chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.  It was reported that 10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit  to 24.7 degree Fahrenheit. HCP mentioned that they always had the freezer between this range. All doses were injected IM in deltoid muscle. It was reported that the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, and they have not had any adverse events. Moderna has stated vaccine could continued to be used until expiration.  Storage condition at the time of the excursion was frozen storage. Maximum temperatures reached, as applicable  was Maximum of 24.7 degree Fahrenheit. Excursion duration was from 09Nov2021 to current date (vials have not been moved from freezer). Currently vials were stored in freezer. Visual inspection noting any vaccine state change was visually inspected frozen (never been thawed). Proposed desired Use by Date (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question) was unknown. Number of vials/doses impacted were 10 15-dose vials. Pertinent details like whether the vial(s) were punctured, any previous excursions with the impacted vial(s) include no other excursions. Two vials were used. Doses were administered on 23Nov2021 and 27Nov2021     Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received contains information on product storage error and added to I narrative supplement.
much swelling and soreness right upper arm where vaccine given few hours after injection. Day after injection headache .fatigue. aching pale color white as a ghost lasted one day. severe itching  whole upper right arm started 2 days after injection and continues off and on since. Apply  hydrocortisone to site for relief from itching.
Heart palpitations are off and on; Left earache; Felt tired and slept; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations are off and on), EAR PAIN (Left earache) and FATIGUE (Felt tired and slept) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Palpitations in 2009 and Heart valve replacement in 2009. Concurrent medical conditions included Hypertension (under control), Diabetes (under control) and High cholesterol. Concomitant products included VERAPAMIL, HCTZ, OXYBUTYNIN, PROGESTERONE, DOCUSATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE and PRAVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (Felt tired and slept). On 07-Apr-2021, the patient experienced EAR PAIN (Left earache). On 08-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations are off and on). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart palpitations are off and on) had not resolved, EAR PAIN (Left earache) had resolved and FATIGUE (Felt tired and slept) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Electrocardiogram: abnormal Cardiologist "saw something" on EKG so patient scheduled to have an echocardiogram (unknown date).         This case was linked to MOD-2021-076706 (E2B Linked Report).; Sender's Comments:  MOD-2021-076706:First dose of vaccine case
Pt is a RN working in the department who had just received her yearly flu vaccination.   Had not had issues in previous years with these vaccinations.  Pt c/o feeling nauseated and sweaty approx. 7 min post injection.  by 1155a, c/o difficulty breathing.  Moved to exam room, pulse ox applied reading 100% on room air, and O2 mask at 6L/min offered to pt to aid with respirations.  At 1157a, received 50 mg Bendadryl IM L arm and maintained O2 Sat 100% on room air and with mask on occasionally.  At 12n, prepared to administer Epi pen when pt states was feeling better.  Continued to monitor over the next 30 minutes with O2 Sat remaining at 100% on room air and by 1220p, pt stated had no issues with breathing and was walking around the room.  Pt stayed in dept for 4 hours while being observed and then was able to go home without any respiratory issues (maintained 100% O2 Sat).
4 days after the shot, I broke out into rash/tiny red bumps all over my left arm. Mostly on the lower half of my arm from elbow down.  Some bumps on right arm, and on 01/24 I woke up with bumps under my chin and down my neck. They are a little painful, and a little itchy. I took Benadryl tablets & put Benadryl topical cream on the bumps.
This case was reported by a consumer and described the occurrence of vaccination failure in a 74-year-old-male patient who received Influenza vaccine Quadrivalent. Co-suspect products included AVANDIA unknown for diabetes. The patient's past medical history included blood pressure high and blood cholesterol increased. On an unknown date, the patient received Influenza vaccine Quadrivalent. In January 2007, the patient started AVANDIA 8 mg once daily (8 mg daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 1st January 2018, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting AVANDIA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The action taken with AVANDIA was unknown (Dechallenge was unknown). Rechallenge with AVANDIA was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovering/resolving. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. The reporter considered the influenza to be unrelated to AVANDIA. Additional details were provided as follows: The patient was on a lot of pills for his cholesterol and high blood pressure. The patient did not have his list with him. These were historical. The age at vaccination was not reported. The patient was on AVANDIA, taken as 2 to 4mg tablets once daily. It was reported that the patient had a flu shot, but still got the flu. The call was transferred from GlaxoSmithKline patient assistance. Manufacturer of the flu vaccine was unknown and the date received was also unknown. This case was considered as a suspected vaccination failure, since the confirmation of lab test and the exact time to onset for flu were unknown.
