chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:44 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered 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.   Age of the patient was reported as 62.57.  Concomitant medication of the patient was not reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 03-Apr-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
Within 15 min of vaccine, Severe headache.  Impaired vision. Returned to work unable to carry on conversation. Pain mostly on left side of head, face and neck. Unable to recall coworkers names. Chills. Took Excedrine for headache. 7 hours later headache less severe however, neck, back and left shoulder ache. Very tired and weak.
Pt describes started noticing swelling around noon on 9/11/2013--on 9/12/2013 pt states arm became very swollen and started running a fever of 100.8 degrees on 9/13/2013 pt stated swelling has started going down and fever is low grade now.
Hiberix was reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix was reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 13-OCT-2023 The nurse reported Hiberix was reconstituted with sterile water and administered to a patient. Details about vaccine and patient were asked and declined; hcp stated was not at facility so had no access to the information. The Vaccine Administration Facility is the same as Primary Reporter. HCP stated sterile water used to reconstitute Hiberix was the diluent that comes with Merck´s MMR vaccine, which led to wrong solution used in drug reconstitution. The reporter consented to follow up via email agreed.
tiredness; wooziness; not feeling that great 2 days; The heaviness in her left arm was more prevalent after getting the 2 shots; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The Patient's medical history included, she was bitten by a bad tick 2 years ago and she ran another blood test, Bell's Palsy, left arm that would become sore when she picked up something heavy. The patient's concomitant medications were not reported. The patient experienced tiredness, wooziness, not feeling that great 2 days, the heaviness in her left arm was more prevalent after getting the 2 shots on an unspecified date.  The patient underwent lab tests and procedures which included blood test for everything: everything returned fine on unspecified date. The outcome of the events was unknown.     Information on the lot/batch number has been requested.
pt rec;d grey cap pfizer vaccine after it was in the freezer for 22 days- pt does not want replacement dose
Patient presented with warmth and redness on left bicep. Described an injection site reaction around injection site on Friday evening and Saturday. Redness spreading was Sunday morning. Patient was sent to clinic to be evaluated on Sunday morning.
Information was received on 19NOV2014 from a pharmacist. The pharmacist reported that a patient was supposed to receive a dose of VARIVAX, but instead inadvertently received a dose of ZOSTAVAX. The pharmacist does not want to be contacted. She stated the ZOSTAVAX was administered by another pharmacist (unspecified name). No symptoms were reported. The pharmacist did not want to provided any further information. Additional information is not expected.
This case was reported by a physician and described the occurrence of swelling in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced swelling. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified.
Received Moderna COVID-19 vaccine on 4/15. She felt well for 2-days after vaccine with no symptoms but then developed severe chills, fatigue, malaise, and myalgias. Was not able to get out of bed due to pain/fatigue and cough was significantly worse with significant sputum production. This lasted about 48-hours and she had persistent lethargy and did nothing for 1-week due to fatigue. Cough remained significant and similar to a severe flare of MAC-IRIS. Seen in clinic on 4/28 and appeared clinically stable but with severe cough. CRP increased from 5 to 102. Remained on anti-mycobacterial antibiotics without change and prednisone. Two days later, fevers recurred to 101 and had severe pleuritic chest pain similar to IRIS flares. Presented to ED on 4/30, and no specific intervention performed as labs were overall stable. At follow-up on 5/3 in clinic, CRP was 134 and CT scan showed increased mediastinal lymphadenopathy with greater atelectasis in right middle lobe. Was started on prednisone 80mg daily at this time for possible IRIS flare. Had improvement in fevers and CRP to 34 but cough and chest pain persisted. Therefore, received dose of infliximab on 5/6 as this has been used to treatment MAC-IRIS symptoms previously. Symptoms dramatically improved over the next 48 hours and continued to do well. Her underlying disease still requires immune suppression with infliximab.
Fever, diarrhea, shaking, tingling, light headedness. No treatment from a medical professional. Took Tylenol, hot bath, and drank water. Lasted 28 hours.
pt recv vax;immed became weak, dizzy & passed out p/ vax;arched back;jerking legs no incontinence;no postictal period;pt nl p/ event;face became red;
pt recvd vax & w/in 24 hrs exp a fever of 102 & devel inject site react consisting of erythema & swelling (15cm x 13cm); resolved aprpox 8 days later; treated w/APAP;
Intermittent lymphadenopathy of the upper body (pre- and post auricular, submental, cervical, axillary, occipital). Fatigue, ear pain, injection site pain still present at day of report. Treatment for intermittent pain has been NSAIDs PRN and Wellbutrin for the fatigue.
