chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; Weakness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) patient was tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Recieved Dtap and IPV vaccinations to Right arm. On 5/3/07 mother reported arm swollen at injection site without redness. On 5/4/07 presented at clinic with redness,warmth, and swelling from injection site to elbow area. Afebrile. Prescribed Keflex 250 mg/tsp one tsp p.o. b.i.d. for ten days and warm/ice pack prn. To go to E.R. if symptoms worsen or new ones develop.
Patient had mild seizure immediately after being given Tdap vaccine. Seizure lasted about 30 seconds and then she was ok and rested at pharmacy for about 30 minutes before leaving with her mother. Told mom to take her to MD afterward.
HEADACHE; 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 10-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. This report was non-serious.
patient presented to me with following symptoms on 11/27 rash on chest. Itching.  started about one week after the vaccine. getting progressively worse. She asked me if she should go to ED. I advised her to go to urgent care. Later that afternoon I received prescriptions for medrol dose pack and benadryl.
the birthmark on her body swelled up and was painful; the birthmark on her body swelled up and was painful; This is a spontaneous report from a contactable consumer (patient). A elderly non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 26Feb2021 as single dose for COVID-19 immunisation at public health clinic/veterans administration facility. Medical history included she has a dominant birthmark with vascular malformation. It was unknown if patient had allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was unknown if the patient had received any other vaccine within 4 weeks or any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, it was unknown if the patient was tested for COVID-19. On an unspecified date, the birthmark on her body swelled up and was painful shortly after her second dose of bnt162b2 vaccine. It lasted to 2 weeks. No therapeutic measures were taken in response to the events. The outcome of the events recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Skin on arm red and warm to the touch, pt states she has severe pain in her right leg and can hardly walk. She also states there are bumps on the skin of her right leg.
Itchy red; Arm broke out; Itchy red; Swelling hurts; Swelling hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 01-Mar-2021 at a dose of One pill. At the time of the report, VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient was taken to urgent care two days later, on 27-Feb-2021 and was prescribed an antibiotic, Keflex and has not seen a change in her condition.
Pt admitted on 6/12 for community acquired pneumonia (no COVID test done on admission). Pt tested for COVID on 6/19 prior to SNF placement and tested positive.
Redness, swelling down bicep of arm hard swelling spot on bicep, patient not feeling well for several days.
raised rash to neck, torso, back and upper arms; This is a spontaneous Report from a contactable Nurse (patient). A currently 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021, at 12:45pm (at the age of 49 years old) as single dose, for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination. The patient received vitamins (not specified) within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced raised rash to neck, torso, back and upper arms on 15Feb2021 at 08:00 AM. The event resulted in a Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the event. The clinical outcome of the event raised rash to neck, torso, back and upper arms was not recovered.
After my 2nd Moderna dose, I experienced excessive vaginal bleeding. The blood was not clotted and was not associated with cramping as a regular period. I would change my vaginal pads every hour because they were heavily saturated in blood. The bleeding started in late September and continued until early November.
Fatigue, Nausea, Dizziness, Body Aches. I couldn't hardly move without being very nauseated, this lasted until 4/27. I'm still suffering from dizziness and some fatigue. I took Phenergan and Zofran 8mg to try and combat the nausea.
