chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 63-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 14-Feb-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.23    Concomitant products were not provided.  On 14-Feb-2021 Excursion time was reported at 09 am ,10 am, 11 am,2pm and 3pm with temperature as 32,32,32,35 and 35 degrees Fahrenheit respectively , total doses given for the day was 162 , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
I was on a cruise, had just landed from a connecting flight. When I departed, I was so fatigued my wife needed to push me in a wheelchair to the car. We came home very late so we went straight home I thought I might get better with some rest, but I started getting congestion, a cough, I did not run a fever. On 03/11/23 I went to a local urgent care to find get treatment for what was going on. I was tested for COVID-19 test that came back positive and Influenza A and B that came back negative. I was prescribed inhalers to help with my breathing, but I was too far into being sick to get PAXLOVID. I still have a bit of a cough and I still need a nap in the afternoons. I am getting better, but I am not quite there.
BLURRED VISION, HYPOTENSIVE, PALE SKIN. EMS TOOK VITALS , NO HX OF VASOVAG. -CLEARED BY EMS.
Rash after a dose of vaccine; Muscle Ache after a dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine). At the time of the report, RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
stomach/GI issues; experienced arm soreness; 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 (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "stomach/GI issues"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced arm soreness".  Additional information: They are both over the age of 65 and received their second Pfizer COVID 19 vaccine on 05Apr2021 Patient and her husband both were received second dose of Pfizer Covid 19 vaccine back in Apr2021. Is inquiring about the booster dose. Stated when she received the vaccine that she experienced arm soreness and had some stomach issues. Stated that she is calling about the booster because her husband is having an ankle replacement in 10 days. Stated that she wanted to know if it would be okay for both of them to receive the booster now or wait until after his surgery in case there are any side effects. Information confirmed as provided. This Report related to a study or programme, event dates was unspecified, Reason for no lot number of Pfizer Covid 19 vaccine was Caller unwilling to complete the report, Expiry Date of Pfizer Covid 19 vaccine Not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the clinic 10/13/2015 with complaint of left arm/shouler pain since receiving the flu shot 09/15/15.
The patient had a needle phobia and was very anxious prior to the vaccine. Once the patient received the vaccine, he waited in the waiting area for 15 minutes post-vaccine. About 5 minutes after the vaccine, he notified the pharmacy staff that he wasn't feeling well and he was feeling faint. The pharmacy staff provided him with a glass of water and was monitoring him. He said he  felt like he fainted and wasn't feeling well. He said he felt warm and sweaty. The pharmacy staff provided him with an ice pack. He then notified the pharmacy staff that he urinated in his chair while waiting post-vaccine. He wanted to be checked out and wanted us to call 911 . The patient began to feel better after about 20 minutes. The EMT arrived and checked the patient. Even though, the patient was feeling better, the EMT recommended the patient be checked further anyways. He was brought to the Triage center and was there for about 1 hour, according to the patient, and was feeling better. He said he felt slightly fatigued that day and the following day, but other than that he was feeling back to normal and no issues. He stated he has severe needle phobia and has experienced these fainting spells and anxiousness in the past. We followed up with the patient and he provided this information to us. He stated he was feeling good and back to normal. He had no further questions or concerns. We told him to follow up with us if questions or concerns came up.
Severe clots on right thigh rushed to urgent care and urgent care referred me to emergency Hospital. Was hospitalized for 5 nights with severe swelling on right thigh. The swelling has since abated but has still not subsided. Feel still very heavy on right thigh.
Premature infant born at 30 weeks gest. at 3# 1oz on apnea monitor. The day he got his first set of vaccines at the clinic he had 8 apnea spells. Normally he would have 3 a day. Also had fever & throwing up.
Redness, swelling, itching x 1d ( red area measured 2 1/2 "x2) alternate ibuprofen/TYLENOL, warm packs, BENADRYL cream by day, BENADRYL po @ night.
Approximatelt an hour after injection, I experienced some dizziness and a change in vision.  The peripheral vision was distorted (kind of a tunnel vision).  I waited it out.  After about two hours, the dizziness subsided and the vision returned to normal.
