chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from contactable Nurse. This Nurse reported similar events for 6 patients. This report is for 4th of 5 patient. This Nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734, and Expiration date: Unknown), via an unspecified route of administration on 28Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller on the line reported an AE for the Pfizer BioNTech Covid19 vaccine. She called to report an outbreak of COVID in the long term care setting where she works at. She said that 'they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine". She said all of them had received the vaccine and 6 people out of 7 or 8 that were infected had the Pfizer BioNTech COVID-19 vaccine. She said that she did not confirm the date of first dose or second dose but she gave the date of 28Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. The outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, Covid 19 and the suspect drug BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients
Patient came to the ER because she had a cut from glass table and since it has been a long time since she had her tetanus booster they gave her one. The patient questioned the nurse that was giving her the vaccine because she was giving it more on the back of her arm and the RN stated no this area is fine. She got the vaccine and went home. She woke up the next day and could not move her arm so she took some over the counter pain meds and a muscle relaxer and slept most of the day Friday but tried to see her PCP on Friday because she was told if she has any issues to follow up with her PCP. She went to her PCP on Saturday and her PCP did not think it was a normal allergic reaction. The patient came on Saturday 8/28/21 and showed me her arm/shoulder which was warm to touch and swollen around her upper arm/red across her chest. She even has a knot close to her neck. Her PCP gave her some medication but wanted to her inform the place where she got the shot. I informed her that we would be happy to see her but she stated she is not sure what else they will do for her at this time since her PCP gave her some medications in the office.
Sore arm at injection site; chills; fatigue; This is a spontaneous report from a contactable consumer. A non-pregnant 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONN), via an unspecified route of administration, in the left arm, on 28Jan2021 (at the age of 88 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 28Jan2021, the patient experienced sore arm at injection site, chills, fatigue. The patient did not receive any treatment for the sore arm at injection site, chills, fatigue. The clinical outcome of sore arm at injection site, chills, fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot number has been requested.
2 weeks after getting the vaccine I experienced a horrible headache that lasted 2 weeks. None of my migraine meds worked on this headache. It was constant, for 2 weeks. It then started letting up, but I woke up with half my face being numb. It starts at my lips and moves up my face to my lower eye lid. My upper teeth are also numb on that side. The left side, When that happened I went to the ER as advised by my doctor (4-12-21). My blood pressure was very high so they treated me for that and did a CAT scan of my head and found nothing.  I was sent home. Saw my Neurologist the next day 4-13-21, She ordered an MRI which was done on 4-17-21. Nothing significant was found.   I also saw my Primary care doctor that same week.  He did bloodwork to rule out auto immune diseases.  Bloodwork was good. I also went to see my dentist that week to rule out dental problems. He did an xray and did not think it was dental related. The numbness is still there.  It has not gone away
p/vax pt stating mouth & tongue were itching;itching all over body;advised pt to to to Er or pvt MD;saw MD who gave DPH IM & PO to take home;
On Tuesday, 01/11, I had muscle pain from my shoulders down. I started developing hives on my face at around 16:00 on Wednesday, 01/12. Next morning, 01/13 it spread to forearms and chest.  This is when I called my nurse. I had these symptoms (albeit more severe) after my second dose in May again 2 days after the vaccination and was on a holding pattern to go to an ER with anaphylaxis. The problem solved within 2 days with Zyrtec and Benadryl this time.
Given 0.5 ml dose of preservative free flu - within 10 minutes rash appeared. Provider viewed - Dx of erythematous macular exanthem area of injection site.
11/5 - pm noted pain, swelling (L) upper arm - 11/6 arm sl warm to touch pink (L) upper arm 4" x 2 3/4" rx BENADRYL/cool compress.
DVT; This is a spontaneous report from a contactable physician via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The HCP received a phone call from another doctor, who had a patient who developed a DVT on an unspecified date 5 days after the 1st Pfizer vaccine dose. The HCP was asking this HCP, if the patient should receive the 2nd Pfizer vaccine dose. The outcome of the event was unknown.   Information about lot and batch number was requested.; Sender's Comments: As there is limited information in the case provided, a plausible temporal relationship, a possible causal association between the events "Deep Vein Thrombosis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
6-29 awoke with 4 urticaric 1-2 mm lesions. By evening still had 4 lesion but evolved to 2-3 cm reddened wheals with 1-2mm vesicular centers.  No change as of 6-30 @ 1500. Afebrile. Denies other symptoms.
