chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammations occurred frequently, treated with antibiotics, resulted in abnormal white blood cell count and passed away suddenly.
Information has been received from a pharmacist concerning a 35 year old female who on 10/18/2001 was vaccinated with the first dose hep b vaccine recombinant IM in the right deltoid. On 10/20/2001, the pt developed a rash on her chest and upper arms. The pharmacist indicated that on 10/23/2001, the pt recovered from the rash on her chest and upper arms. Additional info is not expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 048A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.
Lymph node swelling almost completely gone/ , in the past she was also having ear infections but not since the covid vaccines; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 25Apr2021 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE DOSE (at the age of 18-years-old) for covid-19 immunisation. Medical history included, constipation from an unknown date and unknown if ongoing (She did go to the oncologist and they checked everything, nothing was diagnosed), blood cholesterol from an unknown date and unknown if ongoing (had family history)(Her father side has high blood pressure, cardiac problems, and cholesterol), ear infection from an unknown date and was not ongoing, lymphadenopathy from an unknown date and unknown if ongoing (4 years prior to the covid vaccine), premature baby from an unknown date and unknown if ongoing (she is a triplet). There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No additional vaccines administered on same date of the Pfizer suspect. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) (at the age of 18-year-old) on 03Apr2021 for covid-19 immunisation and experienced swelling went down (The swelling began to decrease about a week after getting the first dose, it wasn't immediate); Xyzal for Lymph nodes, vitamin D for Low vitamin D (her Vitamin D went back to normal) and TUMS. It was reported that patient mother has thyroid disorder and takes medication for it in the morning. Her father side has high blood pressure, cardiac problems, and cholesterol. The patient had undergone laboratory tests on an unknown date includes Triglycerides resulted in high, lipid panel was high, scan on the lymph nodes which resulted in swelling (the swelling was fine, there was nothing cancerous) Vitamin D resulted in low. The patient had no allergies. The patient lymph node swelling almost completely gone on an unknown date. It was also reported that after the first dose, the swelling went down but not as much, then after the second dose the swelling went down completely, there was still a mini bump, but the swelling was almost completely gone, the mini bump from what it was before was also so much better. Usually in the past she would be inflamed again and again in which it would go down but then come back but since the vaccine it was been down and has not returned. It was also reported that in the past she was also having ear infections but not since the covid vaccines. The patient reported that she was a triplet they are all 18, all 3 of them were born as premature. The patient did not visit to emergency room or physician office. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Left arm swelling and warmth increasing over 2 days from time of vaccine. On 10/17 4" in diameter surrounding erythema with minimal warmth and slight tenderness.
No fever, but skin feels hot and  hands & feet are cold & slight headache - a little achy, but Tylenol helped. Symptoms began 24 hours after shot given, but ended by next morning.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6 year old daughter who developed fever, headache, runny nose, sore throat, cough, muscle aches, fatigue and a sinus infection.  The pt received the first dose in Oct 2003.  The child had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered in October 2003.  Dose regimen was 0.5mL (IN).  Concomitant therapy included a 2nd dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 12/03/03.  On 11/01/2003, seven to ten days after receiving her first dose of Flumist, the pt developed a fever (pyrexia), tiredness (fatigue) and a cough (cough).  She also had a headache, runny nose, muscle aches (myalgia) and sore throat (pharyngolaryngeal pain).  The headache occurred "on and off" approximately 3-4 times a week. She was diagnosed with a sinus infection (sinusitis) after being seen by the physician on 8 separate occasions.  She was treated with four different regimens of antibiotics.  After receiving her second dose of Flumist on 12/03/03, the symptoms continued.  As of 02/24/04, the headache, runny nose, muscle aches and tiredness remain. The sore throat and cough resolved approximately three weeks prior to 02/24/04.  No additional information was available at the time of this report.