Pt. has red (L) lower deltoid area, no induration noted able to move (L) upper arm
fever; headache; nausea; sinus congestion; This is a spontaneous report received from a contactable Pharmacist. This Pharmacist reported for female (patient).  A 7-decade-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history includes Anaemia and Dementia both from an unknown onset and ongoing and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced fever, headache, nausea and sinus congestion. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (13Sep2021): 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 have been completed and no further information is expected.
big red Bruise on my arm; area is very hot; area itches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches) 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 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches). At the time of the report, VACCINATION SITE WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: On 25-May-2021, follow up document was attached which contains no new information.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
My son received the FLUCELVAX vaccine and the next day had a severe reaction. The entire arm from his shoulder to his elbow was swollen, bright red, and hot to the touch. He was also in a lot of pain on that arm. No other rash or inflammation anywhere else on his body was noted. I treated him with 1 dose of BENADRYL and the inflammation went down by the next morning. Note - this was the second year in a row he got a reaction to the FLUCELVAX vaccine, although this year the reaction was significantly more severe. He does not get similar reactions from other vaccines, including other brands of flu vaccines.
Starting the evening of the injection -  the site swelled to the size of a tennis ball cut in half; chills; low fever; body/muscle aches; hands tingled. Starting the next day - began to have intermittent palpitations and episodes of like catching my breath. Less than a week post injection - began to also have episodes of flushness, cold, clammy while sweating. This is the point in which I sought my cardiologist and primary doctor's advice.
Localized redness and swelling at sights of injection. Itching, burning and redness to left upper extremity reported by patient. No SOB, but slight cough present. Denies nausea, throat swelling or difficulty swallowing. No angioedema and no anaphylaxis. Patients received vaccinations on 09/16 @ 12:50p symptoms developed during 09/17 leading to presentation morning of 09/18. Treated with diphenhydramine 25mg capsule PO once, famotidine 20mg tablet PO once, and prednisone 60mg tablet (3x20mg) PO once. Patient discharged after short observation post-administration of the above medications.
By 4am (within 10 hours) had severe headache & chills. By 245pm (20hrs later had a temperature of 101.6 and severe headache, dizziness. By 320pm temp of 101.7 and cold chills. By 345pm (21hours after vaccine) temp of 101.6 Has had no side effects to flu vaccines or any other vaccines in past.  Was COVID positive mid-Dec 2020 through mid-Jan 2021 and lost his job.
Muscle atrophy, weakness of right upper arm beginning within 0-1 days of vaccination. Received second dose of moderna covid vaccine at same site on 2/15/2022.
Sore arm and slight swelling on first 2 days post injection. One third day, intense muscle or nerve pain throughout rightside of upper body. Very stiff neck, shoulder, shoulder blade, and pectoral area. On Sunday night, I felt shooting pulses come out through my finger tips. On Monday, I went to an Urgent Care facility and was prescribed: muscle relaxer and steroids. on Tuesday, I feel 75% better.
Large red swollen lump on left arm, about side of orange in width. High fever with severe shaking and very painful joints began Friday June 11th fever broke June 12th joint pain and arm swelling continues
Within 24 hours the patient developed a swollen lymph node/nodule under the left axilla after receiving the seasonal influenza vaccine, Fluzone 0.5ml from the multi-dose vial.
Within a week or so after second injection I started to tire very easily.  I was used to walking my dog 2-3 miles per day prior to the vaccines.  After the vaccines I go a mile and am exhausted.  I feel like I need to sleep all the time.  I told my Doctor and she sent me to a sleep clinic, and they told I was getting enough sleep??  Since the vaccines I have had to force myself to do almost anything.
This spontaneous prospective pregnancy report as received from a registered nurse via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose, frequency, route and indication not reported). The representative received a voicemail from the nurse stating that the patient who received GARDASIL was now pregnant. The LMP(Last Menstrual Period) and EDD(Estimated Date of Delivery) was not known. No other information was left on the voicemail. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
pruritus, hives/urticaria; pruritus occured 3 days p/inject, rash started on 4 day; ER administered an inject of cortisteroid & DPH;
Patient presents to the clinic c/o fever and pox-like lesions scattered throughout the body/head.  A total of less than 40 lesions in all.
Daughter called and said her Mom (the patient) had a really sore arm, like burning sensation and had been having it almost ever since
Information has been received from a physician concerning a 13 year old female who on 13-AUG-2008 was vaccinated with GARDASIL (lot #659184/0843X) and BOOSTRIX (lot #AC52B027AA) both via IM into her left arm at 2:00 PM.  After the vaccination at 2:25 p.m., the patient did not feel good, then she was feeling dizzy.  She was talking, but later on was weak, so she was placed on the table to lie down and an ambulance was called.  An electrocardiogram (EKG) showed right bundle branch block.  Her outcome was not provided.  The reporter considered the events to be other important medical events.  Additional information has been requested. 10/10/2008 MR received for ER visit 8/13/08 with Dx: Vasovagal syncope. Pt passed out shortly after receiving Gardasil injection. Transported by EMS to ER. Normal exam in ER except EKG showed possible RVH. D/C home.
