chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency.   At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received the first dose of the shingrix vaccine 2.5 months prior with no issues other than body aches and a sore arm. Evening after recieving the second dose of the shingrix vaccine (1/3/20),  pt presented with body aches, fever of >101, headache, chills, and vomitting. Took one dose of imitrex and threw it up. Went to ER that night at 4am (1/4/20)and there they took tests (see below)- CT of head, chest XRay, EKG twice to rule out all possible scenerios. They admitted pt to Hospital for severe migraine. Gave dose of Depakote, Benadryl, and Dilaudid to try to help with migraine pain. At hospital gave a migraine cocktail and IV fluids, which then ended up helping. Discharged on Sunday afternoon with a prescription for Topamax. Patient has had a history of severe headaches/migraines, gets headaches 2-3 times a week and had only been taking the OTC Excedrin-Migraine. Patient has also had a history of a severe migraine that had caused him to go to the ER in the past.
Per mom, child given DTaP, IPV, Comvax, Flu and Prevnar and had redness on 11/25/02. Later that day temp increased 102.5 and has been up and down all night and day. Today noted that area LVL inj where flu vacc given with induration.
Onset severe chills, day two through six, temp 102-103 joint pain (hips) three days. Slept 18 hours per day. Duration 7 days.
Pt received Hep B vaccine 9am left clinic returned to OHC with diffuse itching rash - pt given Benadryl/Prednisone/Zantac - pt transferred to ER due to difficulty swallowing.
About 5 hours after the shot, started trembling uncontrollably.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the right arm on 16Apr2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers Danlos syndrome, hypothyroidism and mast cell activation syndrome. The patient was allergic to penicillin and latex. Concomitant medications included acetazolamide (DIAMOX), baclofen (MANUFACTURER UNKNOWN), famotidine (PEPCID), montelukast sodium (SINGULAIR) and levothyroxine sodium (TIROSINT); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 16Apr2021 at 21:15, about 5 hours after the shot, the patient started trembling uncontrollably for about half an hour, and then it resolved. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event about 5 hours after the shot, started trembling uncontrollably was resolved on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
PT stated that she felt like her heart was racing and that she felt generally ill. EMS & nursing staff on site responded. VS taken. Vital signs stable. Observed pt. for 30 minutes. Pt. AAOx3. Verbal. ambulates with steady gait. Stated that she felt fine after a few minutes.
pt recvd vax & devel elevated liver enzymes; also exp fatigue; rt upper quad fullness, abdo fullness & nausea; No further details were provided;
Allergies as per medication list: Pneumococcal Vaccines/ Severe; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies as per medication list with pneumococcal vaccines/ severe on an unspecified date. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Chest pain; difficulty breathing; gas exchange in lungs is decreated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Apr2021 15:15 (Lot number: EW0170) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa drug" (unspecified if ongoing), notes: Known allergies: sulfa drug. Concomitant medication(s) included: LEXAPRO; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1, lot number: ER8734, administration time: 10:45 AM), administration date: 27Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 27May2021 19:00, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset May2021, outcome "not recovered", described as "difficulty breathing"; RESPIRATORY GAS EXCHANGE DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "gas exchange in lungs is decreated". The events "chest pain", "difficulty breathing" and "gas exchange in lungs is decreated" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, dyspnoea, respiratory gas exchange disorder.  Additional Information: The patient age group was an adult. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient had been tested for covid post vaccination. The patient tested for nasal swab test (PCR) on 07Sep2021, resulted for negative. Adverse event: Chest pain, difficulty breathing. Starting about 2 weeks after receiving the second dose, developed a significant amount of difficulty breathing with any exertion. Testing shows gas exchange in lungs is decreated.  Follow-up attempts are completed. No further information is expected.
Patient did not receive Pfizer Bivalent Booster vaccine as it was not available.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6204), at the age of 28, in right arm, on Mar 18, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included arthritis (unspecified if ongoing). The patient's concomitant medications not reported. Past drug history included allergy to ciprofloxacin and prednisone. The patient experienced axillary pain (pain/soreness is worse when touched/restricted movement of arm due to pain from soreness) and swelling (swollen and sore armpit); all onset Mar 24, 2021, with outcome of not recovered. No therapeutic measures taken as a result of axillary pain/pain and swelling. Additional information: The patient did not have COVID-19 prior vaccination. The patient has not tested post-vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. No further information expected.
