chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant Medication use information was not provided by reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 23rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
(10:25) MMR and Td administered. (10:30) Patient noted to be vigorously scratching MMR site in waiting room. Patient was brought back to exam room at 10:32 and approximately 10 cm area of redness noted around MMR site. patient reports at this time chest tightness, facial edema noted. Also flushing and onset of vigorous coughing. (10:40) Benadryl 50 mg IM in left deltoid. Symptoms rapidly worsening. 0.3 ml Epinephrine SC at 10:42. EMS enroute. (10:47) EMS here, coughing and flushing improved; sent to hospital for observation via EMS.
About 6 hours post, had EXTREME Muscle pain in my hips, back, headache, fever at 100.4, fatigue, which lasted 30 hours. Fever is down now but the muscle aches continue.  Injection site pain as well.
Initial unsolicited report received from a nurse on 27-APR-2017. This case involves a 21 years old male patient who was vaccinated with an dose of FLUZONE batch number: UI640AB, expiry date, dose and route of administration was not reported) at left deltoid on 27-APR-2017 at 02:35 PM. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was denied by the patient. It was also reported that patient had no adverse event previously. Concomitant medications was not provided. On 27-Apr-2017 at 02:45 PM, 10 minutes following the vaccination, the patient experienced metallic taste in mouth. Lab data and corrective treatment was not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
most people have more side effects with the second dose; This case was reported by a consumer and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter stated that, most of the patient had more side effects after vaccination with 2nd dose of Shingrix. This case has been linked with case US2020AMR033844, reported by same reporter.
PATIENT WAS IN THE PHARMACY TO RECIEVE ANNUAL FLU SHOT (FLUARIX) AND WAS GIVEN THE COVID-19 MODERNA BOOSTER INSTEAD
Stiff neck; Lymph node pain; persistent pain on both sides of her back; Mild headache; Fatigue extreme; body was sore; bump at injection site that is sore; bump at injection site that is sore; Sleepiness; This is a spontaneous report received from a contactable consumer (patient). This 50-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration on 08Mar2021 at about 21:00 (at the age of 50-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included vitamin D deficiency and hypothyroidism from about 4 years ago as of 2021, and morbidly obese. The patient had not had any other recent vaccinations. Concomitant medications included levothyroxine sodium (SYNTHROID) from at least 4 years ago or more as of 2021. On 09Mar2021, the patient experienced extreme fatigue,  body was sore, at the place where the injection was there was a bump there that was sore, sleepy, and mild headache. On 10Mar2021, the patient experienced soreness, pain, and fatigue which were worse; everywhere on her body hurt, lymph nodes on the side and back of her head and down to her ear on both sides of her neck were hurting so bad; persistent pain on her back where her chest is, she didn't know what that was called, it was like someone punched her there on both sides. On an unspecified date the patient experienced sometimes she had a stiff neck that was new.  The patient wanted to know if she should go to a doctor. The patient had blood work on an unspecified date with results of okay.  The patient did not receive any treatment for the events. The outcomes of extreme fatigue, body was sore, at the place where the injection was there was a bump there that was sore, sleepy, mild headache, pain, lymph node pain, back pain, and stiff neck were unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a female who on an unspecified date received the first dose of Gardasil (yeast) (Lot # not provided). On 02 Nov 2006 the patient was vaccinated with the second dose of Gardasil (yeast) (Lot # not provided). On 03 Nov 2006 the patient experienced joint pain and developed a rash. Unspecified medical attention was sought. At the time of this report the patient was recovering from the event. Additional information has been requested.
The first shot had sore arm for 24-36 hours. I didn't feel it go in.    The 2nd shot was jabbed in and immediately hurt.  Within a few hours I had a sore arm w/very limited mobility.  My shoulder range of motion is still affected.    This is not a big deal but it's a similar reaction to tetanus shot.  I couldn't even put on my coat with the tetanus reaction; this one isn't that bad.  It was probably a year before that resolved.  So, I don't know if it's my anatomy, how it was administered, or both.   Essentially, I can still "feel" the spot on my arm and in some range of motion.    I'm very grateful for the vaccine and would do it again.  Just wonder if the similar tetanus/COVID vaccine is something to look at.
