chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 6 year old black male with no pertinent medical history and no known allergies who on 16-Oct-1998 was vaccinated in the left arm with a dose of varicella virus vaccine live (Lot #626960/0847H). There was no illness at the time of vaccination. Concomitant therapy that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #628404/1175H) administered in the right arm. On 18-Jan-20404 the patient presented to the physician's office with a case of chickenpox breakthrough. The child was noted to have a papular, vesicular rash that first appeared on his stomach and then spread to the rest of his body. No fever was noted. The child was treated with acetaminophen (Tylenol), diphenhydramine hydrochloride (Benadryl), and rest. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information indicated that the adverse event onset was on 17-Jan-2004. Seventy-two percent of the lesions were on his stomach, with more lesions daily moving to his legs and arms. Treatment included diphenhydramine hydrochloride (Benadryl), acetaminophen (Tylenol), and rest. Additional follow up information indicated that the patient developed a rash with vesicles that started on the patient's stomach and "spread all over" over several days. Additional follow-up information indicated that the patient recovered 5 days after onset. The reporter indicated that she had seen two other cases of breakthrough chickenpox in the last couple of months. No further information is expected.
Low grade fever of 99.8. Generalized pain in shoulders, knees, hips and sharp pain radiating up the spine. Next day, fever of 103, day 2, fever of 104, day 3, fever of 100-103, day4, fever of 99.3-99.8, day 5, no fever.
Large local reaction with bruising, swelling, redness. Pain in upper arm, axilla and adjacent breast tissue.
Patient called and reported feeling "terribly nauseated approximately 1 hour after receiving the vaccine. She reports she has never had a reaction like this to a vaccine in the past. She reported having nothing to eat or drink since lunchtime. The patient then took 1 meclizine 25mg tablet and had a snack. When I followed up the next day by phone, she reported feeling some better shortly after consuming meclizine and some food, but did not feel "100% back up to snuff" until the morning.
got so sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient of unknown demographics who got so sick (Illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications 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 expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got so sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  The patient was in bed for 3 days and could not make a sound.  Relevant laboratory test was not reported.  Final diagnosis was got so sick.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
-caffeine intolerance after 24 days after first dose (05/04/2021) -fatigue, chest pain, headache, and dizziness; weakness after drinking even small amount of caffeine, eating, and standing for long periods 3 weeks after second dose (06/01/2021)
Information has been received from a nurse practitioner concerning a 21 year old female employee with a history of helicobacter pylori infection who on 07-SEP-2007 was vaccinated intramuscularly with a 1mL dose of GARDASIL. There was no concomitant medication. The nurse reported that the employees was vaccinated at another office and received 2 doses at once (total of 1 mL). The patient developed extra soreness and a bump on left arm. The patient received unspecified medical attention at the office where she was employed. At the time of this report, the arm was a little sore and there was no redness. Additional information has been requested.
Right ankle is extremely tender and sore, swelling and joint pain. Currently wearing ankle brace and Physical Therapy for support.
red mark and very sore after the shot; red mark and very sore after the shot; red rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team,. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose number unknown (booster), single (Lot number: HF9375) intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2023 as dose number unknown , single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2023, outcome "recovering" and all described as "red mark and very sore after the shot"; RASH ERYTHEMATOUS (non-serious) with onset Sep2023, outcome "recovering", described as "red rashes".
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Nausea-Medium
Patient felt dizzy right after the DTaP shot and laid down for 15 minutes. After that she decided to sit on a chair and immediately she lost consciousness for 5 seconds. Ammonia was used to wake her up.
She received the vaccine 11/30/07 @4:30pm. that evening she was sweaty/did not sleep well I gave her some motrin/very irritable in morning fever 101.6 by afternoon 104.2 fever w/vomiting. I contacted her pedi Dr. advised she should be okay. three hours later sysmptons gone??
