chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Had COVID) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced COVID-19 (Had COVID). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE in March 2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Had COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took three full doses of Moderna.  The name of the monoclonal antibodies was unknown company comment:This Spontaneous case concerns a 74-year-old, male patient underlying medical history of immunodeficiency and Crohn's disease, who experienced the unexpected, non serious  AESI event of COVID 19, approximately 6 months  after receiving a dose of mRNA-1273 as third dose of COVID-19 Vaccine. It was reported that patient received monoclonal antibodies granulocyte at the time of the event COVID-19. The clinical course  was not provided in the case. The patient's  advanced age and underling medical history of immunodeficiency and Crohn's disease may be considered as  risk factors for the event of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 74-year-old, male patient underlying medical history of immunodeficiency and Crohn's disease, who experienced the unexpected, non serious  AESI event of COVID 19, approximately 6 months  after receiving a dose of mRNA-1273 as third dose of COVID-19 Vaccine. It was reported that patient received monoclonal antibodies granulocyte at the time of the event COVID-19. The clinical course  was not provided in the case. The patient's  advanced age and underling medical history of immunodeficiency and Crohn's disease may be considered as  risk factors for the event of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Mild dizziness starting in day after vaccine. Dizziness persisted and grew steadily worse over the next 11 months. For the last several weeks the dizziness is 24/7 and I have fallen from imbalance four times over the last three months. I've worked with my health care providers (PCP, neurologist, ENT, optometrist) to check for many possible causes. MRI for brain, nothing. Ultrasound for carotids, nothing. Xray for hip, nothing. ENT exams, nothing. EMG found peripheral neuropathy in legs. Many blood and urine tests, nothing. Eyes, nothing. I am scheduled a set of tests in November at Hospital for balance and then a follow-up meeting with neurologist.
Rigors started about twelve hours after vaccination and lasted several hours. Had myalgias for about 24 hours after that as well
facial numbing, tingling which began 20 min after shot second dose, same response that did not dissipate  after second dose many additional sx appeared over next 2 -3 months which included erratic BP, pain and tingling in legs, dizziness, body weakness
Had my second shot in my left arm at 10:00 am. My 8:00 PM I developed 2  superficial blood clots in my right breast. A rash comes and goes as well as burning pain in my right breast. The following  Symptoms have started and/ or gotten worse. I?ve seen multiple doctors to no avail. Started multiple meds and can?t get answers Right pain in temple Teeth pain (not sensitivity but PAIN) Breast pain Enlarged lymph node under right arm SEVERE exhaustion Joint pain / muscle pain  Dizziness / brain fog  I am unable to complete daily tasks. This has completely ruined my life. The first shot was fine. And I felt ok after the second. But I developed the superficial blood clots hours after and breast pain and it has been downhill since
28JAN92 inc tem w/max t102 began evening 28JAN92; 29JAN92 erythema around site of inject size of silver dollar; 30JAN92 erythema going away; t102.4 during noc; did not have any more inc temp;
17 years and a half got the first shot; A spontaneous report was received from a pharmacist concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 17 years and a half got the first shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 17 years and a half got the first shot, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.  The patient was qualified for the monoclonal antibodies.   This case was linked to MOD-2021-360105 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 73-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred on unknown latency after the second dose of Spikevax. No information regarding start dates of the first or second dose either latency were reported, so lack of efficacy is not captured. The rechallenge is not applicable. The Benefit-risk relationship of Spikevax is not affected by this report.
MMR II was administered intradermally to a set of 13 month old twin patients.; No additional AE; This spontaneous report was received from a nurse refers to a 13-month-old patient. No information on patient medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intradermal for prophylaxis (exact dose, lot number and expiration date were not provided) (incorrect route of product administration and no adverse event).; Sender Comments: Keywords : US-009507513-2305USA005008:
A week after vaccination, yesterday, I started to develop intense itching, redness, swelling, and induration at and around the injection site. The area has continued to grow and is now, 24 hours later, about 10 inches long  and 4 inches wide.
