chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fully vaccinated patient admitted through ED after a ground level fall.  She has mild cough, but no other respiratory symptoms and remains well oxygenated on room air.  She was tested for routine admission testing and incidentally tested positive for COVID.  "79 YO female w/ history of Hypertension, Diabetes mellitus 2, CAD, CKD, hyperlipidemia, presented with left knee pain following ground level fall. She was found to have closed, left distal femur fracture and subsequently admitted. She was also found to be COVID 19 positive but without any symptoms. During her hospitalization stay, she had a febrile episode with UA showing E. Coli and Proteus therfore she received 7 day course of Rocephin. She was also evaluated by Orthopedic team for her femur fracture and recommended no surgical intervention. She was treated conservatively with leg immobilizer with weight bearing restriction and pain control. Physical therapy recommended further therapy therefore she was transferred to another facility on day of discharge. "
patient was given pediatric dose instead of the 12 and older dose.  This was the second dose in the series.
2  year old who inadverently adminstered Kinirix.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by regulatory authority without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix at the age of 2 years which led to inappropriate age at vaccine administration. The reporter consented to follow up. Healthcare professional declined to provide any additional patient information and did not have any vaccine details.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "unknown" and all described as "COVID".  Clinical information: Description of Potential AE: I'm a physician. Have 10 year old twin boys who are ex-31 week preemies. My husband and I have vaccinated our family as soon as this was available. We developed COVID for first time 15Aug2022 and now twins tested positive 17Aug2022. Is there any trial to allow them to as me antiviral. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200046249 same reporter/vaccine/AE, different patient;
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. unknown if patient had Chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  It was unknown if patient received prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event. Treatment medications were not reported.
Systemic: Shakiness-Severe, Additional Details: Pt reported feeling extremely shaky a few hours after receiving her dose, so much that she could not drive anymore. She called the EMTs, they checked her vitals and said she was fine. However, she did get a hotel room becuase she did not feel safe driving home. only allergy is to pet dander. She will call back tomorrow just to give an update. She is going to call her PCP for further clarification as to what to do for the 2nd dose.
*Day 1 - none *Day 2-3 - Sore arm/muscle near injection site *Day 3-5- upper body aches,  very sore arm *DAY 6-9- sore upper body,  muscle aches, swollen lymph nodes ( neck and axillary  ) and rash at site *Day 9-11-  rash on arm at injection site, raised ,red and hot to touch.  Rash did not appear until day 8.5 -9 . No cellulitis,  by day 13 post injection rash was gone as well as all other side effects
incomplete dose; 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 INCORRECT DOSE ADMINISTERED (incomplete dose) 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 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (incomplete dose). At the time of the report, INCORRECT DOSE ADMINISTERED (incomplete dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
On 11/24/2022, I started to have upper respiratory complications. On 11/25/2022, I did a home Covid-19 test and it was positive. I also experienced a mild cough, sinus pain and my eyes were watering like when I had Lasik surgery. I contacted my Nurse Practitioner and she wrote a prescription for Paxlovid for me. I started taking it on Saturday 11/26/2022. As of today, 11/28/2022, I feel better, but I still have a scratchy throat.
Approximately 1 week post vaccine patient developed small pruritic rash on  both arms near elbow region. On April 13, 2021 by 2 am patient wakes up complaining of severe pruritus covering both upper and lower extremities bilaterally including gluteal region.  Patient administers 50 mg oral diphenhydramine. Patient also applies topical Benadryl to rash sites as well as hydrocortisone 1% cream to the most bothersome areas.   Four hours later patient develops severe bradycardia and presyncopal vasovagal episode.  Patient was instructed to lie down and elevate both legs.  The episode lasted approximately 5 minutes.
Induration lt deltoid area-2cm across w/erythema 7X14 cm.  Discomfort when moving the arm to abduction. Benadryl, Dolobid & prednisone for 5 days.  Use cool compresses.  Was to return in 4-5 days.  Pt did not comply.
Pt. had severe headache & eye pain with 1st dose Severe rash around testicles with 2nd dose Pt continues to have traveling itch
This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date in Jun2018 (reported 3 months from the time of the report) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2018, it was reported that the patient experienced knot in the site of injection. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Red, itchy rash on right torso. It has lasted over 3 months now.