Pt recvd 3 doses of Hep-B vax 26JUL90, 26AUG90, & 27FEB91; following 3rd dose pt devel local rxn that appeared "hot, red, size of a fifty-cent piece;
After patient received the first dose of COVID vaccine she had left arm pain related to site injection. She also had costochondritis that seems to be related to the vaccine. Presenting for the second episode of intermittent chest pain and left arm pain. Patient saw MD for the first time on 2/4/21 for 2 weeks of intermittent chest pain and left arm pain after getting first dose. pain was pleuritic in nature and associated with exercise so got an EKG, Trop and D dimer which were all reassuring. Chest pain likely costochondritis and left arm pain nerve irritation from vaccine. Symptoms improved and not a problem with the second vaccine on 2/8/21. On 2/28/21 patient started having left arm pain and chest pain again-similar to prior but a little higher along sternum and its constant. Left arm feels weak and constant pain in left deltoid and radiates to left pinky. Could not sleep on left or right side after this started. Also reports that pain is radiating to left upper back and left neck. Also had left leg pain that has since resolved.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/19/2021.
My arm hurt badly which I know is normal but it moves to my shoulder and I now have restricted movement in my shoulder. I can?t lift my arm over a certain height without a lot of pain and have shoulder pain now in that arm upon movement. I think the shot was too high and perhaps went into my bursa. It is now as though I have bursitis in my shoulder. I thought it would get better on its own but it has been a month now so I am going to see a doctor. But there is nothing else it could be related to. Since Covid I don?t exercise much anymore other than than walking or jogging. I hurt my right bicep tendon last year and as a result of that, I have not been doing any upper body exercise. This pain came on after the vaccine and has not gone away. I have read that inexperienced people giving shots can do it wrong and I am afraid that may be what happened here. The pharmacist was very nice but he was also very busy that day. A huge line of people. I am not faulting him. I just think that perhaps the shot was up too high on my arm. I was prepared for certain side effects, just didn?t think I would lose motion in my arm. I get my second shot tomorrow and am going to make sure I ask that they are certain it is in the right spot. I know that this is a crisis. Again, I am not faulting the pharmacist, this is a pandemic and people are doing the best that they can to help. I think that the word should get out there that there is this risk. I am going to the doctor and hope that this is something that will resolve itself over time. I have to go to doctor. Will go to orthopedics.
Injection site: appx 10 hours after the injection; pain, tenderness, swelling, redness and swelling(hardness). The tenderness and pain resolved on day 2 after the injection. The swelling(hardness) and redness was mostly resolved by day 4 after the injection.  General side effects: headache.  Chills and begin to feel feverish began appx 28 hours after the injection.  This lasted appx 24 hours.
Nasal blisters both nostrils. Numbness in left hand from injection site thru little finger.  Still numb on 06/21/2021
Extreme Fatigue/weakness Low Grade Fever Body aches/joint pain muscle pain/stiffness/cramping Cold chills Sensitivity to cold temperatures Abdominal Pain Severe headache/pressure Sinus pressure ear pain high Heart Rate (above 100bpm for more than 10 minutes while inactive) nausea Cognitive issues Sore arm at injection site/hot to the touch at injection site slight cough short of breath nasal congestion
This spontaneous report as received from a medical assistant refers to a 11 month old patient of unspecified gender. The medical assistant reported that the  patient, who date of birth was 27-APR_2010, received the 1st dose of VARIVAX (confirmed Lot # 1105Z and exp., 25-AUG-2012) on 13-APR_2011 (dose unspecified), this was outside the recommendations per the VARIVAS prescribing information (inappropriate age of vaccine administration; product use in unapproved population). No adverse effects reported. No further information was provided. No product quality completed was involved. Additional information has been requested.
Pain down length of right arm, numbess in arm down to fingers. Lump in muscle in shoulder.
The same day post vax, the pt began to experience back pain which progressed to the groin area. The pt described the pain as "arthritic like:. Although he has a disc problem in the back, the pt stated that the pain he experienced after the injection was nothing like that he experienced with the disc problem. The pts MD felt that the pts pain was "probably just muscular".  The pt has not yet received his second injection. The most recent information received on 12/17/1999 reports the outcome of the event as resolved after 10 days.
Patient did not report history of adverse reaction to vaccines or fainting.  After receiving a flu and COVID vaccine at a clinic, she very quicky fainted and had some convulsions for approximately 2 seconds.  RPH held her head & arms so she would not fall out of chair.  We laid her down while calling campus EMS to respond - BP was 110/80.  She reported a headache & nausea.  RPH stayed to observe for 20 minutes - friend was also present.  After standing, patient reported to health services on campus for futher evaluation/observation.  EMS & campus health conclused vasovagal response to vaccine administration.  Patient later disclosed that she has fainted before.
Patient had Tdap on 2-20-18. She started with some discomfort on 2-21-18. On 2-22-18 her arm became sore red and swollen around injection site. NP saw patient in office on 2-23-18 and has ordered prednisone for treatment and ice to area.
