chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered dose of vaccine from vial that was refrigerated over 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days) had resolved.        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 relevant concomitant medications were reported.  Treatment information was not provided.
Seen at ER on 9/9/05 with c/o swelling, redness, rash and arm pain x 2 days. Rash present to arms, chest and face. L arm with redness (Smallpox vaccination site) and R arm with enlarged reaction (Anthrax vaccination site) temp 99.1. Levaquin 500mg and Benadryl 50mg ordered.
mild flu like symptoms; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; hard knot in the center of her left upper arm at the injection site/ hard knot in the center where injection was given in upper left arm; Itching left upper arm; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in upper left arm on 09Feb2021, at 10:30 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had received pneumonia vaccine for immunisation about 5 years ago and had experienced localized inflammation on the arm where injection was administered, which lasted for couple of days. The concomitant medication(s) included romosozumab aqqg (EVENITY [ROMOSOZUMAB AQQG]) 2 weeks before administered of the Pfizer COVID-19 Vaccine, precursor to Prolia. It was reported that the patient experienced mild flu like symptoms and developed inflammation and a hard knot in the center of her left upper arm at the injection site. On night of 09Feb2021, the patient had onset of itching left upper arm. On morning of 10Feb2021, when patient woke up noticed onset of a lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm, area was quite large and bright red, about 3 inches in diameter, hot to the touch, the center where she got the vaccine injection was a very large hard knot. Very large hard knot was still there, and was gradually see it spreading, it got a little larger and a little bit lighter. On 10Feb2021, unknown time the patient reported onset of mild flu like symptoms. The patient had been taking antihistamines and Aleve, used all the usual things. On 15Feb2021, the patient had a regular unrelated appointment with her Rheumatologist, who had started her on a course of Prednisone for her inflammation. Patient did not any AE(s) require a visit to emergency room and physician office. No hospitalization. The outcome of mild flu like symptoms was recovered on 11Feb2021 and rest all recovering.   Follow-up attempts are completed. No further information is expected.
Pt called post vax stating that she noticed a pruritic rash on torso, neck, and arms approximately 24 hours post vax. She stated that it lasted 22-3 hours only, disappeared on its own with no treatment.
Pain, erythema, and swelling of the arm which spread from the injection site to the lower arm below the elbow.
It was reported that a patient (4 of 6) received a Fluzone SV '01-'02 vaccination, Lot number UO590AA administered IM on 09/26/01. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01196, U2001-01198 & U2001-01199.
Painful rash developed 1 day after vaccine administration surrounding lower deltoid/upper bicep regions.
Inadvertently administered Havrix vaccine sooner than required. I did not see the first dose Hepatitis A vaccine dose date for 12/12/2022.
Extreme diarrhea and food doesn"t taste right, have accidents in the middle of the night
Double vision; This case was reported by a consumer via media and described the occurrence of double vision in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced double vision. On an unknown date, the outcome of the double vision was unknown.   It was unknown if the reporter considered the double vision to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient developed double vision about 3 weeks after shingles vaccine. The patient asked was this a side effects. The follow-up would not possible as contact information was not available.
23 hours after injection (2:00pm): Worn out feeling Major body aches and pains Fever (100.3°F) Tired Itchy, red, hardened skin at injection site. Symptoms subsided 9 hours after they started. (11:00pm)
Pt received wrong dose of yellow fever and meningitis. Dilution/vaccine rate incorrect.
received the 1st shot of the covid vaccine and have had an intractable migraine ever since (3weeks ago); This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as 1st dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient recently received the 1st shot of the COVID vaccine and have had an intractable migraine ever since (3 weeks ago), had to get 2 MRIs of brain and now was stuck with a 2,000 bill that patient could not afford. It was Pfizers fault because they were told it was safe and it was not. Patient would like help with paying the bill. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said "no side effects" with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was  unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08.  5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux.  ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23.  5/1/09 Received vaccine & PCP medical records of 11/07-1/09. FINAL DX: none provided Records reveal patient experienced torticollis 11/07, Tourette's, depression w/suicidal ideation & psych hospitalization 1/08.  Neuro consult done 11/07 & 12/07 for tics & inattention; final neuro dx Tourette's & OCD.   11/08Self mutilation 3/08 while in psych partial hospitalization & developed infection.  Sinusitis 8/08.  Fatigue & plantar warts 9/08.  Viral conjunctivitis 12/08.  Cough tic 1/09.