Patient awoke on the morning of 4/14/21 and noted swelling of the lip/left facial region; swelling got worse throughout the day. Patient received epinephrine inhalation, famotidine IV, methylprednisolone IV, and diphenhydramine IV.  Discharged 4/14/21.
My period, which has been regular on the dot since I was 14, has been thrown off. I missed it for the first time ever in March and didn't have it again until the end of April. I then missed may and did not start my next period until today. It was 6 weeks late the first time, 7 weeks late this time.
Patient vaccinated with neck pain, fever, body aches, rash on chest, back, both arms and thighs, symptoms amplified to nausea, and shortness of breath. Patient treated in ER. Meningitis ruled out. Patient still has lingering headaches but other symptoms have subsided.
products were out of range for 3 weeks/No AE; Products were out of range for 3 week Products: Apidra, Ipol, ActHIB, Tubersol, Elitek (7.5 and 1.5) and Fabrazyme Lot and expiration for all products unavailable. Stability data not reported in source document and there is no vaccine administered hence case considered as non case.
Pt's L thigh was very red, swollen and hard to touch 1st day, 2nd day had gotten bigger.
It was reported that a 51 year old female patient received a Fluzone SV vaccination on 10/13/2000 at a hospital clinic. The patient developed hives with itching at the waist on 10/15/2000. The hives spread over her entire body. The patient went to the ER and was treated with Prednisone four times. The hives are now gone but the patient is still experiencing itching on her hands, feet and inner elbow areas.
Rapidly lightheaded; Heart was pounding; Felt like she was shaking; Pulse rate was 162; Blood pressure was 112/92 high for her; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung infection (Bacterial lung infection) since 2012.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her). The patient was treated with ALPRAZOLAM ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 112/92 mmHg high. On an unknown date, Heart rate (60-100 /min): 162 /min high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Body aches, chills, L arm pain (lasted 2 days-until 12/26)  Swollen lymph nodes L arm (lasted at least 5 days, current)- have added warm compress.
Patient had General Malaise unknown cause . Onsite EMS was called vitals were taken BP 128/84  100% O2 room air HR 89. Patient refused evaluation/care. Left aginst medical advice.
Covid arm, 1 week later. My arm starting itching and was blotchy with red marks that were hot. It felt like there were little bumps under my skin. I almost thought I had been bit my mosquitos or spider; however the knots were bigger and under the skin.
Utilizing cooler to keep punctured vial refrigerated; Expired doses administered to 6 Patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 3:41 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Apr-2022 at 3:41 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Date the vial was initially stored in the refrigerator was 15-Apr-2022.  Date and time vial was first punctured was 19-Apr-2022 at 13:00.  The vial didn't undergo temperature excursion.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 5 minutes.  Treatment medication was not reported.
I took my son and Aug. 12 for shot's he got three shots one was a hepites A and a chickenpox and a meningococcal. whith in a hour my son started breaking out in hives i took in to the urgent care on Aug.17 and i was then told he had a staff invection to have him soak in a oat meal bath and rub itching lotion on and take Cephalexin 500mg three times a day for ten days. I tryed that it didnt work it got worse it was all over his body by this point so i took my son back in to the urgent care on Aug.24 thats when they told me his was having a allergic reaction and starting him on Hydroxyzine Pamoate 25mg 1 to 2 capsules every 6 hours they also gave him Prednisone 20 mg 2 tablets every day for 4 days and some cream
Slight swelling on the injection site. Patient did not take any medications for the swelling nor seek medical attention.
Information has been received from a certified medical assistant (C.M.A.) concerning a 77 year old male with pertinent medical history and drug reactions/allergies unspecified who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously.  Concomitant medication was unspecified.  On 31-OCT-2006, the patient developed redness, swelling and fever at the injection site that moved down to his forearm.  The patient medical attention.  No diagnostic studies were performed.  The event did not improve.  At the time of reporting, the patient had not recovered.  Additional information has been received from an other at the physician's office.  On an unspecified date, the patient recovered.  No additional information is expected.
Sore arm with a knot; Arm with a knot/Swelling; Redness; Felt like I had the flu; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, local swelling, erythema and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, local swelling, erythema and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm, local swelling, erythema and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm with a knot, redness, swelling, and felt like the patient had the flu for a couple days.  The patient experienced complete recovery. It was a couple of months ago when he had the injection.  This was his second dose and couldn't remember the specific date.