Patient had local reaction on injection site with redness and swelling, after it resolved it left a black mark like a burn mark.
Pt received PENTACEL in (R) ant lat thigh. The next morning injection site was warm, raised and red 11 cm x 11 cm. Sharpie line drawn on perimeter. Resolved this morning.
after 20 hours large swollen rash at sight of injection, after 24 hours, rash over 18 centimeters wide, with a center large and swollen with heat and blisters
High fever 103F for over 10 Hours and low fever 100F for another 24 hours
Well, on Friday two days after my vaccine, I was sitting down and when I went to stand up my foot was numb, so I started walking around waiting for my foot to wake up and it didn't. That lasted, well, I am still having problems with it. So, about a week after it still hadn't gone away, I went to see a chiropractor because I thought I had a pinched nerve or something. I did a few visits with the chiropractor and it did not provide relief. The chiropractor said if it continued that I would have to get an MRI. Within the last week the numbness has been coming and going, I still can't stand for long periods of time. This is all my right foot. I have never had this issue or problem like this before. I am still having a light tingling sensation and numbness there, and no, I have not gone to a medical professional because I work crazy hours.
Information has been received from a consumer concerning a patient who on 07-JUN-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). Reportedly she had no ill affects. Product quality complaint was not reported. Further information was not available. Additional information has been requested.
had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) "on an Tuesday" as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "had a sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: Patient wanted to know if it was okay for to take a Tylenol after getting the vaccine. She has stopped her other pain medications but wanted to make sure of Tylenol. She mentioned that her arm was fine as of calling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech covid-19 pediatric 5-11 vaccine was administered after expiration of vaccine. Recall of vaccine issued on 10/12/2022 while vaccine was given on 10/01/22.
pt came in w/reddened & raised & warm area approx 60mm x 60mm around Td;
Chills, shivering, fever over 101. Severe lower back pain (I never experienced this type of pain ever before in my life. This lasted more than a month). Heart rate was extremely high, even when I was laying down in bed resting. I took Tylenol and Ibuprofen.
On 09/10/2000 the patient was diagnosed with a "mild case of varicella in the office. The number of lesions was not documented. the patient's temperature was 99.1 orally. In follow up, the physician reported that the patient was seen on 09/30/2000 with "mild varicella". The physician reported that the patient recovered. No further information is available.
Patient received vaccine at approx. 4:43 pm on Tues. 8/29.  Family called on-call physician at 8:22pm stating patient was vomiting. Telephone encounter states mom also sick but doesnt give her symptoms. Instructed to treat symptomatically.  Family calls again approx. seven hours later at 3:06am stating patient has awoken vomiting and "burning up" with fever. Discussed vaccine reaction vs. viral gastroenteritis and symptomatic treatment. If worse, to ED. Also instructed to call us in the morning  with an update.
Presented from MD with fatigue and myalgia x1 week; + Covid test in ED; no resp symptoms or fever; treated with steroid/zinc/ minimal O2; discharged home on Room Air
rec'd Moderna vaccine. 9 days later, the injection site because red, hot, painful and itchy
I went to the emergency room the day before I tested positive for COVID-19 for elevated heart rate. They did not test me for COVID-19 at the time. My husband test with a home COVID-19 test that came back positive. I went to a local testing site; my test came back positive. I called my doctor who gave me a prescription for the Paxlovid. I decided against taking the Paxlovid and by day seven was starting to feel better.
about two weeks after the second vaccine, his psoriasis flared and appeared in previously unaffected areas on body (scalp, ears, elbows); This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration on an unknown date May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 62-year-old) for covid-19 immunisation. Medical history included hypertension and allergy both from an unknown date and unknown if ongoing and ongoing localized plaque psoriasis (many years history of localized plaque psoriasis for decades, usually mild and involving the hands). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medication received within 2 weeks of vaccination) included amlodipine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on an unknown date of Apr2021 (Batch/lot number: Unknown) as a dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient about two weeks after the second vaccine, his psoriasis flared and appeared in previously unaffected areas on body (scalp, ears, elbows) on unknown date in May2021. The event caused physician office visit. The patient received treatment for psoriasis (topical steroid cream) but may need systemic medication to clear. Since the vaccination, the patient was not tested for COVID-19. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267253, 2018SA267283, 2018SA267295, 2018SA267293, 2018SA267304 and 2018SA267294. This case involves a [36 years old] female patient who was vaccinated with a single dose of 0.5 ml FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: right deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. 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.
