chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The following occurred within 60 minutes after receiving the Moderna Vaccine: 1. Heavy Head 2. Strong Headache 3. Weakness 4. Lethargic 5. Rapid Heart Beat 6. Heart Fluttering 7. Pain in chest around heart 8. Tightness in chest  9. Sharp Pain on left side of body 10. Sharp Pain in left arm to armpit 11. Sharp Pain in left Shoulder 12. Radiating Pain in Shoulder, Back, and Chest 13. Sharp Pain on left side of neck 14. Sharp Pain under left Jaw  15. Sharp Pain radiating from jaw to left side of face and under ear 16. Tingling and Needle type sensation on left side of face 17. Numbness on left side of face 18. Disoriented 19. Slurred speech 20. Loss of consciousness (loss of mobility, inability to speak, inability to stay upright, inability to stay alert and respond, inability to hear surroundings at all times  21. Flu-like symptoms (fever, muscle aches, head ache, chills, nausea, lethargic, fatigue)
Patient experienced a tingly face with burning sensation on the inside. Her cheeks began to swell and she did not feel right.
Developed apthous ulcers in throat 6 days after vaccine; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK7350), via an unspecified route of administration in left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization in a hospital. The patient's medical history was not reported. Concomitant medication included multivitamin. The patient previously took LEVAQUIN and experienced allergies. The patient developed aphthous ulcers in throat on 05Jan2021 14:00 6 days after vaccine. Patient does not have COVID prior vaccination. The patient has not been tested for COVID post vaccination. Treatment for the event included magic mouthwash, Vitamin C, and one dose of oral Medrol. The outcome of the event was recovering.
Received an Expired Dose; Initial Report Received on 08-FEB-2023 and 09-FEB-2023.  A supervisor reported that a 56 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-FEB-2023, the patient received a dose of HEPLISAV-B (Lot #935849, expiration date 13-JAN-2023 and NDC # 43528-003-01) intramuscularly in the left deltoid from a nurse.   On 06-FEB-2023, the patient received an expired dose of HEPLISAV-B. No adverse effects were reported by patient.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Narrative:  Patient reports a history of generalized rash spots (life psoriasis)  over entire body treated by outside dermatologist. Patient states received the J&J vaccine then within 1 week the vaccine triggered a flare up of full body rash described as red patches with dry areas and itchy. Was prescribed  diphenhydramine po and hydrocortisone cream.
STIFFNESS IN BACK OF NECK; LITTLE NAUSEA; ACHE IN THE BACK OF NECK; SHIVERS; FEVER; HEAVY HEADACHES/ SLIGHT HEADACHE TO THE FRONT SIDE OF HEAD; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included a bit of anxiety problems, seasonal allergies, allergies to dog and cat, marijuana smoker, and non-alcohol user. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced ache in the back of neck. On 28-MAY-2021, the subject experienced shivers. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced heavy headaches/ slight headache to the front side of head. On 29-MAY-2021, the subject experienced stiffness in back of neck. On 29-MAY-2021, the subject experienced little nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from ache in the back of neck, shivers, fever, and little nausea on 29-MAY-2021, and had not recovered from heavy headaches/ slight headache to the front side of head, and stiffness in back of neck. This report was non-serious.
booster; had severe cramping in his feet and legs.; This is a spontaneous report received from a non-contactable reporter. Other Case identifier(s): MOD21-170944. A male patient received bnt162b2  (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: immunization and muscle spasms, outcome unknown. Additional information: Patient thought this was the PFIZER line of reporting AE and said his father got the Pfizer booster and had severe cramping in his feet and legs. Agent let the patient know that this was the Moderna line. Call ended as the patient will call the PFizer line. Product complaint: there is no product complaint associated with this case. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received DTaP 4/10/04. Had nickel size erythematous area around injection site after returning home after appt. (per mom) child complains of itching at site. Two days later when mom next looked at site erythematous area was 14 cm in length & 11 cm width. Child had complained of itching for 2 days. Seen at office & measured erythematous wheal/ urticaria warm to touch. Still has wheal otherwise ok.
Patient was admitted for elective hip arthroplasty and was found to be COVID-19 positive during screening for operation. She remained asymptomatic during admission. Patient was admitted from 9/3/2021 to 9/9/2021.
Faint/dizzy/pale - 3min after HPV #1. Sitting on exam table. Had just had "finger stick" for hemoglobin. Occurred quickly. NO LOC. Placed supine. VS. monitored for 20 min -> full recovery.
This spontaneous report as received from a health care worker refers to an approximately 68 years old patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX. On 09-JUN-2014 medication error reported that the patient received improperly stored ZOSTAVAX exposed to 7F (Fahrenheit) for an undetermined timeframe. No adverse effect reported. There was no product quality complaint involved. The outcome of the medication error was unknown. Additional information has been requested.
