chrisvoncsefalvay/vaers-outcomes huggingface dataset:
asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (asthma). At the time of the report, ASTHMA (asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using  budesonide-formoterol combination  (160/4.5mg), montelukast and inhaler (name Unknown) was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Not significant- Patient declined further contact.
raised red rash on upper thighs upper rt arm & lt lower arm that started on 18AUG93; broke out again on 23AUG94;
Patient presented to the ED on 3/9/2021 with chest pain, headache, and brief blurred vision. There was no signs of stroke or MI event. Reason for admission: chest pain.
doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022.  No treatment drug information was provided.   This case was linked to MOD-2022-576251 (Patient Link).
Moderna COVID-19 Vaccine EUA 03/15/2021 around 9 p.m.: fatigue;  03/16/2021 around 12:30 a.m.: headache, chills, feverish; around 4:30 a.m.: nausea; all symptoms resolved by 03/17/2021 without treatment..  03/17/2021 around 12:30 p.m. observed red rash on right arm, resolved within 24-48 hours without treatment.
Felt burning sensation to area in her spine starting @ 2200 on date of vaccine that appears worse today and having a hard time lifting both arms to do things secondary to pain, she denies numbness
Swelling in right tricep down to the elbow. Black and blue. First four days after I had the shot, my right arm was numb down to my fingers.
Narrative: COVID infection following COVID vaccine series 04/02. Pfizer dose #1 04/23, Pfizer, dose #2 1/1 COVID swab, result: detected 12/21 pt cc: cough, exposure: unknown 1/1 pt admit Medicine cc: SOB, CP dx: Covid Pneumonia AFIB RVR LOS: 4 days 12/31 COVID swab, result: detected 1/1 CTA PE IMPRESSION: 1. No acute pulmonary emboli. 2. Findings of mild pulmonary edema. Superimposed infectious/inflammatory process possible. 1/1 CXR IMPRESSION: No evidence of acute cardiopulmonary abnormality. 1/1 TROPONIN I: 0.023 1/1 BNP: 129.8 1/1 TROPONIN I: 0.025 1/2 FIBRINOGEN: 352 1/2 FERRITIN: 150.7 1/2 SARS COV-2 IGG: 0.21 1/2 PROCALCITONIN: <0.05 1/2 DDIMER: 0.48 1/2 BNP 282.7 1/2 SARS-CoV-2 (COVID-19): 833.1 1/2 LACTIC ACID: 0.84 1/2 FIBRINOGEN: 336 1/2 DDIMER: 0.38 1/2 ESR: 26 1/3 FIBRINOGEN: 436 1/3 DDIMER: 0.47 1/3 ESR: 39 1/4 FIBRINOGEN: 311 1/4 DDIMER: 0.36 1/4 ESR: 23 1/5 FIBRINOGEN: 280 1/5 DDIMER: 0.42 1/5 ESR: 22 1/6 clinically resolved 1/10 COVID swab, result: detected
COVID-19 TEST POSITIVE; This spontaneous report received from a health care professional concerned a 46 year old white, not hispanic or latino male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 07-MAR-2021 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first covid-19 vaccine ad26. cov2. s. Non-company suspect vaccine included: mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, following vaccination with non-company booster dose, the patient tested positive for Covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive (Dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Feel a warmth in my upper arm where the vaccine was administered; Itch in the upper arm area and started to get tinglingly down to my fingertips; Itch in the upper arm area and started to get tinglingly down to my fingertips; The strength in my hand has diminished; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset 2022, outcome "unknown", described as "Feel a warmth in my upper arm where the vaccine was administered"; PARAESTHESIA (non-serious), PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "Itch in the upper arm area and started to get tinglingly down to my fingertips"; MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "The strength in my hand has diminished".  Clinical course: Patient reported that I received my 3rd booster approximately 7 weeks ago and about a week after I started to feel a warmth in my upper arm where the vaccine was administered. subsequently, I started to itch in the upper arm area and started to get tinglingly down to my fingertips. In the past week, I also noticed that the strength in my hand has diminished. I am 69-year-old, and I am wondering if this possible side effect has been reported to you by other patients.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Flu shot(not sure which strand), -high fever, 102.9+ for 7 days no other symptoms.
Pt exp fever, lymphadeno, rash, somnolence, (poss insect bite from a dead coyote);
When I got the injection the nurse said I had a normal "well" I believe she called it. It looked like a mosquito bite. She said it would probably go away after 3-5 hours. It has been 24 hours and the injection site has formed a large red lump that is very itchy and a bit painful.
Rash on arms and back, itches. Two Benadryl 225mg Tab. No pain or swelling at injection site.
High fever, flu like symptoms, weakness for 2 days.  Treated with rocephin IM and oral azithromycin.
