chrisvoncsefalvay/vaers-outcomes huggingface dataset:
March 10, 9am, received injection in left arm.  Minor headache throughout the day.  That afternoon (~3:00pm) noticed itchy neck and face.  (Since I had a rash last year from skincare products I just thought it was same thing).  March 11, rash worse.  Treated with topical 2.5% hydrocortisone ointment.  Back of head started feeling tender.  March 12, evening, back of head feeling worse, took Ibuprofen.  Rash much better on face/neck.  Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head.  March 13, 8:00am, went to urgent care clinic.  Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes.  Rash almost gone.  Back of head extremely tender/painful.  March 14, swollen lymph nodes multiplied on back of head and also on right side of neck.  Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine.  March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain.  Spreading more in right side of neck, which is sore/tender.  Slight rash on neck.
Patient Stated on 10/04/2016 that she feels weakness between her elbow and the fingers of her left arm.
This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, injection site pain, fatigue and muscle pain. On an unknown date, the outcome of the fever, injection site pain, fatigue and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th October 2018, the patient received 1st dose of SHINGRIX. Six days after receiving 2nd dose of SHINGRIX it was reported that, the patient experienced low grade fever (body temperature was 99 to 100 degree F), site pain, fatigue and muscle aches. The patient stated that, site pain was expected and was not the issue, but asked how long should they be concerned about the fever, fatigue and muscle aches.
Itching, rash all over body, large blisters on chest and face. Started exactly 24 hours after 2nd shot. came very fast , within five minutes of no problems.
temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Vomited one time, emptying stomach content.  Restless sleep all night, constant crying.  Woke up at 7:00 am with hives on her left leg, same location as the shot.
Swelling under my arm area, it's real puffy; under the armpit area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling under my arm area, it's real puffy; under the armpit area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; migraines; nausea; dizziness; Fever 100.5 degree F; Fatigue; Severe joint aches unresponsive to naproxen; Crampy abdominal pain; This is a spontaneous report from a contactable physician (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7534, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 15:15 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included pulmonary hypertension, asthma and chronic obstructive pulmonary disease (COPD). The patient's known allergies included cephalosporins. Concomitant medications/other medications received by the patient within 2 weeks included morphine sulfate (MS CONTIN); oxycodone hydrochloride, paracetamol (PERCOCET) and estradiol (ESTRACE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, Expiration date: Not reported), via an unspecified route of administration in left arm on 19Feb2021 at 13:00 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy, daily migraines lasting for a week after both the injections with nausea and dizziness, fever with body temperature of 100.5 degree F, fatigue, severe joint aches unresponsive to naproxen and crampy abdominal pain. These events doesn't result in emergency room visit or physician's office. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
reporting duplicate vaccine given for shringrix 2 dose series... 1 dose & 2nd dose shringrix given in 2019. a duplicate vaccine given 6-15-2022. no reported adverse reaction
This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Seizures) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant) and MALAISE (not looking good). At the time of the report, SEIZURE (Seizures) and MALAISE (not looking good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient Ethnicity was reported as Private. No prior vaccination taken within 4 weeks. Reporter stated that it was sometime in May (unspecified year), patient got Moderna vaccine because she was afraid to get Pfizer because reporter's grandmother died three hours after Pfizer (her lungs started filling with fluid and turned blue). When reporter saw the patient, she was not looking good and started having seizures. No concomitant product was reported. No treatment information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This is a spontaneous case, reported by a patient, concerning a 61-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Seizure, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 61-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Seizure, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Large brite pink spot with underlying lump that is warm to the touch Cold packs donot relieve Does not hinder use of arm
Three retinal detachments (two left eye, one right eye); one retinal tear (right eye); and one macular rupture from 5/14/2021 to 3/29/2022. Six surgeries including two silicone oil removals have left eye with distorted sight and right eye with diminished sight.
I recently got the first dose of the HPV vaccine (I believe its called GARDASIL) about a month ago. That night I came home with what looked to be bug bites (they were different from hives). I couldn't find any bug bites online that looked like them, and I was covered with them on the back of my legs and buttocks, then they turned into what looked like a rash. I had also felt a little nauseous and shot of breath that same night. Today I was in my uncles pool (I have swam in this pool a lot over the years, never any issues) and I went to change after and I noticed hives on my stomach, underarms, and all over my legs. They turned into about the size of a Gatorade cap (sorry, only thing I can think to compare them to) and now they look like a rash. Also every time I get scratched it turns into some sort of rash. I have NEVER in my life had sensitive skin until I got this vaccine. I need to know if this is a side effect of this vaccine, and if it is life threatening or if it will affect anything major in my life. I just seem to be having a lot of allergic reactions and it's very concerning. I'm not sure if I should finish the other two doses, please help me.
