chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of polymyalgia in a adult female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 3 days after receiving SHINGRIX, the patient experienced polymyalgia and mobility decreased. On 5th September 2018, 8 days after vaccination, the patient experienced walking difficulty. The patient was treated with prednisone. On 6th September 2018, the outcome of the polymyalgia was not recovered/not resolved. On an unknown date, the outcome of the walking difficulty and mobility decreased were unknown. The reporter considered the polymyalgia, walking difficulty and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. All the laboratory values were found to be normal for the patient. The patient was vaccinated with the 1st dose of SHINGRIX at a local pharmacy and not at the physician office. Approximately 3 days after vaccination with SHINGRIX, the patient reported that it was an effort to lift her feet. On 5th September 2018, the patient was seen in the office and was noted that she could hardly walk or move. At the time of reporting, the healthcare professional stated that the patient had not turned to be worsened and seemed to be a little better. The healthcare professional reported that the event was due to temporal relationship between SHINGRIX administration and the onset of symptoms and also due to the lack of evidence for any other cause of patient's symptoms. Lab Comments: On an unspecified date, the patient carried out some unspecified laboratory test that showed the values as normal.
A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines).    No concomitant and treatment medication were provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master Case
Pt devel anxiety & a hypersensitivity response, including SOB following vax w/Hep B vax; pt tx w/Theophylline & DPH & recovered; No further details were provided;
Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: Code Medical called immediately. Car seat reclined.. BP 92/50, HR 40, RR18. Pt pale and diaphoretic. 1152: Pt arousing but unable to communicate clearly. BP 98/48, HR 40, RR1. Able to drink OJ, small sips.  911 activated.  1154: Pt removed from car and placed on cot awaiting EMS. 1156: Pt answering questions, remains pale and diaphoretic. BP 102/62, HR 54. Alert & Oriented X3.  1202: EMS arrived and walked pt to ambulance. BS 102, BP 114/68, HR 51. Skin warm and dry. Alert & Oriented. Pt to be transported to ED secondary to decreased Heart Rate.
Possible sz activity about 2 - 2 1/2 hours after vaccines administered. H/o sz. since infant. This episode, student "stared" for about 2 mins. Emergency personnel and Dad notified. Student transported to hosp. ER via ambulance.
Patient noted onset of diffuse abdominal pain on 2/25/21.  This was accompanied with urgency with loose stools.  Subsequently, the patient had persistent vomiting throughout the night.  She denies fevers or chills.  She has never had similar symptoms in the past.  She reports that the abdominal pain localized to the right lower quadrant.
Information has been received from a health professional concerning a female who on 13-SEP-2007 was vaccinated with her first dose of Gardasil.  On 16-SEP-2007 the patient developed a rash.  The patient sought medical attention in the office, but the details of the exam and treatment are unknown.  Additional information has been requested.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
This report was received from the investigator in a trial on 23 April 2010. A 20 year-old male subject with a history of chest pain and headaches received the following vaccines on 02 April 2009: ACAM2000 (lot number not reported); influenza split virus vaccine (manufacturer unknown, lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Five days after vaccination, the subject was diagnosed with an acute myocardial infarction, subendocardial infarction. The subject's record also included ICD-9 code 410.9: acute myocardial infarction, subendocardial infarction, unspecified site with the same diagnosis date. The subject had the following investigations: an electrocardiogram on 14 April 2009 reported as abnormal; a Troponin I level on 20 April 2009 reported as 0.04, abnormal; and an echocardiogram on 08 May 2009 reported as normal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Redness, swelling and pain at the injection site that subsided after 5 days.  Redness and swelling returned at at day 8 following the initial injection and are still present at day 14.
Immune Thrombocytopenia (ITP) diagnosis with very low platelets.  Bruising and petecchae started to develop several weeks after second Pfizer covid vaccine.
