chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ongoing arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ongoing arm soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-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 VACCINATION SITE PAIN (Ongoing arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Ongoing arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, Advil.
Herpes zoster (L) axilla to back dermatome s/p VARIVAX 2/4/13. No pain or morbidity < 24h sx --> treated with acyclovir.
Patient developed three lesions at 2 days post injection, each approx 3-4" in diameter, within a 10" area around the site of injection. Pt applied ice. At 3 days post injection the lesions had become indurated and massed into a red swollen area approx 1 foot in length, possibly resolving and a little less warm to touch.
Headache, Myalgia, Diarrhea & NauseaVomiting Narrative:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:The patient had no known allergies and other medical history.The patient did not receive other medications in two weeks. The patient was administered with Paxlovid for treatment of covid-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Horrible side effects within 9 hours and had to be admitted to emergency room.  Husband and son also got shot at same location with similar side effects but not requiring hospitalization. Massive body shakes, chills, slurred speech, accelerated heart rate, high blood pressure, shaking so hard could get EKG
red sore in his arm; This is a spontaneous report from a contactable consumer (patient himself). A 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm on 13Feb2021 (at age of 88-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red sore in his arm on an unspecified date. It was reported that, caller had his first COVID-19 vaccine on Saturday. Caller was asking once the vaccine was injected in the arm, when could he remove the band-aid and did he need to have any treatment for it. He said that it was already 2 days since he has been vaccinated and he had not removed the band aid once. He was asking what to use for treatment for the red sore in his arm. Caller denied the presence of any other side effects. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt brought to ED by EMS with increasing SOB and diarrhea; sx going on for 1.5 wks and progressively worsening; O2 sats 50% on RA; O2 supplementation; transferred to ICU; pt's condition worsened; intubated; arrested shortly afterwards; gained a perfusing rhythm but critically ill; developed an epinephrine dependent PEA; multiple attempts at resuscitation; family chose to stop resuscitation efforts and she passed away in the hospital
burning/warm to touch; redness at the site of injection extending halfway to the shoulder; swollen; soreness/burning sensation at the area of injection; felt tired; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (burning/warm to touch), FATIGUE (felt tired), CHILLS (really bad chills), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen). On 26-Feb-2021, FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sjogren's; aches; fatigue; dryer than usual eyes; anemia; low iron; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Age at Vaccination was 56 years. Medical history included suspected history of Sjogren's. The patient's concomitant medications were not reported. Previously patient bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and no events reported. The patient experienced general aches, pains, fatigue, dryer than usual eyes 24hrs after the 2nd COVID shot. Blood tests report anemia and low iron. He has a suspected history of Sjogren's. Tests were inconclusive for the diagnosis but doctor's assume from the symptoms it is Sjogren's. Optional Information was reported as previously mention, he was suspected of having Sjogren's. Several doctors were in agreement based on tests and physical presentation. It was asked could Sjogren's exacerbate the side effects and cause the anemia and low iron. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
I  got pregnant 2 cycles after receiving my 2 dose of Covid vaccine. I have had 3 previous healthy pregnancies with no uterine or blood disorders causing miscarriage. At 12 weeks I had a sudden miscarriage and a hemorrhage. After 2 cycles I conceived again and had another 6-7 week miscarriage genetic related. There is no medical reasoning for this to occur with my past history. The only change was my vaccine and husband vaccine. I believe this could be correlated.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non-significant follow-up received contains: Reporter details updated.
Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subsided at 9:00pm woke up at 10:45pm and can?t stop shaking legs and rapid breathing....still going in at 12;30am as I wrote this
a couple of patients past the 6 month time frame for their 2nd dose of Shingrix; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients did not receive the 2nd dose till the time of reporting and were past the 6 month time frame for their 2nd dose which led to incomplete course of vaccination. The reporter declined to provide any patient details, stating that he did not have permission from the patients. This case has been linked with US2021072245, reported by same reporter.; Sender's Comments:  AE-GLAXOSMITHKLINE-US2021072245:Same reporter. 1 patient.
