chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:36 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 38.03.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
SEVERE SHIVERING FOR 3 DAYS; This spontaneous report received from a consumer concerned a 25 year old male. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced severe shivering for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe shivering for 3 days. This report was non-serious. This case, from the same reporter is linked to 20210926966.
recently diagnosed with covid 19 despite completing the series; recently diagnosed with covid 19 despite completing the series; This is a spontaneous report received from Pfizer sponsored program via a contactable consumer.   A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was recently diagnosed with covid 19 despite completing the series on an unspecified date with outcome of unknown, there was no treatment received.  Information related to batch/lot number has been requested.
Information has been received from a health professional concerning a 65 year old retired female with sulfonamide allergy, heartburn, vitamin b12 deficiency and hypertension who on Nov 16 2004, at approximately 10:00 am, was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). Subsequently on Nov 16 2004, the patient developed redness, pain, swelling, and heat at the site of injection, 10x15cm area. It was reported that the patient was treated with amoxicillin (+) clavulanate potassium (Augmentin), heat pad and elevation of affected area. All symptoms resolved by Nov 19 2004 except for some post inflammatory hyperpigmentation. Additional information is not expected.
This spontaneous report as received from a nurse practitioner via company representative refers to a female patient of unknown age. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unspecified date in 2014 (reported as about a year ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#/batch#, expiration date were not reported), at an unspecified retail pharmacy. On an unknown date, the patient has been experiencing a red, itchy bumpy rash that 'comes and goes' since she received ZOSTAVAX. The rash would erupt and then resolve. The reporter could not provide any additional description of that rash. The outcome of event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not assessed. Additional information has been requested.
Chest pain (severe) Felt like heart was being squeezed.  Taken to ER by ambulance, EKG, ULTRA SOUND, and CHEST X-ray.  Released after testing.
NOC 13533-131-01, expiration 3/5/23.  Shot given late Friday afternoon, with in 24 hours I had some aches as expected, within 36 hours I was waking up in agonizing pain, head felt like it was going to split open, light made me vomit...movement made me vomit, headache continued through Sunday, woke up Monday and was pain free. Saturday and Sunday I had a fever of 101.2
Itchy rash on his arm; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 18th January 2021, 7 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   The reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and about one week later developed an itchy rash on his arm.   No lot number or expiration date was known for this vaccine.   No HCP information was provided The reporter did not consent to follow up. This case linked with US2021022952 and US2021022954, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021022952:same reporter US-GLAXOSMITHKLINE-US2021022954:same reporter
Two weeks after the second shot, we notice I had developed one spot of missing hair on head, diagnosed as Alcecia Areala.  Not sure when exactly the alcecia areala started.
Exactly one week after my first dose, had a tunnel vision attack with multiple visions.  Since then have started having migraines, rapid heart rate, dizziness, headaches, eye pain, tiredness, anxiety, light headedness, just weird feelings and pains that I can't describe.  I registered on the date of the vaccine and have been replying to your texts since then.  Last time, I received a voicemail that wanted me to complete a form online.  I'm assuming this is the correct form.  My doctors all urged me to take the second vaccine, which I'm not sure was a good idea.  Would love to hear from you and other patients who have had these symptoms so hopefully I can get some relief and answers.  (Lot number has rubbed off my card but info should be registered from when I logged in on 2/27/21)
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient of an unknown age who experienced pain at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported (dose, expiry date, route and site of administration were unknown). On an unknown date, patient developed a non-serious pain at the injection site, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was pain at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.
She reported feeling itchy in the lips. She took a Benydryl and started to have itchiness in the throat. She was placed in a wheelchair and taken to the ED. she was treated with epinephrine, steroids, Benadryl, Pepcid, and Zofran. To be observed for 4-6 hours, after 3 hours of observation she wanted to go home and her husband said he was comfortable to watch her.
