chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 60 years old female consumer reporting on herself with allergy to penicillin who on 18-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspect were reported. Concomitant vaccines administered on the same date included PREVNAR and unspecified flu vaccine (manufacturer unknown). The consumer reported that on 18-SEP-2012, after her vaccination she began to feel achy all over the from her hands to her legs and arms. ADVIL was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the consumer was recovering. The patient did not seek medical attention. The relatedness for the patient began to feel achy all over from her hands to her legs and arms was unknown for ZOSTAVAX. Additional information is not expected.
Mild pain/soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild pain/soreness at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2, Solution for injection), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) and as dose 2, single (Batch/Lot number: unknown, Expiration date: Unknown) at the age of 65 years for COVID-19 immunization; COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. Doses 1 and 2: Lots/NDCs/Expiries: Unknown, caller did not have CDC vaccine record card with her at time of call. Moderna Covid Vaccine: Booster: Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with her at time of call. The patient had no relevant medical history. There were no concomitant medications.   The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID". It was reported that the patient was fully vaccinated, had both Pfizer Covid Vaccines and then a Moderna Covid Vaccine booster. She did not expect to be very sick with COVID if got it. When tested positive for COVID just came on like whoa, felt really sick and scared. She called her doctor and the doctor prescribed her Paxlovid for COVID, and patient got Paxlovid within 2 hours of the phone call she placed to her doctor. The Paxlovid seemed to really work, she started feeling better, her COVID symptoms weren't worsening at the same time that she noticed the metallic taste onset. So initial onset of both of those events were when she woke up from a nap and thought she didn't feel so bad, but that's also when she noticed the metallic taste. Now the strictly sour taste in her mouth seems to be getting worse, more pronounced at the same time that her COVID symptoms continue to improve. It was reported that the patient was taking Paxlovid for Covid. She is feeling way better, Paxlovid has alleviated her COVID symptoms. That was also the same time that she noticed Paxlovid started working because her COVID symptoms weren't getting any worse, she felt a little better. she's feeling way better regarding COVID, it feels like a cold instead of a really bad flu. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient had no other investigations. Therapeutic measures were taken as a result of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 06/03/2022 I had blood work done for upcoming surgery, it was noted that my platelet count was in  the 80's. I had repeat blood work done on 06/08/2022 and my platelet count dropped into the 70's. I was scheduled to see a hemotologist and he scheduled a series of tests. My platelet count remained low dropping into the 60's. During the tests it was determined I had developed Antiphospholipid Antibody Syndrome. Since this diagnosis on 06/28/2022 I was placed on 81mg Aspirin daily. On 10/21/2022, I was put on hydroxychoroquine 200 mg twice a day in hopes to raise my platelet count. To date my count is 69. My surgery has been cancelled and I was advised not to have my surgery until platelets increase.
diarrhea; headaches; achy feelings; coughing; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included glucosamine taken for an unspecified indication, start and stop date were not reported and (Pharmacy Name) Silver Multivitamin. Historical Vaccine included yellow fever shot on an unspecified date (couple decades ago) and experienced lymph nodes under her left armpit was swollen. On an unspecified date, the patient experienced diarrhea (twice but doesn't have a sensitive stomach), headaches, achy feelings, and coughing. The patient asked if taking pain relievers  after vaccination would neutralize the effect of the COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pancreatitis, mild.  In addition had fever/chills, nausea, headache, joint pain all in first 24 hours.
