chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration) A non-serious spontaneous report of a second dose of FLUMIST given two weeks after the first dose to a two-year-old female child has been received from a Registered Nurse in the USA. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medication were not reported. On 09-Oct-2008, the physician's office gave FLUMIST to the child and on 23-Oct-2008 a second dose of FLUMIST was given to the same child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-Jan-2009 confirmed the child has not experienced any adverse events.
One day after receiving Tdap vaccine patient developed an ovoid 2x3 cm area of induration warmth and erythema and was unable to extend her right elbow due to pain she came to the office the following day and was started on Keflex 500 mg 3 times daily for 7 days/ instructed to ice the area and to do ROM to right elbow.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On  unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M009378, expiry date: 23-APR-2018; lot # M011117, expiry date: 07-DEC-2017). Medical assistant reported that the vaccine underwent temperature excursion at 63.5 F for 36 hours. The vaccine was exposed to a temperature of 50 F for 12 hours previously as well. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
NASTY COUGH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nasty cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty cough. This report was non-serious. This case, from the same reporter is linked to 20211250774. This report was associated with a product quality complaint.
Systemic: swelling in both feet and ankles-Medium, Additional Details: Patient reported swelling of the feet and ankles at around 9pm the night of vaccination. Patient has since recovered since then and reported the event the following day.
I began to feel ill in bed. I stood up to get some water. While pouring the water, I felt much worse - out of it. I dropped the cup but it didn't register with me. I tried pouring again but dropped the pitcher too. My girlfriend came out, woken up by the noise, and then saw me collapse and start shaking. I don't remember anything after dropping the pitcher. When I came to (maybe a few seconds later?), I asked if I hit my head. She said I hadn't (luckily she was there to catch my head) but I did urinate on myself. I was very cold shivering, teeth clattering. She got me over to the shower where I turned the temperature all the way up and sat underneath. After a while I began to feel better - the fog had cleared for sure. I got in bed after and slept it off. When I woke up I had sweat through my clothes and still had a mild fever, but aside from that I felt almost entirely better. It's been about two days since then and I still feel completely well.
Pt subsequently developed an injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. This is 6 patients from this facility who developed and injection site reaction.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported, Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Starting to feel cold and achy. Temp by ear was 100.5. Feel fatigued.  Haven't sought medical attention. Waiting to see if symptoms get worse.
This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis since an unknown date. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE for an unknown indication.   In September 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (body aches). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) (seriousness criterion medically significant). On 30-Mar-2021, MYALGIA (body aches) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant history included no tobacco use and alcohol use. Laboratory data for lab test and blood work included unknown. Treatment for the events were not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5".  The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event,  different patient
Eye operation; Intestinal operation; cold; Pain; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4224022-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single and intramuscular, administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg weekly (40 mg, weekly (citrate free, 40mg/0.4ml (40 mg,1 in 7 d)40mg/0.4ml)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "Eye operation"; INTESTINAL OPERATION (medically significant), outcome "unknown", described as "Intestinal operation"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; PAIN (non-serious), outcome "unknown", described as "Pain". The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of eye operation, intestinal operation. Clinical course reported as the patient was in pain because she had been out of medication for six months. She had an horrible cold and two surgeries one on her eye and the other one on her intestine. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Primary reporter declined to be contacted.  Causality for bnt162b2: The reporter's causality for the event(s) of eye surgery, intestinal surgery, pain and cold was reported as possible, The reporter considered "eye operation", "intestinal operation", "cold" and "pain" related to bnt162b2. Causality for humira 40mg/0.4ml (adalimumab): The reporter's causality for the event(s) of eye surgery, intestinal surgery, pain and cold was not related. Agency's opinion is that there is no reasonable possibility that the events of eye surgery, intestinal surgery and pain are related to humira 40mg/0.4ml(adalimumab). Agency's opinion is that the event of cold is not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events eye operation, intestinal operation, Nasopharyngitis, Pain and the suspect drug BNT162B2.
1/7/22 to ED with c/o chest pain and increasing SOB over past month; 2 days prior to ED visit, pt seen in outpatient clinic and placed on antibiotic for possible pneumonia; admitted; found to be positive for COVID; placed on BiPAP; increasing weakness, decreasing appetite; steroids; AHRF secondary to COVID pneumonia; dc'd to inpatient hospice where she passed away
Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known drug reactions or allergies who in 2007 was vaccinated with the first dose of VAQTA (Lot # not valid). There was no concomitant medication. The physician reported the patient was vaccinated with the second dose of VAQTA on 23-JUL-2010 and on 26-JUL-2010, the patient was seen at the office with sore throat and rash on her extremities and trunk, but not on her hands or face. The next day, on 27-JUL-2010, the patient went to the ER due to facial swelling and was placed on prednisone (manufacturer unspecified) for allergies and released. The patient developed a rash all over her body. The physician stated blood titers were drawn and the patient also showed recent infection with Coxsackie B, so he stated there were confounding factors. The patient had had follow up with dermatologist and allergist. At the time of the report the patient was recovering. Additional information has been requested.
