chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tightness in my chest and lack of appetite. The pressure is the strongest in the center of my sternum. The best way to explain it ? it feels like there in a grape stuck in my lower trachea.
Information has been received via another company from a rheumatologist concerning an approx 84 yr old female with osteoarthritis concerning an approx 84 yr old female with osteoarthritis who in 2006 was vaccinated with pneumococcal 23v polysaccharide vaccine by a general physician. Subsequently, in 2006, the pt presented at emergency dept and was admitted with severe swelling and pain in arm. The pt had high temp of 38C degree. The fluid from the arm was drained and tested. The results showed severe inflammatory response with high white cell count over 17,000 and C reactive protein (CRP), approx 100. At the time of reporting on 10May06, the pt's severe swelling and pain in arm persisted. The reporting rheumatologist believed the vaccine injection might have been administered intraarticularly. The rheumatologist felt that severe swelling and pain in arm were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
not sure which shot caused reaction. pt was given FluAD (65 older).  has gotten HD in past.  unknown wheather reaction caused by shringrix or fluad
Starting today the pain from the injection site has spread from my shoulder to my elbow.; Starting today the pain from the injection site has spread from my shoulder to my elbow and have pain in my joints; I am also sore; I am also sore, lethargic; I have a fever of 100.3; Vomited today; I am experiencing irregular heavy menstrual bleeding; I am experiencing irregular heavy menstrual bleeding; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 22Jun2021 at 14:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit-hyperactivity disorder (ADHD), postural orthostatic tachycardia syndrome (POTS) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/ amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), sertraline hydrochloride (ZOLOFT) and cyanocobalamin (B12);all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Jun2021 at 12:00, the patient experienced pain from the injection site had spread from shoulder to elbow, sore, lethargic, had pain in joints, fever of 100.3, vomited and experienced irregular heavy menstrual bleeding after she had not had a period in over a year when her intrauterine device (IUD) was implanted. The patient reported that it was not bad enough to seek medical attention, but she wanted to report these side effects for the data. On 23Jun2021, the patient underwent lab test which included body temperature test and the result was found to be 100.3 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain from the injection site had spread from shoulder to elbow, sore, lethargic, had pain in joints, fever of 100.3, vomited and irregular heavy menstrual bleeding was not resolved at the time of this report.
Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea and vomiting 1 hour after injection. Body aches and injection site pain also reported.
Donor went to ER due to black stools.  Stool sample neg. HCP at ER suggested black color due to diet.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 14-Oct-2022 Reporter's comment: The reporter declined to provide their credentials and disconnected the chat before providing any additional information. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero in error at clinic, which led to expired vaccine used.
The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033k21-2a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First booster dose) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Drug allergy (Amiodarone), Drug allergy (Dabigatran) and Sulfonamide allergy (Sulfa drugs, Sulfonamides).    On 03-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient ever had COVID-19 positive test or diagnosis. Patients medical history was not relating to mentioned adverse event and both acute and chronic illness at the time of vaccination. The patient does not received any vaccine within 1 month prior to Moderna  COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was unknown if the patient had experienced similar adverse event in the past. The event does not caused the patient to seek medical care. Number of doses or vials and date the vial was initially stored in the refrigerator were unknown. The vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-583804.
Pt received Janssen injection at 1:37pm. At 1:55 pm pt c/o nausea and pain in arm where he was injected. Had pt lie supine and started vitals and placed cold cloth on forehead. Vitals as follows: 1:57 pm (BP: 129/77 106BPM) 2:09PM (BP: 128/79   92BPM)2:20pm (BP 126/7898bpm) 2:28pm (BP: 144/88  92bpm) 2:30pm (pt is ambulating in room without difficulty, drinking H2O without difficulty and stating he feels better and better) 2:45 BP: 128/84, HR 94) 2:50pm ambulating well and leaves clinic with father.
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Patient received the Moderna vaccine beyond the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Date vaccine stored in Standard Freezer on 01-Apr-2022. No treatment medications were reported. This case contains 7th patient information out of 45 patients.
