chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next morning I woke up with a bruise on my left arm, close to my elbow about the size of two quarters. I received the injection on my right arm.
According to the patient about 24 hrs after she developed soreness, swelling and redness in the arm of admin.  She stated ibuprofen helps with the pain, but she had not taken any other meds to attempt to treat the reaction
Pfizer 1st dose 3/16/21 (lot # EL 9266) on LD??Pfizer 2nd dose 4/6/21 (lot # ER8729) on LD??On 4/9/21, a 37-year-old male, with a history of Alport syndrome with kidney transplant, presented to urgent care with some left anterior lower leg pains.  About 6 months ago, he had a small, pea-sized mobile lump in the area, and it did not bother him. About 3 days ago, that little mass disappeared, and in its place, he had some pain, a slightly larger lump/swelling, and significant tenderness.  He said the pain was severe when he put weight on his leg or puts pressure on the lump.  It was suspected that he had a ganglion cyst that ruptured, and x-ray of the tibia/fibula was performed to evaluate for any bony abnormality.  It was not sure if this is a vaccine related incident. Report for record keeping.
Male patient of 25 years receives first dose of Moderna of 0.25ml by administration error.
TSH level were high months after booster; Weight gain (15-20 lbs.) after booster shot; After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back; Lethargy after booster shot/The following day she had lethargy; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster), LETHARGY (Lethargy after booster shot/The following day she had lethargy) and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 036B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LETHARGY (Lethargy after booster shot/The following day she had lethargy). On 27-Nov-2021, the patient experienced WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot) and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back). In February 2022, the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHROID) at an unspecified dose and frequency. At the time of the report, WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot) and BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster) outcome was unknown, LETHARGY (Lethargy after booster shot/The following day she had lethargy) had resolved and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Blood thyroid stimulating hormone: high (High) High.         No concomitant medication were reported by the reporter.  After booster shot her left arm was sore. The following day she had lethargy. The symptoms lasted for 2-4 days. Patient stated that she did not have history of Thyroid disease, but patient has had Thalassemia for many years. The vaccine did not change her lab values for Thalassemia. Her Thalassemia lab values were the same after vaccination.   This case was linked to MOD-2022-511410, MOD-2022-511425 (Patient Link).   Reporter did not allow further contact
Patient endorses symptoms of arm soreness, general malaise, fatigue, and fever (101.8 degrees Fahrenheit) for one day. Symptoms have now resolved.
Patient denied that she had received a COVID 19 vaccination. Patient had 2 previous vaccinations with Moderna.
Patient complained on 9/24/17 that her arm was still achy and it was hard to raise it high.
9/22/2022 lethargic, feverish (101 degrees). 9/23/2022 vomiting, diarreha, fever (102.4 to 100.0 throughout the day and night).  Unable to eat, drank water and Gatorade.  Huge bruise on right deltoid. 9/24/2022 Temp 99.0 and below for remainder of the day. Able to eat some chicken noodle soup.  9/19/2022 Moderna Lot AS7146B (unable to enter above).  22. Flu vaccine given on same day as Covid vaccine, 9/19/2022.
Patient received Pfizer series in March and was hospitalized on October 9 for COVID-19. This was identified as a breakthrough infection.
Rash; Mania; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash and mania on an unspecified date. It was reported that the patient took the Pfizer Covid19 vaccine both shots and she said that she developed a rash. The patient wanted to know the side effect and that's all, hence she talked to the doctor, however doctor did not have the information. The patient clarify that she received Pfizer covid-19 vaccine and not the morphine. The patient had several hours of Mania now she trying to come out. The patient did not realize that was the sneaky thing about that disease. It just with her it's a rapid cycle and was do not hit the middle at all. The patient stated she was going down, but it was not always pleasant. The patient wanted to see if have any likable remarks on people. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx 1.5 hr following receipt of vax, pt devel severe headache & fever. (degree unspecified). Tx w/"anti-fever meds". Pt recovered. Copy of this report forwarded to SKB, mfg of the hepatitis A vax.
Had redness and small blisters around site of (L) arm (deltoid area) warm to touch.
I was given the wrong booster dose yesterday. I had already got 3 COVID shots (primary series and monovalent booster). I was scheduled to receive 2nd booster which is the bivalent one that protects against omicron. I got my shot yesterday and fell sick today with ith fever, chills, body pain, headache and light sensitivity. To my horror, I received a call from pharmacy stating that they gave me the monovalent booster instead of the bivalent one that I was supposed to receive. They said I will not be able to get the bivalent booster till 10 th February. My fever and chills have subsided but I still have body pain and headache and light sensitivity.
