chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; hot; swelling rash; red; Arm hurt for two days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (hot) and PAIN IN EXTREMITY (Arm hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (hot) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR: Outcome of the events are Resolved & 2nd dose received was mentioned
After seasonal flu injection in left deltoid became pale with slow HR and low BP. She complained of being 'lightheaded' after injection sitting with head down. Patient is very pale, pulse slow and weak. 1430 BP 82/50 68HR, RR22 patient feels less 'dizzy' color less pale-lips pink. 1437 BP 100/68, 72HR RR20. 1450 BP 100/68 64HR RR20. 1455 facility called regarding adverse reaction. 1515 Forms completed BP 106/72, HR 62, RR20. Patient color is good, pulse strong, no complaints 'lightheadedness'. Patient instructed to call 911 or go to an emergency facility if symptoms return.
2 days afterwards she was unable to lift more than 10 degrees; Believes Vaccine was administered improperly, saying it hit her shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Believes Vaccine was administered improperly, saying it hit her shoulder) and VACCINATION SITE MOVEMENT IMPAIRMENT (2 days afterwards she was unable to lift more than 10 degrees) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Believes Vaccine was administered improperly, saying it hit her shoulder). On 29-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (2 days afterwards she was unable to lift more than 10 degrees). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Believes Vaccine was administered improperly, saying it hit her shoulder) and VACCINATION SITE MOVEMENT IMPAIRMENT (2 days afterwards she was unable to lift more than 10 degrees) outcome was unknown. Not Provided
Stabbing heart pain; Huge blood pressure increase; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase). At the time of the report, CHEST PAIN (Stabbing heart pain) and HYPERTENSION (Huge blood pressure increase) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) huge blood pressure increase.         Patient had stated that he was an one of the young men who have experienced events and his specialist had told him that he should never had gotten it.  No concomitant information was reported. No treatment information was reported.
injection site itching; rough patich (on top of inj site); clear rash,little bubbles; large circular place; hard; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (large circular place; hard), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE PLAQUE (rough patich (on top of inj site)) and INJECTION SITE RASH (clear rash,little bubbles) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L02A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE INDURATION (large circular place; hard). On an unknown date, the patient experienced INJECTION SITE PRURITUS (injection site itching), INJECTION SITE PLAQUE (rough patich (on top of inj site)) and INJECTION SITE RASH (clear rash,little bubbles). At the time of the report, INJECTION SITE INDURATION (large circular place; hard), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE PLAQUE (rough patich (on top of inj site)) and INJECTION SITE RASH (clear rash,little bubbles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
At 12:55 pm 10 minutes following vaccine being given states feeling lightheaded and flush. Was sitting in the chair.  Encouraged him to lay down on the floor which he did on his own. Feet elevated.  BP 174/70 pulse 82.  Denies any other complaints.  Laid on floor for 15 minutes then sat in chair. Denies complaints. 1:15 pm was allowed to leave. BP 120/80 and states feeling fine.
