chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 73 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 13-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
patient received a vaccine that was not diluted, and she could have received five times the dose; patient received a vaccine that was not diluted, and she could have received five times the dose; fever; muscle aches; headaches; This is a spontaneous report from a contactable healthcare professional, the patient.  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single undiluted dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient received a vaccine that was not diluted, and she could have received five times the dose. She experienced fever, muscle aches, and headaches. The clinical outcomes of the fever, muscle aches, and headaches were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
WOUND UP IN THE EMERGENCY ROOM WITH CHEST  PAIN; This spontaneous report received from a parent via a company representative concerned a 19 year old female. 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, and batch number were 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 patient experienced wound up in the emergency room with chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wound up in the emergency room with chest pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220202442.
Information has been received from a registered nurse concerning a patient with a history of coronary artery bypass who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot number, route and site not reported) after cardiac bypass surgery and then died. It was unknown if the patient sought medical attention. The patient's death was considered to be disabling. Additional information has been requested.
Breast heaviness and ache since I received the first shot which are very  uncomfortable.  Increase in hot flashes and night sweats.
I had burning in my nostrils followed by an outbreak of blisters inside both nostrils which lasted approximately 10 days. Initially, about 12 hours after the second vaccine, I had a headache, body aches, fever chills, then that subsided within 36 hours. Then on the 4th day following the 2nd vaccine, my neck glands became swollen and these blisters appeared in my nose. I believe these cold sores which are caused by a virus erupted as a  result of the vaccine. I have had them in the past, but rarely, maybe 3 times ever in my whole life. My dad had a fever blister break out several weeks following his second shot as well as another friend, so I'm thinking this is a result of the body's immune system being low from the vaccine.
rapid heart beat,weakness of the left arm and leg,trouble breathing,severe chest pain, pain in the arm and leg, large red welts on left side of neck and left thigh which evoled to bruises,dizziness and trouble walking,loss of appetite,tingling in the hand and arm. Sypmtoms persisted on and off until 8/18/09 when she developed sorethroat and fever. Fever ressolved 8/19/09.
NAUSEA, SEVERE MUSCLE ACHES AND WEAKNESS, UNABLE TO WARM UP (NOT CHILLS) , 8:00-10:30 PM. 10:30 PM VOMITING  1/24/2010 BODY WEAKNESS, NAUSEA
Got shot in left arm. Approx one hour later arm went numb all the way to finger tips. Sensation got worse, felt like needles and being shocked by electricity. Blood pressure spiked, feet tingled, ankles tingled, roof of mouth was itching, upper lip was tingling, developed nausea and severe headache. Took a Benadryl and went to ER. Was treated with 2 steroids, Ativan and Zofran. Arm was still numb and tingling when discharged. Was told to follow up with pcp is arm is still numb tomorrow.
large red, swollen rash covering the majority of left deltoid muscle, told patient to take benadryl and let us know if it gets better or worse
Injection given at 1530. Headache started at 1900, nausea and vomiting started at 2030. Symptoms self resolved after rest. Small blisters noted around injection site the next day.
I had a mild fever for about 1.5 days which wasn't bad, but a severe rash spread from the arm (injection site) to all over the upper body (shoulder, underarm, elbow, chest, neck, back, abdomen, inner thigh. I went to a dermatologist Dermatology because at first I thought it was a reoccurrence of an existing chronic rash, but then it became much more severe. I don't know if it was the same rash and the vaccine simply exacerbated the reaction. I was prescribed Triamcinolone Acetonide which helped clear up the rash within a few weeks. Occasional small localized rashes appear on the neck, underarm, inner elbow or thigh area but I don't know if they are related.
