chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I wanted to sleep all day.; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (I wanted to sleep all day.) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SOMNOLENCE (I wanted to sleep all day.) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (I wanted to sleep all day.) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Time of vax 7OCT93 & 1 wk later c/o severe weakness in both legs for 1 wk duration;  2 wks later pt had severe pain in the lt leg, bilateral lower extremity weakness; adm to hosp 18NOV93 w/hypertension, r/o cerebrovascular accident;
This spontaneous report has been received from a licensed practical nurse referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with PROQUAD (lot # L044058, expiration date 02-MAY-2017, and lot #L030591, expiration date 10-FEB-2017, dose and route were not reported) which was improperly stored. The vaccine has been stored under temperature of 40 Fahrenheit temperature for 2.5 hours. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pt received pneumonia vaccine 23 on 5/2/16. On 5/3/16 pt called reported area where she got the injection was red, swollen, (size of golf ball) painful and itching (had tried ice on it). Instructed to continue ice and hydrocortisone for itching.
Red at injection site; Warm to touch at injection site; Tender at injection site; Nausea; Vomiting; Diarrhea; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AB, expiry date 31st August 2020) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Bexsero (intramuscular). On 9th April 2019, less than a day after receiving Bexsero, the patient experienced nausea, vomiting and diarrhea. On 10th April 2019, the patient experienced injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the nausea, vomiting and diarrhea were recovered/resolved and the outcome of the injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, injection site erythema, injection site warmth and injection site tenderness to be related to Bexsero.  Additional information was reported as below: The patient received Bexsero in the left deltoid. At the evening, the patient experienced nausea, vomiting and diarrhea.   The next day on 10th April 2019, the patient presented in the office with local reaction of red, warm to touch and incredibly tender at the injection site (area of 4 by 5cm). The events nausea, vomiting and diarrhea were self-resolved.
Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-366041, MOD-2021-366108, MOD-2021-366045 (Patient Link).
Recurrence of fibromyalgia symptoms especially in my upper extremities, upper back and neck. Extremely sore muscles in those areas and less noticeable in my legs. My fibromyalgia has been in remission for 6 years and I have not taken Savella for FM since 2015.  My allergy and immunology physician, Dr. told me on 03/08/2021 my relapse was caused by the vaccine.  As of this date, 03-12-2021, my symptoms have improved about 80%. I am scheduled for the second injection on 03-26-2021. I am planning on taking the second shot. I am a registered nurse and felt this reaction should be reported.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released until 05-01-2023, sent via e-mail to my supervisor, and then forwarded to me on 05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Had already received earlier dose of Pfizer mRNA vaccine. Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 06/07/2023 and tolerated well.
Blood sugar level higher than normal (340); This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar level higher than normal (340)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar level higher than normal (340)). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar level higher than normal (340)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's insulin bomb is not enough for keeping the blood sugar level normalized. Patient is using extra injected insulin. Concomitant medications details were not reported by the reporter. Treatment Details was not reported by the reporter.
This case was reported by a healthcare professional via a GSK representative and described the occurrence of diarrhea in a 2-month-old male subject who was vaccinated with (ROATRIX, GlaxoSmithKline). The subject received unknown concomitant vaccinations. On an unspecified date the subject received unspecified dose of ROTARIX (1 ml, oral). On 16 April 2009, at an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified
Approximately Oct 1st, 2022 My neck and back started itching.  The next day I broke out in an itchy rash, which wasn't as severe as previous rashes, (which I always get when I'm not feeling well).  It's still a bit itchy Oct. 9th, but thought perhaps I should report it.  I haven't followed up with Dr. for this matter, as this isn't unusual for me.  I have had numerous high dose vaccines in the past and other Moderna boosters, which didn't cause a problem, but I'm thinking maybe getting both of these at once may have been the problem.
Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Date the vial was initially stored in the refrigerator was not known. The vial did not undergo any temperature excursions. It was unknown if any of the patients experienced any symptoms. Treatment medication was not provided.
joint pain on her wrist and ankles; headache; was tired; anxiety; slept okay a little bit/ couldn't sleep real well; felt very lethargic; Patient needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 at 11:30 (lot number: unknown) as first dose, single for covid-19 immunisation. Medical history included temperature and aches (got temperature and aches from shingles vaccine). The patient previously took baby aspirin and blood thinner. Also the patient previously had hepatitis vaccines. On unspecified date in Mar2021, the patient felt joint pain on her wrist and ankles and stated she can handle pain, it was okay. She had a headache, was tired, slept okay a little bit, had anxiety and couldn't sleep real well. She had a whole glass of water and it helped that was what she usually did when she got a headache. When she got backed from the grocery store, she felt very lethargic like when coming out of surgery then she slept for a bit which did helped. Patient reported that she actually tried to went walking because she had medical condition where she needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day. She was home and right night now, her ankles, joint pain and all over headache, for me it was hard to knew because she did had a medical condition. She stated it felt different though. Patient previously took shingles, hepatitis vaccines when she travelled and she got temperature and aches from shingles vaccine and stated this one seems to hit me harder. Patient asked that can she take Tylenol. She reported that she took baby aspirin all the time and also another blood thinner but skipped on vaccination day and medicine to increase platelets. Patient reported that her friends who took the Moderna, they told her they had to take something as well and always waited it out. Patient stated that her pain tolerance was high. Seriousness of the event was reported as non-serious. The outcome of the event headache and felt very lethargic was recovering; outcome of all other event was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
pt suffered w/local pain, fever, chills & gen malaise;fever lasted approx 2 days;
Patient claims she suffered cellulitis to left upper arm, from injection 2 days after FLUZONE HD & PNEUMOVAX.
This spontaneous report has been received from a medical assistant, concerning a 13 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided. Historical drug included a first dose of M-M-R II and varicella virus vaccine live (Oka/Merck) which were administered on 23-APR-2005 when the patient was one year of age. On 02-OCT-2017, the patient was vaccinated at the age of 13 year old of age with PROQUAD subcutaneously, lot # N019249 and expiration date 20-DEC-2018, subcutaneous (strength and frequency were not provided) for prophylaxis. No adverse effects were reported.
Developed a post vaccination rash, seen on 9/21/06 and 9/22/06.  Self resolved in a couple of weeks. Rash not present on visit on 10/13/06. New unilateral trunk rash on right with varicella-like erythematous papules today, starting 9/11/07. No vesicles yet but looks like classic mild shingles to me. rash is very itchy.
fever & crying for @ least 48 hrs p/vax t103 given Ibuprophen @ clinic on 1JUL93;
Was feeling numbness on left arm 20-30 mins after getting her HPV #2 vaccine. Also felt dizzy.
Patient's wife said his arm is very sore and seems to have inability to move it freely. She thinks we may have irritated a nerve in the arm. She suggested that they may have to seek medical care for treatment.
Raised red welt about the size of a quarter a few hours after injection. It went away after about two day but then came back on day 5 after injection. It started off the same size, but is now about the size of a lemon and extremely itchy. It's also raised and hot to the touch. On the first day of came back the lymph nodes under that arm were also painful. That symptom lasted about 24 hours. On day 3 of red and swollen welt and looks to be getting bigger, not going away
No issues until two weeks after shot.  Woke up on a with severe arm pain in upper arm near inoculation site Sunday two weeks and a couple of days after receiving the shot. Could not take on or off shirts without yelling.  After concluding I did not sleep wrong one night and arm pain progressed throughout my arm through the week and dressing was still a one arm operation I went to a doctor one week after initial pain began on Monday 12/19 and received osteopathic manipulation to relieve the tension.  A large bump had formed in my upper arm and needed to be broken down to allow my left arm to function again. It's too early to determine if treatment will relieve all arm pain. 12/20/16.
flashes of light when he closes his eyes/ left eye; This spontaneous case was reported by an other health care professional and describes the occurrence of PHOTOPSIA (flashes of light when he closes his eyes/ left eye) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PHOTOPSIA (flashes of light when he closes his eyes/ left eye). At the time of the report, PHOTOPSIA (flashes of light when he closes his eyes/ left eye) 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.
6/10/2022 Patient received 3rd dose of Janssen vaccine as a 2nd booster dose in error,  patient indicated 1st booster dose. Immunization record was not in the EMR and immunization card was not checked prior to injection.  Vaccination was given without complication. Patient was notified of risks prior to receiving Janssen vaccine and alerted to error during visit, discussed possible risks with patient and stressed importance of notifying physician and Health Department if symptoms arise.
