chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second the pain was less than the first; got hit in the injection site, and now there is numbness an inch and a half around the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: Unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to Motrin" (unspecified if ongoing), notes: Verbatim: allergic to Motrin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Anatomical Location: Right Arm), administration date: 04Apr2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the second the pain was less than the first"; HYPOAESTHESIA (non-serious) with onset 27Apr2021, outcome "not recovered", described as "got hit in the injection site, and now there is numbness an inch and a half around the site".   Additional Information: Caller got his second dose of the Pfizer COVID vaccine last Saturday, 24Apr2021. He had little pain on his arm after the first. After the second the pain was less than the first. He had no other symptoms. He was playing around with his wife, and she hit him on the arm with a closed fist. Since then, an inch and a half around it has a numb sensation. She hit him with the closed fist on the injection site. It had been like that the last couple of days. She had her second dose today, and she asked the site if they knew. They gave her this number to call for more information. Caller did not have a prescribing doctor. He worked as Truck driver for the food service. His workplace sent him a letter to go to (withheld) to get the vaccine. With his first vaccine, he had a little pain in his arm which he felt was normal. With the second vaccine, he had less pain in his arm. He had no other symptoms. His daughter laid on his arm once, and it bothered him a little, but when his wife hit him, it made a light numbness. The light numbness has been there for the past two days since 27Apr2021. It persisted. In the morning he did not really feel it, but if he starts to move it he feels it. It is just an inch and a half around the shot. He got the first dose 04Apr2021 in his right arm, and the second dose 23Apr2021 in the right arm. He did not have his card with the lot number with him. He was allergic to Motrin. If he took it his lip swells. The patient had not taken it since.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hours after 2nd dose - fever of 102.5 (Friday).  Fever remained around 100 degrees the entire next day (Saturday).  Diarrhea began Saturday off and on, including Sunday morning.  Fever reduced Sunday afternoon.
REDNESS AND SWELLING AT INJECTION SITE AND SURROUNDING AROUND ARM, UP TO SHOULDER (RIGHT ARM), PAINFUL
Moderate neck and shoulder pain, increasing 2-3 days after injection. Still persisting at 5 days post injection. Nightmares and difficulty sleeping, still persisting 5 days post injection.  Migraine 3-4 days post injection. Intermittent headaches.  Arm soreness at injection site, still persisting 5 days post injection. Overall muscle soreness, not limited to injection site.
Pt reports approximately 5-6 hours after waking he begins to feel very flushed and hot. After that, he begins to have severe dizziness, to the point that he is unable to ambulate, instead having to crawl across the floor. He checked his blood pressure and blood sugar, both of which were within normal limits. The dizziness can last several hours and is only resolved if he goes to sleep.
Test positive for covid 19 9/5/2021, Requiring hospitalization and supplemental o2
On 7/27/23, during immunization reconciliation, the counts for specific lots of Pediatric MMR vaccine and Pediatric MMRV vaccine in system were noted to be discrepant from the physical Count of inventory in the clinic. MMRV (Lot: X007087 Exp: 9/4/24) was showing in system as having 10 doses in inventory with no doses having been administered, however, the physical count revealed only 9 doses in clinic. MMR (Lot: W007041 Exp: 02/29/2024) was showing in system as having 6 doses remaining, however, physical count of the vaccine in the unit was 7 doses. All other inventory counts were correct. 4 patients had documentation in system showing vaccination with this lot of MMR, since last reconciliation. All 4 patients were also vaccinated with Varicella vaccine during each of their visits. Documentation for each of the 4 patients also noted the MMR (and Varicella) vaccinations. Due to the discrepancies in count, however, it can be presumed that one of these children (although we cannot determine which child) were vaccinated with MMRV in the place of MMR and therefore received MMRV and Varicella on the same day inadvertently. RN reported findings to supervisor. Immunization Program Nurse and Regional Director were notified by RN. Dr. was also noted of above information. PHN contacted parents of all 4 minor patients and notified them of the possibility of vaccination error. Mom denies any reaction of any kind after receiving the vaccine. Child is currently doing fine.
Patient developed full body welt like rash arm/hands swollen, stated difficulty breathing on 8/24 but resolved, recommended to go to urgent care.
