chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently reconstituted the Menveo lyophilized component with a sterile diluent; inadvertently reconstituted the Menveo lyophilized component with a sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA928A, expiry date 31-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Menveo. On 30-OCT-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently reconstituted the Menveo lyophilized component with a sterile diluent) and inappropriate dose of vaccine administered (Verbatim: inadvertently reconstituted the Menveo lyophilized component with a sterile diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-NOV-2023  A License Practical Nurse reported they inadvertently reconstituted the Menveo lyophilized component with a sterile diluent and administered it to a patient. The nurse asked about how to proceed. The reporter did not consent to follow-up. The patient received a dose of Menveo vaccine wrongfully reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I got the vaccine at around 11am on 6th April.  By 8pm the same day I was experiencing very severe chills - I have never felt so cold before in my life,  and the evening was not cold..  The next day, 7th April,  I woke up with bad aches in various, seemingly random areas of my body:  both upper arms, outside parts of both thighs, center of back between shoulder blades.  Interestingly all the aches were symmetrical.  I had not done any serious exercise to cause these symptoms, just a stroll around the park after getting the vaccine. I also experienced crushing tiredness and had to go back to bed in the afternoon.  Today, 8th April at 5:30 pm my left arm at the vaccine site still aches, but all the other symptoms had vanished by the morning.  I'm 5' 4" and weigh 114lbs.  My husband got the vaccine at the same time and had no symptoms.  We are speculating that my smaller size may have contributed to my adverse reaction.  He is 5' 6" and weighs 180lbs.  In spite of this discomfort I'm so relieved and pleased that we were able to get the vaccine.  Thank you!
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB(dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
I had a very bad headache and soreness at the site of the injection for a couple of days after the shot. Since then, I have felt tired and out of breathe. I also felt some angina. I had a cardiology exam and no problems were found.
Initial report received on 30 October 2006 from a health care professional.  A four-year-old female child, with a concurrent upper respiratory infection, and no known allergies, had received a fourth dose, left thigh, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number U2237AA, on 27 October 2006.  Approximately four hours post-immunization, the patient developed a fever of 103.0 degree Fahrenheit, minimal cough, and complained of bilateral eye pain.  No diagnostics were performed, and treatments received were not reported.  The patient was evaluated by the physician three days later, and her neurological exam was normal, her eye pain was gone, and her fever had gone down to 101.0 degrees Fahrenheit.  No diagnostics were performed, and treatments received were not reported.  Reportedly, the patient had experienced a previous temperature of 103.0 degrees Fahrenheit at 18 months of age (2003) after receiving a vaccine (trade name of vaccine not reported).  At the time of this report, it was unknown if the patient had fully recovered from these adverse events.  The reporter for this case is the same as for cases 2006-02858, and 2006-02860.
about 3 hours after vaccine felt foggy and fuzzy-headed, started with headache, then by the end of the day had severe muscle body aches all over, each day after vaccine above symptoms got worse and additionally had sinus pressure, ear pressure, severe heachache, feeling abnormally tired, abdominal cramps and nausea, was unable to eat and then started to feel my heart beat irregulary (3 days after vaccine), tried to alleviate body aches with ibuprofen and Tylenol, but neither touched the pain,  on day 4 all listed symptoms were still present, especially my heart rate felt more irregular and it was "beating in my throat", I felt light headed and "off", I went to a colleague who attached a heart monitor to my chest and saw the irregularity of my heart (very frequent PAC's, PVC's and every now and then a bundle branch block), my BP was borderline low, too, I checked myself into the ER and Dr. checked me through
make me sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via agency through social media on 02-Dec-2020.   This case involves a patient of unknown demographic who felt sick (illness) , while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient felt sick (illness)  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case.
Patient began having "tingling" in fingertips within 30 minutes of vaccine.  Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later.  No Shortness of Breath, Difficulty Breathing, or problems swallowing.  Administered 50 mg Benadryl.  Symptoms improved slightly, symptoms did not worsen.  Observed for an additional 40 minutes.  Went home with husband.  Instructed to follow-up with 911 if symptoms worsened.
Vaccine administered orally at 4 month WCC 2/10/17. On 2/12/17 pt. was fussy (mildly) and had loose bowel movement with blood. On 2/13/17 spoke with parents and only happened x1. Dad to give Probiotics 2x daily and bring in to see Dr. if happens again.
Left arm swollen/redness/warm - told by ER physician to apply ice and take ibuprofen.
Facial flushing, palpitations and orthostasis 3 days following first injection.  Within 10 days the patient began experiences headaches and distal dysesthesias in her hands and feet.  At the time of my examination on 1/9/21 she had widespread hyperreflexia.  She continued to manifest signs of dysautonomia with rapid and disproportionate increases in heart rate with trivial activity.  Her presentation was consistent with acute transverse myelitis.
