chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.03. Concomitant products were not provided. On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  On 21-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 32, 11 AM: 39, 12 AM: 40, 1PM: 40, 2 PM: 42, 3 PM: 43, 4 PM: 43 and 5 PM: 43. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
This case was reported by a nurse via call center representative and described the occurrence of erythematous rash in a 1-day-old female patient who received ENGERIX B pediatric. On 11th April 2017, the patient received the 1st dose of ENGERIX B pediatric (intramuscular). On 11th April 2017, several hours after receiving ENGERIX B pediatric, the patient experienced erythematous rash and mottled skin. ENGERIX B pediatric was continued with no change. On 12th April 2017, the outcome of the erythematous rash and mottled skin were recovering/resolving. It was unknown if the reporter considered the erythematous rash and mottled skin to be related to ENGERIX B pediatric. Additional details were provided as follows: The patient received a dose of ENGERIX B pediatric on right thigh. The patient developed a red mottled rash from hip to knee on the vaccinated leg, following the birth dose of ENGERIX B pediatric. The rash spread to the foot on the affected side. On 12th April 2017 while discharge, it was noted that red patched had cleared on the hip and buttocks and it was less extensive. The health care professional was unable to provide lot number or expiration date, as the report was made from the doctor's office and the vaccine was administered in a hospital.
pt recv vax & noticed red bumps around inj site;2 days p/vax reported a rash starting on the palms of hands & then on foot & chin;called MD who prescribed medrol & DPH;p/2 more day reported hard time breathing & nape of neck swollen;to ER;
Mom called on 10/9/02 talked with RN. pt has blistering rash on L arm c/o burning pain under arm. RN advised mom to give him Tylenol and put cool compresses to sight and to call her. Mom was taking him to Dr. office on 10/11/02 at 2. Mom states Dr dx pt with shingles.
A few days after the vaccine I woke and I could feel that I had a cold sore on my lip. When I got to the mirror to look at it I realized it was swollen up to be the size of about golf ball or lemon. I went to the doctor but before I had gotten appointment I was using an OTC medication and the swelling was going down at that point so we did not treat it further.
Red, raised rash (similar to hives) on right arm (vaccinated arm) and abdomen (middle, above bellybutton but below chest) appeared day after vaccination. Noticed Itching on vaccine day. Rash on arm continued to increase in size for 3-4 days. Rash on abdomen was spots about quarter-size and did not change in size. Rash was not warm to the touch and did not cause pain. Patient took Benadryl and prednisone (10mg) from previous Rx for two days. Rash has receded at time of this reporting but persisted for about 5 days total. The patient called her dermatologist and no additional instructions were given from dermatologist.
12/17 VACCINE 12/18 CRAMP.  EXTREMELY DIZZY.  12/19 SCHEDULED FOR COVID; NEGATIVE 12/20 BECAME LETHARGIC; ER. BP 70/50. HYRDRATION HELPED.  12/21 BODY CHILLS, EXHAUSTION. STILL ABLE TO FUNCTION AND TAKE CARE OF SELF.  12/28 COVID TEST; POSITIVE  12/29 ELOQUENCE, INSULIN, OFF BP MEDICATIONS INCLUDING LIPITOR, PEPCID 5 % LESION CT; COVID (THESE ARE NEW) BP NORMAL, TEMP NORMAL, SATURATION 95-96%
Experiencing increasing Multisystem Inflammatory Syndrome symptoms. Continual muscle pain in arms, shoulders, and hips worsening despite attempts to lower inflammation symptoms. Cognitive and memory issues worsening on a continual basis, especially over the past 2 months (Jan to March 2022). Exacerbation of existing health issues that were under control, IE., peripheral neuropathy and a skin condition.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted 5 miuntes after receiving the vaccine. Pt feels much better after getting water from the staff and getting rested for about 30 minutes. Pt said he does not need an ambulance, and he is doing ok
Patient has pain and swelling in ankles and knees. Had water drained from knees in ER but is still retaining fluid.
Patient's mother called the pharmacy and said that he had developed a rash on his ankle that spread to his knee 4 days after the vaccine was administered. They saw a doctor about the rash and he wanted the pharmacy to be notified to report it.
Patient had full body rash one day after vaccination that went away 2 days after appearing. 15 days later, patient developed a 1.5 cm diameter erythematous region at the injection site with two raised areas.