patient did not receive the entire dose, due to the leakage, no AE; Fluzone HD was leaking during the injection at the needle site, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 88 years old female patient received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AA Exp. Date 09-Jun-2020) via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and needle leak.  It was reported that pharmacist reported "leakage" from the prefilled syringe while administering Fluzone High Dose. The patient did not receive the entire dose, due to the leakage.  At the time of report, no adverse event was reported.  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 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
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown dates, the patients may have been vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) which was stored as low as 31 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Information has been received from a certified medical assistant (C.M.A.) concerning a 74-year-old male with a history of childhood chickenpox who on 12-DEC-2007 was vaccinated subsequently with a 0.65 ml dose of Zostavax (Oka/Merck). There was no concomitant medication. On 09-FEB-2008 the patient developed herpes zoster lesions on left side of face. The patient was seen at a physician's office and a viral culture of the lesions was performed and was positive for varicella zoster virus. This event was reported to be non-serious. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information was received from a physician on 21-FEB-2008. The 74-year-old male patient was vaccinated on 18-DEC-2007 [previously reported as 12-DEC-2007]. It was reported that no rash occurred at the site of the injection site or elsewhere within 42 days of the vaccination 18-FEB-2008 (previously reported as 09-FEB-2008). A herpes zoster vesicular eruption with distribution of the first division of the trigeminal, approximately 60 days following Zostavax (Oka/Merck) vaccination. The eruption was described as a VI dermatome classic eruption on the trunk and the patient's pain on a scale of 0-10 was rated as a 1. A giant cell culture was pending at the time of this report, no direct flourescent antibody was done and no specimen was collected for PCR. It was reported that the patient recovered. Additional information has been requested.
Pt recvd vax 15APR91; on 16APR @ 3AM, mom reported pt had face twitching lt side, upper & lower extremity rhythmic movements @ home; "normal" per mom & grandma by 4AM taken to ER; t104 & 2 more seizures;
Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    No concomitant medications were provided. The patient had not received any other vaccine 4 weeks prior to COVID-19 vaccine. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 19th out of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Tightening in face/jaw after vaccine.  Subsided on its own with no treatment necessary.  Somewhat red cheeks.
Information has been received from a pharmacy technician concerning a 69 year old female with allergy to codeine and no medical history who on 23-DEC-2008 was vaccinated with  ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On 24-OCT-2010, the patient developed a shingles rash under her right breast and side. Site was also painful. The patient's rash and pain persisted. The patient stated she went to the emergency room where she was treated and released. The patient was prescribed prednisone, acyclovir and LYRICA. Additional information has been requested.
Nasal swab for COVID 19 test; Sore throat. First noticed Saturday morning and not to the point where it's painful to swallow.; Burning from the back of left nostril and down throat; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date was not provided) solution for injection, via an unspecified route of administration (on left arm) on 17Dec2020 17:00 at a single dose for Covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. Concomitant medication included ibuprofen. The patient experienced sore throat, he first noticed it Saturday morning (19Dec2020 04:45) and not to the point where it's painful to swallow. Patient reported there was burning from the back of left nostril and down the throat (19Dec2020 04:45). No treatment was administered. The patient underwent nasal swab for Covid 19 test on 21Dec2020 with pending result. Outcome of the event Suspected COVID-19 was unknown while for the other events was recovering.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was considered medically important (OMIC). Follow up information was received pertaining to patient demographics, medical history and product details including additional vaccines, dates of administration and lot numbers. Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a male patient who on 4/18/2005, at 9 months of age, received a third dose of Prevnar. The patient also received the third dose of Tripedia (diphtheria tetanus toxoid acellular pertussis vaccine), the third dose of Act Hib Haemophilus B conjugate vaccine (tetanus) and the third dose of Recombivax HB (hepatitis B vaccine) on 4/18/2005. On 5/14/2005, at 9 months of age, he developed pneumococcal bacteremia. The patient has a past history of ventricular septal defect, reported by the child's mother as hole in heart. Indication for Prevnar was immunization. Product was administered on 4/18/2005. Dose regimen was 1 dose 1 time per day. Concomitant medications were reported as none. On 4/18/2005, 9 month old male patient received a third dose Prevnar. On 5/14/2005, the patient developed pneumococcal bacteraemia (drug ineffective, after a blood culture, done in May 2005, was positive for streptococcus pneumoniae. The reporter indicated the child recovered. Blood culture positive for streptococcus pneumoniae was done in May 2005. See related cases HQWYE165812JUN05, HQWYE164812JUL05, HQWYE165012JUL05, HQWYE165112JUL05, AND HQWYE165212JUL05 (adverse event, expedited)
Oral Lynchen Planus started in the left inside of my mouth the very next day and spread through my mouth and with the second shot it continued to spread through my mouth.  The Lynchen Planus spread and will not let up this is an auto immune disorder and since the Moderna Covide Vaccine is an immune Vaccine it has turned on my auto immune disorder and it will not turn off.  I am in constant pain and cannot eat due to the pain!
