chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Pt felt ill yesterday (the day after the injection). He woke up with an itchy red rash (like a sunburn) this morning (two days after injection)
Information has been received from a healthcare worker and an office manager concerning a 5 year-old-patient who, in approximately December 2002 at one year of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). He broke out with shingles at age 2. It is unknown if medical attention was sought. It was also reported that approximately one year ago he had chickenpox. It was unspecified if medical attention was sought. No outcomes were reported. On 19-Mar-2007 he was given a 0.5 milliliter dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD). It is reported that there was no adverse experience following the vaccination. No product quality complaint was involved. Follow up information received on 09-Jul-2007 from a healthcare worker states that the identity of the patient is unknown and no further information is available.
body feels weak; throat is acting up more meaning it's becoming raspy & he's starting to cough; he's starting to cough; has shortness of breath; feels so bad; head feels dizzy; fever; has a headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath) and FEELING ABNORMAL (feels so bad) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 037A21B and 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath), FEELING ABNORMAL (feels so bad), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills). At the time of the report, ASTHENIA (body feels weak), DYSPNOEA (has shortness of breath), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills) outcome was unknown and DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough) and FEELING ABNORMAL (feels so bad) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.  The patient stated that he had chills, fever, his head feels dizzy, he had a headache, his body feels weak, his throat is acting up more meaning it's becoming raspy and he's starting to cough, and he has shortness of breath.  He stated that he was going to go ahead and go to the hospital because he feels so bad and wanted to end the call.
Rec'd varicella vac. on 4-5-11 - Lt arm - that evening around bedtime - redness, itch locally where vac. given. About  sz 1/2 dollar. Worse today, worse itching with tenderness sz approximately 6" x 3" wide - red & warm to touch. Beginning to feel itchy all over - will see FMD today.
pt recv vax 19DEC96 &  pt c/o hives on the lt arm (inj site was rt arm) & bilat lower extremities;pt states that the hives began p/vax;
Fever of 104.5, difficulty breathing, fussing, discomfort at vaccination site.
Extreme stomach pain she compared it to having kidney stones; Throwing up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune deficiency syndrome and Gastrointestinal disorder.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up). At the time of the report, ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact
Missed dose AE filed due to patient never received 2nd dose of Varivax series; 5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX; No additional AEs or PQC reported.; Reporting AE for HCP.  HCP reports "5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX".  No other information provided.  No additional AEs or PQC reported. Did not have any further information as to why the; This spontaneous report was received from Other Health Professional and refers to a 26-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown date in 2018, the patient started therapy with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP reports that "5 Years ago a 21 year old was inadvertently administered ZOSTAVAX instead of VARIVAX".  No other information provided. No additional AEs or PQC reported. Did not have any further information as to why the error occurred. AE filed as product confusion due to reason unknown. Missed dose AE filed due to patient never received 2nd dose of VARIVAX series.
sudden onset of myalgias 4 days after shot-moderate no fever no cough no ENT sx no ST no HA no rash increased urination/frequency; short bout diarrhea
ACUTE RESPIRATORY FAILURE 1/25/2022 PULMONARY EMBOLISM, UNSPECIFIED.  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/25/2022 PULMONARY EMBOLISM, UNSPECIFIED.  SHOCK, UNSPECIFIED 1/25/2022 PULMONARY EMBOLISM, UNSPECIFIED.