First day I just got arm pain, second and third day( Friday and Saturday morning), chills, pain in the left arm and lower back pain, I staring taking Tylenol, and everything was gone ? the lower back pain still but was controlled with Tylenol monday, Tuesday, and Wednesday had really bad chills, headaches,lower back pain, join pain I took more Tylenol, family came during the weekend I decided wait until monday to go to my primary doctor, they did urine test and I had no infection but the lower back pain still,
Information has been received from a physician concerning a 73 year old female patient who on 21-MAY-2007 was vaccinatedSC on left arm with a dose of Zostavax (lot # 657559/0462U). On 25-MAY-2007 the patient returned to the office with red spots under her bra line radiating to the back becoming fluid filled. Additional information has been received from the registered nurse who stated that on 25-MAY-2007 patient was seen in clinic with complaints of red raised areas with yello fluid forming in several with pain and burning. Lesions were above waist line that progressed on left side to mid back. Patient was treated with ZOVIRAX. It was reported that patient had a follow up appointment on 30-MAY-2007 and shingles lesions were receding. At the time of report the patient had recovered. No further information is expected.
The next day after I received the Covid 19 vaccine, my lymph node under my left arm ( the arm in which I received the vaccine ) swelled to about the size of a softball, and was very tender for 3-4 days in duration.
Rash all over body. Slight itch 10/13/09, 6 days age had FLUMIST.
At 3:00 am on 1-27-21 I awoke unable to control my mouth. Face, arms, Legs and whole body. My entire body was shaking violently.  Finally able to get to my feet and stumbled trying to notify 911. Stumbled to room closest  the front door. Husband opened front door for EMS. For about  1 hour I sat and my whole body trembled. Finally the thrashing about slowed down and stopped. Today I am very tired and achey.
A medical assistant reported that a 12 month old child received an injection of Acel-Immune and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Patient called to report that she "felt bad" and her arm hurts when she moves it, and that she could hardly move it.  Patient was encouraged to call her physician.  Unknown if  she did. Doctor's office notified 10/10/19 1:12pm.
This spontaneous report as received from a registered nurse via company representative refers to patient of unknown age and gender. On an unknown date, the patient was vaccinated on the same day with two doses of M-M-R II (dose, dose numbers, lot/batch number, expiration date, route and frequency were not reported). No adverse effect was reported. Additional information has been requested.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: severe pain, limited range of motion-Severe, Additional Details: has been seen by multiple doctors, including orthopedic specialist; will need MRI, possibly physical therapy
within an hour of vaccination, felt pain and decreased range of motion. Over the next 24 hours, range of motion remained very limited and shoulder painful. Saw physician on 9/30/20 who did Xray, gave prescription for Mobic and concluded probably bursitis from being injected in the bursa. 10/6/20, still no relief. Followed up with physician, started dexamethasone and referred to orthopedic.
Uncontrollable shaking; Almost passed out after second dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after second dose) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after second dose). At the time of the report, TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after second dose) outcome was unknown. Not Provided          Reporter has reported that the patient almost passed out after second dose and visited E. R. in May 2021. No concomitant medication was given by reporter. No treatment medication was given by reporter.
Flu and diarrhea from 4 to 11 Nov. 12 Nov. numbness in arms and legs. 13 Nov fell while walking, 14 Nov. couldn't stand. 15 Nov. unable to move, taken and admitted to hospital by ambulance.
Information has been received from a physician concerning a 10 year old female who was vaccinated with a first dose of GARDASIL. The patient had spotting for two days and then experience resolved. There was no laboratory studies performed. The patient sought medical attention through a call to the physician. Additional information has been requested.
Extreme muscle aches, Headache, Alot of Trouble Focusing on anything, bones and muscle feel extreme fatigue.  Feel out of it like I'm walking around exhausted and not really here in the present.  Brain very foggy.
