chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 12:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 12:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 24.30 for dose administered on 27-Mar-2021 . No concomitant medications were reported. On 23-Mar-2021 , the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, vial was moved to the clinic. On 27-Mar-2021 at 9 a.m to 10 a.m, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. 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 Fisherbrand traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
rec'd 3rd dose (booster - dt autoimmune UC and transplant patient) Within 48 hours developed fever 100.7 and sore throat - appears to have triggered an ulcerative colitis flare in mouth and throat when prior to this has never had ulcerative colitis in this area, has only had issues in lower intestines.
Developed severe (L) upper arm pain within 6-8 hrs after injection. The day after injection developed nausea & temp of 100.3 for 3 days following injection. No redness or swelling at site.
inappropriate schedule; the patient had itching at the injection site; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; This spontaneous report was received from a nurse and refers to a 30-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.    On an unspecified date in her childhood, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On 08-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On the same day, she experienced redness, swelling, and pain that radiated down her left arm to her left elbow. On an unspecified date, the patient went to an unspecified physician and the physician prescribed an unspecified antibiotic as treatment. On 16-JUL-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection in the right arm, lot # S025610, expiration date was not reported but after internal investigation was established as 18-AUG-2021 (exact dose was not reported) for varicella immunization (inappropriate schedule of product administration). On an unspecified date in July 2020 (reported as after the 16-JUL-2020 vaccination), the patient experienced itching at the injection site. The outcome of the events of redness, swelling, and pain that radiated down her left arm to her left elbow were reported as recovered. The outcome of the event of itching at the injection site was not reported.  The relatedness between the suspect therapy and the events was not provided.
28nov89 pt vax hepta B. pt ex pain at inject site. 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2days to 1 week. pt recovered.
One week post vaccine, little blisters lower eyelid, itchy and swollen. Prescribed Erythromycin and Cephalexin. Next day, red eye, blisters worse, swollen and itchy. Second opinion,  prescribed valtrex and doxycycline. Following day starting to improve. Day 4 just blisters now.
This case was reported by a consumer via call center representative and described the occurrence of photosensitive rash in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included AUGMENTIN with an associated reaction of nonspecific reaction (received year before the time of reporting). Concomitant products included SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced photosensitive rash, erythromacular rash and injection site tingling. On an unknown date, the outcome of the photosensitive rash, erythromacular rash and injection site tingling were unknown. It was unknown if the reporter considered the photosensitive rash, erythromacular rash and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received their 1st dose of SHINGRIX in May 2018, and their second injection in late August 2018. About 3 weeks before the time of reporting, the patient began to experience a sunburn like rash on the side of the torso. The patient also experienced tingling at the site. The day before reporting, the patient reported seeing small rash at the torso site of the sunburn described as dot like in appearance. The patient was seen by their physician who did an EKG, chest X-ray, and blood work which was unremarkable. The reporter given consent to follow up. This case has been identified as duplicate of case US2018199619 which is going to be deleted from Agency core and this case would remain as case of record.
Mom noticed new bumps, 1 behind each ear starting 12/13. Mom noted more lumps on the back of his head just today and is here to have those checked. No overlying skin changes, don't seem to bother him.
1/9/2022- Presented to ER, with complaint of SOB. Tested + for Covid 1 week ago. T-100.4,  WBC-32, P-89. RR-22. O2 via nc 2L. Chest x ray-Mild bibasilar atelectasis. Admit with acute on chronic  hypercapnic respiratory failure due to Covid-19 pneumonia with severe sepsis int he setting of home oxygen dependent at COPD 2L. Started on remdesivir, baricitinib, Zosyn, vancomysin and Decadron.  1/10/2022-WBC-21.Tolerating oxygen at 4L. New onset A fib, echo report-no evidence wall abnormality or valvular disease. On Lovenox and started eliquis.    1/13/2022- 3L o2 via NC, 96%. Covid -Test.  1/14/2022- Tolerating 3L  o2, which is his home oxygen base. Afebrile. Discharged to sub acute rehab.
SM changed bandage over SPV site and approx.  3-4 days later develop a localized rash that became generalized over several days.  SM received primary SPV on 09/30/07.  Symptom:  Dermatitis, diffuse, generalized Start: 10/16/2007; 11/01/07: erythema multiforme
shingles; feeling lousy/kind of sick; really bad headache; little bit of reaction; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (Medical history was not reported).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction). At the time of the report, HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-039293, MOD-2021-039117 (Patient Link).
After i left store  after vaccine i had shortness off breath rapid heart beat. Also itching friday 4/9/21 it became worse on my arms and hands
screamed & cried x 3-4 hrs noc recvd vax; low grade temp that noc & following day; min local reaction;
Shingles in left upper chest dermatome. started with itching and discomfort 1-2 days after injection and by day 3 or 4 had blisters on left upper chest and then got more clusters of blisters adjacent in same dermatome
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shot 1. Metallic taste in mouth, awoke with heart beating really hard. Right arm muscular pain the next day that took 3 weeks to go away  Shot 2: 5/20 Arm pain that still has not gone away as of today 6/10
Day 6 after vaccination: swelling and hardness, rednesses, warmth, soreness when touched in upper left arm between shoulder and elbow. Day 7 same as Day 6. Day 8 swelling and hardness, warmth and soreness was reducing some itching. Redness was spreading around about 60% of arm to just above the elbow. Day 9 symptoms continued to be reducing, some itching. Day 10 swelling almost gone, redness reducing.
Patient received the Pneumovax around 0830 on 11/19/2009. In the afternoon of 11/19/2009 the patient was experiencing some nausea and it continued on through the night. On the morning or 11/20/2009 the patient was febrile at 102.0 to 103.0. The patient's left arm at the injection site became red and swollen. The patient was taking TYLENOL every 4 hours for the fever. The patient called on office on 11/23/2009 to get an appointment to come into the office. Dr. saw the patient at 1:17 pm. Vital Signs: Temp 98.4, Pulse 81. Resp per min 12. BP 112/70. 02 sat 98% on room air. Physical Exam left arm states: Significant swelling and redness of her upper left arm, which is tender and measure approximately 6 x 3 inches. No petechia or blisters. Dr. started the patient on BACTRUIM DS (Sulfamethoxazole-trimethoprim) 800-160mg Tabs, 1 tablet by mouth twice a day for 14 days for Cellulitis and recurrent sinusitis. Patient was instructed to outline her swelling of her left upper arm. If it is getting worse, she may need to start IV antibiotics and get imaging studies of her left upper arm. Dr. will check her pneumococcal titers in the coming months. Patient was instructed to give the office a call if she had any other questions or if the arm develops more swelling.
After two weeks the area I got the shot in turned real red again like it did after the it was first injected, only difference is it is not swollen or hot like it did on the second day after the shot. I was told to come to this site to report it.  I have sent a message to my doctor telling him what it is doing but since it is only red I have not done anything else for it.
After patient received vaccination he went to the pharmacy register with his family for checkout. Child fainted and fell to the ground. At first he was awake but somewhat unresponsive. After a few seconds he said he could not feel his legs. We had child sit on the ground and I asked him if he was able to breath okay. He stated he was. He stated that he regained feeling in his legs and was able to wiggle his toes. Child was given a drink of water that he was able to drink without issue. We kept child on the ground until it seemed he had stabilized. After his mom helped him to his feet he walked around the store for a little while and then the family took him home. They declined offer to contact 911 and I recommended they follow up with child's healthcare provider. Incident appears to be a vasovagal reaction.