Headaches, nausea, vomiting, and dizziness after being vaccinated. Due to syncopal episode he was seen at Hospital's ED where he was Dx with Syncope, unspecified syncope episode
Complaint of shortness of breath, difficulty breathing, cough, sore/scratchy throat, headache, runny nose, congestion, myalgia, and malaise.
This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a Dentist concerning a 20 year old female with a history of a drug allergy to cephalosporin who on 13-JAN-2007, at 5:00PM (previously reported as 03-JAN-2007) was vaccinated IM 0.5 ml first dose with Gardasil. There was no concomitant medication. On 27-FEB-2007 the patient experienced numbness hands and feet. Subsequently, the patient recovered form numbness hands and feet on 01-Mar-2007. The patient sought unspecified medical attention. In follow up information the reporter indicated that on 25-FEB-2007 in AM "my daughter called me from college reporting "numbness" of her right arm and slightly in her right foot." The patient was dropping her fork at dinner and being frightned and calling the reporter. The reporter was talking with her each day thereafter. On 10-MAR-2007 (previously reported as 01-MAR-2007) her symptoms never worsened and resolved with no therapy. Her second dose resulted in less symptoms lasting less than 2 weeks. On 25-MAY-2007 complete recovery was noted. Additional information is not expected.
COVID vaccinated patient who admitted to hospital with complications of COVID.  Provider discharge note below:  "63 YO male who presented to the hospital for evaluation of worsening shortness of breath over the last few days. He has underlying chronic obstructive pulmonary disease, diabetes mellitus type 2, hypertension, hyperlipidemia, HIV.  He recently tested (+) and was treated for COVID respiratory illness.  He was not hospitalized.  The patient states that he was doing better until about a week ago.  He reports of increased cough with clear sputum production.  He also reports of increased wheezing and chest tightness  No hemoptysis.  No ongoing fevers or chills.  He denies having any nausea or vomiting.  He did lose his appetite.  He reports of intermittent swelling in the lower extremities.  He does not currently have edema.  Emergency department workup reviewed and noted.  He received 3 doses duo-neb and IBV solumedrol. BiPAP therapy initiated.    1. Acute hypoxic respiratory failure requiring BiPAP therapy due to acute chronic obstructive pulmonary disease exacerbation - ATC albuterol every 4 hours and PRN  - Spiriva respimat  - resume trelegy or equivalent  - decadron 6 mg daily and discharged on a taper   2. Recent COVID respiratory illness  - COVID order set in place  - out of the window for remdesivir - ordered decadron   3. HIV  - last CD 4 count: 788 Results for Patient - continue Genvoya and Prezista    4. DM type 2, diet controlled  - last A1C: 5.7 % on 1 - accu-checks   - SSI    5. Hypertension  - continue Norvasc "
Metal taste in throat, then sore throat, runny nose dry cough, came in 2 days. Headache and body aches. Lots of dry coughing until rib cage was sore. Continued for 10 days, miserable, but no fever or sore arm. Still coughing 12-28-09.
Client presented back at our clinic 4 hours post-vaccination. She reported that her R arm is feeling numb, similar to when an extremity 'falls asleep'. Reports tingling sensation. Reports that the feeling goes up to her head and behind her eyes. She is able to lift her arm above her head with any pain. Injection site inspected and nothing abnormal at injection site. Took patient to the EMS area at our event for further observation.
sudden onset of pain L jaw - radiating c/a, no c/p - hx of high BP and Diabetes
Suffered high fever, flushed face, sweating, racing heart, pounding heart, felt like throat was closing. Went to primary care Dr. who took BP, pulse, EKG and told me to take Benadryl (3 doses). Symptoms lasted 36 hrs but were relieved with Benadryl.
