chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This is a spontaneous report from a contactable consumer (the patient). A 87-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: E69265), via an unspecified route, administered in right arm on 03Feb2021 13:30 (at the age of 87-year-old) as a single dose for COVID-19 immunization. Medical history included aortic valve disease from an unknown date and unknown if ongoing, cardiac pacemaker insertion from an unknown date and unknown if ongoing, eye injury from an unknown date and unknown if ongoing. Allergic to products tetanus, penicillin, sulfa and codeine. Concomitant medications included dulaglutide (TRULICITY), lisinopril (LISINOPRIL), clopidogrel (CLOPIDOGREL), rosuvastatin calcium (CRESTOR), metformin (METFORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination, the patient had not been tested for COVID-19. On 04Feb2021 05:00 PM, the patient experienced mild hives from something in the medications he had been taking but the next day, Thursday, after the Pfizer vaccine increased hives breaking out in new locations. He had a history of reactions. Discussed this with the nurses prior to receiving the shot. The patient did not receive any treatment for hives. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and body pain at 8pm ,
Blood in urine; Pain in all of her body/ body ache; Chills; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186, Expiry Date: unknown), dose 1 via an unspecified route of adminstration, administered in Arm Left on 30Jun2021 at 12:30 (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE was none. History of all previous immunization with the Pfizer vaccine was not considered as suspect. No additional vaccines administered on same date of the pfizer sus-pect. No other vaccinations was done within four weeks prior to the first administration date of the suspect vaccine. On 01Jul2021, the patient experienced blood in urine, pain in all of her body/ body ache and chills. The events did not cause Emergency Room or physician office visit. It was reported that yesterday the patient woke up with body ache, chills and blood on her urine. Today she has no longer have chills or body ache, but there is still blood in her urine and she wanted to know if it was normal. Blood in her urine is worst in the morning. When she cleans herself she can see the blood. She stated that she has been drinking a lot of water and it is about the same color now. She denied any medical conditions, medications, labs, testing or treatments relevant to events. Upon follow-up 0n 02Jul2021, vaccine information including lot number, start date, anatomical location was provided. This report is not related to a study or programme. Seriousness of the events were unspecified. NDC number of Pfizer Covid 19 Vaccine was unknown. Investigation Assessment was not provided. The patient provided her doctors name but did not provide contact information for her HCP. Vaccine was not administered at military facility. Outcome of the event blood in urine was not recovered and the outcome of the other two events were recovered on 02Jul2021.
Information has been received from a physician concerning a 69 year old female patient, who on Oct 9, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M). On the next day, approximately Oct 10, 2002 the patient reported she had developed swelling in the arm that received the injection, and dizziness. Unspecified medical attention was sought. Additional information has been requested.
Cellulitis of left upper arm (redness, tenderness and warmth in area), low grade fever. Redness and swelling was located more where pneumococcal vaccine was given (left upper arm) as opposed to where the influenza vaccine was give (left lower arm); Clindamycin and Methylprednisolone prescribed in addition to icing are 4-6 times a day for 20 minutes at a time only, tylenol every 4 hrs as needed for discomfort/pain
Information has been received from a registered nurse concerning a female "in her forties", who in 1997,  was vaccinated with the three dose series of Hepatitis B vaccine. In a recent blood bank screening, the patient developed positive surface antigens. The patient had a repeat Titer at her doctor's office on 09/28/00, results pending. Follow up information received on 10/19/00 from a registered nurse stated that the patient, who is a teacher, had lab work done by her own physician and it was within normal limits. No further information is expected.
Swelling at the injection site; Redness at the injection site; Itchiness at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX (unknown). In October 2013, within days of vaccination with FLUARIX, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A-A1048966A and A1048968A.
SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing
left herpetic keratitis; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered sharp left eye pain with redness, drainage, photophobia and blurred vision. The patient was diagnosed with left herpetic keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event left herpetic keratitis was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event left herpetic keratitis to be disability.  Upon internal review, the event left herpetic keratitis was determined to be medically significant.
horrible cough; dry cough; dry throat ache; feels congested like if i had the flu; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat ache), COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 immunization.  The patient's past medical history included Blood pressure, Cholesterol and Thyroid disorder.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, the patient experienced DRY THROAT (dry throat ache). On 04-Apr-2021, the patient experienced COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu). At the time of the report, DRY THROAT (dry throat ache), COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
02/16/04: 2:14PM tetanus shot that night complained of myalgias, cannot move neck, shoulders and tightness in throat. 02/17/04, complained of severe headache right side and neck, eye to top of head pain and nausea.  02/21/04: right deltoid (injection site) red, hot, swollen for next.  Looking very eorc.  02/23/04: full range of motion, no bruise.
Patient given the wrong dose for booster.  Given 0.5 mL Moderna (rather than 0.25 mL dose)  No adverse reaction or side effects
Severe ongoing stomach pain, vomiting, diarrhea.  Visted ER, ct scan, blood draw. Diagnosed Colitis, prescribed antibiotics and pain medication.
Redness; Hard lump- 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump- 2 inch diameter) and VACCINATION SITE ERYTHEMA (Redness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M204) for COVID-19 vaccination.     The patient's past medical history included Cystitis (Radiation induced cystitis) in 2013. Concurrent medical conditions included Hypertension since 1975, High cholesterol since 1980 and Type II diabetes mellitus since 1980. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON) for Cystitis, ROSUVASTATIN for High cholesterol, TELMISARTAN, CARVEDILOL and AMLODIPINE for Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (Hard lump- 2 inch diameter). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 25-Feb-2021, VACCINATION SITE MASS (Hard lump- 2 inch diameter) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended on 16-Jul-2021 and obtained information about patient initials, demographics, medical history, concomitant medications, start date and outcome of events
Two days after vaccination, the pt contacted the hospital's pt liason complaining of arm swelling and soreness.
5:15 am - I noticed and felt an itchy, blotchy rash  1" below injection site.  Rash was approximately 2" in length and 1.5" wide.  I applied a thin coat of Fluocinonide (Rx from dermatologist from body rash in Jan 2021).  At 6:15am, I took 2 Claritin tablets.  Noticed that arm was itchy throughout the day.  Tried not to scratch.  At no time did I have any breathing problems or any other reactions aside from rash. Rash is still noticeable and itchy (no change from this morning) at 7:31pm same day.
I couldn't sleep because of the pain in my right arm. I sat on the side of the bed and felt dizzy. The next thing I know, I'm waking up on the floor with my husband standing over me. I passed out twice. I was very woozy the rest of the day and stayed in bed. Took extra strength Tylenol (that did nothing to relieve the pain) All over body aches and fever over 100 degrees all day.
Given expired dosage; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAB (Twinrix adult) (batch number X239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Twinrix adult (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Twinrix adult and Twinrix 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 Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The caller was a pharmacist stated that a patient was given an expired dosage of Twinrix on 26th August 2022 on right arm which was expired on 7th August 2022. The reporter did not consented to follow-up.  No HCP for follow up. Additional Supportive Information: The patient received expired dose of Twinrix adult, which led to expired vaccine used.
1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.
Mother phoned this facility to report child was experiencing "reaction" to vaccine. Vaccine administered 7/10/02 (Prevnar). Mom reported redness to site on 7/15/02 "size of lemon" pan, full ROM to arm. Mother did not bring child in to be checked, although appt was scheduled. Subsequent appts for congestion no further problems of shots (vacines).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
1720 Patient complaint of tightness in throat after receiving vaccination Pfizer. Send to observation clinic and assessed patient. Benadryl 50 mg by mouth given times one. 911 called and report given. 1745 Sent to Emergency Department.
Fever of 102 F, Sore Left arm , headache, nausea.
