chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 4 year old male with egg allergy and a history of asthma who on 08-AUG-2008 was vaccinated with a second dose of MMR II, IM, (Lot # 660020/0504X), manufactured with rHA. The first dose was given on 10-DEC-2004. On 15-AUG-2008, the patient was seen in the office to evaluate recently developed dysuria. A urine test for diabetes was performed. The patient was then diagnosed with diabetes. The patient was hospitalized overnight and was then released. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting,  chills, fatigue  Narrative:
Delayed cutaneous hypersensitivity near injection site. Redness, swelling, area warm to the touch, slight soreness.
pt recv vax & left office & returned w/in 15-20min w/gen urticaria, cough, & wheezing;on arrival given DPH;02 sat 95096%;15min later wheezing;recv epi & 02;
Racy heart, shortness of breath, muscle tingling, cramping, dizziness, and blurry vision happened 5 minutes after the vaccine. I have been having these symptoms for a few weeks already. I recently had panic attacks when these symptoms happened randomly during the days, especially after meals.
23 x 9 cm wheal (L) upper arm, diffuse local reaction, no systemic symptoms.
Narrative:  94 yo with problem list: PROBLEM LAST MOD PROVIDER Constipation (SCT 14760008) (ICD-10-CM K59.00) 06/14/2021 Cerebral infarction (SCT 432504007) (ICD-10-CM 05/21/2019 I63.9) Degenerative lumbar spinal stenosis (SCT 03/28/2018 202788007) (ICD-10-CM M48.07) Hypertensive disorder (SCT 38341003) (ICD-10-CM 05/10/2016 I10.) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 05/10/2016 Impaired glucose tolerance (SCT 9414007) 05/10/2016 (ICD-10-CM R73.9) Benign prostatic hyperplasia (SCT 266569009) 05/10/2016 (ICD-10-CM N40.1) Neuropathy (SCT 386033004) (ICD-10-CM G60.9) 02/16/2016 Insomnia (SCT 193462001) (ICD-9-CM 780.52) 04/21/2015 Patient died on 9/20/21. No information given on place or cause of death. Last note dated 6/21/21. Pt had received covid vaccines on 1/21/21 & 2/23/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
She has had 2 outbreaks after the Moderna vaccines; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 062G20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines). At the time of the report, HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-293061 (Patient Link).
Necrotizing fasciitis in the right shoulder; This spontaneous report was received from an other health professional and refers to a 52-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 27-JAN-2009, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, dose #, anatomical location, route of administration, lot # and expiration date were not provided) and a dose of influenza virus sag 3v vaccine inactivated (FLUVIRIN) injection, lot # 881292P, administered intramuscularly as immunization (expiration date, exact dose, dose # and anatomical location).  On 28-JAN-2009, patient experienced necrotizing fasciitis in the right shoulder. The event caused hospitalization since an unknown date. The outcome of the event was reported as not resolved.  The causality assessment between suspect vaccines and the events was not provided.
Persistent hiccups for 20 mins, stopped 4 hours after. Chills started 6 hours after. Extreme muscle and joint pain started 5 hours after. Extreme arm soreness 2 hours after.
This spontaneous report was received from nurse refer to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that first patient was vaccinated on 06-JUL-2016, second patient was vaccinated on 08-JUL-2016 and third patient was vaccinated on 13-JUL-2016 with improperly stored doses of VARIVAX with lot # L048462, expiry date: 02-DEC-2017 (route, dose and frequency not reported). The vaccine was exposed to temperature of -3.3 Celsius for 2 hours. The vaccine had previous temperature excursion of 20.3 Celsius for 27 hours and 8 Celsius for 31 hours. No adverse effects were reported. No further information provided. Additional information has been requested.
On 11/11/2022 started having COVID-19 symptoms;scratchy throat; body aches specifically my thighs thighs;chills;weakness;fatigue; nightmares;fever of 101.5;sense of smell and taste I was out of work for 11 days nightmare.I  tested positive 11/13. On 11/15 visited Urgent Care and was prescribed a course of Paxlovid for 5 days. I am feeling better but my sense of taste has not returned fully.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. PTC was generated on 06-Nov-2018 under PTC number 100002726. This case involves a 62 years old patient who received vaccine TYPHIM VI lot N1K811M via intramuscular route in the left arm on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to syringe issue. It was reported that administering TYPHIM VI to a patient and the liquid started spraying out of the syringe in the space between where the needle attaches (luer lock) and the syringe.He had to administer the vaccine to the patient using a different prefilled syringe because it was obvious the patient wasn't getting any of the dose. It was unknown if any adverse event was occurred. 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 Directive and Module VI of the 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. Documents held by sender: none. Additional information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. PTC was initiated ant the PTC number was updated. Documents held by sender: none.