administration of PENTACEL without the Hib component, got the liquid component of PENTACEL without the lyophilized component with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 years old female patient who experienced administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without the hib component, got the liquid component of pentacel without the lyophilized component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for prophylactic vaccination; influenza vaccine (influenza) for prophylactic vaccination; and hepatitis a vaccine (hepatitis a) for Prophylactic vaccination.  On 06-Dec-2021, the patient received a 4 dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ464AB; expiry date: 21-May-2022;, strength unknown) via intramuscular route in the right thigh as Immunization.  On 06-DEC-2021, the diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component, got the liquid component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) without the lyophilized component with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported that she would like to know if she should start over the whole dose or if she could reconstitute the powder with something else and administer it.  Action taken: not applicable.  At time of reporting, the outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
breakthrough COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID-19). At the time of the report, COVID-19 (breakthrough COVID-19) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This spontaneous report concerns a male patient of unknown age with no relevant medical history who experienced a non-serious unexpected event of COVID-19 (breakthrough COVID-19 infection). The event occurred unknown duration after receiving the second dose of mRNA-1273. As per the report, the patient was fully vaccinated with mRNA-1273. However, there is no information on first dose of the vaccine or on the latency between the two doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-362734 (Patient Link).; Sender's Comments: This spontaneous report concerns a male patient of unknown age with no relevant medical history who experienced a non-serious unexpected event of COVID-19 (breakthrough COVID-19 infection). The event occurred unknown duration after receiving the second dose of mRNA-1273. As per the report, the patient was fully vaccinated with mRNA-1273. However, there is no information on first dose of the vaccine or on the latency between the two doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax & exp high fever which persisted for 3wk;the medical assistant also reported 2 other pt;
The day following the vaccination he developed yellow blotches on both medial lower legs which to him looked like hives.  The next day he developed generalized pruritus and clusters of water blisters in streaks on arms and legs and beneath his nose. The following day it dawned on him that these tiny blisters were identical to what he had seen in the past on his genitalia during outbreaks of herpes.  So he began the same regimen of treatment which had been effective for his herpes outbreaks.  Within eight hours of the first dose of 2 grams of valacyclovir the pruritus had resolved.  Twelve hours later he took the second dose and soon thereafter the water blisters began crusting over.  Just to be sure he repeated the course the following day.  The rash and all of his symptoms quickly resolved and he has remained asymptomatic since.  He first reported this to me today when he was in my office for an unrelated matter.
Developed a migraine and became really fatigued approximately 8 hours after receiving dose and lasting about 36 hours.
Immediate pain in arm, unable to move arm within 15 minutes for 3 days. Painful to lightly touch. Ongoing pain in arm at injection site.
Full body movement on August 29 that settled in her right arm. Tic-like continuous movement that keep her from using her right arm and hand. She cannot write for school or participate in golf.  We have been to a neurologist, orthopedic surgeon, and other doctors trying to help. It has not been fixed and continues to shake back and forth. Unsure what is going on with her arm, but there was no trauma to patient's arm or unreasonable stress. Her having the shot was one change to something patient was given that month.
This spontaneous report as received from an healthcare worker refers to some patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot#, strength, dosage, route unknown). On 14-MAR-2014 the reporter reported a temperature excursion. Since the excursion that was reported, S ome of these doses of (Oka/Merck) VARIVAX, (Oka/Merck) PROQUAD (captured in MARRS1407USA010908) and ZOSTAVAX (captured in MARRS1407USA010909) had been administered to patients. The healthcare worker did not report an adverse experience. The outcome of the events was unknown. This is one of several reports received from the same reporter.  Additional information has been requested.
Local swelling of LEFT arm around injection site to elbow and on to chest per mother's description. Resolved in 24-48 hours. not seen by physician
Increased TSH level; Colds; high fever; This spontaneous case was reported by a patient and describes the occurrence of BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level), NASOPHARYNGITIS (Colds) and PYREXIA (high fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013120A and 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In March 2021, the patient experienced PYREXIA (high fever). In September 2021, the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level) and NASOPHARYNGITIS (Colds). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In March 2021, PYREXIA (high fever) had resolved. In September 2021, NASOPHARYNGITIS (Colds) had resolved. At the time of the report, BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood thyroid stimulating hormone: Increased.         No concomitant medications were reported.  The reporter's causality for the event of increased TSH level with Synthroid (levothyroxine) was a reasonable possibility. The reporter's causality for the events of high fever onset in March 2021 and colds with Synthroid (levothyroxine) was no reasonable possibility.  In Feb-2022, Blood thyroid stimulating hormone: results not provided.  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.   This case was linked to MOD-2022-630557, MOD-2022-621238 (Patient Link).
Fever evening of 7/31/19 102 and given motrin. Rash started on left forearm Friday Noon.  Rash spread to right forearm then all over by Sat.  Low grade fever after the first evening.  Rash was the worst Sat morning, measles like rash.   Rash now dissipating, gets worse when out in the sun.   Felt fine except for first evening after running a fever.  Did not have any itching.  To Urgent Care - no treatment. To follow up with PCP.
