chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of autism in a 3 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). The reporting physician was from a foreign country, however, the patient received Infanrix in the US. On 7/13/01, the patient received the first dose of Infanrix. Approximately three weeks later, on 8/2/01, the subject received the second dose of Infanrix; this is sooner than the recommended interval of four to eight weeks between the first and second doses. Approximately 11 months later, on 7/19/02, the patient received the third dose of Infanrix; this is longer than the recommended interval of four to eight weeks between the second and third dose. Approximately 11 weeks later, on 10/6/02, the patient received the fourth dose of Infanrix; this is sooner than the recommended interval of 6 to 12 months. On an unspecified date following the fourth administration of Infanrix, the patient developed autism. The patient was seen in a physician's office. The event was ongoing at the time of initial reporting. The reporting physician considered the autism to be unrelated to vaccination with Infanrix. Comment: Autism as assessed as medically serious (OMIC).Approximately 11 weeks later, on 06Oct02, the pt received the fourth dose of Infanrix. The autism was ongoing at the time of follow up. The reporting physician considered the autism to be disabling to the pt.
Difficulty breathing, began about 2.5 hours after FLU vaccination, unable to come back to normal as of 5:45 pm, time of completing this form
Patient is a 84 y.o. female admitted to the hospital on 12/8/2022 for generalized weakness in the setting of UTI and COVID-19.    Discharge Diagnosis and Associated Hospital Course   COVID-19 infection Acute bronchitis - Diagnosed 12/8/2022. Cough, generalized weakness, nausea. Prescribed Molnupiravir as PCP felt Paxlovid would interact with her low dose Eliquis, however patient had not started taking medication - CTAP peribronchial thickening and right middle lobe which could represent bronchitis - She will finish course of oral azithromycin, has 2 days left - ID was consulted 12/10 as Molnupiravir was not on formulary, felt patient would be okay to take Paxlovid instead.  Unfortunately this was not started by pharmacy staff and patient did not receive while in the hospital.  I did discuss this at length with patient on 12/11--risks and benefits. She does not want to begin Paxlovid, which does seem reasonable as her symptoms started about 5 days ago.  Her symptoms are improving with supportive care, she has no significant respiratory symptoms, and she has not required oxygen during her entire hospitalization. She reports she does not plan on taking molnupiravir and has tessalon prescribed by PCP.  She has requested discharge home.   Urinary tract infection - Present on admission. Reporting generalized weakness fatigue nausea vomiting - UA abnormal with large RBCs, elevated WBC, moderate leuk esterase. Urine  - Urine culture was negative. She did complete 3 day course of rocephin.   Generalized weakness - Secondary to active infection - PT/OT consultations--OK to discharge without additional therapy, doing well   Hypokalemia - Mild at 3.4, replaced   Essential hypertension -Poorly controlled here. Continue on losartan and metoprolol at discharge -I would like her to follow-up with her PCP in 1 to 2 weeks after resolution of her acute illness as her blood pressure medications may need to be adjusted at that time   Right lung nodule - Incidental finding. Right lower lobe nodule measuring 0.8 cm on CTAP. - Consider dedicated nonemergent outpatient CT of the chest for further evaluation   Paroxysmal atrial fibrillation - Continue on metoprolol and Eliquis at the time of discharge  Coronary artery disease - Status post stent placement to LAD in 2015.  EF 60% - On aspirin and zetia, continue on admission
Both ears feel full 5 mins after sitting in monitoring area.  EMS Evaluated.  Stayed extra 10 minutes then felt better.
Deltoid area - swelling, redness, warmth, tenderness left upper arm laterally from deltoid to upper 2/3 of arm.
Approx. 8 hrs. after receiving adult Hepatitis B vaccination client experienced episodes of dizziness with one episode of vomiting lasting approx 20 minutes. Occas. episodes of dizziness are occurring to the present time. Also complained of occasional headaches. Is going to be seen by family physician.
This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010402: US-009507513-1708USA010400: US-009507513-1708USA010401:
General body aching first day of second dose, then after one week, severe headache and left ear pain that radiated to left side of the neck and it lasted for 2 weeks. Pain was in tolerable with pain meds( Duexis, Gabapentin) for a week, then intermittent pain with or without pain medications. Primary Dr. prescribed Omnicef for a week, but no ear infection . Then ENT Dr.  prescribed another week of  antibiotics (Levaquin)  and one week of antiviral (Aclovior). Also had ringing of ears. Still have mild - mod pain to the same site and irritation to the left ear. There was no definite diagnosis.
The adverse event may be the brain fog I'm experiencing. It has been getting progressively worse. I saw a Neurologist, who performed an MRI and I will get my results tomorrow 11/11/2021. I am having trouble remembering things that I've done for years.
Diaphoretic, pale, shortness of breath, wheezing, rapid HR, hands numb tingling, faint pulse.
With 24 hours Patient developed soreness and a rash that was very itchy. Soreness is gone; but rash still itchy. Tx topical cortisone and oral antihistamine.
Rashes and hives on neck and chest. No breathing issues. BENADRYL given for itching and hives.
Diarrhea, vomiting, nausea, headache, light sensitivity, fever, chills, fatigue, brain fog, restless legs, rashes, blurred vision, whole body aches, no energy, no smell or taste, cough, hard to breathe/shortness of breath, sore throat, congestion/bad allergy/runny nose, pressure in chest and throat.
This spontaneous report as received from a 60 years old female consumer with allergy to intravenous contrast media (IV dye). On 08-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose and lot number were not provided) (1 time vaccine), subcutaneous in the right arm. Concomitant therapies included TRILIPIX, DIOVAN, ZETIA, CARVEDILOL, ASPIRIN, isovat, XANAX and LANSOPRAZOLE. On 08-JAN-2013, the patient had pain in his arm right and the shoulder, from bicep through shoulder on his right arm. That was the injection arm. He described the pain as feeling like the arm was going to fall off. The patient sought medical attention. The patient received therapy with steroids. Lab diagnostics studies were not performed. The outcome for pain in his arm right arm shoulder right (injection arm) was reported as not recovered/not resolved. Additional information has been requested.
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On  01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
No adverse etlects reported; patient received an improperly stored dose of PED VAX; This spontaneous report was received from a medical assistant referring to a 5 months old female patient. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.       On 03-OCT-2019, the patient was vaccinated with improperly stored dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177, expiration date 08-OCT-2021, route of administration was not provided) for prophylaxis. Administered doses of vaccine experienced temperature excursion of 46.5 degrees Fahrenheit (F) for 5 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1910USA006584: US-009507513-1910USA006415: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006268:
patient had injection site rash; injection site ras with swelling; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly, lot # S026366, expiration date 17-SEP-2020 (exact dose and dose # were not provided) for prophylaxis. On the same day, the patient experienced injection site rash with swelling and was hospitalized on an unknown date. The outcome of the event was not provided.   The relatedness between suspect therapy and the events was not provided.
VAXELIS was administered after three major temperature excursions: Temperature/Time frame: 35.1 F for 4 hours 40 minutes; 35.2 F for 54 hours, 35.3 F for 30minutes; This spontaneous safety report, with reference number 02140661 was received by the partner on 04-APR-2022 and forwarded to agency on 05-APR-2022, from a nurse.   Due to the nature of the event, the causality between the event "VAXELIS was administered after three major temperature excursions" and Vaxelis is not applicable.   Further information is expected.   NON-SIGNIFICANT Follow-up information, with reference number 02140661, was received by a partner on 13-APR-2022, and forwarded to agency on 14-APR-2022, from a nurse. This case is maintained as non-serious.   Due to the nature of the event, the causality between Vaxelis and the event "VAXELIS was administered after three major temperature excursions" remains not applicable.   No further information is expected. The reporter had no new information to offer just wanted to know if the AE letter had to be sent back because there was no other information about the event.
HPI Patient is a 6-year-old male with a past medical history significant for autism who seen in clinic 2 days ago for well-child exam.  Patient achieved his DTaP IPV combined vaccine in his right thigh.  Overnight he has developed redness and swelling around the injection site.  Patient's mother accompanies him today and provides the history.  She states that she first noticed patient's leg was swollen last night.  He intermittently complains of pain in the region and has been itching the area.  The swelling had gotten bigger this morning so the patient sent pictures and called our office for an appointment.  She notes that pt. has been more irritable and fatigued.  He is not eating as much, though drinking fluids well.  They deny any fever, vomiting, or gait changes.  He has no history of prior vaccine reactions.
L thigh with 4-5 fine papular, (-) vesicles, (+) slt erythema at site of Varivax injection
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown. The reporter considered the injection site erythema and injection site rash to be possibly related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The reporting sales representative stated that the office manager reported excessive redness and rash at injection site for a patient between the age of 10 and 16 years old.
PATIENT REPORTED RED SWOLLEN ARM IN INJECTED LEFT ARM. SHE THEN STATED SHE HAD A SEVERE HEADACHE WHICH THEN TURNED INTO 3 DAYS WHICH SHE COULD NOT MOVE OR STAND. HAD TROUBLE SPEAKING , TROUBLE SEEING, AND NO APPETITE. BLOOD PRESSURE DROPPED TO 88/49 AND FELT VERY WEEK. SOME OF THE ABOVE SYMPTOMS HAVE IMPROVED, HOWEVER STILL FEELS VERY LETHARGIC AND WEAK. SIGHT HAS  COME BACK AND ABLE TO MOVE AROUND BUT NOT WELL.
pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On 25th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced pain at the injection site. The patient planned to follow up with her physician. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2019229366, reported by same reporter for the same patient.
Mother stated child developed 2X3inch red area on deltoid, where vaccine was administered. No other symptoms were noted. On 9/15, redness 50% improved.
Patient reports becoming "dizzy, unstable" 10 minutes after vaccine. Within 1 hour, started vomiting and had fever. (Self-reported fever 101.7 degrees F). States he was dizzy for days, couldn't drive for a week. Vomiting lasted several days.
Vaccine administered at 1:15 pm without feeling it at all.  At 1:45 the left side of my face was numb like Novocaine from the dentist went too far.  This has lasted for 6 hours before it started to subside, but still slightly 9 hours later.
Initial report received on 09/Sep/2005 from a health care professional.  A 17-year-old female received an intra-muscular injection of MENACTRA, lot number U1675AA in the left deltoid and an intra-muscular injection of DECAVAC, lot number U1219BA in the right deltoid on 15/Aug/2005 at 3:00pm.  Twelve hours post injection the patient experienced generalized aches, chills and a fever of 103 degrees Fahrenheit.  The duration of her symptoms lasted 36 hours with intermittent fever that fluctuated lower than 103 degrees Fahrenheit at times.  At the time of the injection it was reported that the patient had no history of illness, pre-existing conditions or use of other medications.  The patient recovered from these events.  Follow-up information received on 19/Oct/2005 from a health care professional.  The adverse events started on 16/Aug/2005 at 03:00.  No further information is expected.
Child given 10 mcg dose (instead of 3 mcg dose).  Was monitored x 30 minutes.   Day #1 mild symptoms - body ache - responded well to acetaminophen.  had 1-2 minute complex partial seizure on day #3.
Erythema (14cm X 15cm), itchiness, tender, hot to touch, induration (6cm X 6cm), blistery beginning on 7/23/09. Treated with warm packs, Keflex, & benadryl PRN.
Patient presented to the ED with new hyperglycemia. Patient received regular insulin in the ED. Patient was admitted to the hospital for further evaluation and treatment.
I experienced COVID-19 on 03/31/2023.  I felt like I had a bad cold, which did not improve 4-5 days I did a COVID-19 test and it was positive. I been on Paxlovid on four days, and it really has not improved. I feel like I have the flu today.  I still do not feel better today.
COVID-19 BIVALENT Pediatric dose not reconstituted 0.2ml administered to Left Deltoid. Patient tolerated procedure well.  No adverse events noted at time medication administration Message left on child's parent's voice mail to call The Clinic.
Can barely walk now and has fell in shower since receiving vaccine; Can barely walk now and has fell in shower since receiving vaccine; Knees swollen and difficult to use; Whelps on face; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knees swollen and difficult to use), GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine), FALL (Can barely walk now and has fell in shower since receiving vaccine) and RASH (Whelps on face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0A8212A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease and Walker user (Used walker).   On 13-Mar-2021, 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 13-Mar-2021, the patient experienced RASH (Whelps on face). On 15-Mar-2021, the patient experienced JOINT SWELLING (Knees swollen and difficult to use). On 21-Mar-2021, the patient experienced GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine) and FALL (Can barely walk now and has fell in shower since receiving vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 15-Mar-2021, RASH (Whelps on face) had resolved. At the time of the report, JOINT SWELLING (Knees swollen and difficult to use) and GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine) had not resolved and FALL (Can barely walk now and has fell in shower since receiving vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.
11/18 covid shot 11/22 - severe headache & vomiting at school 11/23 - covid Test NEGATIVE & mild headache  11/24 - Sore throat, sore back, cough 11/25 - Headache, severe sore throat with swollen tonsils, congestion, partial loss of voice, cough that hurts, headache 11/26 - severe headache, fatigue, lethargic, fever 100.3, chills, partial loss of voice, swollen neck glands, extreme fatigue, cough, severe conjestion. At home covid test positive 3:30pm. Sleep 5-7pm, 7:30-10:30pm, 11pm-5:30am, 6am-10am
My son developed a runny nose and nasal congestion a day and a half after receiving the flu vaccine.  He got the shot on Thursday, October 19th, symptoms began on October 21st, and he still currently has the runny nose and nasal congestion. The symptoms began six days ago through current.
Mild headache; took one aspirin.  Next day, 01/14/2010, new event, redness about 2" in diameter, itching, a small lump, feels warm, soreness when lifting arm.
face surgery casing permanent scar on face; Pfizer Covid Vacines (3 ) vaccine causing side effects in with facial fillers. The side effect is swelling and hard lumps more than 12+  near and around the filler injection sites all over my face; The side effect is swelling around the filler injection sites all over my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Nausea", notes: Codeine Vicodin makes me nausea; Vicodin, reaction(s): "Nausea", notes: Codeine Vicodin makes me nausea. Vaccination history included: bnt162b2 (DOSE 2, SINGLE), administration date: 07Mar2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: INJECTION SITE MASS (disability, medically significant) with onset 06Dec2021, outcome "recovering", described as "Pfizer Covid Vacines (3 ) vaccine causing side effects in with facial fillers. The side effect is swelling and hard lumps more than 12+  near and around the filler injection sites all over my face"; DERMAL FILLER REACTION (disability, medically significant) with onset 06Dec2021, outcome "recovering", described as "The side effect is swelling around the filler injection sites all over my face"; SCAR (medically significant), outcome "unknown", described as "face surgery casing permanent scar on face". Therapeutic measures were taken as a result of injection site mass, dermal filler reaction, scar. Clinical course: Patient was in treatment with Privacy who is a Physician Assistant in Privacy. They currently practice at Privacy. Patient was Still in treatment, Surgery, injections corti. Severe adverse side effects from fillers on face after Pfizer Covid Vaccine. Have had ongoing treatment at Privacy.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299899 same patient/product, different dose (LOE)/event;
approx 2 hrs p/receiving vax pt was observed to be very pale-white; pt was picked up & stimulated; pallor persisted about 10" no LOC or dec muscle tone;  nursed weakly;
Was informed from MD's office of perceived reaction to Moderna booster.  Pt stated becoming violently ill and began throwing up shortly after receiving vaccine. Was reported that patient was shaking uncontrollably from hands and feet. Pt felt lightheaded. Pt received shot of toradol in office visit with provider that seemed to provide some relief.  Pt had similar reactions with the first two vaccines and still wanted to proceed with the vaccination.
Tested positive for COVID; Tested positive for COVID; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 18:00 (Lot number: FL2197) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 11Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "athsma" (unspecified if ongoing); "high uric acid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "low cholesterol ratio" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ALLOPURINOL. If other vaccine in fourweeks: No. Known allergies: No The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021 18:00, outcome "unknown", described as "dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 18:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Tested positive for COVID after receiving the vaccine. Therapeutic measures were not taken as a result of vaccination failure, covid-19. If covid prior vaccination: No