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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:55 PM, 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 48.71. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 30-Mar-2021, 31-Mar-2021 and 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: NA, 32, 38, 9 AM: 33, 32, 34, 10 AM: 36, 40, 38, 11 AM: 36, 42, 42, 12 PM: 40, 43, 41, 1PM: 40, 44, 41, 2 PM: 39, 46, 41, 3 PM: 38, 46, 40, 4 PM: 40, 44, 40 and 5 PM: 40, 44, 41. 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.
Woke up with Left arm swollen and painful, mom gave MOTRIN which gave some relief. Mom instructed to continue with MOTRIN prn and ice pack, to call back to office if worsens.
pt recieved shot n 4/11/23 she came to pharmacy to report an adverse reaction. she said some time after having the shot she would have a feeling of mental distress that would last about 8 minutes . she says she has had several times since shot and believes it is because of the shingrix shot. she does not want to get the second dose.
The day after my vaccine I went to bed crying in pain from my lower body hurting so bad. That has continued every day since. The second day after my vaccine, I started bleeding vaginally and it has not stopped and I have bled an insane amount. I?ve had a heavy heavy flow before I was put on birth control but it was nothing compared to this. I?ve gotten dizzy nauseous and had headaches.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patient of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dosing regimen unspecified) lot # L024122, expiry date-30-DEC-2016. No adverse effects were reported. The call was the result of a data logger. No previous temperature excursions were present. The temperature excursion included 14F for 127 hours and 15.1F for 22.5 hours. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two cases from the same reporter. Additional information has been requested.
Two swollen lymph nodes near the clavicle on the right side, the aide where I got the vaccine
Felt sharp pain in my back. Started losing movement of legs and intestines. Paralyzed from thorax down. Treatment consisted on plasma replacement and RITUXAN infused thru port inserted in chest.
This medically confirmed spontaneous report (initial receipt 29-Oct-2013) concerns a 46-year-old female patient with a history of asthma. The patient had no drug reactions/allergies. It was reported that the patient last received a flu vaccination 5-6 years ago and at that time she developed a pustule at the injection site, which then developed a scab on it and left a scar (see 2013038828). On 27-Oct-2013 at 12:00am, the patient was administered intramuscular AFLURIA (batch R54908) into the left deltoid, at a dose of 0.5 mL indicated for vaccination. The same afternoon, the patient developed significant nodular swelling under her left arm, chest wall pain, neck stiffness, tingling of the arm, a fever of 99.9F and stabbing pains at an unspecified location in her body. The patient's lymph nodes in her left arm were swollen to the size of a baseball. The patient was treated with ibuprofen. No lab diagnostics studies were performed. It was reported that the patient had recovered from some of her symptoms, however her lymph nodes were still swollen. Outcome was reported as recovering. Case correction (14-Nov-2013) - case upgraded to serious.
PRESENTING PROBLEM: COPD with acute exacerbation [J44.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 67 y.o. male past medical history COPD, tobacco abuse, HTN, HLD, CAD, PAD and prior history of PE on Eliquis who presents with SOB and cough.   In the Emergency Department, Patient tested positive for COVID 19, RSV and Flu were neg. He had CTA chest that showed no PE and pneumonia but showed some mild bronchial inflammation and mild emphysema. There was also incidental findings of pulmonary nodules. He had CXR neg for acute process as well but showed COPD. Labs were unremarkable in the ER including VBG and BNP. He remained on room air in the ER and his vitals were stable other than occasional tachypnea. He was given solumedrol and multiple inhalers in the ER. He was admitted to the hospitalist team for COPD and COVID. Patient was continued on chronic obstructive pulmonary disease treatment with inhalers and systemic steroids.  Tobacco abuse was treated with Nicoderm patch.  He was encouraged to adhere to complete cessation from smoking tobacco.  Sputum culture revealed Haemophilus influenzae with moderate be WBC count.  He was initiated on Augmentin oral therapy which will be continued for total course 5 days.  He was continued on systemic steroids and remdesivir.  Supplemental oxygen was rapidly weaned.  He was continued on antitussives and mucolytics.  He was noted to desaturate with exertion but had adequate oxygenation at rest on room air.  Home O2 evaluation performed and patient qualified for 2 L supplemental oxygen with activity.  MSW/CM consulted for discharge planning and outpatient DME.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days.  Outpatient pulmonology. Patient voiced understanding was agreeable with plan of care discharge.
Left upper arm swollen & reddened from shoulder to elbow approximately 5 inches induration. Denies pain.
