chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unusual reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unusual reaction) 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 an unknown date, 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 COMPLICATION (Unusual reaction). At the time of the report, VACCINATION COMPLICATION (Unusual reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.  The patient concerned about getting the second dose because, Patient had an unusual reaction to the first dose.
Patient has been experiencing productive cough, nausea, and generalized weakness, and was diagnosed with COVID-19 on 10/21 and prescribed molnupiravir and cefdinir. On 10/27, the patient was seen in clinic and had a repeat BMP that showed sodium of 115, potassium of 3.2, creatinine of 0.7, chlorine of 71, and CO2 of 35 and so was told to come to the ED. Patient reported feeling generally weak with nausea, dizziness, and cough. He was admitted to the hospital on 10/27-11/1 for COVID-19 infection and acute hyponatremia. It was felt the acute hyponatremia was multifactorial due to HCTZ, dehydration, and COVID infection. Patient has received the COVID vaccine and two boosters.
Tingling in fingers, sore arm, chills, fever, tired Short of breath, still short of breath today
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-JUN-2008, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-NOV-2011, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment was related. Additional information has been requested.
ANAPHYLAXIS REACTION,  heart racing, tongue swelled, hot/clammy, feeling of fainting, head ache, nauseous and diarrhea
The episode began three days after having received flu vaccine. Affected area include shoulder and RUQ torso. The patient describes the affected area as itchy, red, and scaly. Associated symptoms include erythema (skin), pruritus, and scaling, Pertinent negatives include bleeding, bleeding skin, cracking, crusting, dry skin, edema, painful rash and urticaria.
2 inch itchy circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site). At the time of the report, VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received captured no new information.
This case was reported by a health professional on 31 July 2007. Seriousness criteria: other-medically significant A four-month-old female patient with no reported medical history had received an intramuscular thigh injection of Daptacel (lot number C2569AA, date of vaccination not reported). She subsequently experienced a body temperature of 96 degrees Fahrenheit, cool extremities, and was lethargic. She was taken to the emergency room and treated with intravenous fluids and a warming blanket. She was diagnosed with "pertussis reaction to DTAP, hypotonic response", and later recovered. The reporter did not have any additional information.
chest pain x2 days,  treatment was heparin gtt, heart cath, ct angio and echo
09jun90 pt vax 3rd hepta B.  pt devel jaundice.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 16th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever, stomach discomfort and rash. On an unknown date, the outcome of the fever, stomach discomfort and rash were not recovered/not resolved. It was unknown if the reporter considered the fever, stomach discomfort and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The pharmacist reported that the patient's fever went as high as 101, and the rash was on her torso, front and back. On an unknown date , the patient's body temperature was recorded as 101 degree F. The pharmacist reported that the patient planned to continue follow up with her physician on an unknown date.
This is a spontaneous report obtained from a contactable consumer (patient). A 65 year old male patient received, on 23Feb2017, PREVNAR 13 single dose, for immunization. Relevant medical history included diabetes. Concomitant medications included insulin glargine (LANTUS) 40 IU, twice daily, from an unspecified date (ongoing), for diabetes and insulin lispro (HUMALOG) from an unspecified date before meals (ongoing), for diabetes. On 27Feb2017, the patient experienced stomach distention and stomach pain. Urine test and X-ray, performed on an unspecified date, in 2017, were normal (not able to find anything). In response to the events, the patient was treated with an unspecified muscle relaxants medications but these products did not work. Clinical outcome of the event was recovering at time of this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: Fi1b2d) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 007m20a), in right arm and on 13Mar2021 as dose 2, single (Lot number: 048a21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; IBUPROFEN; GUAIFENESIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative test adter lastt dose; (unspecified date) Positive, notes: indication: Treatment of COVID-19; (23Aug2022) Negative, notes: Negative test 2 days after last dose; (25Aug2022) Positive, notes: Positive test 4 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Negative test adter lastt dose. Negative test 2 days after last dose. Sore throat 3days after last paxlovid dose. Positive test 4 days after last dose.  No follow-up attempts are possible. No further information is expected.
Patient reported chest pain, elevated heart rate, some tingly feeling. Her O2 Stats were 96 on the pulse-oximeter. Patients BP was 194/94 HR 84. We called the fire department, they paramedics came and took her vitals and transported her to a local ER. She was there about an hour and a half, not admitted and sent home. Patient called to let us know. Then her caregiver also called to report that she was not admitted and was going home. No serious issues.