Patient received Moderna Covid-19 vaccine. Just a minute after receiving, pt's eyes rolled in the back of her head and she went limp and was unconscious, but still breathing. Patient's mom was yelling her name and holding her up. We brought a mat out and laid pt down. She came to about a minute or two after being laid down. EMS was called. Patient was ok and conscious when they arrived. She said she felt ok.  EMS checked her out and said she was ok. Patient left the store with her mother.
Severe grip weakness in bilat arms/hands.  Some paresthesias in upper extremities.  Slowly resolving w/ Naproxen 500 mg bid and time.
I first got symptoms on Jan 19th with extreme muscle soreness from my shoulders to my toes with hives on my thighs and what felt like a bug bite on my knuckle and a circular bite on my left forearm.  The muscle soreness was there for 3 days.  It was very hard to walk for a while cause of just the soreness.  I still feel a little in my ankles and toes still but fully recovered.
head to toe body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th March 2021, 7 days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient reported head to toe body rash following 1st dose of Shingrix in left arm. Till the time of reporting, the adverse event was unresolved. The reporter did not consent to follow-up and also not consent to follow up with physician.
Narrative: COVID infections following completion of COVID vaccine series 02/09/21 COVID vaccine dose #1 03/08/21 COVID vaccine dose #2 07/23/21 Pt reports runny nose but denies any other symptoms 07/27/21 Pt reports muscle pain  onset 07/29/21 Preop COVID test - COVID POSITIVE 08/01/21 Pt reports fever, fatigue, headache, muscle pain, cough 08/04/21 Pt reports cough, headache, but is improving 08/05/21 Pt has met CDC guidelines for stopping home isolation; clinically resolved
The morning after the Covid Booster was administered to me, I woke up in serious pain. All my joints were inflamed. I couldn't even close my mouth because my jaw was in so much pain. Now I can barely walk. My pelvic joint is so painful I can't lift my legs and can't dress myself. My wrists hurt so bad I can't squeeze a tube of toothpaste. I'm a swimmer, Kayaker, Bicycle rider, sailor - but now I can't even lift a glass of water. This has been steadily getting worse and now I am unable to function as a person. Even my ears hurt! I haven't been able to see a doctor because I can barely move. I'm taking 1 gram of Ibuprophen every 5 hours now and taking CBD oil also.  Update: 03/05/22 - Went to (Privacy) ( they administer the Covid Vaccines) for a medical office visit. The doctor -(Privacy) APRN, gave me a prescription for Methylprednisolone (Medrol Dose Pack). The steroid helped with pain but gives me bad cramps and nausea. I am still in a lot of pain and am having a difficult time walking. I can't work and I don't have a full range of motion in most of my joints. My jaw muscle still hurts and it pops and crunches when I eat - it's been over 3 months!!!
The patient presented 2 days after receiving the 2nd Moderna Vaccine with worsening acute onset right-sided lower chest pain and right upper quadrant abdominal pain associated with shortness of breath. CT pulmonary embolus protocol showed subsegmental pulmonary embolus with evidence of pulmonary infarcts for which the patient was started on an anticoagulant. An echocardiogram showed a mild to moderate decrease in LV systolic function with global hypokinesis.  Cardiac MRI findings were consistent with acute myopericarditis with underlying non-ischemic cardiomyopathy disproportionate to the degree of myocarditis. The patient was discharged on a beta-blocker.
This spontaneous report was received from a medical assistant concerning a 6 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007673.
Patient received COVID-19 vaccination and waited her 15 minutes. As she was walking out to her car her throat and tongue started itching and she was having trouble swallowing. She came back to pharmacy and made us aware. I (the administering pharmacist) went out to her and assessed the situation. I instructed staff to call 911 due to the difficulty swallowing and called for a CODE WHITE. I moved pt to IMZ booth where I further assessed the situation. I did determine that epi-pen was not needed due to the pt breathing well. I did give an oral benadryl . EMT arrived and assessed the situation and instructed pt to go to the ER with them, although the pt refused stating they would go home and go to their MD if needed. I called pt later in the day to check and she was doing ok, but the throat itching did come back after the benadryl wore off, so she took another. I instructed pt that if it has not resolved in by tonight she would need to be seen, she agreed.
Pt recvd 3 doses of Engerix-B & titer report dated 27NOV91 indicated pt did not respond;