chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief History: Patient is an 84-year-old male. He is a resident of assisted living. He was diagnosed with COVID at least 3 or 4 days prior to admission.. He fell at assisted living. He was brought to the emergency department and subsequently admitted. He does have advanced COPD. Hospital Course: Patient was admitted and even though he was diagnosed with COVID his CT chest and CXR did not show any signs of this. So he was not treated with remdesivir - However, he was started on steroids, antibiotics, nebulizer treatments - typical COPD treatment. He continued to have high oxygen requirements, using significant accessory muscles to breath and agitation.He did require both morphine and ativan for this. Mutliple converstaions with family lead to family coming and determining comfort care. On 9/28/21 we withdrawaled care. Her son and daughter were both at bedside. He passed peacefully the early morning of 9/28/21 with family at his bedisde.
Daughter called to inform us that patient had a forgetful episode after H1N1 injection. She seems to be ok now (12/30/09) she's fine as of 1/7/10.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
phone call from grandma then father of child reporting pt has swelling lt arm from shoulder past elbow;unable to see elbow d/t severe swelling;
1 single nodule right below my hair line on head or neck  about 1 inch and has been there for one year as I write this. Had taken flu shots for about 15 years , no adverse event.
I got the shot, and still got it/Suspected vaccination failure; Still got it/I got the shot, and still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the shingles shot and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
booster dose administered today; patients were given a dose of the Pfizer COVID Vaccine that was not diluted first; patients were given a dose of the Pfizer COVID Vaccine that was not diluted first; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team for a Pfizer sponsored program. A contactable other HCP reported similar events for 4 patients. This is a 2nd of 4 reports.  A 67 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FH8028) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of the Pfizer COVID Vaccine, lot number EN6202, route was intramuscularly to the patient's unknown side.), administration date: 24Feb2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (2nd dose of the Pfizer vaccine , lot ER2613 , route was intramuscularly to the patient's unknown side.), administration date: 17Mar2021, when the patient was 66 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster dose administered today"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "patients were given a dose of the Pfizer COVID Vaccine that was not diluted first".  Additional information: Patients were given a dose of the Pfizer COVID Vaccine that was not diluted first. Reporter states she had a caller on the line who mistakenly gave three patients a dose of the Pfizer COVID Vaccine that was not diluted first and she was asking for guidance on what to do; states she gave the caller the contact information for Pfizer. Reporter verified the information provided by the transferring agent and clarified to state that four patients were administered the Pfizer COVID Vaccine that was not diluted first. States this patient had the 3rd dose or booster dose administered today and it was the dose that was not diluted and states the patient had the 1st dose of the Pfizer COVID Vaccine on 24Feb2021 with lot number EN6202, the 2nd dose of the Pfizer vaccine on 17Mar2021 with lot ER2613 and the booster dose administered today 19Nov2021 with lot FH8028; states she does not knew the location of administration but the route was intramuscularly to the patient's unknown side. Reporter had 4 patients who were mistakenly giving a dose of Comirnaty that was not diluted. Patients are a 62-year old male, a 67-year old female, a 28-year old male, and a 66-year old male. Reporter wanted guidance regarding this error. As per Reporter, the 28-year old male was not given an incorrect dose. Reporter mentioned all doses were the 3rd dose of the patients.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101624862 similar report from same reporter
Fifteen minutes after vaccine administration, parent stated patient was having a reaction.  One hive noted on patient's left cheek and erythematous patches observed on patient's face, neck, chest, and abdomen.  No difficulty breathing noted.  Hive on left cheek resolved within 5 minutes.  Provider ordered diphenhydramine 4 ml every 6 hours by mouth as needed for hives if they return and parent was advised to call 911 or go to the ER for any reaction beyond a few hives to include difficulty breathing, etc.
sore lt arms-arm sore since 3NOV93 soreness from top of arm to wrist;
headache; mild body aches; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730), via an unspecified route of administration, in Left arm on 25Mar2021 at 10:30 (at the age of 55-year-old) at a single dose for COVID-19 immunization. Medical history included allergies to septra and penicillin. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ELJ1685), via an unspecified route of administration, in Left arm on 04Mar2021 at 10:30 am at a single dose for COVID-19 immunization. The patient was vaccinated at Workplace Clinic and was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced headache, mild body aches and was very fatigued the morning after vaccination on 26Mar2021 at 06:00 am. The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events was recovered at the time of report (26Mar2021).  No follow-up attempts are possible. No further information is expected.
Day after: headaches, high fever (100.5 ), vomiting, anorexia, lac, of appetite, pelvic pain, severe body aches, neck stiffness, fatigue Long term: tachycardia, pelvic pain, headaches,  feet turn blue and feel cold, fatigue.
Information has been received from a physician concerning a patient with diabetes, cirrhosis, hypertension and hyperlipidaemia and no allergies, who on 06-NOV-2008 or 07-NOV-2008, was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 662599/1076X). Concomitant therapy included INSULIN R, LIPITOR and Lisinopril. On 10-NOV-2008 the patient went to the ER and was hospitalized for pneumonia. Laboratory diagnostics includes a white blood cell count of 39,000 and a chest x-ray. Additional information has been requested.
On 8/30/2013 patient presented to employee health clinic complaining of pain in left arm deltoid area where she had received MMR shot and felt swollen to her.
Patient reports lip numbness and swelling treat with prednisone and benadryl in ED.
A report has been received from consumer, concerning a male patient on 20-Jun-2013, height: 28.0 inches; weight: 16.0 pounds (child case). The patient's medical history and concomitant medications were not reported. On 13-Dec-2003, the patient's mother started receiving treatment with nasal FLUMIST (intranasal). The patient, a consumer, reported that she received FLUMIST while breast-feeding her son. The patient stated that both she, and her husband, received FLUMIST on 12/13/02 as recommended by their physician and her son's pediatrician. The patient stated that while breast-feeding, she normally received Prenatal vitamins and MICRONOR for birth control. No adverse events were associated with FLUMIST at the time of this report. The patient stated that her son was scheduled to receive his routine childhood vaccines for 6 months olds, on the week following this report. The outcome of the event of was it ok to receive FLUMIST even though I am nursing was unknown. The report was considered to be non-serious by company physician.
Ecchymosis to r upper arm at injection site. Denies swelling denies limitation or pain with rom in r arm and shoulder. ROM r shoulder intact.
p/vax pt exp stomach cramps, n/v, dec BP & presented to ER;pt tx for dehydration w/IV fluids;toxicology report was negative;pt recovered;report considered an other medical event. Information has been received from a physician concerning a 29-year-old male who on 11-AUG-1999 was vaccinated SC with one dose of VARIVAX in the right deltoid. On 14-AUG-1999 the pateint experienced stomach cramps, nausea, vomiting, decreased blood pressure and presented to an emergency room. The patient was treated for dehydration with IV fluids. A toxicology report was negative. The patient recovered and was released from the emergency room. Upon medical review, this report was considered an "other medical event." No further information is available.
firey red, raised urticarial rash appeared on trunk & extremities on afternoon of the vax; rash disappeared over noc & returned in AM on 30MAR93;
Felt like someone punched me in the center of my chest. Staff infection showed up on lower shin,  Difficult breathing. Felt like a heart attack after a couple of weeks, declining every day. Walking went from 5 miles a day 6 days a week to being unable to walk 10 feet without catching my breath. Working out 3 days a week, 30 minutes a day, unable to workout 10 minutes lite weights
Immunization was given at 11:45 am. Patient started to feel like her throat was closing up around 5:00 pm. She also had dizziness and shortness of breath.
I had COVID on 7 April 2020. My symptoms were fever, severe coughing, light headed and passing out, shortness of breath. I couldn't taste or smell anything. Severe cold and memory affected. After COVID I still have brain fog. I sometimes still cant smell and taste comes and goes. Still light headed and weak off and on and my vision is getting bad. For 2 or 3 months before seeing the doctor I had problems with my breathing. On 24FEB2022 I saw my doctor and was diagnosed with Asthma.
Blood in stools; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stools) and DIARRHOEA (Severe diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe diarrhea) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HAEMATOCHEZIA (Blood in stools) (seriousness criterion medically significant). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, HAEMATOCHEZIA (Blood in stools) and DIARRHOEA (Severe diarrhea) had not resolved.            Concomitant medications included High blood pressure medication and Cholesterol medication. Treatment medications included antibiotics along with above mentioned medications. Patient has a colonoscopy scheduled. Patient had another episode of diarrhea on 21-MAY-2021. Action taken with mRNA-1273 in response to the events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Mom reported pt cried all noc; cries reported as scrreaming; unk fever; 10JUL92 MD started Amoxicillin; 13JUL92 pt is well, giving ATB as directed;
Information was received from a physician concerning his son with no pertinent medical history, who previously, at 15 months of age was vaccinated with his first dose of varicella virus vaccine, live (oka/Merck0. Subsequently the child experienced a 1 centimeter ring of vesicles around the injection site. the physician did not consider the event to be serious because the child did not experience fever or other symptoms. The child was recovered at the time of the report. No further information was provided. There was no product quality complaint
Heart palpitations; Rash on right arm; Itching; This is a spontaneous report received from a contactable consume(patient). A 65-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 20Feb2021 (at the age of 65-years-old) 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history is reported as none. The concomitant medications were not reported. The family medical history relevant to AE(s) was not provided by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. It was reported that no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same Date of the Pfizer Suspect. The Historical vaccine taken was first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: PFR, EN5318, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 28Jan2021 between 10 am and 1pm, midday, during the day(at the age of 65-years-old), and experienced a breakout of a rash on the arm where she was given the injection, it then went away and getting scabs and lesions, within 24 to 48 hours, after the first vaccine. On an unspecified date after her second dose, the patient experienced Rash on right arm and Itching, right arm and she also experienced heart palpitations on an unspecified date. The reporter reported many details, which included that she works out, eats well and is in tune with her body she is aware of the palpitations, and attributes that to the vaccine states she had read documentation that heart arrhythmia is being noted as a side effect of people who have gotten the vaccination and stated that she is unsure of the exact date, but it was close to the time of the second vaccine on 20Feb2021 she thought it would go away over time, but she is still getting palpitations, the rash as it started with the first vaccine and then went through until after the second vaccine it went away, but stayed for a good month. She wants to clarify that the rash was all the way down her arm and states she still has a little bit of the rash left on her forearm, but it is very minimal and itching after first and second vaccine, stated as approximately early evening as it is very minimal on her right arm and as it was lingering. The AE(s) did not required the visit of Emergency Room or Physician Office. The relevant tests are reported as none. The outcome of all the events was reported as resolving.  Follow-up attempts are possible. Further information is expected.
fatigue beginning 18 hours after vaccination ending  39 hours after vaccination, body aches beginning  40 hours after vaccination ending  41 hours after vaccination--took advil; no fever
29-year-old, RHD, female presents with bilateral arm pain since end of July.  Left arm pain began roughly 25 July few days after COVID vaccination.  Began with pain than slight indentation was noticed that progressively worsened.  The indentation progressively has grown with new symptoms of numbness going from indentation to elbow on the lateral aspect.  Right arm pain began first week of August few days after COVID vaccine.  This began with pain and slight indentation that has progressively worsened.  No neuropathies of right arm.  Denies any loss of strength or neuropathies from elbow down.
Patches of swelling 8 inches round about 4 inches from injection site. Red swelling, some hardness and pain.
This spontaneous report was received from a physician referring to a 4 month old infant patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-FEB-2018, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly, for prophylaxis (lot # and expiration date were not reported). No known adverse effects were reported.
Patient was given a Prevnar-13 vaccine when a Pneumovax 23 vaccine was indicated and ordered by the provider. Patient was not due for a Prevnar-13 vaccine at time of administration.
Patient received the COVID vaccine at clinic.  While being monitored, patient stated that his "throat felt scratchy".  Patient was administered 50mg of Benadryl.  Blood pressure was 159/87. Patient was monitored for 45 minutes.  Patient stated that his throat no longer felt scratchy.  Patient's wife was able to drive him home.  Patient was advised to follow up with PCP and go to ER is symptoms returned.
Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; March 8th or 9th had episode of heart fluttering that lasted about 1 minute; faint; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021 at 15:00 (at the age of 39-year-old), as dose 1, single in left arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included hypertension. Concomitant medications in 2 weeks included lisinopril, hydrochlorothiazide and simvastatin; all taken for unspecified indications, start and stop dates were not reported. Patient had no known allergies. The patient was not diagnosed with COVID, prior to the vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks after COVID vaccine. On 08Mar2021 or 09Mar2021, the patient experienced episode of heart fluttering that lasted about 1 minute. Was fainted, sat down, and went back to normal. On 15Mar2021 at 11:30, he went into sustained VTAC of 223 and was in VTAC for an hour. ER revived rhythm. Patient had three ICD/Defibrillator surgeries later and shifting diagnosis from AVRC to cardiac sarcoiditis. Any uncertainty on sarcoiditis leads to a vaccine driven event or awakening of a past virus or harm. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 4 days due to the events. The events were considered as life threatening illness (immediate risk of death from the event), with disability or permanent damage. Therapeutic measures were taken for events which included ICD Implantation and then a cardiac CRT implant. The clinical outcome of the event heart fluttering was resolved on an unspecified date in Mar2021 and the clinical outcome of all other events was not resolved.  Information on the lot/batch number has been requested.
A spontaneous, non-serious report of nausea, vomiting and diarrhea has been received from a nurse practitioner, concerning a 42-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 22-Sep-2009, the patient received FLUMIST. On 25-Sep-2009, the patient presented to the emergency room (ER) with nausea, vomiting and diarrhea. A rapid flu test was negative. The patient was sent home the same day and has recovered from the events. The outcome of the events, nausea, vomiting and diarrhea, was resolved. The reporter did not believe the patient's illness was related to FLUMIST.
a patient received an expired Act-Hib vaccine/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a patient (age and gender not reported) was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] via unknown route at an unknown administration site (lot number: UJ033AAA and expiry date: 22-Apr-2020) on 23-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Pt had a vasovagal event s/p Pfizer vaccination. Pt ws observed and vitals taken for 60mins. Paramedics called and was deemed fine following evaluaation. pt delined to go to hospital.  Pt stated she felt better and release from vaccination site.
Strong localized reaction for approximately 48 hours hot, swollen, gray center & reddened outside injection site to about 3-4 in. diameter. Strongest reaction around 36 hrs. Started around 24 hr.