chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon internal review on 25-JAN-2019, a significant amendment was performed to upgrade the case from non serious to serious (due to medically significant event). Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Healthcare professional via other company (Pfizer). This case involves an unknown age patient who experienced ulcers on cornea, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious ulcers on cornea (ulcerative keratitis), this event was assessed as medically significant following the administration of TETANUS TOXOID. (Other relevant tests included No lab data.) Final diagnosis was ulcers on cornea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ulcers on cornea. List of documents held by sender: none. Sender's Comments: Sanofi company comment 30-Jan-2019: The association of the suspect drug with the adverse events cannot be excluded based on the temporal relation.
Case number PHEH2016US023425, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 56 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly into left arm on 29 Feb 2016. On 29 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
My normally regular menstruation came 3 days earlier and I experienced heavier than usual bleeding with small clots present. This was out of the ordinary. Since then, I have noticed PMDD type symptoms such as excessive mood swings, head fog and feelings of being 'crazy'. My menstrual cycle has now become irregular, it used to be about 32 days long and now its 35-38 days long.
Approx. 5 minutes, post vax, infant started irregular "gasping" respirations. O2 sats decreased to low 80's for 1 minute then recovered to 96-99. Breathing slowly reoccurred to normal over 15-20 minutes. Admitted for observation to hospital. No rashes or fevers. Lungs clear.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder; pt recvd a booster dose of Engerix-B 21AUG91;
Headache, Myalgia & NauseaVomiting Narrative:  N/A
severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 018B21A and 027C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Huntington's disease. Concomitant products included RISPERIDONE, CLONAZEPAM, SERTRALINE HYDROCHLORIDE (ZOLOFT) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced DIARRHOEA (severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diarrhea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
This spontaneous report was received from a dietitian, a female consumer of unknown age referring on herself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expiration date, strength, dose, frequency and route of administration were not reported). Additionally, it was stated by the patient that "about a week" on an unspecified date after receiving the dose of PNEUMOVAX 23, she developed a "terrible cold" (nasopharyngitis). Concomitant therapies were not reported. No Product Quality Complaint (PQC) was involved. At the time of the report, the outcome of nasopharyngitis was reported as not recovered. The causality between the event and therapy with PNEUMOVAX 23 was not reported. Additional information is not expected since the reporter did not provide any contact information.
pt recvd vax; mom states fever of 105;not responding to apap;to er & given rectal suppsitory & popsicles;t return to nl;pt taken home;no oth problems;
Extreme stomach cramping that lasted and kept me awake all night long. Starting around 9 pm and going for about 24 hrs. The last 8 hrs were progressively better. At 3:30 AM I had diarrhea but only once. No vomiting. The closest pain would be contractions as I could feel the cramps literally rolling into my stomach. It was a sharp hot pain. This is my second day home resting and easing into food. I?ve had half a bowl of oatmeal since Tuesday afternoon.
5 days after vaccine stomach cramps then loss of appetite, early satiety, sitophobia; no vomiting, but intolerant of food; at same time no palpable large bruise developed on vaccine site that was not present prior to this time that lasted for more than 4 weeks. Symptoms continue to date but have improved.
After the shot got extremely shortness of breathe and sick but still got the second shot and breathing got worse. It is slowly getting better but is not all the way back to normal just yet.
REALLY SICK WITH COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced really sick with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick with covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208313, 90000208322.
Patient presented to Medical Treatment Facility on 20June06 with c/o bilateral ear pain, sore throat, chills times 4 days. Temp 101.2. TM's not inflammed, slight tonsillar hypertrophy, white spot R tonsil, no lymphadenopathy. L shoulder with swelling, erythema, and warm. Open lesion 1cm diameter surrounded by 21/2 inches swelling/erythema. Smallpox vaccination on 09June06.
Neuropathy symptoms including tingling, numbness, coldness, burning, crawling sensations. Started in hands, quickly spread to arms, feet, legs, face, neck. Also bouts of muscle stiffness in legs and back, and legs feeling very heavy at times. These symptoms are still occurring.
BUMPS ON THE SIDE OF MY TONGUE. FACE FEELS A BIT NUMB
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was treated with AMOXICILLIN for Urinary tract infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided
Patient received Tdap vaccination around 1300 and states that generalized uriticaria and erythema began around 1830 that evening. Patient reports no change in detergents, soaps, medication or diet.
A couple of days after receiving the pneumococcal injection, she had some redness around site and a little swelling.
BODY ACHES; MIGRAINE; SLIGHT FEVER; FATIGUE; This spontaneous report received from a parent concerned a 23 year old male. The patient's weight, height, and medical history were not 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) less than 102F. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 09-APR-2021, was recovering from slight fever, and had not recovered from fatigue, and body aches. This report was non-serious.
1 week after vaccination, patient's parent reports she has flu-like symptoms, muscle aches, and a on and off sharp pain in the back of the shoulder.
Patient received flu shot on LA, swelling on left arm began the next day without fevers per father. Edema of whole (L) arm.
