chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, PEMPHIGOID (Bullous pemphigoid) outcome was unknown and EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        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.   No concomitant medications were  provided by the reporter. No treatment information was provided.  Company Comment  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected
Severe fever over 101F, inability to move with severe pain throughout entire body, Kidney swelling and severe constipation. Sleepiness and intense vivid night terrors. Blood in urine and stool.
Blood oxygen level dropped rapidly to 86 about 30min after shot. Caused a feeling of hypoxia and slurred speech.
HEADACHE; INJECTION SITE PAIN; PAIN IN RIGHT ARM; ANXIETY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, diabetes, glaucoma, neuropathy, high blood pressure, depression, anxiety, venous insufficiency of both lower extremities, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with amlodipine, and lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 10-APR-2021, the subject experienced pain in right arm. On 10-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pain in right arm, and injection site pain, and the outcome of anxiety was not reported. This report was non-serious.
Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's comments: The reporter asked if the patient had to be revaccinated.  The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Patient up to date on COVID vaccinations who admitted to hospital with COVID positive test (no respiratory issues during stay) for sepsis from UTI and active metastatic cancer.  Provider discharge note below:  "Significant Findings and Invasive Procedures) the patient presented with fever, tachycardia and leukocytosis found to be septic from complicated UTI. Mild hydro on imaging and she has ureteral stent. She also had AKI. aki improved as did fever/wbc. Urology recommended outpatient follow up and early stent exchange but not until out of covid isolation, especially given the fact she has resolution of aki and was feeling improved.   She was given 1u prbc due to symptomatic anemia though she was not far from baseline and without observed hemorrhage. She was offered a second unit given 7.5 hgb and mild tachycardia but she declined.   Will complete 7 day course with cipro, ucx was negative but was collected after cefepime given.   Gen: in NAD. Non toxic. Appears improved. HEENT: mucosa moist CV: borderline tachycardic rate, regular rhythm Resp: clear to auscultation bilaterally Abd: soft Ext: left lower extremity with trace pittign lower extremity edema, right lower extremity without any significant edema Skin: warm, dry Neuro: alert, oriented x4 No flank pain.   Issues Requiring Follow Up: (Who, what, when, and how communicated?) follow up urology for stent exchange in 1-2 weeks."
lt arm swollen, red, & sore; also pale; warm compresses, APAP & DPH per MD;
Swelling on the left side of collarbone, believe it is the lymph node; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8731) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included loratadine (CLARITIN) from an unknown date for an unspecified indication and unknown if ongoing. On 24Apr2021, the patient experienced swelling on the left side of collarbone, he believed it was the lymph node and this was on the same side as the injection. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swelling on the left side of collarbone, believe it was the lymph node was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Lethargy; Aches; Nausea for 3 days; Sore left arm at Injection Site; Rash that went down my left arm and included my left hand; Fever for 101; Chills; significant immune response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION (significant immune response), PYREXIA (Fever for 101), CHILLS (Chills), LETHARGY (Lethargy) and PAIN (Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Nov-2020. Concomitant products included SERTRALINE, BUPROPION, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Combivent prn                                                  asthma and OTC Zyrtec for allergies                                       allergies for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced IMMUNISATION (significant immune response). On 16-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand). At the time of the report, IMMUNISATION (significant immune response), PYREXIA (Fever for 101), LETHARGY (Lethargy), PAIN (Aches), NAUSEA (Nausea for 3 days), INJECTION SITE PAIN (Sore left arm at Injection Site) and RASH (Rash that went down my left arm and included my left hand) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-024842 (Patient Link).