Patient's mother states that the child started a fever on 12-6-08 that continues today 12-8-08 Temp 102 degrees denies redness/swelling at injection site. Denies headache, nausea and vomiting or any other symptoms. States "he looks like he feels fine. He just has a fever" Referred to MD.
Info has been received from a physician concerning a 5 year old male who was vaccinated at the age of 12 months old in the right leg on 12/17/99, with a 1st dose of MMRII (lot 632344/1081J). Subsequently, the pt was noted to have an "over-reaction to the vaccine with markedly elevated titers". On 5/5/03, the rubella antibody (IgG) was immune at 24 IU/mL; rubeola Ab. IgG Eia was positive at 3.44 H INDEX; and mumps ASS (IgG) was positive at 4.90 H INDEX. The pt was also noted to develop events after vaccinations with Hep-B virus vaccine (HBsAg) (yeast). No additional info has been requested.
3x3 inches in diameter of redness. Central 1x1 inch area of deep redness and induration at site of injection, warm and mildly tender.
tested positive for coronavirus; This is a spontaneous report from a consumer(patient) via Pfizer Sponsored Patient Support Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had her 1st dose of COVID 19 Vaccine on 21Mar2021 and then tested positive for COVID 19 a week later on 28Mar2021 and she was asking if it was allowed to have the 2nd dose on the 11Apr2021 knowing that she is in that kind of situation. States she is due for her 2nd dose 11Apr2021 and she is wondering if she is supposed to do it or not now or how that works. Caller provides that it is the Pfizer Coronavirus vaccine. Caller clarifies she tested positive for Coronavirus 28Mar2021. States she had the rapid and the PCR and both came back positive. Caller states she was tested on 28Mar2021 and the rapid came back positive that day. Referred caller to her healthcare provider for medical information. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
Client felt nauseous and had palpitation.  Paramedics assess client on site.  Client was released at 10.
Irregular large red area, itchiness, mild-moderate irritation/tenderness lasting 7 days and 2-11-14 - MD prescribed ATARAX, triamcinolone, possible steroid dose pak for future use.
Patient developed all-over itching 10 minutes after receiving the vaccine dose.  He was treated with Benadryl 50mg after it was determined that he was developing no other symptoms.  He stayed in the office and was observed for one hour.  His symptoms resolved within 24 hours and he did not develop any new symptoms within that time frame and did not need to seek out any further medical care.
Dark urine/The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0164) at single dose, in the left upper arm, on 19Apr2021, at 09:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included fast heart rate and gastrooesophageal reflux disease. The patient previously, on 26Mar2021, at the age of 32-years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8732) at single dose, in the left upper arm, for COVID-19 immunisation. Concomitant medications included atenolol 50 mg once a day, from an unspecified date (he started it probably 10 years before this report) and ongoing, for fast heart rate and pantoprazole 40 mg once a day from an unspecified date (he started it probably 10 years before this report) and ongoing, for gastrooesophageal reflux disease. On 19Apr2021, at 19:00, the patient experienced dark urine and other symptoms (unspecified). The adverse event was described as "patient had the second dose of the vaccine on Monday morning 19Apr2021, and he noticed the dark urine Monday evening. The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back. It has fluctuated a little bit during the last day and a half but hasn't gone away at any point. Most of his other symptoms he had were in line with what he had read about with the vaccine". No seriousness criteria reported. Physician office visit and emergency room visit were not required. Clinical outcome of the adverse event at time of this report was unknown.   No follow-up attempts are needed. No further information is expected.
Developed an internal itching on right thigh; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in left arm on 19Mar2021 at 12:00 (at the age of 67-years-old) as single dose for COVID-19 immunisation. Medical history of the patient included allergy to penicillin, sulfa drugs from an unspecified date. Patient received other medications in two weeks, names were unspecified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in left arm on 26Feb2021 at 10:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 09:00, patient developed an internal itching on her right thigh which persisted for over a week. Patient reported to have scratched it and raised a black and blue mark on thigh as a result. Localized to upper right thigh. Patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of itching was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Presented with afib with RVR, cough, dizziness, nausea, fatigue; CXR: bilat infiltrates: Dx Covid PNA, afib; TX- Remdesivir, Vit C, Rocephin, Vit D3, Decadron, Lovenox, Singulair, Zinc, Baricitinib; significant improvement and down to 4 L of NC O2 satting in the low 90s -CXR on admission showed bilateral infiltrates with cardiomegaly.  CTPE negative for PE -strep pneumo and Legionella negative -continue self proning and incentive spirometer use -completed remdesivir course. S/p 7 doses of baricitinib,  -Patient was also treated with Solu-Medrol, vitamin-C, vitamin-D, zinc, Singulair and  Flonase -s/p treatment with doxycycline and Rocephin for initial suspicion for superimposed bacterial PNA Walk test was done and patient required 1-2L of O2 with rest and 3L of NC O2 with exertion.
