chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm achiness; Tenderness; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, several hours after receiving Shingrix, the patient experienced pain in arm, tenderness and fatigue. On an unknown date, the outcome of the pain in arm, tenderness and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient experienced arm achiness, tenderness and fatigue after receiving the 1st dose of Shingrix. The events became worse the following day and the next day and then, were resolved after 3-4 days. For the tolerance of 2nd dose, refer the case- US2020AMR202084. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202084:Same reporter
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on  Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and  20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes.  Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
Patient became diaphoretic, hypotensive and started having dyspnea within 5 minutes of receiving flu vaccine. The nurse administered 0.5 ml epinephrine subcutaneous in left arm and 911 was called. Emt's arrived within 4 minutes.
Started getting intrusive amount of palpitations. Unable to sleep some nights due to palpitations. They would also interfere with my exercise regimen.
Patient reports approximately 1 hour after receiving vaccine, tongue began to swell and had feeling of "white pepper" and burning on tongue with sore throat and severe pain in arm.
Clinical Summary  58 y.o. female patient of DO with history of HTN, asthma, HFpEF. Presents with pneumonitis due to covid-19.     Acute Hypoxic Respiratory Failure Concern for Pneumonia, unspecified Pt presents with dyspnea, oxygen requirement, no home O2 PFT 6/2022 no obstruction, mild restriction  Home regimen Albuterol, Breztri, Singulair  CXR: small L pleural effusion with adjacent opacities which could represent PNA vs atelectasis. CT PA with no PE, ground glass opacities in lung bases that appear persistent from prior imaging S/p azithromycin (3/29-4/02) Ambulating comfortably on RA by the time of discharge. Treatment for covid-19 as below Plan OP follow-up with Pulmonary   COVID + Positive  COVID + Positive on resp PCR 3/30 Treated with Azithromycin for possible bacterial component as above Improved and tolerating RA at the time of dc Completed course of Remdesevir PTD Decadron after discharge to complete 10 days   HFpEF BNP reassuring at 170, however patient obese CXR as above CTPA negative Echo with grade I diastolic dysfunction and normal EF, unchanged from previous Continue coreg 3.125 mg BID, losartan, hold spironolactone and torsemide in setting of AKI Diuresed with IV Lasix during the admission Resume home Torsemide after discharge   AKI, resolved Likely due to dehydration in setting of acute illness   HTN Continue home Losartan, Coreg 3.125 BID, holding torsemide and spironolactone   Presumptive OSA Will need sleep study outpatient
booster given 5 months after 2nd Moderna dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose). On 31-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given 5 months after 2nd Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Patient received half booster dose.
I am currently at home with a shingles flareup. I think this time it was early Horner's syndrome and possible early zoster (shingles) meningitis, but not sure about the Horner?s and headed to PCP in a few regarding the bodyaches and rash on chest...to determine if I need to go to hospital to be evaluated for early meningitis from recurrent zoster.  I went to eye doctor last Friday for acute onset, right-sided eyeball pain and swelling....on same side of my face from my last flareup. He started me on acyclovir and prednisone eye drops. Then. Got better for about a day or two. Now I have a painful shingles rash on my right chest, and I am achy all over and my left thigh and stomach are hurting like I got punched. If a rash appears there, I am going to hospital right away. Going to see PCP at 430. I got the shingrix vaccination due to recurrent shingles flareup prior to that. But they were mild and not so frequent. After both injections last year, for Shingrix, I was out of work sick with flu-like symptoms. Then earlier this year I was out of work for about 2 weeks due to flareup on my face that happened. I?ve had 3 minor flareups in a spot on the back of my leg that come and go. Now the problems I mentioned at the beginning of this paragraph are current as of today. I am on  800mg acyclovir which was restarted by my ophthalmologist for my right eye. I have completed the  prednisone drops. But face is still numb and right chest wall has small painful  rash.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.48.   Concomitant products were not reported.  On 27-OCT-2021 Excursion time was reported at 09:00 A.M and 10:00 AM with  temperature as 29 and 32 degrees Fahrenheit, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021 and 05-OCT-2021, vial was moved to clinic on 27-OCT-2021. 2 and 4  vials were sent to clinic. Vaccine BUD date was 29-OCT-2021 and 04-NOV-2021.  Vial was stored on cooler 1, on 27-OCT-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recvd vax passed out, pale, ammonia inhalant used & woke up; MMR given as being given passed out again, pale diaphoretic twitching of arm eye rolling back last 5-10 seconds; BP 70/0, nerves, twitching, loss of 02;
Patient has developed a large Thyroid nodule after her 3rd shot- experienced soreness in her arm at injection site with 1st 2 doses Thyroid peroxidase antibody 0.8 T3 total 1.4 TSH 1.30 free T4 1.5 Thyroid ultrasouhd: 3.4cmx2.8cm x 2.4 cystic + solid nodule on L Thyroid -ill defined with significant septations -requires biopsy
Upper left arm was red & swollen and had a lot of pain & discomfort, especially at night. Felt very weak & tired 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for antibiotic clindamycin. Follow up with Dr. on 9/19/2011. Hospital diagnosis: cellulitis.