pt had no sx following injects; had acute onset of cyanosis & resp arrest 1 day p/immun; pt had congenital birth defect, Degeorge's synd w/aortoplasty done 17MAY94;
Initial report received on 05 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3199AA received on 12 September 2008 and 21 November 2008, and lot number C3180AA received on 22 January 2009, and 1 dose of DAPTACEL; lot number C2999AA received on 14 August 2009 (routes and sites of administration not reported). The subject developed a cough on 27 June 2012, nearly three years after the last dose. On 31 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 12 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 12 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 54 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report as received from a Medical Assistant refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX with  lot # M035696 and expiration date of 07-NOV-2017 (strength, dose and route of administration were unknown) for prophylaxis which was reconstituted with sterile diluent injection with lot number reported as M026304 and expiration date of 13-MAR-2019  (strength, dose and route of administration were unknown)  instead of VARIVAX (strength, dose, route of administration, lot number and expiration date were unknown) for the same indication. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 80 year old patient. Medical history and concurrent conditions were not reported. On 04-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
was really sick; doesn't feel good; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches). At the time of the report, ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches) outcome was unknown.            patient has MS so he got the third shot earlier.  Concomitant medications were not provided. Treatment information was not provided.
bilateral pulmonary embolus; left leg DVT diagnosed on May 17, 2021
Site: Pain at Injection Site-Mild, Additional Details: Patient called pharmcay to reschedule her 3/7/22 appointment. She also complained to RPh that she stlll has soreness at the injection site of her fiest COVID vaccination. She calaimed no infection was evident when questioned. RPh advised she visit to her priamry care provider to be diagnoised. Now answer when same RPh called back to check on her the following day.
Patient came in for Covid 19 booster dose today. Staff that was preparing the vaccine did not dilute the vaccine prior to giving it. 0.2 mL IM was given, but not diluted, thus resulting in getting a larger dose than intended. MD was notified, pfizer was contacted for adverse reaction information to watch for, family was notified. Family was told to watch for local/systemic adverse reactions to higher dose, call clinic and be seen if any concerns. Staff was re-educated on proper dilution of vaccine, variance was done, VFC point of contact notified, report made with Pfizer, and VAERS forms completed. Patient reports no adverse effects at this time. If adverse effects occur, VAERS will be notified by clinic staff.
fever; chills/severe shivering; hot sweats, cold sweats; hot sweats, cold sweats; severe nausea; body tense from head to toes; extreme headache near back; waves of shaking that started at head and slowly went down my body; couldnt focus on anything; just felt absolutely terrible; This is a spontaneous report from a contactable consumer. This 50-Year-Old female consumer (patient) reported for herself.  A 50-years-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0191, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 26May2021 at 17:00 (50-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included had foot/ankle surgery from 21May2021 (thus the pain meds). Concomitant medication(s) included norethindrone [norethisterone] (NORETHINDRONE [NORETHISTERONE]) taken for an unspecified indication, ketorolac (KETOROLAC) taken for an unspecified indication and acetaminophen; hydrocodone (ACETAMINOPHEN; HYDROCODONE) taken for an unspecified indication. The patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient has no covid prior vaccination, not tested covid post vaccination. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0173, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 18:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. On 26May2021 at 23:00, 06 hrs after vaccination, the patient experienced fever, chills/severe shivering, hot and cold sweats, severe nausea, body tense from head to toes, extreme headache near back, waves of shaking that started at head and slowly went down my body, couldn't focus on anything and just felt absolutely terrible. It was reported that patient experienced fever, chills, hot sweats, cold sweats, severe shivering for hours on end, severe nausea, body tense from head to toes, extreme headache near back of head, waves of shaking that started at head and slowly went down my body, couldnt focus on anything and just felt absolutely terrible. Patient did not receive any treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: NEAR SYNCOPE-Medium, Systemic: Flushed / Sweating-Mild
Within 24 hours post vax, this pt developed nausea, vomiting, diarrhea and upper respiratory infection. She was seen in a ER where a dx of influenza was made. As of 02/07 the pt recovered.
