chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unauthorized age received vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported.
Coronary Artery bypass and hospitalization after surgery. ER visit for confusion and floaters in vision; discharged. Both of these visits were within 6 weeks of receiving COVID vaccine.
Aching throbbing around injection site for several weeks, arm also felt numb and very weak, hurt when moved.  Hands continued to be swollen for a few weeks.
Patient received five doses of the Janssen vaccine instead of one dose. This was an administration error when measuring the vaccine prior to administration. Patient did not have any side effects or long term effects.
The day of the injection I began with a headache and sore arm but for the most part was fine. Then around 7:00 pm that day I started to get the body aches and so I went to go lay down for bed. I started to shake uncontrollably, have horrible body aches and chills, I went from hot to cold to hot again all through the night, i had a fever all night long, bad stomach cramps, super nausea all night long, and bad headache. This last all the way into the following night having me miss a whole day of work because I couldn't get out of bed. Since this second shot I have had severe heart palpitations, prolong period, blurred vision and severe body aches.
My injected arm was mildly sore (enough that I didn't feel the need for a pain reliever), but after a long night's sleep, I woke up the next day feeling very drained. By 2 p.m. my partner noticed I was very warm and took my temperature. I had a 100.1 degree fever. So I took a single adult dose of Tylenol, napped for a few hours, and I felt much better afterwards. I didn't need any further doses because by late evening, all symptoms (except the mild arm soreness) were nearly gone.
3x5 are of redness swelling pain and hot area. Has spread throughout the day into armpit. Now area is about 9 inches long. Pains are shooting type.
Patient experienced some soreness at the injection site on  Friday, the day of the injection.  The next day, Saturday< she experienced a large amount of redness and warmth around the injection site.  She had no pain at the injection site but did have a small bump in the middle of the injection site.  The next day, Sunday, she visited a walk in clinic and received an antibiotic (Keflex 500 mg every 12 hours for 5 days) and a steroid shot.  She also received prednisone 20 mgs- 2 tabs daily for 4 days to be started on Monday.
9/18/08 Immunizations given approx 9:15 AM, fever approx 2 hours later. 100-1022° intermittent. Sore throat 14 hours later, fever continued, recommended parent bring child to MD for follow up. 9/23 attempted follow up phone calls - No response to message left.
Patient (69 year old female) got a Prevnar13 and HD flu shot on 12/14/19 in the left arm. The HD flu shot was on the top and the Prevnar13 was on the bottom. She and her adult- daughter came to the pharmacy on 12/20/19 and showed me her left arm. It had developed a large, patch area that's a rash which itches and there is heat to touch. She reports it appeared yesterday (12/19). I told them it is common reaction from the Prevnar13 vaccine because that is where the rash appears to have stemmed from. I recommended cold compress over the area, hydrocortisone 1% cream OTC, and taking an antihistamine (Benadryl, Claritin, Zyrtec, or Allergra). Pt's daughter voiced understanding.
I got my booster shot last 1/10/2022. Couple days after. I developed SOB that comes and goes. Alongside with generalized urticaria that also comes and goes. I already saw a doctor did X-Ray and it was normal, increase my anti histamine twice a day but still experiencing SOB and urticaria.
Imbalance sensations that were mild with first shot. After  2nd shot, developed severe headaches, imbalance sensation worsened, fatigued/tiredness, voice hoarseness,  and numbness on arm.
lack of appetite; Dizziness; Nausea. Felt like throwing up but nothing came up; terrible headache; Temperature of 102F; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), DIZZINESS (Dizziness), NAUSEA (Nausea. Felt like throwing up but nothing came up), HEADACHE (terrible headache) and PYREXIA (Temperature of 102F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M207) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, FAMOTIDINE and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DECREASED APPETITE (lack of appetite), DIZZINESS (Dizziness), NAUSEA (Nausea. Felt like throwing up but nothing came up), HEADACHE (terrible headache) and PYREXIA (Temperature of 102F). The patient was treated with CAMPHOR, EUCALYPTUS GLOBULUS OIL, MENTHOL, SYZYGIUM AROMATICUM OIL (TIGER BALM [CAMPHOR;EUCALYPTUS GLOBULUS OIL;MENTHOL;SYZYGIUM AROMATICUM OIL]) for Headache, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (lack of appetite), DIZZINESS (Dizziness), NAUSEA (Nausea. Felt like throwing up but nothing came up), HEADACHE (terrible headache) and PYREXIA (Temperature of 102F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (High) 102F.         Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-048000 (Patient Link).