15 min after administration, patient reported dizziness and rapid heart rate. Symptoms passed quickly. 30 minutes post vaccination, HR 70-80, patient felt dizzy, jittery, light headed, and nauseated. First Responder called and patient transported to ED
Patient had 3 Moderna vaccine and wanted to do 2nd booster with Pfizer, however I, Pharmacist, administered Moderna vaccine.
All symptoms developed ~14 hours after injection with the exception of swelling of the left bicep within 30 minutes of injection. Extreme sensitivity to touch at injection site . Swelling of injection site, left shoulder, left trap, inner and outer bicep ~14 hours a Swelling under armpit. Swelling up the left site of neck. Possibly enlarged lymph node under armpit and on left side of neck. Pain at injection site, shoulder and under armpit. Unable to move arm normally on 4-19-22. Pain and swelling have decreased as of 4-22-22 but have not resolved.
Red rash at onset, has grown in diameter to approximately 8 inches- elevated from skin with erythema. Darker red center with upraised white center at injection site.
5 Swollen red spots in the armpit; Pain and swelling at injection site; Pain and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site). At the time of the report, RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included migraine prevention medicine once a month.  No treatment details were provided
About 2 days after my vaccination, I noticed a red patch just under the injection site that has been spreading and continues to spread. It is red, itchy, and swollen but the skin is not raised and has no lesions. At this point, the red area measures about 3 inches high by 5 inches wide. The underlying muscle (bicep) is noticeably sore and feels like my arm was hit with a blunt object. I believe this is a so-called "covid arm" reaction, as the same thing happened after my second vaccination and first booster, though the reaction seems to be more pronounced and itchier after each successive vaccination. All of my vaccines have been Moderna.
Received flu shot arm bled 11/21/06; woke up itching, burning, tongue, mouth swelling 11/22/06; took Benadryl called doc on call told to take Benadryl twice and Pepcid 11/25/06; Went to doctor given Cortisone and Prednisone; back to doctor given shot again and Dexpak; back to doctor told to take Zyrtec and prescribed Triamcinclone cream; Still going to doctor still itching and burning.
Large red area at injection site, hard tissue around area, lymph nodes under arm swollen, (R) arm could not lift arm. TDAP.
feel so terrible 2nd dose today; nauseous; chills; diarrhea; tossing and turning for 5 hours; can't sleep; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feel so terrible 2nd dose today), NAUSEA (nauseous), CHILLS (chills), DIARRHOEA (diarrhea) and INSOMNIA (tossing and turning for 5 hours ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel so terrible 2nd dose today), NAUSEA (nauseous), CHILLS (chills), DIARRHOEA (diarrhea), INSOMNIA (tossing and turning for 5 hours ) and INSOMNIA (can't sleep). At the time of the report, FEELING ABNORMAL (feel so terrible 2nd dose today), NAUSEA (nauseous), CHILLS (chills), DIARRHOEA (diarrhea), INSOMNIA (tossing and turning for 5 hours ) and INSOMNIA (can't sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102.4 High.
Patient developed symptoms of upper extremity weakness 3 days after the flu vaccine, progressing to lower extremity weakness within a few hours of upper extremity weakness onset.  Lower extremity weakness progressed to difficulty ambulating to nearly a plegic.  Patient was treated with a course of steroids.  Patient remains ventilator dependent and requires extensive physical therapy to regain function.  Recovery is pending.  At the time of form submission the patient was day #29 of hospital admission and being reviewed for transfer.  03/07/2008 MR received for DOS 10/28-11/26/2007 with D/C DX: Transverse Myelitis.  Urinary Tract Infection.  Pt presented to local hospital with bilateral upper extremity numbness and tingling which later extended to the lower extremities which began 3 days s/p flu shot.  Progressed to weakness and walking difficulty until pt was unable to walk-almost total plegia of the lower extremities. Initially improved on steroids but developed hypotension, tachypnea, tachycardia, and deteriorated atrial fibrillation and was transfered to higher level of care. Pt was febrile, BP upon arrival 60/20. Ultimately developed multi-system organ failure 2' to Gram (-) sepsis. Intubated and G-tube placed. Trached on 11/24/07. Discharged to rehab on 11/26/08.
I developed loud tinnitus in both ears 2 months after receiving the 1 dose vaccination; I could tell because I had to raise the TV volume from 10 to 18.  It is constant and extremely bothersome throughout the day and especially at night when it's quite.