A report has been received from a Health Professional concerning a 1 year old, male subject, weight: 30.0 pounds, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The 18 month old patient was administered QUADRIVALENT FLUMIST which started on 02-Sep-2014. The outcome of the event of 18 month old patient was administered QUADRIVALENT FLUMIST is unknown. The report was considered to be non-serious.
Suspected Vaccination failure/got shot & several years later had shingles, but not as severe.; had shingles, but not as severe.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and several years later had shingles, but not as severe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Patient felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney cancer. Concurrent medical conditions included Immunocompromised (Immunocompromised patient due to kidney cancer).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Patient felt dizzy). At the time of the report, DIZZINESS (Patient felt dizzy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant product use was reported.  It was reported that the immunocompromised patient due to kidney cancer received their 1st dose of Moderna COVID-19 Vaccine and after 1st dose the patient felt dizzy.  The patient's height was unknown and any allergies to medications, food and other products was unknown. It was unknown whether any recent change occurred in status such as improvement or worsening of medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was also unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number.  Reportedly, it was unknown if the patient had experienced a similar event in the past.  The patient's weight was reported as 142.  No treatment information was provided.   This case was linked to MOD-2022-538919, MOD-2022-538920 (Patient Link).
Rash on vaccine site, warm to the touch of vaccine cite, itchiness on vaccine site
Shot given around 2:20pm. Woke up at 4:20am feeling too hot, then chills, symptoms progressed to headache, dizziness, severe (nearly continual) vomiting.  Most symptoms are gone as of 10/28/2021 2:15pm except the headache and fatigue. Could not stand up without triggering vomiting.
Myalgia, NauseaVomiting, swelling and pain at injection site. Chills. Narrative: Per nursing report: "2nd dose of Moderna yesterday [2/1]. C/o about 4:30 pm [2/1] started having chills, body aching and nausea. also c/o right arm soreness, swelling and pain at the site of injection."
Pt recvd 1st dose Recomb 25FEB91 & following vax pt devel rash & swelling @ inject site, dizziness, & numbness in both hands; few min later lips felt numb; 5 to 10 mins later pt had difficulty swallowing & breathing, tightness in chest;
Pt developed seizure (1st time)-New onset on 11/09/2009 generalized Tonic clonic- lasted 5 min. 2nd seizure on 11/20/2009-lasted 3 minutes- generalized Tonic clonic. Referred to ER.  11/23, 11/24 and 12/02/09  Medical records received for DOS 11/06-11/21/09 Final DX: Seizure, recurrent  Rcvd vaccine 11/6. Also dx w/contact dermatitis/allergic rxn, pharyngitis on same day.   First seizure 11/9. GTC. LOC Jerking mvnts x5 few minutes, HA, blurry vision for a few hours after.  Sleepy prior to sz.  2nd sz 11/20.
