chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician through company representative concerning a "now 10 or 11 year old" female who at approximately 3 year of age was vaccinated with the first 0.5 mL dose of VARIVAX (Merck) (route and Lot# not reported).  The patient developed chicken pox at 3 years of age after getting the first dose of VARIVAX (Merck).  So physician decided not to give the patient the second dose.  Recently, the patient developed a case of chicken pox again.  Unspecified medical attention was sought.  At this time of reporting, the patient was not recovered. Additional information has been requested.
swelling and redness at the injection; swelling and redness at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection). At the time of the report, VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Pt got lightheaded first after standing up to put shirt on immediately after vaccine. 10-15 minutes later was having  tingliness  all over, pain in shoulders, and a warm sensation in his legs
Worsening of Lyme bone pain that started 2 months after vaccination.  Had not had these symptoms since 2012 and no longer spoke about my Lyme history due to having no lingering symptoms (had acute Lyme 8 times in a 10 year period).  Bone pain came back with a vengeance, debilitating at times.
Nausea and vomiting, muscle ache, headache and general malaise. Off work X 1 day, 1/17/03. Signs and symptoms less today.
15 -20 minutes after the administration of Flu and Td shot given in same area per my request, left arm. Experienced lightheadedness, leg weakness and radiating left arm pain. Pt advised to inform of any complications. Pt at home, BP was 113/76. Today 10/18/04 experienced symptom of tingles in left arm.
pt recv vax & devel chickenpox w/twenty lesions that were gen & extremely pruritic & a fever of 99.6;
Fevers, chills, muscle aches, headache, diarrhea Friday night 11/23; Saturday 11/24; Sunday morning 11/25.
Moderna Covid-19 monovalent booster administered after 9/2/22.  On 9/9/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled on 10/25/22.
Mother reports child has sensory disorder, MD plans to test for autism spectrum disorder but has not yet. Reports client's symptoms started getting worse the day after MMR vaccine. Client has always loved water and bath time. She has started having meltdowns anytime she comes in contact with water. She has been fussy and upset to the point of crying daily. She has always had sleeping issues, but has gotten worse since vaccine. She is "having sleep walking type episodes where she tries to jump out of bed, but she is not awake. Client ran fever 101 on 8/31/18 and 9/1/18 but resolved without issue. Mom concerned because symptoms are much worse since vaccination and she is not able to console the child. Instructed mom to take child to her pediatrician, Mom will fax notes from visit to PCP. Mom would only allow MMR on 8/24/18, she chooses her own immunization schedule. Child had birth dose Hep B and received PEDIARIX on 3/30/2014 at another provider. These are the only vaccines child has received.
Patient called another pharmacy, Store 9/20/2018. She complained of a sore neck. She was told to try some ibuprofen and call the pharmacy back and let the pharmacist know how she was feeling. On 9/23/2018 she called pharmacy Store and stated her neck was still sore.
Information has been received from a consumer concerning her daughter, a 20 year old female with a kidney infection and bladder infection and a history of occasional bladder infections and yeast infections who on 21-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  On 04-Feb-2008 she went to the physician's office to receive the second dose of GARDASIL and was inadvertently given hepatitis B vaccine (lot number and manufacturer unspecified).  On 04-Feb-2008 the patient experienced wrong drug administered.  On 16-Mar-2008 the patient was taken to the emergency room with low back pain, vomiting and swelling in abdomen.  The patient was diagnosed with a bad kidney infection and bladder infection.  Patient was given IV antibiotics and IV for hydration and sent home with oral antibiotics.  Patient tried taking the oral antibiotics and would vomit after taking them from upset stomach.  On 19-Mar-2008 the patient went back to the Emergency room and was treated with IV antibiotics and saline IV.  On 01-Apr-2008 the patient completed the oral antibiotics and is feeling better.  Subsequently, the patient recovered from the wrong drug being administered, kidney infection, bladder infection, and vomiting.  Unspecified blood work was done at the hospital however the reporter did not know the results.  Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: After getting the vaccine, patient was feeling lightheaded while he was sitting down. He tripped over the chair and fell over when he tried to get up too quickly. Patient fainted briefly as we were trying to get him to a chair and was pale initially. 911 was called. After he was given water and the paramedics arrived patient got better. paramedics tested vitals and everything was in normal range. patient reported being nervous about getting the vaccine. paramedics left after collecting info
Pt called 5 days after receiving vaccine. Reported 2 lg blisters on non-vaccine arm (right). She said they are spread out on arm and are appx the size of a half-dollar piece. Asked pt to f/u with MD/PCP.
pt recvd vax 1OCT93 & on 16OCT93 c/o sl h/a; 18OCT93 had sudden lost of vision; seen by MD 20OCT93; hospitalized on 23OCT93 for optic neuritis;
Pt. had a generalized tonic clonic seizure x 6 minutes associated with fever.