I asked the patient how his first dose went-he stated it was fine. I counseled that his arm may be sore and he may have side effects such as fatigue, headache, chills after his second dose. I then administered the vaccine in the left deltoid and counseled him to have a seat in the waiting area for 15 minutes. His girlfriend came up to the window about 15 minutes later and said he wasn't feeling well. He was reporting pounding headache and fatigue as well as dizziness. I got him some water and suggested that he lie down until he felt better. It sounded like a typical syncope reaction. After lying down and drinking water for 15-20 minutes he still wasn't feeling better. He requested that we call paramedics, who arrive around 3:15pm and took over.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site) in a female 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reported. Treatment details not reported by the reporter.
Received shots 8/8/03 noticed reaction on 8/10/03 red, swollen, warm to touch from L shoulder to elbow, went to ER 8/10/03 given Motrin, Benadryl, Antibiotic? Per pt mom or bacterial on skin notest ER Dr. stated either reaction to shot.
Patient developed hives within 24 hours of receiving  the vaccine and sought medical attention. Patient had received flu vaccines in the past without any reactions so doctor attributed it to the RSV vaccine
Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is). In December 2021, OFF LABEL USE (Booster dose instead of 3rd dose administered to an immunocompromised  Patient argued that is) had resolved.            No Concomitant medication information were reported. No Treatment medications were provided   This case was linked to MOD-2022-441639 (Patient Link).
Patient received Covid19 (Moderna) vaccine on 5/11/2021.  Patient inadvertantly received Covid19(Pfizer) on 6/9/2021 as second dose.
Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Admit note patient is a 57-year-old female with past medical history of diabetes mellitus II, hyperlipidemia, COPD and recent history of anoxic brain injury for which she was admitted at hospital and subsequently discharged to hospital for completion of rehab. Patient presents to hospital via EMS due to significant dyspnea observed by staff over the previous 24 hours. Per medical record tab, patient was having difficulty maintaining O2 sats and was evaluated by Dr, sats were 77%. Patient had labs ordered and BNP revealed value of 90,000+. Patient received dose of IV Lasix at facility for pulmonary edema and alternated between nasal cannula, CPAP, nonrebreather's and Venti mask. Patient ultimately achieved 85% sat on Ventimask subsequently transported to ED this morning.     Of note, patient was functionally independent and lived with daughter prior to being found down and during late May and subsequently admitted to hospital where she was intubated, treated and subsequently discharged to facility for completion of rehab. Per facility staff, patient was able to speak and answer questions with baseline degree of expressive aphasia just 24 hours prior to presentation hospital. On evaluation at admission, patient appears alert but is not able to answer questions or obey commands. Thus, history was limited to information obtained from rehab and ED checkout. In the ED, an ABG was ambulated which revealed pH 7.35, PCO2 64, PO2 49, bicarb 37. CMP was significant for BG 135, BUN 27, creatinine 1.3, magnesium 1.5, electrolytes otherwise were largely within normal limits. Initial troponin was elevated at 87, BNP was significantly elevated at 111,902. Pro-Cal and lactic acid were negative within normal limits. CBC was largely within normal limits. Urinalysis demonstrated moderate blood with small leukocyte esterase. Vitamin D was significantly reduced to 15. Covid screen was negative. A CT PE was completed and negative for evidence of PE, however demonstrated bilateral pleural effusions body wall edema and ascites. Patient was subsequently admitted to Hospital for further management Neuro admit note: 57 year old female with DM, COPD, HTN, h/p anoxic brain injury. was at nursing home when started having desaturations. BNP was elevated and patient received oxygen and Lasix. Patient was unresponsive and had to be intubated. Was not moving left side very much stat head CTA was done which was negative, was hooked up to eeg and patient was found to be in status epilepticus. currently she is on keppra 1g q8h and propofol. She has had no clinical seizures today and is moving all 4 ext.  MD.  Working diagnosis Acute disseminated encephalomyelitis associated with COVID 19 Vaccine.. Patient responding to high dose steroids (1gm methylprednisolone daily) x 5 days.  Extubated, and alert and oriented. Responding to commands.  Only one oligoclonal band.  Still in ICU, but preparing for transfer to lower level of care.
