chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the 6 month mark for second dose was back in March 2020 / due to COVID.; made her sick for 2 days; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced sickness and social problem. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The reporter inquired about guidance on second dose of Shingrix. Patient  received the first dose of Shingrix in September 2019 and the 6 month mark for second dose was back in March 2020.  Walgreens initially told patient she had a year for second dose due to COVID and another pharmacy said it was 6 months. She called in to get clarity.  She mentioned the Shingrix first dose made her sick for 2 days and she had the flu shot at the same time and she never gets sick from her flu shot. The patient stated that she planned to receive her 2nd dose of Shingrix in a couple of days but she did not specified the date. She also stated that she heard from the pharmacy that it was not a problem when the 2nd dose was applied, but she did not rely on the pharmacy, so she will be reaching her main doctor to clarify. The reporter consented to follow up. The case US2020115710 was found to duplicate of case US2020AMR116179. The case US2020115710 would be deleted and all the future corresponding information will be added in the present case  (US2020AMR116179) which stands as case of record for this subject.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115710:same paient
Mother called clinic and reported that on 7/30/15 when she got home from work, that patient's arm was warm, swollen, red and painful to touch. Provider prescribed cephalexin 500 mg twice a day for 10 days. Instructed mother to place cold compress on site.
Patient's husband reported soreness at injection site that started the evening of the vaccine then starting 12/8/2019 tingling in the hand and pain in the forearm started.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with her first dose of GARDASIL (Lot # and route not reported). On an unspecified date, the patient developed diarrhea. The diarrhea resolved in one week without requiring treatment, and the patient fully recovered. The patient sought unspecified medical attention by contacting the physician by phone. No further information is available. Additional information is not expected.
COVID-19 infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 infection) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication, treatment details were not reported.
Pt with a history of varicella exposure, who on 12/8/97, received one dose of varicella virus vaccine live and on 3/20/00, experienced a generalized varicella rash with "quite a few" lesions on face and upper chest, accompanied by a fever of 102. The pt sought medical attention at the physician's office on 3/21/00, at which time she was afebrile. Additional information has been requested.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: after pfizer vaccine administration,patient started to feel dizzy, nausea, confusion. She was unresponsive for few seconds,but started to respond after smelling alcohol. She vomited as well.We called 911 right away, rescue came and assisted her, she was transferred to urgent care and was there for 2 hours.She was dehydrated, but bloodwork and electro was ok, nausea med given. Patient had hx of fainting. Patient currently at home,healthy and feeling well.
Information has been received from a physician concerning a female patient with yeast allergy who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot# unknown). The physician reported that the patient experienced itching after receiving GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had recovered from itching (date unknown). Therapy with GARDASIL was discontinued. Follow up information has been received from a physician concerning a 22 year old female patient with yeast allergy who on 23-MAR-2010 was vaccinated with a first dose of GARDASIL (Lot # 662765/0821Y, expiry date 25-JUN-2011), IM in the left deltoid. On 24-MAR-2010 at 2:00 am the patient experienced rash (red itchy), shortness of breath, lightheadedness, dizziness, and itchy/burning eyes. The physician stated that on 30-MAR-2010 the patient recovered. The patient sought medical attention. The reporting physician considered rash (red itchy), shortness of breath, lightheadedness, dizziness, and itchy/burning eyes to be other important medical events. Additional information is not expected.
I?ve been having chronic fatigue almost every other day since I got the vaccine.  Some days I have mild headaches and shortness of breathe.
NAUSEA,   MUSCLE ACHE (BOTH STARTED APPROXIMATELY 30 HOURS AFTER SHOT GIVEN)
Provider d/c note: "63-year-old female past medical history of poorly controlled hypertension and medical noncompliance.  She presented on 12/20 for chief complaint of altered mental status.  On presentation patient was noted to be hypertensive systolics in the 240s creatinine 2.8 hypokalemic, complete blood count notable for leukocytosis.  CT was performed showing nonspecific low attenuation in both cerebral hemispheres.  Patient was admitted for workup of strokes and altered mental status.  See initially admitted to the intensive care unit requiring IV blood pressure medications transferred to progressive care unit once titrated off of IV medications.  Patient continued to be noncompliant with oral medications throughout her stay requiring IV supplementation to her blood pressure regimen.  Patient was tested positive for COVID-19, family declined remdesivir and she was not requiring oxygen.  Initial repeat CT was concerning for acute CVA right caudate head lacunar infarct, question microhemorrhage.  Initial MRI was a poor study secondary to patient agitation.  Repeat studies were obtained with IV medications for anxiety/sedation.  MRI showed small attenuated acute infarcts right caudate nucleus right lateral ventricle, left temporal lobe.  Patient was started on dual antiplatelets and seen by Neurology.  MRI was obtained without large vessel occlusion or stenosis.  Patient required prolonged stay secondary to encephalopathy edema secondary to new CVAs, COVID, metabolic encephalopathy.  Renal function improved following IV fluids.  Blood pressure regimen was titrated up former she no longer required IV medications.  She was seen by PT and OT with recommendations for rehab.  Family declined wanting to take patient home.  Patient will be discharged on 21 day therapy dual antiplatelets followed by aspirin monotherapy.  Discharge was delayed secondary to holiday difficulty with coordination of home care.  Family choosing to pursue home care from primary outpatient.  Patient had dysphagia which improved prior to discharge patient was able to eat normal diet."
