chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately felt a sense of being off followed by brain fog,  headache, and fatigue which last for approximately 5 hours.  Then 9 hours after injection, onset of uncontrollable chills for 1 hour then a fever for approximately 4-6 hours.  All adverse events were gone within 24 hours of injection.
This is a spontaneous report received from contactable consumer or other non-HCP. A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL3209), at the age of 44, on Feb 24, 2022, single dose, for COVID-19 immunization. Concomitant medication included simvastatin 20 mg 1x/day for high cholesterol. Medical history included high cholesterol (ongoing). The patient had diarrhea (she has had diarrhea lately), onset Mar 16, 2022, with outcome of unknown. Additional information: Reporter stated her mother got the first dose of the Pfizer-BioNTech COVID-19 vaccine on Feb 24, 2022. She's scheduled to get the second dose on Mar 17, 2022. Her mother is currently using simvastatin and has had diarrhea lately. Reporter would like to know if her mother can get the second dose tomorrow. She was not sure if it was from the vaccine or from the new medication (simvastatin 20mg) the doctor gave her for high cholesterol, which she started a few days ago. No follow-up attempts possible. No further information expected.
metallic taste in the mouth; hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes) outcome was unknown. Details not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. A 35 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 35 years as dose 3 (booster) single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 18Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 30Nov2021, outcome "unknown", described as "dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "This colleague was triple vaxed and had a breakthrough infection 27Dec after exposure to family/PCR positive 29Dec". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Fever of a little over 100 degrees; pain in her arm; tiredness; This is a spontaneous report from a contactable consumer and a contactable other HCP. A female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3248) via an unspecified route of administration in left arm on 10Feb2021 09:30 (at the age of 39-year-old) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Relevant medical history included allergy to latex. Concomitant medications were not reported. On 10Feb2021 120:00PM the patient had fever of a little over 100degrees. It was further mentioned that she had fever, pain in her arm, and tiredness. She still had fever at the time of report but was feeling better. The patient did not have COVID prior vaccination and was not tested for COVID after vaccination. No treatment was administered. The events were resolving.
had Shingrix and still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter had the Shingrix shot and still got shingles. The reporter wanted to know why that was. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor's office/urgent care. Medical history included mast cell activation syndrome and sjogren's: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received 0.3 ml of the Grey cap bivalent product for patients 12 years of age and older and not the Orange cap product
Multi-dose (5 dose) vial dispensed to mom (nurse) who administered whole viale 2 ml instead of one 0.5 ml dose approximately 4/9/07. Patient developed large rash at administration site mostly resolved 1 week later.
Experienced hives for over a week...was told to take BENADRYL and not receive the second dose.
Information has been received from a registered nurse concerning a 23 year old female with no known pertinent medical history or drug reactions/allergies who on 20-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 654539/0742U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ), LEXAPRO and CONCERTA. On 24-JUL-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660620/0571X). The patient experienced burning at the injection with the second dose of GARDASIL vaccine (yeast). The patient sought medical attention in the office. Additional information has been requested. This is one of several reports from the same source.
pt recv vax 19MAY97 & did fine initially;26MAy pt had fever of 103 w/large lymph nodes in gorin area x 2 days;mom noticed blue lips & fingers;took to ER;
Developed Parsonage-Turner Syndrome (long thoracic nerve/brachial plexus paralysis...cannot raise right arm over my head; scapular winging. Started 11/8/20 and continues to present day.  Please note that I also had Shingrix #1 on 8/11/20 and Fluarix (GSK) on 9/9/20
High fever of 103F, chills, full body aches, severe headache, heart palpitations, severe sore left arm, unable to lift head.
LOW GRADE FEVER AND STARTED BREAKING OUT WITH RASH ON FACE ABOUT 3-4 HRS AFTER IMMUNIZATION    THEN SPREAD ALL OVER BODY, NO MORE FEVER, PARENTS GAVE TYLENOL FOR FEVER AND CALLED OFFICE  ON 11/20/19 TOLD HER TO GIVE BENADRYL  TIL COULD BRING CHILD IN TO OFFICE,  OR IF GETS IN DISTRESS TO GO TO NEAREST HOSPITAL.
Client was accidentally administered Pfizer as second dose instead of Moderna. Pfizer lot. #  EW0175. Client was monitor without incident at this time.  Client and family made aware there was no CDC recommendation if further vaccine  is needed.  Health department will contact them if any recommendations were needed.
