chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and healthcare worker (medical assistant) refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 28-OCT-2015 to 13.17 F and 11-SEP-2015 to 13.13 F, time frame: worst case 10 minutes each occasion, cumulative excursion: 13.17 for 40 minutes) doses of VARIVAX (Merck) with lot/batch # L05299, expiry date 17-FEB-2017 and lot/batch # L011084, expiry date 01-APR-2017 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. It was also reported that, on unspecified dates, additional doses of improperly stored (temperature excursion: 5.71F, time frame: 20 minutes) VARIVAX (Merck) with lot/batch # L011084, expiry date 01-APR-2017 (dose, dose number, vaccination site and route of administration not provided) were administered to the patients. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient received Shingrix on an unknown arm. The pharmacist stated that the patient had a very sore arm and was inquiring if an alternate sight (thigh) could be used instead. The caller stated that the patient received the vaccine at another pharmacy and therefore did not had additional information regarding the event.
Patient presented complaining of worsening shortness of breath onset 50 minutes ago after receiving first COVID vaccination.  Sx started as a "pin pricks" in her throat and move down her neck and have continued to worsen. Also c/o nausea, coughing. She received PO Benadryl at vaccination site. Brought to ED and found to be tachycardiac, tachypneic, O2 saturation at 100% on room air with no stridor or wheezing. Pt actively coughing on exam leading to mild respiratory distress, severe anxiety. In ED, given Epinephrine IM, inhaled racemic epi, benadryl 25 mg, Zofran, Decadron, Pepcid. Sx improved over 30-45 minutes, observed for 6 hours with no recurrence.
I experience like my left ear was full and all of a sudden, I couldn't hear out of my ear for a few second and then it stops. My ears also stay cold now. A then my neck was very sore like I had been working out, but I don't work out. I thought maybe if I go to sleep it will get better after that, but it didn't. It has taken 3 months for it to stop hurting. I tried massaging and ring in my ear. So, I went to my doctor, and he stated that it is Tinnitus. He said the doctor said it's from getting older. He then referred me to a ENT doctor. The ENT doctor did a hearing test, and it was normal. Dr. also did an X-ray on my neck and said that I was having neck Spasms and he gave me some Non steroids meds Meloxicam 15 mg and Cyclobenzaprine 10 mgs. I took them for a week and the meds didn't help so Dr. said to stop them. I am now having some new symptoms, on a certain day I started having really bad pressure headaches. I never had a head before. I am a healthy man. Since having the vaccine, I have started experiencing all of these things. With the headaches, both of my eyes hurt in the back of my eyes. It is feeling like something is poking both eyes, along with the headaches. With the headaches being so bad, it makes me really tried and I have to go to bed. When am having those headaches my face feels numb. I have a lump in my ear and on my chin. When I touch it, it hurts. I notice the lump in July 2021 and then went I got the lump under my chin that's when I went to see my doctor about it in August 2021.  He stated that it's just to me getting older. My doctor did a physical in touching the lumps and he stated that it didn't look cancerous.
Within the week of getting the shot, my skin became extremely dry and my skin would crack. Exactly 2 weeks after getting the dot i got Shingles
Approximately 10-15 minutes post vax, the pt complained of dry and raspy throat and a feeling of uneasiness. The injection site was sore. Pt was treated with epinephrine and within 4 minutes the throat was improving and the pt was feeling better. Allegra was given 20 minutes after the epinephrine. Symptoms have resolved.
pt recv vax 15MAR94 & w/in 12 hr of vax pt exp soreness & redness @ the inj site; later devel warmth, pain, swelling & a nodule @ inj site; pain radiated up the arm;
Patient presents with:Covid Like Symptoms: tested positive on 12/29 was given hydrochloroquin. increase in cough, sob, tachypnea.COVID 19 Pneumonia, acute resp failure with hypoxia,cefepime and azithromycin,IV steroids, zinc, vitamin-C/D.Remdesivir and baricitinib. Supplemental Oxygen.
Patient received a Bivalent for patient's 2nd dose of the monovalent series. Patient had monovalent charted, and the sticker was on the card. Parent has been notified and patient is coming in for the correct dose.
Initial follow-up information has been received from a registered nurse concerning a 84 year old female with allergy to ampicillin and medical history of chicken pox, who on 18-SEP-2008 (previously reported as 29-SEP-2008) was vaccinated with the first dose of ZOSTER, Lot #658397/1820U, 0.625 ml, subcutaneously into the left arm. Concomitant therapy included ADALAT, CELEXA and lorazepam. It was reported that on 18-SEP-2008 (previously reported as 02-OCT-2008) the patient experienced herpes zoster rash that was "very painful" with dermatome (L1) after getting ZOSTER. Patient got pain and antiviral medications. In follow-up information from the questionnaire it was reported that the patient on 18-SEP-2008 also experienced nausea,diarrhea,vomiting and abdominal discomfort. It was reported that the patient's maximum temperature "did not feel it". At the time of the report the patient had recovered. Additional information is expected.
