chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump under armpit (left arm injection site); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and LYMPHADENOPATHY (Lump under armpit (left arm injection site)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Fatigue). On 08-Mar-2021, the patient experienced LYMPHADENOPATHY (Lump under armpit (left arm injection site)). At the time of the report, FATIGUE (Fatigue) and LYMPHADENOPATHY (Lump under armpit (left arm injection site)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Patient 1st noted a lump in her right breast in April and mentioned it to her Doctor on May 6.2021. She had a prior BIRADS 1 mammogram on 4/18/2019.  mammogram  Had BIRADS 0 mammogram 5/12/2021 showing a 2.3 cm mass near areola. U/s done the same day showed a very suspicious mass in the same area.  She had an u/s guided core needle biopsy on 5/17/2021 showing  Triple + infiltrating breast  cancer. She has been stated on TCHP neoadjuvant chemo therapy
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with M-M-R II with lot # K002816 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's medical history included neck pain and wrist pain. Concurrent medications were not reported. According to an office note on the date that the third dose of LYMErix was administered, the pt reported, "Neck pain worse. Wrist pain worse." The pt received injections of LYMErix on 10/11/00, 11/16/00, and 3/28/02 "according to the client." An office note from the vaccine provider indicated that the third dose of LYMErix (147F9) was administered on 2/28/02. Documentation from the vaccine provider was only supplied for the third vaccine dose. If the first two doses were administered as the pt reported, the vaccine was given on a 0, 1 and 16 months schedule rather than the recommended schedule of 0, 1 and 12 months. On 9/3/03, the pt's attorney alleged that the pt "suffered stiffness, urinary symptoms, multiple joint pain of wrists, thigh, ankle and neck." Time to onset from immunization, and outcomes of the alleged events were not reported. Upon follow-up received 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "stiffness of the neck, multiple joint pains including bilateral hand and wrist pain, right thigh pain, and left ankle pain." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Patient received second bivalent dose accidentally. She didn't realize she already received a dose on 10/18/2022. No unusual side effects reported.
5 days after receiving seasonal flu vaccine in L deltoid, c/o of increasing pain (sharp, shooting) from L deltoid to L elbow with some incidents of paralysis to L elbow. Advised to visit physician. Did not hurt to touch, but strenuous use (lifting heavy objects) would cause pain. Cancelled appt with physician
This spontaneous report was received from a pharmacist refers to a patient of unknown age (gender unspecified). On 25-OCT-2010, the patient was vaccinated with dose 1 of Hep B (manufacturer unknown) and with dose 2 of Hep B (manufacturer unknown) on 30-DEC-2012. No concomitant medications were reported. The patient did not get the third dose. No adverse effects were reported. Additional information has been requested.
it's like holding a lot of heat; painful rashes popped up on both her knees 7  8 that were slightly risen; This spontaneous case was reported by a nurse and describes the occurrence of MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7  8 that were slightly risen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (painful rashes popped up on both her knees 7  8 that were slightly risen). On an unknown date, the patient experienced MILIARIA (it's like holding a lot of heat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7  8 that were slightly risen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Steroid shot,  Steroid cream are taken as treatment medicines.
Moderna given outside of the window for when the vial was punctured, punctured at 148pm on 03/29/2022, administered at 137pm on 03/30/2022.
Intermittent sharp pain in top of skull began yesterday and has moved to intermittent sharp pain in right ear. No treatment. Just waiting to see if it subsides
Pt. presented to GARDASIL clinic 7-22-08 to begin series. Completed series 4-17-09 after reporting LMP 3-26-09. Presented to health department for + pregnancy test 5-4-09.
almost cost her her eyesight!; This case was reported by a consumer and described the occurrence of visual impairment in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced visual impairment. On an unknown date, the outcome of the visual impairment was unknown.   It was unknown if the reporter considered the visual impairment to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's daughter. The age at vaccination was not reported. The reporter ask to check the side effects. The patient got the shingle shot and still got shingles.
Patient reported feeling dizzy and light headed the night after she received the vaccine. She reported that her head doesn't feel right and feels like she has a brain fog. She reported she started feeling better after few days . She reported that her blood pressure  remained normal.