achy; sick after the first dose; nauseous; feverish, but did not have fever; sore arm; blood work and had infection going on; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), ILLNESS (sick after the first dose), NAUSEA (nauseous), PYREXIA (feverish, but did not have fever) and VACCINATION SITE PAIN (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History.  The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRINA FORTE [ACETYLSALICYLIC ACID]), COLECALCIFEROL (VITAMIN D 3) and FISH OIL for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced MYALGIA (achy), ILLNESS (sick after the first dose), NAUSEA (nauseous), PYREXIA (feverish, but did not have fever), VACCINATION SITE PAIN (sore arm) and INFECTION (blood work and had infection going on). At the time of the report, MYALGIA (achy), ILLNESS (sick after the first dose), NAUSEA (nauseous), PYREXIA (feverish, but did not have fever), VACCINATION SITE PAIN (sore arm) and INFECTION (blood work and had infection going on) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Electrocardiogram: abnormal Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
2.5? x 5? raised, swollen, red area on upper left arm, at injection site Painful and hot to touch Low grade fever and myalgia, headache, stiff neck
She noticed on 10-12-08 her arm was red and swollen. She presented to our office on 10-13 with a reddened,oval shaped 4cmx7cm, indurated and warm area on her right arm 3" above her elbow.  The puncture site from the injection obvious. The shot was not given in the deltoid.  She was started on Augmentin. She was seen in follow uo on 10-14.
Large B-cell non-Hodgkin lymphoma; Large B-cell non-Hodgkin lymphoma; This case was reported by a consumer and described the occurrence of diffuse large b-cell lymphoma in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (around the upper torso and were very painful) and nerve pain (several years ago).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced diffuse large b-cell lymphoma (serious criteria GSK medically significant and clinically significant/intervention required) and non-hodgkin's lymphoma (serious criteria GSK medically significant and clinically significant/intervention required). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the diffuse large b-cell lymphoma and non-hodgkin's lymphoma were unknown.   It was unknown if the reporter considered the diffuse large b-cell lymphoma and non-hodgkin's lymphoma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 80 years or 81 years. The patient received Shingrix vaccine, 3 years before the reporting date. From the last year (2018), the patient have been undergoing chemotherapy for Large B-cell non-Hodgkin Lymphoma and received last chemo at the end of May. The patient tolerated the chemo very well. The patient's daughter was concerned that, this chemotherapy might wiped out the vaccines ability to protect patient from shingles and thought that, the patient should get new Shingrix vaccine. The patient asked, whether this could create any issue if received Shingrix after chemotherapy. Also the patient was on a very limited income and asked for available discount program for Shingrix.
This study case was received from the investigator in a trial on 06 November 2013. A 21 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 14 days after he had received the following vaccines on 17 July 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) an injection of TYPHIM VI (lot number, route and site of administration not reported, and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 02.67 and a normal ECG on 26 July 2013. Echocardiogram results were not available. A lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient presented almost 24 hours post vaccination with erythema, swelling and warmth in right thigh, temperature 100 degrees F, no other symptoms.
Aches/pains; Headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN (Aches/pains) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Aches/pains) and HEADACHE (Headache). At the time of the report, PAIN (Aches/pains) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   Reportedly, customer wanted to know if his son can take Tylenol (or any over-the-counter pain medication) and whether or not that would have an interference with the vaccine.  Treatment information was not provided.   This case was linked to MOD21-074690, US-MODERNATX, INC.-MOD-2021-075407 (E2B Linked Report).; Sender's Comments:  MOD21-074690: US-MODERNATX, INC.-MOD-2021-075407:
Patient had exposure to COVID at home.  Tested positive for COVID 4/8.  Asymptomatic.
Red rash on upper part of left arm in area where shot was administered.  Itches but not sore.
poison ivy on face; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "poison ivy on face". Therapeutic measures were taken as a result of dermatitis contact. Additional Information: The patient's age was reported to be 41 (unit unknown). The patient received first dose of Pfizer BioNTech Covid vaccine on 14Mar2021. She was supposed to receive second dose on Sunday but developed poison ivy on face and had to start a 6-day prednisone taper yesterday. She was to take 30mg for two days, then 20mg for two days, then 10 mg for 2 days. She wanted to know if she is okay to still receive the second dose Sunday or she should delay it. Her PCP was very conservative and told her she wasn't sure. When she spoke to her pharmacist, she said it was a low dose amount of steroid for a short duration but was not sure either.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, pt complained of weakness, face very red, BP 120/90; Pulse-80; R-20. Vital signs were monitored for 1 1/2 hours. Range of BP 120/90 to 136/94; P-68 to 80; R-16 to20. Continued to complain of weakness, shakiness and feeling as though she was going to fall when she stood up. EMS was called and pt was taken to hospital. Told to have a recheck with PCP.