Hiccups has gotten worse; Intractable hiccoughs; Tired and Exhausted; No energy; Losing weight; Cannot eat; Hiccoughs; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: EATING DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "Cannot eat"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Hiccoughs"; HICCUPS (non-serious) with onset Jan2021, outcome "not recovered", described as "Intractable hiccoughs"; WEIGHT DECREASED (non-serious) with onset Jan2021, outcome "unknown", described as "Losing weight"; ASTHENIA (non-serious) with onset Jan2021, outcome "unknown", described as "No energy"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Tired and Exhausted"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Hiccups has gotten worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hiccups, condition aggravated, hiccups.  Clinical course: Thorazine three times a day, after about a week it does not work for the hiccups and he received Lyrica twice a day, after about a week the Lyrica does not work for the hiccups.  Additional information: The patient received Second Dose of the Pfizer Covid Vaccine on 29Jan2021; Lot Number: EN5318; NDC and Expiry Date: Unknown. The patient received Third and Fourth Doses of the Pfizer Covid Vaccine on an unspecified date, Lot Number, Expiry Date: Unknown.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2013 and on 30-MAR-2016, the patient was vaccinated with the first and second dose of PROQUAD as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 25-JAN-2017, the patient was vaccinated with the third dose of PROQUAD lot # M033209, expiration date: 09-JAN-2018, as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Pt fainted shortly after getting the pfizer covid vaccine, she fell and hit her head.  no loss of conscientiousness.  Called 911, obtained VS, and kept pt immobile until cleared by EMTs.  EMTs cleared C-SPINE, and wanted to take pt to the hospital, but pt refused.  Pt left with her friend who drove her home.  Pt was fully awake without deficit when she left, driven by her friend.  I called pt approximately 1 hour after the event and she said she was doing fine.  Instructed pt to go to the ED should she have headache for N/V.  And to call 911 for any difficulty breathing or any other concerns.
Office's practice was to draw up all doses from a vial and discarded vial. They used a sticky not with bivalent NDC, lot and expiration to enter data into EMR. At some point they realized that some days they had pulled monovalent and had administered instead of the bivalent booster as intended. It is impossible to know if patient received monovalent of bivalent.
p/recv vax pt felt tightness in chest, difficulty breathing; elevated heart rate; dizziness, light headed; nauseous; tingling; given o2 therapy; gradually recovered
This spontaneous report was received from a licensed practical nurse and refers to a 12 month 18 days old male patient. The patient had no known drug allergies. Upon general examination, it was found that the patient was pleasant and well developed, well nourished, alert and active. Patient had normal muscle tone and strength, normal sensations, no ataxia and no abnormal reflexes. The patient was born with some jaundice. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (incorrect product storage) of VARIVAX (Merck) 0.5, dose 1, lot number L008273, on the left vastus lateralis. Patient was concomitantly vaccinated with HAVRIX and M-M-R II. The patient's other medication included ZYRTEC. Outcome of incorrect product storage was not known. This is one of the several reports received from the same source. Additional information has been requested.
pt recvd vax 27FEB95 & 2MAR95 mom called & stated pt ran t105; 2MAR95 seen by family MD & was told was not due to shots was treated for influenza;
Initially March 28th light yard work sudden onset of lower back spasm/pain with quality different than ever experienced before.  Assumed this was the immune response body aches   Higher level event April, 15, med light work in house, sudden onset of medium intensity muscle spasm in right side of back that quickly spread across all of mid- to lower back,  this quality matches that experienced, on March 28th but much broader group of muscles involved.    It is now 2:05 in the afternoon of April. 16th.  I did not get out of bed until 1:15 pm and have been moving around very delicately.  Back muscles seem stuck in a contracted state. The tightness now extends up past my shoulder blades and includes the muscles of my shoulders along the back and top. I can?t seem to find a position that allows any release or comfort.   I am trying gentle movements and pandiculation to try and get the muscles to release.   Again, the quality of ache, discomfort, and pain, since getting  the vaccine is completely different than any tweaking or pulled muscles I have experienced before.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Patient fainted for 2 min after 5 mins (11:45 am received vaccine) from receiving vaccine call 911 responsive team came at 11:58am talk and treating patient and fainted again at 1200pm.-Severe, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: He is sent to the Hospital after the responsive team came.
