chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle Cramps/symptoms much, much worse; Muscle Fatigue/symptoms much, much worse; joint ache/symptoms much, much worse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030821A and 019821A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse). At the time of the report, MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-327992 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received and contains No New Information.
Reported Symptoms: NO ADVERSE EFFECT; DRUG ADMINISTRATION ERROR; Narrative: Patient administered second bivalent booster dose in error. Patient received full doses of monovalent Moderna vaccine on 01/30/2021, 02/27/2021, and 09/29/2021 per CDC/provider recommendations. Patient received initial
APPROX. 5 MINUTES AFTER INJECTION, PATIENT REPORTED FEELING LIGHTHEADED, DIZZY, AND NAUSEOUS. HE BECAME PALE, DIAPHORETIC, AND VOMITTED FOR A FEW MINUTES. PATIENT HAD CHILLS AND WAS WEAK. PT HAD A FULL SET OF VITALS TAKEN (WITHIN NORMAL FOR AGE), MONITORED, AND GIVEN WATER TO SWISH AND SPIT. AFTER 30 MINUTES, THE VITALS REMAINED STABLE AND WAS ABLE TO TOLERATE SMALL SIPS OF WATER. COLOR RETURNED TO NORMAL AND PATIENT WAS ABLE TO STAND AND NOT FEEL DIZZY. HE REMAINED AT THE CLINIC FOR AN ADDITIONAL 30 MINUTES UNTIL HE FELT COMFORTABLE TO DRIVE.
fever; headache; shakes; started feeling miserable; had a red, painful arm; painful arm; body aches; This case was reported by a consumer via call center representative and described the occurrence of feeling miserable in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2020, the patient received the 1st dose of Shingrix. On 16th July 2020, less than a day after receiving Shingrix, the patient experienced feeling miserable, erythema of extremities, pain in arm and general body pain. On 18th July 2020, the patient experienced fever, headache and tremor. On 20th July 2020, the outcome of the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient started feeling miserable, had a red, painful arm and body aches. Two days after receiving Shingrix, the patient developed fever, headache, and shakes. The reporter consented to follow up.
The Anthrax vaccine was delivered to my right arm and the small pox in my left arm. My right arm has throbbed for several months. The pain is mostly when I sleep on my right arm. It was pretty bad for about 4 months. In the past couple weeks, it has gotten better. I went to the Dr for the first time today, he gave me some numbing patches.
Vomiting x3, chills, headache, sweats started 2/24/21 Denies fevers but also admits he has been on Abx and Motrin prior to taking vaccine for his tooth being pulled.
My son woke up at 1am and felt like hw was "burning up" and felt like "heart was beating out of his chest".  Heart rate on running watch was in the 150s.  Pt is a runner and typically resting HR is 52-55.   Mom took temperature and it was 104.1.  1000mg of Tylenol was given. Temperature was checked 20min later and it was 104.8 and checked a little bit  later and was 105.4.   He didn't seem himself during  this time.  HR was still in 120s on HR rate watch, it was difficult to monitor it by had because it was going so fast.    During this time I also monitored my temp (mom) and it was 98.1 to see if the thermometer was working appropriately.    The temperature took 2 full hours to gradually come down to 98.9 and HR round 100.  When the temp was down to 102.1 then he started talking clear and said he felt a little bit better.
3AM 11/12/2010. Child awoke with temp 101 degrees, vomiting then dry heaving. Vomiting stopped at 8AM and child was sleeping comfortably.
Constant fever of 102.8, took Tylenol every 5 hours and never got below 100.9.  Started around 3am 4/22 and lasted until noon 4/23.  Major fatigue, body aches, enlarged and red area around injection - hot to touch still.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Case number PHEH2015US019478 is an initial spontaneous report received from a medical assistant on 29 Sep 2015. This report refers to a 56 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: 1516201) multi dose vial intramuscularly at a dose of 0.5 ml in the deltoid on 17 Sep 2015. It was reported that the patient reported immediate itching down the arms and redness and swelling in the deltoid muscle. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Patient is a 63-year-old female with history of hypertension, GERD, asthma and obesity presenting to the emergency department via EMS from home for having generalized weakness.  Patient states she tested positive for COVID on Friday as she was having fatigue, nasal congestion and body aches.  She states she has not been eating or drinking very well because she just does not have the energy to do so.  She admits to nausea without vomiting, denies abdominal pain or diarrhea.  She does states she started to have a cough this morning, denies chest pain.  This morning when she was going to the bathroom she felt very weak and as if she was going to pass out, however she did assist herself down to the floor, she did not have an injury from this.  Upon arrival to the ED, her main complaint is feeling very weak and tired.  She did receive the Johnson & Johnson COVID-vaccine.  She denies any fever or chills. Associated Symptoms: cough, fatigue, nausea, weakness
unusual reaction, three inch circle of redness; warm to the touch; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2021, the patient received the 2nd dose of Shingrix. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced localized erythema and skin warm. On an unknown date, the outcome of the localized erythema and skin warm were unknown.   It was unknown if the reporter considered the localized erythema and skin warm to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in unknown arm yesterday and had an unusual reaction. On his/her arm had a three inch circle of redness that was warm to the touch. The edge of redness was two inches away from the injection site. No itching. The follow-up could not be possible as no contact details were available.