pt recv vax 19OCT98 & devel an inj site rxn characterized by redness, swelling & warmth;
generalized urticaria 48 hrs p/getting red, swelling @ site w/2nd soes; skin tested a/1st dose; 6JAN94 f/u is recovered;
seven patients received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 043B21A and 032B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-604813 (Patient Link).
diarrhea with blood; This is a spontaneous report from a contactable consumer (patient's husband).   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration (at the age of 61 years) on an unspecified date as dose number unknown (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea with blood on an unspecified date. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Went to ER with fever of 101, No hives, Given Prednisone & Benadryl. To take Benadryl as needed at home.
Fever 99-102 F for 3 consecutive days. Gave TYLENOL during day, MOTRIN before bed. Cranky and irritable. Not herself.
Within one hr of TD vac., Pt. experienced headache 2 Tylenol reduced pain which rebounded w/i 3hrs. Pt also states she had low grade fever on the evenings of 12/1 and 12/2/08 and continues to have soreness at site. Symptoms remain (no headache).
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Date of refrigeration: 07-May-2021.
Patient presented to the ED on 4/9/21 with abdominal pain. Patient presented to the ED on 4/15/21 and was subsequently hospitalized.
Diarrhea, extreme gas, blood in stool, mucous in stool. Baby was evaluated for possible intusseption. Uncontrollable crying. Lethargy. Refusal to eat. Dehydration.
Immediately following immunization procedure, Pt collapsed in waiting area.  "Black-out" lasted for a short period of time (<1 minute) and then became conscious and alert.  Pt does not recall incident but did feel dizzy and light-headed before blackout.  Pt did not eat breakfast.
Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days later he had HA, fever, myalgias, weakness, numbness of the hands and fingers, and abdominal pain that lasted a few days. He states the only sx that has persisted is the weakness and numbness of the hands and fingers.  The pt states that his arms and legs are equally weak. Pt reports that today he had a fall due to the weakness today, and he denies any head strike or injuries from this fall.  MRI of the brain with and without contrast was done showing no acute intercranial abnormality.  MRI cervical spine showing no spinal cord abnormality.  And MRI T-spine showing no spinal cord abnormality.  Lumbar puncture was performed in the emergency room.  Protein was found to be elevated at 109.  Glucose was elevated at 134 CSF cell count within normal limits.  CSF PCR panel within normal limits.  Patient continues to complain of weakness.  Lumbar puncture was completed showing a protein elevated at 109 likely representing GBS.  MRI brain, cervical spine and thoracic spine showing no structural lesion.  At this time we will start IVIG 0.4 g/kg daily for 5 days.  Patient will be seen by physical therapy and Occupational Therapy.  We will also consult inpatient rehab.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 at 14:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 38 years, in left arm 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 was not reported. Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Jul2022 to 25Jul2022.  Clinical course: Patient received other medications within 2 weeks of vaccination.
1245: Patient vitals taken, BP 169/122, HR107, 02 SAT 98%, Temp 98.4. Patient advised he no longer has the headache but still feels flushed . 1257: vitals taken again BP 167/122, HR 101, O2 SAT 98%. Patient also advised he was having GI upset (diarrhea). Dr. monitoring patient with this RN, aware of patient vitals, Allegra 80mg PO given at 1300 by CNO per protocol.  1315: BP 172/116, HR 108, O2SAT  98%. Dr. has advised patient to log BP's at home and that he may have underlying hypertension. Dr. has advised patient that he will be called for a follow-up appointment tomorrow with a physician.  1326: BP 174/104, HR 103, O2 sat 99%. Patient states he is now felling back to normal, denied headache and flushing at this time. Dr. had given the patient clearance to return to work at this time. Advised patient that if he starts to have any s/s again to go to Urgent Care or ER. RN will follow-up with Caregiver.  1537: Spoke to patient states he currently had a mild headache and is fatigued. States he left work an hour early and is going to go home and rest.  1547: Spoke with Dr., MD advised for Caregiver to be seen at Urgent Care today for follow-up. Patient states he feels ok to drive and will make his way to Urgent Care now.  1653: Patient called RN back, states he is feeling better and declines going to urgent care at this time. He advised his headache and fatigue is resolved, stating "I only have mild soreness at injection site." Patient states he will go to Urgent Care tomorrow for a follow-up. RN will follow-up with Caregiver tomorrow.
I tested positive for COVID-19 on 12/1/22. I had congestion, cough, fever, and chills. I contacted my doctor and was prescribed 5 days' worth of Paxlovid. I started feeling better after taking Paxlovid, but I still have a cough. I can't seem to get rid of it.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).