7/28/07 Right arm red/swollen 4x2 1/2 (DTaP) Left arm 1x1 area (Varivax) Parent gave Benadryl to help with itching and Tylenol - getting better now.
Patient was given 2nd booster (4th dose), thinking it was the first booster, and after vaccine was administered, it was realized that patient already received the first booster and was not eligible for the 2nd booster yet.
vomited immediately following rotovirus 'drink'. On 2/12/09, pt. had fever (101.5) rectally, vomited for 3 hrs. Was very, abnormally fussy and agitated from 2/13-2/16.  Fever broke  2/14/09.
Severe muscle pain at the site of injection.  Chills.  Impaired movement of the arm.  Headache.  Redness & swelling.
Warm to the touch Injection Site; Hard to the touch Injection Site; Itching Injection Site; Red Injection Site; Swollen Injection Site (Size of grapefruit); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's medical history was not provided. No relevant concomitant medications were reported.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTI ITCH CREAM [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)) outcome was unknown.     On 3 Mar 2021, the patient experienced the events red injection site, swollen injection site (size of grapefruit), hard to the touch injection site, warm to the touch injection site, itching injection site.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial unsolicited report received from a non-healthcare professional on 09 June 2015. A five months old male patient, whose medical history and concomitant medications were not reported, had received first dose of PENTACEL (batch number C4828AA and expiry date, site of administration was unknown) via intramuscular route on 24 April 2015. The patient also received the first dose of IPOL (batch number K1694 and expiry date, route and site of administration was unknown) on the same day on 24 April 2015. Thus it was an overdose for IPV. It was reported that patient had no reactions post vaccination, however two months after vaccination, the patient developed contact dermatitis and the patient's mother was trying to claim the two doses of IPV administered in April as the cause. It was reported that patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Documents held by sender: none.
Vomiting and diarrhea after 6 month vaccines. Diarrhea x 5 days. Onset 30 hours after vaccines administered. 12-14 stools/day.
Report  fever (102.), sore throat, runny nose, cough and chills began day post vaccination. Treatment: Tylenol. Outcome: no change in symptoms. Referred for COVID testing.
Hib (PRP-OMP) date given: 01-JUL-1999/Hib (PRP-OMP) date given: 23-AUG-1999/Hib (PRP-OMP) date given: 09-NOV-1999/Hib (PRP-OMP) date given: 29-AUG-2000; Hib (PRP-OMP) date given: 23-AUG-1999/Hib (PRP-OMP) date given: 09-NOV-1999; This spontaneous report has been received from a physician via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (2303USA004466), concerning a 6-month-old, female patient. The patient's previous immunizations included: hepatitis b vaccine (recombinant) (2 doses, administered on 26-APR-1999 and 27-MAY-1999). The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 01-JUL-1999, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "Hib (PRP-OMP)") (exact dose, lot #, expiration date, site and route of administration were not provided). On 23-AUG-1999, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "Hib (PRP-OMP)") (exact dose, lot #, expiration date, site and route of administration were not provided). On 09-NOV-1999, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "Hib (PRP-OMP)") (exact dose, lot #, expiration date, site and route of administration were not provided) (inappropriate schedule of product administered). On 29-AUG-2000, the patient was vaccinated with the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "Hib (PRP-OMP)") (exact dose, lot #, expiration date, site and route of administration were not provided) (extra dose administered). Between the vaccinations with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), the patient received additional vaccinations on following dates: inactivated polio virus (IPV) vaccine (23-AUG-1999); hepatitis b vaccine (recombinant) (09-NOV-1999); inactivated polio virus (IPV) vaccine (29-AUG-2000).  This is one of three reports regarding the same patient.   All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA004466: US-009507513-2305USA001541:
Herpes zoster type rash developing on R lower leg 6-7 days after vaccination examined today 4-27-09.  No other identifiable cause.
Patient presented 2 days after vaccine administered with moderate redness and swelling on back of right arm, around the vaccination site. Redness/swelling had worsened overnight. No pain or other symptoms reported.