This is a very pleasant 64-year-old female patient with a known medical history of chronic kidney disease stage 5, hypertension, hyperlipidemia, morbid obesity, type 2 diabetes mellitus with hyperglycemia, neuropathy, obstructive sleep apnea, osteoarthritis, pulmonary hypertension, rheumatoid arthritis, history of stroke, CAD with history of stent, adrenal mass, anemia, asthma who presented to the ED with complaints of cough and mild shortness of breath and secondary to these complaints she has missed her scheduled dialysis treatments.  She was diagnosed with COVID on August 31, 2021, she did receive her 2 doses of COVID-19 vaccine.  She denies any recent fevers, chills, chest pain, palpitations.  Supposedly she did not get her dialysis on Tuesday nor today secondary to her worsening cough and shortness of breath.  She follows with Dr. outpatient for chronic kidney disease stage 5 undergoes dialysis Tuesday, Thursday and Saturday, her last dialysis treatment was last Saturday and per patient report 2 L were taken off.  She presents today with volume overload and acute on chronic renal failure with worsening creatinine at 10.68/BUN 53, after review of her readings in June her creatinine was at 4.  She also presents with an elevated troponin 298 with BNP 29437.  Patient will be admitted for dialysis and consultation to Nephrology as well as trending her troponin and cardiac consultation.                                          Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints
I fainted while driving and I am lucky to be alive... No one told me there was ANY possibility I could faint after taking the vaccine. I was told to wait 15 minutes in the lobby, which I did although I was not monitored (i.e. I could've just walked out immediately).  About 10 minutes after leaving the pharmacy (and approximately 25 to 30 minutes after the vaccine), while I was driving 35 MPH headed back to my house, I suddenly felt I was going to pass out.  I had a moment of panic because I knew I was driving and if I fainted I was going to wreck... The next thing I knew I woke up after the accident occurred.  It's hard to make anyone else understand what I just went through and how traumatizing thinking about what my parents would have gone through if things had just gone slightly differently.  I have driven the same car for 16 years. It was totaled on Monday October 25th, 2021 because I was FORCED (mandated) to get the vaccine at threat of losing my job.  I'm not happy.
is seeing double; left eye was really blurry; This is a spontaneous report from  contactable consumer (patient). A 74-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 09Mar2021 at 12:00 (at the age of 74 years) at a single dose in the arm right for COVID-19 immunization. Medical history included ongoing high blood pressure diagnosed 5-6 months ago. Concomitant medication included amlodipine taken for high blood pressure from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on an unspecified date, patient was driving to get kids from school and all of a sudden he is seeing double. Also, on 10Mar2021 at 13:30, patient's left eye was really blurry. Stated blurriness had kind of cleared up before went to bed and woke up and it was still blurry. Stated it happens from a distance. Stated that if he covers his left eye that it goes away. The outcome of the events was not recovered.
Suicidal thoughts; Mood swings; Depression; A spontaneous report was received from a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced suicidal thoughts, mood swings and depression   The patient's medical history was not provided. Concomitant medications were not reported.  On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced mood swings, depression, and suicidal thoughts after getting the shot. The patient provided limited information before ending the call   Action taken with second dose mRNA-1273 in response to the events was not reported.   The outcome of the events, suicidal shots, mood swings, depression and patient got violent were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sudden appearance of itchy, red rash with slight swelling, at site of injection 7 days after the injection of 2nd dose of Moderna Covid vaccine.
This case was reported by a other health professional via sales rep and described the occurrence of lost consciousness in a 63-year-old male patient who received SHINGRIX (batch number 4492P, expiry date unknown). On 6th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th March 2018, 3 hrs after receiving SHINGRIX, the patient experienced lost consciousness (serious criteria GSK medically significant), fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain. On an unknown date, the outcome of the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain were unknown. It was unknown if the reporter considered the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient stated that three to four hours after vaccination he started to feel light headed, when he was speaking with his wife. The patient sat down, and he felt like arms and legs went stiff. The patient then fainted, lost consciousness, duration unknown. After regaining consciousness the patient reported that less than a day after vaccination, all the muscles in his body were hurting, joints hurt and then tingling. The patient did not go to urgent care or emergency room. The patient visit was at 11:30 and received injection approximately at 12 noon, fainting happened around 3 PM and he felt the joint pain until 11 PM. Next morning patient reported that right hand was still tingling. The patient had requested not to be given the second dose. Visit was a wellness visit and the patient did not receive any other injections at physician visit.
Voice is hoarse; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice is hoarse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0037217 and 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHONIA (Voice is hoarse). At the time of the report, DYSPHONIA (Voice is hoarse) outcome was unknown. Not Provided          Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown). In 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the outcome of the pain in right upper arm was unspecified. This is one of three cases reported by the nurse; see case A0815869A and A0816149A for subjects who had pain in upper right arm following vaccination with FLULAVAL.