chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigued; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and HYPERSOMNIA (slept all day) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HYPERSOMNIA (slept all day). On 20-Feb-2021, the patient experienced FATIGUE (fatigued). At the time of the report, FATIGUE (fatigued) and HYPERSOMNIA (slept all day) outcome was unknown.            Treatment details not provided.   This case was linked to MOD21-038182, MOD-2021-025031 (Patient Link).
Fever, Knee swelling  in L knee which has had multiple prior surgeries, arthritis, and tears.
1.  Sudden decrease in visual acuity in right eye from 20/20 to 20/800 per opthalmologist. She was treated with eye drops and seen every 2 weeks. Vision has since recovered to 20/25. 2.  Diffuse maculo-papular rash on arms, legs, back, abdomen, and neck causing scaling and scabbing and pruritis. Patient using topical steroid cream, Rash has not resolved.
Patient stated she had red arm with swelling and hot to touch. She went to her physician for treatment on 11/3/22
After receiving vaccine, patient is not able to get blood drawn from the right arm.  Through unexpected ED visit, patient also had bruise in the puncture sides when any medication was adminstered.
I have had ringing in my ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I have had ringing in my ear) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced TINNITUS (I have had ringing in my ear). At the time of the report, TINNITUS (I have had ringing in my ear) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient had received second booster dose.  No treatment information was provided.
DIZZINESS; NOT ABLE TO SLEEP OVER NIGHT; HEART RATE WAS FLUCTUATING HIGH AND LOW; HIGH BLOOD PRESSURE; MIGRAINE AND SEVERE HEADACHE; FEVER; CHILLS; THROAT FEELS SORE; NECK FEELS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had any history of blood pressure or heart rate issues. 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 to left arm on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced throat feels sore. On MAR-2021, the subject experienced neck feels sore. Laboratory data included: ECG (NR: not provided) Normal. On 13-MAR-2021, the subject experienced heart rate was fluctuating high and low. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced migraine and severe headache. Laboratory data included: Blood pressure (NR: not provided) 141/ 93. On 14-MAR-2021, the subject experienced dizziness. On 14-MAR-2021, the subject experienced not able to sleep over night. Laboratory data included: Heart rate high (NR: not provided) 112. Treatment medications (dates unspecified) included: amitriptyline, erenumab, and ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, heart rate was fluctuating high and low, high blood pressure, throat feels sore, neck feels sore, dizziness, migraine and severe headache and not able to sleep over night was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
CLIENT RECEIVED MODERNA VACCINE FORMULATION AT 15 YO. MODERNA VACCINE IS APPROVED FOR AGES 18YO AND UP.
a couple weeks later began to notice back/side/hip pain I had not had before--finally was able to locate the pain being in the sacroiliac joint. Hardly able to bend over when I first get out of bed.  Turing wrong in bed could be painful.  Standing for very long very uncomfortable.  Sometimes worse. Aspirin helped.  Still bothers lots. Sometimes worse than others.  Mentioned it to my Primary care physician.  He said if artheritis, not much a person can do anyway, so didn't x-ray or carry further.
Bumps all over body, crying and fever, received immunizations 2/15  Patient at home with mom.Patient had 4 mos vaccines ( 2nd series, OK last time) on 2/15/23.That afternoon , patient given bath with new soap with oat exract, and lotion with oatmilk and dimethicone. That night patient had fever " 105F" forehead temp , only forehead is hot , body not flushed or hot . Rx Tylenol, fever went down to 102F after 1 hr . Next day 12/16/23, no more fever , but noted rash on legs, then spreads to body today 2/17/23, few rashes on face, Slight fussy but eats OK . No other symptoms . Assessments 1. Rash and other nonspecific skin eruption - R21 (Primary) 2. Postvaccination fever - R50.83 Treatment 1. Rash and other nonspecific skin eruption  Start Benadryl Allergy Liquid, 12.5 MG/5ML, 2.5 ml, Orally, every 6 hrs as needed, 7 days, 100 Notes: stop all products with dimethicone and oat extract. OK sensitive soap/ wash.  ________________________________________________________ Date: 02/21/2023     Time: 08:48 AM spoke to mom to follow up on Fever/rash dicussed through video visit on 2/17 mom stated patients sxs are completely resolved picked up Benadryl rx sent on 2/17 the next day on 2/18 states fever stopped since then Rash looked better on Sunday 2/19 and woke up Monday 2/20 with rash completely resolved Mother offered no further concerns at this time.
Pt when asked her age said 11 but mom wrote 12 on form. Pt was given the ped. dose instead of an adult dose.