Information has been received from a RN concerning a male pt who was vaccinated with a first dose of varicella virus vaccine live. One week post vaccination, the pt had a breakthrough with eight bumps. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Per mandate all healthcare workers need to be vaccinated by 10/29/21.  This RN was very against the vaccine and was anxious. She spoke with her director. Director agreed to talk to her about it and administer the vaccine. Once the RN was comfortable the director administered the vaccine and minutes later the RN started to have trouble swallowing. RN took oral pepcid and again hours later benadryl. Next day throat still scratchy from reaction. Continuing to take benadryl. Refuses to be seen in ED. Overall RN is ok and doing better.
NO SYMPTOMS. Patient received expired vaccine (12/06/22). Was taken out of freezer without checking expiration date (11/24/22). Called Moderna, who said that for most cases it is fine with no change in efficacy due to short timeframe of expiration date until administration and that it was taken out of freezer on administration date. Called and left message with patient.
They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; collapsed in the bathroom at 10pm; He was having trouble breathing. He collapsed in the bathroom at 10pm; he wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's son). A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 57-year-old. Medical history included alcoholism, seizures. There were no concomitant medications. The patient experienced cardiac arrest on 23Sep2021, pulmonary embolism on 23Sep2021, trouble breathing and collapsed in the bathroom at 10pm in Sep2021, wasn't feeling well in Sep2021. The patient died on 23Sep2021. An autopsy was not performed. The outcome of wasn't feeling well was unknown, outcome of other events was fatal. The clinical course was reported as: his father died yesterday, and the only difference recently in his health was that he got the COVID vaccine. His father died 9 days later on 23Sep2021. The coroner denied an autopsy. The hospital denied an autopsy. His father was not obese or diabetic, and he was only 57 as healthy as a horse. His father had gotten the vaccine, and said he wasn't feeling well to his girlfriend. He was having trouble breathing. He collapsed in the bathroom at 10pm. They called an ambulance who did everything they could do to bring him back. They pronounced his dad dead 23 minutes after midnight on 23Sep2021. They said it was cardiac arrest, but the reporter thinks it was a pulmonary embolism. His dad was not COVID positive. His father did have a history of alcoholism. Any time he would try to quit drinking, he would drink too much water out of compulsion since he couldn't drink beer. He would flush his system so much that he would deplete his sodium. His dad would get seizures every time he quit drinking. He tried to tell his dad that he needed to drink the normal amount of water. He can't just sit there and drink that much water to replace all the beer he drank. It would flush his system of all that sodium.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; He was having trouble breathing. He collapsed in the bathroom at 10pm
flu shot killed patient; Initial information received on 13-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional via social media.  This case involves a male patient who died after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was not reported if any laboratory tests were performed before he died.  It was not reported if the patient received any corrective treatment before he died.  The patient died on an unknown date. It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns an elderly patient who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Reporter reported more than 1 pt devel hardened areas to the inject site, redness & soreness; reporter has not had this problem reported a/;
pain in arm / still experiencing pain; tingling sensation in arm; hands and fingers numb; cannot work or  type on computer; hard time sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) and (batch number 7A799, expiry date 10th December 2021) for prophylaxis.   On 5th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid.  The patient was not immunocompromised. After receiving Shingrix, the patient experienced pain, tingling sensation in her arm, sometimes to the extent that her hands and fingers were numb. The patient was seen at emergency room and bone and joint practice but was still experiencing pain.  The patient could not work or type on computer.  The pain lasted all day and night and she had a hard time sleeping. The reporter consented to follow up.
his COVID-19 PCR was positive, CXR demonstrated new interstitial opacities predominantly involving the right mid and lower lung which can be seen with COVID-19 infection, new small bilateral pleural effusions. complaints of dyspnea, cough, and fatigue
Arm swollen to half the diameter of a tennis ball, hot, red, tender and itched an entire week
Mom states child has 2 red spots on right leg on 10/27/00, which got worse everyday. Child ran a fever of 100.5F on 10/27, 10/28, 10/29 and 10/30/00. Mom called his pediatrician who referred him to health dept. Child has 4cm X 1cm red area on right thigh.