Increasing flu like symptoms over the course of the first day including aches and pains, fever, nausea. The next day I was very sick with the same symptoms with the addition of diarrhea. I took Tylenol once in the morning. I was somewhat better by the third day and well by the fourth.
Pt stated she felt hot at site of injection. Pt stated she felt very low energy or tired for 2 days after injection was given. Pt stated she also had stomach upset.
Increasing malaise ~6 hrs. post inoculation. Fainted & collapsed briefly. Profuse sweating for ~10 min. following collapse. Shaking chills for ~1/2 hr. Slept & recovered overnight.
PATIENT HAS SHINGLES-LIKE MARKINGS ON RIGHT ARM ONLY.  THE MARKINGS WERE SWOLLEN/RASIED BUT HAS FLATTENED AND DARKENED. PATIENT EXPRESSED PREVIOUS ITCHING SENSATION BUT DID NOT SCRATCH TO CREATE OPEN WOUNDS. PATIENT DESCRIBED SEEING THIS <24 HOURS AFTER VACCINE  ADMINISTRATION ON 5/22.
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received SHINGRIX. On 5th March 2019, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 6th March 2019, the patient experienced chills. On an unknown date, the outcome of the chills, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced chills 1 day after receiving ASO1B liquid adjuvant only portion of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number 465HX for SHINGRIX did not exist and was updated to 4G5HX as per the sales database.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 ARTHRITIS OF LEFT KNEE  PERIPHERAL NEUROPATHY 11/16/2022 ARTHRITIS OF LEFT KNEE  HYPOTENSION 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE RESPIRATORY FAILURE 2/21/2023 ARTHRITIS OF LEFT KNEE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 ARTHRITIS OF LEFT KNEE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 ARTHRITIS OF LEFT KNEE  HYPOXIA 8/1/2022 ARTHRITIS OF LEFT KNEE  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 CANCER METASTATIC TO BONE  PERIPHERAL NEUROPATHY 11/16/2022 CANCER METASTATIC TO BONE  HYPOTENSION 1/5/2023 CANCER METASTATIC TO BONE  ACUTE RESPIRATORY FAILURE 2/21/2023 CANCER METASTATIC TO BONE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 CANCER METASTATIC TO BONE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 CANCER METASTATIC TO BONE  HYPOXIA 8/1/2022 CANCER METASTATIC TO BONE
AT APPROX 10 PM 11/4/05 CHILD C/O FEVER SHAKING UNCONTROLLABLY, UNABLE TO FOCUS AND NOTED FEVER OF 104. CHILD STATED LATER THAT SHE WAS HAVING TROUBLE BREATHING BUT DID NOT TELL PARENT AT TIME. MOTHER CALLED ER FOR ADVICE BUT DID NOT SEEK TREATMENT AT THAT TIME. SYMPTOMS LASTED ABOUT 12 HOURS.  TODAY CALLED PCP'S OFFICE TO NOTIFY OF EVENT. NO TEMP TODAY MUCH IMPROVED BUT CONTINUES TO BE TIRED. NO FURTHER COMPLAINTS OF SHORTNESS OF BREATH.
Parents brought child to emergency dept with decreased vision in both eyes. MRI brain and orbits showed bilateral optic neuritis, ADEM vs MS. Lumbar puncture ICSF studies and blood work were negative. Child improved with 5 day course IV SOLUMEDROL.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) ongoing since an unknown date at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form; CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE (PEPCID COMPLETE) ongoing since an unknown date at a dose of 1 dosage form and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) ongoing since an unknown date at a dose of 1 dosage form. In January 2021, VACCINATION SITE PRURITUS (itchiness at injection site) outcome was unknown. At the time of the report, VACCINATION SITE MASS (injection site was hard/little knot), VACCINATION SITE WARMTH (injection site was hot) and VACCINATION SITE ERYTHEMA (redness at injection site/pink at injection site) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Patient contact detail(email) was updated.