Patient received first dose Pfizer, approx 4 minutes later reported feeling faint. Patient c/o of feeling dizziness and "shaky" and "cold" to observation nurse.  Pt had near syncopal episode and fell to floor.  Per pt, no LOC as he remembers everything that happened. Taken by  nursing staff to clinic room.  Mentions symptoms have happened with previous blood draws in the past.  Reports to have had low platelets on a previous blood draw but no known medical hx.  No medications taken.  Charge RN, ANM, onsite provider notified.      @1301: BP 91/41 HR 65 RR 14 O2 99%.  Patient placed in recliner.  Pt denied n/v, SOB, headache. AOx4. Pt continue to c/o of feeling shaky. Continued monitoring by observation RN. Patient able to tolerate drinking water.  @1309: BP 116/74 HR 79  O2 99% Continued observation. Patient states feeling better. Pt able to ambulate and per provider, continued monitoring outside in observation area. Denies nausea, vomiting, CP, SOB. @1348: Patient states feeling left side chest pain and "shaky" again. Per provider recommendation, pt ambulated back to triage area with observation RN for further assessment.  @1401: BP 140/89 HR 79 O2 98%  @1409 Per provider recommendation, transport was called to escort pt to urgent care for further evaluation of L side chest pain that is unimproved with rest.  @1421 Patient still reported feeling "shaky". Pt escorted to Urgent Care for further evaluation there, by transport via w/c, accompanied by friend.   ED Course: Pt developed vomiting and reports a near syncopal episode.  Per pt, no LOC.  Reports never happening before and has received vaccines in the past. He continues to report leg pain and shakiness in the legs, lightheadedness and chills. Denies fever, HA, SOB, trouble breathing, rashes, swelling in the face or neck, paresthesias or paralysis.  Pt observed and discharged 9/17 @1:38AM.   Plan: -Advised pt to establish PCP as his Hgb, HCT and RBC were low and IFP high which pt reports he is aware of. -advised pt to take advil and tylenol as needed for myalgia in the legs.  -Return to ED if symptoms persist or worsen -Strict return precautions discussed such as increased edema, throat itching, rash/hives, or difficulty breathing and patient verbalized understanding of these return precautions   Diagnosis and disposition discussed with patient at length. Patient to be discharged in stable condition. Patient was in agreement with this care plan and verbalized understanding of it.
STROKE. Patient presented with left hemiplegia and facial droop with MRI/MRA for large acute/subacute right MCA infarct. He was afebrile, normotensive, without any electrolyte derangement. He had recurrent seizure activities on 11/23 and 11/24, for which he received Keppra and fosphenytoin. He was weaned of the fosphenytoin on 11/28 and continues on Keppra. Left hospital for inpatient rehabilitation for 2 weeks. After, at home with outpatient physical and occupational therapy 3x week.
Swelling of arm and neck.  She returned to the pharmacy and stated that she is ok now.
Information has been received healthcare provider concerning a 9-year-old male who on 16-AUG-2002 was vaccinated with a dose of VARIVAX (Merck). On 01-JUN-2008 the patient developed an itchy rash times 1 day that was described as multiple lesions (over 60) in various stages. On 02-JUN-2008 the patient was diagnosed with varicella. The patient was treated with acyclovir 400 mg QID for 5 days, BENADRYL and CALAMINE LOTION. No diagnostic labs were performed. On an unspecified date, the patient recovered from varicella. Additional information is not expected.
Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash.  Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not.  She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit.  She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination.  Information on lot/batch number has been requested.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Initial fever with neck, back and right thumb pain.  Eventual diagnosis of sepsis. Four day hospital stay. Discharged home on Keflex antibiotic and meds for back pain. Four weeks later diagnosed with low EF of heart. Receiving meds to improve EF.
14 hours later I started with headache, body ache and joint pain, low grade fever 99.8  I did not see a doctor because I was told that these symptoms would be normal and to take pain relieve.
Started having a dry hacking cough and fatigue on the 08/28/2022. Call Dr and was prescribed Tessalon Perles and Paxlovid.  Tested negative 10 days after.
It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information of 5th out of 6th patient reported by reporter. Concomitant medication use information was not provided by reporter. Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were Administered. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
LETHARGY; BODY ACHES; DRY IRRITATED THROAT; CHILLS; HEADACHE; FEVER; NAUSEA; ARM PAIN; This spontaneous report received from a patient concerned a 30-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced arm pain. On 31-MAR-2021, the patient experienced nausea. On 01-APR-2021, the patient experienced lethargy. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced dry irritated throat. On 01-APR-2021, the patient experienced chills. On 01-APR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, headache, body aches, fever, dry irritated throat, chills, arm pain, and nausea. This report was non-serious.