On 09/21/2021 everyone in house was sick and family member tested positive and on 09/22/2021, had a headache,  and congestion. The patient tested posted positive for COVID had the antibodies treatment on 09/23/2021 only side effect was headache and stuffy noise.
They are light pink and dark red patches; hives on legs, arms, back and abdomen; flu type symptoms; shivering; headache; nausea; buzzing in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, 2 days after receiving Shingrix, the patient experienced flu symptoms (Verbatim: flu type symptoms), shivering (Verbatim: shivering), headache (Verbatim: headache), nausea (Verbatim: nausea) and ear buzzing (Verbatim: buzzing in ears). On 26-JUL-2023, the patient experienced hives (Verbatim: hives on legs, arms, back and abdomen). On an unknown date, the patient experienced skin red (Verbatim: They are light pink and dark red patches). In JUL-2023, the outcome of the flu symptoms, shivering, headache, nausea and ear buzzing were resolved (duration 3 days). The outcome of the hives and skin red were not resolved.   It was unknown if the reporter considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.     It was unknown if the company considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.   Additional Information: Receipt Date: 02-AUG-2023 The consumer was the reporter stated that he had his 1st Shingrix vaccination. Two days after vaccination he started experiencing flu like symptoms, shivering, headache, nausea and buzzing in his ears, which lasted for 3 days. On 26 July 2023 he stated that he had one hive on his abdomen.   On 2 August 2023 the reporter reported having hives on his legs, arms, abdomen and back. The hives were of different sizes and shapes with the largest being the size of a lemon.   They were light pink and dark red patches.   The consumer had an appointment with a dermatologist on 2 August 2023 (on the day reporting). The reporter did not consent for follow up. The case is linked with US2023105231, by same reporter.; Sender's Comments:  US-GSK-US2023105231:Same reporter
Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever. Weakness,chills and fatigue and headaches progressed until 4/01/2021 when patient experienced complete weakness in left arm and leg and unable to stand or walk. Prior to 2nd dose, patient was recovering from a stroke and was beginning to walk with assistance and a cane. After April 1, 2021, patient is unable to stand or walk. Chills, headaches weakness and fatigue continue as of April 11, 2021
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt has pain/swelling/redness at injection site that has lasted greater than 10 days; advised how to self treat at home and to call md if no improvement
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced incorrect product storage. On 10-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-MAR-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for the prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about December 2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Fever up to 104.3f, HA, chills, runny nose, fatigue, weakness, and nausea. Took Coricidin and Ibuprofen alternatively every 4 hours. Chills started in the evening of the day of the day of the vaccine, Wed 01/20. Woke up at 3 am with temp of 104.3. Took Ibuprofen and Coricidin alternately. Drinking plenty of water and eating very little.  Low grade fever and weakness until yesterday. Only weakness today. Back to eat as normal.
Missed Miscarriage at 8 weeks; This is a spontaneous report from a non-contactable consumer or other non HCP (Patient reported for self). A 36-years-old (pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: E40584), via an unspecified route of administration, administered in Arm Left on 07Jul2021 14:00 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient did not receive other medications in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 10Aug2021 17:00, the patient experienced missed miscarriage (also reported as gestational period: 1'). The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. Last menstrual date was 20May2021. The mother was due to deliver soon after. The pregnancy resulted in spontaneous abortion. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. COVID tested post vaccination, the patient underwent lab tests and procedures which included sars-cov-2 test (covid test type post vaccination=Nasal swab): Negative on 13Aug2021. Patient was received treatment for event. Adverse event was treated with D and C. The event was serious (Congenital anomaly or birth defect). The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
1. Within 24 hours of receiving the 2nd Moderna vaccine injection, I noticed some "dropped" heart beats, where a heart beat should have been, but wasn't. It worsened over the next several days and became so concerning that I visited the Urgent Care on March 27, 2021. The 12 second EKG did not show anything at the time, but I was still experiencing this phenomenon. On March 30, 2021, I visited Dr. and was placed on a 7-day cardiac monitor. The "dropped" heart beats eventually resolved on its own in approximately 30 days.  2. I also noticed that the pharmacist injected the Moderna vaccine very high and off center into my left arm.. Almost immediately I felt significant pain where within 24 hours I had trouble lifting my arm. I read that this may be a side effect, so I didn't think much of it, assuming this was in the normal course of events. Within a few days I had developed a "frozen shoulder" or "adhesive capsulitis of the shoulder" and to this day am still experiencing significant pain, and am currently in physical therapy. An x-ray and and MRI was done to confirm the diagnosis.
0800- BP166/114 HR 71 RR 20 OXYGEN 99% 0805 - BP 162/123 HR 78 RR 20 OXYGEN 98% 0810- BP 163/114  HR 81 RR 20 OXYGEN 98% REDNESS ON CHEST, HEAVY FEELING IN CHEST, MILD HEADACHE, NO ANGIOEDEMA NOTED, NO RASH OR HIVES NOTED ON UPPER BODY, FACE OR NECK. UPPER LUNG SOUNDS MINIMALLY DECREASED-NO WHEEZING OR STRIDOR NOTED. BLOOD GLUCOSE 86.
