chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US004975, is an initial spontaneous report received from a nurse on 25 Feb 2016. This report refers to 36 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904 and expiry date: not reported) at a dose of 1 ml, intramuscularly on 23 Feb 2016. The reporter stated that, FLUVIRIN was administered after a temperature excursion of 1.4 degrees C (Celsius) for 1.5 hours. No adverse event was reported following this medication error.
12/20/2021 - Came to ED with SOB/fall. Bp 148/61, RR 22, HR 99, temp 101.1. WBC normal, D-dimer 260. Admit multilobular bilateral covid pneumonia/sepsis. Covid positive in ED. Chest xray shows bil infiltrates. Dexamethasone, Baricitinib, Ceftriaxone, Remdesivir, Lovenox, and 2-4L O2 as needed initiated.  12/22- Sp02 95% on 2LNC, RR 26. BiPAP placed briefly. treatments continued. 12/25 - D/c Ceftriaxone and Doxy. Transition Decadron to PO. Wean off O2. Remdesivir complete 12/26 - Now on RA - saturating in mid 90s. Feels more comfortable with 2L02 NC.  12/27 - Discharged to home with home care and supplemental O2 PRN for 30 days.
I had very large painful red welts on my left arm, fever of about 100.5-101, which I took Tylenol for, I was sick like when you have a bad cold for about 2 days, in bed sick. I had bad swollen lymph nodes, you could see them with your naked eye, in my left armpit. That swelling was very painful at first, but the pain subsided in about a week, but the significant swelling never went down. I read some stuff online that swelling of the lymph nodes is common with the vaccine, but it doesn?t go down in 12 weeks you should see a doctor. I went to the doctor for the swollen lymph nodes. They did not prescribe any medications. They just examined my lymph nodes. They did some blood work to see if this was just because of the vaccine, and they came back normal.
Redness, swelling, pain, itching at site of injection.  Instructed pt. to use warm compresses,  topical BENADRYL or Calamine lotion, ADVIL or TYLENOL for pain, elevation of arm.
Swelling and redness of upper left arm, may have been allergic or cellulitis.
3-10-04 phone call from mom has pink eye but developed fever 3-8-04 in the evening. Low grade 100-101 degree. No other symptoms voiced -
This spontaneous report was received from a register nurse, refers to a 33 year old female patient with iodine allergy and food allergy. The patient's medical history included skin disorder. The register nurse reported that on 24-FEB-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) intradermally in her forearm, lot # L035126, expiration date> 14-SEP-2017. Concomitant therapies included tramadol hydrochloride. The register nurse also stated that the same day immediately following the vaccination, the patient developed redness, irritation and tenderness at the injection site. The patient sought medical attention by an office visit and started treatment with an unspecified oral antihistamine, application of hydrocortisone 1% cream and cool packs to the area. Subsequently the patient recovered within 20 minutes. The patient was given a prescription for betamethasone cream to apply to the area as well. There were not laboratories diagnostics performed. The patient did not return to the office for follow up, but per the patient's husband all symptoms have completely resolved as of 04-MAR-2016. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/6/2022 Discharge Date: Oct 9, 2022  PRESENTING PROBLEM: Infarction of spleen [D73.5] Splenic infarct [D73.5] Splenic infarct in the setting of COVID infection Splenomegaly History of mild Von Willebrand syndrome Mild persistent asthma with mild exacerbation History of small lung nodule, remote history of smoking Abnormal left thigh lump HOSPITAL COURSE: Patient is a 74 y.o. female with past medical history significant for Von Willebrand syndrome, Lyme disease with chronic arthritis, former smoker, and mild intermittent ashtma on rescue inhaler who presented to emergency department with several months of cough, runny nose, "fevers", presented for abdominal pain and found to have splenic infarct and also COVID 19+. She has only had 1 J&J vaccine 11/2021.   Abdominal CT was done and showed a splenic infarct with splenomegaly.  Splenic infarct was thought to be 2/2 recent covid infection. She was seen by Hematology who felt in the absence of associated vessel thrombus, itself does not require anticoagulation. Data has shown no benefit with anticoagulation over aspirin for organ infarct. Given that she is already on ASA 81 mg daily long term, I recommended a short course of increased dose to 325 mg daily x 1 month, empirically in the setting of COVID+ and associated hypercoagulability with this. She conceded to two baby ASA tablets (= 162 mg) daily.  Echocardiogram was negative for cardio-embolic sources.   Hematology checked for other viral illnesses that can cause splenomegaly (EBV, CMV) and appropriate to screen for some hematologic conditions: 1) myeloproliferative condition with Jak2/MPN and BCR-ABL FISH. 2) PNH.  Most of these labs were pending at the time of discharge and will be followed up by Hematology who plan to see patient in their clinic outpatient.    Chest x-ray did not show evidence of lung infection. She has been on room air with O2 sat above 97%.  