Looked like cellulitis; Redness had spread; Painful; Itchy; Arm became really hard and swollen; Dose above deltoid; A spontaneous report was received from a consumer concerning a 25-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed hard and swelling, itchiness, redness and pain at the injection site which resembled cellulitis, and she received the vaccine in the wrong anatomical location.   The patient's medical history and relevant concomitant medications were not reported.   On 04 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper shoulder joint for prophylaxis of COVID-19 infection.   On 11 Jan 2021 the patient's arm became hard, swollen, itchy, and painful.    On 12 Jan 2021 the patient's arm was red and resembled cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, she received the vaccine in the wrong anatomical location, was resolved on 04 Jan 2021. The outcome of the event itchiness resolved on 12 Jan 2021. The outcome of the events swelling and pain at the injection site which resembled cellulitis were not reported..; Reporter's Comments: This case concerns a 25 years old female patient, who experienced product administration error, and a non-serious unexpected event of limb discomfort, vaccination site cellulitis, and non-serious expected event of pruritus, pain and redness. There were no reported AEs associated with this case of product administration error. The events of limb discomfort, pruritus, and pain occurred 8 days after first dose of mRNA-1273, lot # unknown. The event of erythema, and vaccination site cellulitis occurred 9 days after first dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (vaccination site cellulitis, pruritus, limb discomfort, pain and redness) a causal relationship cannot be excluded.
A few minutes after injection patient complained of feeling dizzy and shaky, she thought it might be from anxiety.  About 10 minutes after injection nursing staff asked that I check on patient.  She was alert oriented, trying to be calm but was anxious.  No rash or swelling to upper chest/face noted.  Nurses report she was pale but never diaphoretic.  Patient denies trouble breathing, she was eupneic and breath sounds clear to auscultation, no coughing.  Heart rate 110.  Patient c/o lump in her throat.  Given Epinephrine 1:1000,  0.3 ml SQ R upper arm.  After about 5 minutes patient reports lump in throat has subsided.  She was tremoring, heart rate 110-120.  About 8 minutes later she was given Benadryl 25 mg PO from marked pill bottle in her purse.  About 12 minutes after 1st epinephrine dose she stated the lump in throat feeling was coming back.  Gave another dose of Epinephrine 0.3 ml and called EMS.  When EMS arrived about 10 minutes later patient said no lump in throat. it just felt dry.  O2 sat 99$  Heart rate 130, BP 130/60.  Transported to ER.  Called patient next day to check on her.  Reports in ER given IV steroids, sent home on PO steroids and an epinephrine pen.  Told not to get second dose of vaccine.  Patient states hasn't had any problems since.  Never had a rash or swelling or trouble breathing.
Received a call, reporting immunization system, stating that patient went to pharmacy and received covid Pfizer 3 days prior to Janssen dose with another Pharmacy. On the immunization consent form, patient stated "no" to the question "Have you received any vaccination in the past 4 months?". Due to patient's decision to get another covid immunization without accurately answering the consent questions and not within CDC guideline recommended time period, we cannot guarantee patient's immunity status.
Approximately May 5, 2021 felt flu like symptoms.  Extreme fatigue, headache, upset stomach and muscle aches. Saturday May 8, 2021 started feeling pain in left shoulder and upper left side of pack.   Sunday May 9, 2021 first blister appeared under left arm. Monday May 10th, 2021 rash and blisters spread to left side of chest, left under arm and upper left side of back and shoulder.
Had syncope approx. 10 minutes after receiving Hepatitis A and HPV vaccines. Patient was taken to an area where she was put supine with legs elevated. Vital signs normal, immediately regained consciousness.  Was observed for 10 minutes and was well after that.
Pt began to have chest tightness around 15 mins after vaccine. Pt stated his throat felt scratchy. Pt had clear lungs bilaterally and good heart sound. No stridor noted in the neck and tongue. Throat appeared clear at time of observation.
