chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; Patients were administered refrozen vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient MRN ID was 07858380.  Concomitant medication list was not provided.  The vials were frozen, shipped in refrigerated temperature and then refrozen for storage once arrive at facility. Further it was reported that vial was moved to fridge on 06-Oct-2021. Both 5.5 ml and 7.5 ml vials were received in partially thawed/liquid condition. Maximum or minimum temperature reached was 8 degree Celsius. Total duration of excursion was 4hrs.  Treatment information was not provided.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose and strength were not provided) intramuscular injection in arm for prevent HPV. During the night, but after midnight on Tuesday 06-AUG-2013 she felt suddenly fatigued and had a feeling of her "eye balls shaking." The patient called the office. The outcome of event was not provided. Additional information has been requested.
On Friday, 4/3/09, I received two vaccines, a tdap in the left arm and a pneumococal polysaccharide vaccine in the right arm. Within a few hours, I started having diffuse joint aches in my body. Also, my right arm started to have severe pain and locked up. Then, on looking at my arms, the left one looked okay, but the right arm, where the pneumonia vaccine was given, had a reddish marks and streaking going from the outer arm toward my underarm. I called the triage nurse for my medical insurance. I was instructed if it was not better by the a.m. to go to urgent care. She did not advise any treatment to be done in the meantime but said I could take my pain medicine if needed. On Saturday, April 4th, my arm was very locked up until getting into a warm shower; the pain was still present but improving, and the rash was much worse. I went to urgent care in the afternoon, as the rash was spreading. Because of my diabetes and other health issues, the physician prescribed Levaquin, but he said to wait until the next day (today) before starting it to see if my symptoms would improve. I have not felt well since the vaccination, and although the rash has lightened up, it covers a bit larger area, so I started the Levaquin today.
warm sensation in my chest, upper stomach, lower chest area; I felt real wired. I felt like wired warm sensation in my chest, upper stomach, lower chest area; I have been feeling funny from the past Saturday; Dizzy; Fatigue; normal chills; body ache; headache; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 24Jan2022 (Lot number: FJ1614) as dose 1, single for covid-19 immunisation. Relevant medical history included: "had covid previously" (unspecified if ongoing), notes: had covid previously. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 24Jan2022, outcome "unknown", described as "I felt real wired. I felt like wired warm sensation in my chest, upper stomach, lower chest area; I have been feeling funny from the past Saturday"; DYSPNOEA (non-serious) with onset Jan2022, outcome "unknown", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 24Jan2022, outcome "unknown", described as "Dizzy"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "normal chills"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "body ache"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; FEELING HOT (non-serious), outcome "unknown", described as "warm sensation in my chest, upper stomach, lower chest area".  Follow-up attempts completed. No further information expected.
I had a headache and a fever developed the day of the second shot. I took Motrin that night. I experienced a lot of ear ringing, which has not gone away.
heart murmur; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter considered the event as caused by suspect product. Patient never had a heart murmur until she had the Covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine.  Treatment medications were not provided.  This case was reported for elderly patient 16 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
Maculopapular coadescy rash on arms/hands/legs with vesicles. Three weeks ago vaccinated.
inappropriate schedule of vaccine; soreness; swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 1st July 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced incomplete course of vaccination. On 6th July 2018, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and reported that he experienced soreness and swelling at the injection site.  The reporter consented to follow up. Shingrix asymptomatic reported.  The patient reported that he missed his 2nd dose, but planned to get it in the near future, which led to incomplete course of vaccination.
For weeks, I had trouble breathing and my heart would race whenever I exercised, even as little as walking from the car to a store. This continued for 4 weeks after the second vaccine. Then i developed extreme vertigo. Even the epley maneuver did not help. I couldn't walk and was vomiting. This lasted for about a week, gradually getting better. Finally, I started itching all over my body, but mostly at the joints. This lasted a couple days.
Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on January 21. Generalized body itching started on January 26 and then woke up on January 27 with facial swelling. Instructed to follow-up with PCP or urgent care.
I was treated for atrial fibrillation in 2006 with ablation and have had no recurrent events until the COVID-19 vaccine was administered. Sudden and recurring afib events happened for 2 days at which time I made appointment with cardiologist. By the time the monitoring equipment was installed on my body (about a week later) the events had disappeared.  The events recurred after receiving the second dose of vaccine but only lasted about 3 days.
