or was this a product of my imagination?  I wasn't "looking" for any adverse reaction, I just started to feel this, and suddently it came to my mind that this could be an effect from the vaccine. It lasted for only very few minutes, and I just thought you might want to know about this.
Information has been received from a consumer concerning his girlfriend with no medical history or drug allergy who on 22-JAN-2009 was vaccinated with the first dose of GARDASIL, 0.5ml.  There was no concomitant medication.  Subsequently the patient developed redness and itchiness at the injection site.  The patient did not perform any lab diagnostics study.  At the time of the report the patient was recovered.  The patient did not seek medical attention.  No further information is available.
Four days post vax, pt experienced swelling of the right wrist, painful right hip, generalized muscle tenderness and difficulty walking. WBC 9100, differential was normal; ESR was 23; rheumatoid factor was less than 1-20 and a mono spot test was negative.  Pt was treated with aspirin and recovered within several weeks. Follow-up information states that no further information is available.
Covid-19 after BNT162B2 vaccination; Covid-19 after BNT162B2 vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid. Patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 after BNT162B2 vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 16Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
This spontaneous report as receivfed from a physician assistant refers to a 12 year old female patient. On 24-JUL-2014, the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. The physician assistant reported that on 26-JUL-2014, the patient experienced small bumps at the injection site. The pyatient was treated with BENADRYL and the bumps resolved on 02-AUG-2014. Additional information is not expected. There is not permission to contact the physician.
She complained of muscle and joint pain - whole body, nausea, felt hot the day after her shot. Passed out around 7:30 pm that evening.
broke out w/red rash on Sunday 2JUN;ran a fever;rash is clearing 5JUN96 according to mom;
Approx. 24 hrs after, right arm below where vaccine was given turned red, very sore, started swelling and kept spreading till it completely covered my right upper bicep and large portion of right upper arm.
Headache, generalized fatigue, area of redness at injection site, warm to the touch - states started evening of injection  States remembers having similar reaction as a child but can't remember what the injection was.  After discussing with her mother it was discovered it was after DTP injection and arm redness was more sever than current reaction.  Referred employee to Prevnar 13 VIS that was given at time of injection regarding contraindication with Prevnar 13 and diptheria toxoid.  Employee states has not had any issues with Td booster since childhood reaction.  Employee offered appointment with occupational health physician or PCP declined stating if arm redness became worse over the weekend she would make an appointment.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reports as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 2 years old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of VAQTA LOT # J005010 and expiry date 23-OCT-2015 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
pt says about 30 hours after getting the 1st covid vax she had muscular pain all over her body but extremely bad in the lower back and was unable to walk.   She had trouble getting around due to the intense pain and has not been able to sleep more than 4 hours per night yet feels very tired.  She has a head ache along with restless muscles. She had a flare up of her skin disease. These symptoms were still present but was getting better when she got the 2nd dose of the covid vax on 5/20/21 (right arm Lot# 039B21A).  About 24 hours after getting 2nd dose she developed all of the same symptoms she had after getting the 1st dose but more aggressive.  She spoke to Dr. and he told her he could up her prednisone meds which she decided not do.  Pt says she feels like her symptoms are slowly  improving at this time.
patient received an expired dose / exp 08/01/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received HAV (Havrix) (batch number BE5554, expiry date 1st August 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 detials were provided as follows: The patient received dose of Havrix in the left thigh. The reporter stated that, the patient received expired vaccine of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Case number PHEH2014US002075 is an initial spontaneous report received from a pharmacist on 27 Jan 2014. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13465P) intramuscularly on 25 Jan 2014. On 27 Jan 2014, two days after vaccination, he experienced small red blotches on his face. It was reported that around the same time of vaccination, he also started using a new hair care product. Outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
Child collapsed to ground, eyes open, unresponsive for approximately 10-20 seconds, eyes with absent stare and then closed. Child head and shoulders cradled and  child regained consciousness; then appeared pale but able to talk and answer questions appropriately.
Pt recvd 2nd dose of vax 5DEC91 & immed exp fatigue, h/a, fever & nausea; also devel lymphadenopathy, oral thrush & abdo pain; also devel oral candidiasis;
Patient received Moderna COVID vaccine at nursing home on 5/4/2021.  Patient developed facial swelling, mouth pain, dysphagia and was admitted to Hospital Center on 5/8/2021 with bleeding from mouth.  Patient denied any new medications, sick contacts or travel.  Lab results revealed pancytopenia, high AST/ALT, Bilirubin, Hepatitis B antigen +, Hepatitis B PCR 1601 IU/ml.  Patient had multiple bleeding events.  Bone marrow testing was consistent with aplastic anemia.  Patient was treated for re-activation of hepatitis B and aplastic anemia.  Hematology consult think that COVID 19 vaccination induced aplastic anemia or COVID 19 vaccination caused re-activation of hepatitis B that induced aplastic anemia.  Patient is still hospitalized at date of this reporting 6/3/2021
Child's face, hands, neck glands were swollen, no fever, nor irritability; Taken to MD told child had rxn to vax; Tx DPH;
Dose #1  Pfizer 3/22/2021 Lot # ER2613  pt currently has covid 19 8/8/2021
SORENESS AT INJECTION SITE; SHORTNESS OF BREATH; VOMITING; NAUSEA; FEVER; CHILLS; JOINT ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint aches. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, joint aches, fever, chills, nausea, shortness of breath, soreness at injection site and vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Limbs falling asleep easily, tingling, ringing in ears, nausea, headache.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with one dose of 0.65 ml ZOSTAVAX (lot number 672429/1606AA, expiration date 13-JAN-2013) (expiration date 30-APR-2012 as reported) subcutaneously on 15-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-MAY-2012 the patient experienced expired dose of ZOSTAVAX administered. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional is not expected.