Headache for 25 minutes. Given Tylenol 500mg and felt better. Vital signs stable before, during and after headache. No rash, no difficulty breathing.
Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
pt recvd vax; broke put in approx 12 chicken pox lesions;
Red rash and swelling at site of injection, fatigue, loss of appetite, headaches and sinus congestion w/ clear discharge.
Patient is a 98 y.o. male patient of MD with history of HTN, CAD, COPD presented on 8/23/2023 with generalized weakness and fall, found to have COVID-19 infection. consulted by Hospitalists, Generic for continuation of care out of ICU.   Acute hypoxic respiratory failure Bilateral pleural effusions COVID-19 Sepsis Secondary to COVID-19 infection versus superimposed bacterial pneumonia Patient presented to the ED hypoxic and tachycardic He said there were 2 sick contacts in his home that were positive for COVID Chest CT 8/23 with evidence of bilateral pleural effusions Chest x-ray 8/23 showed volume overload with interstitial prominence and small bilateral pleural effusions IV fluid IV fluid resuscitation initiated as well as steroids given in the ED Urine antigens negative Ferritin/Pro-Cal ratio 9,560, likely COVID pneumonia rather than bacterial.   Decadron started on 8/23, given course while inpatient Remdesivir started on 8/25, completed 5-day course Currently remains stable on room air Case management consulted for disposition arrangements in anticipation of discharge 8/29 Currently medically stable for discharge   Pancytopenia, resolved Anemia of chronic illness Secondary to infection vs chronic pancytopenia vs lab error vs malignancy CBC on admission: WBCs 3.97, RBCs 2.17, hemoglobin 6.3, hematocrit 20.5, platelets 109 S/p 2 units PRBC.   Iron study showed low Fe (16), high ferritin (1434), and low TIBC (178), not conclusive, but possibly due to both iron deficiency and chronic illness.   Monitor CBC.  Hb stable at 10.3   Hyponatremia Patient presented with generalized weakness Sodium on admission 121, likely global cord deficiency versus SIADH versus reset Osmostat Has had a history of hyponatremia Urine osmolality elevated at 575, urine sodium 140 FENa 1.5% Rehydration with normal saline and P.O., goal sodium correction rate of 6 in 24 hours, goal sodium is 127 by 10:00 am 8/24 Legionella urine antigen negative Sodium currently 131   Intrathoracic stomach Hiatal hernia.   Patient has a history of reflux and is on omeprazole CTA 8/23 noted an intrathoracic stomach Continue PPI.
Twenty six hours after getting the shot I had mild tinnitus in both ears and a mildly sore area. 1/16 I had tinnitus. 1/17 tinnitus on and off and left facial tingling 1/18 tinnitus and tingling and pressure in left side of face and head; 1/19 right foot tingling and left side of head pressure and tingling; 1/20; 1/21 same except no foot tingling; 1/22 same; 1/23 same but no tinnitus; 1/24 same but milder tingling in head and face. Of note is that I had these ?symptoms? 20 years ago when I had Lyme Disease and they lasted for about 3 years.
This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored MMR II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored MMR II lot #J003785 and expiration date: 28-MAR-2015. She stated that the dates of administration of MMR II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
His neuropathy is gone now after Covid vaccine; This is a spontaneous report from a Pfizer-sponsored program, Support via a contactable consumer (reporting for himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included neuropathy and type 2 diabetic. The patient's concomitant medications were not reported. On an unspecified date, the patient stated that his neuropathy is gone now after COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse refers to a 9 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
9 days after vaccine got warm itchy rash at injection site. Had initial redness, pain swelling at injection site the day after vaccine also but that went away after a couple of days then the second rash showed up later.
