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 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:55 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced 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). 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 76.74 for dose administered on 27-Feb-2021 and 76.82 for dose administered on 27-Mar-2021.  Concomitant product use was not provided by the reporter.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Got her Pfizer covid vaccine booster; Has bruising on her toes on the opposite side of her body that the vaccine was given on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Got her Pfizer covid vaccine booster"; CONTUSION (non-serious) with onset Nov2021, outcome "unknown", described as "Has bruising on her toes on the opposite side of her body that the vaccine was given on". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Nov2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that included: event details, seriousness.  Follow-up (16Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Erythema and edema left shoulder, started the same evening/ night of the IZ's. Cool compress with Tylenol as needed.
I experienced headaches, sinus pressure, chills and fatigue. The chills and fatigue went away in a couple of days. The headaches and sinus pressure are still ongoing. The headaches and sinus pressure aren't as bad or as constant, but still happen.
Abdominal pains with light bleeding from the vagina. Sore throat on Wednesday afternoon, 9/29/2021, abdominal pains all day on Thursday 9/30/2021, had light bleeding from vagina after getting home from work. Haven't had a menstruation in about 8 years.
Pain in tongue.  It appeared to be a lump/bump on my tongue and it seems as if my entire tongue was hurting.  Enough to interfere with eating.  I was able to breathe.  It felt as if it was swollen, but I could not tell.  Today it feels much better/normal.  Should I get the second shot?
presented to ED with stroke like symptoms, slurred speech, weakness, hypotension and tachycardia. Stroke team activated and no hemorrhage noted on CT. Treated with alteplase after consult with neurology and then transferred to hospital for further evaluation and treatment.
a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore; The swelling has elongated down the cheek bone, It was sore to the touch, throbbed; It was sore to the touch, throbbed, and my jaw and ear hurt; It was sore to the touch, throbbed, and my jaw and ear hurt; red puffy place under my eye; Had a red puffy place under my eye; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 11:00 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation, at 74 years old, at hospital. Patient is not pregnant. Medical history included blood pressure (abnormal), migraines, back surgery from an unknown date. The patient received the first dose of BNT162B2 on 04Jan2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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's concomitant medications were not reported.  On 12Feb2021, the patient experienced a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore. It was sore to the touch, throbbed, and her jaw and ear hurt. Patient couldn't lie on the right side. Patient also had a red puffy place under her eye. Events required physician office visit. Dermatologist and PCP gave her steroids for a month. The bump improved, but still present and less sore.  Patient was sent to allergist. Together they put her on antihistamines (Zyrtec -24 hrs. Tablets twice a day,) Pepcid and lisinopril 5 mg. Patient only took lisinopril for 5 days. Patient is still taking the antihistamine and Pepcid. Patient have only had 1 filler in that area in October 2020 (as reported). Outcome of the events was reported as not recovered.  No follow-up attempts are needed; information on lot number has been obtained.
chills, nausea, vomiting, shortness of breath, diarrhea, chest tightness, skin discoloration of the fingers
Patient had J&J vaccine as primary series.  Came here today for a booster dose of Moderna (0.25mL) and received a full dose of Moderna (0.5mL)
Flare-up of my preexisting, intemittent  divertiulitis Augmintin 2x/day for 9 days Ongoing
Patient developed hives on lower extremities and abdomen. Then the next day felt chest tightness. He was taking Benadryl. Seen at the office on 12/31/16 because hives were not improving.
Patient stated that she felt fine after waiting the 15minutes after receiving the vaccine and left the pharmacy. A short while later her mother called to report that she fainted when she got home. Patient states that when she pulled into her driveway she began to feel dizzy, heart was racing and she felt clammy. Once she got into her home she fainted.  Patient states she has never fainted or felt dizzy after receiving an immunization. I called the patient back about an hour later to check on her at which time she was checking in to the ER. She stated that she was better but then started to feel dizzy and her heart felt like it was racing again. She contacted her doctor who advised her to go to the ER.
It was about a week or so after getting 1st shot, I started feeling dizzy at times, having a bad headache just about everyday, feet have been swelling, have this cough that won't go away, a sore throat that comes and goes, I have a Dr appt scheduled for Aug 18, 2021 to get everything checked out.
Information has been received from an 82-year-old female consumer with allergies to PERCOCET and NOVACAIN and a history of shingles 16 years ago, who on "about the 9th or 10th of July, 2007" was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (+) simvastatin (MSD), OS-CAL, CENTRUM, vitamin D (unspecified), ECOTRIN and ACIPHEX.  It is reported that the patient felt shingles symptoms coming on a couple of days before she received her vaccination.  The day after vaccination, 10-Jul-2007 or 11-Jul-2007, the patient developed lesions.  Unspecified medical attention was sought.  There were no laboratory or diagnostic tests performed.  The outcome is reported as recovering.  No product quality complaint was involved.  Additional information is not expected.
stiffness, heaviness in arm, resistance when lifting arm, soreness, splotchy rash, itchy, warm to touch, feels like arm has been punched.