Hives on legs and back started on Friday and resolved on Sunday.  Patient did not feel sick.
This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 12-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Patient was at Covid Vaccine Clinic to receive a second booster.  Patient stated that he received a text from phone tool on Wednesday that he was eligible to receive a second booster due to working in the health care field.  Patient showed text on phone to RN.  RN verified that patient did not meet requirements for a second booster as patient was under 50 years old and not immunocompromised.  RN reached out to her manager for guidance on the situation.  Patient was discussed, CDC guidelines were read, and manager decided due to information on the CDC guidelines it was ok to give second dose booster.  It was marked in patient's chart that he was given second dose booster because of healthcare worker status.  Booster dose was give, patient handled vaccination well, no problems in observation period and patient left clinic.  After further consideration, verbage of CDC recommendations were rendered that patient was no part of the group that was eligible for second dose booster.
"CIN2" with abnormal cells; On another unspecified date in 2008 after her vaccinations in 2008 her daughter was diagnosed with "HPV".; This spontaneous report was received from a consumer referring to her 27 years old daughter. The patient's medical history included gallbladder removal with digestive issues. Concomitant therapies included iron, B12 shots and birth control. The patient was allergy to amoxicillen and penicillin.  On unspecified date in 2008, the patient was vaccinated with 3 complete doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (route reported as "3 shots in arm"; strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis.         On another unspecified date in 2008 after her vaccinations in 2008, the patient was diagnosed with human papillomavirus (HPV). On unspecified date in 2019, the patient was then diagnosed with cervical intraepithelial neoplasia II (CIN2) with abnormal cells after "colposcopy" was performed. Afterwards, on another unspecified date in "late September of 2019" the patient had cryotherapy. The outcome of events was recovering. The patient sought medical attention for the events. The causality assessment was not provided.
Mini seizure; Diarrhea; Slight temperature; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of slight temperature/fever, vomiting, diarrhea and short seizure early in the morning.  The patient's medical history include type 1 diabetic, history of mini seizures and had a pacemaker installed a week ago-did have check up after and was good. Concomitant medications reported were levetiracetam  - anti seizure, Insulin 2 times per day taking for type 1 diabetes.  On 22 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029120A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  He was fine after taking vaccine, but on 28 Jan 2021 started developing symptoms.  On 28 Jan 2021, the patient experienced the events of slight temperature, vomiting and diarrhea. On the same day, patient experienced the event of mini seizers for about 5 min in early morning and took levetiracetam. No other treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's history of seizure was a strong confounder of the event of short seizure early in the morning.
SIDS death 16JUL92; petechial hemmorrhages; pulmonary parenchyma is dark red-purple, deeply congested & exudes large amounts of bloody frothy fluid on sectioning; autopsy dx generalized visceral congestion;
Soreness at site, tiredness, headache, sleepiness, soreness at hand joints, lymph nodes inflammation.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Patient stated they felt like they were going to pass out and felt very nauseous, was also visibly sweating a lot.  Called 911 and rescue treated patient on scene, patient walked out of store with EMTs after being monitored/treated for around half an hour.
Why am I so sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Why am I so sick) 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 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Why am I so sick). At the time of the report, ILLNESS (Why am I so sick) outcome was unknown.
Vaccine administered was from a vial punctured ~27.5 hours earlier so was beyond use date. It had been in a temperature monitored refridgerator during that whole time except for 3 brief intervals to draw up maccine.  Patient had no adverse effects except mildly sore injection site for 2 days. He & his provider have been made aware of the error. He's returning today to repeat the 1st dose of the series. He'll be advised per MD recommendation to return in 8weeks for the 2nd dose of the 2 dose series.
Immunization given in am.  Mom called and reported generalized hives and a temp of 102 in the evening.
Vaccine given at 4pm on 8/31. At 10:30pm that night, baby vomited. The next day, 9/1, baby had four BMs (two were very runny). Two days later, baby had five BMs (very runny), Three days later, 9/3, baby has already had five BMs and it?s only 7pm. Baby has always had only one bowel movement a day. He is now having five bowel movements a day and the BMs are all very loose/runny.
