chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), rotavirus vaccine (non-gsk), DTaP, haemophilus influenzae type b vaccine (non-gsk), pneumococcal vaccine (non-gsk) and poliomyelitis vaccine inactivated (non-gsk). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck given on 29 June 2009; pneumococcal vaccines (non-gsk); Wyeth Labs; unknown given on 29 June 2009. On an unspecified date the subject received unspecified dose of Rotavirus vaccine (Non-GSK) (unknown). Unspecified dose of DTaP (unknown), unspecified dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (unknown), unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown). At an unspecified time after vaccination with DTaP and Hib (Non-GSK), PCV (Non-GSK), IPV (Non-GSK) and RV (Non-GSK), the subject experienced fever. The subject became febrile after four month immunization with "RV, DTaP, Hib, PCV and IPV". On 29 June 2009 at 15:45 the subject received 1st dose of HAVRIX (unknown, right thigh) and experienced inadvertent overdose (asymptomatic). Pediatric subject received adult dose of HAVRIX. At the time of reporting the outcome of the fever and inadvertent overdose (asymptomatic) were unspecified.
IM injections were given at 2:30 pm; Pt waited in the room for 15 minutes.  Waiting then to have lab drawn noticed her right hand swelling on the dorsal surface over the 2nd & 3rd metacarpals and tingling of her 2nd & 3rd fingers; normal movement, grip, and pulses; A dose of ALLEGRA 180 mg was given; After 30 minutes her symptoms were improving, less tingling, less swelling; Pt went home
Body aches, muscles aches, tightness in the chest and pain. Little bit of asthma symptoms weezing a lot. Neck pain and feeling a rundown.
3 inch area on inside of right forearm; located 12" away from the injection site.  Area contains 2 1-cm welps and striated redness/welps sporadically up inside of right arm.  Pt expresses area does NOT itch, but is stinging.  Recommended diphenhydramine 25mg q4-6h.
Red, round rash/lesion at injection site,  Approximately 2 1/2 " diameter. The area is firm and slightly painful to touch.  It is also itchy at times.    I initially had a red round rash/lesion for a few days upon vaccination (Saturday evening) that appeared (Sunday/Monday) but slowly receded (not noticeable by Thursday/Friday) but it then reappeared (Saturday night/Sunday) and it is slightly bigger and as described above.
Erythema, severe itching at site of administration (left SQ arm).  Swelling to 1 inch diameter.
Hives/rash - generalized over body (back, Rt leg, both arms, butt, head). Unsure of actual start date (week of 4-11-11). BENADRYL by mouth & cream for itchy rash -> no relief -> going to prompt care.
My left elbow swelling, collecting fluid.; collecting fluid.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient previously had no known allergies. Medical history included plaque psoriasis. Concomitant medications included secukinumab (COSENTYX) 150 mg/ml 2 pen from unknown date, for unknown indication. 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 24Mar2021 at 18:00 the patient experienced, left elbow swelling and collecting fluid (bursal fluid accumulation). It was unknown if the patient received any treatment for the reported adverse  events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event elbow swelling and collecting fluid (bursal fluid accumulation) was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
pt recv vax;seen in er overnoc w/ cough, fever; exam revealed bulging,pulsatile fontanelle; T 99.1;no oth pos findings;CBC:WBC=15600
arm hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt a little bit".  Additional information: Caller was calling about her son, at which time she also mentions that she and her son's father both had side effects. Report 3 of 3. Caller was discussing her son's symptoms and added that her son's father's arm hurt. Caller added that the father's arm hurt a little bit, but she does not want to file a report regarding this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction N17.9 - Acute kidney failure, unspecified
Nausea, vomiting, diarrhea, headache,joint pain all over, temperature101,  neuritis type pain on the right side of face/jaw. Started feeling better today4-1-2021