56 yo F presents to clinic for booster dose. While waiting for observation pt started to cough and c/o chest tightness, worsened over 20 minutes. Pt stated she does have asthma and proceeded to treat herself with inhaler @1410 (3 puffs). VS @ 1415: BP 135/70, HR 72, O2 100; @1424 BP 124/79, HR 72, O2 100; @1440 pt states she was feeling better. Pt refused ER transport.  Allergies to amoxicillin and iodine. No previous issues with previous vaccines, or covid vaccine series.
Full body rash breakout; Small spots with raising and clear liquid in some; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6304), via an unspecified route of administration in the left arm on 15Mar2021 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included NUVARING for unknown indication. The patient has no known allergies to food, medications or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 20:00 the patient experienced full body rash breakout and small spots with raising and clear liquid in some. The patient did not receive any treatment for rash. The clinical outcome of the events rash and rash macular was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
red raised rash over body; fever; fatigue; diarrhea; intestinal stomach pain; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection on 12Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. The patient received BNT162B2 dose number 1 in Dec2020. Medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced fever, fatigue, diarrhea and intestinal stomach pain. On 18Jan2021, the patient experienced red raised rash over body. The outcome of the events fever, fatigue, diarrhea, intestinal stomach pain and red raised rash over body was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Over two hours after receiving vaccine, patient was sitting in a meeting. States her "heart was fluttering". She continued to attend meeting but symptom never stopped, worsened. She felt like she may faint, Coworker drove her to a local Urgent Care clinic, who advised her to go to ER for cardiac symptoms. She was taken by coworker. Slight headache, blood pressure up some. Given Benadryl and another medicine to help "settle her down". Patient was discharged home with no meds, no instructions to follow up, only if symptoms returned.  11/06/2019 I spoke with patient and doing well. She plans to schedule appt with PCP,  "fluttering" comes and goes, example while combing her hair this morning. Not taking any meds ( cold/cough/OTC) Not drinking excess caffeine or energy drinks, no smoking. Patient will call to let us know  what her diagnosis is.
This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored GARDASIL (dose, route, frequency: unknown, lot number: K011325, expiry date: 08-APR-2017). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Knee is killing me( left leg); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee is killing me( left leg)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee is killing me( left leg)). At the time of the report, ARTHRALGIA (Knee is killing me( left leg)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment information were not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 on 12/11/2022. I tested positive for COVID-19 on 12/13/2022. I was really sick with extreme fatigue. I contacted my provider and got a prescription for PAXLOVID. I tolerated the medication with no complications. In the end of January, I had gastrointestinal issues. I went to the emergency room as I had an infection in diverticula. I was on an antibiotic for seven days. I am eating a normal diet and taking a stool softener. I also presented with kidney failure but that is doing better. At times, I am very weak.
fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes; pain in the arm; rashes; headache; chills; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 033H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis NOS (sinus problem causing her allergy) and Heart disease aggravated. Concomitant products included RIVAROXABAN (XARELTO) and NADOLOL for Heart disease aggravated.   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 08-Jan-2022, PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient  took Ginger candy for nausea.  Patient said that sinus problem causing her allergy. Patient is taking Vitamin-D for unknown indication
This child diagnosed with chicken pox 01/22/01, after vaccine 07/10/1996.
Information has been received from a registered pharmacist concerning a 65 year old male patient who on 28-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck), (lot # and expire date not reported), subcutaneously. On 29-OCT-2010, the patient developed an injection site reaction after receiving ZOSTAVAX. The area around the injection site was hard, red and sore. The patient sought unspecified medical attention. At the time of the report, the patient's events had not resolved. Follow-up information has been received from a registered pharmacist concerning a 65 year old male patient with no pre-existing allergies, birth defects or medical conditions who on 28-OCT-2010 was vaccinated with the first dose of ZOSTAVAX (Merck), subcutaneously into the left arm in the morning. Concomitant therapies included the first dose of FLUVIRIN (Lot n. 111796P1), intramuscularly into the left arm and the first dose of PNEUMOVAX 23 (lot n. 665708/0651Z) subcutaneously into the right arm. Pharmacist reported that on 29-OCT-2010, injection site and radiating down to the elbow was red, tender and hot to the touch. The patient was advised to call back if it did not resolve. The patient did not seek medical attention. At the time of reporting the patient had recovered. Additional information is not expected.
Hives; treated with Zyrtec 1/2 - 1 tsp daily.
Pt recvd vax 17DEC92 & devel rash on hands, ears, feet, & eyes on 17DEC92; sx treated w/DPH & hydrocortisone; sx persist;
Intense bi-lateral kidney pain, nausea, chills and headache began around noon one week post injection.  Kidney pain was rated a 7 out of 10 about 6 hours after onset.  This level of pain continued overnight and is gradually decreasing in intensity.  No blood in urine, odor or increased frequency of urination noted.
Within 8 hours of receiving the vaccine, it felt like my arms, legs, and back were being beaten. I have pain in my neck. I have bright red splotches on my inner thighs.
