chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arrhythmia; Small palpitations; Cough; Harder to breath; Tachycardia; Fatigue; This serious initial spontaneous safety report was received by Novavax on 31-OCT-2022 from a consumer via contact center.   A 76 year-old female of an unspecified race  was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 19-SEP-2022 in the right side at a pharmacy.   The following medical history was reported: Polymers allergy, Drug hypersensitivity (sulfa allergy), Interstitial lung disease and Rubber sensitivity.  No concomitant medications were reported.  On 23-SEP-2022, reported as 5 days after vaccination, the individual experienced some small palpitations (PT: Palpitations) that went all the way until the 13th day. On 24-SEP-2022, reported as 6 days after vaccination, the individual reported that she experienced fatigue (PT: Fatigue), cough (PT: Cough) and it was harder to breath (PT: Dysponea). On 01-OCT-2022, reported as 13 days after vaccination, the individual experienced arrhythmia (PT: Arrhythmia) (Serious: Medically Significant) and tachycardia (PT: Tachycardia).   Treatment included: Individual checked with their doctor three weeks after. Reported as everything went away after about three week.  Relevant lab tests included: Cardiac monitoring (Result: No results available; Unspecified date in 2022) and Blood pressure measurement (Result: No results available; Unspecified date in 2022).  At the time of reporting, the event outcomes of Arrhythmia, Tachycardia, Fatigue, Cough and Dyspnoea were recovered/resolved and event stop date was on an unspecified date in 2022 (about 3 weeks from the onset date), Palpitations was recovered/resolved and event stop date was 01-OCT-2022.; Sender's Comments: This 76 year-old female experienced: Arrhythmia, Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Arrhythmia was assessed as serious. The events Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient was administered a dose of ZOSTAVAX (strength, route not reported) approximately on an unknown date in 2012 (also reported as unspecified date two years ago) and a second dose on 08-OCT-2014. No adverse events were reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Vaccine administered via Intramuscular route in error at 3:20.  The correct administration is Subcutaneous.  Patient observed for 30 minutes.  Vaccine tolerated well.   Pt advised to hydrate and take tylenol or Ibuprofen for discomfort
Narrative:  91yo male patient with PROBLEM LIST: PVD (ICD-9-CM 443.9) Otitis (ICD-9-CM 382.9) Hypertension (ICD-9-CM 401.9) Hyperlipidemia (ICD-9-CM 272.4) Anxiety (ICD-9-CM 300.00/300.09) Died on 11/28/2021. Pt received minimal care from agency. No information about pt's death given. Last chart notes are covid vaccine documentations given on 1/19/2021 & 2/16/2021. This death is likely not related to the vaccinations due to patient's advanced age, and length of time from vaccine administration.
PNEUMOVAX 23 on 2-17-16 - red, warm to touch, tender and minimal swelling.
Information has been received from a 64 female with asthma and an allergy to imipramine hydrochloride and a history of back pain, trigeminal neuralgia, chickenpox in 10 years old and usually childhood diseases who on 02-JAN-2008, was vaccinated with ZOSTER (Oka/Merck), 0.65ml, injection in the right arm (lot # 658602/1080U).  Concomitant therapy included aspirin, KLONOPIN, ZOLOFE, ZOVIRAX, BENADRYL, QVAR and NEURONTIN.  On approximately 20-Sep-2008 the patient started to have itching on her back.  Then each day when waking up the itching circled around the left side of her trunk and then about seven days later the itching went on the inner aspect of the arm and under the arm pit.  The patient stated that the itching was mostly on her back and she had a shooting stabbing pain in her arm, where it felt like "a hot nail going into her skin."  The patient stated she did see her physician on 26-Sep-2008 but they could not do anything since there were no blisters, but told her to come back if blisters appear.  The patient stated that a couple days ago the blisters appeared on her back, left side of her trunk and on the arm and arm pit, but once the blisters appeared the itching went away.  The patient reported that she saw her physician on 01-Oct-2008 and they diagnosed her with the shingles and provided her with VALTREX.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  There was no sample specimen obtained.  The physician reported this as a mild typical herpes ZOSTER rash of approximately 7-9 lesions distributed on the upper back and axilla in dermatome T2.  There was no recent exposure to chicken pox or shingles.  Other systemic symptoms included 6/10 pain, intense itching, rash and post herpetic neuralgia.  The maximum temperature of the patient was 98.5.  At the time of the report, the patient recovered from all the symptoms except for low level (3/10) post herpetic neuralgia.  Additional information is not expected.