Weight: She has gained weight since covid; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via intramuscular, administered on Right arm on 12Jan2021 11:30 (at the age of 78-years-old) at single dose for COVID-19 immunization. Medical history included breast cancer (19 radiations and they took out three lymph nodes on the left, she was diagnosed 3 years ago); blood pressure abnormal (Additional Information for Concomitant Products Losartan: she has been taking for years and Additional Information for Concomitant Products Amlodipine besylate: added about a year ago); vein disorder (She clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She was asking if it is possible that may have anything to do with it. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020) and herpes zoster. No additional Vaccines Administered on Same Date of the Pfizer Suspect reported. Concomitant medication(s) included losartan (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 100 mg, 1x/day (once a day) for blood pressure abnormal; amlodipine besilate (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 5 mg, 1x/day (once a day) for blood pressure abnormal; and tamoxifen (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 20 mg, 1x/day (once a day) for breast cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced weight since COVID-19 infection on an unspecified date. She clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020. Reports she had the shingles shot a few months ago. She will call her doctor to see if she should get a sonogram or x-ray of her calf to check for blood clot. The patient underwent lab tests and procedures which included that she was 136 pounds and she weighed herself and weighs 142 pounds. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On 21-MAR-2006, the patient received the first dose of VAQTA (dose, route, lot number and expiration date were not reported), and on 19-SEP-2006, the patient received the second dose of VAQTA (dose, route, lot number and expiration date were not reported) both for prophylaxis (extra dose administered). No adverse effects were reported.
PATIENT HAD PFIZER KIDS 5-11 DOSE 1 AT 11:30 11/24/2021. PATIENT'S GUARDIAN CALLED ABOUT 14:30 TO REPORT THAT PATIENT HAD JUST VOMITED FOR NO APPARENT REASON. PATIENT WAS ALSO COMPLAINING OF NECK PAIN OF UNKNOWN ORIGIN. I SPOKE WITH THE GUARDIAN FOR ABOUT 5-7 MINUTES, BY THE END OF WHICH, THE MINOR PATIENT HAD REPORTED THAT HIS S/SX WERE GONE AND THAT HE FELT FINE.
bitter taste in mouth; Had 3 vaccinations for Covid and tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (bitter taste in mouth) and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 010M20A and 026L20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    Concurrent medical conditions included Sinus disorder, Macular degeneration and Cholesterol. Concomitant products included ATORVASTATIN for Hypercholesterolaemia, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, AMOXICILLIN for Sinus infection.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-Apr-2022, the patient experienced DYSGEUSIA (bitter taste in mouth) and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid). At the time of the report, DYSGEUSIA (bitter taste in mouth) had not resolved and COVID-19 (Had 3 vaccinations for Covid and tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         The bitter taste in mouth was felt to be constant all the time on 21-Apr-2022 and a little bit on 20-Apr-2022 for the patient. The patient took Paxlovid in the evening of 20-Apr-2022 and in the morning of 21-Apr-2022. It was reported that patient was on antibiotics for sinus infection. 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.   Reporter did not allow further contact
About 15 minutes after receiving the vaccine, I developed a metallic taste in my mouth which lasted throughout the day. Since then, the metallic taste has re-appeared every other day or so. I also have developed numbness in my face. The numbness will appear in different parts of my face on different days. I am still able to taste and smell. The feeling resembles the after effects of getting a shot at the dentist. I am very hesitate about getting the 2nd vaccine since these reactions are ongoing and have not stopped.
I had a small nodule on the left hairline of my neck, and I had dermatomal pain along the left side of my scalp to my forehead. This was recurrent in the same location which I had 6 months ago right after my third shot as well. I started taking valacyclovir 1000mg immediately and it resolved within a day for the symptoms. The previous case which was a week after my 3rd shot, I had a biopsy on the nodule and it did show herpes zoster.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 15-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling, at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1501USA001475). Additional information has been requested.