Initial report was received from a health care professional on 01 August 2011. A 51 year-old male patient who is a smoker with no other significant past medical history had received a Yellow Fever Vaccine (manufacturer, lot number, route, site and date of administration not reported) and 21 days later, he experienced pain behind his right eye, postnasal drip, tactile fever and a swollen lymph node in his right neck. He was evaluated by a physician. During physical exam the patient was found to have sinus pressure and tender lymphadenopathy. The physician treated the patient for a sinus infection. According to the physician, the patient's "history was complicated by having received the vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 06 September 2011. The patient's birth date was reported. The patient received a right deltoid injection of YF VAX, sanofi pasteur Inc. lot number UF805AA, on 13 July 2011 at 5:55 PM. The outcome was reported as recovered. Documents held by sender: none.
Suspected that powder component of MENVEO was diluted with MENACTRA and injected IM. Pt. had a fever for 2 days treated with TYLENOL and MOTRIN. No other symptoms, no arm redness or soreness. Recommended by CDC to repeat dose and mom informed on and plans to do.
Patient has had consistent shoulder pain since he received his flu shot. He has not seeked any treatment so far.
Severe Mitral Regurgitation  -S/p Successful Transcatheter Mitral Valve Repair with MitraClip NTW X 1 at medial aspect of A2-P2 via R transfemoral venous approach. He will be discharged to home with close follow up planned. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient came by the pharmacy a few days after the injection complaining that her arm was still very sore and that she could not lift it. She called about a month later saying her arm was still terribly sore. She went to ER and was given pain meds but they did not help. Administering pharmacist did note that the Vaccine was given a little high due to the shirt the patient was wearing --had to pull shirt off of shoulder instead of rolling up sleeve and the patient had limited mobility in other arm due to a stroke.
No additional AE; Patient was administered both improperly stored RECOMBIVAX HB and improperly stored ROTATEQ on 11/01/2021; This spontaneous report was received from a certified medical assistant and refers to patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided. On 01-NOV-2021, the patient was vaccinated with improperly stored doses of the following vaccines: Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1742078 was confirmed to be valid, expiration date 06-JUL-2022 (dose and was not reported) and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # T032918 was confirmed to be valid, expiration date 12-NOV-2022 (dose, route and site of administration were not reported), both for prophylaxis. The administered doses were exposed to the temperature of 62.2 degrees Fahrenheit (F) for 6 hours. There was also previous temperature excursion reported as 36 F to 46 F (46.07 F) for 15 minutes. No additional adverse event was provided.; Sender's Comments:  US-009507513-2111USA000921:
Headache, Myalgia, NauseaVomiting, pain/swelling at injection site, swollen lymph nodes under chin Narrative:
COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, with frequency 1 total used for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the consumer called to learn more about the Janssen COVID-19 vaccine and if it was a Gene therapy and being forced on people. Then, she started yelling and cursing that 3 people died from COVID-19 along with her grandmother. However, she was unsure whether these patients died after the vaccine or not and claimed that Johnson & Johnson was hunting her family and blood line. They were storing her ancestor Deoxyribonucleic acid (DNA) and forced people to get the vaccine. She also claimed that Johnson & Johnson was responsible for the death of her family members and friends from COVID-19 and then trying to cover up things. On an unspecified date, the patient experienced suspected clinical vaccination failure and patient died from covid-19. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a Product Quality Complaint. This case, from the same reporter is linked to 20210950686, 20210950479 and 20210950539.; Sender's Comments: V0- 20210950658-Covid-19 vaccine ad26.cov2.s -Covid 19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210950658-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19
She was admitted to the hospital and she was put in intermediately care while they were trying to decide if to put her in the ICU or not. Husband stated that they were trying to keep her off incubation but she was being transferred to a hospital for possible ECMO. He stated that she had been symptomatic since March, but has had 6-8 negative COVID tests and has been diagnosed with atypical pneumonia, non-specific pneumonia, and has had very abnormal chest x-rays. Husband stated there was no shift in symptoms before testing positive and becoming more ill but she had a brachial procedure the week before that had caused somewhat of a sore throat
about 4 hours after vaccine, patient passed out and when came to, vomited profusely.  Transferred to hospital ED.