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter (consumer).  A male patient in his 20's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Contracted COVID". Clinical course: The patient could have contracted COVID last Sunday (19Dec2021) where there has been traces back to COVID spread. The reporter believed it was confirmed by test, but he/she was not 100% sure.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Patient noticed & experienced symptoms that started approximately 6 hrs after vaccine administration. She broke out in a rash, felt"hot" and "jumpy". She has no SOB, dyspnea, swelling of lips or respiratory distress. Local diffuse redness noted at injection site, redness radiates to left scapula and clavicle. Very warm to touch.Red rash on trunk, arms,face & abdomen that continued and worsened throughout the day of vaccination and the following day. Patient presented to clinic this morning with additional C/O of "throat feeling tight", lips & eyes swelling. She has been taking all medications as prescribed.
About 10 minutes after receiving the vaccine the patient was showing signs of becoming light headed and pale and passed out momentarily. She slide out of her chair tot he floor but quickly regained consciousness. She said she felt light headed and was having trouble breathing. We called 911 and kept her comfortable until they arrived. No medication was given.  Patient left with the squad.
6:40 am April 1 2021 sore arm and feeling really tired, at around 8:30 am April 1 2021 nausea, body aches, chills, tenderness at injection sight. I went to bed slept until 1pm had a headache and tenderness. Went back to bed slept until 4pm woke up with only tenderness in arm.  Noticed on Friday April 2 at about 6pm my arm had a big red patch, warm to touch, very tender.  It did start itching around 5pm on Saturday, April 3.  As of today April 4th I have tenderness, itching, big red patch and warm to the touch and it looks a little swollen.
Raised itchy rash (Urticaria) appeared initially around neck and spread to entire body.  Patient took Benadryl at home without relief over the weekend.  Patint reported to Clinic on 12/14/2009 at 13:30 PM for treatment of allergic reaction.  Patient presented awake, alert and orientated to time, place and person. Multiple skin lesions present, wheals were identified on neck and shoulders (Urticaria).  Assessment of injection site showed no abnormalities. Treatment included 125mg/2ml Solumedrol IM to left deltoid at 14:35 PM.  Patient provided with Prednisone 10mg Tablets and Hydroxyzine 10mg Tablets (1-2 QHS for itching) to take home.  Patient reported symptoms completely resolved on 12/16/2009.  Patient exempt from future H1N1 vaccinations based on reaction.
Headache; Stuffiness symptoms; This is a spontaneous report from a contactable consumer. A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6202; expiration date and NDC number were not reported) via an unspecified route of administration on 24Feb2021 at 11:50 in left arm as a single dose for COVID-19 immunization. Medical history included ongoing hypertension and ongoing hip arthroplasty. There were no additional vaccines administered on same date of the Pfizer suspect. History of all previous immunizations with the Pfizer vaccine considered as suspect was not reported as this was the first dose. The patient did not receive any prior vaccinations within 4 weeks and there were no adverse events following prior vaccinations. Investigation assessment was not provided. Patient was on other concomitant medications, but caller did not have the list to provide. As per the description, the caller reported that his aunt got the COVID vaccine on Wednesday (24Feb2021) and had headache which started half an hour after getting the shot at 12:20, and stuffiness symptoms (coded to nasal congestion) started later that evening. There was no emergency room or physician office visit. They spoke with the patient's doctor and the doctor wanted them to let us know about the events. Caller also mentioned he was wondering if there was anything that can be done to help relieve that events. The doctor suggested the patient to go and get tested for COVID. However, caller indicated the patient had not been out of the house besides going to get the shot. Patient had been quarantining in house for almost a full year and had not been going anywhere. She was deathly afraid of getting the disease. Hoping that getting the vaccine would at least allow her to go out more but do so cautiously. Caller stated he was not sure what rabbit hole the doctor was trying to go through or what was meant by the doctor recommending patient get tested for COVID. Relevant tests were not reported. The action taken with drug was unknown. The outcome of all events was not recovered.   No follow-up attempts are possible; No further information is expected.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/30/20pfizer,Lot#EL0142 2nd dose: 01/20/21,Pfizer,Lot# EL3247 Symptoms began:07/14/21 Diagnosed covid positive:07/18/21 Exposure:Unknown Symptoms:Fever, cough
Patient had syncope about an hour after administration, per parent report. Patient was not fully alert and then had another episode of syncope. Event lasted for undetermined amount of time. Mom reports she was pale.