patient received an expired dose of TYPHIM VI with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 6 years old female patient who received an expired dose of Typhoid VI Polysaccharide vaccine [TYPHIM VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Influenza) for Prophylactic vaccination.  On 06-Nov-2023, the patient received an expired 0.5 ml dose (strength: standard) of suspect Typhoid VI polysaccharide vaccine Solution for injection of lot U2A471M and expiry: 02-Nov-2023 via intramuscular route in the right deltoid for immunization; with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1), administration date: 01Mar2021, when the patient was 41 years old, for COVID-19 immunisation, reaction(s): "she was tired", "headache"; BNT162B2 (Dose 2), administration date: 22Mar2021, when the patient was 41 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "booster dose"; HEADACHE (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 07Dec2021, outcome "unknown", described as "low grade fever (2 and a half days after the booster dose)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The course of the event was as follows: The patient received the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on Saturday, 04Dec2021. She said she had the headache since Saturday night, but it was not horrible and that she just took Advil. But this morning, 07Dec2021, she said it was really bad. She said she was been taking Advil since Saturday now. Today, 07Dec2021, she said she had low grade fever (2 and a half days after the booster dose). The thing was she felt good, like she did not had a fever. She even took a COVID test and it was negative. She was wondering if we have seen a delay in reactions as it has been 2.5 days later since getting the shot.   The lot number for BNT162B2 was not provided and will be requested during follow up.
PATIENT REPORTED LEFT ARM (PNEUMOVAX) WAS VERY SORE TO THE TOUCH AND HE WAS UNABLE TO LIFT THE ARM.  I ENCOURAGED HIM TO APPLY A COOL COMPRESS TO THE SITE OF INJECTION AND SEEK MEDICAL ATTENTION IF IT DIDN'T IMPROVE WITHIN A FEW HOURS OR WORSENED.
Touch of soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Touch of soreness in my arm) 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 first 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 MYALGIA (Touch of soreness in my arm). At the time of the report, MYALGIA (Touch of soreness in my arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-322925 (Patient Link).   Reporter did not allow further contact
because they were unable to use a bandaid they used a cotton ball to put pressure, within two minutes it was a sense of pain up and down her arm from shoulder to elbow where she was vaccinated. after 5 minutes it calmed down, after the 30 minutes she felt all her joints hurt and felt swollen, prior to vaccine her whole body was sore from the day prior, the doctor came in and she was given an icepack for her shoulder. She was then getting very confused and just couldn't focus when the doctor asked for her medical condition and needed to call in her mom to assist because she was beginning to panic, blood pressure did go up and was then given Benadryl, within this time she had drank 2 big cups of water, after the ice pack and benadryl the bones felt better but not okay. She said an hour after the vaccine,  the shoulder and neck area felt bad for 10 days after, she still has irritating pain in her neck and shoulder, on 4/30/21 she got a migraine and it hasn't gone away since, she is unable to return to work, since the migraine she has gone to the ER twice, an acute care once and a neurologist, she can't be in front of a screen or read a book it hurts to think, when she tried looking at a screen after 1 hour she couldn't continue,   today on 5/17/21 she can't bear the shoulder pain,
Fever, redness, swelling entire upper arm.  Symptoms were noted on the day after injection.
10 min post injection, reported slight throat swelling so was escorted to the ED in wheelchair Narrative:
Information has been received from a licensed practical nurse concerning a 72 year old male patient with chronic obstructive pulmonary disease, arthritis, hypertension, hypercholesterolaemia and a history of hernia surgery, elevated liver enzymes caused by lovastatin (unspecified) and stomach upset caused by high doses of AUGMENTIN, who on 30-MAR-2009 was vaccinated S.Q. in his right upper arm with a 0.65 ml dose of ZOSTAVAX vaccine (Merck) (lot # 662858/1558X). Concomitant therapy included NEXIUM, DIOVAN, allopurinol as needed and simvastatin (unspecified). On 17-APR-2009 the patient developed 3 spots on the left side of his breast that looked like round blisters. The physician assistant sent in samples to a lab and the results came back positive for shingles. The patient was seen for an office visit but he has not required treatment. Follow-up information has been received from a physician assistant concerning the patient with no history of chickenpox and not recent exposure to it. It was reported that on 20-APR-2009 (previously reported on 17-APR-2009) the patient developed 3-4 small round spots that looked like blisters and seen to be spreading. The spots were painful. From a 0-10 scale, pain started at a 6 level going to a 9 level. The patient presented other systemic symptoms such as itching, and axilla tenderness. The maximum temperature was 97-98. On 24-APR-2009 herpes zoster was reported as positive per lab. No specimen was collected for PCR. No photos were taken. As of 08-MAY-2009 the patient had not completely recovered (had 5-6 red pindot spots) but was doing well. No further information is available.
Dizziness, chest tight ness, shortness of breath and lightheadedness. Transferred to urgent care.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date and route not reported) off schedule. No adverse symptoms were reported. Additional information has been requested.
Headache, CHILLS,PAIN/SWELLING AT INJECTION SITE Narrative:
Started with lymph node swelling starting the 2nd day on 12/13. Continued to have shooting pain in the left breast/chest. General discomfort in the chest. Bad rash with itchness developed all over the back starting around 12/15.
Patient has experienced chills and low grade fever starting on the 9/26 and resolved about 1 to 2 days later. She woke up with night sweats on the 27th, this resolved as of 10/2. She has had a "migraine-like headache" starting the 27th and has been improving though still present. For the headache she has taken ibuprofen and pseudoephedrine. She has had "buzzing" that is in the right ear and possibly the left as well, she is unsure. The buzzing is consistent and her most concerning symptom. No other reported changes over the past week, no myalgia, mild rhinorrhea which she attributes to having taken pseudoephedrine.
Shot hurts so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Shot hurts so bad). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles shot hurted so bad. The follow-up could not be possible as no contact details were available.
pt recv vax & devel mild arthritis & pos ANA of 1:80; No further details were provided;
Dementia began; psych analysis done professionally, experimental early All Rx begun... 2022, January.
Ongoing exposure to spouse  who became symptomatic on 7/26/21 and tested positive on 8/3/21. Tested negative via rapid on 8/2/21. Became symptomatic on 8/4/21 with influenza symptoms - cough, fatigue, body aches. Tested positive via rapid on 8/5/21. Symptoms resolved on 8/6/21.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB lot#M001813 with expiry date:14-OCT-2018, lot#M014926 with expiry date:17-FEB-2019, lot#M027883 with expiry date:15-APR-2019, lot#M032149 with expiry date:18-APR-2019, lot#M036058 with expiry date:19-MAY-2019 and lot#M036057 with expiry date: 18-MAY-2019 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of PEDVAXHIB were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M001813, lot#M014926, lot# M027883, lot#M032149; 37 minutes for lot#M036058, lot#M036057 and 66 minutes for lot#M020101. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Approximately two hours after getting the shot, I felt clammy and had a fever.  Very fatigued, left arm very sore.  In bed by 7 p.m.. Slept till 7 a.m. Friday(3-5). Chills and fever subsided that morning.  Headache and ringing in my ears. This and extreme fatigue lasted until Sunday(3-7). Unable to work for 2.5 days. Lost income. Went back to work Sunday morning, but not completely recovered. Felt back to normal by Monday morning .
Felt very disoriented. Could not complete simple tasks. Felt like I was delayed or on "pause". Very scary feeling. Was unable to concentrate.  Symptoms decreased by 5pm that day. Felt fatigue the next few days.
This spontaneous report was received from a pharmacist and refers to a 14 year old female patient. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient as an infant was administered the three-dose series of RECOMBIVAX HB (exact dose, route of administration, lot #, expiration date, anatomical location and frequency were not reported). There were no concomitant medications reported. On an unknown date (reported as "just recently"), the patient was tested for hepatitis B immunity and her results came back as "indeterminant".  The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
I had my vaccination on 10/22/2022. On 11/18/2022 I started to experience runny nose mild cough. I tested COVID-19 Positive on 11/20/22. I contacted my physical on 11/21/2022 and I was prescribed Paxlovid. I presently feel great on 01/23/2023 and took about 6 weeks to recover.