Shot 1 (Booster) above - severe illness, high fever, severe headache to migraine, body aches, nausea, dizziness, lymph node swelling and soreness - this is Day 5 for all symptoms;     Shot 2 above in May 2021 - same reactions as above except that lymph node swelling continued for 60 days;     Shot 3 above in April 2021 - less severe reactions, however, lymph nodes swollen until next shot.
Tuesday on 9/8,  had painful joints, pain in the neck /skull area up and down to the spine and the cranial area.  Could barely move. It gotten worse throughout the night. Next day the pain started to subside. By the afternoon, was able to move around, not great. This morning took Tylenol and is now feeling fine, pretty much back to normal.
Got pneumonia shot 10/12/05. On 10/13/05, got swelling in upper arm and fever of 101.3. Able to control with ice and Ibuprofen.
A nurse reported that a 9 month old male received his 2nd dose of Prevnar and Recombivax-HB (Merck) on 6/2/00. On 6/5/00, he developed a fever of 102.1F. Additional information received on 6/26/00, indicated that the pt was seen by the physician on 6/7/00 and a dx of herpangina was made. He recovered.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. 13-OCT-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and indication were not reported), and on 04-NOV-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and indication were not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
1/28/03 10 a.m. currently with 3-4 lesions that are blanching, erythematous, papules (? look like early vesicles) probable varicella rash.
Blood and mucous in stool, increased irritability around bowel movements.  Positive occult blood test of stool at visit 7/17/23.  F/U 7/19/23 - Negative occult blood in stool, still some fussiness Phone f/u 7/24/23 - fully resolved, back to normal self
my blood pressure was 129 over 70; my blood pressure was 129 over 70; I get episodes of racing; I get episodes of fast-beating heartbeat; I continued to have pain at the point of each injection; The pain has now begun to radiate now from the injection site down to my right and left elbows; My Right-Collar bone has discomfort; I have recurring days of diarrhea; Recurring headaches; slight dizziness; An overall feeling of weakness and tiredness; An overall feeling of weakness and tiredness; I get episodes of fluttering; Second dose same date 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 15Jun2021 (Lot Number: EWOP6) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at Public Health Clinic. The patient had not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Known allergies: Not confirmed, Possible Penicillin. Other medical history included high blood pressure and sticky heart valve. There were no concomitant medications. The patient reported: 'When I went to the doctor's office on 21Sep2021, my blood pressure was 129 over 70. The blood pressure has been at around 110 over 68 for years. It was 110 over 68 this past Jan2021 when I when to my doctor for an annual examination. I get episodes of racing, fluttering, fast beating heartbeat; I continued to have pain at the point of each injection; the pain has now begun to radiate now from the injection site down to my right and left elbows, I have difficulty working with my arms above my shoulders. My Right-Collar bone has discomfort. I have recurring days of diarrhea, recurring headaches and slight dizziness (the last dizziness was on 27 and 28Sep2021; an overall feeling of weakness and tiredness)'. Onset date of blood pressure increased was 21Sep2021, while onset date of other events was 20Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events had not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I had severe pain in my right shoulder for over 10 days my shoulder was so swollen I had to take Ibuprofen to take the swelling down in shoulder it felt like it was dislocated from its socket it was so swollen I have fibromyalgia already and had a terrible arthritis flare up as well after the vaccination and now I do have a another blood clot issue after getting my vaccination so not sure how I feel about getting the 2nd one my doctor told me to report this thank you
Shaking, trembling,chills, high (102.4 degree) fever, whole body muscle aches.  My husband called our family physician emergency line. Dr. was on call and recommended Tylenol and fluids to relieve symptoms. I took 500 mg Tylenol every 4-6 hours and water throughout the night. Symptoms abated by morning but I had no appetite for the next 24 hours, and aches continued throughout the next day and night, ending after about 48 hours.  I don't ever remember feeling this sick in my life.  My blood sugars still require extra humalog to bring them down 5 days after vaccinations. I called the Department of Health for the information about vaccines that are required in this form and reported my symptoms.
patient reported sore arm/shoulder pain beginning about a week after immunization and continuing.  patient has been using ibuprofen and icy hot /lidocaine and cold paks.  still has continuing pain.
