chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 10-AUG-2015, the patient was vaccinated with ZOSTAVAX lot # L012475, expiration date: 16-JUL-2016, subcutaneously in his right arm. On 10-AUG-2015, after receiving ZOSTAVAX, the patient experienced itching on his left arm and down the left side of his body. The patient sought medical attention: called the pharmacist. At the time of the report the patient did not recover from the event. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pt received vaccine 9/16/04. Was seen on 09/18/04 for approx. 8cm red and swollen area on right anterior thigh. Center of area was injection site area tender to touch. Symptoms starting evening pt received injection. Redness spreading to back of thigh was seen again 9/20 w/ symptoms improved. Treated w/ antibiotics and prednisone.
pt recvd vax;subsequently, it was noted that vax had expired 30sep90;
after 4 hours soreness in arm. after 12 hours aches and fever developed. site of injrction was red. aches and fever persisted for 24 hours. after three days inection  site is still tender and red
Seeing increase in people saying they have a sore arm; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient seeing increase in people saying they have a sore arm on an unspecified date with outcome of unknown. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received my triple flu vaccination on Octob. 4th. By Oct 5th I had a fever of 100 - felt nauseous - was unable to work.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two weeks ago from the reporting date, the patient received a dose of SHINGRIX. The patient concerned about her pain in the arm as it lasted more than 2 weeks. The patient informed to her physician about the adverse event she experienced and he said, it was too new to have a lot of data. It had been advised to the patient that, her physician or pharmacist can contact to medical information department regarding questions on SHINGRIX and provided the contact details for the same. At the time of this report, the patient could not raise her arm without pain. The patient had been advised to contact her Heath Care Provider (HCP), if she continued to experience the arm pain, or it bothered to her.
STARTED PERIOD EARLY AND IT HAD EXTREME BLEEDING WITH EXTREME CRAMPS. THATS WITH THE 1ST DOSE.  THE LAST ONE STARTED PERIOD EARLY AND IT IS WORSE.  BEEN BLEEDING FOR ALMOST 3 WEEKS AND IT IS HEAVY AND AMOUNT IS MORE THAN THE FIRST DOSE WAS TIMES TEN.  IF IT DOSENT STOP BY FRIDAY I AM GOING TO SEE A DOCTOR. NEVER HAD THIS HAPPEN BEFORE.  PS. MY TUBES ARE TIED .
On November 20, 2021, patient received his first COVID-19 Pfizer vaccine (batch/lot#33030BD). He reported no symptoms initially but one to two weeks later noted more dyspnea, notable with exertion and some labored breathing. He reported no wheezing, cough or chest pain. He was able to perform aerobic activity to include running, but felt this was more difficult compared to the past. He received his 2nd COVID-19 vaccine on December 12, 2021 with no reported change regarding  immediate symptoms. Labored breathing continued. He thought it was slowly improving over the past few weeks. He was evaluated by cardiology (labs and echocardiogram). He reported being told cardiac workup normal. There is no planned follow-up appointment pending.
chancre like sore on his tongue; chancre like sore on his tongue; welts on his tongue; some white circular canker type sores came on my tongue around the tip area; Vaccine and hydroxyurea might be working against each other; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation;  hydroxyurea (HYDROXYUREA), route of administration, start and stop date, batch/lot number and dose were not reported for Platelet count high.  The patient had been taking hydroxyurea for 24 years now. The patient medical history was not reported.  The patient's concomitant medications were not reported.  After the first dose, in 2021, the patient experienced chancre like sore on his tongue and some white circular canker type sores came on my tongue around the tip area. After the first one, there was some welts that came up on my tongue in 2021. So from 19Feb2021 until a couple days ago he has not been able to see the doctor who prescribed the hydroxyurea to him and when he met with him he was saying that the vaccine and hydroxyurea might be working against each other. So, today he has not taken any hydroxyurea. He has not done anything to the welts, they look almost like canker sores but they are clearing up on their own right now. He has not taken it from yesterday morning and the welts seem to be clearing up now since he did not take it but he doesn't know for how long he can not take the hydroxyurea. He received the second shot on 15Mar2021. The action taken in response to the event for hydroxyurea was temporarily withdrawn on an unspecified date. Outcome of the events chancre like sore on his tongue, welts on his tongue, some white circular canker type sores came on my tongue around the tip area was recovering. Outcome of the event Vaccine and hydroxyurea might be working against each other was unknown.  Information about the Lot/batch number has been requested.
