chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported similar events for four patients. This is 3rd of four reports. A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms days after receiving 1st dose of meningococcal group b rlp2086, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019271974 Same reporter, same drug/event, different patient
Severe Light headedness and dizziness lasted for about 4 days  Headache , Muscle ache , Chills
Patient started sweating and said he felt he was burning up about 13 minutes post vaccination. He was slightly disoriented. We quickly checked his temperature however it was within normal range. We applied cold packs to his wrists, forehead, and face for about 12 minutes. I checked for normal capillary refill and asked him questions to assess his mental status. About 20 minutes after starting the treatment, patient started improving. He returned almost back to normal in about 30 minutes.
RASH ON LEGS, ARMS, ABDOMEN AND BUTTOCKS. EARS RED. PT. WAS SEEN BY A DR. AND WAS PUT ON AN ANTIBIOTIC FOR AN EAR INFECTION. BENADRYL CREAM ORDERED FOR RASH.
Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 23-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, fatigue and presyncope.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007594: US-009507513-2301USA007602: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007595:
Severe thrombocytopenia PLT 4K requiring hospitalization for several days.   Dx'd with ITP requiring steroids and IV IG
SAT 11/20I WOKE UP WITH AN ITCHY THROAT AND HACKING DRY COUGH THAT CONTINUED THROUGHOUT THE COURSE OF THE DAY.  BY 10PM THAT NIGHT, I STARTED A FEVER 99.9 FLUCUATING TO 102.1. WITH THROBBING HEADACHES THAT GOT WORST WHEN I COUGH, LOSS OF APPETITE AND BY 11/23 LOSS SENSE OF SMELL AND TASTE TO PRESENT DATE. AS WELL AS 11/24 DEVELOP SINUS CONGESTION.  RIGHT NOW AS OF TODAY, 11/26, THE FEVER AND DRY COUGH HAS STOPPED. THE HEADACHE IS STILL PRESENT BUT NO WHERE AS BAD AS WHEN IT STARTED. I STILL HAVE A COUGH WITH GREEN PLEGM, AND THE NASAL CONGESTION IS STILL ACTIVE, SO I HAVE TO BREATHE WITH MY MOUTH OPEN. I TRIED USING MUCINEX AND THERA FLU FOR COLD AND COUGH HOPING THAT WOULD WORK BUT IT HAS NOT. I STILL CAN'T SMELL OR TASTE ANYTHING AT ALL.
Patient noticed devloping hive at arm that was inoculated. Within 5 minutes hives started spreading and patient started to develop periorbital edema. No breathing difficulties. Advises to reutrn to center for evaluation patient back in center and given Epineprhine at 14:56 and 17:18. Hives and itching diminished. Patient given Predniosone 60mg po x 1 and a Medrol dose pack taper as well as an Rx for Epipen and instructions to take Benadryl 50mg q6h prn.
Nausea, fever, chills - went to bed and stayed there for one day. Arm swollen and red and rashy below injection site. Itches. Very sensitive to touch. Still that way 4 days later, though much improved. Applied ice pack several times per day.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (route, lot# and expiration date were not provided), which were stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected.
ADULT VACCINE WAS ADMINISTERED TO PATIENT LESS THAN 20 YEARS OF AGE, NO SYMPTOMS OR ADVERSE EFFECTS REPORTED.
No additional information or AE's reported; one dose of GARDASIL 9 was administered this morning prior to realizing there had been an excursion; This spontaneous report was received from an Other Health Professional and referred to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 27-APR-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter injection, 0.5 milliliter, lot #W013388, expiration date: 16-DEC-2024, administered intramuscularly for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had been an excursion before administration (Product storage error). No additional adverse event.
Patient was pregnant at time of vaccination with estimated due date of 28Oct. All vital signs normal throughout antenatal course. 2nd dose of covid vaccine received 27September. First elevated blood pressure reading  30Sep, second elevated BP reading  01Oct- diagnosed with gestational hypertension. Diagnosed intrauterine growth restriction 05Oct. Induced at 37 weeks, delivered at 37+1 weeks.  Infant weight at birth: 2487g.
pt recv vax 16JAN96 & 17JAN96 pt devel a 4 to 5 inch area of swelling & soreness of the inj site, felt like was getting sick & had chills;pt arm was also red, warm & tender to touch;pt recovered 27JAN96;
Sore, red, warm area at the site of the HPV. Recommended cool compresses, MOTRIN and started KEFLEX.
Got a tingling and numbness feeling  going up into my left cheek. Lasted about half the day.
Itching, pain, swelling, and redness at the injection site began 1 week after receiving vaccine. The affected area is approximately 5" in diameter. On day 8, redness and swelling are still present, but pain and itching have lessened.