>> May 6, 2021  8:31 AM staff wrote: Pt has diarrhea, vomiting, headache, upset stomach, legs and back hurts. Pt has fever yesterday but not today. Pt is cold all the time. Pt has no cough. Sx started Mon 5/3.  ED Discharged  5/6/2021 (4 hours) Hospital Emergency Department  MD Last attending ? Treatment team Viral gastroenteritis Clinical impression Diarrhea ? Vomiting Chief complaint ED Provider Notes PA-C (Physician Assistant) ? ? Emergency Medicine Cosigned by: MD at 5/7/2021  9:34 AM Expand AllCollapse All      HPI      Chief Complaint Patient presents with ? Diarrhea ? Vomiting  ED Discharged  5/9/2021 (3 hours) Hospital Emergency Department  DO Last attending ? Treatment team Non-intractable vomiting with nausea, unspecified vomiting type +1 more Clinical impression Nausea Chief complaint   MDM MDM Records requested and reviewed by me showed patient was here and evaluated on May 6 at that time had a normal WBC count normal electrolytes with exception of chronic kidney disease with GFR 48 normal lactic acid and a coronavirus test which was positive. 5:09 AM After Zofran, patient has tolerated oral intake.  Will discharge to home to follow-up as an outpatient with her primary or return to the emergency department at anytime for worsening symptoms or concerns.  She was advised symptomatic treatment drinking plenty of fluids and rest. =================================================================== Initial pulse oximetry reviewed. Patient is 98% on room air indicating adequate oxygenation.     ===================================================================     The patient is in Stable condition at the time of 5:09 AM. Office Visit 5/12/2021 Family clinic  PA-C Family clinic COVID-19 virus infection +1 more Dx Hospital Follow-up  Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 ? ? Signed Cosigned by: MD at 5/14/2021 10:35 AM Expand AllCollapse All      Assessment/Plan       Patient was seen today for hospital follow-up.   Diagnoses and all orders for this visit:   COVID-19 virus infection Comments: 5/7/2021. today she is asymptomatic and afebrile.   Diarrhea of presumed infectious origin Comments: has resolved, she has some loose stools, but that is her normal. Rest Plenty of fluids  Continue sitting outside Vitamin D and C Handwashing wear mask at all timed Social distancing   All the patient's questions were answered to their satisfaction.  The patient verbalized understanding and agreement with plan.  Patient was asked to return to clinic if there is any worsening of symptoms or no improvement of symptoms.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 31 year-old male subject whose past medical history included high blood pressure, abnormal ECG, shortness of breath and headaches was found to have secondary cardiomyopathy, unspecified one day after the subject had received the following vaccines on 01 October 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), Pneumococcal vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 8 (manufacturer, lot number, route and site of administration not reported). An abnormal ECG on 02 October 2013, Troponin I and echocardiogram results were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Had DTaP 3-30-04 right leg has red, warm area width 13 cm, length 8-9 cm not infected. Came in next day area larger told if area got large advise come back or go to ER.
I am feeling sick (throat pain, muscle ache, shivering etc); I am feeling sick (throat pain, muscle ache, shivering etc); I am feeling sick (throat pain, muscle ache, shivering etc); I am feeling sick (throat pain, muscle ache, shivering etc); This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, the patient was feeling sick (throat pain, muscle ache, shivering etc). Everyone including the patient from their household at home only and working remotely. The patient enquired regarding what were the possibilities to get symptoms like this after first dose. Should these side effects of vaccine last even after 15 days? Should she worry about these symptoms? After first dose of vaccine if someone gets COVID do they experience these kinds of symptoms? If someone got attacked by COVID right before first dose of vaccine, do they experience these kinds of symptoms? What if someone got vaccinations and not aware of having COVID did they experience these kinds of symptoms? Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feeling sick (throat pain, muscle ache, shivering etc) were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 30th June 2015). On 17th October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, several days after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm and movements reduced were not recovered/not resolved. The reporter considered the pain in arm and movements reduced to be possibly related to FLUARIX QUADRIVALENT. Additional information: Patient reporting 10 days after flu vaccination, she is having intense pain in her upper left arm. She also is reporting limited range of movement in left arm.
pt recv vax on 3JAN, & 13JAN pt devel gen red rash & h/a;
Immediate pain when given the vaccine, a burning sharp sensation shot through the arm and up into the neck. Extreme pain for 3 days after, then symptoms became a bit milder. 11 days later and right arm still can?t move in certain directions without pain, and can?t lift heavy objects either.
Loss of consciousness, low BP, low HR (40s), profuse sweating, loss of color/appetite, nausea within 3 minutes of injection. Was treated by EMTs, HR and BP monitored for about 30 minutes until within normal range and pt could sit unassisted and felt "normal". Pt was given water and food and released.
Tinnitus - ringing in the ear(s) of a high pitched sound. Was the most prominent during sleep and woke me up numerous times. Can still be heard when very quiet also.
SWELLING STARTED IN LIPS AND AFTER A COUPLE OF HOURS EYES BECAME SEVERELY SWOLLEN BY 2:00 AM THEY WERE ALMOST SWOLLEN SHUT. AFTER 4 BENADRYL THEY ARE STILL SWOLLEN AND LOOK LIKE I HAVE BLACK EYES 24 HOURS LATER.
I was really dizzy, tired, achy, and my ears were ringing for three days. I started to feel better and then it would return. Somedays I would have a hard time breathing and then it would go away. I would check my blood pressure and oxygen and it would be normal.
Patient immediately bled at injection site and was concerned since he had never bled previously from a flu vaccine
Hair loss occurred first then severe weight loss, from 200 lbs on 3/20/2021 to 175 lbs. on 9/15/2021.  Healing from the pancreatitis has slowed down or stopped as per CAT scan taken approximately 9/23/2021.  Doctor recommends a procedure to remove excess fluid and pancreatic  tissue through the mouth within the next few weeks.   Patient has appointment with a general practitioner on 10/17/2021.