she felt a surge from the injection site on her left arm which went up to her shoulder, her neck, her face, and then her brain.; pain; swelling; take a nap; Felt the injection travel up her arm, into her neck, and into her brain, she could feel it moving; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 10:40 AM (age at vaccination: 70 years), as a single dose for COVID-19 immunization. The patient was taking covid vaccine because she didn't want to get infected and infect anyone else. Vaccine was not administered at military facility. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient mentioned that she received the 1st dose of the vaccine on her left arm last 13Mar2021. She mentioned that everything went well and there were no problems. She got home and about half an hour later she lied down and she felt a surge from the injection site on her left arm which went up to her shoulder, her neck, her face, and then her brain on an unspecified date. She wanted to take a nap because she got up early, she wasn't tired from the vaccine. The patient felt the injection travel up her arm, into her neck, and into her brain, she could feel it moving. It happened so quickly then went away and the patient felt it move into her brain and asked was it a clot, was it the medicine itself. The patient has been walking and has been fine. This happened in the left arm, the same arm that the vaccine was given in. She described it as like a marble moving up inside her arm. It went away eventually and she was feeling fine now. She did not expect that feeling, not like the pain and swelling she initially felt on her injection site which was normal to her, just like when getting a flu shot. She took one Tylenol for the pain and swelling and it went away. She mentioned that there was nothing wrong after that and would just like to report it. She was also asking if she should take the 2nd shot. The adverse events did not require a visit to emergency room and physician's office. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Lethargic, muscle pain, joint pain, fever, chills, night sweats. Lasting 36 hours.  Previous positive COVID-19 PCR May 2020 (fever, muscle and joint pain, loss of smell and taste, night sweats, lethargy) and IgG Sept 2020.  Unconfirmed positive COVID-19 March 2020 with symptoms (Fever, muscle pain, joint pain, lethargy, loss of smell) lasting 48-72 hours.
I am premenopausal and have not had a regular cycle for 2.5 years. My last menstrual cycle was late July and as it has been going, I wasn't due for another cycle until  November or later. However after my 1st shot in September, I started bleeding after 4 days of receiving the vaccine. After my 2nd dose on October 8th, I again started bleeding after 5 days.  I haven't had a consecutive menstrual cycle in years, and to have 2 cycles in a matter of 3 weeks is concerning to me.
some side effects 15 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose). The patient was treated with IBUPROFEN at a dose of 400 milligram twice a day and PARACETAMOLUM at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose) outcome was unknown.
Occipital Head pain approx. 1 1/2 hr after injection.  Fever rose to 103.8 next morning with all over joint and muscle pain.  Fever dropped to 101 and lasted 2 days.  Chills lasting for a week with no fever, low core body temp.  Head pain and low back pain ongoing .  Intermittent numbness and tingling in face with sinus pain. 1 episode of migraine with aura, aura lasting 40 minutes followed by head pain in top of head.  Elevated blood pressure.  Pain in low back with right side pain. (Went to Medical Center, seen by Dr. on March 18, 2021) performed urine culture - test normal. Sent to Health System on March 22, 2021 forUltrasound of Kidneys  - test normal.  Normal covid test.  Chest discomfort and shortness of breath.
Patient was woken from sleep with crushing, burning chest pain, rated a 7/10 on pain scale, blood pressure was 155/90. Wife brought him to local ER, initial troponin level 2.13, recheck 1.5 hours later, 3.11. Transferred to larger city hospital, underwent several tests finally concluding with a cardiac catheterization, Cardiologist team diagnosed patient with myopericarditis.
I received the Pfizer doses of the vaccine.  The two entry points on my right shoulder immediately started becoming inflamed, and never healed.  2 years after the incident, the site of the shots had turned into Basil Cell Carcinoma.  At which point he had the entire site removed at a $1,000 cost.
Patient reported racing heart (100 bpm) at rest and fever. He was encouraged to seek medical attention but did not. He reported the event 10/04/2014 about 9 am. A care call in the afternoon revealed that he was feeling much better.
Got a swollen lymph node in my groin with abscesses after flu shot; Initial information regarding an unsolicited valid serious case received from a consumer (patient) via social media on 03-DEC-2020.  This case involves a patient of unknown demographics who developed a swollen lymph node in groin with abscesses (Lymph node abscess), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect INFLUENZA VACCINE  the patient got a swollen lymph node in groin with abscesses (Lymph node abscess).  Seriousness: The event was medically significant.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The outcome was recovered for lymph node abscess.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a patient of unknown demographics who presented with Lymph node abscess after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
approx 1 1/2hr p/vax pt broke out in urticaria all over body;no other sx;was taken to MD stated it was d/t an insect bite;concerned since another MMR will be given at kindergarten entrance;
Pt admitted to hospital after presenting to ED with SOB and weakness. He tested positive on home COVID test. He has been vaccinated and boosted against COVID. Pt started on dexamethasone and Remdesivir, Pt is currently on 3L O2. He is still hospitalized
no seroconversion; Therapy non-responder; Therapy non-responder; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Zostavax (received Zostavax when he was 48years old).   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, Hepatitis B vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder, therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder, therapy non-responder and therapy non-responder were unknown.   It was unknown if the reporter considered the therapy non-responder, therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was nor reported. The patient received 6 hepatitis B vaccine over the last 20 years. The patient received Zostavax when he was 48 years old and Merk included him in a study for Zostavax because of his condition of not converting Hepatitis B vaccines. The patient believed his hepatitis B vaccination was also Merk's and that was why they wanted to include him in a study, but could not confirm that all of the 6 vaccines received were Merk's. The patient stated he got the initial series (3 doses) of Hepatitis B vaccine and then through his profession had a titre drawn and given a booster dose. Then found again after booster dose to not be protected and received two additional doses, again with no conversation. The patient had no other reactions and no problems converting any other vaccines. For tolerance of Shingrix, refer linked case US2019088015.      Lab Comments: On an unknown date, the lab tests were performed.