Patient experienced lightheadedness, overheating, blurry vision, and blacking out approximately 10 minutes post vaccination.  Patient was awake and alert with normal breathing shortly before EMS arrived.
c/o muscular aching since 24MAR93 vax; unable to extend arm above head or reach behind back-limited ROM; MD exam of inject site 1 1/2 months ago/approx 10AUG93 xray recommended by MD
3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy.  Had a headache and glands felt swollen.Took a 2 1/2 hour nap.   3/11/2021- Flu like feeling. Pounding headache, tired, sore muscles, injection site was sore, low grade temperature.( 99.9, 99.5, 100) 3/12/2021- Headache,feeling tried and unwell. Injection site very itchy and staring to swell 3/13/2021-two areas on the left arm are swollen and very itchy. Top swelling in  arm near the injection site. Lower swelling is 2 inches by2 inches large 3/14/2021-Swelling in arm increased to 3 inches x 3 inches at the widest spots. Arm was red, hot to the touch and very itchy. 3/15/2021-Swelling in arm was the same. Call Dr.  Was told I had " COVID arm"
mom came to office states pt broke out in rash w/small blisters to lt thigh area approx 1hr p/vax 11JAN96;rash moved to lt buttock & up back;pt states had t101-102;called ER & was told poss allergic rxn to DTP-watch fever & call if worse;
Sunday evening began to experience painful, throbbing area six inches below the injection site; Monday felt exhausted, anxious, arm became bright red, and knot in arm noted six inches below injection site; arm felt like it was on fire; pain decrease when redness developed and symptoms diminished within seven days
Immediately within an hour, my arm had a very large red circle probably 6 inches in diameter around injection site and it swelled and then the next few hours it got very hard. Throughout the next couple of days I developed a knot on inside of arm as well and it was warm but wasn't red. The redness on the outside of my arm stayed for over a week and to this day I can pinpoint exactly where the shot was. Within the first 24 hours I spiked a fever of over 103 and I continued to run a fever for nearly 2 weeks and it ranged between 100.5-103 during that period. I experienced extreme body aches throughout my entire body and tremors that were different from my normal tremors. Just kind of a constant shivering. I was nauseated for several days into the next week and I threw up multiple times over the course of a week and a half. I had diarrhea and an extremely hard time eating because I was so nauseated. I really couldn't eat anything except maybe some jello. I slept a lot and I had an absolute horrible headache and it was my whole head not just a one sided migraine and it lasted about five days. I was dizzy and I had to use my walker or my cane because I was so unsteady on my feet. I was very weak, and the bed covers hurt because my body was very sensitive. I called my Doctor regarding symptoms and they called me 3 days in a row just to monitor me and to determine whether they wanted me to go to ER or not and by the 12th day my fever finally broke. My Doctor said that the extended fever was very atypical but they didn't feel like I had anything else going on other than just a pretty bad reaction to the shot. I had a virtual visit with my Doctor twice and 2 phone calls for 4 days in a row. I was not prescribed any medication, but they instructed me to take Tylenol or ibuprofen for my fever. They also told me to take Vitamin D as well. I had general malaise almost like a very bad flu. Especially with the nausea, vomiting, diarrhea, fever, and the body aches were extreme. I couldn't stand up and in bed I couldn't ever get comfortable. I had a massive headache. I remember I was very thirsty, but I figured I was on the dehydrated side so that is one thing I kept was Gatorade and water going throughout the day. If I drank too much, I threw it up. I do remember I drank small amounts of hot broth just trying to get some nourishment into my body, but it took me a very long time to get my appetite back, at least month. I lost about eight pounds during all of this. I did sleep a lot during this time. My Right arm has hurt ever since, and we are investigating to see what is wrong with it and my next step is going to neurology. I had pain from elbow to shoulder in my arm for at least 10 days after vaccine and it never really quite subsided all the way. It's actually worse now than when I was sick. It might be neurologically related if I have pinched nerves. With the arm the pain is in top right shoulder but its also in same area as where my shot was in the fleshy part of my elbow and I can't lift it and I can't reach back or do my hair, I can't pick anything up.
