chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full dose instead of a half dose; Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 037K20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today). On 29-Oct-2021, ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant Follow Up : Event added and Contact information (Fax No.) Updated
Redness, swelling, induration of 50x45 mm explained to pt's parent to ice area.
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 medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-MAR-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
None at this time, vaccine error was realized by myself, Office Mgr., after patient left the office today. We will notify patient and follow.
onset of rhinitis & parotitis (lt side) 4 days post vax; no treatment indicated @ present time
Left deltoid/arm red and swollen, rash spreading to shoulder area, hot and tender to touch. Started two days ago.
Mother of patient reports that child has a large "knot" under right underarm.  Mother of patient states that child will not let anyone touch the arm. Shots were given on 08/03/2007 and mother noticed the "knot" on 08/08/2007. Mother told to take child to PCP or ER
Had mild Covid 2nd week of February. Day of vaccine at night developed chills, back pain, headaches and fevers (pretty much same symptoms he did with the disease). day 2 post vaccine, same symptoms plus night sweats on day  day 3 feeling good during day, just headache and late night was cold as ice for long period of time. day 4 at around 7 am woke up with chest pain and pressure, weakness, dizziness, turned paled. pulse oximeter read HR 32. Watch read EKG as Sinus bradycardia. Had a shot of espresso and called 911. by the time they got home EKG repeated and HR was in 40's and 50's.  they repeated the EKG about 10 minutes later and was in low 50's. called a friend who is a cardiologist and saw me the same day in the afternoon.  he repeated the EKG, HR was in 50's. Echo was done, and holder monitor placed for the next 24hrs. stress test ordered but not done yet. that day I still felt some weakness but no more chills or fevers and HR stayed in the 60's and 70's rest of the day.
Swollen arm at site, headache, nausea (no vomiting) body aches, dizziness when arising, no laying down, red and hot, chills/sweating.
28 weeks pregnant, was told to get the dtap vaccine as standard procedure in all pregnant women in third trimester. Estimated delivery date of 04 February 2024. The night of the injection, itchiness presented in hands and feet. The following day, itchiness spread to almost full body, except pelvic and butt regions. Took Benadryl, which eased the itchiness but did not alleviate  it. 24 hours after initial vaccine administered, itchiness is still present.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-408587, MOD-2021-408592.
Patient experienced swelling and erythema to right anterior thigh 24-48 hours after vaccination with pain and induration.
Dose 1 given 3/19/2021 lot # 040A21A Moderna. Patient died at Medical center from Covid 19 complications
This is a spontaneous report from a contactable consumer reporting for himself. This 65-year-old male patient received on 16Oct2017 9:45 PREVNAR 13 at single dose in the left deltoid due to recommendation of the doctor because he was 65-year-old. Medical history included mild asthma. In the first week of Sep2017 the patient received influenza vaccine for immunization and no reaction occurred. Concomitant medications were not reported. On 16Oct2017, the patient had tightness and pain in shoulder, limited rotation and movement (described as cannot lift arm and point it straight out and cannot open a door knob or take off a bottle cap), trouble sleeping because he cannot sleep on his left side, pain at injection site, cannot put pressure on his left arm/hand to go from a sitting position to a standing position to get up, couldn't lift arm straight out and still can't without significant pain. Outcome was not recovered. Course of the event was reported as follows: He received the vaccine that day at approximately 9:45 AM. He had some tightness and pain in his shoulder. He went out for a walk in the neighborhood. He was swaying his arm back and forth and by midafternoon, his arm was painful and he lost rotating motion. It was painful at the injection site and all over the upper arm. He took 2 over the counter naproxen at approximately 3 in the afternoon and couldn't lift arm straight out and still can't without significant pain. It has been almost 48 hours since he received the vaccine. By 5pm the day of the injection, he had taken a VICODIN and by 7pm, he called the nurse line and talked to the nurse. The nurse thought maybe they hit a nerve. He woke up about 4 AM and took another hydrocodone/paracetamol. Clarified that he didn't really wake up because he never really slept. The nurse called back yesterday morning because he was really worried about him. They offered to have him come in but he declined. Mentioned that he didn't sleep at all 17Oct2017. On 17Oct2017 evening he was watching tv and saw a commercial with pneumococcal 13-val conj vac (dipht crm197 protein) and saw the disclaimer and 2 of them mentioned were pain in the injection site area and limited movement of the shoulder and he wrote those down. He called the nurse back on 17Oct2017 evening after hearing these and asked why he didn't have this information and why wasn't he told about them. As of 18Oct2017, he was not doing a whole lot better, didn't sleep well as can't roll on that side, can't open the cap to a pill bottle and can't hold the pill bottle. Extreme pain in the whole upper arm. Holding elbow to his torso because if he lets his arm swing out he has pain. He was upset because he wasn't given this information about the side effects at his doctor office so he was worried he had a torn ligament and he was going to need physical therapy and everything, that is how bad the pain was. He has continued pain in the area of the injection and decreased movement in the area of the arm. He was relieved to know these were side effects because he thought it could have been something else. I took an additional naproxen on 17Oct2017 morning. He stated it was only 10% better.
