chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has not received the second shot 36 days post first vaccine, can not find appointments; A Spontaneous report was received from a consumer concerning a 21 years old, male patient who experienced had not received the second shot 36 days post first vaccine, can not find appointments.  The patient's medical history was included was kidney disease. No Concomitant medications were reported.    On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: [LOT/BATCH: unknown] intramuscular route for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient experienced not received the second shot 36 days post first vaccine, can not find appointments.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, had not received the second shot 36 days post first vaccine, can not find appointments was considered as recovered on 30 Jan 2021.; Reporter's Comments: This report also refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot # unknown), with no associated AEs. Further information has been requested.
Right breast infection. Given Augmentin . Three days into taking antibiotics at time of report. Right breast is hot, swollen, and hot pink in color. Causing significant pain and itching.
insomnia Narrative:  Pt reported having insomnia since receiving her first dose 12/31/2020. States she had seen her PCP several times and has been Rx'd sleeping medications which have been ineffective. OTC medications offered her no improvement & better sleep hygiene did not resolve c/o as of the date of this report  Other Relevant History:
experiencing joint/muscle pain throughout my body; experiencing joint/muscle pain throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, acid reflux (esophageal), sleep apnea, blood pressure high and sulfonamide allergy (sulfa products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), Medoxomill (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 10:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, beginning one week after second vaccine, he began experiencing joint/muscle pain throughout his body when he exerted a regular amount of usage with arms or legs. It had been ongoing (when reported). He just had a tele visit with his doctor to alert him of his symptoms. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain and muscle pain were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 2 years old female patient who was inadvertently given expired product with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received 0.5 ml total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 07-Oct-2022, (latency: same day) the patient was inadvertently given expired product with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.; Sender's Comments:  01314490:
No adverse event at all, but vaccine was administered 7 days past BUD (but still months before product expiration)
another 1-2 days later, the patient got another full cycle period again; This spontaneous report as received from a physician concerning a 12-year-old female patient.There was no information about the patient's medical history or concomitant medication. The patient had completed her normal menstrual cycle and 1-2 days later got the shot, date unspecified. On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).  After receiving the shot, another 1-2 days later (on an unknown date), the patient got another full cycle period again(menstruation irregular). The patient's parent was concerned and thought maybe it had to do with the of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  injection and the parent was now hesitant for the patient to receive the second dose. The physician is now requesting information on of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and menstrual cycles. No additional information. No PQC reported. The outcome of menstruation irregular was unknown.The physician did not asses de causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and the event. The  patient's parent  was concerned and thought maybe it had to do with the vaccine.
Fully vaccinated with J&J, not boosted.  COVID breakthrough infection with inpatient hospital stay.
Very uncomfortable (7/10) kidney pain since injection, severely interferes with walking/standing and working/concentrating. Not muscular pain, is an internal organ sensation. Frequent urination, kidneys feel painfully full after drinking water, then painfully empty after urination. Have tried eating and drinking different amounts to alleviate, no progress. Drank electrolytes with no progress.  Did not drink coffee 8/30 to eliminate diarrhetic effect, no change. Tried mild exercise, no change. More minor side affects for entire duration after shot include fatigue, dizziness, brain fog, and headache.
Cardiac proteins elevated; chest pain; scapular pain; cardiac abnormality attributed COVID & Vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2022 (unspecified if ongoing), notes: in Summer 2022. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant) with onset 2022, outcome "recovered", described as "Cardiac proteins elevated"; CARDIAC DISORDER (non-serious) with onset 2022, outcome "recovered", described as "cardiac abnormality attributed COVID & Vaccine"; CHEST PAIN (non-serious) with onset 2022, outcome "recovered"; MUSCULOSKELETAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "scapular pain". The events "cardiac proteins elevated", "chest pain", "scapular pain" and "cardiac abnormality attributed covid & vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Myocardial necrosis marker: (2022) Elevated, notes: but no sign of CV event. Therapeutic measures were taken as a result of myocardial necrosis marker increased, chest pain, musculoskeletal pain, cardiac disorder. Patient contracted COVID in Summer 2022 and then developed chest pain and scapular pain over course of 3 months post infection. Went to ER and had elevated cardiac proteins but no sign of CV event. Cardiology consult described cardiac abnormality attributed COVID & Vaccine. Aspirin was given for treatment.   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-202300054565 same patient, different dose and event;
About 24 hours after patient was vaccinated, mother noticed her left arm had a red, swollen area (10 area of DTaP). No other symptoms and child not in pain. (Child came in for PPD read and they mentioned this reaction).