During the hospitalization, had a CT chest which showed Stable several a small 1-2 mm solid pulmonary nodule likely benign in etiology. New 3 mm groundglass nodule within the left upper lobe most likely due to infection and inflammation. Mild bronchial wall thickening due to infection or inflammation. No bronchiectasis. No focal airspace consolidation.  She was placed on a short course of prednisone due to her underlying asthma by Pulmonology.    A left UE soft tissue ultrasound shows an  Ill-defined focus of increased echogenicity within the subcutaneous fat of the anterior thigh correlates with the patient's palpable lump. Differential considerations would include a focus of fat inflammation versus a ill-defined hyperechoic mass. MRI LLE was recommended however,the patient opted to have it done outpatient with her PCP.   The patient was discharged in stable condition
Fever; Body aches; Red Rash; This is a spontaneous report from a contactable female consumer.   This consumer (patient) reported for herself by Pfizer Non HCP letter that: A 65-years-old female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot Number: EW0161), dose 2 intramuscular, administered in upper arm Left on 15Apr2021 11:15 (at a age of 65-year-old) as dose 2, single for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2; solution for injection; Batch/Lot Number: ER8733), dose 1 intramuscular, administered in upper right arm on 25Mar2021 11:15 (at a age of 65-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history and prior vaccinations was reported as none. On 16Apr2021 10:30, the patient experienced fever, body aches, red rash. Patient was not received treatment for the events. On an unspecified date in 2021, the events were recovered.  No follow-up attempts are needed. No further information is expected.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Concomitant medication was not provided.  Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose.  Treatment information was not provided.  This case contains information for the 5th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received SHINGRIX (intravenous). On 1st July 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route, vaccine administered at inappropriate site and injection site hemorrhage. In July 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route, vaccine administered at inappropriate site, injection site hemorrhage and injection site erythema were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient received SHINGRIX injection in the left arm below the deltoid. The patient noted that the pharmacist hit a vein, and there was blood running down the arm, which led to intramuscular formulation administered by other route. There was redness at the injection site. The patient showed her arm to her doctor, and reports that she did not get her injection in the deltoid, which led to vaccine administered at inappropriate site.
Day following immunization, coughing to point of choking (spasm), stomach hurt, urination, fatigue, runny nose, red eyes. Felt poorly and missed work 11/30, and went to ER 12/1 and missed work..At work 12/4/2017.29.
Axillary neuropathy x4 mo - physical therapy. Polymyalgia rheumatica, ongoing. Tx: Prednisone.
Bilateral optic disc edema R>L with vision loss in the right eye Intraretinal fluid on the right side Bilateral optic nerve enhancement on MRI Lymphocytic pleocytosis in cerebrospinal fluid Treated with IV methylprednisolone and acetozolamide
back pain on 02/13, body aches which intensified at work. symptoms persisted over night with addition of chills/shaking and missed work on 02/14
Patient had flu-like symptoms with a low-grade fever. Patient also had mild swelling to injection site.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 01-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
pt recvd vax 223NOV92 & exp upper resp sx for several days; 3DEC92 had a sudden onset of fever & exp a 2 minute generalized sz @ home; eyes rolled back & legs were jerky; taken to ER dx w/ear infect;
Pt reports that with the second covid19 vaccine dose pt had severe covid symptoms as well as difficulty walking, very dizzy, this lasted 2 days and then fully resolved. Pt reported this at appointment in clinic around 6 months after the second covid19 vaccine dose in order to request exemption from getting covid19 vaccine booster dose at this time due to severe symptoms after the second covid19 vaccine.
Nurse note 10/25/13 - 62 y/o male came as walk-in c/o cold like symptoms x6 days since Saturday; sore throat, body ache, headache, nasal congestion, sinus pressure, chest congestion, productive cough, coughing up light brown thick mucus, per patient. he received a flu sot on 10/19/13 and since then felt sick and Sunday he started to have all these symptoms that he mentioned. MD note on 10/25/13 - I recommended he go to the emergency room for some fluid and hydration for a likely flu related reaction to the flu immunization, but he was not interested. Nothing he does not want to go to the emergency room for hydration, I said he can home and he can take Tylenol and Motrin for the discomfort. However, if he gets a high fever, vomiting, diarrhea, or unable to hold down fluids, he will have to come here for hydration and for therapy. I also documented that the influenza shot is not a good medication for him.
/Win seconds following immun pt collapsed & exhibited tensing of all muscles which lasted 1-2 min. No convulsion occurred. The pt was in exhausted state @ time of immun.
lymph nodes swollen; body keeps heating up on the inside; felt like she was going through menopause; face and neck broke out and looked like a burn; face and neck broke out and looked like a burn; This is spontaneous report received from Pfizer Sponsored Program. A contactable consumer (patient) reported herself. A female patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route for Covid-19 immunization. Medical history included latex allergy. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. Patient received both doses of the vaccine. Patient almost body keeps heating up on the inside, felt like she was going through menopause, lymph nodes swollen, face and neck broke out and looked like a burn on an unknown date. Lab data included body temperature  was high on an unknown date. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.            No concomitant medications were reported. The reporter's causality for the event of Headaches with co-suspect humira was not provided. No treatment medications were reported.
Swelling tenderness redness at injection site. Occasional itching one week later. Still red one week later.
experience high blood pressure; fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose), administration date: 20Feb2021, for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious) with onset Mar2021, outcome "unknown", described as "experience high blood pressure"; BLOOD PRESSURE FLUCTUATION (non-serious) with onset Mar2021, outcome "unknown", described as "fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension, blood pressure fluctuation.  Additional information: The patient had no family history of high blood pressure. Clinical course: After receiving her 2nd dose, patient began to experience high blood pressure; after speaking with her physician, she was placed on a 2nd medication for the treatment of her high blood pressure. Reported since being placed on the 2nd medication her mother experiences fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331379 Same reporter, suspect drug and events; different patient
22 days after injection, my right arm muscle started to hurt seriously. Any movement caused pain. On the second day, the pain comes only when I flex that muscle.  There is no pain in my other my arm.
within 5 minutes of receiving the vaccine patient lost all color  claimed he wasn't feeling well  nearly fainted
NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEELING IN MY HEAD, EXTREAMLY WEAK, THE 1ST DAY NOT SO BAD BUT DAY2-6 MUCH WORSE DAYS 7 &8 GETTING BETTER DAY 9 BACK TO NORMAL SELF.
Fever - low grade (8/11/16 - today), myalgia, dizziness, fatigue. Took CLARITIN to stop redness, ALEVE for pain.
Information has been received form a RN concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently, the patient experienced a vesicular rash. Medical attention was sought. The patient was restricted from work for one week. The patient received a second dose with no side effects noted. No further information is available.
anaphylactic shock secondary typhoid vax; hypotensive, tachycardic, cool, clammy skin;
more severe side effects with the second dose of Shigrix compared to the first; This case was reported by a consumer and described the occurrence of adverse event 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, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experience more severe side effects. For tolerances of 2nd dose, refer case US2020AMR099926, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR099926:same reporter
Immediately after vaccination I was sick. I had body aches, feeling hot and cold, no energy and in pain. My head was feeling heavy, just feeling really weak and tired and achy. Day 2 was a little better and by the 4th or 5th day I could start to move around and feel better. After that life was normal, a few headaches. Gradually I have felt worse and worse. I have every symptom of a staph infection, an ongoing temperature. There is white bumps, pain. I saw a doctor and was diagnosed with attention deficit disorder (ADD). My concentration is horrible and even with the add medication. My blood pressure is high now. There is nothing that my doctor can not pin point what is wrong. I had a normal checkup last year.
Information has been received from a pharmacist concerning an 84 year old female who on 22-JAN-2008 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 658603/1081U). Concomitant therapy included PLAVIX. On 22-JAN-2008 the patient experienced bruising at the injection site that became progressively worse over the days following vaccination. The patient sought medical attention via speaking to the pharmacist. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Additional information is not expected.
2nd dose received before 2 months; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's comment: The registered nurse reported that the patient received second dose of Shingrix greater than 28 days after first dose but less than two months after the first dose of Shingrix. As per reporter patient was immunocompetent and it indicated age range for Shingrix administration. At the time of reporting, the reporter did not have any additional details about adverse event (that was patient demographics, dates of Shingrix administration, lot and expiration dates of Shingrix vaccines) The reporter did not consent to follow up. Additional supportive information: The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient with no medical history or allergies who on 16-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). There was no concomitant therapy. The LPN reported that on 16-OCT-2006, the patient vomited in the office after rotavirus reassortant vaccine live (human-bovine) was administered. The LPN indicated that the vaccine was vomited as well as the contents of the patient's stomach. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. The LPN noted that there have been on residual effects since the vomiting. Additional information has been requested.