chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered with the vaccine that has been stored in the refrigerator for more than 30 days; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had received second booster.  Pharmacist reported that they administered 7 doses of the COVID-19 vaccine that had been stored in the refrigerator for more than 30 days. The vaccine was initially stored in the refrigerator on 15-Jun-2022 and administered on two dates 19-Jul-2022 (3 doses on 11:11AM, 11:15AM, 02:27PM), 20-Jul-2022 (4 doses on 09:43AM, 01:31PM, 03:05 PM, 06:18 PM).  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Follow-up received as patient details and product information was updated.
Pt had trouble breathing about an hour after injection. Husband was going to take her to ER, but pt couldn't move out of chair. Pt was taken by ambulance and hospitalized x 2 days. She had a drop in BP and was treated for anaphylaxis. Pt is doing fine and at home now.
Imperceptible inflammation injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site). At the time of the report, INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Concomitant medications were not provided.
Shoulder pain and swelling, CT revealed edema and air bubble, no necrotizing fascitis.
woke up with an extreme case of vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 08:45 (Lot number: ER2615) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIPIZIDE; SYNTHROID; HYDROCHLOROTHIAZID. The following information was reported: VERTIGO (non-serious) with onset 23Mar2021 07:30, outcome "not recovered", described as "woke up with an extreme case of vertigo". The event "woke up with an extreme case of vertigo" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Clinical course: It was reported that 4 days after receiving the vaccine, patient woke up with an extreme case of vertigo. It got better over the following 4 to 5 days and became tolerable. Now about 6 months after the initial onset patient still have it especially on standing or rolling over in bed. A month or so after the initial onset a neurologist had and MRI of brain taken which showed nothing unusual.  No follow-up attempts are possible. No further information is expected.
CHIEF COMPLAINT:   PT states coughing and dizzy for the last 4-5 days.  denies fever   HISTORY OF PRESENT ILLNESS:     57 years old female with past medical history of morbidly obese, denies history of coronary artery disease no congestive heart failure, no diabetes she denies obstructive sleep apnea comes to the ER complaining of feeling weak, fatigue, decreased exertional capacity for the last week, she was found to be hypoxic in the ER COVID-19 screening was positive.  Patient denies orthopnea, no PND, denies fever, no cough, no abdominal pain, no dysuria.
Pain down left arm, weakness in hand brachial radiculopathy.  4/22/2008 MR received for neurology OV of 3/19/2008 with Dx: Left Brachial Neuritis s/p DPT.   Pt developed a "knot" feeling and pain in the mid scapular region which radiated to the inner arm, 2 weeks s/p TDaP. Pain decreased but tingling/paresthesias developed in the left 3rd and 4th fingers as well as the base of the palm.  Mild weakness. PE (+) for minimally decreased cervical ROM, and minimal weakness of the interossei ADQM on the left. Otherwise WNL.
Pt presented w/ no voice p/ recvd YF vax, urticaria on arms, face, & trunk.  Tx w/ Benadryl & EPI.
Heavy bleeding outside normal menstrual cycle 6 days after vaccination. Couldn't tell how much blood, but I bled through my underwear and skirt then bled onto a seat of a car. Bleeding for about 2 hours, then it stopped until I got my next period.   My next period was the heaviest period of my life. I was dripping blood into a toilet and filling super plus tampons in 10 minutes. I had a panic attack because of how much I was bleeding. I was so concerned that I went to my OBGYN for bloodwork and a transvaginal ultrasound on October 18. Both came back clear.  I am not sexually active and have never been. Date of last period before event: Friday September 2 Date of random heavy bleeding: Sunday September 25 Date of next period: Friday October 7
pt devel 5cm indurated erythematous swelling @ site of inj rt thigh & @ same site & vesicular lesions 3mm, also scattered vesicular lesions;
The consumer called on behalf of her daughter who received the first dose of the Pfizer-Biontech Covid19 vaccine, 2 weeks ago. The patient developed stiffness in her neck, and they thought maybe she had "pulled her back out" because she was experiencing pain on the right side of her back. The medical staff at the Clinic (also reported as urgent care (pending clarification), where she was seen, think that she's experiencing "shingles without the rash" and indicated that they'd had "a lot of people" present this way after vaccination. The patient will be having bloodwork done to confirm shingles and will know in the next 72 hours. The reporter asked if there had been reports of shingles following vaccination. The reporter indicated that she does not want her daughter to receive a second dose of vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. In 2012 the patient was vaccinated with the first dose of RECOMBIVAX HB injection "10 Y" (strength, dose, route, lot# and expiration date not reported). Then the second dose (strength, dose, route, lot# and expiration date not reported) was administered on an unknown date in September 2015 for the same indication. No adverse effect was reported. Additional information has been requested.