pt recv vax 21JAN83 & approx 20 days later pt allegedly hosp & dx w/meningitis;attorney stated a relevant stool analysis had been reported & that CDC confirmed a vaccine-induced polio case;
Hives; Flu like symptoms; Felt pretty bad; difficult to pick up her head; Chills; Weird headache behind the eyes; Nausea; Fever; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Felt pretty bad), HEAD DISCOMFORT (difficult to pick up her head) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Allergy NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy NOS.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced URTICARIA (Hives), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Felt pretty bad), HEAD DISCOMFORT (difficult to pick up her head), CHILLS (Chills), HEADACHE (Weird headache behind the eyes), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (throwing up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Felt pretty bad), HEAD DISCOMFORT (difficult to pick up her head), CHILLS (Chills), HEADACHE (Weird headache behind the eyes), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (throwing up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-117926 (Patient Link).
Flu like symptoms reported daily on CDC vaccine follow up app.  Headache, body aches, random pin pricks of pain throughout body, joint pain in toes, knees, elbows, neck, stiff muscles.  Stiffness and joint pain worsened weekly and still continues.  Can't do yoga due to pain.
pt recv vax 19JUL96 & 25JUL96 & 26JUL96 pt exp fever;27JUL96 pt devel a peppered rash all over which subsequently devel into small vesicles;vesicles were small about 3 vesicles looked like real chickenpox;
Headache, dizzy, blurry vision, chest and stomach pain, nausea, drained/no energy, muscle pain, chills, feeling of fever but none. Both times that I had the vacciine, I am 54 years of age.
sharp mid-back pain from neck to mid-thoracic back, aching, stiffness
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 01-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA005873: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Guillain barre syndrome; Initial information was received on 07-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a 69 years old patient who experienced Guillain Barre Syndrome, while the patient received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain Barre Syndrome (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported as patient took one flu shot and got a virus from it called Guillain Barre Syndrome and had never took another dose.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 69 year-old patient who experienced Guillain-Barre Syndrome after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Symptoms of serum sickness were present upon awakening 11/17/12 but were not evident the night before.  Localized injection site reaction, severe headache, muscle pain in neck and arm, fever, exhaustion lasting two days. Injection site swelling and erythema persisted through 11/20/12, with itching remaining through 11/26/12.
Chills, fever, headache, nausea, muscle soreness, vomiting, pain at injection site, and tiredness
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A 4-month-old female infant was administered her "vaccines," which included PREVNAR 13, separately, on an unspecified date. Relevant medical history and concomitant medications were not provided. Past product history included apneic episode after "initial set of vaccines" (not further specified). On an unknown date, within 48 hours of the separate administration of PREVNAR 13, the infant was found to be blue in her crib, with an apneic episode. Subsequently, on an unknown date, the infants was then given her "6 month vaccines." It was reported that the 6 month vaccines were again given separately. Subsequently, within 48 hours of administration of the PREVNAR 13, the infant's apnea monitor alarmed, but she did not turn blue. The outcome of the events at the time of the report was unknown.
Moderate left arm pain (whole arm from shoulder to mid forearm), with movement and w/o movement.  No redness or swelling. Just very tender to touch at injection site.  No other symptoms
chills, perspiration on neck, S.T. early noc since administration of the flu shot;
Pt recvd HIB TITER/OPV/DTP & w/in 24 hrs had an inject site react consisting of swollen leg (2-3 times normal size) erythema, hot to touch, inability to move extremities; fever 102-103; sx completely resolved w/in 48hrs; no tx initiated;