chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a 8 week old patient. On 15-OCT-2013 the patient was vaccinated with ROTATEQ (oral, 2 ml, dose 1, lot # 0380AE EXP 30-SEP-2013). The patient was administered an expired ROTATEQ no adverse effects reported. Additional information has been requested.
Headache, tenderness/pain (L) upper arm. Persists despite use of ALEVE. Pain with elevation/internal rotation & abduction (L) shoulder at least 1 week later. Unable to elevate above shoulder level.
No adverse reaction currently. Patient asked to monitor. Accidentally given 3rd dose of pfizer vaccine
At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations and blurred vision and stated ? it feels like my sugar is low.? Patient reported she did not have glucometer and had been feeling like this for 10 minutes.  EMT assessed patient vitals: blood pressure 140/90 mmHg, pulse 110 beats/minute and SpO2 99%. Patient reported history of diabetes mellitus type 2, asthma, leukemia, and ovarian cancer. Patient reported taking metformin, insulin, and an inhaler. At 1443, nurse activated EMS. At 1451, paramedics arrived and assumed care. Patient blood sugar was 123. Patient declines transport to hospital and signed Against Medical Advice form. At approximately 1500, paramedics left facility. Patient vitals reassessed at 1505: blood pressure 130/90 mmHg, pulse 102 beats/minute, and SpO2 99%. Patient stands up and reports feeling dizzy again. Nurse offered crackers. Patient consumed crackers and stated she felt better and was not dizzy anymore. At 1316 lead nurses assisted patient who is pushing her mother in a wheelchair to her vehicle. Patient left facility with steady gait and unlabored respirations.
myalgia 2hrs, chills-rigors 2hr, malaise 24-48hr, insomnia
The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022; No adverse event; 6 doses administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    Concomitant medications details were not reported by the reporter. Date the vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668074, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668215, US-MODERNATX, INC.-MOD-2022-668214 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668074:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter US-MODERNATX, INC.-MOD-2022-668214:Same reporter
Information has been received from a physician concerning a female friend of the physician's patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient was diagnosed as having had a stroke.  A computed axial tomography scan of the brain revealed an unspecified lesion or mass.  The patient's outcome was unknown.  It was unspecified if the patient sought medical attention or not.  Upon internal review, stroke was determined to be an other important medical event.  No further information is available.
I received my 1st dose of Moderna on 01/07/2021. My adverse event started on the next day with a fever of 101.00. The fever was gone after few days of taking TYLENOL. On 01/11/2021-01/16/2021 I noticed swelling on my left arm on the injection site. It was itching, pain, redness and warmth. It was from my left deltoid area extended to the bottom. I didn't seek care from a doctor but I took BENADRYL 2 times a day for 3-4 days. Overall my problem resolved within 10 days period. It took me 2 weeks for the redness to go away.
they gave an expired dose of Daptacel; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that they gave an expired dose of DAPTACEL.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  Information on the batch number was requested.  It was a case of actual medication error due to expired product administered.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.
Swollen lymphnode it left axillary. Golf ball sized lump below vaccine site. Painful & warm to touch. Antihistamine regimen, cool compress, rest fluids.
Chills; Severe Headache and last night she was in bed all day; Throat swelling; Difficulty breathing; Having dry scratchy throat similar reaction as her food allergies; Having dry scratchy throat similar reaction as her food allergies; This is a spontaneous report from a contactable consumer. A 45-year-old female patient (age at vaccination: 45-year-old) received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on 30Sep2021 17:00 as dose 2, single for Covid-19 immunisation. Medical history included has some certain food allergies. There were no concomitant medications. She had her dose 1, single of bnt162b2 (lot unknown) on unspecified date in Sep2021 at age 45-year-old for Covid-19 immunisation (further reported as 21 days before second dose, not clarified). On 30Sep2021, she got chills, severe headache and last night she was in bed all day, started to get some swelling in her throat, difficulty breathing, had dry scratchy throat and similar reaction as she experiences like her food allergies. The swelling in throat, difficulty breathing after taking an antihistamine (treatment) all kind of gone away. Took antihistamine (Loratadine 10 mg) for dry scratchy throat. She took Motrin tablet 200 mg for headache. The outcome of throat irritation, dry throat was not recovered; for difficulty breathing, pharyngeal swelling was recovering; for other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt recvd 2 doses of Engerix-B p/both doses exp wrist pain @ the join & weakness @ wrist; treated w/Motrin; 3rd dose will not be given;
Approximately 12 minutes after receiving the injection, the patient complained of itching on the left arm and head.  Patient stated no issue with mouth or lips.  With the parents approval, I administer one 25mg diphenhydramine tablet.  Mom and patient was counseled to observe for other signs of an allergic reaction, such as hives and swelling of the lips, tongue, and face.  If allergic reaction continues to develop, they were counseled to contact their physician on call 911.