Complaint of chest pain, states she was getting over COVID 19 dx on 4/2/2021,  Chest pain rated 5 out of 10/  Feels like something sitting on her chest.  Denied radiation of pain to chest.  Patient was placed on stretcher. Paramedic arrived and place patient on a monitor.  At 1:45pm pt. Received Asa 81mg four tablets by mouth.  Ambulance notified per paramedic.  Denied sob, res. 18 deep and even.  EMS present with patient.  She was offered transit to ER, but declined transit to ER by ambulance.  Patient left.  EMS notified DPH of incident and patient status.  CMO had ordered the ASA 81mg tablets to be given.
ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt. c/o redness and edema of left upper arm starting today. Site feels warm to touch. Left arm is site of Prevnar injection, administered on 10/14/16. Denies insect bites. Denies being outdoors and states she wears long sleeved shirts. Denies scratching area. Pt. reports placing Lidoderm patch on affected area on Saturday morning for arm pain, removed it on Monday and replaced it with a new one. She removed that patch today which is when she noticed erythema of left upper arm. Diagnosis Cellulitis left upper arm. Treatment: Sulfamethoxazole trimethoprim 800-160mg oral 1 tab q12 hours x 14 days. Follow up office visit scheduled 10/21/16.
Patient states that by the time she got home form office inj. site was sore, red and swollen. Pain was a '10' till 7-26-17. Redness and welts spread down to (L) elbow. Welts were 3" x 2" and 3" x 1". Inj. site redness and welt was 3.5" x 2". (L) arm was itchy also. Upper (L) arm was warmer to touch than forearm. Patient states has 'Bad' headache also. No fever. (lasted 8 days)
Inconsolable crying for 5 days. Also had T to 99.6dF 5 days after vaccine. Greener bowel movements for last 5 days (also given rotavirus vaccine at same time).
Developed COVID shortly after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed COVID shortly after the vaccine) in a female 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Developed COVID shortly after the vaccine). At the time of the report, COVID-19 (Developed COVID shortly after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Urinary track infection (after receiving the first dose of Moderna COVID-19 vaccine); This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary track infection (after receiving the first dose of Moderna COVID-19 vaccine)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary track infection (after receiving the first dose of Moderna COVID-19 vaccine)). The patient was treated with CIPROFLOXACIN at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (Urinary track infection (after receiving the first dose of Moderna COVID-19 vaccine)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included that she was prescribed a 7-day course of an antibiotic (ciprofloxacin) and that her UTI symptoms resolved once the antibiotics were completed.  Concomitant product use was not provided by the reporter. Lab details were not provided.   She states that she experienced no other symptoms.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14 MAY 2021,Additional information received, information about antibiotic course included, outcome of the event updated as resolved. On 08-Jul-2021: Follow up included no new information.
Bones/Muscle aches; vomiting; tired; stomach ache; weakness; Bones/Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 26Apr2021 at 08:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, arthritis (Arthritis of spine), pain in leg, pain in spine (Chronic pain in spine and leg). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient received other medication within two weeks of COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 09:30, the patient experienced bones/muscle aches, vomiting, tired, weak, stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bones/muscle aches, vomiting, tired, weak, stomach ache was not at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 24-OCT-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection lot # N007931 with expiration date on 17-NOV-2019 (dose and route of administration were not reported). The administered vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 3 hours and 15 minutes. There was a previous temperature excursion of 9 to 25 degrees Celsius for 15 minutes. Digital data logger was involved in recording of the excursions. No adverse effects were reported.
Large local reaction to right arm extending below the elbow. Edema, erythema, warmth to touch, joint pain to right elbow, and limited range of motion were noted.
Patient was vaccinated with Moderna that expired on 8/11 from Refrigerator.  Moderna was place in the refrigerator on July 12th from freezer stock