Dermatitis, erythematous, patches and plaques with some photo distribution, not strictly photo distributed.  Some improvement with Clobetasol cream, not completely resolved.
Myalgia, Fever, LOSS OF SMELL AND TASTE-RESOLVED Narrative:
Pt has experienced exploding head syndrome / hearing clicking sound which wakes her up. It doesn't happen everyday but enough for her notice it. has been seen by neurologist, no med given. It has been a year since vaccination but pt just notified us today, 10/11/19
bones ache; bad cough; chills; running a fever; sick/ sick as a dog; inappropriate schedule of vaccine administered; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick/ sick as a dog), BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (6 months ago Second dose) and Pfizer (6 months ago First dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VOMITING (vomiting). On 21-Dec-2021, the patient experienced ILLNESS (sick/ sick as a dog) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BONE PAIN (bones ache), COUGH (bad cough), CHILLS (chills) and PYREXIA (running a fever). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, ILLNESS (sick/ sick as a dog) had not resolved and BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting), CHILLS (chills) and PYREXIA (running a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         Concomitant medications included sweat pill and vitamin. No treatment medications were reported. They went to the emergency clinic today where they tested him for COVID-19. The results have not come back yet.   This case was linked to MOD-2021-425588 (Patient Link).
tiredness; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tiredness and muscle aches. Patient experiencing like muscle aches and tiredness after she took the first dose of the covid-19 vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of all the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected
myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 22-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization), outcome "recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of MYOCARDITIS due to temporal relationship and current known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever, restlessness, unable to sleep Checked arm next day, itching, soreness large welt on arm continued fever
Swelling of bilateral legs L>R by report seen at ER pm day of reaction. Examined by me 1 day later. + lower ext petechiae few scattered, spoke to father 05/09/07 no rash, no fever and no leg swelling
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION/MILD SYMPTOMS/COLD/LOSS OF SMELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid 19 infection/mild symptoms/cold/loss of smell and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection/mild symptoms/cold/loss of smell and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183529 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210645515-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Narrative:  2/4/22: moderna 3rd dose covid booster. Next day Saturday started feeling a headache/chill moving up his neck into the back of his head. Also had chills, woke up with a headache at the base of his skull, acetaminophen no help, a little better with a hot shower but headache returned, though less intense. Woke up Monday again with pain at base of skull and headache, decreased to a dull pain with hot shower. No headache after Wednesday. Headache did NOT wake him from sleep, he woke up as normally then felt a headache.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm for several days after, but the same as experienced after the first shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included flu shots for unknown indication. Past adverse reactions to the above products included pain in arm with flu shots. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm for several days after, but the same as experienced after the first shot). At the time of the report, pain in extremity (sore arm for several days after, but the same as experienced after the first shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-330801 (patient link).
shakes; slept a lot; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 0101A21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood and Gout. Concurrent medical conditions included Deep vein thrombosis, Atrial fibrillation and High cholesterol. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, ALOPURINOL for Gout, ALIROCUMAB (PRALUENT) for High cholesterol, UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMIN D3 for an unknown indication.   On 01-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills). On 02-Feb-2021, TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills) had resolved.            Treatment medication was not reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received, patient medical history, product details. On 07-Aug-2021: Non Significant Follow-up
five -ten minutes post vaccine patient feel from standing after reporting dizziness to mother,  mother reports lightly hitting back of head on chair. , patient reported no pain to head , no deformity on palpation or visual inspection.  Patient monitored, continued to report dizziness and numbness of arms and face, airway patient and no reports of oral numbness or angioedema   vital signs monitored  during event , stable and consistant  111/78 bp 72 HR 20 RT, only minor fluctional from this during monitoring.  Symptom not resolving and we called 911 with the patients consent .  Monitored inn ambulance for 15 minutes then patient left the scene  Patient reports not eating and a history of anxiety  / agoraphobia
6/12/2021 - worse than COVID-19, the left arm with injection very sore. Couldn't lift for about 3 days, very tired, in bed 3 days, dropped a lot of weight, nerve damage, right leg completely numb no feeling in her leg, couldn't walk, lost feeling in foot couldn't make it up the stairs, felt really bad, no temperature, hot and cold chills, panic attack, anxiety attack, headaches on and off. Taking Tylenol every four hours last 3-4 days, crying all the time.