Patient received vaccines on 10/26/21. Patient was seen in the clinic on 11/09/2021 for vomiting, decreased urinary output, and lethargy. Mother was instucted to take child to Hospital emergency room immediately after leaving clinic. Child was treated at Hospital and then transferred to another Hospital where he later died.
new onset Raynaud's in 1 great toe only. started 24 hr after injection
Brain fog; chills; Headache; Fatige; Fever of 100.5F; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F). At the time of the report, MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had Tylenol as treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: outcome of the event has been updated
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient had a well child exam 8 days after the vaccine was given. No signs or symptoms were reported at that well child appointment. Patient appeared to be in good health. Family is being notified of the incident and will be recommended to have the patient revaccinated.
Information has been received from a health professional concerning a 33 year old white day care female with no known drug allergies/reactions and no pertinent medical history reported who on 01-JUL-2008 was vaccinated the first dose of with GARADSIL (lot # 660553/0070X) intramuscularly. There was no concomitant medication. On 02-JUL-2008, 4 hours after vaccination, the patient experienced migraine and headache. The patient did not seek medical attention. Subsequently, on 04-JUL-2008, the patient recovered from migraine and headache. Additional information is not expected.
Vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021 at 8:30 AM, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
I had heavy pelvic cramping and bleeding. The first time it happened it was 20 days of bleeding. Then the following month after a week of no bleeding another period started and that was 15 days long. I was having 12-20 days of bleeding every month. Pelvic pain was daily and nonstop.  Ultimately I had to have a hysterectomy in January 2022.
Airway began shrinking   took Albuterol. 2 Puffs.  Better in 20 minutes
Within 24 hours of DTaP administration developed black stools. Afebrile.
Information has been received from a physician concerning a 27 year old female pt with asthma, hypertension and anticonvulsant therapy, no known allergies and a history of migraines who was taking montelukast sodium, atenolol and Neurontin. In approximately January 2001, the pt presented to the physician's office with typical chickenpox lesions (red blotches with white vesicular centers) on her trunk, back and face. At that point in time there were 35-50 lesions. The pt's mother stated that the pt never had chickenpox, but the pt thought she had chickenpox as a child. It was reported that the pt baby-sat for 2 children who received varicella vaccine "last week" (approx. January 2002). One of the children developed a rash which was thought to be roseola when seen at te pediatrician's office (WAES0203USA01915). The pt was prescribed acyclovir and instructed to use Benadryl as needed. The physician declined to sending isolates for an analysis. Additional info has been requested.
This case was reported by a physician via sales representative and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 22 February 2011 the subject received 1st dose of KINRIX (.5 ml, unknown, unknown arm). On 22 February 2011, immediately after vaccination with KINRIX, the subject experienced injection site redness. That same day on 22 February 2011, after vaccination with KINRIX, the subject experienced fever, injection site muscle pain, muscle pain and arthralgia. On 24 February 2011, the injection site redness, fever, injection site muscle pain, muscle pain and arthralgia were resolved.
Not having control of their bowels; Completely confused; Constant itching; Very lethargic; Never slept past 9am but after receiving the second dose they could not get up before 11am; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL INCONTINENCE (Not having control of their bowels) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METOPROLOL for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced BOWEL INCONTINENCE (Not having control of their bowels) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Completely confused) (seriousness criterion hospitalization) . On an unknown date, the patient experienced PRURITUS (Constant itching), LETHARGY (Very lethargic) and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am). At the time of the report, BOWEL INCONTINENCE (Not having control of their bowels), CONFUSIONAL STATE (Completely confused),  and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am) outcome was unknown, and the events of PRURITUS (Constant itching), LETHARGY (Very lethargic) was not resolved.   On 06July2021, the caller could not get a hold of the patient. The caller called 911 to check on the patient. The caller found the patient at home completely confused (not knowing themselves or recognizing any family members), the patient was in their underwear. The patient was admitted to the hospital and stayed for about 10 days. The health care providers have done every test possible according to the caller and tests have come back negative and the HCPs stating "the patient is 100% healthy. No treatment drug details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had severe blockage and infection in my left ear producing green mucous initially treated with 150mg Amoxicillin the upon returning treated with 250mg Augmentin and steroids with improvement at the time of this report.
Pt began to notice redness extending down her right arm from the site of the vaccination on 10/9/18 in the evening. The reaction covered the majority of her upper arm wrapping around to the interior part closest to her body. She had a slight fever, never over 100 degrees, and felt bad all day the day after her immunizations keeping her in bed most of the day. The arm remained red and slightly swollen through 10/14/18. Reaction was completely gone by 10/15/18. The arm was also very itchy during the whole reaction.
I want to state that I am unsure of what manufacturer these vaccines are. They don't give that info to patients. I just know I received hep B and influenza. I took BENADRYL over the counter and watched for hives to spread more on my face. After an hour went by it didn't seem that they spread any further and I went to bed. I have hives on left side of face and they burn and itch and my face felt some what right.
Patient fainted for a few seconds after that patient had major headache, in addition patient pain on upper right arm.
Within hours of receiving flu vaccine, patient began running a fever (up to 102 degrees F) and having muscle aches.