Vaccine injured, i am seriously disable from shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of injury 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 injury (Verbatim: Vaccine injured, i am seriously disable from shingles vaccine) (serious criteria disability). The outcome of the injury was not reported.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.     It was unknown if the company considered the injury to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient injured from shingles shot. The patient seriously disables from shingles vaccine. The patient stated that it's not for everyone. The follow-up could not be possible as no contact details were available.
tightening of throat, tightening of chest, SOB, dizziness, chills, skin tingling-was given Epi & DPH;
fatigue/chills Narrative: She developed a pruritic rash, chills, fatigue, and nausea after the initial vaccination: *Pruritic rash: started ~6-7 hours after the vaccination. Initially localized to "small" area around injection site (not able to provide reference for size), noted it was well-circumscribed at the time and not warm to touch or indurated. This lasted for about 2x days and relief of itching a/w OTC topical bendaryl. *Chills/fatigue/nausea: all described as mild, started evening of vaccination and spontaneous resolving after about a day. No therapies were tried or applied.
Beginning on Friday Nov 5th, fatigue, daily debilitating panic attacks and uncontrollable anxiety. Lightheadedness, loss of appetite, shortness of breath, depersonalization. Still ongoing till today November 12.
Pt. came in on 11/9/18 and said the first week he had swollen lips. He also said his arm is still sore after 3 weeks. He also wanted to know if pain in chest was related. He will see Doctor in a few days if it does not go away.
Mom brought patient in today because his left arm where he received the BEXSERO vaccine is still hurting and sore two weeks after the vaccine. Provider examined him and there is no redness or warmth or rash. He does have a small "knot" of tissue in the deltoid muscle about two finger widths below the acromion that is tender to the touch. Provider thinks it is a little scar tissue that forms when vaccines are given as she has seen these before with MMR, IPV and PNEUMOVAX. It is not a contraindication to further vaccination but I may not wish to repeat BEXSERO right away for him.
Patient had red welts under arms. Redness and warmth at area where vaccine administered and has spread to elbow area. Both arms sore despite only getting vaccinated in right arm.
According to the client's caregiver, his daughter picked him up the day following his vaccination to drive him to a visit with the his elderly father a few hours away.  The client apparently displayed increased confusion and was unable to walk.  Care was sought at a nearby healthcare facility and the client was admitted for observation.  He was feverish and a chest x-ray showed mild Pneumonia.  The client received fluids and IV antibiotics.  His confusion improved during this period.  The client's caregiver added that, according to a physician's note following his first dosage of COVID-19 vaccine, he had no side effects.
Narrative:  Patient COVID-19 positive after receiving both doses of Moderna vaccine Jan/Feb 2021.
Nurse was notified of the flu mist vaccine expiring sooner after the dose was given to the patient. Expiration on the box was 12/14/22, however nurse was notified today, 12/2/22 that emails have been sent out previously indicating that the expiration was moved up to 11/26/22. Patient received vaccine on 12/1/22.  Per recommendations patient is recommended to repeat flumist in 30 days.
Syncopal episode that occurred within 15 minutes of vaccination that appeared to be vasovagal.  Patient recovered after rest and hydration and food intake.  Discharged to home.  No additional injuries noted.
I95.9 HYPOTENSION 4/20/2023 CEREBRAL ATHEROSCLEROSIS
severe back pain/ but within 3-4 hours after, her back ache got really worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: EW0150) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe case Fibromyalgia", start date: 2006 (ongoing), notes: started more or less 15 years ago, in those days they didn't know much about it, but she was diagnosed in 2006. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE time: 9:30  left arm injection LOT: EP6955, She took treatment as Tylenol Extra Strength.), administration date: 19Mar2021, when the patient was 60 years old, for Covid-19 immunisation, reaction(s): "severe back pain".  The following information was reported: BACK PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "severe back pain/ but within 3-4 hours after, her back ache got really worse.".  Additional information: It was reported that, amazingly, when she got her second vaccination on 11Apr2021, for the record, she never experienced a fever or chills, nothing, nothing that they said might happen, but within 3-4 hours after, her back ache got really worse. The pain continued on to the 2nd dose. If memory serves her right, the pain shot down her hip.  On a level of 1 to 10, it was like a 6 or a 7. The pain was tolerable, but very high. She would be exaggerating if she gave it a true number. The pain continues. Everybody says everyone gets body aches. She was 100% sure of this. It is persistent pain. Her pain tolerance is very high. No prior Vaccinations (within 4 weeks) of COVID vaccine.  Description of Product Complaint: The patient who  took Tylenol Extra Strength for pain after her first dose of the COVID vaccine, but the pain continued through until after she received her second dose and is still ongoing. No further details about the extra strength Tylenol were provided by the caller.  No follow-up attempts are possible. No further information is expected.
Patient presented to the pharmacy with a severe swollen left arm. The arm was more swollen to the inner of the left arm. Also presented with the hives on the back of both legs.