Admission History: 2/14/2022  Hypoxic respiratory failure due to CAP +/- covid pneumonia 1/29/2022  Acute Hypoxic Respiratory Failure/COVID 19: Likely 2/2 COVID
This spontaneous report was received from a healthcare worker refers to a 88 year old patient. on 16-APR-2013, the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot number reported as 1649AA, expiry date 21-JAN-2013, route was subcutaneous). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Severe sore arm, headache, myalgias, weakness and fakeness, and nausea which lasted 36 hours  The same side effects occur in one of my medical associates
arm soreness, fatigue, joint pain, muscle aches, headache started 12 hours after vaccination.  Cessation 36 hours after vaccination.
redness around the injection site; swelled up around the injection site.; significant pain in arm; She had difficulty lifting the arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness around the injection site), injection site swelling (Verbatim: swelled up around the injection site.), pain in arm (Verbatim: significant pain in arm) and movement disorder (Verbatim: She had difficulty lifting the arm). The patient was treated with non-drug therapy (Ice Pack (No Medication)). In JUL-2023, the outcome of the injection site erythema, injection site swelling, pain in arm and movement disorder were resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and movement disorder to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, pain in arm and movement disorder to be related to Shingrix.   Additional Information: GSK Receipt date: 27-JUL-2023 The reporter reported that the patient took injection of Shingrix and had significant pain in arm with redness that swelled up around the injection site. The reporter reported that she had difficulty lifting the arm and had to put an ice pack on it, this was within the past 7 days from the reporting day, but she reported that the symptoms had gone away now. The reporter did not consent to follow up.
Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included alprazolam and hydroxyzine.  On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection.   On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
minor soreness in near injection site (within fifteen minutes of injection, continuing for several days) severe chills, causing whole body shivering (eight hours after injection, for approximately forty-five minutes) interrupted sleep (nine hours after injection, then ten hours after injection) hot flashes (nine hours after injection, then ten hours after injection, each for approximately ten minutes) body aches (ten hours after injection, lasting until twenty-four hours after injection) elevated heart rate, hovering around 130 bpm while walking, standing, and sitting (ten hours after injection, lasting for approximately thirty minutes) dry heaving (ten hours after injection, lasting for approximately ten minutes) joint pain (ten and a half hours later, lasting until twenty-four hours after injection) mild fever of up to 100.7 (eighteen hours later, lasting until twenty-four hours after injection) Body aches, joint pain, and fever were successfully resolved with a dose of Tylenol, administered about twenty hours after injection.  All other symptoms resolved on their own.
On 2/27/2021 at 12:46 pm, the patient developed chest pain.  Not helped by nitroglycerin x 2.    He was transported to the hospital where he died.
Local site pain; lymphadenopathy/swelling in axilla going all the way down to left breast.; arthralgias; fatigue; fever; swelling in axilla going all the way down to left breast.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FE3592) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 08Jan2021, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: EK5730, Location of injection: Arm Left), administration date: 21Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Local site pain"; LYMPHADENOPATHY (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "lymphadenopathy/swelling in axilla going all the way down to left breast."; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "arthralgias"; FATIGUE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fatigue"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; SWELLING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "swelling in axilla going all the way down to left breast.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, lymphadenopathy, arthralgia, fatigue, pyrexia, swelling.  Additional information: Facility type vaccine: Hospital. Known allergies: No. Other vaccine in four weeks: No. Other medications in two weeks: no. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment with Tylenol, ibuprofen.  No follow-up attempts are possible. No further information is expected.
Covid vaccine x2 tested positive for Covid on 09/13/2022. Admitted to Medical Center on 09/13/2022. Expired on 09/18/2022
7 days subsequent to receiving one dose of varicella virus vaccine live the pt experienced a local injection site rash on the right leg. It was described as a red, not raised, hard and approximately the size of a half dollar. The pt sought unspecified medical treatment. Follow up information indicated the pt experienced swelling, erythema and itching at the injection site. The skin was indurated 2 X 2 cm and warm and the puncture site was prominent. The pt recovered. No further information is available.
Fever, chills, weakness. Palpitations about 12 hours after vaccine admin.
Fainted, dizziness, occasional chills and occasional episodes of clamminess and perspiration.  Occurred in the middle of the night 14 days after receiving the Tdap vaccine.
Client states that she started having a rash on face, neck, torso, and right upper leg. Also report of fever and sore throat. Did not seek medical treatment, used over the counter Benadryl.
Pt came back into the clinic on 10/02/2005 complaining of headaches he was getting. he stated the headache started after receiving the tetanus shot on 09/18/2005.
like she had a slight burn from a hot coffee; sore throat; rash like spots in mouth; Raspy voice; This is a spontaneous report from a contactable consumer, the patient. A 58-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 in the arm left on 19Feb2021 at 14:30 as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. One to two days post vaccination at 15:30 in Feb2021 the patient experienced sore throat, and almost rash like spots in her mouth like she had a slight burn from a hot coffee and raspy voice for 24 hours. The patient did not receive any treatment for the events. The clinical outcomes of the events sore throat, rash like spots in mouth, and slight burn were recovered on an unknown date in 2021, and raspy voice was recovered after 24 hours on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.