difficulty moving arm; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Nov2022, outcome "recovering"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Nov2022, outcome "recovering", described as "difficulty moving arm". Therapeutic measures were not taken as a result of joint range of motion decreased, pain. Additional information: 11 days prior to this report (on 31Oct2022) he got a shot of Prevnar 20, he has had difficulty moving his arm up to the present and cannot left his arm up and is in pain. He wanted to know what the remedy would be. Pain and difficulty moving arm started the following day. Treatment: declines any.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Discussion/Plan:    Upon patient interview and exam, patient is in no acute distress.  Cardiac and pulmonary exams are unremarkable.  Neurologic exam is unremarkable, no focal deficits noted.  No signs of ataxia, normal finger-to-nose, normal gait.  No aphasia, no pronator drift.   Diagnostic exams were reviewed.  ECG reveals no acute ischemic changes with no evidence of arrhythmia.   Given patient's history, unremarkable exam, negative ECG, I feel patient is appropriate for discharge and outpatient follow-up.  Doubt central process causing vertigo, neurologic exam is unremarkable.  Doubt DVT or PE, patient denies any chest pain or shortness of breath.  Patient was given meclizine for symptomatic relief.  Upon reassessment, patient states she feels somewhat improved.  Patient is to follow-up with primary care for further work-up and evaluation of dizziness.  Patient to report back sooner to this ED for worsening symptoms.  Patient understands and agrees to plan.   Discharge:     Patient has remained well appearing and stable throughout entire stay in the ED  Plan to discharge with follow up with PCP in 1-2 days
several hr post vax pt devel eye bloodshot, face reddened w/swollen lips;during noc lymph nodes painful;started hard cough & sinuses got congested;
Numerous spontaneous nosebleeds/gushing blood that has taken hours to stop after holding my nose; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8723), via an unspecified route of administration, administered in Arm Right on 26Mar2021 at 12:15 PM (age at vaccination was 65 years), as DOSE 2, SINGLE for covid-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Concomitant medications included Atorvastatin calcium (LIPITOR), Procaterol hydrochloride (PRO-AIR) and Nortriptyline; all taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Left arm on 04Mar2021 at 01:45 PM (age at vaccination was 65 years), as DOSE 1, SINGLE for covid-19 immunization. No other vaccines were received within four weeks prior to the administration of Covid vaccine. On 27Mar2021 at 08:00 AM, the day after the second shot, the patient experienced 4 spontaneous nosebleeds (numerous spontaneous bleeding). These had continued for the weeks since, with 2-3 incidents per week. The ones the last few weeks had involved gushing blood that had taken hours to stop after holding the patient's nose. No treatment was received for the events. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (Nasal Swab) on 22Apr2021. The outcome of the events was not resolved at the time of this report.  No follow-up attempts are needed. no further information is expected.
Patient presented to ED with tachycardia, HR 140s, TSH <.006, new diagnosis of hyperthyroidism.
Seizures started 9/14/02 two wks post vaccine. Dx/hx: ventricular sept. defect, anoxic brain damage, CHF.
massive excruciating headache from eyes to the back of her head; chills; burning sensation in her veins; slept all day; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day), VACCINATION SITE PAIN (pain in the arm), CHILLS (chills) and HEADACHE (massive excruciating headache from eyes to the back of her head) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain in the arm). On 30-Apr-2021, the patient experienced BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day) and CHILLS (chills). On 01-May-2021, the patient experienced HEADACHE (massive excruciating headache from eyes to the back of her head). The patient was treated with PARACETAMOL (TYLENOL) from 29-Apr-2021 to 30-Apr-2021 for Pain, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation in her veins), HYPERSOMNIA (slept all day), VACCINATION SITE PAIN (pain in the arm), CHILLS (chills) and HEADACHE (massive excruciating headache from eyes to the back of her head) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported     This case was linked to MOD-2021-100457 (Patient Link).