Bumps Welts Hot to touch Red super painful for a day 5 inches in diameter
Information has been received from a registered nurse concerning a 44 year old female with seasonal allergies and no known allergies who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651404/0352F), intramuscularly. Concomitant therapy included ALLEGRA and NASOCORT. There was no illness at the time of vaccination. On 24-OCT-2006 the patient was seen by a physician complaining of swelling, redness and severe tenderness of left axillary area. The patient had a fever to 102. The physician prescribed OMNICEF and DILAUDID. The patient was re-examined on 25-OCT-2006 and on 26-OCT-2006. On 26-OCT-2006 the physician prescribed MEDROL dose pack and CLARINEX in addition to staying course of OMNICEF. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released. No further information is available.
Sedation, Myalgia, Fever, RespDepression, NauseaVomiting, Chest pressure, Chills/Rigor,  Narrative: Received 2nd dose 1/26/21. 14 hours after dose started to develop significant SOB and chest pressure -- felt like anxiety attack -- lasted 5 hours, unable to sleep. At 0300 1/27/21 had severe nausea until mid morning. Horrible myalgias, significant chils/rigor until 1300 on 1/27/21. Had 102 temp 0100 until 2000 on 1/27/21. At 2100 1/27/21 symptoms resolved, except profound fatigue lasted through 1/28/21. Missed work x 2days. No known prior COVID infection
Patient called after 2 days from receiving Tdap and Menactra both shots where given in left arm. Patient complained of redness, swelling, warmth, tenderness on arm as well as arm pit area underneath, prescription for KEFLEX given for precautionary measure.
Red rash at sight of injection - oval in shape.  No other information left on message to us.
The injection site is hot; I have left breast pain; stiff neck; The injection site is painful; My arm continues to swell at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The injection site is hot), BREAST PAIN (I have left breast pain), MUSCULOSKELETAL STIFFNESS (stiff neck), VACCINATION SITE SWELLING (My arm continues to swell at the injection site) and VACCINATION SITE PAIN (The injection site is painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0152M0A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE SWELLING (My arm continues to swell at the injection site). On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (The injection site is hot), BREAST PAIN (I have left breast pain), MUSCULOSKELETAL STIFFNESS (stiff neck) and VACCINATION SITE PAIN (The injection site is painful). At the time of the report, VACCINATION SITE WARMTH (The injection site is hot), BREAST PAIN (I have left breast pain), MUSCULOSKELETAL STIFFNESS (stiff neck), VACCINATION SITE SWELLING (My arm continues to swell at the injection site) and VACCINATION SITE PAIN (The injection site is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant list was provided. Treatment information does not provided.
Patient complained of fever, body aches and pain in arm. Patient was recommended to take ibuprofen as needed.
Nurse realized after she gave injection that there hadn't been resistance and questioned whether syringe was empty. She pulled up remaining vaccine from vial and found that although this patient's dose should have been dose #4, she still had 7 remaining vaccines in the vial. She gave a full dose of vaccine to patient, on the assumption that he remained unvaccinated. She then notified staff and the medical director at the site and explained to the patient what had happened. Dr. spoke with the patient and his wife. He was feeling well and had no symptoms after vaccination or during the observation period. I gave him my contact information with instructions to reach out if he had any questions or symptoms.
Extreme soreness at site. Bruise at site. Swelling at site. Headache. Body aches. Overall fatigue.
pt recvd vax; devel erythema, induration & tenderness; 2" in diam at inject site w/ edema of fingers of affected arm;
Pt was admitted on 3/19/21 with symptoms of dysarthria and was diagnosed as having a Transient Ischemic Attack. Platelets were down to 19,000 from a baseline of 10-150,000. He was diagnosed with Thrombotic Thrombocytopenic Purpura. This was the first ever episode of TTP for this patient. Patient was started on plasma exchanges, steroids and Rituximab and recovered well.
I instantly had a metallic taste in mouth that lasted a day and a half. The night of injection I noticed a quarter size hard lump in my arm, by morning it was the size of a baseball, red, hot to touch, painful to touch and to move arm. I got injection on 12/29/2021 and today 12/31/2021, I still have the baseball size hard lump.
Pt returned to clinic apx 5 minutes after imms given with swelling of eyelids and pink, blotchy, macular rash over forehead, cheeks, few on upper chest. No peri-oral edema. No respiratory distress or wheezing. Pt examined by M.D., placed on oximeter (sats 97% RA), given 8mg diphenhydramine. Observed x 40minutes w/ 90% resolution of erythema and edema, no resp sx at any time. d/c to home; follow-up call to mom this am = PT remains well, no recurrence of rash or swelling.