Patient fully vaccinated (J&J) but not boosted admitted to the hospital with COVID-19 associated symptoms.
(L) arm swelling, redness, onset same day, body aches 2 days later seen at ED Rx with abx and steroid. Continued Prednisone ? serum sickness.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256201 (same reporter). This case involves a six-months old male patient who was vaccinated with a 0.25 ml single dose of FLUZONE QUADRIVALENT (lot number: UT6262MA; expiry date: 30-Jun-2019) (route of administration was not reported) in right thigh on 04-Sep-2018 that was in a shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; ROTATEQ for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to incorrect product storage. No known reported symptoms. 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. List of documents held by sender: none.
4-5 days after each vaccine, experienced extreme palpitations and cardiac discomfort daily and nearly constant. Went to ER on 4/07/21. Cardiologist at Hospital ruled out disease and explained and showed me on monitor that I was having PACs and PVCs. Same occurred after second vaccine. I then wore a monitor for 5 days in May, which showed PACs, PVCs, tachycardia. Subsequently saw Dr. at Hospital to review monitor results and he confirmed these are benign, no medical treatment. Palpitations and racing heart lasted for 6 months. Mild palpitations and eye twitching from Moderna booster lasted only 1 week-10 days.
Joint pain beginning in left side of body (hip, knee) then rapidly spreading to rest of body. Currently,  extreme joint and nerve pain throughout entire body up to 10 weeks later. Weakness in limbs, unable to work or exercise like before. Referred to rheumatologist after bloodwork came back with no answers. Trying different doses of gabapentin. Unknown if it will help yet. No sign of cure or disappearing by itself.
Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately age 70, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history and drug reactions and allergies. On unspecified dates in July 2015, the patients were vaccinated with improperly stored PROQUAD (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events were reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Circular reddened and raised area around injection site appearing about 2 weeks after first dose.  No pain or itching associated with rash.  I noticed it looking in the mirror, otherwise I would have been unaware of it.  I called my PCP office the day after noticing the area and was seen in a telehealth visit.  The only reason I called was because I was scheduled for my second dose about a week later and wanted advice about whether I should get it.  I was seen in a second telelhealth visit on 3/15 and given advice to proceed with second dose, but to take an antihistamine before receiving it.    I had no rash after the second dose, received on 3/18/21.
Baseball sized area of tender induration at injection site surrounded by 8cm extending area of erythema. Progressed for 3 days then began regressing. Still present after one week.
COVID arm- large red welt around injection site and hardness under skin. Approx. 3 inches in circumference.
Around 01/10/2022- pain in my gum, on the lower left side at the very back, where I used to have my wisdom tooth.  01/13/2022- I went to see my dentist, he could not see anything, He said there maybe something under the gum and he asked me to use salt water to rinse. After a week after I saw the dentist it resolved. On 01/22/2022- I had the pain in my gum again, this time on the right side lower gum, at the very back. I treated it by rinsing it with salt water and it resolve after 5 to 7 days. Around that time, I started thinking,  could it be related to the vaccine. So when I received the prompt from the smartphone based tool I entered it into the system.
1) Alopecia Areata 3 months after vaccine - large patches of hair fell out until I got steroid treatment from a dermatologist.  2) Idiopathic DVT in upper arm (blood clot from elbow to clavicle). No other health conditions and the Hematologist could not identify any other cause. First signs were in early October (7 months after vaccine), but the condition likely started before then. Treatment: blood thinner Rx. According to the Hematologist, the clot is not expected to go away and I will be on blood thinners forever.
Pt said he went into A. fib 1 hr. after he received flu shot (has not been in A. fib for several years per pt). It lasted about 2 days. He spoke to an MD regarding issue.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients in her facility received doses of GARDASIL (strength, dose, route and lot number were not provided). that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses that were administered. Additional information has been requested.
severe pain; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), dose 2 via an unspecified route of administration on 31Aug2021 16:30, as DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took first dose of the vaccine 25 days ago bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), via an unspecified route of administration on 06Aug2021 , as DOSE 1, SINGLE for covid-19 immunisation. It was reported that caller felt fine before the receiving the dose and feeling fine until 4:00am 01Sep2021 and the patient experienced severe pain, vomiting, diarrhea. Caller reported experiencing similar symptoms as after the first dose and said she has a telemedicine appointment in the morning and is trying to make sure she have done all her research. The hospital beds are so full and she is afraid and have a hard time getting admitted without proof. Caller said she was trying to find out if anyone has had these symptoms. The clinical outcome of the events were unknown.      That information on the Lot/Batch number has been requested.