chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; This is a spontaneous report from a contactable other health care professional (patient) reported that a 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via intramuscular, administered in left arm on 19Mar2021 at 08:00 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension, psoriasis; both were from an unknown date and unknown if ongoing. known allergies includes sulfa. At Hospital facility where the most recent COVID-19 vaccine was administered. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included losartan taken via oral at 50 mg for hypertension from an unspecified start date and ongoing; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported, which were received by the patient within 2 weeks of vaccination. On 19Mar2021 at 05:00 PM, the patient experienced itching inside nose, mouth, vagina, rectum and then skin. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. Therapeutic measures were taken as a result of the events with Benadryl. The report seriousness was non serious. Outcome of the events was recovered on an unspecified date in 2021.
she felt tired; red circle on the injection area that starts to get bumpy; red circle on the injection area that starts to get bumpy; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported this female patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient felt tired and experienced a red circle on the injection area that started to get bumpy. The outcomes of tired and red circle on the injection area that started to get bumpy were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
possibly getting a connective tissue disorder; Isaac syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONNECTIVE TISSUE DISORDER (non-serious), outcome "unknown", described as "possibly getting a connective tissue disorder"; NEUROMYOTONIA (non-serious), outcome "unknown", described as "Isaac syndrome".  Additional information: It was reported have issue with the COVID vaccine to possibly getting a connective tissue disorder as well as being diagnosed with Isaac syndrome. Need to speak to someone. Have doc records to confirm would like someone to contact me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a female nurse of unknown age, referring to herself, via a company representative. The patient had no allergies or drug reactions. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot# and expiration date were not provided). No concomitant therapies were reported. On an unknown date after vaccination, the patient developed shingles. The patient sought unspecified medical attention, but no laboratory diagnostics were performed. The outcome of herpes zoster was reported as recovered on an unknown date. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
Breakthrough case Covid-19 after fully vaccinated (doses mRNA OR 1 dose viral vector)
After I took the 2nd shot I became weak an very tired .. I missed work left early an then on may the 31had a small strike.. I?m still off work.. I don?t know if the shot had anything to do with it but I never completely got my strength back.. an I worked every day until I got the shot. I just didn?t feel like working?
DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.
Child received immunizations below on 2/19/03. On 2/21/03 mother called the Health Department and reported that the child's left leg where child received immunization on 2/19/03 was very swollen and red, seemed painful and had some pustules on it. Mother was instructed to bring child to clinic for a check on left leg. Parents came to HD at noon time and upon arrival child was ambulating without difficulty. Left anterior thigh noted to have approximately 100mm X 170mm erythema with 50 mm induration with scattered small pin point pustules. Child was referred to emergency room at Community Hospital. Telephone call to mother on 3/4/03. Mother states child was seen at ER and  was told that swollen leg was probably a reaction to the immunization but just in case it was an infection was given two different antibiotics to take for 2 days with instructions for child to return to the emergency room for a recheck. Mother states child completed the medication and the leg was normal two days later, now only having some peeling of the skin. Mother states child never returned to the ER for recheck.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. An adult female patient of an unspecified age (reported as over 65) and race received, on an unknown date, PREVNAR 13 single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine. On an unspecified date, the patient experienced pain that prevented movement at the shoulder in the arm where was administered pneumococcal 13-val conj vac (dipht crm197 protein) (she received the flu shot in the other arm). She also had swelling in her hand. Clinical outcome was unknown at time of this report.
had a family member die 3 days after getting COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program PFIZER support from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated they had a family member die 3 days after getting COVID-19 vaccine. The outcome of the event was fatal. The patient died on an unspecified date.  It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: had a family member die 3 days after getting COVID-19 vaccine
BODY ACHES; CHILLS; SORE ARM; LOW GRADE FEVER; EXTREMELY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, sore arm, low grade fever, and extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body aches, sore arm, low grade fever and extremely tired was not reported. This report was non-serious.
The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.; Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.; Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021). On 28-May-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Patient was administered with Moderna Covid-19 vaccine which was 30 day beyond use date. No adverse events were reported by the patient at the time of this report.  Treatment information was not provided.
p/ pt recv vax approx 2 yrs later devel breakthrough chickenpox consisted of spots, runny nose.
Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.; Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Between the 3rd and 4th doses of Pfizer BioNTech vaccines, the report had a Covid 19 infection.". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: There was no covid prior to vaccination and it was unknown if patient tested for covid post vaccination. It was unknown if patient received other vaccine in four weeks. The patient most recent dose was Comirnaty dose 6.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product cannot be fully excluded.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted post administration briefly. patient stated that this is a normal reaction to vaccines. declined further care. patient was brought to sitting position, given water and left shortly after.
Gastrointestinal tract issues and diarrhea.  Varying degrees of sickness since 4-15-21. Can't eat solid food without digestive issues and diarrhea.
Began with general malaise. One night of transient pains perceived as white balls of pain during night of Feb 9. Exhaustion and fever of 100.4 and chills occurred on February 10, and I spent 4 hours in bed during the day. Transient pains  again with strange nightmarish  perceptions during night of February 10, Some shortness of breath on February 11, and onset of fairly severe chest, lung, and middle body pain, This pain intensified during night of Feb 11, and continued through February 12,  but energy returned. Pain diminished by February 13, when I was almost feeling normal again.