PASSED OUT; TIGHTNESS IN CHEST; SWELLING IN RIGHT LEG AND RIGHT CALF; DIZZINESS; NAUSEA; STOMACH PAIN; LEG CRAMPS; FOOT PINS AND NEEDLES; LEG PAIN; CHILLS; FEVER; NIGHT SWEATS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced night sweats, chills, fever and leg pain. On 30-MAR-2021, the patient experienced leg cramps, stomach pain and foot pins and needles. On 08-APR-2021, the patient experienced swelling in right leg and right calf, tightness in chest, dizziness, nausea and patient passed out The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 08-APR-2021, and night sweats, chills, and fever on 26-MAR-2021, and had not recovered from leg pain, stomach pain, foot pins and needles, swelling in right leg and right calf, tightness in chest, dizziness, nausea, and leg cramps. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Had fever of 102 which slowly lowered throughout the next 24 hours until gone.  Had severe shaking (trembling) for about an hour.  All this started about 12 hours after getting the vaccine.
Pt. states that after receiving the 1st dose of Moderna 09/15/2021, started experiencing symptoms 09/17/2021 of Chills, headache, nausea, arm throbbing in pain, skin rash (abdomen area), face *cheek area with lumps. Still continuing the experience symptoms. No noted Primary visit.
Patient given too early at 4 weeks of age, five vaccinations, DTaP, IPV, Hep B, Prevnar and Rotateq.
No other AE for this patient.; patient received PROQUAD after a temperature excursion/Temperature 11.5F, Time frame 13 hours; This spontaneous report has been received from a health care worker referring to a male patient with unknown age.   The patient's pertinent concurrent conditions, medical history, drug reactions or allergies and concomitants therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with an improper storage vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, (strength, dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number U022729 has been verified to be a valid lot number with expiration date on 16-JAN-2023, administered as prophylaxis. The administered dose of the vaccine underwent temperature excursions from 11.5 Fahrenheit (F) for 13 hours. There was no previous temperature excursion reported. No other adverse event (AE) was reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008545:02230187 US-009507513-2208USA009042: US-009507513-2208USA008719: US-009507513-2208USA008698: US-009507513-2208USA009322: US-009507513-2208USA008698:
dizzy, nausea, weak, headache, sweating, shivering, fever. 2 days.  Nausea still continuing.
10/8/09 Flu shot give at 1300-1830 had diarrhea, body aches. 1930 chills and fever. Through noc temp went to 103.8. Taking ALEVE. 10/9/09 temp down in AM, 99.3 at 11 AM.
Fever, chills, SEVERE muscle and joint aches, migraine, nausea. Onset was in the early evening around 10 hours after receiving the vaccine. Lasted for the next 48 hours. Felt weak and shaky until the 72nd hour.
tested positive for COVID Narrative: Patient positive for COVID on 1/30/21. On 2/5/21 he went to the emergency department for low oxygen saturation. He was not admitted, but was there for several hours. Treated with IV medications (patient did not know the names and records weren't available).
dx coalescent macular rash 3" diameter around site & extending to groin, opposite thigh, & lower back; some noted on arms & lower shoulders; pt also on last days of Amoxicillin course for UTI; pt recvd DTP/OPV/MMR t99.2;
received dose 9 am. no immediate issue. 5 pm started feeling malaise , nausea  (had not eaten any new food and no known food allergies) by 10:30 pm fever, chills, 102-104 fever, swollen lips, itchy throat, rapid hr,  presented to Hospital ER for care treated for anaphylaxis, epinephrine, Benadryl
At 9:30am on 9/26/15 patient came to the pharmacy with red dots and rash all over body mostly on her arms, chest and stomach. She stated that on 9/24/15 between 2 and 2:30pm, she received 3 vaccinations. She came home and went to bed, 6 hours later her thumbs swelled up, her hands were stiff. Her chest was on fire. Her back felt like someone hit it with a hammer. The patient said she took Naproxyn that she has at home and felt okay. In the morning of 9/26/15, the patient woke up with red spots and itchy rash on her body. I recommended her to use topical Benadryl cream and Zyrtec tablets to alleviate the itch. I also recommended her to take Benadryl at night only to help her sleep (itch and hives). I warned her about the drowsiness side effect of both over the counter antihistamines, mostly Benadryl. At 4:15pm later that day, I followed up with the patient and she stated that the Benadryl cream works very well. She said " I will be okay". I advised the patient to call the Pharmacy with any questions and keep us informed.