Pain at injection site; Arm tingle; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7534) via an unspecified route of administration in the left arm on 08Apr2021, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced pain at injection site and arm tingled for about an hour. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event of vaccination site pain was resolving and the event of arm tingling was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
AFTER RECEIVING THE VACCINATION AND SITTING IN WAITING ROOM FOR 5 MINUTES, PERSON PASSED AND FELL FROM CHAIR, HITTING HIS HEAD ON THE FLOOR. HE WAS HELPED BACK TO HIS CHAIR BY NURSES AND PARAMEDICS, WHO THEN ASSESSED HIS CONDITION. HE STATED HE HAD NOT EATEN ALL DAY. NURSE WHO ASSISTED HIM STATED UN RESPONSIVE TO COMMANDED, DIAPHORETIC PROFUSELY, HOT, HAD VOIDED ON HIMSELF, AND WAS LSLIGHTLY MOANING. HE STATED "MY HANDS FEEL WEIRD," AND THAT HIS VISION WAS BLURRY. PARAMEDICS COMPLETED CHECK UP INCLUDING RUNNING AN EKG ON THE SPOT. PATIENT WAS TAKEN TO THE AMBULANCE ONSITE BUT REFUSED ADDITIONAL TREATMENT.
Small cyst on selective area on (L) thigh no swelling, no redness no tenderness.
On July 8th I had plane travel, I went to a conference. I will say I wear my mask generally more than 95 percent of others. I noticed somewhere around the 11th I started noticing mild symptoms. The first thing I noticed was not being able to sleep well, tossing and turning. I took a rapid COVID-19 test that was negative. I tested positive on Tuesday the 12th. I talked to the doctor the 14th and got a PAXLOVID prescription that is now finished. Symptoms have been relatively minor. I have had loss of appetite, trouble sleeping, malaise, post nasal drip. I also had a small dry cough and slight sore throat. I am still testing positive and the only symptom remaining is slight fatigue.
RECIEVED SHOTS 11/28/07 AND BROKE OUT IN HIVES- STARTED THAT NIGHT AFTER RECEIVING SHOTS.
Fever of 102, extreme fatigue, dizziness, confusion, cough.  Lasted until about 10:00 AM on 11/01/2009.
Fatigue all day after injection,  Fevers (tmax 100.7), chills, headache, body ache, nausea began 12-14 hours after injection. Still present 24 hours post injection
Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse    I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
Rash all over left side of body; A spontaneous report was received from a consumer concerning an 80 years old, female patient who experienced rash all over left side of her body/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced rash all over left side of body.  Treatment for the event included antihistamine.   Action taken with mRNA-1273 in response to the event was not provided.  The event rash all over left side of body was considered resolved on 22 Jan 2021.
15SEP95 twitching inner part around big toe arch-lasting 15sec stop 10sec, cont real fine twitching, different areas of body, all day until sleep-cont Sunday not as bad, later in evening started again different areas of body;
Red, raised, swollen, painful, hot to touch. On 5/7/18 area was 4 inches X 3 1/4 inch oval and still growing. Fever of 101 F.
Rash on arms and legs; patient was prescribed 5 day course of Prednisone by Dr.
hasn't had the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter enquired about how to proceed with the 2nd dose of Shingrix. The reporter did not consent to follow up.
Received smallpox vaccination 2/24/03, scab loss 3/31/03. Re-eruption at original site April 7-8, 2003, lethargy, fatigue, paleness, malaise, afebrile.  On April 10 and again April 14, 2003 pustule, erythema 6-7 mm at initial vaccination site (left deltoid), achy at site, malaise, lethargy, fatigue. Notified nurse who administered, Regional Director, local Health Dept Medical Director, TDH and CDC MD. Digital picture taken and e-mailed.