Severe/chronic joint pain at injection site since receiving flu vaccine 11/18/2010.
flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE (form, strength, dose, frequency, site, route, batch number, manufacturer, administration site and expiry date: unknown) for Flu.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "Yes but we are getting the flu! "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event .
pt recv vax & exp pain during insertion of needle which inc during actual inj; 30 mins later exp tingling in digits; exp arthralgias & myalgias; also exp h/a, hot flashes & neck pain; devel rash; JUN93 consulted MD for nerve paresthesia
I broke out into full body hives after receiving the vaccine. I went to see an allergist and was diagnosed with Chronic Urticaria. Although I broke out in hives for my first dose the reaction for the second dose was much worse. I have been seeing a Dermatologist as well as continued care from the Allergist. Currently I am getting hives daily and Allergy medicines have not helped.
Decreased appetite, possibly dehydrated, cough, fever. Ibuprofen and Acetaminophen. Shot administered on 7/21 and symptoms started to appear on 7/22.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's concurrent or historical conditions were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K01569 exp. date 23-JUN-2016 and lot# J006278 exp. date 22-MAY-2015) (dose, frequency and route were not reported). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
mom states that 1 wk p/MMR had diffuse rash, enlarged glands in neck, t103 for 5 days;
Patient received an incorrectly prepared ACTHIB vaccine. ACTHIB was prepared with MMR diluent instead of diluent packaged with ACTHIB Vaccine.
Paramedic who administered shot gave it too high.  I noticed this maybe 10 minutes after administration when I felt that the Band-Aid was high and a nurse practitioner I work with confirmed that it was too high by observing the puncture site.  Pain started about 2-3 hours later, with restricted range of motion left shoulder joint
Mother called stating child has rash, itchy, stomach and thighs.  Temperature 101.
Vaccine administered on 11/7/14 at 4:25 p. Patient stayed in store for 15 min, but not reaction. Went home and noticed rash on face around 7 pm that night, felt malaised, shortness of breath that continued through next two days. Treated with hydrocortisone cream and BENADRYL. Rash still present, but improved.
This spontaneous report was received from a pharmacist, via Pfizer (other company notification of adverse event) on 04-SEP-2015, refers to a currently 76 year old, female patient. Concurrent condition and medical history were not reported. In 1998 and 2006, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot #, expiration date, route of administration and anatomical location were not reported) for routine vaccination. The pharmacist reported that in 1998 or 2006 (it was clear whether it was in 1998 or 2006) and within 25 hours of receiving PNEUMOVAX 23, the patient developed arm swelling and he required prednisone to decrease the swelling. The prednisone did work. The pharmacist did not have details as to who the prescribing physician was at the time of the event. He presumed, the patient required a doctor's visit to get the prescription for the Prednisone, but the patient may have just called the office. No hospitalization was required. There was not a product quality complaint (PQC) involved. At the time of the report, the patient did not uses any steroids. The reporter stated that he did not aware of any vaccination within four weeks prior, but the patient could have been a flu shot (on unknown date). At the time of the reported, the outcome of the event was reported as recovered and the reporter considered arm swelling was related with the suspect therapy PNEUMOVAX 23. Additional information has been requested.
Redness in area around injection site first noticed the morning after the shot. Redness gradually lessened over the next few days. Tonight it has started to itch.
Headache, NauseaVomiting, Reported lightheaded, pain & heaviness in left arm Narrative:  Other Relevant History:
pt recvd 3rd dose of vax in fall of 1992 & lab eval revealed pos surface antifen & pos core antibody; No further details were provided
Nurse reporting an AE for VAQTA that was administered to a 2 month old.; No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 14-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml, lot #U026792, expiration date: 28-OCT-2022 (strength, dosing schedule and route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Developed rash on legs bilaterally 1/14/94. 9 AM vomited 1/16/04. Stuffy nose and cough 1/18/04. 1/19/04 runny nose and mild cough. 1/21/04 congestion and productive cough. 1/22/04 axillary temp 101.2. No BM.
This spontaneous report as received from a licensed practical nurse and refers to 5 unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, 5 doses of improperly stored (Merck) PROQUAD (lot # reported as L026728 with expiration date on 15-JAN-2017; dose and route of administration not provided) were administered to 5 unspecified patients. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.