Discharge Provider: MD Primary Care Physician at Discharge: DO Admission Date: 2/18/2023  PRESENTING PROBLEM: Pancytopenia   HOSPITAL COURSE:   80 year old femal with past medical history significant for RA, CHB s/p dcPPM, CAD, AS s/p TAVR, HFpEF who presented with hypoxia and new O2 req. Recent admission for same found to have rib fractures and hemothorax. Presenting with b/l effusions L>R loculated, worsened from last admission. Also evidence of bronchial debris on left concerning for aspiration. Transferred here for further management and workup of pancytopenia, which has been present intermittently since 9/2021 (at that time, underwent BM Bx and comprehensive workup which was negative for heme malignancy / MDS, thought to be multifactorial ie CKD, chronic blood loss, chronic inflammation 2/2 RA).   This admission was found to have Streptococcus sanguinis bacteremia felt to be likely from aspiration pneumonia with loculated pleural effusions.  She was covered with IV antibiotics with IV Unasyn to complete a 7 day course as recommended by Infectious Disease.   Pulm eval for bilateral persistent effusions.  Recommended bilateral thoracentess.  IR consult for drain placement and she had left-sided pleural drain placed on 02/21 with right-sided thoracentesis.  Fluid studies consistent with exudative pleural effusion.  During admission she was also found to be COVID-19 positive; however, unclear if contributing to any her for current active medical issues.   In terms of her pancytopenia, Hematology was consulted who recommended bone marrow biopsy to workup which patient refused multiple times.  Etiology of pancytopenia was felt possibly secondary to methotrexate use with possible component of sepsis contributing.  Patient's blood pathology came back suggestive as well of immunosuppressive medication as well as sepsis for possible etiologies for pancytopenia.  Patient needed multiple transfusions of packed RBCs and platelets during admission.   Despite appropriate medical therapy patient declined.  Patient expressed that she did not wish to continue with any further invasive procedures if possible.  She did develop metabolic encephalopathy and DPOA was activated with her sons who were co-DPOAs.   Palliative care was consulted.  Goals of care was held with patient's family members and patient was transitioned to comfort care on 02/23.  Felt to be GIP appropriate and admitted to GIP hospice 2/23. Patient peacefully passed away 02/24/2023 08:32 PM   Please see attendings attestation for further information.    I was paged to patient?s bedside at 19:57 PM by remote physician due to concern that the patient had passed.  No spontaneous movements were present. There was no response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses were palpable. No heart sounds were auscultated over the entire precordium.  Patient pronounced deceased at 20:32 on 02/24/2023 Family at bedside were notified. They will make funeral arrangements at Funeral Home. Family was notified to contact funeral home. Attending to be notified in the morning.
EPILEPSY, UNSPECIFIED 6/14/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)  ACUTE RESPIRATORY FAILURE 7/29/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)  EPILEPSY, UNSPECIFIED 6/14/2022 ALTERED MENTAL STATUS, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 7/29/2022 ALTERED MENTAL STATUS, UNSPECIFIED  EPILEPSY, UNSPECIFIED 6/14/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)  ACUTE RESPIRATORY FAILURE 7/29/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)  EPILEPSY, UNSPECIFIED 6/14/2022 SEPTIC SHOCK  ACUTE RESPIRATORY FAILURE 7/29/2022 SEPTIC SHOCK  EPILEPSY, UNSPECIFIED 6/14/2022 LEFT HEART FAILURE  ACUTE RESPIRATORY FAILURE 7/29/2022 LEFT HEART FAILURE  EPILEPSY, UNSPECIFIED 6/14/2022 LEUKOCYTOSIS  ACUTE RESPIRATORY FAILURE 7/29/2022 LEUKOCYTOSIS
Weakness pallor after 3rd HPV hair loss after 1st HPV vaccine. Hair loss worsened after the 3rd vaccine of HPV.
Pt had varicella vaccine on 05/10/2005. Pt returned to our office 05/19/2005 with a rash on left arm. Had 4-5 drying vesicles on red 2 1/2 cm around base at site of varicella injection . Pt also had pharyngitis but no fever. Throat culture sent and pending.
blurry vision in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blurred vision in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 24th October 2020, 2 days after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was not recovered/not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional deatils were provided as follows: The reporter was patient wife. The age at vaccination was not reported. The patient was vaccinated with Shingrix on 22nd October 2020. On 24th October 2020 and 25th October 2020 patient had blurry vision in one eye. No further deatils were provided.