Achy arm day of vaccine, woke next morning with generalized body aches and extreme fatigue, temp 103-104 for about 10 hours. Chills, headache. By 6pm I was able to get out of bed and shower, eat some soup and hydrate. Woke next morning (today)feeling fine but worn out.
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet,  toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
Large area of raised redness and moderate-severe tenderness and warmth.  Area approximately 6 to 8 inches in diameter.  Some edema also present.
I had quite a bit of sneezing with headache. I also had sinus congestion. I tested myself on November 27, 2022, and that test was positive.  The sneezing increased and I developed a low-grade fever.  I contacted my doctor who prescribed Paxlovid. I started the medication on Monday the 28th. My symptoms improved after about 36 hours. I felt 95% better but I took another test on Wednesday and Friday and I am still testing positive. I have completed 4 or 5 test so far. My symptoms are not gone but I am much better.
On day 9 after my second vaccine, I experienced extreme fatigue, muscle aches and joint pain with neuropathy in feet, hands that has continued until today day 14  I was tested for COVID 19 and was negative on day 12
No other issues or concerns at time of call.; patient who received an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 27-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot #S020962, 07-JUL-2021 exact dose, route of administration, and anatomical location were not provided for prophylaxis. There was no additional adverse event reported.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient passed out while sitting in post vaccine area.  The first person who saw the patient reported he appeared to be seizing briefly. Patient was conscious but somewhat disoriented when I made it to him.  EMS came and transported patient to hospital for evaluation.
Fever with max of 101.9, headache, chills, heartburn, cough, fatigue.
Employee received varicella vaccine on 03/29/07. and on 4/12/07 developed fever of 103.1, chills, and rash.  Injection site red, swollen and tender.
2:58 pm PT c/o dizziness, staff helped him down on his back, legs elevated, SpO2-98%, HR-40, AOx4 2:59 pm EMS arrived, SpO2-98%, HR-40, AOx4,  3:04pm PT repositioned upright, drinking Gatorade, he c/o nausea, diaphoretic 3:07 pm staff helped PT on his back , BP 88/42 mmHg, PT diaphoretic, c/o nausea 3:09pm PT sitting, c/o nausea, drinking  Gatorade, diaphoretic, BS 119mg/dl, T-96.6 15:10 911 called, AOx4, EMS doing EKG, 15:13 HR-59, SpO2 98%,  15:15 PT c/o nausea 2/10, not diaphoretic, skin warm to touch, AOx4,  15:18pm EKG NSR per EMS,HR-66, SpO2 -97% 15:22 PT standing BP 131/77, HR 50, SPO2 98%, PT reported feelong "OK"  15:25 PT sitting AOX4, BP 107/70, PT reports "feeling good" also is eating food.
Adverse event was a positive PCR test. Two weeks prior to my positive test my two grandchildren (1 and 3 years) had the same symptoms (cough, fever, runny nose). Their other grandmother visited during this time and came down with the same symptoms. My 3-year-old granddaughter had a negative rapid test 1.5 weeks prior to my positive PCR, and I had a negative rapid test 1 week prior to my positive PCR.  The other grandmother, my granddaughter, and I all had PCR tests three days after my positive PCR test, and we all had negative results. Two weeks later we all have lingering coughs.
This spontaneous report was received from a nurse practitioner refers to a 13-year-old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 09-OCT-2017, the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter (1710USA002936, 1805USA004616, 1805USA004664 and 1805USA004665).
Patient reports redness, swelling, pain from bicep area of arm injected extending to the elbow. Symptoms began to resolve after 48 hrs. Patient did not seek medical care.