Patient had a migraine for 4 days and a fever for 4 days. Patient states they were hallucinating. Patient states they had a seizure but the hospital advised them not to come in.
Very sore arm from time of vaccine which was on a Friday until Monday. On Sunday and into that week I had some severe lower back pain worse than ever and then on Wednesday 3/31/21  I woke up severe pain to bilateral lower legs upon getting out of bed to point I could barely walk. Once I got moving a little I noticed big bruises all over my legs and arms which I knew to be Erythema Nodosum which is an autoimmune rash that I did have before but not this severe. I was later seen at work at my clinic by PA and tested + for strep as well and my throat wasn't even hurting and given Bicillin shot and some steroids to take at home. The pain from the rash got better within 5 days but rash persisted for another week or so. I was also very fatigue.
Patient was given the MMR. We knew he was allergic to it because of his previous reactions to immunizations. We refused to immunize him, eventually after 12 months of fighting the system, we were forced to do it.  Patient got a low grade fever, broke out with the measles on the first day, this lasted for 3 days. On the 4th day he broke out with mumps, this lasted for 2 days, on the 6th day he broke out with the measles again and had a petite mal seizure.  He is autistic now and has severe speech delay as a result of this vaccination.  He was treated only with cortisone creams, benadryl, zyrtec, and the dr's apology.
On the night of the day I received the vaccination, my left arm (where the shot was) began to feel stiff and painful - down to my hand. My body began aching horribly, especially from the waist down; it was difficult to move and/or stand up and walk. I began having chills and running a fever (around 101),  and had a headache. I was very weak. I could not function to work, etc.  The symptoms continued to increase through the night and the whole next day. And, as I am writing this I am still very symptomatic. I am feeling like this may continue for at least another day - at this point. And, based on what I have read the side effects can last up to a few days.
feeling chest pains ever since 2nd dose, specifically on left side. anxiety. hard time to breath at times
headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; headache, dizzy, ringing in ears, and nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: HEADACHE (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "headache, dizzy, ringing in ears, and nausea".  Additional information: Patient stated she may not get the second COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a fever which I expected and I woke up and the whole left side of my face was swollen. I took allergy medicine and went back to bed. When I woke up around 11 am the swelling was spreading my entire left side of my body was swollen.  I went to the the emergency room, they did a chest X-ray. They diagnosed me lymphadenopathy.
This spontaneous report as received from a pharmacist from a pharmacist refers to a 65 year old female patient. On 05-JUN-2012 the patient was vaccinated with ZOSTAVAX 0.5 ml once (route and lot # were unknown). Concomitant therapies included MICARDIS and PREMARIN. On 06-JUN-2012, the patient reported a sore arm and swollen glands. The outcome of patient reported events was reported as recovered/resolved within 5 days (before 10-JUN-2012). The reporter considered events was related to ZOSTAVAX. Additional information is not expected.
Patient experienced ringing in both ears 3 days after vaccination.  Episodes only lasted for a minute at a time couple times per day.  Lasted for 3 days.
Headache, fever (103), pain side of neck and face, malaise, no appetite, flushed, dry mouth.   Doctor agreed symptoms consistent with Mumps. Fever burned out within three days, and with rest and hydration he recovered.
strong chemical taste; burning feeling in her eyes and scalp; A spontaneous report was received from a healthcare professional concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events strong chemical taste (dsgeusia), burning feeling in her eyes and scalp (skin burning sensation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A)(route unknown) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the event(s) strong chemical taste and burning feeling in her eyes and scalp.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) strong chemical taste and burning feeling in her eyes and scalp was considered resolved on 31 Jan 2021. .
the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 160.8. No concomitant medications were reported. It was reported that, the pharmacy had sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date. The vials did not undergo any temperature excursions. No adverse event reported by the patient. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow-up received included reporter, patient and suspect product information added.
Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm soreness from 5 hours after vaccination until 36  hours after time of vaccination