Patient called clinic with complaints of possible reactions to the second dose of the vaccine today. States that after she was observed for 15 minutes following the second dose of the Pfizer vaccine, she went home and noticed some slight tongue tingling that lasted for a few minutes then went away. She had her second dose today at 0945. Denies any reactions after her first dose. States now she has bumps on her skin similar to a skin rash with some pruritus. Denies wheezing, dyspnea, SOB, lip/tongue swelling, throat tightness, dysphagia, chest pain, nausea, vomiting. States she did take Zyrtec 10 mg this morning which is normal for her as she has allergies. She was currently at work when calling. Advised Pt of the following for treatment:   1. Topical hydrocortisone 1% cream to affected areas for the itch.  Cool compresses for swelling and the itch.   2. OTC Zyrtec-- advised her to take a second dose of 10 mg tonight when going to bed. Also advised her to take Benadryl 25 - 50 mg every 4-8 hours as needed, max 300mg daily. Can be sedating, do not take with driving or operating machinery. Decided it would probably be best for her to leave work and go home in case she gets sleepy. She denied needing a work note at this time.    3. Advised to call 911 if signs and symptoms worsen at any time. Advised Pt not to follow up at \center if having any red flag symptoms but rather go to the ED immediately. Red flag symptoms: SOB, wheezing, lip/tongue swelling, throat tightness, chest pain.   Discussed reaction with collaborating physician who was also the clinical observer for the vaccines today. Also made clinic manager aware
Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0017C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom). At the time of the report, DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
I have had daily headache and extreme fatigue since I've received my 1st vaccine dose. It has now been 3 weeks.
Slight headache; Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for three patients. This is second of three reports. A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Sep2021 (at the age of 15-year-old) (Lot Number: FC3180; Expiration Date: 16Sep2021) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number and Expiration Date not reported) as dose 1, single for COVID-19 immunization. The patient experienced rhabdomyolysis on 15Sep2021. The patient went to the emergency room on 15Sep2021 and considered her a mild case of rhabdomyolysis and didn't admit her. The patient had a slight headache on 16Sep2021. The outcome of events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Rhabdomyolysis and the suspect drug BNT162B2  cannot be excluded. 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.
Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   ARNP  reported that 6 patients received the first dose of expired Moderna COVID-19 vaccine on 12AUG2021.  It was reported that the vial did not undergo any previous temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD21-129698, MOD21-129760, MOD21-129763, MOD21-129764, MOD21-129765 (E2B Linked Report). This case was linked to MOD-2021-285598 (Patient Link).; Sender's Comments:  MOD21-129698: MOD21-129760: MOD21-129763: MOD21-129764: MOD21-129765:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Pineapple allergy" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation; MONTELUKAST oral; TYLENOL oral, start date: 25Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (01Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. The patient took PAXLOVID and was negative for 3 days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201279378 Same patient, different product and event;
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (COVID-19 symptoms nine days after the first vaccine/positive COVID-19 test) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 vaccination. No medical history reported. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 28, 2021, patient experienced COVID-19 (COVID-19 symptoms nine days after the first vaccine/positive COVID-19 test). On Apr 10, 2021, COVID-19 (COVID-19 symptoms nine days after the first vaccine/positive COVID-19 test) resolved. Diagnostic results: On Mar 28, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (lot number: R010724, expiration date: 07-JUN-2020) for prophylaxis using a with a 5/8 inch needle that might had been intradermal administration (strength and dosage schedule were not reported). No adverse effects were reported.
ABOUT 10 SECONDS AFTER TIME OF INJECTION, PATIENT LOST CONSCIOUNSESS AND PASSED OUT AND SLUMPED OVER. AFTER ABOUT 20 SECONDS, HE CAME REGAINED CONSCIOUSNESS AND WAS SHAKING FOR ABOUT 3 SECONDS OR SO. PATIENT WAS VISIBLY NERVOUS AND CLAMY TO THE TOUCH. PATIENT WAS ABLE TO COMMUNICATE WITH US WHILE EMS WAS CHECKING VITAL SIGNS.
The child was vaccinated in the morning and by the afternoon of the same date he developed a high fever. During the next morning the high fever continued and the child convulsed. The child was taken to the ER were he was treated and discharged the same day.