Swelling, erythema, and increased warmth developed 2 days ago on L arm around site of Menactra vaccine. Patient's mother reports a small reaction to previous vaccination, resulting in a small area of erythema. Patient's mother reports he applied ice to the area last night.         Erythema: yes, mild        Drainage: none        Pain: none        Pruritus: yes        Last Tdap:         Denies fever or respiratory sx such as SOB or palpitations. EXTREMITIES: L upper arm:         Mild localized erythema and increased warmth noted.         11cm x 22 cm region.         No TTP.         Neurovascular signs intact. NL turgor.         FROM of arm intact.   Reassured mother local reaction, though larger then usual. Advised to use benadryl 25 mg three times per day if needed for itching or swelling. Use cool compresses as directed..
Dizziness; Headache; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (chills) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the treatment. No Treatment medication provided
pt noted by mom to have swollen, redened area aprpox 3 in diameter @ inject site rt arm w/in 24 hrs of inject; advised ice to affected area & APAP;
May 13th I woke up to a severe attack of vertigo. I was vomiting, sweating, and I had trouble walking. After 4 days of minimal change that is when I went to see my physician's assistant. My symptoms are moderate now, I am still having dizzy spells but they are steadily improving. My physician's assistant prescribed me meclizine 25mg three times a day.
On the eve of the vaccine, I felt a lot of pans shooting from vaccination sight down arm, felt feverish, chills, fever was 101.0, The morning of the 22nd, I felt fine, but around 6 in the evening I got another fever, closer to 102.0, injection site still very sore, a week later I got another fever and it was around 101.5, a few days after that I started to get leg pain but the arm pain had subsided. Because I had had a surgery 5 weeks before the thought of blood clots was on my mind, I began stretches and walking but it seemed to make it worse. That leg swelled and started to change color, it was my left leg, I went to ER they prescribed Xarelto, I was told I had clotting from my side to my ankle and circulation restriction. Bloodwork showed positive results for blood clots.  I still have some pain and swelling. I did walk with a limp for a couple weeks. Treatments with Xarelto will continue for 3 more months. I had a follow up at trilakes primary on 06/08/2021. She confirmed it was blood clots and said she believes it was vaccine related.
arm blew up like a footballl so so sore; my arm blew up like a footballl; This case was reported by a consumer via interactive digital media 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 mom had got shingles in her early 80's she was in so much pain for many weeks she was peppered with it her lower torso and even in her vagina she suffered so bad).   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 and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling 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's mom had shingles, but she was now doing great. The patient got Shingles shot and his/ her arm blew up like a football so sore. The patient stated that it was a nasty shot, but the patient was glad to get it. The follow-up would not possible as no contact details were available. For tolerance of second dose refer case, US2021AMR198050.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198050:same reporter
Patient began to complain of swelling in throat and difficulty breathing. She was asked by EMT if she has an Epi pen at home that she uses as she states this happens often. She does not have an epi pen and states that it usually goes away with Benadryl. The EMT administered 25 mg Benadryl PO. After 15 minutes of observation patient reported that she was feeling much better and the swelling had gone away and that her trouble breathing had subsided. She was able to leave after being monitored for the additional 15 minute time frame.
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU &  COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
Dose Number: 1 Batch/Lot No: FE3592 Location of injection: Leg Right Vaccine Administration Time: 01:30 PM; After I received my first Covid dose I could only pump 5oz of milk at work the entire day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 07Sep2021 13:30 (Lot number: FE3592) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "not recovered", described as "Dose Number: 1 Batch/Lot No: FE3592 Location of injection: Leg Right Vaccine Administration Time: 01:30 PM"; LACTATION DISORDER (non-serious), outcome "not recovered", described as "After I received my first Covid dose I could only pump 5oz of milk at work the entire day.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of incorrect route of product administration, lactation disorder. No follow-up attempts are possible. No further information is expected.  Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
I got covid; I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown", described as "I got COVID"; DRUG INEFFECTIVE (medically significant) with onset 09Dec2022, outcome "unknown", described as "I got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. 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-202201366310 Same reporter/patient, different AE.;
Restless sleep; kept waking up thinking something was in throat; Mild headache; Exhaustion as a result; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac. The patient was allergic to gluten. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL) for unknown indication and from unspecified date. On 25Mar2021 at 12:00 the patient experienced restless sleep, kept woke up thinking something was in her throat, exhaustion as a result and mild headache. The patient received TYLENOL as treatment for the event mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleep restless, throat discomfort, exhaustion and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.