Acute hypoxic respiratory failure persists after completing 5 day course of Remdesivir, day 6/10 of Decadron while on CPAP.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 25Nov2022 to 29Nov2022 for COVID 19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Received 2nd COVID 19 vaccine 3/4/21.  On 3/5/21, was tired, but otherwise did okay.  On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication.  She has gradually grown more short of breath and distressed since then.   She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray.  She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90.  She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.
Itchy arms, back, legs Noticed rash on bilateral arms, legs, and lower back
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 11:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:52 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. 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 66.64.  Concomitant products were not provided.  On 13-FEB-2021, Excursion time was 9A, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.   On 20-MAR-2021, Excursion time was 9A, temperature was 34, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 30 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.   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.
I was unable to pin down onset of symptoms. Patient was vaccinated on 04/10/2021 and sometime thereafter developed dizziness and double vision. Patient visited his ophthalmologist on 04/22/2021 and was advised to contact his PCP to schedule and MRI to rule out stroke. Patient is insistent that this needs to be reported despite my explanation that his symptoms are probably not vaccine related. I strongly advised patient to see his healthcare provider for further evaluation or go to the ED of local hospital.
Patient experienced no symptoms for 48 hours and then noted increased redness, swelling and purple tinge with warmth to the area in the upper right deltoid. At time of exam, pt had warmth to the area, approximately 2 cm x 2 cm. Pt was treated with Prednisone 40 mg daily for five days and Topicort 0.25% topical cream bid.
recurrent loose, NM,NBS stools for 4 days with the appearance of red rash all over the face, trunk and extremeties and low grade fever since 2 days ago. he has had recurrent diarrhea for 2 weeks, about 4 bouts. Attends daycare with 2 siblings in school. has been on whole cows milk since birth.
The patient started having severe chills, and muscle aches on the back and neck at 10:00 PM . Then he took Tylenol for the pain at around 12:00 AM and then started sweating profusely.
Pt came in on 11-19-12 for 6 mo WCV and received vaccinations. On 11-20-12 parents took child to ED for a seizure we had or was having.
Irregular heart beat/racing; Fatigue; Nausea; Headache; Muscle aches; Just don't feel good; Sweeping in my legs and hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 10:00 (Lot number: FD0809) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; ALEVE. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Irregular heart beat/racing"; FATIGUE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Muscle aches"; FEELING ABNORMAL (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Just don't feel good"; HYPERHIDROSIS (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Sweeping in my legs and hands". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, nausea, headache, myalgia, feeling abnormal, hyperhidrosis.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
8/10/16 - Pt. Received MMR, Varicella, HepA, PVC 13. 8/11/16 - Pt. Developed 101 fever and rash, all over body. 8/16/16 - No fever, Rash still Presenting. 8/18/16 No rash present.
Abdominal pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain) outcome was unknown.            No concomitant medications were reported. No treatment was reported.
Severe Itchy reaction throughout all of right arm and hands. Red rash at injection site.
Following vaccination patient was dizzy and seeing stars.  Moved patient to floor and checked blood pressure 118/68 heart rate 70.  Patient did not faint and felt better.  Observed patient and patient left with family member feeling fine and did not want further intervention.
Injection given 5/15/2023, left arm pain & swelling 5/16/23 am, body aches, fatigue, left arm pink raised erythema 10cm X 14cm. Ice applied taking Motrin,
Following the injection 11/23, the Pharmacist stated that a significant amount of liquid squirted back at him. I conferred with the lead Pharmacist - Pharmacy cannot legally provide another dose. We'll need to hope the #1 & #2 Moderna doses along with the partial Moderna booster will keep Cofid-19 at bay. I called pharmacy again and was ensured he did all that was required by law.  My Doctor authorized the booster because I work with Autistic, have a heart issue and care for elderly parents.
osteoarthritis; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. This 74-year-old female consumer (patient) reported that:  A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced osteoarthritis with outcome of unknown. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
significant facial/lip angioedema first noted ~20 hours post vaccination, leading to intubation in ED due to concern for airway protection.  extubated and discharged in 2 days
Hives on injection arm just below the injection site; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; The area is both itchy and tender.; The area is both itchy and tender.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: IN8730) via an unspecified route of administration in the left arm on 23Mar2021 at 15:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and chronic low vitamin d levels. The patient had no known allergies to medications, food or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12) and multivitamin; all for an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 19:00, the patient experienced hives on injection arm just below the injection site. Affected area which roughly covers a 4 x 2-inch surface area was red, hard and hot to the touch. The area was both itchy and tender. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event hives on injection arm just below the injection site, affected area which roughly covers a 4 x 2-inch surface area red and hard and hot to the touch, itchy and tender were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 15:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.