3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this morning and could hardly get out of bed. Denies abdominal pain but feels nauseated and has been vomiting off and on all day. No other GI sx. Pt has known hiatal hernia but doesn't take anything for GERD right now because he doesn't have heart burn sx. Denies chest pain. Gets sweaty randomly and chilled, but this is more chronic. Sees neuro for early onset parkinson dx but no change in medicine in over a month. No new supplements. Denies dark stools. Pt taking all his medications with compliance. Has been getting more headaches lately too but thinks this is stress and from wretching. Has chronic headaches. Pt has OSA and has been wearing his Cpap with compliance. Gave patient zofran, prilosec, carafate for suspected gastritis sx. Recommended he come get labs in the morning as well. Pt agreed.  4/1 ER HPI: 47 y.o. male who presents with complaints of nausea vomiting abdominal pain ongoing now for the past day reports that is better with rest worse with movement denies any other complaints issues  4/1 Admission HPI: 47 y.o. male that was recently diagnosed with Parkinson's disease.  He presented to the emergency room with the a several day history of fluctuating blood pressure and nausea/vomiting and generally feeling very poorly.  He has been having a lot of new onset health issues lately and so his wife and family were concerned.  He was brought into the emergency room.  He denies any severe abdominal pain.  However, he states he has been feeling extremely nauseous.  He is vomited at least once a day for the last 5 days.  He does admit that he is under an extraordinary amount of stress between his new onset Parkinson's, his insurance business, and his full-time job as a pastor.  The patient also does have a history of alpha-gal allergy.  He states it is possible he ate some cross contaminated meat, but states that this nausea and vomiting does not act like his typical response to eating something that he is allergic to.   The patient states that about a month and a half his neurologist did increase his Requip up from 0.5 mg 3 times a day to 1.5 mg 3 times per day.  However, it has never made him nauseous before.  He denies any definite chest pain.  He denies any exertional dyspnea.  He does admit that his blood pressure has been fluctuating for quite some time.  He states he was having a skin biopsy done last week and they almost abandon the procedure because his blood pressure was so high.  He currently takes a combination of Benicar and hydrochlorothiazide.   In the emergency room his lipase was found to be a little bit elevated.  Creatinine was found to be a little bit elevated.  His blood pressure was very elevated in the systolic 170 range and he did require some IV labetalol.  The patient states he really has not missed any doses of his medications.
Patient presented to ED and subsequently admitted to the hospital on 3/19/2021, within 6 weeks of receiving COVID vaccination.
Headaches (consistent) within 5 hours of dose,; Exhaustion the next day; Consistent 102F temperature through day 3 and 4; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA 24 HOUR) for an unspecified indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, within five hours of the dose, the patient experienced headaches (consistent). On an unknown date, the next day of vaccination, the patient experienced exhaustion. On an unknown date, through day three and four of vaccination, the patient experienced consistent 102 degrees Fahrenheit temperature. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches (consistent) within 5 hours of dose, exhaustion the next day and consistent 102 degrees Fahrenheit temperature was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe, persistent fatigue and lethargy resulting in extended period of sleeping of approximately 18 hours. Lack of energy, poor concentration; called out to  regular scheduled shift with employer.
6 mo infant rec'd DTP/OPV & 2nd HIBTITER on 31JAN91. 10FEB91 became symptomatic & was dx w/HIB Meningitis on 13FEB91. Hospitalized. Child doing well at time of this report.
Rash to Left Arm; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On 2nd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 48 hrs after receiving Shingrix, the patient experienced rash and injection site pain. On an unknown date, the outcome of the rash and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a rash on her left arm and pain at the injection site.   The reporter wanted to know if she could give chicken pox or shingles vaccine to her 4 month old grandchildren.   The reporter provided caller with the information found in Content and from Shingrix PI and provided the caller with the Medical Disclaimer to talk with her HCP.   The caller was offered Shingrix PI and this information was emailed to her. The reporter consented to follow up. No other contact information provided per caller.