My daughters heart races (tachycardia) and goes into afib. She gets short of breath and also has chest pains.
nausea; tired and fatigue; headache; felt strange; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: EN0198, Expiration Date: 26Feb2021) at the age of 69 years as dose1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "heart procedure", start date: 19Feb2021 (unspecified if ongoing), notes: ablation for atrial flutter, for fast heartbeat. There were no concomitant medications.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovered" (01Mar2021), described as "arm was sore"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "tired and fatigue"; FEELING ABNORMAL (non-serious) with onset 27Feb2021, outcome "unknown", described as "felt strange". Therapeutic measures were taken as a result of headache, nausea.  Additional Information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: left shoulder. Other Conditions: diagnosed 20 years ago and he doesn't take any medicine for it. On Saturday 27Feb2021 and Sunday 28Feb2021 he felt a little different, when asked to clarify "felt different" caller stated he didn't feel like himself, he doesn't know how to break that down, he didn't feel sick but he knew that he felt strange. Caller reported that he didn't feel horrible. Obviously his arm was sore a couple hours after injection, it was sore from injection. When he lift his arm it was sore for a couple days and that has gone away. Then last night he had headache and he woke up with this morning. He took Tylenol (Tylenol Extra Strength capsules, 1 by mouth, he took one on Saturday 27Feb2021, and took one today 03Mar2021) and headache improved. He also woke up with nausea. He had some ginger tea so he doesn't feel nauseous right now. He reported a little fatigue and a little tired. His energy level was not where it usually was. Yesterday, 02Mar2021, he felt great. He washed the car, he ran errands, he did all sorts of things. Then today it was a different experience. He was wondering 5 days after the injection if this should be happening. Caller was not sure if the injection reached the muscle of his shoulder. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) none. Prior Vaccinations (within 4 weeks) no. No follow-up attempts are possible. No further information is expected.
Ocular ischemia that the blood flow into my eyes; Told me I am going to go blind; I could wake up blind or gradually go blind, that I was going to lose my sight; Black spots and a bunch of floaters; Black spots and a bunch of floaters; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID  19 mRNA VACCINE; formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that patient just want to ask about some side effects from having the vaccine. He/she had the first Vaccine on 02Apr2021 and that was the Friday and the following Friday patient had to scramble for an emergency eye appointment. He/she woke up with some black spots and a bunch of floaters and by the time everything was done they told he/she had ocular ischemia that the blood flow into my eyes, it was kind of (incomplete sentence). He/she did not had the comorbid for the diagnosis, people who have that usually have high cholesterol or uncontrollable sugar and things like that but patient did not. And he/she was wondering if this was something that Pfizer has seen because basically they told him/her that he/she going to go blind. By the time patient got out successfully and everything they told him/her that he/she had ocular ischemia. And he/she did not have the comorbidity for the disease process. And frankly patient had been a little scared to take the second one because they told he/she could wake up blind or gradually go blind, that he/she was going to lose his/her sight and that was a huge change in life here. He/she did not know if it has occurred in other patients as well or had vaccinated or not. It was also reported that patient was supposed to be on the same day when he/she saw that specialist about his/her eye which was the 20th of, the 23rd and he kept him/her all day long, he/she am not kidding he kept him/her in his office from 8:45 till 16:30, he/she was all day long he was running test after test on me. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recv vax 9MAR97 & 1hr p/vax face became bright red & swollen;pt had no localized rxn;BP usually 120/70 range, rose to 152/98;h/a pt had @ time of inj persisted p/inj;pt to clinic & rash noted;pt described by nurse as hyper person;
COVID-19 Treatment; COVID-19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Five inch raised red lump at injection site w/one-inch wide white ring around the red lump. Began to feel like bee sting.  Less red and stinging when Ice applied.  Larger (6"-7") lump next day.  Stinging again. Reduced w/ice pack. First sign that raised area was decreasing in size and stinging decreased on it's own was 01/04 2010 PM.  It gradually decreased in size and discomfort over the last four days. I now have a 1 1/2" bruised-like circle w/white ring around it and really no discomfort.  This is the 9th day after my vaccination.  I guess I'm recovered?