have noticed i have gotten PVC(Premature ventricular contractions); on Sep2021 I noticed that i started having extra beats on heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset Sep2021, outcome "unknown", described as "have noticed i have gotten PVC(Premature ventricular contractions)"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "unknown", described as "on Sep2021 I noticed that i started having extra beats on heart". The events "have noticed i have gotten pvc(premature ventricular contractions)" and "on sep2021 i noticed that i started having extra beats on heart" required physician office visit. Additional information: Reporter stated getting third shot of the mRNA vaccine early Jan2021. On Sep2021, noticed to have started having extra beats on heart. Patient went and saw an EP (Electrophysiologist) and they have noticed patient have gotten PVC (Premature ventricular contractions).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Subject in pneumococcal vaccine trial, with severe COPD, had an outpatient surgical procedure due to worsened menorrhagia. Vaccination took place 2.5.2009. According to the physician the relationship is none. We would be happy to fax you the studys SAE report.
Pt. states that after receiving the 3rd Booster of 11/29/2021, started experiencing symptoms that evening of chills, nausea, fever, fatigue, headache, loose stool, loss of appetite, and dry cough. No noted Primary visit/communications.
Patient presented to the hospital 37 weeks pregnant on 8/24/22 due to anemia. Tested for COVID as part of routine process and was found to be positive. No symptoms.
First shingrix 5 years ago, then it became unavailble; This case was reported by a consumer via interactive digital media and described the occurrence of product availability issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix vaccine when he/she turned 65 years of age. It then became unavailable in his/her area for many months, which led to product availability issue. By then, the patient was very much involved in caring for a seriously ill family member. The patient asked could he/she get 2nd dose now or need to start over.
Patient states that arm has been sore and there is a hard  bump around the injection site that has been ongoing since the date of the vaccine. She has not taken any medications or seen a doctor for this. It's now 3 months later and she came to the pharmacy to let us know that it has been hurting since November.
This spontaneous report as received from a pharmacist refers to a 77 years male patient. The patient was vaccinated SC, with a dose of 0.65 ml ZOSTAVAX on 16-AUG-2012. No other co-suspects were reported. Concomitant therapy included unspecified blood pressure, thyroid, pain and cholesterol medications. On 16-AUG-2012 the patient experienced full body shaking. The patient then called poison control for information on treatment. No treatment information was performed. The patient's symptoms resolved later on that day(16-AUG-2012). Additional information has been requested.
Hour after vaccination I started feeling nausea and chills. Four hours after I started having stomach pains that were sharp and burning, they would come in waves. Injection site started to be warm, firm, and hurt a lot. Ten hours after vaccination I started feeling more stomach pains as well as bloating, lower back/hipside pains, mid upperback discomfort below ribcage and 99.1 fever with chills. 12 Hours after vaccination I continued to feel bloating, stomach discomfort, chills, but also headache and increased heart rate and over all unwell feelings. Throughout night from midnight until 3:30 am I would wake up with increased heart rate and feeling hot and stomach bloating and discomfort. Heart rate would range from 82-100 bpm resting and fever never went past 100 degrees with one does of 500 mg tylenol. The next morning I continued to have stomach discomfort in upper stomach right under ribcage on both sides, mild bloating, nausae, on and off side and mid back under ribcage discomfort, and 99.2 degree fever with no medication. A week later my period started (on time) but a lot heavier than normal, with larger clots and headache/neck pain and extreme fatigue.
Patient reported having stomach pain that is severe and has not had a regular bowel movement since getting the vaccine
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 07-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
358 patients received potentially expired vaccines; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (358 patients received potentially expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A, 038C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (358 patients received potentially expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (358 patients received potentially expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment reported.
102.3 temp that lasted more than 4 hours; it responded well to Advil but still took about 1 day to get below 99.  Strangest side effect was a chirping sound.  It felt a bit hallucinatory and went away once the fever came down. Overall felt poorly - aches, pains, insomnia, skin hurt, sore arm for about 30 hours.