Pfizer Dose 1 1/14/21 (lot NA) Pfizer Dose 2 2/4/21 (lot NA) Pfizer Dose 3 10/26/21 (FF2593) COVID Positive 3/1/22  3/1/22: Patient is a 94-year-old male history of chronic underlying dementia presents to ER via EMS from facility for altered mental status that is characterized as unresponsiveness.  History today is very limited majority was obtained from ER physician, per ER provider report patient tested positive for COVID-19 on February 28, family was updated regarding patient's condition in ER requested for comfort care.  Patient is DNR/DNI.  3/2/22: Patient is admitted hospital, continued on comfort measures.  Hospice consult is requested, patient is evaluated by hospice team, and is discharged back to Facility with hospice.
Second day after the vaccine in March, I had fatigue, aches, AND CHILLS IN MY LOWER EXTREMITIES.  These symptoms carried over until noon on the third day. THEN I developed weak muscles in my legs and sprained my R knee. I continue to have weak muscles and the knee (R) was swollen.  I have alleviated the swelling but continue to practice stretching to strengthen the leg. The leg is still not as strong as it was before the vaccine in March.
Erythema, heat. No cellulititis. Area about 21 x 14cm.
This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly PROQUAD lot # L047305 (expiry 23-MAY-2017) and L046507 (expiry date 17-MAY-2017) (dose and route not reported). The temperature excursion time frame was reported as "-4.7 C for 682 hours, -5.3 C for 130.45, -14.9 C to -10C for 121.95 hours, -9.9 C to 5.3C for 8.5 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Subjective fever (felt feverish),  Runny nose/Congestion, Cough, Hospitalization 8/21/2021 due to fall
Bruise at injection site. Redness/swelling - 2" diameter at injection. Headache/nausea. Pain at injection site and deep into arm.
systemic rash on arms, leg, neck, face & trunk w/in 2hr of vax;rash was erythematous round lesion similar to pityriasis rosea;
Pain 3 inches below the injection site with itching and tenderness. Red in color and warm to the touch.
New rash/cellulitis on pt's right arm. Site of PIV / pneumococcal vaccination placement on 2/2/2010. Painful, but pain proportionate.
All I felt was a real tingling pain where I got the vaccine; All I felt was a real tingling pain where I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of the Pfizer COVID vaccine yesterday (21Jan2021). Patient had some severe symptoms after receiving the vaccine. It was not bad at first right after when he/she got the vaccine. After he/she got the vaccine he/she sat in the area of the hospital for 15 minutes. All he/she felt was a real tingling pain where he/she got the vaccine but when he/she came home the pain stopped (21Jan2021). So patient knows it is related to the vaccine and 'none of them like but patient' and they are getting better and patient just wanted to report it to Pfizer because when patient left the hospital they gave him/her this fact sheet where he/she could call Pfizer and he/she could call other places when he/she have severe symptoms. Outcome of the events was recovered on 21Jan2021.   Information about batch/lot number requested.
Information has been received form a receptionist concerning a female who was vaccinated with GARDASIL. The patient expressed that the vaccine really hurt. It burned all the way down her arm. No further information is available.
Patient report being dizzy . The facility nurse took blood pressure and heart rate while I supported patient in her chair. She was sweating and clammy to the touch. I applied an ice pack on her neck and head . She yawned about 8 times in 90 seconds. Her blood pressure was very low.  Since she was diabetic we checked her blood sugar and it was 190.  She said several times she thought she was feeling better so we transferred her to the wellness center for more observation.  The patient reported her tongue was swelling so I decided to administer epinephrine into her left thigh.  The  nurse called EMS to take over care at this point. The patient reported an improvement within minutes.
Within 5 minutes after vaccination, during the monitoring period the patient experienced a sudden onset severe headache and sinus pressure.  The patient was assessed by on-site EMS, patient was found to be hypertensive.  After monitoring, there was no improvement of BP and patient was transported to hospital Emergency Room for further evaluation. Patient stated she was observed at the Emergency Room and her Blood Pressure returned to normal limits.
Severe increased joint and muscle pain that has lasted for several months and is still ongoing.  The severity worsened with the second dose which was taken on 02/19/2021. There has also been crepitus, popping, and instability in my joints that wasn't previously there.  This is also ongoing. Increased fatigue which has been ongoing.
Symptoms resembling Covid-Toes.  Swelling, redness, pain of toes of both feet.
w/in 10 mins of receiving vax pt returned to nurse c/o very painful lt arm; o/E noted red wheal approx 0.3-0.5cm @ inj site & reddened area of tissue approx 3.0-5.0cm surrounding & posterior to site area warm & tender to touch; P68 regular;
At 8pm I developed extreme itching throughout my entire body, inside my ears,throat eyes. No rash or hives no sob or swelling. Headache also noted. I took tylenol 1000 mg and at 9pm I took benadryl 50 mg. I woke up 12-18-2020 with less intense itchiness but it was still present, not my throat or inside my ears. I took allegra 180 mg. At 1100 I developed a headache and took tylenol 1000 mg.
pt recv vax 25MAR96 & 23MAR97 pt devel severe case of chickenpox;f/u information reported that pt recovered;
Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine; Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021.     This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine). On 31-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine) had resolved.      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 reported.  No treatment information was provided.
Immediately after - a little rash or bump around injection site - but mild; Fever - got up to about 102, body aches and chills and fatigue. It lasted for probably 38 hours. Other event - main one I'm reporting: Both of my rotator cuff were very painful when I woke up. It was difficult to use my arms. It faded and within two weeks the right arm was fine again. The left arm - can't lift it more than 45 degrees - very painful around rotator cuff. It's like it's frozen. I did not have any injury. It came out of the blue. No history of Rheumatoid Arthritis in family. For left arm, the pain shoots  down towards my wrist. Now my sister has a similar problem with rotator cuff on the side of the injection site arm. I've been going to Physical therapist and he has been doing strengthening exercises and passive lifting of the arm to increase mobility; pain still hasn't gone away. He is dry needling now - Monday this week, for the second time,  he also used the dry needles and charged them electrically - sent a pulse of electricity through the deltoid muscle and the rotator cuff. It has improved the pain. for about two week but it doesn't give me the mobility back. I do take ibuprofen sometimes, too, for the pain.
pt was found, dec, p/a nap @ daycare;presumed SIDS;no apparent illness, asymptomatic;autopsy results not available @ this time;
pt recv vax 29DEC97 & approx 5JAN98 pt exp an erythema multiforme rxn;
Patient reported that he had a 102 degree fever, coughing, fatigue, 3 inch wide redness around injection site, labored breathing, shivers
TWO AFTER I RECEIVED THE FIRST DOSE, I GOT SEVERE PAIN IN BOTH SHOULDERS WITHOUT ANY CAUSE OR INJURY. I WENT TO EMERGENCY ROOM, WHERE THE DOCTOR TOLD ME I HAD TENDINITIS OF BOTH SHOULDERS. I RECIEVED PHYSICAL THERAPY WITH MODEST RELIEF.  I RECEIVED BOOSTER DOSE ON OCTOBER 28, 2021. FEW DAYS LATER, I GOT SEVERE PAIN IN BOTH ANKLES AND KNEES. I AM GETTING PHYSICAL THERAPY.
patient that received an expired dose of Tenivac with no adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 20 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 25-Oct-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U6852AA, expiry date: 07-Oct-2022) via intramuscular route in the left deltoid for immunization.  On 25-Oct-2022 the patient developed a non-serious patient that received an expired dose of tenivac with no adverse event (expired product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
shot should hurt for that many days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11-SEP-2023, the patient received the 2nd dose of Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot should hurt for that many days).The outcome of the pain was resolving.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient had his/her Shingles shot last Monday. The reporter stated that today was Saturday and the pain was almost gone. The reporter could not believe a shot should hurt for that many days.
Face became very red and then chest and legs had redness and hives within 30 minutes of receiving the #2 shot of Pfizer.  Rash was itchy and warm to the touch.
15 min after, when standing up, had medium pain in my left groin area between groin and leg.  Then around 930pm became extremely itch, starting with left leg. Moved to all over body by 1030 pm
-Sore arm (4/13 until 4/15 morning) -Sore neck (4/13 entire day) -Red, swollen injection site (started 4/27, end to be determined). Note that arm was not red until now.
Sore arm, nausea, vomiting, diarrhea, headache, muscle pain