Narrative: 65 yo male with NICM, EF 20% s/p AICD, prior hx of chronic ETOH use in remission, severe tophacious gout on chronic prednisone, admitted with progressive dyspnea, cough productive of yellow sputums, weakness with a recent fall patient reports that he has visited 3 different ERs in the past week due to these same sx, as told at outside ED that he had COVID after an all day ER visit, but d/c to home. patient had both covid vaccines. ROS positive for loose stool, absent for any abdominal pain, negative for n/v HOSPITAL COURSE: 1. Acute COVID-19 pneumonia -CXR with bilateral infiltrates -Patient never actually required any oxygen and was never hypoxic and the patient's main symptoms were generalized weakness -Patient did undergo a CT scan on the inpatient setting it was fairly unremarkable -Patient is already on chronic prednisone at home and this has not been increased -Patient is not a candidate for remdesivir in the setting of his GFR being around 20-25 -Patient was evaluated by physical therapy and the recommendation was for rehab, the patient was medically stable for days but needed 10 days of quarantine 2. Acute bacterial pneumonia -Certainly possible given the chest x-ray findings as well as the elevated white blood cell count that the patient does have a superimposed bacterial pneumonia and will order a CT scan to further clarify -Patient completed Rocephin on the inpatient setting
Patient received a Moderna vaccine instead of a Pfizer vaccine.  Parent reported no adverse outcomes.
Body ache from left arm, rib cage to neck across to right arm. Nausea, headache, joint pain, muscle pain, dizziness
Got the vaccine, had COVID arm for 3 days, excruciating pain, couldn't lift it, beyond tenderness.  8 days later on 2/9/21 he broke out in hives.  Started on the left arm at the wrist, moved to his knees, then scratched like crazy, moved to his elbows.  Both elbows got it, then his right arm, now on his chest, and also has it on the side of his face,  and neck.  His entire neck is now red and blotchy.  He went to the hospital yesterday and received Prednisone and topical hydrocortisone. Even after the prednisone he has continued with the extreme itching and hives.
received an accidental 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received an accidental 3rd dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021 at 10:39 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (received an accidental 3rd dose). On 03-Apr-2021, EXTRA DOSE ADMINISTERED (received an accidental 3rd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment information were not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was not applicable.   This case was linked to MOD21-069109 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: No significant information received.; Sender's Comments:  MOD21-069109:
Pt stated that they completed COVID vaccine series 5/15/2021. Now hospitalized with diarrhea and weakness. tested positive for COVID
Information was received on 17-JUL-2017 from a pharmacist regarding a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with GARDASIL 9 injection (Merck Sharp and Dohme) (lot # N004798) (dose, route, and site of administration not reported) for the indication of HPV prophylaxis. "A few days later the patient experienced soreness of the arm in the area the vaccine was administered." The patient had an outpatient visit to an unspecified hospital's emergency room on an unspecified date and received unspecified treatment. No further adverse event information provided. The outcome of the event was reported as not recovered. The relationship between the event and GARDASIL 9 was not provided. Additional information has been requested.
On Wednesday April 7, 2021 client received her second dose of Pfizer COVID vaccine (LOT # ER8729, EXP 7/2021) at approximately 3:45pm. During assessment questions, client stated she had a "mild reaction" to her first Pfizer dose after 15 minutes in the Observation Area and a history of a weakened immune system. At 4:05pm, client report to EMT Peuvion of "minor tightness" in her throat. Per EMT Peuvion report, client was observed to have minor flushing and splotching on her hands. Lead RN was notified and authorized 50mg of Diphenhydramine HCL oral solution per protocol be given with a water bottle. Initial vitals were taken at 4:07pm: BP: 120/70, HR: 72, RR: 16, lungs: clear bilaterally. Vitals were reassessed at 4:15pm: BP: 134/74, HR: 82, RR: 16, lungs: clear bilaterally. Client stated her initial throat tightness had subsided. Vitals were reassessed 4:25 and remained stable and normal: BP: 124/68, HR: 74, RR 16, O2 sat: 94%. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was advised that if new symptoms develop or current symptoms worsen to seek emergency care. Client was further educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site at approximately 3:45pm with a steady gait.
I woke up with tingling on entire left side of body;  Dr. ordered MRI; done on the 10th; showed no change in brain; Today, 2/26/2021, I still have some tingling; with left hand and fingers more so.