Patient reports chills and muscle aches within 2 hours of receiving 2nd round of vaccine. The next morning temp of 100.3, terrible chills, terrible headache, joint pain, very sore arm and next. Didn't get off the couch the entire day. 1/21/2021 temp is 99.7, reports feeling better.
4/4/02 Mother brought child to health department with baseball sized swelling and redness in left deltoid.  Afebrile, no other symptoms. Discussed treating symptoms with Tylenol and cold packs intermittently.  Will F/U later with mother. 4/16/02 F/U with mother on telephone who states symptoms rexolved the very next day.
Fully vaccinated patient tested positive for COVID-19 on 7/21/21. Symptoms included cough, headache, myalgias, malaise. Patient was hospitalized briefly on 7/24/21 for oxygen saturations reading in high 80s range and was discharged after diagnostic testing revealed stable condition.
is going to be out 63 days out before she can get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 028L20A) with no associated AEs.
General muscle weakness and mild inflammation of right neck, with mild headache upon waking up in the morning.  Soreness at injection site first noticed on 12/25/2010 upon waking up in the morning.  The symptoms are continuing and still present with the exception of the injection site soreness, at the time this report was filed at approx. 2 PM on 12/26/2010.
pt recvd 2 doses of vax for prophylaxis;w/in 3 hrs exp hoarseness
extremely itchy rashes; itching; scratching; immune reaction; This is a spontaneous report from a contactable consumer (patient). A 71-year-old (also reported as 72years) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm on 04Mar2021 16:15 (at the age of 71years) as dose 2, single for Covid-19 immunization. There were no medical history and concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot Number: EL9261) on 11Feb2021 (at the age of 71years) for Covid-19 immunization. The patient reported she have broken out in extremely itchy rashes over her entire body in various places 2 weeks after her final shot. She has been to her primary physician about it in late March. She added that 1 week after the second shot she has had the worst rash all over. She stated it was still going on and she has an appointment with her dermatologist tomorrow. Patient stated that she has taken all kinds of over the counter medications like Benadryl. She got the second shot on 04Mar2021, the following week, around 11 or 12 Mar 2021 she started scratching like a cougar. She stated that she has used lots of over the counter things like Benadryl and Zyrtec. She stated that it doesn't bother her at any certain time of day, or on any certain place on the body. It was everywhere. Prior to the shot she did not have this issue. She went to her own doctor in the latter part of March and he said it could be from the shot, but he wasn't sure.  Stated it could be her body having an overabundance of immune reaction to the shot. The patient also mentioned that she woke up at 0300 the other day itching. She had run out of Benadryl and had to go to the gas station to get some more since it helps with the itching. She mentioned that she has scratched her skin off in places. The events extremely itchy rashes and itching required require Physician office visit. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of event extremely itchy rashes was not recovered; outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Vaccine was administered 3 days after vial expiration date. Parent notified by provider. Provider chosen not to revaccinate. Parent agreed, child doing well.