Death; This is a spontaneous report from a non-contactable consumer. This is one of 5 reports      A patient of unspecified age and gender received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died on an unknown date from an unknown cause.    It was not reported if an autopsy was performed. The reporter stated that the vaccine was kept in ice box for like 5 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944710 same reporter/drug/event, different patient;US-PFIZER INC-202100944708 same reporter/drug/event, different patient;US-PFIZER INC-202100944711 same reporter/drug/event, different patient;US-PFIZER INC-202100944709 same reporter/drug/event, different patient; Reported Cause(s) of Death: Death
ringing in her ears/ringing in ears that is worse than others; tingling like pains and needles on top of her head; arms and legs like jell-O and weak; pulse elevated at times; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown, Expiration Date: unknown),via an unspecified route of administration, administered in Arm Right on 29Jan2021 at 09:00 as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications.The patient did not have any history of previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. No adverse event prior to vaccinations. No problems with vaccines in the past. She does not even get a flu shot. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Patient did not had Illness. In Jan2021, the Patient had side effects since she got the first dose of what she calls Pfizer Biotech Covid-19 vaccine. Patient also went to the doctor and also was a little concerned, Patient had ringing in ears that is worse than others, has tingling like pins and needles like it would have in the toes, but it was on top of head, Legs and arms were like jello and they were weak are slightly better, but still had it. Symptoms started a few days after the vaccine, her pulse also was elevated at times, was really bad at one point and was better than it was, but still there. Adverse event resulted in physician visited physician office and not visited emergency room. The patient underwent lab tests which included pulse: elevated in Jan2021. The outcome of event pulse elevated at times was unknown and not yet recovered for rest of the events.  Follow-up attempts completed. No further information expected.
Both feet are a little numb; Numbness in middle right toe; Cramping in left foot; Tingling (numbness) in his right foot; 16 year old given vaccine; Patient received second dose 36 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot), HYPOAESTHESIA (Both feet are a little numb) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose). On 15-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling (numbness) in his right foot). On 19-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in middle right toe) and MUSCLE SPASMS (Cramping in left foot). On 22-Aug-2021, the patient experienced HYPOAESTHESIA (Both feet are a little numb). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 36 days after the first dose) had resolved. On 25-Aug-2021, PARAESTHESIA (Tingling (numbness) in his right foot), HYPOAESTHESIA (Numbness in middle right toe), MUSCLE SPASMS (Cramping in left foot) and HYPOAESTHESIA (Both feet are a little numb) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tingling in his right foot started on 15-AUG-2021. On  19-AUG-2021 reported numbness in middle right toe and cramping in left foot. On 22-AUG-2021, both feet are a little numb.  Patient race is On 25-AUG-2021 reported no numbness or any other symptoms.  No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-280894 (Patient Link).
This vaccine was used after the BUD. Parent did not report any adverse reaction  after receiving this vaccine.
This is a spontaneous report from a contactable physician. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. Medical history included diabetes. Concomitant medications were not reported. On an unspecified date the patient had inflammation at the site of injection, fever and malaise. The events were non-serious with outcome of unknown. Follow-up (03Dec2014): Follow-up attempts completed. No further information expected.
The pt developed swelling, redness, 10 cm red and indurated not area. Was given steroid for the treatment.
2 cm mark at (R) thigh (anteriorly) nontender. No erythema. Advised to gentle massage.
Lower half of face swelled; Lips swollen; Tongue swollen; Face and lips flushed bright red; Voice became hoarse; Hot flashes through chest and arms; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 30Mar2021 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune allergic condition (autoimmune disorder), allergy to sulfa drugs and allergy to shellfish since unknown dates. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and lovastatin (MANUFACTURER UNKNOWN); all for an unknown indications and from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 18:45, the patient experienced lower half of face swelled, lips and tongue swollen, face and lips flushed bright red, voice became hoarse, hot flashes through chest and arms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lower half of face swelled, lips swollen, tongue swollen, face and lips flushed bright red, voice became hoarse and hot flashes through chest and arms were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients were vaccinated with improperly stored VAQTA lot # L018499, expiration date reported as 25-FEB-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degree Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
My arm & shoulder swelled, very sore, could not move arm well, had to have help getting clothes on. Doctor gave Prednisone 5 mg 6 day pak plus refill.
Patient is experiencing redness at the injection site which arose this morning when she woke up. It does not itch but is a little warm.
Triceps and deltoids itching. Burning with erythema (Redness) and edema. Pain and burning sensation over post upper arm from shoulder to elbow.
Information has been received from an administrator referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554 with expiration date 25-DEC-2017, lot # L024993 with expiration date 17-OCT-2017, dose and route unknown). The lot # L037554 of the vaccine was exposed to temperature excursion of 46.58 Fahrenheit degree (F) for 26.5 hours and lot # L024993 was exposed to 50.45 F for 32 hours 45 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on trunk, arms, neck, cheek and legs.  Administered Benadryl for rash.  Two weeks post-vaccination, episodes of petit mal seizures daily, eyes rolling back into head, for two weeks. Noted MMR vaccine reaction by LPN on 4/25/08.
Treatment of COVID-19; Treatment of COVID-19; Dose 1: Moderna/ Dose 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer) from product quality group. The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 09:00 as dose 1, single (Lot number: GJ3268) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2023 at 09:00 as dose 2, single (Lot number: 203E73A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2023 at 09:00, outcome "unknown", described as "Dose 1: Moderna/ Dose 1: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19 from 20Oct2023 to 24Oct2023. Clinical course: It was unknown whether the patient had other medication in 2weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350763 Same patient, different drug/AE;
pt devel elevated temp 101-102 w/prolonged sz (up to 1hr) w/apnea;adm to hosp 10JAN98;placed on ventilation 10JAN98 x 9hr;
No additional adverse events reported; Nurse practitioner states a dose of PEDVAX HIB was given along with a dose PENTACEL on accident today; This spontaneous report was received from a nurse practitioner referring to a 12-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 03-MAY-2021, the patient was accidentally vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter, lot number T001208, expiration date 09-JUN-2022 (route of administration not reported) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid(PENTACEL) 0.5 milliliter, lot number UJ421AAA, expiration date 08-MAR-2022 (route of administration not reported) both for prophylaxis (medication error).
No additional AE reported; expired dose of STERILE DILUENT was used to reconstitute M-M-R II and administered to a patient on 22-APR-2022; expired dose of STERILE DILUENT was used to reconstitute M-M-R II and administered to a patient on 22-APR-2022; This spontaneous report was received from licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 22-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) at a dose of 0.5 ml, lot number U023829 was found to be valid, expiration date 30-JUL-2023 (strength, route of administration and injection site were not reported) for prophylaxis. The vaccine was diluted with an expired dose sterile diluent at a dose of 0.5 ml, lot # S008565 was found to be valid, expiration date 09-AUG-2021 (expired product administered, product preparation issue). The caller confirmed that the dose of sterile diluent did not experience a temperature excursion. No additional adverse events were reported (No adverse event).
1st Dose as Moderna and Second Dose as Pfizer Vaccine.; 1st Dose as Moderna and Second Dose as Pfizer Vaccine.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.).    It was reported that a 5-year old received her 1st dose from Moderna before patient turned 5 years old and received the Pfizer-Biontech Covid vaccine for her 2nd dose when patient turned 5 years old. No concomitant product reported. No treatment medication reported.   Reporter did not allow further contact
3/27/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  redness and feeling flushed to the facial area.   Assessment : Time of assessment 1100am, 1100am Alert and oriented. Voices feeling flushed to face, she has some redness to cheeks,   Actions taken:  obverservation x 30 minutes, VStaken 1100am BP-145/79, P-93, O2- 100%, recheck VS at 1119am- BP-119/82, P- 90, 1130am- VS are BP-109/85, P- 89, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Moderna COVID-19 Vaccine 3/27/2021 10:52 AM 0.5 mL 12/1/2020 Intramuscular   Manufacturer: Moderna
No reaction after first shot on February 28, 2021.  Second shot on March 19, 2021 a Large red, itchy rash started two days after injection with arm being warm to touch, swollen and a large bump at the injection site for 7 days and then on the 8th day redness disappeared somewhat but then hive-like bumps appeared and itch worsened.  The Pharmacy called and we had to come in two days early as the vaccine was going to expire on Saturday at 3:00 p.m. so we went on Friday at 6:00 p.m.
while walking to the waiting area she was feeling sick and  she lay down on the floor before passed out. Never pass out. BP and pulse were stable. Able to sit on a chair and observed for 10 minutes client voices feeling fine and sign the observation release form and went home in accompany of her mother.