I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to get up from the toilet that I lost consciousness and fell forward. My husband discovered me laying there some time later. Before passing out I felt hot, and my ears were ringing.
Had screaming reaction while DTP. Gave booster dose as DT. Decided to give 5 year old dose as Acellular DTP. Mother called that child grumpy and crying last night. Better today but stayed home from school. No treatment
Mom states when pt got home yesterday after shots started itching all over and rash developed. Gave BENADRYL. No allergy to eggs. Not on any other medications.
Patient hasnot received 2nd dose yet; Patient got COVID positive after first dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient got COVID positive after first dose) and PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet). In 2021, the patient experienced COVID-19 (Patient got COVID positive after first dose). In May 2021, PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet) had resolved. At the time of the report, COVID-19 (Patient got COVID positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No Treatment medication was provided.
TIA experienced on 2/13/2021 upon rising from sleep/found lacuner infarct on MRI in ER on 2/13/21
Severe pain in arm and shoulder to touch and movement, fever of 101 with 600mg of Advil, nauseousness all day, exhaustion, headache for 4 days. On day 5 arm still hurts to touch and movement red splotches appear on arm and arm temperature was still noticeably hot, but pain was diminishing and fever broke. Day 6 fever headache and exhaustion are gone. Arm still is sore to the touch, and movement but significantly less. red blotches are gone from arm.
Pt requested both immunizations in same arm.  Administered approx. 1 inch apart.  Pneumovax slightly anterior; Fluzone HD slightly posterior.  Pt reports redness about size of dollar bill, extending to slightly above elbow crease.  Warm to touch.  Initiated within 24-48 hours.  Continuing 4 days past vaccination date (reported 11/20/2020, vaccine doses administered 11/16/2020).  First year getting Fluzone HD Quad (previously received FluBlok Quad).  No reactions with Prevnar 13 (10/21/2019).
The 3rd dose of Hepatitis B vaccine was administered in the student's right arm on 10/8/03.  She stated that her arm and shoulder area has had pain and soreness since that time.  Came to the clinic on 10/20/03; no erythema, swelling or tenderness to the touch in the deltoid area of her right arm.  She did complain of discomfort when she elevated the arm.  Recommended tylenol or ibuprofen for discomfort; and to call back to the clinic if the discomfort continues past 4 weeks.
Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm.  Used Tylenol or Motrin PRN for relief as well as heating pad intermittently.  After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists.  Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder.   Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.
This spontaneous report was received from a pharmacist referring an 81 year old female patient. The patient's current conditions and historical drugs included drug reactions/ allergies to erythromycin and sulfa drugs. Medical history, concomitant medications were not reported. On 07-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N013541 and expiration date 23-JAN-2019 for routine vaccination. On an unknown date in October 2017 (reported as soon after receiving the PNEUMOVAX 23"), the patient experienced  a red itchy rashe (rash pruritic and rash erythematous) that spanned from the injection site to her elbow. At the time of reporting, the patient had recovered from the events of rash pruritic and rash erythematous. The pharmacist did not mention the causality assessment between the events of rash pruritic and rash erythematous, and PNEUMOVAX 23.
sore throat; This is a spontaneous report from a Pfizer sponsored COVAX Support reported by a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her 2nd dose of Covid vaccine next Saturday but she would like to reschedule as she has a sore throat. Event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Allergy; This spontaneous report was received from a consumer via Pfizer referring to a currently 72 years old female patient. The patient's pertinent medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were not reported) for prophylaxis.         The patient was allergic to the zoster vaccine live (ZOSTAVAX). The outcome of the event was unknown. Action taken with Zoster Vaccine Live (ZOSTAVAX) was not  applicable.  The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
both glands were swollen and painful; sounded like she had bad cold; left gland was swollen from the jaw to the throat and the glands under her; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (sounded like she had bad cold), LYMPHADENOPATHY (left gland was swollen from the jaw to the throat and the glands under her) and LYMPHADENOPATHY (both glands were swollen and painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced NASOPHARYNGITIS (sounded like she had bad cold) and LYMPHADENOPATHY (left gland was swollen from the jaw to the throat and the glands under her). On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (both glands were swollen and painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (sounded like she had bad cold), LYMPHADENOPATHY (left gland was swollen from the jaw to the throat and the glands under her) and LYMPHADENOPATHY (both glands were swollen and painful) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Made me feel like someone hit me in the back with a baseball bat many times as hare as they could. Back was very sore like being in a car wreck of something. Started seeing blood in my urine and this continued until 9/22/2021 It finaly cleared up and appears to be okay now. Back still a little sore.