Pt came to medical center around 3:05pm C/O fatigue/feeling weak/drunk. Episode had begun around 11am, 2 hours after getting Typhoid vaccine in preparation of upcoming travel (see travel consult note). She tried to ignore it, took it easy, ate lunch, but symptoms progressively worsened to point that she couldn't focus/coworkers noticed. They suggested she come downstairs. She came unaccompanied, was able to walk herself down. She was brought back to exam room immediately, and vitals were assessed. No SOB, oropharyngeal swelling, dizziness, rash. Pt's vitals were assessed right away, found to be normal. Sugar elevated but appropriate based on her medical history (and fact that she ate dried mango 20 minutes ago). After assessing that she did not appear to be having a delayed anaphylaxis reaction (vitals stable, O2 normal, no wheezing, SOB, tongue swelling, rash, dizziness, etc), we allowed her to lay down to rest, and we watched her closely with repeated vitals every so often. She was able to sleep for a little, though we (myself and, RN) kept interrupting to her assure no development of any new symptoms. Pt has Hx of anaphylaxis to flu shot (containing egg about 7 years ago, that required treatment at hospital) and she assures this is NOTHING like that (swelling, rash, SOB, etc). I reviewed the Manufacturing Reference for Typhoid - does not contain any egg products but it does mention post marketing rare adverse reaction of asthenia. I spoke w/ Dr. (supervising physician) and relayed presentation. We would both not be comfortable letting her leave on her own so patient was given 2 options -> 1. Transport to hospital via ambulance for observation or 2. Call husband, and have him accompany her own so that she can be assisted to the hospital if worsening symptoms were to develop. Pt would prefer the 2nd opinion, so her husband was called and instructed to come to the clinic. Pt was able to give him clear instructions on how to get here. By 4:45pm, Patient was feeling much more energized, less weakness. She had drank 2 bottles of water, and urinated twice, and felt much more stable on her feet. I accompanied her to desk (pt able to walk unassisted) to collect her computer and belongings. Husband arrived at Clinic around 5:10, joined us. Pt signed AMA (witnessed by, RN) refusing transportation to hospital, but pt agrees to seek care with progression of symptoms or any new worrying symptoms. Pt discharged home via car service at 5:15pm accompanied w/ husband.  Instructions were given to both Patient and husband about what to look out for. I received a message from Patient at 8:05 am on 4/3, she woke up with slight headache, was going to take APAP and go back to sleep. I spoke to her around noon on 4/3 - she had woken up, headache was gone, she had no lingering fatigue or weakness. She will let me know if anything changes.
left-sided enlarged axillary lymph nodes, had a subjective fever which was not measured, chills, body aches, fatigue, left arm soreness, headaches, and some sharp chest pain x1 episode, started 20APR2021 warranting ED visit, mostly resolved other than fatigue and dyspnea on exertion by clinic visit 21APR2021
Headacke; Dizzyness; Nasua; Loss of bladder control; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732), via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes, heart failure and COPD. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not 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 at 05:00, the patient experienced headacke, dizzyness, nasua, throwing up and loss of bladder control. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, dizziness, nausea, throwing up and loss of bladder control were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax & devel a HIB infect; exp was felt to be life threatening; addtl details are being requested;
Covid Arm after first dose on 3/4/21. Itching and rash on day 8. Lasted 3 days.  Tinnitus a month after 2nd dose. Still have ringing in ears. Hearing tested by audiologist and not effected.
violent nausea and vomiting for 36 hours; headache, body ache, incapacitating weakness (could not get out of bed for 36 hours) and poor speaking volume.. the 3rd day I could eat light meals and got exhausted when climbing a flight of stairs.
No adverse effects; inadvertently received first doses of VARIVAX and PROQUAD concomitantly/Nurse confirmed misuse was related to human error and not product confusion; inadvertently received first doses of VARIVAX and PROQUAD concomitantly/Nurse confirmed misuse was related to human error and not product confusion; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patients concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 28-OCT-2019, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # S019463 and expiry date 24-JUN-2021 verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # S019463 and expiry date 24-JUN-2021 verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis. Both vaccines were reconstituted with sterile diluent. No adverse effects were reported.; Sender's Comments:  US-009507513-1911USA000667:
Facility had been administering an expired lot number to multiple patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.  Date the vial was initially stored in refrigerator on 15-Oct-2021. Other administration dates prior to 03-Dec-2021 and also on 03-Dec-2021.
swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling arm). At the time of the report, PERIPHERAL SWELLING (swelling arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Patient called 1/24/22 and reported that she got the booster on 1/4/2022 and experienced symptoms of covid and tested positive on 1/19/2022
expired TENIVAC was given with no reported adverse event; Initial information received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional (Pharmacy intern).  This case involves a patient of unknown age and gender to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength not reported) (lot U7183AA; Expiration Date: 24-Sep-23) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken: not applicable.  Outcome was Unknown.   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.