Body pain, body aches; Painful leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL9267), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced some body pain, body aches and painful leg. The patient reported that he had Tylenol and still want to know if he could take two or some. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a doctor of pharmacy refers to a 73-year-old patient, gender unspecified. On 10-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0171AE, expiration date 20-MAR-2013, route not reported). No adverse effects reported. Additional information has been requested.
Vaccination site red; Vaccination site sore; Vaccination site itchy; Vaccination site red; Vaccination site pain; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red) and VACCINATION SITE PAIN (Vaccination site sore) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and OMEPRAZOLE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved and last episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I have a sharp pain that moved from my left arm, to the base of my neck, now the pain is shooting down my spine and into my other arm.
Patient with intermittent headaches prior to initial COVID vaccine but approximately 2 weeks after 1st dose had first episode of severe headache associated with nausea/vomiting, dizziness and numbness to bilateral arms that gradually improved. Had second episode of severe headache with similar symptoms on 6/23 and additional episode on 7/3 with persistent severe nausea, vomiting and dizziness with fall at outside ED. MRI at that time showed multifocal posterior circulation ischemic strokes possibly secondary to vascular insult with left vertebral artery dissection but very subtle on imaging.
swelling in left leg and left arm   (side of body where vaccine administered) .  patient states having difficulty walking due to swelling in his leg
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N010866 for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT).  On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD and sterile diluent (STERILE DILUENT).  Sender's Comments:  US-009507513-1709USA002548:
After receiving immunizations client immediately left clinic with mother and siblings.  She felt light headed and fainted.  This was not witnessed by any staff members.  Mother reported child struck right cheek when she fell.  At home developed nausea/vomiting and became very tired.  Mothe took child to emergency department for evaluation.
Patient experienced faintness,rigors,weakness, diaphoresis, and c/o of neck and jaw pain.  Blood pressure was elevated with complaints of shortness of breath as well. Vaccine administered at 1:39 and adverse reaction at 1:45pm. Benedryl 50mg IM given at 2pm. Symptoms resolved about 2:45pm.  Patient was discharged to home with family member.  Patient declined EMS transport to ER. Patient encouraged to follow-up with PMP.
Several hours post vax the pts leg was very red, swollen and tender. The pt was treated with Tylenol and ice packs.
SLEPT FOR PROBABLY 20 PLUS HOURS; ACHY; FEVER; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced slept for probably 20 plus hours, achy, fever, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and fatigued, and the outcome of slept for probably 20 plus hours and achy was not reported. This report was non-serious.
No side effects were documented at time of vax. Phone call received to state child had a fever 101 and no other symptoms 05/03/1994.  05/20/97 Mother completed report stating that child ran very high fever of 104. Called physician at 10:30 PM and was told to sponge her off with tepid water and rub briskly. Continue with Tylenol until fever cooled and check back in the morning.  Pt had bilateral hearing loss dxed 05/14/1997. Pt has received permanent medical exemption from receiving the MMR due to "severe reaction with previous vax" by her pediatrician as of 10/2/1998.  Follow up 08/22/2000: "Patient ran a high temperature for several days and nights.  One night went up to 104 and started vomiting.  Called MD at home and MD assured that patient was ok.  Spoke to nurse next day, nurse informed that it was normal for patient to have fever that high.  Tylenol was given every 4 hours.  Patient was very sick for several more days repressing to take formula and still running fever of 104-105.  MD refused to give patient the second shot stating that patient was allergic to the vaccine.  Patient wears hearing aids in both ears, and has speech problems."
I started experiencing side effects from my vaccine 24 hours ( at 2pm) after my second shot, 8/31/2021. I started with aches, injection site pain, and an overall feeling of not being well . Shortly after that started ( at 2:45pm), the lymph nodes under my left arm  began to swell to the size of a tennis ball. I applied heat and took OTC pain medication. The pain continued to worsen through the night to the point that I was unable to use that arm. I did notice that the lymph nodes on the left side of my neck had started to swell. Today, 9/1/2021, the swelling in my arm pit has not gone down and has spread into the left side of my breast. The lymph node in my neck has reduced in size but now I have noticed that the lymph nodes located in my inner thighs have started to swell. I am still rotating ibuprofen and Tylenol to try to minimize the pain and get the swelling to go down.
4 hours later, facial swelling, itching, redness, terrible headache. Headache lasted 4 days. For next dose, pre-treated with Tylenol and Benadryl and she tolerated it.
1 hour after receiving Pediarix, Hib & Prevnar, baby began crying and could not be consoled. Would quiet for a few minutes and then begin crying again. Eating very little, would not take breast. Still happening 48 hours after vaccines when examined by MD.
Received a spontaneous report on 12JAN2017, 13JAN2017 and 18JAN2017 from personnel. The physician reported that on 11JAN2017, employee was to leave soon, was administered a dose of BIOTHRAX which had expired on 07JAN2017. The subject did not experience any adverse events. Further information was not available.