She got her vaccine, it immediately started hurting really bad that lasted for about 30 seconds to a minute and then felt fine.  Felt fine for the first 2 weeks after and then about 2-3 weeks afterwards started having severe muscle pain and cramping.  It started out light, here and there and then became more and more severe.  She would have to stop working when she would eat as she was having tachycardia.  This was extremely new to her as she had never had any health problems.  4 months later on 7/31/21 she got up and called her son (his birthday), drank her vitamin drink and she hung up with him and started having the tachycardia and beating over 118 BPM, and would not stop.  She sat down adn lied down and tried to relax and could not.  They called the ambulance to come and get her as it would not stop.  They did blood work and was told that she had hypothyroidism and Grave's disease as her pituitary gland was not sending signals to her thyroid.  Her PCP did tests to see if she had any tumors or anything.  She then felt that possibly the vaccine caused it and did research and showed that it does.  She has no cancer and went to see a thyroid doctor (endocrinologist - Dr, and felt that it could have been due to that.  Now has numerous medical bills due to this process and wanted to report it and try to get some help.    On 8/9/21 she was started on Methimazole and not able to work 40 hours due to the illness.  Her endocrinologist said that she had never seen anybody to respond to the medication that quickly as after 3 weeks her thyroid level was normal and stayed low for several more months after that and told her that she could not take it anymore as she felt sluggish and stopped it on her own.  She wanted to keep her on the medication as long as she could as was informed that it takes 1 - 1 1/2 years to correct the problem.  When she could take the medicine for the first couple of months it would be low and she would slack off of it, and then would increase her dose.  She was on the medicine for 6 months, and stopped it on 1/22/22.    She believes that the vaccine caused this, and right now her Grave's disease went into remission and in January was in remission and normal as well.   No history of Grave's disease in her family dating back to 1800's, and her age is over 40.   She went to Hospital.    She does not feel the same as she did prior to the vaccine.   She now has built back up to 30 hours a week, but still not able to work 40.      She has fatigue and no energy, and not back to where she was.  She was healthy before the vaccine, and has had irregular heart beats and told in the past that she was okay and not dangerous and now has the extra heart beats.  Her head feels like it's in a cloud and her body still aches and she gets tired more easily now.  She gets really tired and sleepy all the time now.
Vaccine was administered post use date. Patient's provider Dr. the contacted parents or guardian on 03/10/23 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
No adverse event; Nurse reported 5-year-old patient received GARDASIL 9. The operator of the product was a healthcare professional. No additional AE/no PQC.; This spontaneous report as received from a nurse referring to a 5 year old patient. Information regarding the patient medical history, concomitant medications drug allergies or reactions was not provided.       On 12-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis (strength, administration route, lot number and expiry date were not provided) (product administered to patient of inappropriate age). No additional adverse event was provided.
Case received on 30 September 2011 from a healthcare professional. A female patient, with no known allergies, with no history of medical condition and no illness at the time of vaccination, had received on 27 September 2011 her dose of FLUZONE (batch number UT433AA, route of administration not reported) on her right deltoid. She had already received several doses of flu vaccine. No concomitant therapy was reported. On 27 September 2011, i.e. the day of immunization, the patient developed at 2 inches below injection site a 60x30mm wheal-like area which was pink and warm to touch. She also experienced stuffy nose and runny nose. No corrective therapy was reported. At the time of reporting, the patient had not recovered. This case has been already reported to doctor. Documents held by sender: none.
pt recv vax 12FEB96 & 19FEB97 pt exp small red bumps around inj site & one blister on back;
Information has been received from a medical assistant and a person from the office concerning a 74 year old female patient who on 9/4/02 at 10:56 was vaccinated in the right arm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L). There was no concomitant medication and the patient was well at the time of vaccination. On 9/4/02 in the afternoon the patient complained that her arm where she had received the injection was itchy. On 9/6/02 at 11:00 the patient developed a hot area around the injection site that was swollen to an area larger than a tennis ball and injection site redness. The patient presented to the doctor's office, and her experience was reported to be a severe topical reaction at the site of injection. The physician prescribed levofloxacin 500mg PO for five days and instructed the patient to call the office in two days if the symptoms persisted. As of 9/16/02 the patient has not called and has not been seen in the office again. On 12/20/02, it was reported that the patient had recovered. Additional information is not expected.
Headache, severe brain fog, dizziness, vertigo, loss of balance, nausea. It started 8 days after the shot, and still feel that way 4 days since. Took ibuprofen once which might have helped a bit for a little while.
Moderna Booster   RASH on arm at injection site.  Also got one 13 days after first Moderna vaccine 1/29/2021-reported
Information has been received from a physician concerning a female who received her Gardasil doses on the following schedule: first dose 17-DEC-2007 (no lot # provided), second dose 16-JAN-2008 (no lot # provided), third dose 01-MAR-2008 (lot # 659655/1486U). On 04-MAR-2008, "approximately three days post vaccination" with her third dose of Gardasil (lot # 659655/1486U), the patient experienced severe back pain. The patient sought unspecified medical attention. No further information is available.