On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.
vomiting; muscle pain; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) 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 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache). On 06-Jun-2021, VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's husband had a terrible case of shingles, still had pain 21 months later). Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot with no side effects except a sore arm. For tolerance of second dose refer case, US2021AMR226595, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226595:Same reporter US-GLAXOSMITHKLINE-US2021AMR226600:Same reporter
it's warm at injection site; site of injection, warm; rash at injection site extending 4-5 inches; red mark like rash that may have cropped up at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 1 dosage form and CORTISONE ACETATE (CORTISON) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site) had resolved. the patient had appointment with nephrologist who diagnosed the events as looked like allergic reaction.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used ice packs as a treatment.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: significant follow up : event outcome updated for all events
40 min. injection - 200/100 - blood pressure - and was sent to ER to get follow up and was there for 90 min, until it was 156/99. And they released me. 10  days of very high blood pressure and headaches. Just started coming down (Blood Pressure) the day before yesterday. 98/72 now. Primary Care doctor - Telemed appt-  had advised me to wait it out a little and now it's down. Feel better now. DIdn't take anything to treat it. Just rested.  Only worked 1/2 of day of  work- and not a full 8 hr shift on my scheduled shifts. But going back now full time. Blood type RH Negative.
immediately p/vax pt fainted became very diaphoretic; was responsive @ times; had repeated fainting; BP was 78/40; taken to ER;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # K008822, expiry date 19-JUN-2016; lot # L017142, expiry date 13-MAY-2017; lot # L013827, expiry date 21-APR-2017; exact dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache  Vomiting  Fever  Chills  Aches  Fatigue
Red pigment to L hand below wrist. pt denied any itching, swelling, discomfort.
One week after the vaccination, sudden onset of severe itching at the site, with a raised red bump at site of needle puncture.  The itching is severe, bad enough to prevent sleep, and there is redness around the injection site followed by burning pain.  It has been a day since the itching started, and it has not let up.
At approximately 1035, approximately 15 minutes after receiving first Pfizer COVID-19 vaccine, patient was walking out to leave and this RN overheard her state nausea and feeling hot.  This RN intercepted patient in the hallway and advised that she come sit down.  Patient diaphoretic and not completely coherent.  She responded appropriately to questions and instruction, but was slow to respond and gait slow.  Patient denied feeling dizziness and like she would fall at the time.  Patient escorted to recliner, feet elevated, head reclined.  Patient evaluated by this RN and NP.  Vitals at 1040  96.1 degrees F (temporal artery) 110/60, manual right Heart rate 84 bpm, regular 99%, room air Respirations 20/minute  LS clear and equal throughout. No respiratory distress.  Patient denied throat tightness/swelling.  No rash or itching present.  Patient denies history of reactions to vaccines or medications.  Allergies in electronic medical record reviewed with patient as accurate (dust, hay, nickel).  Patient denies history of diabetes or issues with blood sugar or medications that effect blood sugar.  Patient reported that she ate blueberries and _____ today.    She was provided graham crackers, water, and apple juice.  Patient improved quickly.  Diaphoresis and feeling hot resolved.  Nausea resolved.  At this time, patient reported that she had felt nausea within a few minutes after receiving the vaccine.  That escalated to diaphoresis and feeling warm with dizziness approximately 10-15 minutes later.    At 1100, symptoms resolved.  Vitals: 98.1 degrees F (temporal artery) 116/88, manual right Heart rate 88 bpm, regular 100%, room air Respirations 24/minute  LS clear and equal throughout. No respiratory distress.  Patient denied throat tightness/swelling.  No rash or itching present.  Patient stated that she feels much better and feels safe to leave.  Symptoms of delayed allergic reaction and when to seek medical care discussed.   Encouraged patient to eat and hydrate well prior to second COVID vaccine and to inform vaccinator of today's event.  Recommended that she stay for monitoring longer (at least 30 minutes).    Patient verbalized understanding.  All questions answered at this time.  Patient evaluated and examined by this RN and NP who agrees patient safe to discharge home at this time.  At 1105, patient discharged home.
Within 15-16 hours, soreness at the injection site as well as fever, chills, and myalgia.
Severe vertigo; blurred vision: dizzy - movement restricted: nausea without vomiting: digestive upset: exhaustion; sweating; chills; malaise
I got the vaccine approx 10:10am yesterday. About 4 hours post-vaccine, I developed severe pain in my left arm which limited flexion and adduction. I started to become nauseous, but initially thought this was due to pain. Once I returned home from work, at approximately 5 PM, I started to develop chills and a worsening headache. After taking acetaminophen, I took my temperature and found it was 101.5. This remained all night, and I had a difficult time sleeping, waking with chills, sweats and Aching in my joints. Today, I took off from work and slept all day, waking occasionally with the sweats. My fever began to go down slowly and is now approx 99.7 with use of fever reducers every 6 hours. Headache is still present. I anticipate these will dissipate in another day or two.
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 20-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022).    No concomitant medication information was reported.  Vial size was of 2.5 mL and there were a total of 2 vials.  The vial did not undergo any temperature excursions.  No adverse events were reported.  No treatment information was reported.