fatigue/Tired/wiped out; brain fog; weak; clammy; headache; eye pain; racing heartbeat; feelings of anxiety; tenderness at injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from AE Reporting, Adverse Event Report.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:30 (Lot number: EP7534) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obese, possibly other comorbid conditions" (unspecified if ongoing), notes: obese, possibly other comorbid conditions. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "fatigue/Tired/wiped out"; FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "not recovered", described as "brain fog"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "weak"; COLD SWEAT (non-serious) with onset 25Mar2021, outcome "not recovered", described as "clammy"; HEADACHE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "headache"; EYE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "eye pain"; HEART RATE INCREASED (non-serious) with onset 25Mar2021, outcome "not recovered", described as "racing heartbeat"; ANXIETY (non-serious) with onset 25Mar2021, outcome "not recovered", described as "feelings of anxiety"; VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "tenderness at injection area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccine Facility information was Pharmacy or Drug Store. Allergies to medications, food, or other products was unknown. The patient had not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were unknown. Reportedly, serious: no.   No follow-up attempts are possible. No further information is expected.
10 y/o test positive MYBPC3 familial hypertrophic cardiomayopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 10 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown", described as "10 y/o test positive MYBPC3 familial hypertrophic cardiomayopathy". The patient underwent the following laboratory tests and procedures: investigation: positive, notes: patient genetic test positive for MYBPC 3.  Clinical Course: 10 yo patient genetic test positive for MYBPC 3 familial hypertrophic cardiomyopathy, as is mom and mom's side. Mom is being evaluated for palpitations and inappropriate sinus tachycardia after your 2nd Covid 19 vax and again after the booster. No history of true myopericarditis. I imagine not population information, but is this myosin genetic abnormality "prone" to myocardial "irritation", and is there predictable problems for the child with the same genetic substrate abnormality?.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200463173
Pain, increased warmth, hives (L) shoulder 24 hours after injection in (L) upper arm. Suspect localized allergic Rx but covered with KEFLEX for possible injection and OTC BENADRYL.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198) and on 17Mar2021 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Lot number: 939909) and on 02Jun2022 as dose 4 (booster), single (Lot number: 054142219) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medication in 2weeks product=Anti-anxiety; "Oral Contraceptive" (unspecified if ongoing), notes: Other medication in 2weeks product=Oral Contraceptive; "Antihistamine" (unspecified if ongoing), notes: Other medication in 2weeks product=Antihistamine; "Antiviral" (unspecified if ongoing), notes: Other medication in 2weeks product=Antiviral. Concomitant medication(s) included: SERTRALINE taken for anxiety; ALLEGRA-D 24 HOUR taken for antiallergic therapy; MUCINEX DM; LO LOESTRIN FE taken for oral contraception; BABY ASPIRIN; AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; VALACYCLOVIR [VALACICLOVIR] taken for antiviral treatment.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: I tested positive for Covid-19 on 06Jul2022; (12Jul2022) Negative, notes: I tested negative for Covid-19 on 12Jul2022; (15Jul2022) Positive, notes: I tested positive for Covid-19 on 15Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid-19 rebound after Paxlovid. Patient tested positive for Covid-19 on 06Jul2022. Patient initiated Paxlovid that night, 06Jul2022 and continued through the morning of 11Jul2022, completing the therapy. Patient tested negative for Covid-19 on 12Jul2022. Patient started having symptoms on 14Jul2022. Patient tested positive for Covid-19 on 15Jul2022.The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Hives, terrible itching all over for about 2 weeks now, bumps and welts, stinging sensations on skin, itchy eyes, some joint body aches, arm still tender after 3 weeks
I was unable to open my jaw. I was unable to eat and difficulty swallowing. All I could have was water. I could barely open my mouth & jaw, even at the ER, it was very hard to open it because my jaw was so swollen.
HOSPITAL COURSE: Briefly, this is a 35 y.o.,male, with a PMH of ESRD on HD, HTN, tobacco abuse , who was admitted on 1/27/2022, for nausea, vomiting, malaise found to have Acute Hypoxic respiratory failure, sepsis 2/2 COVID. For more detail, including PMH, PSH, PFH, Social Hx and further info please see admission H&P.    Hospital course dictated by problem: COVID-19 Pneumonia  Sepsis 2/2 COVID  Acute Hypoxic Respiratory Failure  Suspected OSA  Tachycardic, febrile, tachypenic on admission. Symptom onset 1/26, tested positive 1/27. Fully vaccinated/boosted. CRP 0.6, D Dimer 0.43. Treated with two doses of dexamethasone, stopped when hypoxia resolved. Oxygen requirement of 2L on admission resolved after dialysis, however had desaturations and episodic bradycardia while sleeping, given neck circumference and snoring strong suspicion for OSA.  - outpatient sleep study referral to be completed when convalescent from COVID  - tessalon prn    ESRD On HD TTS. Scheduled for dialysis 1/29 in COVID unit    HTN  Borderline CHF EF 40-45% 11/29/2020  - PTA amlodipine, coreg, Imdur, Bumex, losartan, ASA     Obesity cont Topiramate    Tobacco Use  Declined nicotine replacement, encouraged cessation    DM2  Diet controlled
C/o chronic pain to (L) deltoid area (aching & throbbing). Treated with warm soaks & ALEVE.