5/15 presents with maculopapular pink rash on trunk, 7 extremities (measles-like) and low grade fever.
The patient was due for a DTaP, Hib, Hep A, MMRV, PCV13 and Flu. The nurse Drew up a Kinrix, Hep A, MMRV, PCV13 and Flu. The Patient was not due for a polio which he recieved and did not recieve the HIb. The nurse called the patients mom and let her know, she verbalized understanding and will bring him in for the HIb in about 1 month.
Mother states Rt arm is swollen & red about 4" circle, warm to touch, uncomfortable, no fever.  Will use a cold pack & cloth on arm & see if it gets better; if not may go to ED this afternoon (9/30).  called 10/4; left msg; no return call.
Location on (R) posterior area of arm. Rash is pink, warm (Hot)/ and induration. Pt complains of pruritis and pain to touch. Tx: pt seen by Dr. pt prescribed antibiotic. Pt has f/up appt on 6/11/2010 to check on skin condition.
PATIENT HAD PFIZER VACCINE ON 1/7/21 and 1/28/21, AND TESTED POSITIVE TO COVID.
Myalgia & Arthralgia Symptoms started on 12/25/2020 and continued through 12/28/2020. Recommended to see rheumatologist.
Provider hospital summary "This is a 80 YO male with h/o Dementia, Parkinson's, Normocytic Anemia, HLD who is presenting to the ED for evaluation of shortness of breath and altered mentation. He was brought in to the ED for evaluation and found to be hypoxic requiring BiPap therapy but fairly quickly weaned down to 4L NC. He was found to be COVID +. He states he "feels better". He is not oriented to place or time but is able to follow simple commands. He was unsure if he was vaccinated but per chart review he received the Moderna vaccine (2/2) in February and March of 2021. CTA completed in the ED was negative for PE but demonstrated a LLL infiltrate. He is to be admitted for sepsis, hypoxia in setting of CAP and COVID 19 Pneumonia.    Upon admission, patient was completed 10 days of decadron and 5 days of remdesivir, PPI for peptic ulcer disease prophylaxis with steroid. His CAP was initially treated with Ceftriaxone 11/24-26 and doxycycline 11/24-28. Repeated CXR later on shows worsening infiltrates and CT showed likely aspiration with material in left bronchus. Patient then suspected Aspiration pneumonia. Patient then started on Zosyn, Give Tessalon, Robitussin, Flutter therapy. CXR 11/30: Markedly improved aeration of the left lung base compared to the prior CT and chest x-ray. Mild residual atelectasis in both lung bases. Zosyn stopped 12/1. SLP evaluated patient, recommends Level 2 mechanically altered, nectar thick. Patient's respiratory function improved significantly, but still require 2-3L NC for maintenance. However, patient continue to have day by day baseline sundowning, confusion, delirium 2/2 his Parkinson's disease and dementia. Patient was then added Seroquel 25 mg nightly without clear improvement. Patient's wife initially resisted to allow patient to go to SNF, then agreed to go to facility due to significant caregiving challenges to the family. Patient will be discharged today to SNF and then will be admitted to SNF later. He will follow up with Neurology with Dr.."
After my first shot I developed a red lump on my chest which grew slowly. Then another appeared on the back of head.  After my second shot the number of red bumps continued to increase on my chest and back of my head.  The existing lumps or bumps stopped growing outward and sort of flatten and they are now increasing in diameter.  In the past week I now have two lumps on my neck under my chin and several red bumps are beginning to appear on right arm.
16 Y old young man with CTLA4 haploinsufficiency (aka CHAI) with history of autoimmune cytopenias (ITP, AIHA), lung nodules, LAD/splenomegaly, bilateral anterior uveitis (diagnosis 4/2020), and psoriasis (started 10/2020) with new onset of headache (now improved), fever from 9/11-9/20, and cough since around 9/14 who had negative COVID-19 and viral testing without improvement on initial antibiotics despite new chest xray findings, but did have worsening labs including CRP and findings of early AIHA, as such was started on prednisone 30 mg BID on 9/18 in discussion with immunologist given concern about a flare of his inflammatory process related to his genetic disorder (CHAI). With start of steroids has had improved labs and clinical status. Unclear if exacerbation related to mRNA vaccine third dose given 9/3 or if other trigger but in the past 2 years has not had any other flares. Did however tolerate first two doses of mRNA vaccine without any significant adverse events.