Left leg 0.5x0.5mm lump. No tenderness, no redness.
I have Factor V Leiden, tested positive for Covid on Nov 9, 2020.  I received my Covid vaccine on Dec 29, 2020. On Jan 8, 2021 my upper right arm had a red area that was swollen, hot and painful.  It continued to spread down my upper are to my forearm.  On Jan 12, 2021 I spoke with nurse to see if anyone had reported blood clots as a reaction to the vaccine.  Nurse did research this and stated he did not see any cases.  After discussion with nurse, we agreed that I would get my PCP to order a venous doppler to rule out clots so we could make an informed decision to receive the 2nd dose vaccine.  On Jan 14, 2021 the doppler showed superficial clots.
VACCINE GIVEN OUTSIDE OF LICENSED AGE RANGE. NO ADVERSE EVENT REPORTED.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-JAN-2015, the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is  one of several reports received from the same reporter. Additional information has been requested.
Information has been received from an unspecified reporter via a website of the Internet referring to 3 patients with warts. On an unknown date the patients were vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) (dose, dose# and route unknown). Some of the patient's warts disappeared after they received the HPV vaccine. Some experienced an improvement just two to three weeks after vaccination (therapeutic response unexpected). It was unspecified which patient's warts disappeared and which patient's warts improved. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Have had Covid symptoms for 4 days.; Vomiting bile; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and covid-19 in Jan2021. The patient had no known allergies. Concomitant medications included metformin hydrochloride (METFORMIN) used for unknown indication from unspecified dates. 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 01May2021 at 12:00 the patient experienced covid symptoms for 4 days, vomiting bile and loss of appetite. The clinical outcome of the events covid symptoms, vomiting bile and loss of appetite was not recovered at the time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information was received on 13-JAN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 lot number M043987 expiration 30-JUN-2018 or lot number M036161 expiration 06-MAY-2018 that was exposed to a temperature excursion for 48 hours. The pharmacist was not sure which of the 2 lot numbers was the administered dose. The temperature excursion was reported as greater than 46F through less than or equal to 77F range for 48 hours. No adverse effects were reported. No further information was reported. Lot number M043987 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent.) Additional information has been requested.
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute.    Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer.   Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room.   Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns.    Ate granola, blueberries, yogurt for breakfast this am   Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things   In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72.   No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD    Patient alert and oriented during entire visit and pleasant in conversation.
Received smallpox vaccination on 18 Feb 03; positive HCG on 17 Mar 03
Mother of pt called today w/ c/o pt's local reaction on R arm -red, raised, swelling increased from yesterday, 8/25/13, reported diameter of local reaction > 2 in, warm to touch but pt denies pain, afebrile, range of motion within normal, skin intact, states no red streaks on R arm, and site itchy. Mother stated applied-home treatment - ice x 2 days but redness and swelling worse today; no oral OTC meds given. Mom will continue ice and apply hydrocortisone to site. Mother instructed to seek MD care if no relief w/ home treatment and symptoms worse. Mother agreed w/ plan.
Fever temperature of 99.9; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced a fever temperature of 99.9.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30-dec-2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient began to experience a fever temperature of 99.9.   Laboratory information included body temperature of 99.9 F.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The event fever temperature of 99.9 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
the vaccine does not seem to be working like the first one; arthritic pains; A medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left upper arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included arthritis. The patient previously took the first dose of bnt162b2 () for COVID-19 immunization. Concomitant medications were not reported. On 12Feb2021, the patient experienced a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine and soreness at the injection site. She stated that she felt the arthritic pains more after the 2nd shot than the 1st shot. The 1st shot felt good and cleared up her sinuses. On 12Feb2021, the patient experienced does not seem to be working like the first one. The patient reported that with the first one she did not feel as bad and it is taking her longer to get over the second shot. The patient stated that with the first dose, her sinuses and her joint pain cleared up faster. The patient reported that her symptoms seem to be a little bit better on the day of reporting. She clarified that she got over her symptoms faster last time. Her left ear feels clogged up and it cleared up faster with the initial shot. She has arthritis on her right side with her hips and shoulder and stated that the joint pain is still there. It is still quite sore. On 12Feb2021, the outcome of the event a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine was recovered and was unknown for the rest of the events.  Information about lot/batch number has been requested.
Parents concerned that vaccine (s) have caused chronic pain. Has had ulcers and cholecystectomy (abnormal gallbladder scan), but persists with abdominal, back and shoulder pain, headaches.  5/18/09 Received vaccine & PCP medical records of 7/30/08-4/28/2009. FINAL DX: none provided Records reveal patient experienced chest pain & palpitations 8/08 & seen in ER.  Cardio w/u WNL.  Referred for GI consult, GB US.  Began home schooling 9/08.  Had cholecystectomy.  Developed sinus infection 12/08.  Found disc herniation & referred to PT.  Recurrent sinusitis 2/09.  Returned to school but was missing enough that returned to home schooling.  Seeing pain mgt & accupuncture but still w/chronic pain.  Discussed possible referral to rheum for possible fibromyalgia & return to GI for continued abd pain.