shakes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US084984.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "shakes".  Additional information: Patient mentioned that the shakes was started when she got the COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; General unwell feeling; Pain in the left arm where the vaccine was injected; High fever (98); This is a spontaneous report from a contactable consumer. This 39-Year-old male consumer (patient) reported that:  A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 24Mar2021 at 13: 45 (at the age of 39-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, calcium gluconate, proteins nos, silicon dioxide, colloidal, zinc gluconate (IMEDEEN [ASCORBIC ACID; CALCIUM GLUCONATE; PROTEINS NOS; SILICON DIOXIDE, COLLOIDAL; ZINC GLUCONATE]) taken for an unspecified indication, start and stop date were not reported and both medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 01Mar2021 10:30 (at the age of 39-years-old) as dose 1, single for COVID-19 immunization. On 24Mar2021 at 23:30 patient experienced pain in the left arm where vaccine was injected, high fever (98) and later after 12 hours on 25Mar2021 at 01:45 had headache, general unwell feeling. The patient did not receive any treatment for AEs. The patient underwent lab tests and procedures which included body temperature: 98 on 24Mar2021, sars-cov-2 test (Nasal swab): negative on Dec2020, sars-cov-2 test (Nasal swab): negative on Jan2021 and sars-cov-2 test (Nasal swab): negative on Feb2021. The clinical outcome of the events was recovering.   Query: The Regulatory Agency recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines.  Response: Awareness Date: 24Mar2021 (As the patient, it is when I became aware of the reported events).  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 15 month old male who in approximately 2005, (about 3 years ago") was vaccinated subcutaneously with the 1st dose of MMR II. In approximately 2005 the patient experienced very bad rash. The patient was treated with steroids. Subsequently, the patient recovered from very bad rash and it was considered to be disabling. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. Follow-up information received by the nurse practitioner indicating that the patient was actually a 1 year old female (initially reported as male) who on 03-May-2005, was vaccinated subcutaneously with the 1st dose of MMR II (lot#649225/0938P). On 12-May-2005, approximately 10 days after the vaccination, the child experienced morbilliform rash (initially reported as "bad rash") and a fever. The patient was treated with prednisone and the patient recovered 4 days later. It was initially reported that the AE's were considered disabling, but it is now a non-serious report. Further information is not expected.
Redness about 1 1/2 inches around injection site, edema to right arm, r side of neck, r breast, r shoulder, temp 99.3, increased blood pressure.     Patient went to primary care physician. She was then sent to the ER. She was Covid (+) in July 2020
Woke up at 6AM, felt warm to dad. Grand mal seizure x 3-4 minutes with 2hr postictal state followed by complete return to baseline in 3hrs post seizure. Medical Record received on 1/3/2005 states fever.
I95.9 HYPOTENSION 6/17/2022 PANCREATIC CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 6/17/2022 ASTHMA, UNSPECIFIED
Started feeling arm pain, later in the evening chills. Calves were sore for 2 days. Started itching, very red. the inj site is hard, warm on the inside, lower back pain. Got cycle 2 weeks early.
On 11/8/21 I had a itch ring patch on my arm that I didn?t think much about. Today on 11/12/21 I have a bright red ring around the area that is the size on my palm. No hot or pain to us at of right now but it is very large. Pharmacy recommended I fill this out.
Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022; Dose administered to 2 patients 20 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 076C21A, 008B212A and 026A21A) for COVID-19 prophylaxis.     The had never had COVID and test or diagnosis.  Concurrent medical conditions included Sulfonamide allergy and Drug allergy (Oxycodone).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that the 2/1 vial was initially stored in refrigerator on 17-Jun-2022, was first punctured on 23-Jun-2022 at 09:49 AM and was administered on 24-Jun-2022 at 09:25 AM and 09:30 AM. Post puncture the vial was left at room temperature for 23.5 hours. The vial did not undergo any temperature excursion. It was mentioned 3rd dose was administered on 03-Mar-2021.  Treatment medications were not provided.
Patient wife just called and wanted us to report the event- said patient got rash all over the body which was noticed the next day morning when the patient woke up (with in 24 hours of 2nd vaccine) and since then its been like that . Patient went to multiple doctors and its still been not resolved yet. The patients body has rash, inflamated and raised skin per patient's wife
Woke up in the middle of the night to use the bathroom and I couldn?t see properly; my vision looked like black splotches. I felt faint and dizzy and couldn?t see my bed to lay down. After laying down, my head and body was tingling. I was sweating but felt cold.   I took 2 hydroxyzine and fell asleep. I woke up fine but with body aches. The body aches continued through the day but I took acetaminophen and the body aches went away.
I felt very fatigued the following three days after the vaccine.   The adverse event was a red/swollen/hot to the touch pea size lump at the injection site.
Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion.  09:00 am to 1:50 pm:  Slept with profuse sweating.     Friday 4/09/21 at 12 midnight:  Fever with ears red and burning.  Applied wet cold towels on body.  Vomited once, followed by dry heaves. 10: 00 am Nauseous.  Checked temperature with ear thermometer- afebrile.  Checked oxygen saturation with pulse oximeter- 96% HR 35.  Checked pulse manually with a range of 39-44 and irregular.
This spontaneous report was received from a medical assistant concerning an approximately 22 year old female patient with asthma and latex gloves allergy. The medical history of the patient included chickenpox and migraines. On 13-JUN-2013, at 4:00 pm, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as H021346 and 01-OCT-2015 respectively), intramuscular. Concomitant therapies included contraceptives (unspecified) and vitamins (unspecified) (reported as multivitamins). On 13-JUN2013, by 08:00 pm, her lips and face were swollen. She took BENADRYL with good results. It was reported that there was no shortness of breath. The patient sought medical attention. The patient presented to the office the next day (on 14-JUN-2013) and she was examined. Her upper lip was still slightly swollen. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Patient received 2 doses of the fluAD. 1st dose: 8-28-2021 and 2nd dose: 10-19-2021
TIREDNESS; CHILLS; ARM SORENESS; FEVER; ACHINESS; LOW ENERGY LEVEL; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on Left Deltoid. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On MAR-2021, the subject experienced low energy level. On 24-MAR-2021, after 10 hours, the subject experienced achiness about. On 24-MAR-2021,after 12 hours the subject experienced fever. On 25-MAR-2021, after 12 hours the subject experienced chills. On 25-MAR-2021, the subject experienced arm soreness. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness on 26-MAR-2021, and chills, and fever on 25-MAR-2021, was recovering from tiredness, and arm soreness, and the outcome of low energy level was not reported. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On an unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (Lot # H021346, expiration date 01-OCT-2015) (dose and route not reported) on schedule. The medical assistant reported that the patient missed the third dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
10/26/21 presents to EC ED after syncope; PMHx most significant for HTN, hypothyroidism, had a recent mild COVID-19 infection on 10/7/21.
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 7th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a medical assistant. The patient developed a rash (unsure of timing).
The high dose flu vaccine was given to person who is under 65 years of age. This is a vaccine administration error.
developed chest pain,  heart rate increase and blood pressure increase.  Chest pains lasted about 2 weeks but baseline heart rate went from resting average of 65 to resting in mid to high 80s and increased with light activity to over 110, this has continued even now several months later.  Blood pressure when from average baseline of about 125/78 with 12.5 mg of Losartan taken for renal protection to requiring 75-100 mg daily with persistent BP of 150/100 or higher.  this has resulted in ER visit.  These numbers have not normalized.  I am now taking Losartan 50 mg and Toprol 25mg daily.    The chest pain happened after the second injections on 2/2/21 also about the exact same time frame.  it was positional like a pericarditis type pain.  Both time the Chest pain resolved after about 2 weeks.  the heart rate and blood pressure are still elevated, heart rate is coming down but BP is still volatile.  I did not think the first time was the vaccine but then it happened again exact same time frame after dose 2.  I am now convinced this was absolutely a vaccine reaction.
Gave vaccines, pt. was nervous, I left the room so pt. could get dressed.  MOP said pt. got up to change and pt. fell back.  Pt. was pale.  We laid her down in the bed, gave her water and checked vitals.  Was checked by physician after and was cleared to go home.  Ok.
some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days; some swelling around his face and jaw; lump is numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb). At the time of the report, SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       healthcare professional  has ordered to perform  an ultrasound on 23-APR-2021  no relevant concomitant product was reported  no treatment product was reported
Pt developed left leg redness and swelling one day after receiving vaccines. Lip swelling also noted.
got kinda sick a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got kinda sick a little bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got kinda sick a little bit). At the time of the report, ILLNESS (got kinda sick a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment information was reported.