Quickly deteriorating energy, rise in fever, trouble breathing,  shortness of breath, severe ?whooping? type cough, chest pain
Patient came in to pharmacy at 750pm complaining of soreness and difficulty moving.  2 staff pharmacists examined his arm and injection site.  The site may be higher than usual but not directly on the bone and did not see any swelling at the time.  We advised patient to monitor and may take tylenol and icepack (15 mins on/off) on affected area.  And if see any swelling or worsening, we advise patient to see doctor or go to urgent care or emergency immediately.
developed severe muscle cramping in leg.  Cramping began approximately 3 hours after administration.  Continued for approximately 15 hours.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Patient's pertinent medical history drug reactions and allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provide). There were no concomitant medications reported. It was reported that "within the last month" approximately in July 2016, after receiving ZOSTAVAX the patient experienced an unusual rash in the hip area on unspecified date. It was reported that the patient sought medical attention with an unspecified healthcare provider and was prescribed an unspecified steroid for treatment. At the reporting time the outcome of the rash was unknown. The causal relationship between the rash and vaccination with ZOSTAVAX was not given by the reporting pharmacist. Additional information has been requested.
Numbness in the right side of the body; Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the right side of the body), MYALGIA (Soreness) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LISINOPRIL and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in the right side of the body), MYALGIA (Soreness) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Numbness in the right side of the body), MYALGIA (Soreness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 80, 320, and 320 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as a LCI case of Influenza A/H3N2. The outcome was not reported.
A few small patches developed near injection site. Patches are itchy, raised, somewhat like pimples, yellow center surrounded by red, size of pen cap, scabby. Not oozing, warm, swollen or painful. Advised Benadryl, warm compresses.
On day 2 post vaccine, patient developed a low grade fever, was more confused than normal and was "shaking more that usual"  This lasted 2 days then patient resumed to her normal
fever; bad migraine; arm was a little sore; did not sleep well through the night; head feels like it is splitting wide open; her joints feel, head feels like it is splitting; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 62-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received her second dose shot of Pfizer BioNTech COVID-19 Vaccine 31Mar2021. After the second dose shot, unspecified date in 2021, she developed a fever last night and bad migraine. She has a past medical history of migraines. After the second dose shot her arm was a little sore which was expected, she did not sleep well through the night, her joints feel, head feels like it was splitting wide open although she does tend to get migraines. She asked can she take an over-the-counter product like Excedrin or Tylenol for the migraine after having been administered the Pfizer BioNTech COVID-19 Vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
1 1/2 hours after receiveing vaccine client lost vision in his left eye and was dizzy for 2 hours. After that he was sick to his stomach, felt like vomiting and had a severe headach which lasted 5 or6 hours until he went to bed.
Patient 16 years of age. Moderna vaccine for those 18 years and older. Too young to receive the Moderna vaccine.
Had injections on 2/17/15 and 2 days later noticed welts on her lower arms.
Heart attack related symptoms; Severe chest pain; Numbness and tingling in the left arm, face, and legs; Numbness and tingling in the left arm, face, and legs; Very elevated heart rate and blood pressure; Very elevated heart rate and blood pressure; This is a spontaneous report from a Pfizer sponsored program.. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 02May2021, as second dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine on 02May2021. The patient had sickness 12 hours after (May2021) with very elevated heart rate and blood pressure. 2 weeks after the vaccine (16May2021) when the patient was fully immunized, the patient began to experience severe chest pain, and numbness and tingling in the left arm, face, and legs. The patient was fearing that he/she was having heart attack related symptoms and was rushed to the emergency room (ER) for all events. The patient was wondering if he/she could speak to anyone in regard of billing for the hospitals bills from this. The outcome of the events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up Document received on 15-JUN-2021 contains no significant information
Local reaction to ski. Itchy, irritated red in an area around injection site about 2 x3inches.
Left leg weakness and numbness when woke up at 9 am 5/24. Had venous saggital sinus thrombosis on  venous mri with contrast . Had bilateral lacunar infarcts acute  on mri. Symptoms gradually subsided with lovenox snd warfarin. Residual weakness left leg but milder than initial presentation Bp very high in ED 5/24/2021 controlled with IV cardene
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender with no pertinent medical condition reported. On an unknown date (reported as when the patient was 19 years old) the patient was vaccinated with the first two doses of GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The pharmacist reported that the patient received the first two doses of GARDASIL when the patient was 19 years old. The patient was now 25 years od and was in the office to get the third dose. No adverse effect was reported. Additional information has been requested.