First dose received intramuscularly on right thigh; ran a slight fever; I got sick; felt like sickly and terrible; shaking; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0167), intramuscularly in the right thigh on 10Aug2021 (at the age of 38-year-old), dose 1, single for COVID-19 immunisation. Medical history included pulmonary embolism, hypokalaemia (also reported as potassium, calcium), Hashimoto's disease, and blood clot. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE), apixaban (ELIQUIS), vitamins (reported as vitamins for potassium and phosphorous), prenatal vitamins (has more of everything in it). The patient did not receive other vaccines four weeks prior to COVID-19 Vaccine. In Aug2021, after the first shot, the patient got sick. The patient felt like sickly and terrible. The patient was shaking, ran a slight fever and then everything ended. The outcome of the events was recovered in Aug2021.  No follow-up attempts are possible; No further information is expected.
pt recv vax & approx 11 wk p/vax pt exp a macular/papular rash w/persistent lesions on buttocks & back, & a sore throat;the exp persisted for approx 2wk;there was no assoc fever;
Vaccinated 7-19-12 at 11:00 am. Woke up next day stated arm hurt. Mom looked at arm 7-20-12 at 2:00 a.m. Area from injection site to elbow swollen, purple red itchy hot & painful difficult to move. Has eczema & this ached up in (R) arm elbow also called MD. Take 25 mg BENADRYL & ice to area. Mom states child needed nebulizer tx at home - resp difficulties 7/23/12 resolving somewhat still like red in color, pain & itching.
Redness and swelling at area, left arm given subcutaneously. Area of left upper arm noted 24 hours after vaccination. Seen the next day in office; red area has expanded. Only mildly tender. No discharge. Antibiotic given for potential cellulitis development.
multiple outbreaks of herpes zoster and post herpetic neuralgia; multiple outbreaks of herpes zoster and post herpetic neuralgia; pt under the age of 60 received zoster vaccine live (ZOSTAVAX) before March 2011; Information has been received from a lawyer, regarding a case in litigation, and refers to an adult patient (pt) of unknown gender and age at the time of the events, who was approx. 50 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 17-OCT-2008, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a local drugstore for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): multiple outbreaks of herpes zoster and post herpetic neuralgia. The outcome of the events was not provided. The reporter considered the events of multiple outbreaks of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Knot developed in the arm at site of injection, swollen, hard, warm to touch.
t101 forehead, slept most of wed 15NOV95;no nap Thursday & awake all noc Thursday cried more than 3hrs;APAP q 4hrs; seen no MD & did not call MD thought pt was cutting teeth & coming down w/cold on 17NOV95
very sick; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (age not reported) who got very sick (sickness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness) within a week  following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not reported.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
I had chills, and muscle aches starting around 12 noon on 4/1, this progressed into cold sweats and hot flashes over night. By about 10 or 11 AM on 4/2 the side effects had subsided.
Little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little soreness in arm). At the time of the report, PAIN IN EXTREMITY (Little soreness in arm) outcome was unknown.            Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was Not Applicable   This case was linked to MOD-2021-013942 (Patient Link).
Patient is fully vaccinated. 80-year-old male with past medical history of seasonal allergies, hypothyroidism, hypertension, CAD, GERD, diabetes, COPD on 2 L home O2 PRN, CKD, CHF, atrial fibrillation, pacemaker, who presented to the emergency department with worsening shortness of breath for several days. On arrival to the emergency department patient's oxygen saturation was 87% on room air. He was placed on 4 L nasal cannula and oxygen saturation improved to 99%. Patient reports positive Covid swab on day of presentation to the emergency department. Treatment:  oxygen therapy, bronchodilator treatment, steriods, remdesivir. Antibiotics.  Continue anticoagulation with Eliquis. Acute on chronic kidney disease.  resolved.  Discharged with home health care.
Information has been received from a consumer via internet concerning a female who on an unspecified date was vaccinated with GARDASIL (lot number, injection site and route not reported).  It was reported that the patient was offered a college scholarship for her athletic skills in track and field, and "now can barely run 50 yards without resorting to use an inhaler."  The patient used a nebulizer every couple of hours as she could barely breathe.  It was unknown if the patient sought any medical attention.  The outcome of the patient's experience was unknown.   Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.
Patient reported throat swelling about 30 minutes after the vaccine was given. The patient had normal vital signs and was given 50 mg of Benadryl, and said that her throat felt tighter and it was more difficult to speak. Called 911 and EMS monitored the patient. The patient said they were starting to feel better, so EMS let the patient go home.