Initial report was received on 03 January 2012 from an electronic lay press article. It represents a cluster of unidentified patient's reported by the same reporter who developed whooping cough following previous vaccination with a PERTUSSIS VACCINE (manufacturer not reported). The unidentified patients had each previously received a pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed whooping cough. The article stated the total number of confirmed whooping cough cases at a single elementary school had increased to seven. According to the county medical director, besides the confirmed cases, there were nine additional suspected cases. None of the students at the school were given exemptions for vaccinations. In fact, 100 percent of the children had been vaccinated. It was unclear if all of the adults working at the school were vaccinated. The patients' outcomes were not reported. Documents held by sender: none.
pt recv vax; erythematous area approx 3x3 inch on upper lt arm & 1 blister; no tenderness, no fever noted; eval by hlth dept
ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an 24-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211238177 and 20211239215.
Starting 01/19/2022, I thought I started having a cold. I was getting sicker. I had an appt with my pulmonologist around that time and she gave me a different asthma medicine. I took an at home test which was positive on 01/20/2022. A few days later, per request of my job, I got an official PCR test done at an urgent care (01/22/2022) and tested positive. I had a fever until 01/23/2022. I went back to work on 01/28/2022 because my fever had been gone for 5 days, but my cough was still pretty severe. I had to wear an N95 mask if I was to be around coworkers. Recently, I have had a lot of vision changes. I saw my optometrist and she believes the sudden vision changes are due to COVID. Also, I normally have a slightly elevated cholesterol level with other normal lipid levels but recently my blood tests showed extremely elevated cholesterol levels and lipid levels (~60 pts above where they normally are) and my doctor feels thats likely contributable to having COVID. I have more pain lately and I am still having a persistent cough that I need to have looked at by my pulmonologist.
Patient presented to emergency department on 10/1/2021 with worsening shortness of breath. She was found to COVID-19 positive at  an outlying facility on 9/27/2021. She was admitted for further management of COVID-19 infection and sickle cell crisis. She was discharged home on 10/7/2021.
Patient received vaccines, walked out of the booth to wait for a relative who was getting the same vaccines. He said his vision was blurring, so he walked back around and his relative saw he looked pale and like he was going to fall, so he grabbed him before he hit the floor. This occurred within 5 minutes after receiving the vaccine. We placed the patient in a sitting position and I had a technician reach for a bp cuff and EPIPENS. The patient removed his hoodie, his bp was 124/65 with a pulse of 86. He was alert and speaking, periodically clearing his throat. He regained his coloring and waited on the floor for about 20 minutes. There was no progression or signs of anaphylaxis. We helped him up and he was able to walk without assistance. His relative drove home with him. The patient states he has no previous history of fainting or allergic reaction to vaccines, he was just embarrassed.
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female with no medical history and no drug allergies who on 18-AUG-2011 was vaccinated with VARIVAX (Merck), 0.5 ml (lot # and expired date not reported). There was no concomitant medication. Shortly after receipt of the vaccine, the patient became pregnancy. Her LMP was 02-SEP-2011. Estimated date of delivery was 08-JUN-2012. The patient sought unspecified medical attention. Follow up information was received from a healthcare worker. It was reported that the patient delivered a healthy baby on 24-MAY-2012. More information regarding the baby and the information regarding the delivery was unknown. Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 5 year old male patient, with no known pertinent medical history, or no known drug reaction/allergies, who on 18-JUN-1997 was vaccinated with the first dose of VARIVAX (Merck) (Lot No 622969/0423E) 0.5 ml, subcutaneous.  The licensed practical nurse reported that on an unknown date, after the vaccination the patient developed hives soon all over his body.  The licensed practical nurse reported that the patient's mother did not tell the patient's primary care physician, until recently when the patient was scheduled to receive the second dose.  The licensed practical nurse reported that the second dose had not been administered.  There was no mention that this was a chickenpox outbreak, rather it was hives.  The licensed practical nurse believed that when the patient had hives, the on-call physician was seen.  On an unknown date the patient had recovered.  Follow up information has been received from the licensed practical nurse, which reported that the male patient, on 18-JUN-1997, developed hives 1 hour after vaccination, approximately after 5:00 pm, with VARIVAX.  The doctor on call was called.  It was questioned whether the patient should receive the second dose of VARIVAX (Merck).  On 10-NOV-2008 a Varicella Zoster IGG test (HVZG and HVZM) was performed and the titer drawn was 6.58 (greater than 1.10 = positive IgG antibody to varicella.  Additional information has been requested.
