chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQC reported; Temperature excursion VARlVAX had been administered; This spontaneous report was received from a medical assistant referring to a 17-month-old patient of unknown age. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 12-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #: T021826, expiration date was 25-JUN-2022, dose, strength, and route were not reported) for prophylaxis.  Temperature excursion of this vaccine was -58 degrees Fahrenheit and +5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds, -58 degrees Fahrenheit and +5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds with previous temperature excursion. The digital data logger which was involved in recording excursion details.; Sender's Comments:  2104USA008022: 2104USA008185: 2104USA008342: 2104USA008255: 2104USA008022: 2104USA008081:
Tenderness around the injection site /Pain around the injection site; Redness around the injection site; Swelling around the injection site; Rash/ rash that ran across the patient's chest; Shortness of breath; This case was reported by a physician via sales rep and described the occurrence of injection site tenderness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In February 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site tenderness, injection site erythema, injection site swelling, rash and shortness of breath. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were unknown and the outcome of the rash and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, rash and shortness of breath to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the internal Glaxosmithkline representative. The age at vaccination was not reported. The patient received dose of Bexsero and had pain, redness, swelling, and tenderness around the injection site. The patient had rash that ran across the patient's chest and was experiencing shortness of breath. The reporter stated that, on the day of reporting, the patient came into the doctor's office for follow up the rash and shortness of breath have resolved. The reporter did not consent to follow up.
clearing throat; slight cough; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history included pneumonia 12 days ago. Concomitant medications were not reported. On an unspecified date, the patient experienced clearing throat/slight cough. Patient just finished antibiotics. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Pt stated arm started itching about 5 hrs after shot & by next morning arm was red and swollen around injection site. She came to the Pharmacy on day 3 after shot to show me and the red area was about the size of a soft ball & was swollen & warm. Told her to take BENADRYL & arm was back to normal within a week.
They do not store them in the refrigerator, they directly thaw them from the freezer before administration; administered with expired vaccine on 29 Apr 2022 - 5 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses) and PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Received 3 doses). Past adverse reactions to the above products included No adverse event with Pfizer.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses) and PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. A medical assistant reports that they administered an expired dose of the Moderna Covid-19 vaccine to 11 patients on different dates (15-Apr-2022 - 2 doses; 29-Apr-2022- 5 doses; 13-May-2022 - 4 doses). Lot number 066H21A; expiration date 04-Apr-2022. No patient adminstered with the vaccine had reported any event at the time of the call. Number of doses/vials: - 11 doses; probably 3 vials. The vial did not undergo any temperature excursions. No treatment information was reported.
Pt complaining of nasal drainage, going down throat, cleared throat, had phlegm  No throat swelling.  Vital signs normal.  @1115 118/70, HR 75, OXSat 98, RR 16.  @ 11:32 BP 115/82, HR 75, OxSat 99
Pain and limited mobility Physical Therapy with Iontophoresis Ortho consult Steroid Injection Oral NSAIDS and Oral steroids
Felt fine (with some muscle ache in my arm ) until  approx 6:00 p.m  when a migraine headache started.  I did not take any medication because I didn't want to undermine the success of the vaccine.  I also experienced  severe chills but at the same time my body felt hot.  As the eve wore on I had a bad stiff neck.  I went to bed with an ice pack &  did not sleep much.  I still had the same symptoms the next day until I finally took 1 Motrin at 2:00 p.m. & another approx 1 hr. later.  Then the symptoms began to lessen.  Did not sleep well Sat eve either - my legs just felt weird.  Finally I felt better around 9:00 a.m.  on Sunday but still somewhat dizzy when moving too  quickly.
Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine; Still tired all time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) and FATIGUE (Still tired all time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) and FATIGUE (Still tired all time). At the time of the report, COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) outcome was unknown and FATIGUE (Still tired all time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
menstrual bleeding; infection; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was: unknown), via an unspecified route of administration, administered in Arm Right on 23Jan2021 (at the age of vaccination 27-year-old) as single dose for COVID-19 immunization at Doctor or other healthcare professional office/clinic visit. Medical history included MHE (Minimal hepatic encephalopathy) and Known alleries Sulfa-containing drugs. Concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was not received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and Since the vaccination patient was not tested for COVID-19. The patient experienced menstrual bleeding and infection on 24Jan2021. Reported as Started menstrual bleeding about 24 hrs after infection. I didn't think anything was abnormal at first, but I am still having bleeding 2 months later. I have never experienced prolonged menstrual bleeding before. My periods have always been no longer than 4 days in length, with some missed periods here and there. I have been to see my GP and no direct cause could be determined at this time. I looked back on the date I received my first dose of Pfizer vaccine and the saw a possible correlation between that date and the onset of my symptoms. After doing some research I ran across this article and I believe there may be a connection to what I'm experiencing. As of this time I was still bleeding. No treatment received for the adverse events. The outcome of the events was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received 2nd COVID vaccine on 2.13.2021. Patient's family says the patient experienced fatigue, shortness of breath, dizziness, and muscle pain after the second injection. Family says the patient was taken to the ER and airlifted on a ventilator to hospital. Family says she has not tested positive for COVID and that she does not have a diagnosis at this time. As of today, 2.25.21, the patient is out of the ICU, but still hospitalized.
Chills.; sweating; Headache; Nausea; Tired; This is a spontaneous report received from a contactable consumer, the patient. A 28-years-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot number: En6205) via an unspecified route of administration in the left arm on 25Feb2021 at 14:45 (at the age of 28-years-old) and a second dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 16Mar2021 at 15:45 (at the age of 28-years-old), as single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medication included magnesium (MANUFACTURER UNKNOWN) and ZYRTEC initiated from unknown date and for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 02:30, the patient experienced chills, sweating, headache, nausea and tiredness. The patient did not receive any treatment for the events. At the time of this report in Mar2021, the events chills, sweating, headache, nausea and tiredness were recovered.   No follow-up attempts are needed. No further information is expected.