Pain, swelling, redness to site of vaccine continues 2 1/2 weeks after administration.
I21.4 ACUTE NON ST ELEVATION MI 7/5/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/5/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/5/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about  06-OCT-2009 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician assistant at the emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient sought subsequent treatment from the physician for complications and ocular interference of her herpes zoster infections that spread to the eye. The patient was prescribed Acyclovir, Clindamycin and hydrocodone-acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
DTaP was ordered, but patient received PEDIARIX. Patient received 2 doses of IPV in the same day. No symptoms have been reported.
probable SIDS, died 11FEB98 approx 38hr p/vax;pt cried for a short time;APAP given & went to sleep;opistohonic w/resp distress;
Vaccine administered to pregnant patient; Altered sense of taste- everything tastes burnt; everything smells burnt,dog food smells sour; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Altered sense of taste- everything tastes burnt), PAROSMIA (everything smells burnt,dog food smells sour) and EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (rapid test positive) on 19-Feb-2021. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 10-Jan-2016 to an unknown date for Anxiety, ESZOPICLONE (LUNESTA) from 12-Mar-2013 to an unknown date for Insomnia, VITAMIN D NOS from 15-Jan-2021 to an unknown date for Vitamin D deficiency.   On 16-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-May-2021, the patient experienced TASTE DISORDER (Altered sense of taste- everything tastes burnt) and PAROSMIA (everything smells burnt,dog food smells sour). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). At the time of the report, TASTE DISORDER (Altered sense of taste- everything tastes burnt) and PAROSMIA (everything smells burnt,dog food smells sour) had not resolved and EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient called her primary care provider for clinical advice, however she was told that no treatments could be administered for altered sense of taste or smell.  No treatment was reported for the events.    Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: initial additional. On 08-Jul-2021: contains no new information. On 08-Jul-2021: NNI received.
Headache x 3 days, Moderate pain worsened in right deltoid/large bump in deltoid muscle x 3 days, Fatigue, body aches, and low-grade temperature x 3 days.
HPV #1 3-27-10 and HPV #2 6-15-10. 7-28-10 pharyngitis, lymphadenitis; fatigue, headaches; 8-22-10 to today -> seizure. Headaches -> hospitalized x 3 , 3 other ER visits.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: anxiety attack
Developed a light rash on face, lower arms, and upper back starting about three days after vaccination.  The rash is nearly gone after three days (today).   The only other symptom was mild soreness at the injection site the day after the shot.
MA  made the mistake of grabbing the adult dose hep a from private due to the state hep a being gone.  MA did document the borrowed vaccines from private, but was not aware we had a adult and pediatric dose of private hep A.  Pt has not called clinic or reported to clinic with any symptoms of any sort.
Pt presents to pharmacy on 3/7/12 late afternoon for ZOSTAVAX; seen by provider 3/9/12 morning for shingles or shingles like sx.
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB that were exposed to a fridge excursion on 21-JUL-2017 (lot # M001578 expiration date 21-NOV-2018, lot # K012875 expiration date 27-AUG-2016, lot # L048209 expiration date 31-MAY-2018, lot # 042826 expiration date 15-SEP-2017, lot # L010595 expiration date 12-NOV-2016, lot # L027733 expiration date 13-SEP-2017, lot # L040458 expiration date 04-FEB-2016). Lot # 042826 is an invalid lot number for hepatitis B vaccine (recombinant). This is one of the several reports received from the same reporter. Additional information has been requested.