Dark reddish-purple rash on neck that started to spread to the chest area about 1 hour after the vaccine was given - took 1 Claritin and 1 Benadryl and slept.  I woke up a few hours later with chills, headaches and body aches.  I took another Benadryl and slept for the rest of the night.  The next day, I woke up with the same symptoms, but worse.  I was very drowsy and slept all day.  I had no appetite.  That evening, I took some Tylenol and began to feel better a few hours later.  The next day, the symptoms had mostly resolved.  A little bit achy and sore but overall, I felt good.
I have had a headache ever since my first shot.  The headache came on 2 days after my first shot (4/1/21) and has not gone away to this day (6/4/21).
patient reported that after getting her covid-19 booster shot and she felt increase in her joint pain. she has to go on a steroid course to be able to function. she spoke with her md and he is in the process of getting the enbrel approved for her. in the meantime she is going to continue on humira. patient tried methotrexate before and it was making her sore around the injection site and the oral elevated her liver enzymes
Patient stated that 6 days after vaccination her left arm around the injection site developed a rash extending downwards. Positive for itching.
Pt. received TDAP and MENVEO, was taken to the checkout window where she fainted.
a 38 years old female received her first  dose of pfizer #lot: EW0180 in 07/02/2021. She refer that in the next sunday (july 4,2021) her eye star to tearing. In the next day (july,5,2021) patient noted an inflammation in her left eye. Patient said that her eye left eye  have the appearance of a burn.  Patient call her dermatologist but he never respond. She take  panadol and eye drops.
10:22 - Pt reported  becoming lightheaded and dizzy.  Felt like passing out.  She was placed in the supine position, provided with O2 at 2 L/min.  BP: 162/114, O2 100%, Pulse 125.  Pt breathing comfortably, no coughing, wheezing, facial swelling, SOB, or rash.  Due to history of allergies, but no s/s anaphylactic, Benadryl 50mg PO given.  Continued to monitor pt.  Reported nausea, but no vomiting.   10: 31 - BP 162/130, O2 100%, pulse 104 10:36 - BP 172/87, O2 sat 100%, pulse 98 10:41 - No rash, wheezing, or SOB.  Nausea improved.  Shaking improved.  BP 158/94, O2 99%, pulse 86 10:46 - nausea, flushed, lightheaded with movement.  c/o chest aching.  BP 168/111, 100% O2, pulse 95 10:51 - BP - 160/105, O2 99%, Pulse 106 10:56 - C/o chest aching and burning.  BP 166/89, O2 Sat 98%, pulse 111 11:01 - 175/117,  O2 98%, pulse 111  11:05 - Epinephrine 0.3mg administered IM R leg due to lack of recovery, 9-11 called. 11:06 -   169/111, O2 sats 100%, pulse 147  11:11 - 171/104, O2 98%, pulse 134 - Pt stated that she takes blood pressure medications but had not taken it today. EMS arrived at 11:11 and assumed care.  Pt taken to hospital ER in good condition without wheezing, SOB, facial swelling.
This spontaneous report as received from a Registered Nurse regarding to a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-JUN-2015, the patient was vaccinated with the dose of improperly stored ZOSTAVAX, 0.65 ml, subcutaneous. No concomitant medication was reported. The patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Patient received a DTaP and IPV vaccines in left thigh and developed cellulitis of left thigh
No actual adverse effect observed. Reporting administration error in timing. First dose in series was given on 4/1/23, second dose was given today 5/27/23, not within the 2-6 month recommended window per CDC's guidelines.
Extreme fatigue and muscle stiffness in legs and back commenced on Wednesday, Feb. 17, and have continued through today, 2-21-21. Experienced considerable injection arm soreness for 12 hours after injection on 2-4-21. Injection was at 10:25 a.m.,  and, remarkably, soreness disappeared by 10:00 p.m. on 2-4-21. I have been getting extra sleep, and walking at little less than my usual routine of 6,000 steps per day. Extreme fatigue not noticed for ten or eleven days, until 2-17-21.
I experienced a fever, chills and body aches, and soreness after receiving the 2nd vaccine shot.
CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and chills was not reported. This report was non-serious.