Received false information that pfizer was approved for children ages 5-11 , Later found out it was leaked to the media by pfizer before the CDC recommendations.  No reactions since vaccine no fever, headaches, body aches, sore throat, vomiting or diarrhea.
severe cellulitis; 14DEC92 f/u 48 hrs p/Td devel pain, swelling in area to deltoid; neg axillary nodes; low grade temp 99; given Omoniflox; 27MAY92 cellulitis improved; no edema, mild erythema only on upper arm;
Treatment of COVID-19; Treatment of COVID-19; Dose 4: Pfizer vaccine and Dose 3,2 are Moderna vaccine and Dose 1 Janssen vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 2 (booster), single (Lot number: 050CZ1A), in right arm and on 30Mar2022 as dose 3 (booster), single (Lot number: 048L21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 1805018), in right arm 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 09Sep2022, outcome "recovered", described as "Dose 4: Pfizer vaccine and Dose 3,2 are Moderna vaccine and Dose 1 Janssen vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Positive rapid test 48hrs after negative test. Asymptomatic, at this time. Therapeutic measures were taken as a result of drug ineffective, covid-19.
fatigue; sick with headaches; sick with headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious), ILLNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "sick with headaches".  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-202101077096 same reporter/SD/AE, different patient
Expired product administered. Expired in June 2023. Patient had no adverse event. Follow up vaccine given on 09/27/2023
Symptoms started 9/28/2021 Admitted to Hospital on 10/1/2021 Diagnosis of Acute Hypoxic Respiratory Failure, pneumonia in immunocompromised host, COVID-19 virus, and  elevated Fungitell - suspected PJP pneumonia Treatment included: Remdesivir, Steroid, Cefepime, Zyvox, Meropenem, Bactrim, and Lasix
Extreme soreness upper right arm, within few hours that lasted for 5 days, then right shoulder since injection
SEVERE RIGHT ARM PAIN, SHORTNESS OF BREATH, LETHARGY, BODY ACHES, WEAKNESS, DIZZINESS
Chest pain, right sided kidney pain. Pain is pressure like with radiation to the left neck. Also with fatigue.
Moderna vaccine administration during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 25-Oct-2020 and the estimated date of delivery was 01-Aug-2021. On 16-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 16-Mar-2021, EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.
Arm painful with upper arm swelling that increased 2nd. day down her entire arm.   Pt states she had a fever, arm was warm and reddened.
The second shot was very mild up every 2 hours urinating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 15:00 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel syndrome. Family history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: OCUVITE AUGE; RALOXIFENE; VALSARTAN taken for hypertension; AMLOPINE taken for hypertension; LIPITOR [ATORVASTATIN]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EN6200-6202, Anatomical site- left arm), administration date: 23Feb2021, for COVID-19 Immunisation, reaction(s): "Was up all night urinating/starting urinating at midnight/excessive urination". The following information was reported: POLLAKIURIA (non-serious) with onset 2021, outcome "unknown", described as "The second shot was very mild up every 2 hours urinating". Therapeutic measures were not taken as a result of pollakiuria.  Additional Information: Concomitant Drugs: Drug name: OCUVITE Reason for use: eyes Route: pill, Drug name: Raloxifene Reason for use: breast Route: pill, Drug name: Valsartan Reason for use: High blood pressure Route: pill, Drug name: Amlodipine Reason for use: High blood pressure Route: pill, Drug name: Atorvastatin Route: pill. FIZER/BIONTECH COVID-19 Vaccine Details: Dose: 1st; Date: 23Feb2021; Time: 11:00AM; Anatomical Site of injection: Left arm; Route of administration: a needle; Batch/lot number: EN6200-6202, Dose: 2nd; Date: 16Mar2021; Time: 03:00PM; Anatomical Site of injection: Right arm; Route of administration: a needle.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225826 same patient, drug, different dose and events
Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates multiple unspecified patients were vaccinated with improperly stored PROQUAD (dose, route , lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA008431: US-009507513-1708USA010012:
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild