chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX SC. There was no concomitant medication. The patient experienced ophthalmic zoster three times after vaccination. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested.
Seizure disorder with initial seizure episode 6 days after administration of 4 month immunizations. Evolved into infantile spasmhildrens and subsequently hemi-myoclonic tonic seizures. Patient received IM ACTH therapy for 8 weeks and is currently on Tegretol and Keppra for seizure control. Nurse follow up on 07/29/04 states: "ALTE; capillary hemangiomas." Multiple records are rec'd. from the reporting PMD's office. The initial ER visit on 2/4/04 refers to this event as possible seizure episode, ALTE. A second episode occured in the ER that date and child was transferred to a higher level of care facility for a 2-day admission. The neuro eval in house, suggested epilepsy, idiopathic complex partial seizures. At that time, 5 capillary hemangiomas were observed and child was also found to have a mild RSV infection. The ER record refers to a 3-day history of nasal congestion for this child and her sibs just prior to this AE. She was treated w/ Pediacare at home. On 2/8/04 child returned to the ER due to 2 similar episodes. She was apparently being treated for BOM at the time and was given Sudafed at home. There was no temp elevation in the ER. She was again transferred to the hospital, treated w/ anti seizure meds and ACTH. The initial MRI and EEG did not suggest the diagnosis of infantile spasm. An inpt record for a 6/30/04 admission notes presence of hemi-myoclonic-tonic type seizures w/ a (R) sided focal onset felt to be consistent w/ DGX of idiopathic mixed seizure disorder. The discharge notes for the 2/5-2/6/04 admission refer to findings of (+) RSV results, bronchiolitis and seizure disorder aggravated by viral etiology. The discharge note for 2/9/04 notes a diagnosis of seizure and (+) RSV.  Per the follow up report-developmental delay-mild. Still on seizure medication but seizure free for about 1 year.
COVID-19 in Nov 2020. At the time had sore throat, runny nose, and body aches for about 3 days. No chest pain at the time.  Patient developed episodic chest pain starting Saturday 4/24 (2 days after vaccination). First episode 4/24 and then again 4/25 PM. Found to have elevated troponins, cardiac imaging normal (EKG, ECHO, chest CT). Depending on trend of troponin may receive IVIG, although currently not indicated given improvement in troponins.
Inappropriate age for vaccine administration; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 11-AUG-2021, the patient age was corrected to 16 years.
Patient felt light headed, clammy, and nauseous. The patient was brought to the medical clinic where he laid down and was given benadryl 12.5mg.
Pt began to run a fever of 102F 4 to 6 hours after vaccination. Fussy, spitting up more than usual, poor appetite.
She is still suffering pain between the shoulder and elbow; Arm pain; Shoulder pain; Fatigue; headache; chills; Neck pain; Swelling neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN, SWELLING, PAIN, VACCINATION SITE PAIN, and ARTHRALGIA in a 75-year-old female 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 information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced NECK PAIN, SWELLING, VACCINATION SITE PAIN, ARTHRALGIA, FATIGUE, HEADACHE, and CHILLS. On 16-Aug-2021, the patient experienced PAIN. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN, SWELLING, PAIN, VACCINATION SITE PAIN, ARTHRALGIA, FATIGUE, HEADACHE, and CHILLS outcome was unknown.            Concomitant product information was not provided. Treatment information includes Muscle cream.
Extreme pain head to toe. Dizziness and I passed out 28 hours after my second shot. I passed out walking to the bathroom when I felt nausea. I have never passed out before.  After the second shot in March, I have also experienced slight twitching in my legs and sometimes across my temples and other locations in my head. Not visual twitching but I can feel it. Now more than one month from second Moderna and I still feel it. Will this go away?
She has had a fever for 1 week resistant to treatments. Vaccine may be leading to polypharmacy due to her complicated history. Immunocompromised, so this fever is causing her to be on several antibiotics and antivirals.
Medication Error- No adverse reaction-  17 year-old was given Hepatitis A Adult formulation instead of Pediatric formulation of Hepatitis A.
Chronic diarrhea x 2 wks & unintentional wt loss (15lbs in 2 weeks). Pt started a self administered oral typhoid vaccine 2 weeks prior to onset of symptoms.
No additional AEs; Inadvertenly administered expired vaccine to a patient; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and drug allergies or reactions were not reported.   On 01-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), at the dose of 0.5 milliliter (ml), for prophylaxis (schedule, anatomical site of injection and route of administration were not reported), lot number S020161 has been verified to be a valid lot number, expiration date reported and validated as 30-JUN-2021 (expired product administered). No adverse event nor product quality complain involved.
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath.  It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days.  After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today.  The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
Headache, Myalgia, Arthralgia, Chills, clammy "no fever" Narrative:
Gradual onset of dull ache and pain in left upper arm / shoulder. Pain occurred intermittently initially then increased in frequency and intensity. Within one month I developed limited ROM in left shoulder and continuous pain. I have pain at night, increased when I lay on affected shoulder, I have pain intermittently throughout the day. I am a former nurse and have been treating this pain with alternating ice, heat, Salon Pas topical analgesic patches, and ibuprofen.  In addition, I use physical therapy exercises designed for the Rotator Cuff muscles. I do get some relieve with the above treatments. I am concerned because the pain and limited ROM is not improving - it is worsening.  I am a full time student, unemployed, and do not have insurance to cover cost of physician. I will continue with the above treatment until I am unable to get any relief from pain or limited movement. Note: I have been vaccinated against influenza every year since 2003, with the exception of 2010, and have never had any type of reaction.
This spontaneous report was phoned in by a sales representative (US12-052962) reported by a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history is unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Route and dose were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date after vaccination of ZOSTAVAX, the patient reported a rash and pruritus. No treatment information was reported. It is unknown if there is any relevant laboratory data. As of 29-OCT-2012 it is unknown if the patient will have another ZOSTAVAX. The patient recovered from the rash and pruritus after three days. The relatedness for pruritus and rash is unknown for ZOSTAVAX. Additional information has been requested.
In a short time, he was infected; In a short time, he was infected.; This is a follow-up spontaneous report from a non-contactable consumer via pfizer product quality group providing investigation results. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), via intramuscular on 01May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient in a short time, he was infected and the patient wants to know when the 2nd dose of the vaccine should be applied. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to include the reported finished goods lot ER8727, the fill lot EP8679, and the bulk formulated drug product lot EP8566. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. The complaint was not confirmed. The clinical outcome of the patient in a short time, he was infected and the patient wants to know when the 2nd dose of the vaccine should be applied were recovered.   No follow-up attempts are possible. No further information is expected.
Menactra administered at 1458 into right deltoid. At 1510 patient began complaining of right arm pain below injection site, muscle spasms  and swelling in right upper arm. No signs of anaphylaxis. Right arm was not red or warm and patient able to move right arm/shoulder freely without pain, normal color and sensation of right upper arm. Symptoms improved with ice pack. Monitored patient for 30 minutes and red area noted below injection site. 25 mg of oral benadryl was administered at 1530. Patient remained stable without signs of anaphylaxis or distress. Continued to monitor patient. At 1545 patient developed chills, heart rate elevated but other vitals remained stable. Patient's mother requested the patient be transported to nearby ER for close monitoring, and she wished for EMS to transport patient as she did not feel comfortable driving him. (patient remained without distress, tachycardia present, no signs of anaphylaxis). EMS arrived at 1556 and transported patient to ER.Patient appeared stable upon leaving the clinic.
Approximately 1 hour after vaccination, I experienced a migraine aura. It began with blind spots in my vision, and progressed to a 20-minute scintillating scotoma. There was a slight headache, and sluggish feeling for hours afterwards. I typically experience migraine aura once or twice yearly. This aura was the same except the blind spots were much worse than before. I did not experience migraine aura with any previous vaccinations.
Covid19 breakthrough.  1st vaccine received on 05/22/2021.  20 y/o male with PMHX of perforated appendicitis s/p open appy in 2017 with small bowel obstruction s/p exp lap and adhesiolysis in 2017.  Pt presents with c/o Right upper quadrant abdominal/ epigastric pain that is worsening since the day before.  Pt endorses 12 episodes of emesis, chills and constipation.  Pt afebrile, GB US shows acute cholecystitis and possible stone in CBD.  CT abdomen with Small bowel obstruction.  Pt scheduled for colonoscopy/flexible sigmoidoscopy, pre procedure COVID test -positive.  Pt afebrile, room air sat 100%. No Covid treatment ordered.
4/7/2021 COVID-19 Positive Breakthrough Case >14- Days Post Vaccination Series Completion  Narrative:   Other Relevant History:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 04-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Headache, Elevated Blood Pressure (160/101) Blood pressure has decreased over the past 5 days and is at (140/79)
Painful, itchy rash that's hot to the touch, on upper left arm at the injection site, has persisted for several days
Patient stated she had soreness at the injection site that evening and woke up to see a red rash (not painful or itchy just red and hot) the next morning. She said that day (15 hours after vaccine) she felt tired, lethargic, and achy so she went to take a nap for 2 hours. She said the rash seems to be spreading and currently is located from the injection site area (left deltoid) down to about 3 inches above the elbow on the back side of her arm.
Left arm. Thursday evening had temp of 102 x 2 inch red circle around site of injection. Fri AM more redness and by Friday afternoon around 3:30, arm was very swollen, red, hot, hard from shoulder to elbow. Treated in Emergency department with IM antibiotics. is on 10  day course of abx. On 12/14/04 mild swelling remains, but symptoms much improved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Lot number: fd0809) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREGABALIN, stop date: 12Jun2022. Past drug history included: Tetanus, reaction(s): "Known allergies: Tetanus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: Tested negative on June 20; (22Jun2022) Positive, notes: Tested positive on Jun 22. Clinical course: Patient received Other Medication in 2weeks. Finished the course of treatment on on 17Jun. Felt better. Tested negative on 20Jun. Started to fill sick the next day. Tested positive on 22Jun. Was sick until testing negative again on 01Jul.
no adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.).    Patient ID was reported as Unknown. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
"bowel movements with bleeding"; "diarrhea"; "high blood pressure."; "headache"; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache"). At the time of the report, HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache") had not resolved.            The patient reported no concomitant medications.  There was no treatment for the side effects.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
THE PATIENT CAME FOR A FLU SHOT, AND COVID BOOSTER. THE PATIENT ALONG WITH THE TWO SHOTS REQUESTED GOT AN ADDITIONAL DOSE OF FLU SHOT. PATIENT WAS INFORMED AND A PHARMACY INCIDENT WAS REPORTED TO PHARMACY. PATIENT IS DOING FINE, AND WILL REPORT IF ANY ADVERSE REACTIONS
Patient called me today, 11/11/21, and described an allergic reaction that could be related to her Janssen booster vaccine. She received the vaccine on 11/2/21 and began developing bumps on her hands, elbows, and "multiple other areas" on 11/4/21. She described the bumps as itchy and small. She said they have progressively been spreading every day. She says she is allergic to Benadryl so she has been using OTC Hydrocortisone. She is going to seek medical attention today because it is still not getting better.
Onset of dizziness and mild nausea shortly after her shot. Near syncope described by patient with blurry vision briefly.  Multiple prior V-V events including syncope described by her. No allergic type symptoms. BP, Pulse, O2 sat OK throughout 28 minute stay. Symptoms improved when supine and resolved on their own with time.   No orthostasis.