few days p/vax fever 107;had sz & taken to hosp;also had bad sinus infect @ time & felt maybe this or immun;
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Office visit April 29, 2021  Patient is here today for symptoms following her covid-19 vaccine. She received the Pfizer vaccine, dose #1, seven days ago. 10 minutes after the shot, she developed a hot flush. 30 minutes later, she developed a numb feeling in her throat, it wasn't hard to swallow but it felt like she had to concentrate on swallowing, heart racing, tight chest and a stabbing pain in her chest. For the last 7 days, she's felt increases and decreases in her heart rate, feels like a pounding in her chest, then a rapid beating, then slows back down. She is urinating frequently but also drinking a lot of pedialyte. She started some magnesium yesterday. She has trouble sleeping due to her symptoms as well." MD  Office visit January 25, 2022 Chest tightness  Office visit August 22, 2022 COVID-19 diagnoses  Office visit January 10, 2023 Pericarditis "HPI:  Pericarditis follow up - Patient traveled for Christmas. She developed an upper respiratory infection after being exposed to her friend's baby who had RSV. She felt nasal congestion, copious nasal mucus, fever of 102 and shallow breathing for several days beginning December 25th. She visited a physician December 29th, pulse was 145, EKG abnormal, cardiac ultrasound showed pericardial effusion, sent to ER, hospitalized for 6 days, treated with 2400mg ibuprofen daily and colchicine 0.6mg daily and Nexium. She had a cardiac ultrasound daily in the hospital with last US showing 1.1cm effusion. She saw Dr. yesterday and another doctor today at clinic. Today shows 1.6cm effusion per patient. She will see Dr. per her spouse's request this Friday, January 13th. Currently she is feeling much better but continues to have sinus congestion, pasty white mucus when she blows her nose and some chest tightness when she walks. She is worried about her immune system overreacting so often. She questions if the Covid vaccine contributed to her pericarditis. She wishes to avoid antibiotics for her sinuses at this time; she will let me know."
sick; hurting everywhere; tightness in left calf muscle; cut off circulation; ringing in my ears; soreness deep in calf; joint pain, hurt badly all over especially shoulder joints; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation) and TINNITUS (ringing in my ears) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints). The patient was treated with TRAZODONE at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), PAIN (hurting everywhere), MUSCLE TIGHTNESS (tightness in left calf muscle), POOR PERIPHERAL CIRCULATION (cut off circulation), TINNITUS (ringing in my ears), PAIN IN EXTREMITY (soreness deep in calf) and ARTHRALGIA (joint pain, hurt badly all over especially shoulder joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Eye drops For open ended glaucoma. Treatment medications included Trazodone, Aspirin.   This case was linked to MOD-2021-066572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021 added with additional events
Patient lost consciousness and was unresponsive for few minutes.  She came to and began to vomit.  911 was called immediately and the area was secured with privacy screens.  In the meantime, patient was moved to the ground to lie down on her side.  She continued to feel nauseas and out of it.  The EMTs arrived promptly and took over, once they arrived.
This is a spontaneous report from a contactable healthcare professional via a Pfizer-sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bruise at the injection site on an unspecified date. The outcome of the event was unknown.
I had a rash from chin to the chest that was red, blistered looking, and angry looking