I had a very painful injection site and also area got swollen and red. Like a bruise.  For about 4 days. I took Ibuprofen and Tylenol and it was hard to sleep because it was very painful. New Years eve I started feeling my throat scratchy so I made me some honey tea. As I sipped  the tea, my son entered the room and made a remark regarding the tea smell and then I realized that I could not smell the tea, but could still taste it. Concerned it could be a sign of COVID I sanitized all areas and stayed in my room. Next morning I noticed my smell and taste were compromised.  I communicated with the employee health and was tested on the 4th and my rapid test was negative and I could not believe it.  So I decided to go to the UC and I was tested for flu, strep and Covid I was tested positive around 4PM on the same day (01/04/2021).  On 01/02 I noticed I was nauseated around 6:30PM til 10PM and next morning it was gone. On 01/03 I had headache and chills about the same time, I developed diarrhea on the 4th later in the evening as well. On the 5th, 6th and 7th I had cough and on the 9th I had diarrhea again and after that by the weekend everything had resolved  and I felt better.
Left upper arm with swelling, warmth, redness at site of injection influenza. KEFLEX Capsule, 500 MG, 1 capsule, Orally, every 12 hrs, 7 days.
Wrong vaccine administered.  DTaP instead of Tdap.  I (patient) discovered error when filing paperwork for insurance.  I returned to Clinic to ask and they told me vaccines were interchageable.  I showed them the VIS I had downloaded (they never provided it to me prior to vaccinating me) and pointed out that "DTap is not licensed for adolescents, adults, or children 7 years of age and older."  They offered to write me a note stating it was OK and I said that was unacceptable.  I insisted they call the manufacturer, who confirmed what I said.  At that point, they said it was fine, I had received more of the diphtheria and pertussis components, but I would be fine and did not need to be re-vaccinated.  They don't seem to think they did anything wrong.  I do.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Redness, swelling, tenderness to injection site. Evaluated by provider 7/21 recommend ice to area, monitor for improvement, RTC, if any concerns/no improvement in 5 days.
Rash, itching, angioedema weeks after vaccination. States she was told this was due to reaction to Naproxen, but that it happened in the weeks following the second and third dose as well. Unclear if true association.
Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Presented to ED where he was found to have fever to 101.3, tachycardia, tachypnea, leukocytosis to 25, and lactate 6, meeting SIRS criteria. Pt was admitted and started on Zosyn, but infectious w/u completely unremarkable (neg BCx, unremarkable CXR, normal UA, normal abdominal imaging, no elevated LFTs given h/o cholangitis). He was observed for 24h off of Zosyn and did not develop any further hemodynamic instability or recurrent fevers and rigors. His WBC improved daily 25 -- > 11.5 -- > 7.1 and lactate cleared on night of admission with fluid resuscitation.
Information has been received from a patient's mother reporting about her 15 year old daughter, who on unknown date was vaccinated with the first dose of MMR II (lot#, dose and route not reported). Patient's mother reported that her daughter on unknown date had a reaction to the first MMR II shot but she was fine after the second one. The patient had a brain surgery 1 and a half years ago. Upon internal review, brain surgery was consider to be an other important medical event. At the time of reporting the patient status was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Pfizer-BioNTech COVID-19 Vaccine EUA  Employee was found in the staff lounge by crisis RN. Patient stated she was lightheaded (almost passing out), denies falls, and having palpitations. She tested negative for covid on Tue 1/12/2021 and had her first dose of vaccine on Friday 1/15/21. Today, she c/o intermittent numbness/tingling in left arm and foot. Neurology consulted for L sided paresthesia. Pt absolutely refused an MRI due to past experience. CT brain w/o contrast was normal. Patient discharged from emergency department.
Approximately 42 hours after receiving my second vaccination, felt tenderness, soreness and inflammation at both the injection site on my arm, and swelling/tenderness in the lymph nodes under my armpit.
Received Expired dose of vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Skin problem/rash Fever Dx: 1) acute urticarial. Tx: Improved with Benadryl 6mg x 1 in clinic 2) Eruption b/l arm, b/l post angle of jaw improved post Benadryl. Monitor x 24 hrs. ER if not improving or facial swelling