3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Breakthrough case admission after 3 vaccines PFizer 3/12/21 lot# EN6207;  Pfizer 4/2/21 lot# EW0150;  PFizer 10/29/21 lot# FH8020
No adverse symptoms, but at a regular checkup two days after vac the blood test showed a very low white blood cell count according to the Primary care Dr. who then asked alternate Dr. to follow up.  At subsequent blood test a month or so later, cell count had improved, and then back to normal. Recent colonoscopy did not disclose any likely cause for this and no other causes apparent , suspected, or likely.
48 patients received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment information was provided by the reporter.  The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.
Pt reported feeling dizzy as she approached monitoring table.  Pt was assisted by EMS fire  & M.A. Agee.  Vitals taken x4 and water /snacks given.  Pt reported improvement in condition and was released by fire/EMS to leave with family.  Pt. self ambulated with family to exit of building. 3:48PM BP82/36, HR 60, OxSat 99%, BS 105.  At 3:50PM bp 80/41, HR 80, OxSat 98%.  @ 3:52PM BP 98/59, HR 77, OxSat 97%, @3:57PM BP 116/61, HR 92.
Gave FluBlok instead of Fluzone.  Individual was 17 not 18 and should have been given Fluzone.  NO adverse effects noted by patient.
Erythema, swelling and tenderness in area of left deltoid. The follow up received on 11/7/03 states, "mom unsure of the onset as she noticed the arm on the date that I reported the event."
104 fever lasting 24 hours with extreme malaise, nausea, and headache.   Then 102 fever lasting 24 hours with still headache and malaise and then 100 fever lasting another 24 hours then down to normal.
This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In December 2021, unknown after receiving Shingles vaccine, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter reported that 2 days with low fever and aches. The patient was very tired. The patient informed that the day of reporting was day three and he/she felt fine. The patient further stated that they need 2 doses about a month apart.
First Dose of Moderna on 3-3-21:  Dizzy and lightheaded within the 15 minutes for the wait time at facility. This feeling continued for 3 hours post-injection. 2 Hours after injection, more fatigued than normal and that continued until early evening. Arm pain lasted 2 days.  Second Dose of Moderna on 3-31-21:  Extreme fatigue began 7 hours after injection. 13 hours post-injection, awoke to extreme severe arm pain, slight headache, slight, but fleeting chills, skin extremely sensitive and hurt like with the flu, sore glands in throat, off and on sweating , severe joint pain in knees, elbows, shoulders, toes, back and neck, felt foggy minded. These symptoms lasted until the morning of 4-2-2021.  4 Advil every 6 hours helped to alleviate aches somewhat.
This spontaneous report as received from a registered nurse via a company representative refers to two patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) injection (lot# L006389 and L021599; dose, route of administration and expiry dates were not reported). It was reported that a total number of 2 doses was administered. There were no concomitant therapies reported. On unknown dates, the patients returned to the clinic with "similar unspecified complaints", which were then confirmed to be cellulitis. All of the patients received treatment with unspecified oral antibiotics. The outcome of the event was not reported. The relatedness between PROQUAD and the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Little headache; Patient was in her first trimester of pregnancy; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of HEADACHE (Little headache) and MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced HEADACHE (Little headache) and MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy) had resolved. At the time of the report, HEADACHE (Little headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Company comment: This is a spontaneous case of maternal exposure during pregnancy, concerning a 29-year-old female patient, with no reported medical history, who experienced the expected and non-serious event of headache on the same day of the first dose of mRNA-1273 vaccine. The vaccination occurred in her first trimester of pregnancy. Last menstrual period was not provided; hence, weeks of gestation at the time of vaccination could not be assessed. The delivery occurred on an unknown date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.    This case was linked to MOD-2022-648794, MOD-2022-648795 (Patient Link).; Sender's Comments: This is a spontaneous case of maternal exposure during pregnancy, concerning a 29-year-old female patient, with no reported medical history, who experienced the expected and non-serious event of headache on the same day of the first dose of mRNA-1273 vaccine. The vaccination occurred in her first trimester of pregnancy. Last menstrual period was not provided; hence, weeks of gestation at the time of vaccination could not be assessed. The delivery occurred on an unknown date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Patient complained redness-heat and mild swelling on the anterior right thigh where vaccine was given.
Information has been received from a nurse referring to multiple, unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot# K004863 with expiration date of 04-OCT-2016, lot# L007228 with expiration date of 03-SEP-2016, dose, strength and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital.  Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious.  No follow-up attempts are possible. No further information is expected.
10/1/13 PM - onset of lower back pain, urinary retention and bilateral leg numbness, vomiting x 2. 10/2/13 0900 - to ER -> another ER MRI results - transverse myelitis.
Redness and swelling the size of an orange, hot to touch. Treated with antibiotic.