1:16 After patient received vaccine; started feeling lightheaded and face was flushed.  Vitals were taken to assess her symptoms:  BP 142/96, heart rate 101, O2 98%, respiration 22, temp 97.2  Patient stated she felt better.  Stated she had not eaten today only drank coffee.  Was given water to drink and cleared.
Information has been received from a registered nurse concerning her 1 year old daughter who on an unspecified date was vaccinated SC with a single 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently the patient developed a low grade fever. The patient is one of triplets whose sisters (WAES0608USA05091 and 0608USA05187) have also had adverse experiences after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 10/06/2006. Information has been received from a registered nurse concerning her 1 year old daughter who was delivered prematurely at 31 weeks gestation, who on 26-JUL-2006 was vaccinated SC with a single 0.5 ml dose of PROQUAD (Oka/Merck upgrade process). Concomitant vaccination included a dose of HAVRIX and a dose of poliovirus vaccine inactivated (unspecified) (manufacturer unspecified). Subsequently the patient developed a low grade fever. The patient recovered "a couple of days after onset". The patient is one of triplets whose sisters (WAES # 0608USA05091 and 0608USA05187) have also had adverse experiences after vaccination with PROQUAD (Oka/Merck upgrade process). Additional information has been requested.
p/vax pt exp a generalized rash described as a drug rash w/a fever;medical attention was sought;
Increased muscle pain in neck all the way up to ears. Very difficult to turn my head to the left. Difficult to turn my head to the right also.
Inadvertently administered expired dose to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Nurse supervisor. The reporter stated that, they inadvertently administered an expired Infanrix dose to a patient, which led to expired vaccine used. The reporter asked if the efficacy of vaccine was still good. The reporter did not consent to follow up.
Mild headache all day. After school, blurred vision in right eye, throwing up and paralysis of right side. At emergency room, was given Vicodin and was better in three days.
soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 25-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 28-Jan-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 28-Jan-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 29-Jan-2023, PAIN IN EXTREMITY (soreness in the arm) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medications were not reported.  The patient had not experienced any additional symptoms/events.  Treatment information was not reported.
When she had the vaccine she felt like serum going down her left hand. Also she has a ringing in her left ear. Went to ENT.
Headache, Myalgia, CHILLS, LOSSOF APPETITE, FATIGUE Narrative:  Other Relevant History:
Persistent global headache that is still ongoing more than 24 hours post vaccination. Neck soreness and stiffness started about 18 hours post vaccination. No meningismus. Only partial relief with acetaminophen.
I had a very red, hot, and itchy arm on the side of the vaccine.  It was about 5 inches long and extended around for about 6 inches. I still have it but it has faded.  I am wondering if I should get the second vaccine in the same arm.
This spontaneous report was received from a consumer via a social media site concerning a female who on an unspecified date received GARDASIL. Concomitant medications and medical history were not provided. The reporter posted on the social media site. No further information was provided. Follow-up information was received on 04-MAR-2016 from a consumer via social media concerning a female who was reported to have received a dose of GARDASIL. It was reported: "The sudden death of a 12 year old girl... just hours after receiving the HPV GARDASIL vaccine has shocked the girl's family and sent local medical asking questions as [...]". No other information was provided. Additional information is not expected.
sore throat, cough, runny nose, headache, sinus congestion, nasal congestion, wheezing, post nasal drainage, fatigue, nonproductive cough, body aches. starting on 10/3/21.  First vaccine given through employer, unable to access LOT #
1 1/2 hrs p/immun fever; 2 days later during noc 21FEB vomited x 3; ax fever 102.6F; has not been eating x 2 days; taking APAP for children 2 tabs q 6 hrs; advised to bathe in cool water. keep clothes off, given APAP 4 hrs; to ER is worsens
March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues.  1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb.  3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.
Tingly/numbness in right arm immediately with injection.  Lasted about an hour.  Fatigue and achiness the following day.  4/17-4/19 tingly and soreness in neck and shoulders.  Virtual visit with doctor on 4/19 to discuss if symptoms were related to blood clots and/or vaccine.  Week of 4/25 extremely swollen and sore lymph nodes.  5/4 -5/6 fever (101).  COVID test 5/5 and negative result received 5/7.  Fever returned higher (102.9) on 5/8.  Virtual visit with doctor 5/10 to discuss fever and fatigue symptoms.  5/13 UTI test.  No infection but blood in urine.  Off and on fever and extreme fatigue continue along with loss of appetite and weight loss.  5/18 in person doctor visit to check symptoms, another UTI test and bloodwork.  Blood work came back normal, UTI normal, still blood in urine.  5/20 X-ray to check for pneumonia (none found) and ultrasound on kidneys and bladder to check for infection, kidneys stones (none found).  Also had more blood work done that day to check for mono (had as a teen with similar symptoms).  5/24 confirmed reactivated mono.  Symptoms have slowly improved since 5/23.  Another test is scheduled for the future to check the blood in urine again.
