chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short breath; Very ill/disperatly ill; Fever; Spittle like form egg whites; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill) and PYREXIA (Fever) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Disability.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Short breath) (seriousness criterion hospitalization), ILLNESS (Very ill/disperatly ill) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and SALIVA DISCOLOURATION (Spittle like form egg whites). At the time of the report, DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill), PYREXIA (Fever) and SALIVA DISCOLOURATION (Spittle like form egg whites) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) temperature was 102 that indicated fever.         No relevant concomitant medications were reported. No treatment information was provided.  Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report was received from a Nurse Practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On 23-FEB-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot # J004269 and expiration date 12-JUL-2014) (strength, dose and route were not reported). No adverse effects reported. No product Quality Complaint (PQC) was involved. Additional information has been requested.
After I was done administering the immunization to the patient, she stated she was feeling lightheaded and her eyes rolled back and she slouched over. Her mother and I were holding her up and trying to talk to her, and she urinated herself while passed out. After about 45 seconds, she came to and we gave her water to drink.
Axillary nerve palsy. Unable to abduct arm past 15 degrees. Improved on day 11 with gradual return of abduction. Resolved day 14. Observed - no treatment.
Narrative:  Contacted the patient to review rare but serious Adverse events being reported by the CDC and to review the monitoring recommendations for patients. During the conversation the patient described having a headache. Recommended that she go to nearest ER for evaluation and to let them know she had received the JJ vaccine. Also informed her PCP team of headache.
It is very hard under that spot; Skin feels prickly.; Started to have minor itching at the injection site; It is very red; Arm started to get swollen again; Feel warm; Today it feels worse; Arm feels like Its on fire if I touch on it; size of the palm of my hand.; Swollen arm; Little sore; Little warm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PAIN (Little sore), FEELING HOT (Little warm), PERIPHERAL SWELLING (Arm started to get swollen again) and INJECTION SITE WARMTH (Feel warm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PAIN (Little sore) and FEELING HOT (Little warm). On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started to get swollen again), INJECTION SITE WARMTH (Feel warm), CONDITION AGGRAVATED (Today it feels worse), VACCINATION COMPLICATION (Arm feels like Its on fire if I touch on it), PRURITUS (size of the palm of my hand.), RASH (Skin feels prickly.), VACCINATION SITE PRURITUS (Started to have minor itching at the injection site) and VACCINATION SITE ERYTHEMA (It is very red). On an unknown date, the patient experienced VACCINATION SITE INDURATION (It is very hard under that spot). At the time of the report, PERIPHERAL SWELLING (Swollen arm), PAIN (Little sore), FEELING HOT (Little warm), PERIPHERAL SWELLING (Arm started to get swollen again), INJECTION SITE WARMTH (Feel warm), CONDITION AGGRAVATED (Today it feels worse), VACCINATION COMPLICATION (Arm feels like Its on fire if I touch on it), PRURITUS (size of the palm of my hand.), VACCINATION SITE INDURATION (It is very hard under that spot), RASH (Skin feels prickly.), VACCINATION SITE PRURITUS (Started to have minor itching at the injection site) and VACCINATION SITE ERYTHEMA (It is very red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  Patient mentioned that she got the root canal done on 24feb2021 and they gave 3-4 injection of Lidocaine in that area and Nitrous oxide.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Nonsignificant Followup Appended-NNI On 03-May-2021: Non Significant Follow up-NNI
Dehydration, vomiting/ABD pain. Emergency Dept breathing difficulty. Pain if consumed food.
Information has been received from a pharmacist via a nurse on a hospital floor who wished to give a 63 year old male inpatient (with an allergy to codeine) a dose of influenza vaccine, but was unsure if she should since he developed hives in the past after receiving Pneumovax 23.  It was unknown if influenza vaccine was given.  The patient's outcome was not reported.  No further information is available.