In the morning I was SOB. A couple weeks ago I was just getting off Gabapentin. 10 days after I got off of that, I had the SOB and I thought I had anxiety. I was watching my HR and I knew that there was something going on. Later in the day, I had another appointment and I called and told them I was SOB and when I got there, they sent me to the ER. There they tested me and saw that my d-dimer was high and they did the CT and found the pulmonary embolism. So they looked to see where to send me for a hospital because the ER was full. And I was sent to Hospital. There I was given oxygen, Heparin, also told me I had a type 2 MI as well. Also did an echocardiogram. The diagnosis from the ER was multiple sub segmental pulmonary emboli without acute core pulmonal. When I was at the hospital, they did a venous ultrasound on my leg and that's where I had the DVT left lower extremity. Put me XARELTO, I followed up with my doctor on 10/06, went back to work 10/11. Last week, my leg was hurting again and went and had an ultrasound and the clot is still there in my left leg. Continuing to take the XARELTO 20 mg and following up within the next month. I was admitted to the hospital on 9/28, discharged 9/30/2021. August 2021 - had a physical and nothing was found at that time, prior to health event.
Anaphylactic reaction to COVID-19 booster (2nd shot)  Refractive Asthma brought on due to anaphylaxis
patient received on November 4th 2022 the liquid portion only of Shingrix without the lyophilized portion; patient received on November 4th 2022 the liquid portion only of Shingrix without the lyophilized portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number kk3jm, expiry date 25th September 2023) for prophylaxis.   On 4th November 2022, the patient received Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The license practical nurse reported that the patient received the liquid portion only of Shingrix without the lyophilized portion. The reporter did not consent to follow-up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received the liquid portion only of Shingrix without the lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a health professional concerning a 72 year old 159 lb. 67 1/2 in. female with a history of allergies to Relafen who "10 days ago" (17-OCT-2007), was vaccinated with a single dose in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot#/ 658287/1173U), but was supposed to have been given zoster vaccine live (Oka/Merck). Concomitant vaccination included a dose in the left deltoid of Fluzone (lot# U2441AA). There was no reported illness at the time of vaccination or adverse events following prior vaccination. It was indicated that the patient did not develop any adverse experience as a result of the vaccination. There were no relevant diagnostic tests or laboratory data. Medical attention sought and current patient status was not reported. A quality complaint was not reported. Additional information is not expected.
Expired Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received included patient demographics, vaccine information
Initial report was received 03 December 2008 from a health care professional. A 22-month old female patient with no past medical history, had received FLUZONE No Preservative 2008-2009 (route and site not reported), lot number UT2794GA on 02 December 2008 and 30 minutes later, she began vomiting which worsened to where the patient was vomiting bile and a coffee ground substance. The child was taken to the emergency room and admitted overnight. Laboratory test results included elevated WBC and BUN levels. The patient was discharged on 03 December 2008. The patient had no concurrent illness at the time of vaccination. The patient had not been taking any concomitant medications and had not received any other vaccines during the four weeks prior to receipt of FLUZONE. At the time of the report, the patient was not recovered from the event. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03866 which involved the patient's twin sibling. Documents held by sender: None.
Some day local reaction was arm sore red warm and big 5PM had softball sized swelling are of injection with some nausea and felt feverish that day. Felt fine next day except re jot soreness and edema con't X 2-3 wks (in L arm)
Site is now hard; This spontaneous report was received from the patient's couple via Agency, regarding a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 24-NOV-2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and the same date the vaccination site was hard (vaccination site induration).  At the reporting date, the event was not resolved and the reporter assessed the causal relationship between the event and vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) as related.
Suspected sacroiliac joint inflammation - buttock pain, TTP along SIJ b/l, associated AM stiffness, persistent x 2 weeks. Overall improvement. Treating w/ meloxicam
Under Arm / Armpit (Lymph Node swelling), Aches, Fever of 101.3. Self monitoring,
I did not have an adverse reaction to the vaccine but I tested positive for COVID-19 06/28/2022. I started feeling systems on 06/26/2022. I felt achy all over, headache and I was coughing. I took ZYRTEC and TYLENOL for my symptoms prior to testing positive. I had a telehealth visit with my doctor and they prescribed PAXLOVID.
2 days post vaccine, red, painful induration 6in x 6.5in. Impression: cellulitis. Treatment: Keflex 250mg/5cc, 2 tsp BID x10days.
minor throat swelling; This case was reported by a consumer via call center representative and described the occurrence of throat swelling in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on end of September 2020, refer link case US2021014406).   On 4th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced throat swelling. The patient was treated with ibuprofen (Advil). On 5th December 2020, the outcome of the throat swelling was recovered/resolved.   It was unknown if the reporter considered the throat swelling to be related to Shingrix.  Additional details were provided as follow: Caller was the patient and reported a reaction when taking 2nd dose of the Shingrix vaccine.  The patient received 2nd dose of Shingrix vaccine on 4th December 2020 in the morning and reported a minor throat swelling during the night after she received her 2nd Shingrix vaccine.  The reporter asked was this a side effect of Shingrix and took an Advil tablet for the swelling.  The swelling was completely resolved in an hour after taking the Advil tablet. The reporter did not consent to follow-up. The reporter does not give permission to contact HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014406:same reporter