Hard lump on vaccination site that lasted 7-10 days with a little bruising and lump under armpit that I noticed about 12 days after shot.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 22 year old female who was vaccinated intramuscularly with the first 0.5 dose of GARDASIL in the left upper arm in August 2008 during her first month of pregnancy, reported in (WAES # 0809USA00445) the second dose of GARDASIL in her right upper arm in October 2008 with no other vaccines was given on this date and the third dose of vaccine on her left arm on 04-NOV-2009. Concomitant therapy included 250 mg FLAGYL for bacterial vaginosis infection and folic acid 3 weeks after the visit and the flu vaccine in her right arm. The patient delivered a male child by caesarean section due to gastroschisis 3 months ago. Child had complication gastroschisis, abdominal defect, which required surgery and a longer stay at the hospital after birth. child was being seen by specialist. Follow up information was received from the physician concerning the patient with no obstetric history as well as no medical history or concurrent conditions who was vaccinated with her first, second and third dose of GARDASIL on 05-AUG-2008, 09-OCT-2008 and 04-OCT-2009 respectively. Concomitant therapy included FLAGYL, folic acid from 07-AUG-2008 and influenza virus vaccine on 01-NOV-2008. Amniocentesis indicated that the patient had 4.5 months pregnancy (LMP: 12-AUG-2008; RDD: 19-MAY-2009). On 12-AUG-2009, at 35 weeks of gestation, the patient delivered a abnormal male baby weighting 4 pounds, 18 cm in length with head circumference of 35. The baby was born with gastroschisis. There were no complications or abnormalities for the baby. The mother had not complication during pregnancy and had complication during labor/delivery. The mother did not experienced any infections or illnesses during pregnancy. Amniocentesis indicated that the patient was at 4.5 months gestation. Other medication used during this pregnancy included. Follow up information was received from the physician via telephone on 09-NOV-2009 concerning the patient received the second pregnancy and had an outcome of a 3 month premature delivery with a baby with gastroschisis. It was reported that LMP was not known and the patient conceived sometime in February 2009, at least 2 months after receiving her second dose of vaccine. The physician arrived at this approximate date working backwards from her Cesarean delivery date of 14-AUG-2009 (also reported baby was born on 12-AUG-2009) three months "early". It was reported that the baby had had surgery (date not provided) for the gastroschisis, was still in the NICU, had gained weight and was "doing well." He also said the mother had recovered from her Cesarean she was doing fine. The reporter considered gastroschisis and abdominal defect to be disabling, life threatening and other important medical events. Additional information had been requested.
Significant hair loss on day 9 since receiving vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 at 09:15 (Lot number: 33025BD) at the age of 46 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication included: VIT D.  The following information was reported: ALOPECIA (non-serious) with onset 19Jan2022 at 08:00, outcome "unknown", described as "Significant hair loss on day 9 since receiving vaccine". Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Chest pains, shortness of breath, and sore arm. ER visit at 9:00 pm
Her glucose dropped about almost 50 points/sugar was 100 and 84; Arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 14:30 (Lot number: FF2589) at the age of 77 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Covid 19 virus", start date: Jan2021 (unspecified if ongoing), notes: she had Covid 19 virus; "Diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Lot number: FD0809; Anatomical Location: arm), administration date: 18Sep2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 13Oct2021, outcome "recovered" (17Oct2021), described as "Her glucose dropped about almost 50 points/sugar was 100 and 84"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovering", described as "Arm was hurting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Day after the shot her glucose dropped about almost 50 points. Thought something was wrong with the test strips or meter. She called her diabetic coach and was sent a Brand-new meter and strips and now it's 4 days later and it's almost back to normal. Believes it was the shot that was the problem. Usually, her sugar was between 125-135 and the first day afterwards it was 100 and 84 the next day. Tried both the old one and the new one and her numbers were still like 90. 2 days later it is back to normal. It was a 4-day span of low numbers and the only thing different was the second shot. Usually checks her sugar once or twice daily and when it was down to 84 she tested it 5 times. States it just dawned on her of what could possibly cause her drop in sugar and her arm was hurting and thought maybe it was the shot. The events did not result in emergency room or physician office visit. Illness/AE were none. Family medical history relevant to events was none. Relevant tests were none (except glucose test). No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer vaccine. Vaccination Facility Type: Pharmacy/Drug Store. Vaccine was not administered at Facility. No events after first BNT162B2 shot. Livongo glucose meter for glucose test once or twice daily. Unable to provide the NDC, UDI, Lot, or expiry for the old or new Livongo glucose meter. Unable to provide the NDC for the old Livongo test strips but provided the Lot number of 891230 and expiry of 07Sep2022. Reporter seriousness for the events was unspecified.  No follow-up attempts are possible. No further information is expected.