Client reports increased head pain (has hx: daily persistent headaches) approx: 6:30PM.  Then had 3 or 4 non-epileptic seizures, "not as severe as last time" between 9:00PM & 11:00PM.  (Ibuprofen - did not help head pain).
1st dose given 2/10/21, 2nd dose given 3/3/21, 3rd dose given 11/9/21. All MODERNA
Large area of flaming red (feverish) (as big as my hand) that kept growing, itching, sore
The pt developed redness, hardness, swelling, itching, tender to touch area size of a baseball in the upper right arm. Treated with Benadryl and ice.
12/21/2022 at around 7PM that night, I started seeing double vison horizontally. I was seeing two of everything, it lasted to around 7:03PM. It was over, I took my blood pressure, and it was normal. Once it happened it was nothing to worry about. I may have had a dizziness. I did sit down very quickly. I was afraid I was having some cerebral event. Having that happened the next day I called my PCP and was directed to go to the ER that afternoon after researching my symptoms. After the testing at the ER all was cleared for me to go home. I believe I had a mini stroke; I believe I will be having testing done shortly. I will see my PCP on the 01/11/2022, a carotid arteria sonogram, and another and MRI of my head.
Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital.
Patient received Moderna COVID vaccine on 3/18/21 (lot # 045A21A), 4/15/21 (lot # 042B21A), and 12/21/21 (lot # 069H21A). On 1/8/22, patient tested positive for COVID. On 1/10/21, patient admitted to our inpatient facility med/surg unit with colitis (maroon ostomy output, abd pain, and increased WBC), hyperkalemia (need additional HD), and COVID-19 infection (asymptomatic).  As of today (1/13/22), patient is still admitted in the med/surg unit and remained asymptomatic for COVID-19 infection.
Varicose vein in left leg became painful and swollen, took an aspirin in the middle of the night and pain subsided.  Went to see Dr the next day and had ultrasound to check for blood clots.
Patient stated feeling well right after vaccination, while ambulating to observation area he fainted and fell to the ground. Vital signs stable, he had not eaten yet and was given food. Left vaccination area with parent without further issues. He did receive 2nd vaccine dose on 05/21/2021 without incident.
Iadvertently gave Pfizer as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose). On 08-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.; Sender's Comments: This case concerns a 68 year-old, male with no relevant medical history reported, who experienced the event of INTERCHANGE OF VACCINE PRODUCTS with no other AE reported . The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
hands developed a rash and blisters; hands developed a rash and blisters; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Jul2021 (Lot Number: EW0172) (at age of 15-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported, and patient had no known allergies. The patient's concomitant medications were not reported. The patient had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number unknown), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and she had not been tested for COVID-19 since the vaccination. The patient reported that her hands developed a rash and blisters on 10Jul2021 07:00 am. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The outcome of the events was recovering.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Nurse practitioner cannot be certain it was caused by vaccine, but thought it looked like cellulitis; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; This is a spontaneous report from a contactable other healthcare professional via Pfizer sales representative.   A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot# CG9017 Exp. date: Feb2022) on 14Feb2020 at single dose in arm for immunization and levofloxacin (LEVAQUIN) from an unspecified date to an unspecified date at 500 mg once a day for 14 days for an unspecified indication. The patient was on multiple medications for other health conditions at the time of injection (no other details reported). Medical history included unspecified health conditions; concomitant medications were not reported. A day later vaccination (Feb2020) the patient was seen back in the office and she presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection. Nurse practitioner cannot be certain it was caused by vaccine, but thought it looked like cellulitis.Patient was taking levofloxacin at time of vaccination for another condition, so no other antibiotic was prescribed.  The final outcome of the events was unknown. Action taken for levofloxacin was unknown.; Sender's Comments: Based on the information available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the onset of cellulitis suspected at the vaccination site.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.; Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.). At the time of the report, VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that joint pain and swelling were moving from wrist to elbow. Patient have an MRI scheduled because they were going to get to the bottom of this and figure out what was going on and why joints kept swelling up.  No treatment drugs were reported.