Rash, itching, shortness of breath, light headedness, felt very hot. BENADRYL~ 25mg & PROAIR inhaler.
Chills Nausea Headache  Cold sweats Dizziness Arm tingling / numb sensation Chest pain
Pt came in for primary covid shot # 1 but instead received a bivalent booster.  We are in communication with the health department and the Agency to figure out what her next shot should be.  This is complicated by the fact that she was getting vaccinated in order to progress with her immigration status, so time is of the essence.
DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 25 year old male. 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: Unknown) dose was not reported, administered on 07-APR-2021 11:30 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and dizziness. This report was non-serious.
At about 4:30 pm my arm started to hurt and was swollen, I rub it but that didn?t help, at about 7 pm my muscle in my left shoulder was swollen I started putting ice on and off every 15 minutes and took Tyrol, so from that night my muscles were swollen and sore and had pain.  The pain started to go away sometime in early March, but the soreness  continue and went under my arm into the pit  it was swollen under there, it stayed there for a few days then the soreness went back to the muscle in my arm. The soreness went away, just about 2 weeks ago. It feels a lot better now
Patient was unresponsive shortly after giving the vaccine. Eyes open wide and pupils were dilated. Felt really clamy and heart was racing. Was able to wake patient up shortly after going unresponsive. Was confused for about a minute but then was answering questions. We made patient sit with us for over 30 minutes after the incident and seemed much better. After calming the patient he admitted he had been nervous and that something similar to this had happened after the second shot but wasn't immediately after but the following day after the vaccine.
Child was given the 3rd dose too soon , Given after 30 days instead of 60 days.
Noted the left arm red, swollen, warm to touch, pain and itching sensation to area. Pt. stated symptoms started 1/24/2021 and then reported to the health department clinic. The HCP was notified of the pt. complaint. The HCP prescribed warm compresses to left arm area 4 times daily. He advised that the pt. consult with her primary physician. the measurements of the site are 5.25 in in length and 3.5 in. in width. the area was outlined to monitor for further progression of the redness and swelling.
She has been to a cardiologist, who diagnosed her with IST; This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST). At the time of the report, SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
high fever; extreme fatigue; patient had allergies, but it was unknown  what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the eighth of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.
Cough began approx 5 min post vaccine, then pt experienced flushing of neck, chest tightness and SOB.  Placed on O2 mask at 8L/min, given 1 dose of Epi and transferred to ED
sore arm, rash became larger covering the bicep, diareahha, naseau, fatigue, 99 degree temperature
7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Bright Red Rash that developed late the night of the vaccine, and two days later is still bright red. And at the same time, it has become  sore to the touch on the inside portion of my upper arm. The area now also has a swollen "pocket" not there yesterday.  The rash is warm to the touch.  Had a pale "pinkish" smaller rash that developed around 7 days or so after dose #1. That rash never itched, or was swollen and the rash faded out completely within 3 or 4 days.   I am glad I "googled" about this rash,  or else I would be VERY worried about this reaction. However, contrary to most of the reports, My rash after dose#2, is much worse than after dose #1. I figured you all might want to know to add to your Stats.
11/29/12 Approx. 9 pm pt noted (L) arm itching. Pt saw 3 circles - 1 at injection site, 2 toward inner aspect of arm. 12-1-12 8:30AM contacted office - 3 circles, warm, red & itches. Treatment: LIDEX cream to site, ZYRTEC PO.
Information has been received from a nurse concerning a female "born in 1983" with no pertinent medical history who on 29-MAR-2007 was vaccinated with the first dose of GARDASIL (lot# not provided), and on 29-MAY-2007 was vaccinated with the second dose of GARDASIL (lot# not provided) 0.5ml intramuscularly. Concomitant therapy included ORTHO TRI-CYCLEN LO. In July 2007 the patient experienced pulmonary embolism and experienced a second one in August 2007. Patient sought unspecified medical attention. At the time of this report the patient's condition was unknown. Upon internal review, the pulmonary embolism was determined to be an other important medical event. Additional information has been requested.
I am having muscle cramping all over my body within 24 hours; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 17Mar2021 at 14:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included COVID-19 prior to vaccination. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 12:00, the patient experienced muscle cramping all over her body within 24 hours. The patient did not receive any treatment for the event. The clinical outcome of event muscle cramp was not recovered at the time of reporting.   Information about lot/batch number cannot be obtained. No further information is expected.
rash which slowly spread from chest to entire upper torso and next day spread to buttocks and upper thighs