chest pain; shortness of breath; rapid heartbeat and pulse; not feeling well; felt anxious; very tired; left arm hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 16:00 (Lot number: FC3183) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 14Sep2021, outcome "not recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "shortness of breath"; HEART RATE INCREASED (non-serious) with onset 14Sep2021, outcome "not recovered", described as "rapid heartbeat and pulse"; ANXIETY (non-serious) with onset 13Sep2021, outcome "unknown", described as "felt anxious"; MALAISE (non-serious) with onset 14Sep2021, outcome "unknown", described as "not feeling well"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "unknown", described as "left arm hurt"; FATIGUE (non-serious) with onset 11Sep2021, outcome "unknown", described as "very tired". The events "chest pain", "shortness of breath", "rapid heartbeat and pulse", "felt anxious", "not feeling well", "left arm hurt" and "very tired" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reports that on Friday her daughter was ok except her left arm hurt. On Saturday and Sunday her daughter was very tired. She was tired yesterday, 13Sep2021 as well and her daughter felt anxious. The caller let her daughter stay home from school yesterday, Monday, 13Sep2021. She told her daughter it had been over 48 hours, everything should be alright. Her daughter returned to school today and the school nurse called around 1:00PM and told the caller the daughter is not looking or feeling well.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report has been received from a healthcare worker refers to a 31 year old female patient with allergic to LORTAB. There was no pertinent medical history. On 09-JUL-2015 the pregnant patient was vaccinated with the first dose of GARDASIL (confirmed not GARDASIL 9) (dose, frequency, route, lot # and expiration date were unknown) (inappropriate schedule of drug administration). There was no concomitant therapy. On 10-JUL-2015 (the reporting day), the patient was gestation 26 weeks. The last menstrual period (LMP) was estimated as 09-JAN-2015 and estimated date of delivery (EDD) was on 16-OCT-2015. At the time of reporting, the patient was in the office and no lab diagnostic studies were performed. The pregnancy outcome was unknown. No adverse symptoms were reported. Additional information has been requested.
This spontaneous report as received from an office manager refers to a female patient of unknown age with diabetes, hypertension, smoker, anxiety, fatty liver, and reflux disease. The office manager reported the patient who was vaccinated with 3 doses of RECOMBIVAX HB experienced injection site pain. The first and second dose of RECOMBIVAX HB (unknown lot # and expiration dates) were given on unspecified dates. The third dose of RECOMBIVAX HB (lot # L042846, unknown expiration) was given on 22-AUG-2016. Concomitant therapies included LIPITOR, Hydrochlorothiazide (+) Lisinopril and metformin. The patient experienced injection site pain after the first dose and the pain continued to linger one month after the third dose. The injection site was described to have redness and swelling. The patient cannot move her arm. The patient did not seek medical attention for the adverse reaction, however, she reported it to the physician during her regular visit on 11-OCT-2016. There were no lab diagnostics studies performed. The outcome of movement disorder, infusion site swelling, injection site erythema and injection site pain was reported as not recovered/not resolved. No further details were provided. Additional information has been requested.
Had chills this morning and was cold and tested positive for COVID; she received the Pfizer Covid19 booster vaccine months ago and has tested positive for Covid today; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Sep2022, outcome "unknown", described as "Had chills this morning and was cold and tested positive for COVID"; DRUG INEFFECTIVE (medically significant) with onset 19Sep2022, outcome "unknown", described as "she received the Pfizer Covid19 booster vaccine months ago and has tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: has tested positive for COVID today.  Clinical course as follows: patient received the Pfizer COVID19 booster vaccine months ago and has tested positive for COVID today. Caller states she is driving in the car on the way to pick up her grandson from school and is asking "am I still contagious if I wear a N95 mask". Serious was reported as No. Got booster of Pfizer COVID vaccine months ago. Had chills this morning and was cold and tested positive for COVID. Called before last year regarding her vaccines. Now this morning when she had this problem her daughter and son-in-law don't have anyone to pick up her grandson. Called Pfizer to see if ok to pick him up. Caller mentioned that she already completed her primary series and booster shots for Pfizer COVID 19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil.  The patient developed a swollen gland under her arm two weeks after receiving a dose of Gardasil.  As of 30-AUG-2007, the outcome of the patient's swollen gland was unknown.  The patient sought medical attention.  No further information is available.
thursday night I starte dto develop flu like symptoms- cold sweats, upset stomch, bpdy aches, pain in injection site. started to develop an itchy, red area on the left side of my rib cage with a small node under the skin on friday midday. The itchy site grew along my rib cage on the left and spread. I went to an urgent care center and was diagnosed with Shingles on Tuesday May 4th and started an anti viral that evening.
Pt woke up with rash all over body, red itchy, raised bumps, fatigued, declines fever, had low grade fever @ appt today of 100.5.
Red bump appeared 3 days after immunization. It got larger each day then a rash spread to other areas of the body after 5 more days. Patient went to urgent care and was given prednisone/BENADRYL.
This case was reported by a nurse via call center representative and described the occurrence of local reaction in a female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related SHINGRIX. Additional details were provided as follows: This case was received via click to chat forum. The age at vaccination was not reported. The healthcare professional reported that she had the patient who received their dose of SHINGRIX and had a local reaction. No further information was reported.
This spontaneous report was received from the registered nurse regarding a 15 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 17-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
2 circle rash one on chin n one on chest.; Itching all over body; Tongue felt heavy; Tongue swollen; Difficulty breathing normal at night; Headaches; This is a spontaneous report received from a contactable health care professional, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. No relevant medical history was provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. On 18Mar2021 at 23:00, the patient experienced 2 circle rash one on chin and one on chest, itching all over body, tongue felt heavy and swollen, experienced headaches for 2 days and difficulty breathing which was normal at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received as a result of the adverse events. The clinical outcome of event headache was resolved while the outcome of events spot-like rash, itching, tongue discomfort, swollen tongue and difficulty breathing was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fast beating heart beat, shortness of breath, tingling in face, lips, arms and legs and feet. Instant Dry mouth with tongue discomfort. Blurry vision, instant headache. Feeling like a floating feeling, feeling dazed.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 2nd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient had a red raised puffy area about 6 inches under where vaccination occurred which was super itchy, burns, and felt hot.
Fairly uncomfortable, "splitting"  headache in front and sides of head.  Nausea, muscle aches, chills and sweats.  Lasted for 1 day as moderately intense symptoms and 1 additional day at less intense symptoms.    No treatments or medications used for symptoms.
A report has been received from a Health Professional concerning a 31 year old, Female subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 17-Sep-2013. The patient was administered two full doses of FLUMIST, one in each nostril which started on 17-Sep-2013. The outcome of the event of two full doses of FLUMIST, one in each nostril is unknown. The report was considered to be non-serious.
Starting in the middle of the night feeling feverish, sore left shoulder.  Checked temp at 6AM was 101.4  I believe this is normal but was told to report any symptoms
Patient started to exhibit chest pain on 12/31/21. Mom said he felt like he was having a heart attack and trouble breathing. He was taken to ER and diagnosed and treated for Myocarditis.
The day following administration, a red raised rash with some white centers developed.  It was a fixed rash. It started on her chin and chest and eventually included some papules (red) on her legs.  She was fussy.  Appetite and Bowel movements were normal.  There was no Darier's sign, no fever,no mouth sores.  No rash 5/2.
Redness, heat, swelling, and pain, gradually spreading to about 6" diameter from injection site across elbow and arm lasting about 5 days.
15 mins. after vaccines given broke out in rash on upper arm, upper chest. no other symptoms. Advised to given Benadryl if gets worse to call MD
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received 2 doses of Pfizer Covid vaccine in May 2021. Patient presented with covid-19 pneumonia and admitted on 1/1/2022 signifying therapy failure.   59 yo M with Hx smoking, hypertension, headaches who presented to the hospital with shortness of breath, cough, fevers. Found on arrival to the emergency department COVID positive. Vaccinated, though no booster yet No known allergies
pt recvd vax; fever, erythema,edema, induration at inject site; onset several hrs p/ vax;
Flu like symptoms; Headache; muscle aches; nausea; elevated heart rate; This is a spontaneous report from a contactable consumer (Patient himself). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:30 (Batch/Lot Number: EL3247) as 2nd dose, single for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm right (Batch/Lot number: EL3247) on 26Jan2021 12:30 PM as 1st dose, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021 23:30 the patient experienced flu like symptoms, headache, muscle aches, nausea, elevated heart rate. No treatment was taken for the event caused. The patient underwent lab tests and procedures which included heart rate results elevated on 16Feb2021. The outcome of the events were recovering.  Follow-up (24Feb2021): This is a follow-up spontaneous report received in response for the first awareness date of the adverse events caused by Pfizer COVID-19 vaccine and the response included with event onset date. (16Feb2021).
Client came to clinic to receive booster. He was screened by registration desk via system. Although there were several COVID vaccine listed for this patient, the registration staff only wrote down the first 2 Moderna doses, onto the form that goes to the vaccinator. The vaccinator reviewed the CDC screeing checklist as well as the information on any previous doses given to the vaccinator, and the patient did not inform the vaccinator that there were more that the 2 Moderna doses given. He was given a booster dose of Moderna. So in total, he had received the following: primary series of Moderna on 3/3/21 and 3/31/21, Janssen on 5/6/21, Janssen on 6/3/21, and then a Moderna booster dose on 11/24/2021. He did not have any adverse outcomes with this booster dose as of today which is 12/1/2021.
Patient reported a red warm rash going down arm from deltoid down past elbow, noticed at 9/12/15 9:00 pm, saw primary physician on 9/14/15 & was diagnosed w/adverse reaction. Started KEFLEX & prednisone.
Received vaccines on 11/5/18. Since back in office on 11/9/18 with C/O knot on head that came up 24 hrs after vaccines. No injury. Full fontanelle. U/S head on 11/9/18 normal.