Blurry vision for 3-4 minutes immediately after receiving the dose; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision for 3-4 minutes immediately after receiving the dose), CHILLS (chills) and PYREXIA (fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VISION BLURRED (Blurry vision for 3-4 minutes immediately after receiving the dose), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN on 12-Mar-2021 at a dose of 1 dosage form. On 11-Mar-2021, VISION BLURRED (Blurry vision for 3-4 minutes immediately after receiving the dose) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102 (High) Fever of 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
When I got the shot, I had no reaction to it at all, and I felt fine. At the end of July or beginning of August 2021, I didn't feel well. When I woke one morning, I had a headache, my eyes were puffy and kind of achy, and my throat felt dry and scratchy. As the day progressed, I felt tired, and my nose began to feel stopped up. At that point, I thought I felt like I had a fever, but I took my temperature, and it was normal. I took some BENADRYL and ALEVE before going to bed that night. When I woke up the next morning, I felt even worse. It felt like my body was fighting the flu. I still had a headache, my nose was stuffier, and I was tired and achy. My voice was dry and scratchy, and my voice began cracking. It was then that I decided to get myself checked. I went to a pharmacy and underwent a PCR COVID-19 test, and the result was positive. I isolated myself from my husband and son for ten days. I immediately started doing breathing exercises in the hope that they would help me. I called my doctor, and she basically told me to take vitamin C and go to the ER if I couldn't breathe. I never developed a cough, but one night my chest felt tight and burned, and I thought that I might develop a cough. It was gone the next day, though. I also began to have stomach cramps and diarrhea, which lasted for two days and were probably the worst part of having COVID-19. I never had a fever during the daytime, but during the last couple of nights of my illness, I had a fever that never reached above 100 degrees. By the time I came out of my ten-day isolation, I felt fine. I underwent another PCR test on 8/13/2021 and got a negative result. It took a few months for me to regain my normal energy levels, though.
diagnosed with pericarditis after receiving the booster dose; pressure on heart sensation; couldn't breath and couldn't call 911; thought I was dying; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (diagnosed with pericarditis after receiving the booster dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (diagnosed with pericarditis after receiving the booster dose) (seriousness criterion medically significant), CARDIAC DISCOMFORT (pressure on heart sensation), DYSPNOEA (couldn't breath and couldn't call 911) and FEAR OF DEATH (thought I was dying). At the time of the report, PERICARDITIS (diagnosed with pericarditis after receiving the booster dose), CARDIAC DISCOMFORT (pressure on heart sensation), DYSPNOEA (couldn't breath and couldn't call 911) and FEAR OF DEATH (thought I was dying) outcome was unknown.            No concomitant medications were reported.  Patient reported that she was diagnosed with pericarditis after receiving the booster dose. Patient states that she went to the hospital due to pressure on heart sensation and thought she was dying, couldn't breath, couldn't call 911.  No treatment information was reported.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with no medical history reported, who experienced the expected AESI of pericarditis and other associated unexpected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The vaccine dose date and event start dates were not provided. The patient sought consult, however, no details were provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-072624 (Patient Link).; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with no medical history reported, who experienced the expected AESI of pericarditis and other associated unexpected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The vaccine dose date and event start dates were not provided. The patient sought consult, however, no details were provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Today is Day 17 since first positive antigen test for COVID; Today is Day 17 since first positive antigen test for COVID; Extreme fatigue; congestion; cough; sweats; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2 , single (Lot number: EW0169), in left arm, on 02Dec2021 as dose 3 (booster) , single (Lot number: EW0217) at the age of 55 years, in left arm and on 25Mar2021 as dose 1 , single (Lot number: ER8733), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies: Sulfa drugs" (unspecified if ongoing); "allergies:shrimp" (unspecified if ongoing); "allergies:crab" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "Extreme fatigue"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022 at 19:00, outcome "not recovered" and all described as "Today is Day 17 since first positive antigen test for COVID"; CHILLS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "sweats". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 17 since first positive antigen test for COVID; Negative, notes: Tested negative antigen test on Day 10; Positive, notes: Symptoms rebounded and are worse starting on Day 14. Therapeutic measures were not taken as a result of vaccination failure, covid-19, fatigue, nasal congestion, cough, hyperhidrosis, chills.  Additional information: Today was Day 17 since first positive antigen test for COVID. I started taking Paxlovid on Day 2. Felt improvement in symptoms by day9 .Tested negative antigen test on Day 10. Symptoms rebounded and were worse starting on Day 14. Extreme fatigue, congestion, cough, sweats and chills, but no fever. No improvement since Day 14.
started itching again; noticed raised, red area about the size of her hand on her arm; sore, hot, itchy arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (sore, hot, itchy arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (started itching again) and VACCINATION SITE ERYTHEMA (noticed raised, red area about the size of her hand on her arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (sore, hot, itchy arm) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (started itching again) and VACCINATION SITE ERYTHEMA (noticed raised, red area about the size of her hand on her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (sore, hot, itchy arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (started itching again) and VACCINATION SITE ERYTHEMA (noticed raised, red area about the size of her hand on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included cool towel