Received Td, MMR, and Tb skin test on 12-1-03 at approximately 4 pm. Pt. stated at approx. 5 pm her right eye began to water. By 6 pm the right side of face was palsy stricken with severe ear ache.
After the vaccine I started coming down with fever and I don't remember the exact temperature but it was low grade (100-101) and I had that fever for six weeks and I had a terrific headache to accompany the fever for six weeks, The fever would vary each day and it would drop down and come back. The headache was continuous and all the glands in my neck were swollen so greatly that it actually pushed my jaw forward and so I lost my bite, it pushed my teeth and they didn't align so I had trouble eating and chewing and that lasted for a good six weeks. Gradually after that period of time my glands started going down --took more than six weeks for it to go down but the headaches and the fever did decrease shortly after six weeks but the gland thing was going on for several more weeks but it was milder. I contacted my Doctor's office about this, and they just listened to my list of complaints and said they couldn't do anything and that was it. Swelling in my neck felt like I had lumps. I did have arm soreness and redness the night after the vaccine.
Reported to clinic on 02/15/13. Had a blistered area on right side of head. Had shingles vaccine on 2-7-13. Rates pain at a 3. Noted it first on 2/11/13 to have one spot on 2/12/13 shaved head and has since developed further blistered areas.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm around 4:00 PM and he experienced pain at the injection site. The patient also reported a reddish circle around the injection site and the area was aching all day with touch and he described it as painful to the touch.
Student had immunization by injection in Lt arm.  Observed for 20 minutes.  30 minutes later, student "felt flushed and had severe headache".  Vital signs - T 97.8, P 72 R 20, B/P 100/70.  Mother picked-up student - to take home.
Varivax ---> 30 minutes, reyeitch hives, cough, wheeze, increase HR, nausea.
extreme pain under arm the night of shot lasting 12 hours itchy rash on same arm 2 days later bruising(red discoloration) on same side of body 4 days after shot additional bruising approaching area of breast 5 days after shot sore nipple on breast 5 days after shot
50 year old female patient inadvertently treated with an expired Fluzone High Dose Quadrivalent vaccine with no reported adverse event; 50 year old female patient inadvertently treated with an expired Fluzone High Dose Quadrivalent vaccine with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 50-year-old female patient who was inadvertently treated with an expired fluzone high dose quadrivalent vaccine 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, influenza quadrival A-B high dose HV vaccine via unknown route in unknown administration site for prophylactic vaccination (formulation, strength, dose, batch number and expiry date: unknown) was inadvertently administered to 50-year-old female that was expired with no reported adverse event (expired product administered and product administered to patient of inappropriate age) (same day latency).   Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.  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.
Information has been received from a nurse concerning a female with no drug reactions and no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Merck) (lot# 665306/1150Y, expired date unknown) on 06-JAN-2010. Then the patient experienced shingles around the eye and on the face on 07-JAN-2011. The patient sought unspecified medical attention and was given an unspecified treatment. At the time of the report, the patient outcome was unknown. Follow up information has been received from the nurse who reported that on 06-JAN-2010, this 64 year old patient with allergy to penicillin and a history of chickenpox at age of 9 was vaccinated with ZOSTAVAX (Merck), 0.65 ml, in her right arm, SC. Concomitant therapy included PERIOSTAT. There was no rash occurring at the site of injection post-vaccination. The nurse also reported that the patient did not have recent exposure to chickenpox or shingles. On 04-JAN-2011 (previously reported as "07-JAN-2011"), the patient developed herpes zoster, dermatome unknown; "CN2" (cranial nerve II), with systemic symptoms: tingling, hypersensitivity, pain in face, swelling eyelid and stabbing pain. The patient's maximum temperature was 101 F. The patient had no other concurrent medication at time of infection. On 07-JAN-2011, a sample was obtained from her scab lesions. It was reported that the sample was forthcoming. At the time of the report, the patient was only 50% recovered from the event. Follow-up information has been received from the registered nurse. It was reported that other concomitant therapy included NEURONTIN and oxycodone. On 04-JAN-2011 at 2:00 PM, the patient experienced stabbing pain in "nature" right forehead and eruption of vesicles in right forehead into hair and eyebrow, pain and swelling of eyelid. The patient was examined by the ophthalmologist. The results showed no corneal lesions. The patient had a fever. Follow-up information has been received and indicated that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 14-FEB-2011. The sample was taken from a vesicular lesion on the patient's forehead. The patient added all specimens to one "baggie". The specimens arrived in laboratory, no VZV DNA and beta-globin DNA amplified. The final PCR specimens result was inadequate specimen. Additional information is not expected.
swollen arm; hard and raised welt; red arm; hot arm; sore to the touch arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included Omeprazole                                                     as needed, UBIDECARENONE (COQ), CALCIUM, SELENIUM, NIACINAMIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DOCUSATE, Loratidine, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MAGNESIUM, MELATONIN, PSYLLIUM HUSK [PLANTAGO OVATA HUSK], MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and BIOFLAVONOIDS NOS, RESVERATROL, VITIS VINIFERA SEED (GRAPESEED EXTRACT [BIOFLAVONOIDS NOS;RESVERATROL;VITIS VINIFERA SEED]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache). On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm). On 10-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. Patient regularly takes showers.
A report has been received from a health professional concerning a female patient born on 21-Sep-2003. Patient relevant history, concurrent diseases and concomitant drugs were not provided. The patient has been receiving FLUMIST (intranasal), unknown frequency, started on 30-Oct-2014 an unknown indication. The reporter stated that patient got a little bit of FLUMIST in one eye on 30-Oct-2014. The outcome of the event of got a little bit of FLUMIST in one eye was unknown. The reporter assessed the event of got a little bit of FLUMIST in one eye to be non serious.
Pt had nausea, vomiting, and dizziness 1 day post seasonal flu vaccination.
Term 4-mo female infant presented to ED 6/9/21 with 1 day history of motor weakness.  ~ 2 weeks ago she had mild URI symptoms (cough) for only a couple of days and recovered to baseline.  On  6/7 she received her 4-mo old vaccine series without acute side effects.  She passed stool that day that was more smelly than usual with green tinge. The following day 6/8 AM she appeared generally well, several sneezes produced green mucous and her eye lids were slightly puffy.  She was sent to daycare as usual.  In the afternoon when dad picked her up she appeared ill with eye lids being puffy, poor head control.  She only ate 2 out of 4 bottles during the day, 4 being her usual feeds while at daycare.  When dad attempted to bottle her she had trouble latching on and milk was running out the corner of her mouth.  Through out the evening she progressively became weaker with decreased limb movements.     She presented to local ED overnight and was noted to have temp of 36.1F, RR 24 sating 99% on RA.  She was noted to be lethargic and hypotonic.  There was concern for sepsis/meningitis.  She received 20 mL/kg IVF bolus.  Her glucose was 89.  She had a urinalysis which showed 1+ ketones but was otherwise reassuring.  Her rapid influenza/SARS-CoV-2/RSV was negative.  White blood cell count 8.2 (43% neutrophils, 47% lymphocytes), hematocrit 33.9, platelets 343.  Sodium 138, potassium 4.2, chloride 105, bicarb 21, BUN 9, creatinine less than 0.2, AST 22, ALT 14.  Lumbar puncture demonstrated WBC count of 4, RBC 4, glucose 57, protein 125.  CSF Gram stain did not show any organisms.  Sterile CSF culture. Chest x-ray was normal.  The patient was noted to have an apneic event with an associated desaturation and was placed on 6 L HFNC. She was subsequently transferred to  Hospital PICU for further evaluation and management.  Upon arrival she continued to have worsening respiratory status necessitating intubation.  Per parents there had been no fever, N/V/D.  She feeds breast milk and formula, no solids, no honey, no soil/dirt exposure. There's no family history of neuromuscular disorder.  Baby remains intubated on mechanical ventilation in PICU