Patient presented with cough and congestion and COVID-19 diagnosed and was in isolation for 10 days. She was given Mucinex for congestion.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # 1019989, expiry date: 01-JUN-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT STATED SHE WAS VERY TIRED WHERE SHOULD HAD TO KEEP GOING TO BED. SHE HAS A TERRIBLE HEADACHE AND DIARHHEA. SHE ALSO HAD SHINGLES ABOUT 8 YEARS AGO AND THIS VACCINATION REACTIVATED THE PAIN THAT SHE HAD WHEN SHE HAD THE SHINGLES. IT HAS BEEN 3 WEEKS AND THE SYMPTOMS HAVE STILL NOT GONE AWAY. SHE IS AFRAID TO GET SECOND VACCINATION AND WILL BE SPEAKING TO HER DOCTOR ABOUT THE ADVERSE REACTION SHE IS EXPERIENCING. SHE HAS PAIN ALL ALONG HER SIDE AND ACROSS HER BODY.
I'm really weak and grouchy; I'm really weak and grouchy; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in left arm on 17May2021 at 14:00  (at the age of 18-years-old) as 1st dose, single for COVID-19 immunization. Medical history included shrimp allergy. Concomitant medication included Ibuprofen. The patient was vaccinated at Hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient reported that he was really weak and grouchy on 17May2021 17:00. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP.  I was leaving the hosp. and started feeling strange and my heart was racing and I felt shaky. I went to the ER at the hospital I received my vaccine at.
Loss appetite; Bone joints ache; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss appetite), ARTHRALGIA (Bone joints ache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DECREASED APPETITE (Loss appetite), ARTHRALGIA (Bone joints ache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 04-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, DECREASED APPETITE (Loss appetite), ARTHRALGIA (Bone joints ache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
More than 30 days in the refrigerator; No adverse event; Moderna COVID-19 more than 30 days in the refrigerator and administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered), PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No medical history reported by reporter. Patient did not have allergies to medications, food and other products. Unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health condition.  No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 15-Aug-2022 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered), PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered) and PRODUCT STORAGE ERROR (More than 30 days in the refrigerator).    No Concomitant medications were provided. Patient age was reported as 1 year 10months. Patient race was reported. Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14AUG2022.  No reported symptoms. No additional doses, medications, or treatments had been administered at that time.
Hives over face, chest, back, extremities.  Had been pretreating with Zyrtec 10 mg once daily. Dose increased to 3 times a day with continued break through hives and inching. Benedryl 25mg at night. Transitioned to Claritin redi tabs twice daily after 2 weeks. Continues to have break through hives after nearly 6 weeks.   This is his 3rd time having this reaction after the flu shot.  2016 and 2017 he had similar reactions with hives starting within days to a week of the injection and lasting several weeks.
Initial report received from a healthcare professional on 15 Jan 2010: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch no. 102123A), 0.5 ml, IM on 13 Jan 2010. The reporter was reported medication error (the hub of the needle leaked during vaccination), patient did not received full dose.
Apneic episode with cyanosis approx 78 sec. MR received from PCP. PMH: 2 well child exams from 2 and 4 months with only c/o gassiness/possible colic, otherwise healthy. OV on 11/17/2006 which led to above admission for observation after apneic spell. Assessment- Apnea/cyanotic spell. Hospital MR received which revealed infant transported to ER after mother witnessed an ~ 35 second episode of apnea with cyanosis 3 days after 4 month immunizations. No report of any seizure activity PMH: significant only for mild reflux.  Clinical exam WNL without any further episodes. Assessment:  Apneic spell x 1.  Differential:  possible gastroesophageal reflux disease vs. adverse event 2' to recent immunizations.
1, Fever lasting at least 2 days/ (37 Celsius).  2, whole body muscle pain. 3, cill. 4, sever pain of the site having injectoin on the left arm. lasting the whole first day.
92 Y F with history of mixed dementia, HTN, CKD3, fully vaccinated against COVID-19, recent exposure to COVID 19 (son passed away from COVID 2 days ago and daughter who lives with her is also has COVID-19), who started having sx of slight cough, fatigue, raspy voice and diarrhea as of 8/19. COVID-19 + on 8/26. Pt lived in own home with daughter staying with her, but pt needed help with some ADLs. Baseline was could go to BR, take her own bath, feeds self, uses a FWW sometimes. Pt lives in her own home, her daughter lives with her. Son is main contact   COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 8/19. COVID positive on 8/26. Pt completed a course of remdesivir 8/31-9/4 and received decadron for which she will be discharged on a tapering course. Patient was never symptomatic from a respiratory standpoint, symptoms mainly manifested as sleepiness. Her overall clinical condition improved with increased alertness and po intake. She was able to ambulate with only standby assist from RN staff. Her oxygen measured with ambulation was 90% on 9/4.    Hx HTN/HLD: on amlodipine and statin. Stable. Initially BPs were low but they began rising and she will restart amlodipine on discharge.   Hx mixed dementia: pt was sleepy initially and had received 2.5 mg po zyprexa in ED on admission, presumably for agitation, but for the bulk of hospitalization was forgetful but answered simple questions and was cooperative and pleasant with no agitation.     Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Covid Pneumonia