6cm X 9cm indurated area with warmth and erythema and pain to touch.
received  covid19 pfizer booster on 06/10/22.   Mother called physican on-call.  Got advice over the phone.  Per on call providers note on 6/11/22 "History: Mother called the after hours seeking advise for child, who got covid booster yesterday and woke up with muscle aches, fatigue, low back pain and right side leg pain and concerned if this reaction from the vaccine. Advice: History taken, confirm on right lateral hip pain radiating to her knee and some right side lower back pain, no other allergic reaction from the vaccines, no rash, breathing well, no sob, throat not closing up. Advise to give ibuprofen 200 mgs 2 tabs". Mother told that pt had toxic synovitis hip.
BODY ACHES; BODY TEMPERATURE 95.5 F; LETHARGY; NOT FEELING LIKE HIMSELF; CHILLS; HEADACHE; FEELING WORSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling worse. On 15-JUN-2021, the subject experienced body aches. On 15-JUN-2021, the subject experienced body temperature 95.5 f. On 15-JUN-2021, the subject experienced lethargy. On 15-JUN-2021, the subject experienced not feeling like himself. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 95.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature 95.5 f on 17-JUN-2021, and had not recovered from headache, body aches, chills, lethargy, not feeling like himself, and feeling worse. This report was non-serious. This case, from the same reporter is linked to 20210651363.
Pt got vaccine Monday and experienced swelling at site of injection had to see her doctor to get antibiotics and steroids to treat inflammation.
Fever (101.5F), headache, muscle pain, chills, nausea, join paint, fatigue and swollen glands in the neck.
Anaphylactic to all nuts to point can?t be near them, anaphylactic to gluten when consumed
This spontaneous case was reported by another health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided
Numbness in his left hand that ran up his left arm to the vaccine area where the shot was administered.; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 as a single dose for COVID-19 immunisation. Patients medical history and concomitant medications were unknown. Allergies were unknown. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Apr2021, the patient experienced numbness in his left hand that ran up his left arm to the vaccine area where the shot was administered. He said that he was willing to speak to Pfizer if they wanted to contact him. The event resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events numbness in his left hand that ran up his left arm to the vaccine area where the shot was administered was recovered with sequelae.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to five patients of unknown age and gender. Information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L030865, expiration date 27-AUG-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of two reports from the same source. Additional information is not expected as no consent for further contact was given.
Narrative:  Hospitalization for clotted AV graft and need for dialysis; found to be COVID-positive by asymptomatic. Fully vaccinated and boosted.
Yellow coating on tongue and palate, dizziness, blurred vision, headache, red, warm area at site, metallic taste in mouth.
Approximately 8 days after the first dose (given 3/17/21) formed a rash that stayed for 2 days at injection site. Approximately 1 day after second dose (given 4/14/21) formed larger rash at injection site, still there as of 4/17/21. Also experienced extreme fatigue, chills, and muscle aches since the second dose.
breathing difficulty; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (breathing difficulty) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Blood test- negative. On an unknown date, Computerised tomogram: negative (Negative) Computerised tomogram-negative. On an unknown date, Electrocardiogram: negative (Negative) Electrocardiogram-negative. On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Treatment medication reported includes Albuterol and Flovent inhaler ,Prednisone and singulair. He will have stress test and pulmonary tests week.
soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 immunization, reaction(s): "soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "soreness of the upper arm where the injection site occurred". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296272 same patient, different vaccine doses/event;US-PFIZER INC-202201296757 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296758 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296759 same patient/event, different vaccine doses/event;
Information has been received from a health care provider concerning a female who was vaccinated with a dose of Zostavax. Subsequently tow or three days after vaccination, the patient developed shingles on her face. Unspecified medical attention was sought and the patient was treated (unspecified) at the clinic. There was no product quality complaint involved. Additional information has been requested.
After receiving vaccines, patient appeared pale and lost consciousness for about 3 seconds. Patient was laid back on exam table. Patient became responsive and alert and oriented. Vitals were obtained, BP 108/71, HR 98. Cold compress was applied. Patient was given juice and lollipop. Patient was monitored for additional 25 minutes. Vitals were rechecked, BP 108/74, HR 84. Her color returned to normal and she stated she felt better. Patient left office with mom in stable condition.
UrticariaPruritus  Narrative:  1445: C/O ITCHING rt arm and tingling of lips. 125/84 75 100% RA RR 12..SX resolved @ 1457 INTERVENTIONS: ICE PACK AND WATER
I got my vaccines in Jan 2021. In September, I started having "ringing" in my ears. In Feb 2022, I got my booster shot. As soon as I got my booster shot that day, my ringing got worse. I finally put the two and two together.
Patient received vaccine (it appears to be the 3rd booster) on 10 November 2022 @ 0700. On the morning (0700) of 24 November, patient experienced paralysis on right side of face.  Patient presented to Urgent Care where stroke was ruled out.  It was determined that patient experienced Bell's Palsy symptoms.  As of the morning of 28 November, symptoms persisted.  This was brought to my attention by our organization's Medical Staff and the patient in question.  I was subsequently asked to enter a VAERS report.
devel fever 8PM, was given APAP @ 4PM rose to 105; next day wouldn't walk on leg, became sleepy; vomited, temp still elevated, loss appetite; pt taken to ER 3AM 23SEP;
Mother reports that for 2 weeks after the vaccination, child experienced higher anxiety and required PRN doses of anxiety medication.