Patient vaccinated and then developed dizziness. History of vertigo and MS. After an hour of sitting in first aid, dizziness persisted despite rest and hydration. MD performed some assessments with patient that she was unable to perform. Patient sent to ED for urgent evaluation.
THERE WAS NO SECOND SHOT THAT DAY, DIDN'T KNOW HOW TO DELETE.  SORRY MY MISTAKE   NO ISSUES OTHER THAN SORE ARM AND ITCHY AT SHOT SITE NEXT DAY- BUT DAY 9,10, AND 11 MY ARM BECAME HOT, ITCHY AND I NOTICED I COULDN'T TASTE FOOD.  I CAN MAYBE TASTE 10% OF WHAT I EAT NOW.  IT'S NOT IMPROVING MUCH AT ALL AND IT'S BEEN 2 AND A HALF MONTHS.  I CAN SMELL BUT NOT TASTE FOOD.
Patient reported symptoms of rash, nausea without emesis, feeling flushed, itching, myalgias.
Patient c/o SOB, chest tightness and swelling of hands and tongue. XOPENEX breathing treatment given and ZYRTEC 10 mg po.
Approx 40 min after immun developed cold sweats, blacked out upon arising; headache x 12 hrs; muscle ached, diarrhea, temp 97.0.
Extreme fatigue; Slept heavily; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma and the patient had no other relevant medical history. The patient had no allergies to food, medications, or other products. Concomitant medications included eyedrops (MANUFACTURER UNKNOWN) for glaucoma and vitamins (MANUFACTURER UNKNOWN), both taken from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 19:30, the patient experienced extreme fatigue and slept heavily for 16 hours after the vaccination. The patient experienced the events for one day only and was fine at the time of this report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme fatigue and slept heavily were resolved on 09Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash on legs and cheeks of face. Father states looks like blisters. Father states blister/rash noticed on 1/24/00 at 11:35 am. Called back at 3 pm, father states rash/blister disappeared.
Side effects started with a headache and fatigue about 8 hours after shot. Did not sleep well, took Tylenol in morning since headache did not go away. Headache came and went during the day after the shot.  Not that severe. Also fatigue and slight muscle aches. Took about 3 dozes of Tylenol during that 24 hour day.  Slept much better the 2nd night, awoke with left armpit hurting.  There seems to be a lump in the left armpit and I assume it is a swollen lymph node. Continuing to hydrate a lot and rest as needed.  Avoiding Tylenol unless pain gets severe. No signs of fever, some muscle aches in left arm. Injection site got more sore after 12 hours but is almost gone at 36 hours.
Right thigh petechiae seen at Urgent Care and emergency room. Rx: supportive care.
One week after my first Moderna dose, I noticed an enflamed reaction at the injection site. There is mild itching and a red area about 2.5 inches in diameter. I did not notice this reaction in the days immediately following the shot. I did, as expected, experience moderate soreness in my left arm for 2-3 days. Is it recommended to receive the second dose in the opposite arm?
No more than 60 seconds or so after vaccine was administered, patient stopped responding verbally then his head tilted backwards (seemed to be vasovagal response). Held patient's head upright so that he did not hit his head on wall and applied ice pack to the back of his neck. Patient twitched, sneezed, then muscles tensed and then relaxed. He came to not 45 seconds after initially losing consciousness. Patient was very pale and sweaty. He asked for water and sat for 5 minutes or so. Patient said he was then feeling  a bit lightheaded so we gave some orange juice. 5 more minutes passed and he said he was feeling much better. Patient described feeling very dizzy and not being able to hear clearly before losing consciousness
Developed Shingles within few weeks of vaccination / Suspected vaccination failure; Developed Shingles within few weeks of vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Developed Shingles within few weeks of vaccination / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Developed Shingles within few weeks of vaccination). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's relative via interactive digital media. The reporter reported that the her mother in law got the shingles vaccine and developed shingles within a few weeks.   The reporter stated that the vaccine did nothing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2023AMR067518, reported by same reporter. The follow-up could not be possible as no contact details were available.
Patient returns to clinic after 2 days with report of redness/swelling at Zostavax injection site (noted area - right upper posterior arm).  Otherwise, asymptomatic.  Instructed to take Tylenol/Motrin for pain/fever.  Antihistamine as requested as directed.  Follow up with PCP/ER if symptoms worsen or persist.
Was notified on 10-29-14 that patient's arm was red and hot to touch from injection site to elbow.