Vaccine given 9-25 in the evening. Reaction on arm noticed 9-26 morning. About a 3 in circle pink reaction - warm to touch.
Patient reported: Around 10pm that night, patient noticed swelling/redness site of injection, redness radiated down to her underarm. Swollen lymph nodes under her arm, weakness. Nausea, body aches, headache, muscle pains in legs. Watery diarrhea. Shaking chills, reports she felt "deathly sick" and almost called the ambulance. T 101.5.
Several minutes after vaccine patients arms and legs went stiff and patient passed out. Patient recovered shortly after.
Fever, severe sinus headache, nausea for 18-48 hours after injection.  Continued sinus headeach & pressure & general lethargy for another 2 days following.
Feb 15, got both vaccines.  Feb 16 small rash on left arm appeared.  Feb 17, could not sleep because chest pain.  Feb 18, 19 could not sleep because chest pain.  Feb 20 checked in ER, DR ruled out heart problem and no blood clots.  There were 2 rashes on left arm.  Feb 22, two rashes merged into 1.  Feb23 the rash started to go away.  Feb 28, woke up with rash all over my body.  Feb 29, the rash is getting worse and I am seeking help today
Severe headache, chills, body aches - Legs & Arms starting the evening of the vaccine. All symptoms proceeded for the first 2 days following. Chills stopped after 2nd day. Severe headache, and body aches - Legs & Arms proceeded into 3rd day. Body aches - Legs & Arms stopped after the 3rd day. The severe headache continued throughout the rest of the week 5-6 days. During days 5 & 6 I noticed new symptoms- a feeling pressure/constriction in my hands/wrists. In addition, I noticed (2) bloody stools over days 5 & 6 - 1 each day in the morning.  Both symptoms seemed to have gone away after day 6. However, pressure/constriction in my hands/wrists and headaches has been noticeable intermitately since. No distinct or identified activities or food-related timing during or causing the onset of the pressure/constriction in my hands/wrists or headaches symptoms thus far.
I am experiencing debilitating menstrual cramps to the point I couldn?t get out of bed.  I have never been one to get horrible cramps and when I do they are not bad and come and go, but my last two cycles, my cramps lasted about 4 days when it usually only about the first and second day of my cycle.  Something is definitely not right and this all started after my first shot. I refuse to get the second as I?m afraid it?s effecting woman?s reproductive system.  I am not the only one out of my group of vaccinated friends to have this happen to after being inoculated.
Information has been received from a registered nurse concerning a 14 year old female who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). After vaccination, the patient fainted (outcome unknown). Patient's mother called the doctor's office on 31-JUL-2008 stating her daughter was not feeling well, not feeling like herself and was lethargic. At the time of reporting, the patient had not recovered. Additional information has been requested.
Heart palpitations, heart arrhythmia (Non-sustained Ventricular Tachycardia)
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 76-year-old female patient received on 04Nov2015 a single dose of PREVNAR 13; (NDC number: 0005-1971-02; Lot: M16258; Expiry date: Apr2017), and a dose of AFLURIA; (NDC number: 33332-015-01; Lot: U51209; Expiry date: 30Jun2016). The patient medical history was none. Concomitant medication included Albuterol as needed, NORVASC 5 mg daily, COREG 25 mg 2x/day, CATAPRES 0.1 mg 2x/day, PLAVIX 75 mg daily, LASIX 20 mg daily, LOMOTIL as needed, LANTUS 50 units QHF, lisinopril tablet, 20 mg 2x/day (1 tablet twice a day), loratadine 10mg as needed, GLUCOPHAGE 1000 mg 2x/day, PROTONIX 20 mg as needed, ZOCOR 40 mg as needed and tramadol 50 mg as needed. On 04Nov2015, 1 minute after receiving the immunization, the patient got dizzy. She received oxygen for 15 minutes and after that, she recovered. On an unknown date she passed out. The outcome of loss of consciousness was unknown.
Pain in left shoulder as shot administered & immediately after. Soreness/stiffness within 6 hrs - radiating joint pain - extreme pain to touch or move left arm, swollen redness, hot to touch in arm area, under armpit and left rib area - redness in all areas - chills, fever, nausea from Wed, Thur, Fri, to present. Redness in arm still swollen painful to touch, hot to touch in arm & rib area as of today. Sat joint aches continue. 800 mg MOTRIN every 6 hours.