Soreness and bruise on arm, low grade fever (101.5 F), achiness, chills.  In response I took 1,000mg of Tylenol every 6 hours for 30 hours. Aside from bruise, all symptoms were gone after 36 hours.
Employee administered Fluzone "high dose" Quadrivalent  by 11-7 Supervisor on 10/5/21. Employee under 65 years of age. Currently employee reports no adverse reactions.
Received FluMist at approximately 1600.  by 2030, severe coughing, vomiting, diarrhea. By 2200, laryngitis was present.  hives started in the evening, but wghen woke up the next morning, hives were scarrered over body and getting worse.  Went to Dr. who prescribed Prednisone 20 mg BID and Benadryl prn.
he tested positive with Covid-19 after he got the 2nd dose of the vaccine; he tested positive with Covid-19 after he got the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-Sponsored Program. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) and the first dose via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported), both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called in because he tested positive for Covid-19 on an unknown date, after he received the second dose of the vaccine. He received the first dose of the vaccine on 09Mar2021 and the second dose on 30Mar2021. He's asking what's his incubation period. The event outcome was unknown.   Information on the batch/lot number has been requested.
No symptoms or side effects; a patient received their first dose of PROQUAD at the age of 14; This spontaneous report was received from a pharmacist referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.       On 11-AUG-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X009733, expiration date was not reported, but upon internal validation established as 02-SEP-2024; strength, dose and route were not reported) for prophylaxis at the age of 14 years (Product administered to patient of inappropriate age). No symptoms or side effects were reported (no adverse event). No further details was provided. No other adverse event was reported.
Information regarding PREVNAR was received from a healthcare professional regarding a 17-month-old female patient who experienced pneumococcal meningitis/drug ineffective. At 12 months of age, the patient received the fourth dose on 08-Dec-2009. On 04-May-2010, the patient developed pneumococcal meningitis. Treatment included (unspecified) intravenous antibiotics. On 07-May-2010, the patient died. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.
Headache & Fever Narrative:  persistence of bifrontal headache moderate to severe and fever (99-100 F) 4 days after vaccination . Not resolved by Acetaminophen tablet and Ibuprofen oral since day 2 .
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 22nd patient out of 77 patients described by the reporter. No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122: case
I am 62 years old. I received my first Moderna vaccine on 3/3/21.  Very painful, red and swollen at the injection site. One week after the shot  I developed an itchy red and swollen palm on my left hand, shot was in my left arm.  The second shot was 3/31/21. I chose to switch to my right arm due to the reaction to the first shot. On 4/2/21 I had a severe stomach upset which is highly unusual for me. I developed spasms in my throat which traveled down into my side. Very painful. I became nauseous during the night causing me to vomit. Went to the ER in the morning, had an ultrasound to rule out gallbladder problems and was diagnosed with esophageal spasms. First and only time to ever experience this.  Developed an itchy red and swollen palm again, this time in right hand, corresponding with the shot in right arm.  On 4/17/21 I woke up with pain on the right side of my tongue, I thought it was a canker sore. Right half of my tongue started to swell immediately.  I had trouble speaking and speech was slurred. Second trip to ER in two weeks. Very scary. I was given an IV with Benadryl, Prednisone, and Pepcid. Took several hours for swelling to go down.  I have never experienced these symptoms before nor have I had severe reactions to any other vaccinations. I have been in the hospital twice in my 62 years.....37 and 35 years ago to deliver our two sons. I firmly believe that these problems were directly related to the vaccine. I still believe that getting the vaccine is the right thing to do. I am hoping that knowing about my reaction is helpful in some way shape or form.