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The pharmacist stated that patient was not feel good for a long time after receiving SHINGRIX. The reporter consented to follow up.
Pain and Lump on Right Arm Pain And Stiffness. Traveled up Shoulder And Neck. Shoulder And Neck Still Stiff And Sore 11-9-7
Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself.  I mean like a full conversation with someone that isn?t there.  He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath  No fever thank goodness and taste and smell are normal
EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization.  The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020.  There were no concomitant medications.  The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath.  The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose.  Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks.  The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
Severe malaise, body aches, joint pain, extremely sore arm, but no fever or redness
Left upper arm/shoulder pain that started within 2 days after influenza vaccine administered left upper arm/deltoid. Pain has persisted 2 months, and worsens with activity over 90 degrees abduction of shoulder.  Shoulder ultrasound confirms subacromial/subdeltoid bursitis. Treatment plan is aspiration/steroid injection of left subacromial bursa.
Janssen COVID-19 Vaccine EUA Headache began ~1 hour after receiving vaccine - treated with 1 extra strength Excedrin;  Body aches and chills began ~6 hours after receiving vaccine, headache persisted - treated with another 1 extra strength Excedrin;  ~9 hours after receiving the vaccine I had a fever of 101.3, severe body aches and chills, headache persisted - did not treat at this time; ~15 hours after receiving the vaccine I still had a fever of 100.3, milder body aches, severe headache persisted - treated with 650 mg Tylenol
Patient had Monoclonal  Antibody subcutaneously injection on Sept. 14th2021 and came in for a covid booster shot on November 11th, 2021.  CDC recommendation is 90 days, so he was 14 days early.  He got the normal side effect from the vaccine: body aches, sore arm for 3 days.  He called on December 3rd. to make sure he was ok.
patient received a second dose PNEUMOVAX 23 2 years after receiving her first dose; now can't lift arm; arm (...) throbbing; her arm feels hot; swelling; This spontaneous report was received from a pharmacist and refers to a 47-year-old female patient. Her pertinent medical history included hypertension. Concomitant therapies included influenza vaccine (reported as "flu shot'). She had no drug reactions or allergies.  On an unknown date in approximately 2019 (reported as 2 years ago), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, via intramuscular route (injection site, lot # and expiration date were not reported) for prophylaxis. On an unknown date in approximately 2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe injection, 0.5 milliliter, via intramuscular route, lot # U003306, expiration date 15-OCT-2022 (injection site was not reported) for prophylaxis (inappropriate schedule of vaccine administered).   On 05-NOV-2021 (also reported as "now"), the patient could not lift arm, her arm felt hot, and was swelling and throbbing. No treatment was given fo the adverse events and no lab diagnostics and studies were performed. The patient sought medical attention. The outcome of the events was reported as not recovered. There was no causality assessment provided by the reporter.
PATIENT REPORTS SORE SPOT ON INNER ASPECT LEFT LOWER LIP, LEFT HAND TINGLING (WENT TO ER FOR THIS COMPLAINT 05/05/2021 PRIOR TO VACCINE AND DIAGNOSED WITH CARPEL TUNNEL), ITCHY NOSE AND FACE
rash developed in left armpit.Rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:30 as (at the age of 56 years old) dose 1, single for covid-19 immunization. Medical history included tongue cancer metastatic from 2017 to 2017 (diagnosed/treated 2017), spleen disorder from 2017 to 2017 spleen removed. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. It was reported unknown if patient taken any medication 2 weeks prior to vaccination. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 24Mar2021 four days after vaccine the patient experienced rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days. Upon follow-up (01Apr2021) it was questioned to confirm awareness date that reporter became aware of the adverse events in this report as this effects regulatory reporting timelines for report # Submitted on 29Mar2021. This awareness date is the date reporter became aware of the occurrence of the reported events. It was reported that, if you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events was 29Mar2021 as per the response. Therapeutic measures were taken as a result of rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days included with Steroids-oral & topical. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up (01Apr2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This report included that: Awareness date confirmed.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reports itching and rash that started in her head and went to her face, arms and stomach. Rash was tingly to the touch, accompanied by headache and some chills. Patient reported "warp" at the injection site with a rash on her arm.