Prevnar given inadvertently instead of polio vaccine. Client received 2 doses of Prevnar in right vastus lateris. Parent notified. F/U on 6/16/06, Client had temp 101.5 with constipation, no other complications reported. Physician notified. Pt recieved 2 doses pf prevnar at same time not 2 doses before date on Box 10.
Approximately 24 hours after vaccine syncope started with intense vomiting for the next 36 hours. Tissue lining of esophagus was torn from vomiting causing minor bleeding that did not need emergency service to heal. Phenergan was taking orally and rectally to combat vomiting sessions but did not work.
This case was reported by a pharmacist to a sales representative and described the occurrence of injection site hemmorhage in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. The pharmacist reported that more than one subject experienced injection site bleeding, however,a specific number of subjects was not reported. On an unspecified date on or before 24 April 2006, the subject received a dose of Engerix-B at an unspecified site of administration (dose number and lot number not reported). Less than one day after vaccination with Engerix-B, on an unspecified date on or before 24  April 2006, the subject experienced injections site bleeding. The pharmacist reported that, "the TIP-LOK syringes were making the patients bleed." The outcome of the event was not reported.
Received Trumenba injection on 8/ 4/20.  Later that day she felt "hot and cold ".  She then  developed some diarrhea, said she had a headache and her ears were ringing at one point.  No fever nasal drainage or cough. She also had nausea  and swelling and soreness of left upper arm at the injection site, since later in the day on 8/ 4/20. Patient was treated with Zofran and ibuprofen for the swelling and pain in her arm.
missed the time frame for the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose) 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.   No concomitant and treatment medication information was reported. Patient stated that she has received her first dose in March and was supposed to get her second dose in April but did not get it.
Systemic: Tachycardia-Mild, Additional Details: Patient called day after vaccine administration and stated that her smart watch alerted her to an elevated resting heart rate.  Patient stated that her resting heart rate had been at 120 bpm for over an hour.  She did not perform physical activity, was not experiencing anxiety, not contributed to any beverage or medication.  Advised patient to go to urgent care as she does not have a primary care physician at this time.
muscle aches; Fever of 99.6 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and PYREXIA (Fever of 99.6 degrees Farenheight) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZ0A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (muscle aches) and PYREXIA (Fever of 99.6 degrees Farenheight). At the time of the report, MYALGIA (muscle aches) and PYREXIA (Fever of 99.6 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 99.6 (High) Fever of 99.6 degrees Fahrenheit..         Concomitant medication included steroids. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-269887 (Patient Link).
Patient received 1st dos of Moderna at a Pharmacy on 09/04/2021. She came to a different pharmacy ( our pharmacy) on Monday 09/27/2021 for 2nd dose. My immunizer technician  unintentionally gave her 2nd dose of Moderna  1 day too soon.
First on 10/2/2020, had not received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd October 2020, batch number:454st, expiry date: 5th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received the first dose and had not yet received the second dose of Shingrix till the time of reporting, which led to incomplete course of vacation.  No further events were reported. The health care professional agreed to be contacted for follow up.
Patient reported severe tachycardia, fever over 101 degrees and atrial fibrillation.
Soreness, redness, swelling and a lump to left deltoid where Injection was administered. Patient complained of fever, and soreness throughout entire body, stated he couldn't even get out of bed or move.
Client report receiving 2nd COVID dose on 04/24/2021 about 09:30 am, report adverse reaction starting the next morning on 04/25/2021.  Adverse reaction of headaches and fatigue.  Headache pain located in forehead and top of head, that is always there.  The headache pain rate 7-9/ 10, today 4-5 / 10.  Client fatigue has caused her to take naps lasting 1-4 hours, and still being able to go to sleep at bedtime.  Client report having symptoms of headache and fatigue after first COVID vaccine on 04/01/2021, but these symptoms went away 24 - 48 hours after starting on 04/02/2021.  Client has made PCP aware of symptoms and has been seen at the Emergency department, was given IV fluids and a medication (name not known).
Patient passed away suddenly without previous illness. Patient complained of chest pain to her husband several hours before the event as reported by Dr.
This is a spontaneous report from a contactable nurse. A 66-year-old male patient receives PREVNAR 13 (Lot number: S43277, Expiry date 30Sep2018, NDC number 0005197102), intramuscular at 0.5 ml single in the left deltoid on 05Oct2017 15:30 for immunisation. Medical history none. Concomitant medications were not reported. On 06Oct2017, the patient experienced arm swollen, red, hot and painful at the site of injection. The outcome of the events was not recovered.