12/4/21 Cough  - CXR w b/l infiltrates  - pt states he finished a course of abx for pna  in oct and has had persistent cough since - CT chest wo conttrast - covid/flu/rsv, sputum cx, urine ags 62 yr/o male with hx metastatic prostate cancer to bone status post previous chemo, DM, CKD, HTN, and DVT in left upper arm status post a PICC line who presents with severe low back pain for the last week.  He states he can hardly stand and can only pivot when unassisted.  Otherwise he needs assistance in getting up and walking any distance at all, even to the restroom.  He denies any bowel or bladder complaints.  He states he saw Dr. in the office yesterday and an MRI of the lumbar spine was done
Resident was noted to have increase in confusion and lethargy with elevated heart rate and BP.  Resident was transferred to hospital where he required an increase in supplemental oxygen.  Resident was admitted to the hospital and diagnosed with exacerbation  of asthma.  Uses oxygen for exertion and CPAP at night.
redness and pain at the injection site, painful to walk- mom administered Benadryl; on exam there was a 22 cm area of warmth, tenderness on right anterior thigh, extending inferiorly to above the knee; Cephalexin and Prednisolone prescriptions given
High fever  with chills approximately 12 hours after vaccination. Severe headache, mild nausea, loss of appetite, joint pain. Arm pain significant with almost no range of motion without pain. Swelling around armpit. Ibuprofen taken with minimal relief. Arm pain, headache, intermittent fever is ongoing at this point in time.
Small very very red area raised with visible blood underneath, around 3 inches next to injection site; A spontaneous report was received from a consumer concerning a 73-years-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed a small very very red area raised, with visible blood underneath.  The patient's medical history included heart issues. No concomitant medications were reported.   On 30 Dec 2020 , approximately six hours prior to onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot/batch number: unknown) in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, he experienced a small very very red area raised and you can see blood underneath. It was around 3 inches next to the injection site. The patient did not receive any treatment to treat the symptoms.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event a small very very red area raised, with visible blood underneath was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient had swelling, redness with burning, chills and fever after receiving injection. Called to report and sent to walk in care on 09/10/17. Did have erythema, swelling and area showed ecchymosis. Was given Ibuprofen to take for pain and to use warm oil massages. To f/u with PCP in 3 days. She did follow up with Dr. on 9/13/17 and c/o of same symptoms with swelling, redness. Arm had large induration. Was told to take BENADRYL and Ibuprofen. Called back on 9/28 with difficulty moving arm. Was told to take prednisone. No call back till patient came to see doctor for routine appointment and she stated she wanted manufacturer aware of SE.
Patient reports swelling and redness of the left upper arm that spread from shoulder to elbow. Patient said the redness developed the next day and continued for about a week. She claims benadryl OTC 25mg helped the redness drastically. She reports never having this reaction.
Pt received ZOSTAVAX 10/25/13. About Nov. 2013 hand started shaking. Rt side is affected. Rt leg shakes. Speech slightly impaired. Dr cannot find a cause. Pt states she is worse.
Swelling in the lymph nodes under the arm pit; The injection site in the arm is sore; This spontaneous case was received on 24-Nov-2021 from other non-healthcare professional (consumer) via Agency (reference number: SEQW21-05638) and concerned a 67-year-old, female patient.  The patient's past medical history included lung cancer, a couple of years ago. The patient's historical vaccines included unspecified both Covid-19 vaccines used for an unreported indication. The patient was not taking any concomitant medications.   On an unspecified date in Oct-2021, reported as six weeks ago, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Oct-2021, reported as six weeks ago, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced swelling in the lymph nodes under the armpit and the injection site in the arm was sore. The patient did not use any corrective treatment.  At the time of initial reporting on 24-Nov-2021, the patient had not recovered from swelling in the lymph nodes under the arm pit as the patient stated that she was still experiencing and that the swelling was reducing day by day but it was still bothering a lot.  The outcome of the vaccination site pain was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Case updated on 26-Apr-2022: Correction made to information received on 24-Nov-2021: Regulatory authority was deleted from Intermediary field and Report Sent to Regulatory Authority by Reporter was changed from 'Yes' to 'Unk'. No changes in the narrative.  Company comment: A 67-year-old female patient experienced lymphadenopathy and vaccination site pain after receiving Fluad Quadrivalent. Based on information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A 67-year-old female patient experienced lymphadenopathy and vaccination site pain after receiving Fluad Quadrivalent. Based on information provided, causality for the reported events is assessed as possibly related.
Pfizer-BioNTech COVID-19 Vaccine EUA (administered on 03/26/21)  Fever, chills, headache, general soreness all began on 03/27/2021. On 03/28/2021, I began to notice chest pain and simultaneous pain in my left arm on 03/28/2021. The fever, chills, headache, and general soreness subsided on 03/29/2021, but the periodic chest and arm pain persisted and continued to get worse. On 03/29/2021 I also had nausea/vomiting and sweating. On the morning of 03/30/2021 during an episode of chest and arm pain we went to the Emergency Department at. At the emergency department, they detected elevated troponin levels indicating damage to the heart muscle. I was rushed via ambulance for an emergency heart catheterization. I was admitted to the hospital and monitored while various other tests were performed. It was determined that there was inflammation of the heart muscle (myocarditis).