Soreness at injection site, chills and fever that lasted for approximately 5 hours, general overall aching that lasted 24+ hours, intense muscle spasms in both arms resulting in Tourette's-like behavior, burning out-of-body sensation, pinpointed sharp pains in body parts including teeth, heart, back of head, ovaries, and ankles, mild hallucination, dizziness, sore glands in neck
Initial and follow up information has been received from a medical assistant via the pregnancy registry for GARDASIL, concerning a 22 year old female with allergies to amoxicillin, CECLOR and erythromycin, who on 25-JAN-2007 was vaccinated with a single, first dose of GARDASIL at another clinic (lot #654510/0962F).  Concomitant therapy included an unspecified prenatal vitamin and ferrous sulfate (unspecified).  Subsequently the patient became pregnant (LMP 09-JAN-2007, EDD 16-OCT-2007).  On 19-MAR-2007 an ultrasound showed that the pregnancy was 10.8 weeks along, her EDD was 08-OCT-2007, and it showed the "size and dates" (not further specified).  As of 25-APR-2007 the patient had not experienced any side effects.  Follow up information from the MA, confirmed that on 08-OCT-2007, an 8 pound 9 ounce, 20 inch long, normal female infant (Apgar score 8.7) was born, at 39 weeks after the date of LMP.  The pregnancy and delivery had been without complications.  Follow-up information was received from a health professional.  The baby had a head circumference of 31.5.  The patient was Group B streptococcus positive.  The patient had herpes in the last 3 weeks of pregnancy and was treated with acyclovir.  The patient also had UNISOM for allergies and PRILOSEC for heartburn.  Additional information is not expected.
On 04/09 the pt was treated for ear infection with antibiotics, also nasal congestion, no fever. On 04/10, varicella like rash developed on abdominal, back and injection site (red, swollen and hot to touch). On 04/13, the pt developed diarrhea and diaper rash. On 04/15, rash faded. On 04/17, larger pustules formed on buttocks, torso, arms and legs.  Knees and elbows swollen and red and painful. On 04/18, seen by a physician and treated with antihistemine and steroids. On 04/22, the pt felt better, elbows and knees look like a bruise now, rash faded with some red dots. Rash never weeped or crusted over.
Extreme headache lasting 72 hours Nausea off and on for more than 72 hours Body aches lasting more than 48 hours
47 Days between 1st and 2nd dose; Feeling dizzy; Nauseous; Feeling wore out; Fatigue; Headaches; Tenderness at injection site; Diarrhea; Nausea; Fever started about 5pm the day after vaccination, lasted throughout the night, temperature never; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness at injection site), DIARRHEA (Diarrhea), NAUSEA (Nausea), PYREXIA (Fever started about 5pm the day after vaccination, lasted throughout the night, temperature never) and FATIGUE (Feeling wore out) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #032L20A and #013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, RABEPRAZOLE SODIUM (ACIPHEX), PRAVASTATIN and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (Tenderness at injection site), DIARRHEA (Diarrhea), NAUSEA (Nausea) and PYREXIA (Fever started about 5pm the day after vaccination, lasted throughout the night, temperature never). On 18-Mar-2021, the patient experienced FATIGUE (Feeling wore out), FATIGUE (Fatigue) and HEADACHE (Headaches). On 24-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (47 Days between 1st and 2nd dose). On 18-Mar-2021, PYREXIA (Fever started about 5pm the day after vaccination, lasted throughout the night, temperature never) had resolved. At the time of the report, INJECTION SITE PAIN (Tenderness at injection site), DIARRHEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Feeling wore out), FATIGUE (Fatigue), HEADACHE (Headaches), DIZZINESS (Feeling dizzy) and NAUSEA (Nauseous) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (47 Days between 1st and 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Mar2023, outcome "recovered" (28Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Mar2023) Positive; (28Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173716 Same patient, different drug, different event;
11/18/21 presents to EC ED as transfer with "hemorrhagic CVA". PMHx "left PCA CVA on 81mg ASA, DM2, HTN, hypothyroidism".