10 years old patient was administered Flublok instead of Fluzone Quad/no AE; 10 years old patient was administered Flublok instead of Fluzone Quad/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case is linked to case 2019SA267184 (same reporter).  This case involves a 10 years old patient of unknown gender who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown where adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial report received from healthcare professional on 09 October 2013. A 41-year-old female patient whose medical history and concomitant medications were not reported received dose of FLUZONE HD (route, dose, frequency and batch number not reported) on an unspecified date. On an unspecified date, the patient had flu like symptoms such as weakness, fatigue, slight fever and weakness. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Woke up with a headache, arm feverish and itching. Used a cold wash cloth and went back to sleep for awhile. Woke at 6:00 am - headache, arm swollen, red and feverish from below elbow to above my shoulder. At the site of the injection was a round hard knot the size of a baseball. Called Dr. He said to take Advil and I took BENADRYL that I had on hand - the swelling itch and redness finally slacked off 9-15-13. I still had a large brown area on my arm.
Pt. experienced rash/hives starting on 7/18/2016, after receiving MENACTRA, HPV and Hepatitis A injections.
Woke at 3am (9/5) feeling achy & cold so added a blanket. Woke at 5am with body aches(whole body, from toes to head), uncontrollable shakes & vomiting (only one episode with numerous vomits of bile) & temperature of 101. Took 2 ibuprofen for aches + 2 Tylenol to reduce my temperature. Returned to bed, slept until 10:30am, waking hungry & temperature down to 98.7. Continued taking ibuprofen/Tylenol according to bottle directions.  Woke at 5am(9/6) with my left arm, beneath the injection site, red/swollen/itchy/hot & temperature at 99.8. Took 2 Benadryl & continued according to Direction. Arm remained like this until 9/11. Slowly going pink.
On September 20, 2022, I came down with symptoms that were confirmed to be COVID-19 by my home test. On day 9, I went into cardiac arrest due to a pulmonary embolism. I did not have any symptoms other than a slight sore throat. I was planning to go back to work the following Monday. My wife found me collapsed in the bathroom and we called the ambulance. I went into cardiac arrest in the emergency room. They did CPR for about 40 minutes. They administered TPA and my heart restarted. I was in ICU for four days under critical care. I was then in the hospital for an additional 2 weeks. As of today, I have no brain damage. I did have kidney failure while in the hospital and I am on dialysis two days a week.
Within 24 hours of receiving IPV and DTaP in Right thigh on 08/4/04, pt had onset of redness, swelling locally.
Swollen lymph node; Big lump under armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Relapsing remitting multiple sclerosis" (ongoing), notes: Relapsing remitting multiple sclerosis; "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing), notes: Complex ptsd; "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing), notes: Disk bulging; "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Flare up" (unspecified if ongoing), notes: Flare up; "Swollen lymph node" (unspecified if ongoing), notes: Swollen lymph node; "Marijuana usage" (unspecified if ongoing), notes: Marijuana usage; "Paxlovid" (unspecified if ongoing), notes: Paxlovid. Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID taken for covid-19 treatment; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph node"; AXILLARY MASS (non-serious), outcome "recovered", described as "Big lump under armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report tingling feels like it has been asleep and is waking up. No edema, redness, increased warmth. States tingling goes down arm from deltoid to last two fingers.
Information has been received from a 27 year old female patient with no drug reactions / allergies and no pertinent medical history, who on 12-JAN-2012, was vaccinated with a dose of VARIVAX (Merck), a Pregnancy Registry Product, SC, (lot number 670801/0816AA, expiration date 07-JUN-2013) (dose not reported). There was no concomitant medication. It was reported that the patient received ad ose of VARIVAX (Merck) and she was 3 to 4 weeks pregnant. Her last menstrual period was in December, 2011. Estimated date of delivery was 27-SEP-2012. The patient did not seek medical attention. Additional information is not expected.
had chills 7 hrs p/flu shot; was shaky lasting until the next morning;
Patient developed hives 30 minutes after receiving injection.  Received Benadryl and seen in ER for evaluation.  No further issues reported.
Dose #1 - headaches, loss of taste / smell, fatigue, diarrhea, fever  Dose #2 - Tingling in fingers / hands, tingling in toes / feet, left neck side pain, upper back pain, chest pain.
First noted some itchiness two days after the second dose, but merely shrugged it of as bug bites. The morning of the third day, I had woken up at 1:30 am with hives all over my body. Almost an hour later, my lips began to swell up, doubling in size.
fever documented at 38.8C (101.8F) within 3 hours post vaccination, treated with acetaminophen, persisted approx. 7 hours; frequent vomiting began 4 hours post vaccination with over 20 instances, ceased after 10 hours; extreme lethargy and irritability also noted
pt recv vax SEP95 & pt exp low grade fever, rxn @ inj site w/swelling, erythema, & pruritus, urticaria, & joint pain;swelling extended up the pt arm & down back to waist;pt also exp malaise;urticaria, arthralgia;elevated ESR;hair coming out
Only a sore left arm for 48 hours after injection on February 5, 2021.  No soreness at all til 8 days later.  Injection site is sore, red, itchy, and slightly swollen. The area is at the injection site and is about 2 inches wide and 4 inches long.
Patient seen 5/30/08 for her routine kindergarten physical - no concerns noted, left. On 5/31, mom noted some bruising near shot site then noticed bruising on shoulders and skin. Continued to spread. By 6/4/08 c/o of ear pain and was seen in office. Diagnosed with ITP.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates between 07-JAN-2016 and 25-JAN-2016, the patients were vaccinated with improperly stored ROTATEQ lot # K023159 (exp date 09-JUL-2016) (dose and frequency were not provided). No adverse effects were reported. Concomitant medications were not reported. Concomitant medications were not reported. No product quality complaint (PQC) was reported. The reporter stated that vaccines were stored at a temperature of 30 degrees Fahrenheit as lowest, for a time frame of 318 hours cumulative since 07-JAN-2016 to 25-JAN-2016. Additional information has been requested.
Woke up with very itchy hive-like rash on arms and face, but no fever.
Rash all over, hives at 1st, gone by Sat started Thurs, evening, achy joints, hoarseness, injection site tender hoarseness continues today.
Patient was administered expired vaccine  by MA. Vaccine expired 7/22/21. No adverse events noted. Patient notified of situation and was very understanding.
Information has been received from a medical assistant concerning a 5 year old male with no pertinent medical history or allergies who on 14-AUG-2006 was vaccinated subcutaneously with 0.5 ml first dose of VARIVAX (Merck) (lot # 653358/0442F).  On 30-JUL-2008 the patient was vaccinated subcutaneously with 0.5 ml second dose of VARIVAX (Merck) (lot # 659845/0270X) in the left thigh.  At the same office visit, the patient also received DTAP in the left thigh.  On 30-JUL-2008 the patient developed red blotches on the left thigh area near the site of vaccination.  On 31-JUL-2008 the left thigh became swollen.  On 31-JUL-2008 the patient was examined by the physician.  No laboratory diagnostics studies were performed.  The patient was prescribed ORAPRED.  No other symptoms or treatment reported.  At the time of the report, the patient was recovering.  At the time of the report, the patient was recovering.  Additional information has been requested.
Left arm very sore and stiff. Not able to out stretch or grasp things with hand. Very fatigued. Slept all day. No appetite.Saturday morning woke up and I was fine.
This spontaneous report was received from a health professional, refers to a patient of unknown age. On an unknown date approximately 6 months ago, the patient was vaccinated with PNEUMOVAX 23, intramuscular. On 17-JUL-2014 the patient received a second dose of PNEUMOVAX 23. It was reported by the Medical assistant, that the first dose of PNEUMOVAX was 'never documented on patient's chart that is how patient received a second dose'. Medical Assistant also reported that on 17-JUL-2014, it was documented that dose administered was 1 ml, intramuscularly in left arm in patient's chart. The dose was confirmed twice with Medical Assistant as 1ml, not 0.5 ml for does on 17-JUL-2014. The outcome of dose administered was 1 ml on 17-JUL-2014 and dose administered approximately 6 months ago is unknown. No other information was reported. Additional information is not expected.
Reddened rash around injection site - no swelling or bruising noted. C/O pain (L) arm from elbow up into (L) side of neck radiating to (L) site up back. Injection site & reddened area hard to touch. Reported nausea & diarrhea on 1/1/20 - started around 5pm
Kind of look like bites on his neck only on the right side; He had red dots behind his ear/ He has three on the back of his neck/wells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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 immunisation. The following information was reported: BITE (non-serious) with onset Mar2021, outcome "unknown", described as "Kind of look like bites on his neck only on the right side"; RASH MACULAR (non-serious) with onset Mar2021, outcome "unknown", described as "He had red dots behind his ear/ He has three on the back of his neck/wells".Additional information: Reporter reported for husband. Patient got the Pfizer Vaccine. He got his second dose on 25Feb2021. It was just 2 weeks on Thursday a couple of days (Mar2021) before that he had red dots behind his ear. They kind of look like bites or may be little 'wells' on his neck only on the right side. He has three on the back of his neck, one next to it and one above his right ear. We were concerned, he had never had anything like that. If that is any type of I do not want to say a reaction but a part of having the COVID-19 Pfizer Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received dose #2 of Pfizer vaccine on 6/10/2021 and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/13/2021 as recommended. No adverse reactions identified on site.
Patient was vaccinated with the Moderna COVID 19 vaccine on Wednesday 3/3/21. On Friday 3/5/21 she noticed that her arm was red and swollen around the injection site. She reported the event to the pharmacy on 3/8/21. She stated she has been applying ice to the site. She was advised to continue using ice on the site as needed and she can also take Tylenol if needed.
Went to hospital; said I was acting jittery; more or less because of periodic moments when I was suppose to be docile. Asked me questions, yet they were not satisfied with the answers. Therefore, asked for urine but couldn't urinate; they persisted, I insisted. They then said and injected me with PCP and gave me no acknowledgement of the vaccine. I heard this from the outpatient dept referral request form after ordered. I was administered for these jittery symptom because I had a few drinks and stayed up all night; making me jittery.
Pfizer vaccine 2nd shot caused my daughter to have a fever that reached 101. She also experienced body aches, congestion and a headache.
Vomiting on afternoon & evening that received immunization. Fever during night received immunization and the following day.