In 2 months time from the original vaccine, I had been diagnosed with significant hearing loss in one ear. It was suggested by the staff conducting the hearing test that this phoenomena was recently more common and I was asked how recently I had my vaccine. They did not suggest It was the cause of hearing loss but a possibility.
Sunday 11/29/20 -Itching feeling in back Monday 11/30/20- welt and large hive lower back Tuesday 12/1/202- woke up hives and breathing issues went to local er was given medication Wednesday 12/2/2020 itching Thursday 12/3/2020 ER due to hives and reaction again.
pt was fussy & w/fever noc a/& all day that noc about 10PM;pt became very hot & given APAP 5min later;911 called took pt to hosp dx autism;behavior changed, (sz disorder), loss eye contact
This is a spontaneous report from a contactable physician, through a Pfizer sales representative. A female patient who was in late 70s was administered PREVNAR 13 unknown dose, route, at unknown time. Relevant medical history included high blood pressure and diabetes, still ongoing. Relevant concomitant medication was unknown. In 2012 at unknown time while on PREVNAR 13 she experienced severe rash at the site of injection and fever which was 103 degree for which she was hospitalized. Relevant lab data was unknown. At the time of report it was unknown if she was on PREVNAR 13. At the time of report the clinical outcome of all the above mentioned events was unknown. Follow-up (14Aug2012): Follow-up attempts completed. No further information expected.
Received the booster while breastfeeding.; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 28-May-2021 and Pfizer (Second dose) on 18-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.). On 28-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.) had resolved.            Concomitant and treatment medications was not reported. Patient's baby was 9 months old and eligible for vaccination. Patient did not had COVID test or diagnosis.
Woke from sleep screaming around 11pm-12am, and wouldn't fall back to sleep. Pain at injection sites, trouble standing (injections in upper legs), inconsolable crying for 3+ hours, legs shaking, unable to sleep (even with Tylenol), vomiting, fever, sweating.
Extreme weakness leading to patient falling and unable to get up.  Nausea, headache, large itchy welt on arm lasting 7 days.
Pt recvd 1st dose of Engerix-B & the evening of 6FEB92 pt exp diarrhea; pt was taken to ER; reporter indicated tha a stool sampling will be taken to determine if pt has a gastrointestinal infection; Immodium will be started p/cult;
Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a rash to left upper arm.   0954: O2 sats 99%, HR 130 bpm, BP 150/90. Offered PO Benadryl per vaccine standing orders for adverse reactions. Patient refused PO Benadryl. O2 at 2L/NC applied at this time. EMS notified and in route.    1000: Patient remains very anxious and complains of dry mouth, dizzyness and tingling tongue. Attempted to administer EpiPen per vaccine standing orders for adverse reaction. Patient refused EpiPen.    1002: EMS on site. Patient continues to refuse EpiPen. O2 sats 99% on 2L/NC, HR 123 bpm, and BP 137/76. Patient ambulated with EMS personnel outside. After ambulating with EMS personnel, patient stated she felt better and refused to be transported to the hospital. Returned inside for follow up and monitoring.  Late Entry 1025: Patient waiting to sign AMA form and had another episode in the hallway. Patient stated she did not feel right and squatted in the hallway. Staff assisted her to a chair. EMS notified and in route. Dr.  notified.    1028: O2 sats 99%, HR 94 bpm and BP 138/102. Patient refused EpiPen at this time. Patient complains of feeling dizzy and short of breath. O2 at 2L/NC applied for comfort.    1032: O2 sats 98% on 2L/NC, HR 88 bpm, and BP 128/84.   1035: Dr. at bedside assessing patient.    1040: EMS here. Patient agreed to be transported to the local hospital for evaluation. O2 sats 98% on 2L/NC, HR 86 bpm, and BP 140/81.
Loud tinnitus in both ears but especially the left.   Can?t cancel out the sound - it is a constant high pitched and loud ring.
Covid vaccine 14 days ago and then contracted Covid/2 weeks afterward she became infected with covid; Covid vaccine 14 days ago and then contracted Covid/2 weeks afterward she became infected with covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program .  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received the Covid vaccine 14 days before 01Feb2021 and then contracted Covid. She got the first dose of the covid vaccine on 23Dec2020, 2 weeks afterward (Jan2021) she became infected with covid. The outcome of events was unknown. Patient wanted to know when she can get the 2nd dose or how to proceed.  Information on Lot/Batch number has been requested.
Getting boil on the arm where shot was taken. Arm getting sore and little painful. Headache and weakness felt
Hives all over body. Lasted 2 hours. OTC BENADRYL was taken as treatment.
The beginning of July 2021, symptoms were constant diarrhea for 3 weeks Lots of weakness and dehydration. July 23, lots of bloody diarrhea was passing. Was admitted into the hospital July 23, 2021. After a week in the hospital, patient had a heart attack. It was known her enzymes were very high. Also, after a week, lab results from stool it was Clostridium Difficile. She was treated for the heart attack and enzymes numbers came down. She is currently on an antibiotic for c.diff.