ENTIRE FACE PUFFY; LIPS SWOLLEN; JAWLINE ITCHY AND TENDER; UPPER LEFT ARM STARTED TO ACHE A BIT; GLANDS UNDER JAW STARTED TO SWELL; SCATTERED HIVES THAT ITCHED LIKE MADNESS INCLUDING A FEW ON FACE AND LIPS; THROAT STARTED TO HURT, SORE THROAT THAT FEELS LIKE SWALLOWING SHARDS OF GLASS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 10:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced throat started to hurt, sore throat that feels like swallowing shards of glass. On 16-SEP-2021, the patient experienced upper left arm started to ache a bit. On 16-SEP-2021, the patient experienced glands under jaw started to swell. On 16-SEP-2021, the patient experienced scattered hives that itched like madness including a few on face and lips. On 17-SEP-2021, the patient experienced entire face puffy. On 17-SEP-2021, the patient experienced lips swollen. On 17-SEP-2021, the patient experienced jawline itchy and tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat started to hurt, sore throat that feels like swallowing shards of glass, scattered hives that itched like madness including a few on face and lips, entire face puffy, lips swollen, and jawline itchy and tender, and the outcome of glands under jaw started to swell and upper left arm started to ache a bit was not reported. This report was non-serious.
Pt recvd inject lightheaded 2-3 hrs later; devel pruritus & hives on face 12 hrs later; generalized pruritus; malaise & lightheadedness persisted for several wks; No SOB, no laryngeal edema; on exam-no distinct hives but neck & face flushed
The handwriting on the lot number recorded on my Vaccination Record Card is hard to read and may not be accurate. Headache, weakness, fatigue, feeling of nausea which has lasted to date (midday 4/27/22), much longer than milder symptoms I experienced with a previous Moderna vaccination. I was bedridden and sleeping for more than two days.
Initial report was received from a healthcare professional on 06 July 2013. A 61-year-old female patient received two doses of intramuscular injections of IMOVAX, sanofi pasteur, lot number unknown (site, and side of administration not reported). The first dose was given on 02 July 2013 and the second dose was given 05 July 2013. An unreported amount of time later, the patient developed paresthesia of the right temporal area. The patient was evaluated in the emergency department on 06 July 2013 and 50% of paresthesia symptoms subsided at this time. The animal, a bat, tested negative for rabies and the physician was stopping the series. The patient's outcome was unknown. Documents held by sender: None.
Mom called complaining of child's left leg being swollen and hot to the touch. Told mom to use cold packs and massage area. If no better in a few days to call back.
p/vax pt devel large swelling & red ring around inj site; ER & tx w/warm compresses & antibiotics; rpt had violent react;
01/11/23 presents to ED for "generalized body aches". PMHx of "ESRD on dialysis"
Extreme headache + irritability; backache neckache no fever; chills; nausea lack of apetite; sore arm ; dizzy
Fever, vomiting, stomachache for 24 hours. Admitted to hospital to rule out sepsis due to sickle cell, got IV fluids and ceftriaxone. Fever resolved and pt resumed normal activity in 24 hours.
Prior to my vaccine I have had VERY tight muscles in shoulder and back as well as right hip pain. Right hip pain came after being sick with Covid for 3 weeks. Shortly after vaccine, I noticed my muscles completely relaxed , back pain is gone and hip pain was gone. It was not a bad reaction. I just found it strange that  after the vaccine it felt like my body loosened up. Even the right hip joint pain.
Woke up night after vaccine with pain under the arm in the arm of vaccination.  Two days later noticed swollen lymph nodes under the arm (axillary) and also on the supraclavicular lymph node.   3 weeks later nodes are still swollen and ahcey
Headache & Rash Narrative: employee states: on 1/4/2021 she experienced a slight headache for about an hour. Now (1/13/2021)more recently she has a delayed skin reaction where the injection site is red, itchy, and warm to touch. There is also a small raised area below the injection site. The arm has 5 raised spots.
A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 19-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient presented himself at the base clinic for an unscheduled immunization. FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. There is no information whether the FLUMIST used on 06-Oct-2008 was taken out from the immunization clinic's refrigerator or whether it was delivered to the clinic on that day. On the same day, the immunization clinic informed the logistics office which handles storage of vaccine that expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 07-Apr-2008 and incorporated into the narrative: no adverse events reported. Additional information received on 09-Apr-2009 and incorporated into the narrative: added Product Complaint Investigation results.