chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had severe shoulder pain after the first dose; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included frozen shoulder and hashimoto's disease.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. Concomitant products included Steroid Injection. The patient received 1st dose of Shingrix in right deltoid, more than 6 months before the date of reporting and experienced severe shoulder pain.  Till the time of reporting, the patient did not receive 2nd dose. No primary care physician information given. The reporter consented to follow up.
Severe headache, undoubtably a migrane. Began approx 4 hours after vacinnation and ended approx 3 hours later.  I very rarely get migrane headaches - approx one evry 2 years so this seemd like too much of a coincidence
Chills, fever, muscle contractions, shooting pain, headache. Red, sore hot at place of vaccine size of baseball.
This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023159, expiration date 26-JUL-2016) (dose, strength and frequency were not reported) oral. Concomitant medication was not reported. No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Pt  is only 14 years old and was given booster of Moderna Vaccine which requires 18yrs and above for booster . No sypmtoms,signs of any adverse reaction noted.
Fever of 100F; Chills; muscle and joint aches; red spot on the injection; sore injection site; tender injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection) and INJECTION SITE DISCOMFORT (sore injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site). On 25-Jan-2021, the patient experienced PYREXIA (Fever of 100F), CHILLS (Chills) and MYALGIA (muscle and joint aches). At the time of the report, PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 100 (Inconclusive) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
2 d after MMRV administered pt developed redness at injection site; 3 d after inj erythema, pallor increased from elbow to shoulder with sl itching at site; No vesicles no fever; 9/9/13: decreased pallor/decreased erythema; site improving.
Erythematous swelling at site of injection (-) fever (-) systemic symptoms. No other signs.
5 hours after getting varicella injection, patient developed high fever (104.3). Unable to get temperature down. Took to ER at 7 PM and admitted to hospital. High pitch cry, red rash on chest. Was given IV antibiotics and antibiotics to take PO. Discharged from hospital 4/30/04.  Nurse follow up on 07/30/04 states: "allergic reaction immunization; otitis media; irritability."
Rash to Rt. Upper arm at injection site.   Patient became anxious.  Pulse ate 100.  No DIB.  BP, Resp. WNL.  RRT called for additional monitoring.  Patient monitored > 15 minutes.  Cleared to go home at 5:07pm without incident.  Resolved anxiety.  Pulse:  77
Soreness/Pain at site of injection. Tiredness/Lethargy for two days
I hear a high-pitch ringing or buzzing sound constantly. I hear it at all times since it set in a day or two after my second dose covid vaccination. I believe this is called tinnitus. A week after my second dose, it is still loud and may be getting louder. I believe this is called tinnitus. I can still hear quiet sounds, at least in other frequency ranges. But it is quite annoying, particularly when I am in a quiet environment with nothing to distract me.
Got shot on Saturday  - Sunday morning at 1 am I woke up with a slight headache, chills, sweating, and my muscles felt heavy.  Went back to bed, woke up and was fine. Once I started moving around my muscles become achy again and I got chills. This lasted all day Sunday. Monday I have minor muscle aches.
swelling in dermal fillings and numbness in arms and feet. Feet turn white when walking 10 mins standing up
Info has been received from a medical assistant concerning a 66 year old female pt who on 09/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640576/0923L). Subsequently, the pt had a "severe topical reaction at the site of injection". On 09/11/2002 the pt presented to the doctor's office with injection swelling, injection site redness and the pt complained of pain. The physician prescribed doxycycline 500 mg every 6 hours for 10 days. As of 09/16/2002 the office has not heard from the pt. Additional info has been requested.
rt leg reddened & swollen shot area, did not start until next afternoon;warm compressed to area, improving everyday;
Same day reaction-large, local, red, round, welt and warm mass on thigh at injection site. Went to clinic and was told it was MMR reaction. It went away the next day. Mom brought in picture.
Fever 101, Chills, sweats starting about 11:30PM, lasting until 7:00am, Tylenol.
Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB and subsequently developed an adverse event. Additional information has been requested.
administered only the liquid portion of the Menveo vaccine; administered only the liquid portion of the Menveo vaccine; first dose received in 14AUG 2015 and second dose received on 09 JUN 2021; that arm was sore; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menveo (1st dose received on 14th August 2015).   On 9th June 2021, the patient received the 2nd dose of Menveo .5 ml, Bexsero and Bexsero Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Menveo and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long. In June 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient received Bexsero and Menveo vaccine in different arm. The patient received 2nd dose of Menveo, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter stated that the patient came in on 9th June 2021. There was a temp working in the office and she inadvertently administered only the liquid portion of the Menveo vaccine (she forgot to reconstitute), which led to inappropriate preparation of medication, inappropriate dose of vaccine administered. The patient also received a dose of Bexsero on the same day and experienced sore arm (on which she received  Bexsero vaccine). On 10th June 2021, the office realize what happened with dose of menveo, they called the patient to explain what happened. The reporter stated that on 24th June 2021, the patient would receive the correct dose of Menveo. The reporter was not aware of any side effects. The reporter consented to follow up.
Felt fatigue went to bed with hot throat. Woke up with shoulder pains, joint pains on Shoulders, knees. worst is the back of my upper thighs fell like I walked or hiked (Severe Muscle pain to the touch. NO fever just wide spread pain all over especially the shoulders, elbows and knees. So far I have not gone to the doctor but will if not better by this MONDAY coming.
red and itching on arms and chest - started at 7:00 pm and still itching next day at 1:50 pm red circle where injection when in is getting bigger - 2 quarters side by side size and hot to touch very tired
no additional adverse evetns; A 17 year old patient had two doses of GARDASIL 9 and was told that was all that was needed fro the series; A 17 year old patient had two doses of GARDASIL 9 and was told that was all that was needed fro the series; This spontaneous report was received from a pharmacist referring to a 17 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On approximately 2021, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter for prophylaxis (route and site of administration, lot number and expiration date were not reported) and was told that was all that was needed for the series (wrong schedule and product use issue).  No adverse event were reported.   Pharmacist had encouraged patient's mom to talk to her child's healthcare physician to seek recommendations of 3 dose series for age of 17.
I began to experience swollen lymph nodes on the armpit and pain that inhibited me from completing basic functions and impacted sleep and caused severe pain. This began Sunday December 12th in the evening time.  Beginning on Monday, my throat began to feel sore, which became progressively worse, quickly. By Tuesday morning, it felt like I was swallowing hot glass, unlike any pain I have experienced before. I was unable to work Tuesday morning and was able to work Tuesday afternoon, as I talk for a living. By Wednesday evening, I did not have a voice at all and was unable to speak for five days. I missed work and other activities and felt awful. I stayed in bed and was unable to complete other functions that did not require me to speak. By Monday, my voice sounded raspy, and I was understood to some degree and tried to work some that following week, still not at full capacity. One spot in my throat still hurts today when I swallow and this morning, felt like it was splitting again and hurting like before.
Redness and swelling at injection site, warm to touch, tingling down arm to hand, pain in arm and hand.
Pain at the injection site and leg starting at 5:00 AM, headache starting at 6:00 AM, nausea starting about 1:00 PM, pain in fingers, side of the face, and back starting about 3:00 PM.  Pain has been moderate but enough to wake me up during the night. After taking ibuprofen at 3:00 PM, the plane is less at 4:00 PM
Initially sore upper arm, some swelling and tenderness. Increased swelling and tenderness by nightfall - 10:00pm. Even more swelling and actual pain all day 6/19/2013 accompanied by nausea and loss of appetite, chills, fatigue, and slight fever (2 degrees above normal). Noticed that upper arm had swollen to twice normal size by early morning of 6/20/2013 and upper arm had developed red blotches extending from mid-upper-arm to elbow joint.
mild-moderate pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received Shingrix. In August 2021, less than a day after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got Shingrix shot yesterday from the day of reporting and had mild-moderate pain.  The reporter asked how long the event do last typically, one day or longer. No contact details were available.
Pt started crying as soon as taken home & didn't stop crying according to mom; Pt seen @ clinic;
Extreme diarrhea episodes; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea episodes) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea episodes). At the time of the report, DIARRHOEA (Extreme diarrhea episodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 55-year-old, via an unspecified route of administration, administered in left arm on 16Feb2021 08:30 (Lot Number: EN6200) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 20Feb2021, the patient started developing some tingling and the right side of his face doesn't work anymore. The next day (21Feb2021) he went to the doctor and he was diagnosed with Bell's Palsy. He has got full blown, right side of his face was flop, bell's palsy. He went to the doctor and they put him on Prednisone, which he was still treating. The event required a visit to the physician office. The outcome of the event was unknown.
pt diagnosed positive for COVID on 8/25; received monoclonal antibody infusion on 8/30; presented to ED on 9/2 with increasing SOB, cough, weakness, N/D, poor appetite; found to have A Fib with RVR; hypoxic respiratory failure due to COVID 19; PMH of liver/pancreatic lesions; pt does not want chemotherapy treatment; started on dexamethasone and remdisivir, 2-3 L O2 via NC; AKI on CKD; pt elects to forego liver bx; comfort care measures were instituted and pt died in the hospital
Patient is developing fever blisters. Got prescription for Valacyclovir 500 BID x 3 days on 4/20/18. Vaccine given on 3/22/18.
Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol  acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.
Suffered 1 day after Moderna shot, left arm, pain in armpit area both arms a little into breast (not in chest).  Pain in bottom of triceps bottom of arm when any pressure or extended reach.  Pain in both legs inside thigh area (gone now). Still to date suffering with pain in armpit area, right arm forearm area (stretch/picking anything up).  I went to Urgent care on 3/9/21, got diagnosed with "Myalgia" and prescribed 500 mgs Niacin 2 times a day.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2520 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
syncopal episode x3.  Loss of consciousness each time less than 1 minute.  pale, diaphoretic.  Bradycardic, HR low 50's.  Blood pressure stable.  Neurologically intact.  EMS notified and transported to Hospital for further evaluation. 7:36 to 800:
Beginning the day after the second injection, I experienced severe headaches and diarrhea. Diarrhea lasted two months, daily. Headaches, severe and intermittent. Also, beginning the day after the second injection, I began to experience, and continue to experience to this day, intermittent muscle pain. I can best describe it like I'm being poked randomly with a pencil. The pain is sharp, it throbs, and is random and intermittent throughout the day and night. It wakes me up from my sleep. The jabbing pain will last about 30 seconds to 1 minute, then it will randomly occur in another location a few minutes later. Additionally, I experience waves of fatigue and a feeling of heaviness throughout my body. This also is intermittent and random. As a runner, I have lost my stamina and have been reduced to walking for exercise.
Case number PHEH2014US020713 is an initial spontaneous report received from a medical assistant on 14 OCT 2014. This report refers to a 55 years old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with expired FLUVIRIN 2013/2014 (batch number: 1309501) intramuscularly on 11 OCT 2014. No adverse events reported after the maladministration (expired vaccine used).
Ten minutes after receiving Anthrax, JEV, and Smallpox vaccinations patient began to feel lightheaded. He then began to have tremors and started sweating profusely. Vital signs remained normal. Symptoms improved after receiving IVF and Morphine.
I was unable to put weight on both hips.I had to use a walker. It gradually shifted to left hip. I was unable to work. It took 6 days for pain to go away and feel normal.it has been 12 days lam still having pain in my left hip.I had a left hip replacement in 2018.
Pt was to receive 0.25 ml booster dose Sars-2-COVID, instead received 0.50ml dose. Sore arm for a couple of days.
No adverse event; bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) in an elderly female patient 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 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No concomitant medications were reported.  The patient in their 70s and had 4 doses of the Moderna COVID-19 vaccines. The most recent was a bivalent Vaccine however, it was administered as a dose of 0.25mL. The vaccination facility recommended they come back into that facility to receive an additional 0.25mL dose.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-680160 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680160:Husband case
This spontaneous report as received from a treating physician (M.D.) via a company representative refers to a 12 year old female patient. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot # J003727, expiry date 07-NOV-2015), route reported as injection (dose not specified). She was seen at the Emergency Room of an unspecified hospital that same evening (05-AUG-2013) with symptoms of dizziness, slurred speech and slow response to stimuli. The patient ws not kept overnight. on 06-AUG-2013 the slurred speech returned and the physician was contacted by the Parent. The patient was seen at the office of the physician again. The symptoms resolved after being given carbohydrates (unspecified), GATORADE to drink. It was not stated whether or not a third shot of GARDASIL would be given. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, Expiry date, route and dose were not reported) that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
Possible "Covid arm":  Significant itching occured at the inj site the day after vaccine was administered but went away the following day. Yesterday, 7 days later, significant itching at vaccination site began again, continues today. Area is still red, hot, and raised.
Difficulty breathing, tight chest, gave 1 EPIPEN, 50mg Diphenhydramine IM. EMT came and Pt refused to go to hospital. Appears to be resolved.
12 hours after dose began to have cold chills, body aches, and headache. Lasted for approximately 12 hours.