Received vaccine on Feb 25. One Feb 28 started feeling like coming down with cold with runny nose and by evening mouth was beginning to feel strange. Monday through Wed with sores on lips, gums, tongue. roof of mouth. Sores were red inside and not raised on lips sores were blister like, raised and sore. Sore on tongue also blister like. All sores were painful. Had difficulty eating especially sour things. Gums were very sore. Today, is feeling a little better. Issue not yet resolved. Tried salt water mouth rinse with fair results to decrease pain. Used OTC meds for pain relief.
I was instructed to wait 15 minutes after shot in case of allergic reaction. About half an hour after shot, or 15 minutes after departure from clinic, I experienced intense shortness of breath for a few seconds and increased heart rate.
Pericarditis that has been unsuccessfully treated with Ibuprofen and Colchizine. Currently I am taking a steroid.
Gradually over the last several weeks I have developed all over body swelling, lymphedema triggered, nodules under my arm, pressure on my chest, difficulty catching my breathe, out of breathe walking or even doing nothing, tired, elevated heart rate
2/13 0800  Post second vaccine. Weak, dizzy, unable to walk per self as usually does.  SBP 80 when getting up to use commode with diarrhea.  Syncope lasting approx 15 seconds.  Came to et  was oriented X3 at that time but having times of confusion.  Staff reports pt felt weak and same way after first Covid vaccine.  Encouraged hydration, bed rest, use of stand aide for use of BR.  Gave Claritin 24 hour tablet.  Held lisinopril.  2/14 @ 10 am.  Feeling some better, mostly oriented with episodes of intermittent confusion.  Drank lots of fluids over past 24 hrs.  SBP 99.  Continued with some diarrhea.  Held lisinopril et gave another Claritin 24 hr. Tablet and encouraged hydration.  Monday 2/15.  SBP. 114/51.  Gave  Claritin 24 hour tablet and held lisinopril.  Encouraged fluids.  Feeling some better.  Not as weak.  Denies dizziness.  Able to walk some per self.  In evening used stand aid.   2/16 dayshift. BP 123/47 et heart rate 78.  lisinopril held.  Able to ambulated in room with supervision.  Mentation at baseline.  2/17 dayshift.:  lisinopril held.   Ambulation per self in room and hall with supervision.  BP 114/59 with heart rate  of 57.  No confusion.  Mentation at baseline.
This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation.  Medical history included pneumonia about 4-5 years ago. Concomitant medications were not reported. On an unspecified date, the patient experienced feeling terrible, muscle ache, everything ache, shaking, fever over 102°F. The outcome of fever was recovered and the outcome for the other events was unknown.
p/vax pt c/o redness, swollen, tolerable pain; skin warm to touch site itchy;self treated;afeb;seen by MD 12cm red, center clearing tenderness;dx delayed localized rxn;tx Ibuprofen & cold compress;
I?m broke out with a rash that won?t go away. I?ve undergone treatments fir scabies, hives, shingles twice each, had steroids, antibiotics, the best of creams, lotions, ointments? been to urgent care, Er, dermatologist, family md, skin dr to no avail. I?ve had this since Sept and it?s not getting better.
AVRT Supraventricular Tachycardia, currently controlled at the rate of 1 episode per month with the use of telmisartan.   Prior to telmisartan therapy, SVT episodes were increasingly occuring up to the rate of 3 episodes per week.  Episodes are controlled effectively with valsalva maneuver.
Significant dizziness and disorientation, even when sitting still. Slight loss of hand-eye coordination; it was hard to  hold a pencil to write my symptoms down. Cloudy thoughts and giddiness. Mostly I just bumped into things a lot and had a hard time thinking straight. This was accompanied by a fever. Symptoms started about 4 hours after injection and subsided after 8 hours of sleep and resting the next day. I was only concerned because the dizziness and disorientation isn't listed under common symptoms. No headache, nausea, or pain.
Systemic: Body Aches Generalized-Medium, Systemic: chief complaint of left neck muscle soreness (opposite of inj site)-Medium, Additional Details: Pharmacist who gave the vaccine was contacted and explained that the immunization encounter "was just a very normal" one. No reports of adverse events were given to the pharmacy personnel.