Local reaction - 1 day after vaccination pt. experienced redness and inflammation. Inflammation reduced but redness spread. Pt. went to see doctor. Doctor said not infected and prescribed ELOCON cream.
In right deltoid muscle, pt. injected with needle/syringe that was just previously injected into her husbands deltoid muscle. Pt. then received new injection in left deltoid.
Pt developed chest pain and heart palpitations 10 days after vaccination. Upon workup with cardiologist, pt was found to have mitral regurgitation, dilated aortic root, and dilated ascending aorta. Pt had no symptoms prior to vaccination. Pt was previously a healthy, active 23 year old.
Pain at the injection site/ soreness; Doesn't go out of the bed; Pain all over the body; Extremely chills; Extremely fatigue; Intense headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/ soreness). At the time of the report, FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue), HEADACHE (Intense headache) and VACCINATION SITE PAIN (Pain at the injection site/ soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
itchy rashes and bumps; itchy rashes and bumps; recurrent pain in left deltoid and shoulder joint; swelling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jul2021 12:00 (Lot number: 11345) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Low back pain" (unspecified if ongoing); "Muscle relax" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 1994 (ongoing); VIT. E, start date: 2015 (ongoing); MAGNESIUM taken for muscle relaxant therapy, start date: 1995 (ongoing); IBUPROFEN taken for back pain, start date: 1993 (ongoing); SUMATRIPTAN taken for migraine, start date: 1994 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Time: Approx. 12:00 PM, Lot no: 16161, Anatomical location: Left arm, Parent route of administration: intramuscular), administration date: 05Jul2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious), MASS (non-serious) all with onset 26Jul2021 12:00, outcome "not recovered" and all described as "itchy rashes and bumps"; ARTHRALGIA (non-serious) with onset 26Jul2021 12:00, outcome "not recovered", described as "recurrent pain in left deltoid and shoulder joint"; PERIPHERAL SWELLING (non-serious) with onset 26Jul2021, outcome "not recovered", described as "swelling in hands". Therapeutic measures were not taken as a result of rash pruritic, mass, arthralgia, peripheral swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. No known allergies were reported. Clinical course includes Patient didn't see a doctor and is still breaking out with itchy bumps. She has started a low glycaemic/ anti-inflammatory diet in hope to resolving this.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 3 vaccines Moderna 2/26/21 Lot# 010A21A;  Moderna 3/26/21 Lot# Lot# 018B21A;  Moderna 12/1/21 Lot# 012H21B
itching/Persistent itch on head, scalp, back of neck and upper shoulder; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date not reported), via intramuscular, administered in Deltoid Left (reported as left shoulder in the muscle), on 19Mar2021 11:00 (at the age of 83-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included high blood pressure. The patient was on two high blood pressure medications. It was reported that, over the course of time, she has shrunk. It was prior to the vaccine and stated most people lose height as they age. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via intramuscular, administered in Deltoid Left (reported as left shoulder in the muscle), on 26Feb2021 (at the age of 83-year-old), as dose 1, single, for COVID-19 immunisation and experienced no side effects. No additional vaccines administered on same date of the Pfizer suspect. After second COVID shot, two or three day after the injection (Mar2021), the patient started itching. It was a persistent itch to her head, scalp, back of neck and upper shoulder. It was fairly constant. The patient wanted to know if it was a result of vaccine. She has had her head examined and there was no evidence of flakes or bugs. The patient asked how long the symptoms last. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
I was only a little tired Monday night, but overnight I had the worst nightmares that were almost hallucinogenic.  It was horrible and nothing like I have ever experienced before.  I literally have no words to describe the experience.  I had reorient myself when I woke up Tuesday morning as it was quite upsetting. I had a headache and a low grade fever the next day which subsided as the day progressed.  No nightmares during my naps on Tuesday or Tuesday night.  Was able to go to work on Wednesday.