PATIENT REPORTS A BULLS EYE RASH AROUND THE INJECTION SITE MEASURING 6 INCHES IN  DIAMETER.  PATIENT STATES IT WAS A RED HOT ITCHY RASH. THE PATIENT USED CLOBETASOL CREAM/OINTMENT ON THE RASH AND IT CLEARED UP.  PATIENT HAD NO OTHER COMPLAINTS BUT WANTED TO REPORT THE REACTION.  SHE WILL REPORT THE REACTION TO HER ALLERGIST AS WELL.
Employee states that a 2 month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose.; This non-serious spontaneous safety report, with case ID 02389872 (Interaction Number 02389865), was received by partner, on 16MAY2023 and forwarded to agency on 17MAY2023 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Employee states that a 2-month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose.".  Further information is expected.  Significant Follow-up information was received by the partner on 02-JUN-2023 and forwarded to agency on 02-JUN-2022, from a physician. The case is maintained as non-serious.   The reporter confirmed that there were no adverse events following the accidental early administration of Vaxelis second dose.  The causal relationship between Vaxelis and the reported event  "Employee states that a 2-month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose" was assessed as not applicable due to the nature of the event.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received on 07-JUN-2023 by the partner and forwarded to agency on 07-JUN-2023.  The case is maintained as non-serious.  The causal relationship between the event and Vaxelis is not applicable due to the nature of the event.   No further information is expected.
Mom states that next am after immunization, patients left arm was hard and red then thru out the day his arm got swollen, red area with hardness spread. Called on day 2 after immunization. large, red, hard, swollen, warm to touch from shoulder to elbow. Treatment; cold packs, Tylenol PRN and monitor call MD if no improvement.
1st dose on mar2020, no 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in March 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingle vaccine, which led to incomplete course of vaccination. The patient enquired if he/she should get 2nd dose now or start over again with the 1st dose. The follow-up could not be possible as no contact details were available.
Initial report received on 29/Dec/2005 from a health care professional. A male patient of unknown age and date of birth had received an administration (route and site not reported) of DECAVAC (lot number not reported) on an unspecified date for a wound. Two to three weeks later, the patient received another administration of DECAVAC in the physicians office. At an unspecified time later, the facility where the patient resides reported an increase in the patient's confusion. It is unknown if the patient recovered from this adverse event at the time of this report. Follow-up information received on 27/Jan/2006. Per the reporter, when the adverse events were reported to the physician, the physician felt all changes in the patient' condition were related to his chronic disease state (disease state not reported). The physician did not feel the application of the DECAVAC had anything to do with the patient's decline.
booster injection sore; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (booster injection sore) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (booster injection sore). At the time of the report, VACCINATION SITE PAIN (booster injection sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient reported that their booster injection sore has never healed and they got it six weeks ago.  No treatment information was provided.
The pt developed a high fever to 105.5F, the evening following immunization. Seen at MD's office the next day, still febrile that morning temperature of 103F. Lab work ordered.
Reports that he was watching the news and noticed a taste of blood and looked and found that his gum line of his left upper jaw was bleeding.  He states it bled for approximately 2 hours and then spontaneously stopped.
101 fever about 12 hours after injection, headache, weakness, chills, body felt like it was on fire
PATIENT VACCINATED 2-4 OR 2-8 SECOND VACCINE 3-11-21. 3-29 PT HAD A POSITIVE COVID RESULT
Severe arthritis & tendonitis, glossopharyngeal neuralgia, pituitary tumor
ant to document in my medical file the significant negative reaction to the COVID booster. I had eaten breakfast before my appointment (eggs, spinach and water)  Booster administered around 9 am 1ish pm lunch In the afternoon I was very tired, could easily gone to sleep for a couple of hours but was at work.  Dinner around 5:30, wS feeling a little achy so I took a Tylenol Out to watch an event in town (so sedentary)  Home around 11Pm. I was cold, particularly my hands and feet. When I brushed my teeth, my saliva was mucusy I could NOT get warm.  I woke up after an in and out sleep to my body shaking/shivering like I?ve never felt before. I was cold. There were pulse points(wrist, behind knee, groin) that would have a sharp pain and I was feeling parched. All I could think of was blood clots.  I got up and took two 81 mg baby aspirin  I shivered for a couple of hours, took huge advantage of a warm torso next to me, though my shivers kept him awake too, then fell to sleep around 3:30. Awakened by various alarms and a phone call at 7:15. My hands were swollen and asleep, and I was overly warm, slightly sweating  A shower helped but my whole body is achy and tender, and swollen. I?m a little stuffy. Jeans hard to get into, boots even harder to zip up all due to swelling.
Swollen lymph nodes, ringing in ears, pressure in head, fever, fatigue, 3" reddened swollen area around vaccination site. These symptoms started on day 8 after vaccination. Used gauze and tape at site. Ibuprofen didn't help symptoms. Patient was down in bed for three days. Did not see a physician. Patient has recovered. Information was obtained from patient on 4-17-2003 from "call back" from vaccine diary returned to the State.
Hard bump, redness and swelling right of injection. Fussy 50cent piece size hard bump, redness day after. Use Advil/Tylenol, cool compresses.