Caller tested positive for COVID after the first dose; Caller tested positive for COVID after the first dose; This is a spontaneous report from an other Health Care Professional  (HCP).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on  an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Information has been received from a physician's assistant concerning a roughly 60 year old female who on 20-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported). On 20-JAN-2009, after the vaccination, the patient developed a shingles-like rashes. The physician assistant looked at the rashes and it looks like it was a bad case of shingles. The outcome of the patient's experience was like unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician's assistant concerning a roughly 60 year old female who on 20-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, injection site and route not reported).  On 20-JAN-2009, after the vaccination, the patient developed a shingles-like rashes.  The physician assistant looked at the rashes and it looked like it was a bad case of shingles.  The outcome of the patient's experience was unknown.  Follow-up information was received which reported that the patient was not seen in their clinic.  Additional information is not expected.
pt recv vax;fever,fussiness starting  late eve;father reports T of 103 or 104 but did not use thermometer;did not sleep well;to MD for cont complaints;MD reported swollen lymph nodes behind lt ear;dx of a torticollis;18aug95 no fever/swelli
Patient requested a Pfizer vaccine booster, per our system she was eligible to have the booster. Booster was given and when the nurse asked for the patients vaccine card to document the booster there was already a booster documented on the card from a local pharmacy that was given on 03/09/22. Patient states that "I must have forgot that I already had it".  Patient was given a second booster only one month after her 1st booster.  Patient did not have any adverse reactions after waiting in the office for 30 minutes.
About a week after the 2nd shot. Ibegan to experience headaches that lasted all day; Felt like I was walking through a fog; A few days later my left legs went numb; I was walking with family when it happened and I stumbled; The next day my leg hurt, leg just stopped working; I think I pulled a muscle when I stumbled; Mild depression; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 26Jun2021 at 13:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 03Jun2021 at 14:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 02Jul2021, about a week after the 2nd shot, the patient began to experience headache that lasted all day and the patient felt like she was walking through a fog. A few days later, on an unknown date in Jul2021, her left leg went numb. It was numb for 2 days and went back to normal. It went numb again and had been for most of the day when her leg just stopped working. She was walking with family when it happened and stumbled. The next day her leg hurt. She thought she pulled a muscle when she stumbled. Her headache, foggyness, mild depression and numb left leg continued to be an issue at the time of report, 16 days after the 2nd shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache that lasted all day, the patient felt like was walking through a fog, left leg went numb and had been for most of the day when her leg just stopped working, stumbled and mild depression was not resolved at the time of this report.
Headache 2nd shoot; Joint pain / Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease and Central nervous system inflammation (Central nervous system inflammation syndrome as a consequence of Lyme disease).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia) had resolved.            Concomitant product use was not provided.   This case was linked to MOD-2021-308016 (Patient Link).
TINGLING SENSATION IN SPINE TO CRANIUM; BALANCE DISORDER; ODD FEELING; GENERAL MALAISE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, every 1 total from 08-MAR-2021 to 08-MAR-2021 on right arm for prophylactic vaccination. The batch number was requested. No concomitant medications were reported. On 08-MAR-2021, the patient experienced tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise on 15-MAR-2021. This report was non-serious.
101 degree fever, body aches, fatigue, nausea, diarrhea.
Patient has reported nausea & has vomited once. he also reports sharp stomach pain. He was able to eat, drink and still is at work.  Patient is also diabetic.
Large red spot at injection site. The area is hot and swollen. There is some itching. I had fever yesterday, then excessive sweating over night. The arm is the only lasting side effect.
Patient reported elevated blood pressure and heart palpitations at her doctor's visit on 6/1/21 @8:15 am. She made 2 trips to the ER for elevated blood pressure/heart palpitations on both 6/7 (MD follow up on 6/8) and 6/10 which included an admission to the hospital for 4 days. Patients thinks it is due to the vaccine as nothing else has changed.
No other AE or PQC reported; temperature excursion and was administered; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On an unknown date in August 2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, 1 time dose, lot# 1707487, expiration date: 23-MAR-2022) orally for prophylaxis.  It was reported that, on 25-AUG-2021, the suspect vaccine was exposed to a temperature of 50.5 Fahrenheit (F) for a time frame of 1 hour. No digital data logger was reported. There were no previous temperature excursions. No other adverse event (AE) information was provided. It was also reported that Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# T012806, expiration date: 14-APR-2022; lot# T016198, expiration date: 11-MAY-2022) was involved in the temperature excursion, but was not administrated.  This is one of the two report from the same reporter.; Sender's Comments:  US-009507513-2108USA007369: