chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A TECHNICIAN WAS GIVING A PEDIATRIC PFIZER DOSE WHEN THE CHILD MOVED HER ARM AND A LITTLE BIT OF THE VACCINE SQUIRTED OUT ON THE BANDAID. MOST OF THE DOSE WAS GIVEN.
Overnight chills and fever, took Motrin, fever resolved.  Lost a day of work catching up on sleep.
Deep Vein Thrombosis to thge left common femoral, femoral, popliteal veins
redness at the injection site; soreness at the injection site; swelling at the injection site; soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), MYALGIA (soreness) and SWELLING (swelling) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus non-insulin-dependent, Blood pressure high and Inflammation. Concomitant products included PREDNISONE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (soreness) and SWELLING (swelling). On 16-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). On 18-Feb-2021, MYALGIA (soreness) and SWELLING (swelling) had resolved. On 19-Mar-2021, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: follow up received includes Patient medical history, concomitant medication, events updated.
headaches; Fever; joint pain; diarrhea; abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), ARTHRALGIA (joint pain), HEADACHE (headaches) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Previously administered products included for Diverticulitis: Antibiotics (had diverticulitis and was taking antibiotics until the day before receiving the vaccine). Concurrent medical conditions included Diverticulitis.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal cramping). On 17-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 19-Jan-2021, the patient experienced HEADACHE (headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headaches) and PYREXIA (Fever) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-082322 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Second dose AE information; mailing address
Significant swelling of Deltoid area without involvement of joint. Reported pain to axilla and neck.
PATIENT C/O BUMPS AND ITCHING ON FACE THAT LATER RESOLVED THE SAME DAY
Extremely tired/fatigue; Low grade fever; chills; Dizziness; This is a spontaneous report from a contactable consumer reported for herself. This 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, Expiry date: 30Apr2021) in right arm on 21Jan2021 4:30pm for COVID-19 immunization. None medical history nor concomitant medications. Patient got her of the vaccine around 4:30pm. They made her stay there for about 15 minutes to make sure she didn't have any kind of reaction. She got home and went right to bed early around 10pm. The next day she was extremely tired, and had difficulty getting up in the morning; has fatigue. She also thinks she has a low grade fever because she has the chills, but she doesn't have a thermometer to check her temperature. She also has some dizziness. Her dizziness has improved, but she still doesn't feel comfortable driving. No emergency room or physician office visit. The outcome of fatigue was not recovered, of other events was recovering.
Patient stated her arm was sore for longer than she expected after receiving her flu shot on 11/9/2022. By January  of 2023 she sought medical treatment and was diagnosed with tendonitis and bursitis with impingement of the left shoulder. She underwent a CT scan and was placed in physical therapy. She notified the pharmacy 4/27/23.
pt c/o discomfort @ inj site of flu vax had raised hard area @ site;approx size of half dollar, discomfort extends to elbow;began about 1 1/2-2hr p/vax;ice to site-meds given;
Leaking Prior To Opening; no adverse event; This spontaneous report was received from Other Health Professional.   Healthcare professional (healthcare worker) states when the cap was taken off one of the GARDASIL 9, the product began dripping out. Caller states GARDASIL 9 was discarded and not administered to a patient. Caller was unable to confirm if the product is supplied in a vial or prefilled syringe, but believes it may have been a syringe. Caller did not have any other information related to the PQC, therefore questions were not answered in the notes. Caller was provided with case number for call back to provide information related to the PQC. AE filed out of precaution due to caller not able to confirm if contents were exposed to healthcare worker. Pictures unable to be provided and product not available for retrieval due to product being discarded. Caller was unable to confirm the NOC, LOT and Expiration. No additional AE or PQC reported.
Patient states that after receiving the 3rd dose of Pfizer 01/09/2022, started experiencing symptoms that evening of extreme fatigue, muscle aches, pain in both arms from the neck down, chest pain, neck pain, and nausea. Symptoms have subsided besides nausea, no noted Primary visit/communications.
Red at injection site; Knot at injection site; Itches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03l20a) for COVID-19 vaccination.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Cholesterol medicines.  No treatment information was reported.
Patient had severe anaphylactic reaction. It started 4 hours later - had throat swelling, dizziness - took BENADRYL. Developed severe flu-like symptoms which lasted 24 hours. (Fever, shiver, etc.).
The patient was supposed to receive the RSV vaccine Abrysvo, but received Fluzone HD in error. The patient had already received Fluzone HD on 9/1/2023, so this was the patient's 2nd flu shot within a month. The patient was informed of the mistake on 9/28/23. The patient said she only felt tired starting 9/28/23, no other side effects.
About 2 minutes after the shot my Face flushed. Red immediately. Red rash all over.. My tongue immediately started to swell, I couldn't Breathe and hard to swallow. Breathing very fast and heavy.
Muscle pain/tightness in upper right arm at injection site restricting ability to raise arm. Onset at 6:30 p.m. Intensified until bedtime. Next morning on wakening, it had significantly improved. The following morning, improved to negligible level.
Headache, shortness of breath, swelling of legs, dizziness, drowsiness, joint pains, discomfort in the chest
Just another case of "Covid Arm": big red itchy square rash around the injection side.  I also had pretty severe muscle and joint pain the day after injection but ibuprofen took care of that.
PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse concerning a 19 year old female who on 09-JUL-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) intramuscular. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The Nurse reported that on 11-JUL-2008, the patient experienced nausea, vomiting, numbness throughout her body after receiving the dose of GARDASIL vaccine. The patient was brought to the emergency room were it was determinate that the symptoms were due to a virus and low magnesium level. Subsequently, the patient recovered from nausea, vomiting, numbness, virus infection and low magnesium level. Additional information has been requested.
Pt felt her tongue was swollen during the 15 minutes post vaccination. She also described a tingling sensation in right leg. No impairment of breathing  or swallowing. No treatment given.
Patient was vaccinated in error with 2nd dose of covid 19 one week prior to the 28 day recommended time lapse between first and second doses.
This case was reported by a pharmacist and described the occurrence of elevated liver function test in an adult female subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis.  On an unspecified date and 28 December 2007, the subject received 1st dose and 2nd dose of Engerix B (unknown).  On an unknown date, at an unspecified time after receiving the 1st dose of Engerix B, the subject experienced pain in her arm post vaccination.  The subject's arm hurt for one week after the injection and resolved.  On 4 January 2008, 7 days after 2nd vaccination with Engerix B, the subject experienced elevated liver function test, stiff neck, headache, and fatigue.  The reporting pharmacist did not know which liver enzyme(s) was elevated.  At the time of this report, no treatment had been necessary.  The pharmacist was unsure if the Engerix B series would be continued.  No other subject information was provided.  This case was assessed as medically serious by GSK.  At the time of reporting, the events associated with the 2nd dose of Engerix B were unresolved.
Intense blistering on both my right and left heels of my feet and some on my toes.  Also my surgical spine area L5-S1 is inflamed and hurts more intensely, to the point I could not walk.
Before my second Covid Phizer\BioNTech vaccine on 4/13/2021, I had not had a Herpes Simplex outbreak in  approximately one year.  Starting in June 2021 - approximately- I started having Herpes Simplex outbreaks almost monthly.   As I rarely had Herpes Simplex outbreaks before the second vaccine,  I suspect the vaccine is related to the multiple outbreaks received after the second vaccine.
I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.
Gradual onset in the twelve hours follow vaccination of lower back and left hip pain and stiffness.  I think of this reaction as a "Flare-Up" of sciatica and lower back pain. I first attributed it to sitting at my computer desk for an extended period, but I was getting up and walking the stairs frequently.  By the next morning pain in lower back and left hip was so severe I had a hard time getting out of bed, with shooting pains, stiffness, and numbness in the left leg. The pain persisted to the point of throbbing until several hours later I retired to bed and slept several hours, which eased the severity of pain.  Walking was possible, but painful.  I spend much of the first day (Thursday) in bed.  The next day (Friday) I actually went back to the facility for scheduled tests, where I reported the reaction to my doctor's nurse. The pain seemed to lessen Friday evening, but returned worse on Saturday. I sit here on Saturday afternoon submitting this report with nagging lower back pain, stiffness and "hip pointer" pain.  I also today have had some neck stiffness and jaw pain.  I am a teeth grinder and have osteoarthritis in the cervical spine also. Is it possible that this is a reaction to the vaccine of my worn body parts resulting in a flareup?
tinnitus and ringing in the ears after first dose; Has not received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). At the time of the report, TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided. Treatment information not reported.
Medication Administration Error. Patient received Pfizer monovalent vaccine instead of Pfizer bivalent booster. The patient was notified of the error and will return at another date to get the bivalent booster.
After the vaccine I started to have pain all over my body and fatigue. I started to have bad tremors. I went to the emergency room because I was having back pain that was unbearable. I was given an injection, and prescribed a new muscle relaxer. I am still having tremors.
Dizziness. Drank half cup of water, resolved. BPs 99/52 (pulse 78), 100/54 (pulse 72). O2 sats 100%.
103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 20mg of Cetrizine HCl daily in the evening of 3/27 for the rash/hives and it cleared up in 2 days. I visited the Emergency Room on 4/1 for the remaining symptoms. I was prescribed a 5 day dose of Azithromycin and I do not know what else I was administered through my IV.
hospitilization, increased confusion, fever, nausea, vomiting, unknown symptom onset  Received 3rd dose Pfizer COVID vaccine 11/2/21, Lot # FF2587,
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267293 and 2018SA267304 same reporter. This case involves a 30 years old female patient who received a 0.5ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Patient received an adult dose during vaccine clinic, did not catch that patient was under age until 11/16/21 when mother called inquiring about 2nd dose pediatric.  This nurse questioned if patient had any adverse reactions-chest pain, weakness, hives, swelling, anything unusual.  Patient's mother stated "no she has had nothing, she wasn't even ill from the vaccine".  Ensured mother we were reporting in the VAERS system just in case and to speak with physician about the 2nd vaccine as a pediatric dose.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 44-month-old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continues to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006659; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 10-JUN-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# J010131, expiration date 11-MAR-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Muscle soreness like flu shot; I could not get warm/I was cold; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING COLD (I could not get warm/I was cold) and MYALGIA (Muscle soreness like flu shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), MONTELUKAST SODIUM (SINGULAIR), NIACIN and POTASSIUM for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (I could not get warm/I was cold). On an unknown date, the patient experienced MYALGIA (Muscle soreness like flu shot). The patient was treated with PARACETAMOL (TYLENOL) for Prophylactic, at an unspecified dose and frequency. At the time of the report, FEELING COLD (I could not get warm/I was cold) had resolved and MYALGIA (Muscle soreness like flu shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333379 (Patient Link).