This spontaneous report as received from a registered nurse refers to a patient who was vaccinated with a dose of M-M-R II (lot # 668070/1059Z; Exp Date 11-AUG-2012) on 29-AUG-2012 which was expired. No known adverse effects. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Day One: I got a headache. Day Two: I woke up with light nausea. By afternoon, I developed light diarrhea. Day Three (today): The nausea and diarrhea have become worse, but not intolerable or alarming. I took 5mg ondansetron for the nausea. Diarrhea involves stomach cramping today -- watery and "fluffy" stools. I am also a bit tired and achey -- muscles and joints. It almost feels like I have a mild case of the flu, but don't feel particularly ill. Otherwise I feel fine -- no fever. No chills. Appetite a bit low, but not significant. Did not sleep well the past two nights due to headache, which may account for being tired.
Patient fainted while sitting in chair a few minutes after receiving vaccine. Patient hit the floor face first. Patient was observed to have some bleeding from his nose and/or mouth. Patient transported by EMS to hospital for treatment to be checked out.
Painful red appeared approximately 48 hours after injection administration; ~6inches below the injection site.
headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient's mother reported that the patient was having a headache after taking the 2nd dose on an unknown date and was asking if the patient can take Ibuprofen, Tylenol. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient fainted as he walked away from vaccination table but was partially caught by an staff member. He came to quickly and nurses evaluated him. His initial BP was 100/50 but soon rose to 120/70. Patient was given apple juice and water once he was able to sit up. He reported eating lunch at 1PM that day and had been feeling normal prior to his shot. He walked away feeling fine at 4:06PM.
Pt recvd a series of three Engerix-B  28SEP90, 29OCT90 & 16APR91 & did not serconvert;
Initial symptoms. Extreme exhaustion, elevated heart rate. Following day chest pain, difficulty breathing, very elevated heart rate. Pain more severe when bending forward. EkG suggested cardiac event. Further tests at cardiac unit led to pericarditis diagnosis. No blockages or heart attack apparent. Medication ibuprofen, colchicine and pantoprazole. Outcome released from hospital on day 5. Full recovery at 30 days.
had flu like symptoms; had a rash on his feet & ankles that looked like eczema or poison ivy that last about a week/was more on his left than right foot; was sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms), RASH (had a rash on his feet & ankles that looked like eczema or poison ivy that last about a week/was more on his left than right foot) and MYALGIA (was sore for a day) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu like symptoms), RASH (had a rash on his feet & ankles that looked like eczema or poison ivy that last about a week/was more on his left than right foot) and MYALGIA (was sore for a day). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms), RASH (had a rash on his feet & ankles that looked like eczema or poison ivy that last about a week/was more on his left than right foot) and MYALGIA (was sore for a day) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Pt recvd 3 doses  (dates not recorded) of Engerix B. Titers were checked 6 months p/ the last dose. Titer result was 6.3, indicating a low response.
pt recv vax; 3 days later,devel myalgia; sx worsened p/ pt began taking Keflex for unrelated throat infect; sx improved when tx w/ ibuprofen, however still present;
Inappropriate schedule of vaccine administered; 17-year-old patients received the first dose of Moderna COVID-19 vaccine by accident; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patients received the first dose of Moderna COVID-19 vaccine by accident) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 038c21A) 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) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patients received the first dose of Moderna COVID-19 vaccine by accident). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On 09-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patients received the first dose of Moderna COVID-19 vaccine by accident) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021, no new information was recorded On 28-Jun-2021: Second dose details and start date was updated.
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 1:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Jan-2022 at 1:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity reported. Concomitant products were not provided. Patient received booster dose vaccination time was reported as 13:33:16. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment medications were not reported.
First COVID Moderna vaccine done 3/11/21. She had mild soreness in arm and headache. On March 19 she developed itching hardness swelling 8 days later. It's been 6 more days and reaction is mostly faded and resolved but she can still see the outline of the rash area.
Patient got lightheaded immediately following vaccinations. Sat Pt down, used smelling salt, gave pt sips of ice tea, had pt sit an additional 20 minutes , released to care of father.