Information has been received from a medical assistant concerning a 13 year old male patient with PEDIAZOLE allergy. Medical assistant stated no pertinent medical history, no previous history of tremors. On 19-APR-2011 patient was vaccinated intramuscularly on the left arm with 0.5 ml of GARDASIL (lot # and expiration not provided). Medical assistant reported that the child was vaccinated with the first dose of GARDASIL on 19-APR-2011. Immediately post vaccination child became diaphoretic, shaky, dizzy, with LE lower extremity and UE upper extremity tremors. Child was monitored and the reaction lasted about 25 minutes. When child left the office his blood pressure was 100/60 and his pulse was 70. That evening on follow up call child was okay. However child was back on the doctor office on 21-APR-2011 and was lightheaded and dizzy. At time of the report, the patient' outcome for lightheaded and dizzy was unknown. Additional information has been requested.
Local rxn rt deltoid/lt deltoid; pain in joints - especially back; headaches.
This case was reported by a consumer and described the occurrence of a 46 year old female subject testing negative for  hepatitis B antibody's following vaccination with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included arm fracture. Concurrent medical conditions included cirrhosis, hypertension and type II diabetes. Concurrent medications included insulin and unknown medications. In January 2007, the subject received a dose of Twinrix, third in the series. Dates of 1st and 2nd administrations of Twinrix were not known. In February 2007, the subject tested negative for hepatitis B antibody's. At the time of reporting the outcome of the event was unspecified. Follow-up received via physician. The subject received the initial dose approximately June 2006. The reporter considered that the events were serious but did not indicate a serious criteria. The reporter stated that the events could have been associated with the history of cirrhosis. The reporter considered that the events were related to the use of Twinrix. The events were unresolved at the time of reporting.
Next day began a fever of 101.3 to 102.5, felt hit by a truck.   Sore throat, nausea, vomiting, body aches, swollen joints, headache and migraine. Loss of appetite and loss of desire to hydrate.  Lasted over 5 days.   Took my routine pain meds, percocet, tylen rapid release gels alternating with generic excedein tension headache. Lots of hot baths, humidifier at night for my severe dry mouth.
Patient was given MMR vaccine IM instead of sub q had audit 1/25/17 and auditor saw patients chart and noticed MMR was given IM and was informed to report it.
High fever (spiked to 103), diziness, body aches, headache, severe chills (shaking so badly could not hold a spoon), rash on entire upper portion of left arm lasting weeks after vaccine, in bed for three days after vaccine
pt recv vax & devel an inj site rxn characterized by a fist-sized area of erythema, swelling & tenderness;pt was treated w/ice & recovered;
Patient says her arm was numb around injection site by the time she got home. Her arm went completely numb that evening, and she went to the doctor in the morning. It took awhile for her arm to get better. She is having other people drive her around. She missed at least one day of work.
Blood Sugars went very high. Then the fluctuation just continue to go on for another two weeks. I was not able to get control over it.
Around 8 minutes post-vaccination patient started complaining of itching in her eyes and legs. RN in room with patient, vitals obtained immediately.  While obtaining patients vitals, patient started to feel tingling on her face starting at her cheeks and going down towards her mouth, but no itching or swelling of mouth, throat, or tongue.  NP brought into room to evaluate patient and Benadryl 50 mg given at 1125.  Patient expressed that tingling was spreading to jaw and down into neck.  911 called at 1127 per recommendation from NP.  While waiting for EMT's to arrive, patient complained of tingling down to her chest at 1133, and the tingling progressed down to her legs at 1136.  Patient still denied any difficulty breathing, trouble swallowing, shortness of breath, swelling of mouth, lips, and/or tongue. Patient was able to talk without any difficulty during the entire event. EMT's arrived at 1139 and patient walked out to ambulance without assistance and was transported to ER for evaluation.  At ED, pt reports she started getting tingling sensation all over her body, fullness sensation in her throat, feeling flushed, itching eyes and all over her body within 10 minutes of receiving vaccine. Pt notes she has had antibiotic allergies in the past that are very similar to this experience. Pt also endorses numbness/tingling sensation stretched from head to just below abdomen.  Pt received famotidine 20 mg IV x 1, methylprednisolone 125 mg IV x 1, 1L NS IV x 1 (in addition to diphenhydramine 50 mg PO x 1 she received at clinic). Pt states she felt no improvement so diphenhydramine 50 mg IV x 1 ordered. Half hour later pt felt she wsa not getting worse, but not better and she stated her thoat felt full and she had tingling all over. Pt received albuterol 2.5 mg nebs x 1 and epinephrine 0.3 mg IM x 1.  Discharged to home with prescrpitions for Medrol Dosepak 4 mg PO tabs x 6 days, famotidine 40 mg PO QHS x 5 days, hydroxyzine 25 mg PO QID PRN x 5 days. Instructed to return to ED with worsening condition and to discuss 2nd dose of vaccine with PCP.