Erythema on injection site spreading through arm, neck and face. Itching reported T=98.2F. No respiratory distress noted or reported. Symptoms appeared within 30 minutes of vaccination. Patient was given Diphenhydramine 25 mg orally. Pt reported improvement over night.
had severe depression and only had colds after the first 2 doses; had severe depression and only had colds after the first 2 doses; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "had severe depression and only had colds after the first 2 doses".  Additional Information:when patient had the 3rd dose he no longer had depression.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
May 3, 2022 onset of Covid symptoms. On 5/6 tested positive for Covid. Had a fever and cough. Went to urgent care clinic was given inhaler for lungs, also given steroids'. Still have SOB. Allergy symptoms, runny nose and congestion.
The day following my vaccine my right middle finger began swelling and very painful. Could not fully make a fist or apply pressure. Messaged PCP and was told to try 5 days of naproxen sodium. Taking 2 tablets the first dose and 1 tablet twice daily for 5 days and to follow up if it does not improve. After beginning the naproxen sodium I started to notice an immediate improvement. I would currently put my recovery at 65%.
Site reaction that was red; Site reaction that was swollen; Site reaction that was hard; Body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 21st March 2022, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site induration. On 26th March 2022, the patient experienced general body pain and fever. On 24th March 2022, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved. On an unknown date, the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, general body pain and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Apr-2022 Reporter's comment: The caller was the mother of the patient.  The caller did not want to provide any further demographics. The patient did not want to supply the patient's birth date, but she mentioned her daughter was a senior in high school. The caller stated that her daughter got her first Bexsero vaccine in left arm and the patient immediately had a site reaction that was red, swollen, and hard for 3 days.   The patient then started with fever and body aches about 5 days later that lasted a week.  The patient was recovered from all these symptoms.   Did not consent to follow-up. No health care professional for follow up.
One week after the first dose I developed a rash on the injection site that lasted one day.  It?s been almost two weeks since my second dose and I developed a fever of 100.8 degrees that lasted overnight. I had chills and woke up with body aches.
At site (Lt Deltoid) red spots (hives)/ sore to touch - appear to be shingles ready to erupt.  Patient was put on Valtrex for 7 days.
Extreme soreness, warmth, no redness, patient had to call in for work shift the next day. Still now have severe muscle soreness, difficulty lifting, muscle aches, trouble moving arm. Pain and soreness somewhat alleviated with naproxen twice daily.
Unknown proportion of the dose was on the patient's skin and not administered intramuscularly Narrative:
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
70 year old male, with a hx of CABG x 4 2016 (LIMA LAD, SVG OM, SVG PDA, seq to PLA), PAD S/P recent stent to the R ext iliac artery, DMII on insulin, and COPD who presents with severe  DOE and syncope. Pts COPD worsening, but labs on admit c/w NSTEMI; ECG suggested evolving ASMI vs IMI.  Angiogram surprisingly showed no obstructive CAD; all grafts patent.  Syncope most likely due to severe COPD exaccerbation. Note on TTE LV low normal; RV systolic function down. PAP could not be calculated.   1.  Syncope - likely due to COPD. No arrythmias; LV function normal. 2.  Trop leak - likley demand due to hypoxia 2.  COPD -  Pt urged to F/U with his pulmonologist.  He picked up his new inhalor last night. Urged to wear CPAP nightly  (he does this) 3  CAD - 3 vessel. High intensity statin Rx, lifelong ASA, beta-blockade 4.  DM - Cr 1.2 5.  PAD - S/P R ext iliac art stent 12/20. Excellent pulse; no bruit. No claudication Pt will follow with Dr   OK to DC from a Cardiology perspective. F/U in DC orders.