Immediately after the shot I felt fine, I went to bed on 5/9 and woke up the next day with a very arm sore, I couldn't lift it above my shoulder. On the second day 5/11 I took the bandaid off and noticed that it was red underneath the bandaid. The soreness had gone down, but I noticed a new swelling, slight itchiness and heat coming from the spot. The swelling was bulbous and round around my shoulder muscle. If the swelling or soreness doesn't go down by tomorrow, I might make an appointment to see a doctor.
On 1/17/01 the pt went to bed at 8:30 PM, woke up at 10:30 PM with an elevated temp of 103.4 rectally. The pt was given Advil. At 2:15AM seizures started affecting body. The pt was taken to ER. Valium was given rectally, child then vomited, seizures stopped but the child was lying limp on left side of body, unable to hold up head. The child was transferred to a pediatric ICU at another facility. The pt was still unable to use the left side of body. All tests were negative. Child went home from hospital on 1/19/01.
The pt developed erythema, edema at left deltoid approx 10cm X 12cm area of tenderness to palpation and pruritus.
Chills, body aches, tiredness, nausea, and lost taste for sweet things lasting for 24 hours and starting around 7 hours after shot
Rash to bilateral buttocks, very painful, raw, sensitive, scaly; Rash to bilateral buttocks, very painful, raw, sensitive, scaly; Rash to bilateral buttocks, very painful, raw, sensitive, scaly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 17:00 as dose 1, single (Lot number: FK5227) at the age of 7 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DERMATITIS ACNEIFORM (non-serious), RASH (non-serious), EXFOLIATIVE RASH (non-serious) all with onset 16Nov2021 at 16:00, outcome "recovered" and all described as "Rash to bilateral buttocks, very painful, raw, sensitive, scaly". Therapeutic measures were not taken as a result of dermatitis acneiform, rash, exfoliative rash. Additional information: The patient did not had any known allergies. The patient did not received any treatment adverse event. No follow-up attempts are needed. No further information is expected.
Onset of shingles-itchy-painful-spreading rash 10 days after immunized
Information has been received from a physician concerning a 26 day old female infant who on 05-MAY-2008 was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). It was noted that the patient received her second dose of ROTATEQ vaccine live (human-bovine) (lot # 657668/1390U) on 30-JUN-2008. There were no problems reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Patient reports shoulder pain since booster dose on 11/1/2021. Sharp shooting pain, worse at night. She did seek medical attention and her provider ordered scans to rule out other causes. Medication was ordered and sent to outside pharmacy to help with the pain.
Nausea, vomiting, tremor, pruritus, dyspnea a few minutes after vaccine was administered.
At a work place COVID vaccine clinic the patient requested a Janssen vaccine. It was confirmed that he had not had a COVID vaccine from completed patient form and verbally. Upon adding his information into the state immunization data base it was found that the patient had received a Moderna vaccine from another establishment in June. When identified, patient was asked about this and he stated he though it was a flu shot. An interpretor was brought in and the patient confirmed this again in his native language. Location where the Moderna vaccine was given was called and this vaccination was confirmed. Patient was held for a longer observation after vaccination and nursing on site at work location was notified. No adverse signs/symptoms seen or noted. State immunization board labeled Moderna shot as invalid.
Started gagging after shots. Patient went home approx 15 minutes later returned to office with hives allover. Left upper arm with 2.5 cm x 2 cm raised warm erythematous lesion below injection site of MMR. Patient received Epi 0.2g SC X and oral children's Benadryl 1.5 tsp. vitals monitered.
Patient reported hives, swelling, redness and blisters on feet. Her  foot was completely red and covered in blisters. Nose bleeds and bleeding gums and blood in the urine.
714PM phone call to on call MD screaming cont 1hr +, leg red & swollen;
Pt is 17 years and 11 months old, and was given Moderna shot with is approved for 18 years old and over.  Pt has had no symptoms or adverse events.
3/19/21 Sore left arm, could not lift arm, pain in chest and back. Went to ER due to chest pain. Lasted 6 hours. Within 2 days all better.