chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per Agency: Regarding The form for Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a agency Reports on the all clients you have identified.
Swollen lymph nodes on my left arm the next day, lasting for 3 days; A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better; A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better; Dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 19:00 (Lot number: 320308D) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 07Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 03Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Mar2021, when the patient was 40 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 26Oct2021 19:00, outcome "unknown", described as "Dose_number=3"; LYMPHADENOPATHY (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Swollen lymph nodes on my left arm the next day, lasting for 3 days"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better".Therapeutic measures were not taken as a result of lymphadenopathy, erythema, pruritus.Prior to vaccination, the patient  was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.
Information has been received from a nurse concerning a male relative of an employee at the physicians office who on 11/7/06 was vaccainted SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 655500/1005F). On approx 11/7/06 the pt developed a painful and swollen injection site in his arm and was hospitalized. At the time of the report, the pt outcome was unk. Additional information has been requested.
Patient fainted in a chair in the waiting area during observation period (~10 minutes after vaccination). Patients guardian said the patient has a history of vasovagal syncope in medical environments. Patient recovered in a few minutes. Patient remained in the chair for 15 minutes until her guardian and her were able to leave the store on their own accord.
On January 5 I was treated for Covid. My husband had tested positive on 1//3/22 and I tested negative. I just had a dry cough at that time. On 1/5/2022 I was very sick. My Doctor felt I had Covid and treated me for it. I was sick for 10 days. I don?t have all my strength and stamina back yet. Our son had been visiting for three days. When he got home he, his wife, and two of their three children tested positive for Covid.
My son contracted COVID in July, about half a year after the vaccine. He had vomiting, chills, fever, and all flu like symptoms. Sometime after he started getting bumps all over his body, like hives. The doctor prescribed him Cortisone, but it did not go away and got progressively worse. We went to the dermatologist who suggested a steroid ointment which started to get better, but then when we stopped it came back and got worse. He got a bacterial infection on top of the rash, so we went back to the dermatologist who gave us the ointment again. It was not until the beginning of the next month when it went away.
She had her own autoinjector with her. Epi administered into Right thigh anterolateral aspect, through pts. pants. Pt. stated she felt better in less than 1 minute. Client did not want EMT's to see her, but said she wished to go home, and her Dad picked her up. No loss of consciousness, no dizziness or lightheadedness reported. Client observed until 4:25pm, she was alert, stable &oriented X3. Vital signs within normal limits. Informed of risks of not going into ER, pt. aware, and stated she had her epi pen if needed, and would be with her father. Telephone call to pt the next day, she stated she felt like she had Covid again (had earlier this year), with fever , fatigue, but otherwise was fine, and no return of allergic reaction. Instructed to go to ER if she needed to use her epi pen, and to consult with her allergist prior to getting the 2nd Moderna Booster.
Malaise, headache, fever nausea, muscle aches ony 4 days after a revaccination (15 jabs) -- clinical diagnosis: an unrelated viral-like syndrome. [Vaccination on 13 Feb 03 followed "no take" to 3 jabs a week earlier.]
No adverse reactions reported. Client did not meet the age 18 criteria per Moderna's manufacture guidance.
Acute COVID-19 signs and symptoms and had a strong positive on a home antigent test; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, 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 04Oct2023, outcome "unknown", described as "Acute COVID-19 signs and symptoms and had a strong positive on a home antigent test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) positive, notes: This morning patient awoke with acute COVID-19 signs and symptoms and had a strong positive on a home antigent test.  Clinical course: The patient received the latest COVID-19 (the 2023-2024 formula) vaccine yesterday (03Oct2023). The reporter was not sure if it was the Pfizer or Moderna vaccine. This morning (04Oct2023) patient awoke with acute COVID-19 signs and symptoms and had a strong positive on a home antigen test. The patient is at increased risk of hospitalization and death and the reporter would like to start Paxlovid as soon as possible. The reporter asked if there's a contraindication/drug interaction for treatment with Paxlovid following COVID-19 administration.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the event COVID-19 was not considered related to the suspect vaccine bnt162b2 omi xbb.1.5 as the vaccine may have not provided protection yet. 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.
My son first grade class was mass spread. I was concern so I was testing everyday. My son caught it first and then I caught it. The whole family has COVID-19. Tested on May 2nd and came out positive. Started with itchy throat then cough. I had fever, body ache, chills, fatigue, headache, and cough badly that makes my chest hurt. I started taking antiviral (Paxlovid) the 3rd day. It has been terrible. The medicine has not made it any better.
I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including eyelids, joint pain.  On 4/11, 11 days after second shot I developed burning/stinging nerve pain throughout body. Went to ER. All tests normal except my abdominal lymph nodes are swollen. Only mild pain relief with morphine. Being referred to a neurologist. Have never experienced this before. Only history of nerve damage is an injury in right foot. In extreme pain with no explanation yet.
Starting the evening of the shot and for the following 5 days, I had a fever of 102, reaching 103 at multiple times and despite medication, would not break. Aside from the severe aches and pains that prevented me from performing normal activity, I periodically had pain and tightness of the chest.
I was 45 minutes into a zumba class. I started yawning repeatedly, which is very unusual for me. My feet were not obeying orders. I stopped to drink some water and left the studio in case I was dehydrated or overheated; neither helped. I went back into the studio but was unable to keep up with the music so I sat on the floor until the class ended. I started feeling better but my classmates took me to the ER at Hospital, where a series of doctors, nurses, and techs did a number of examinations, labs, and images over the next five hours. They all showed normal results and I was released.
Patient felt nauseated and complaint stomach pain and gag up gas. 10 minutes later, patient started vomiting. patient's dad said patient has a "bad" stomach, whenever he stressed, he would start having gas and vomiting. We called paramedics. The Paramedics came about 15-20 minutes after patients vaccine dose, patient's blood pressure is 147/84, HR: 87. Blood oxygen level : normal. Patient was taken to hospital by paramedics.
4/5 cm of inflammation at (L) thigh - 2/3 cm of induration not warm to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, any known allergies or reactions and pertinent medical history. On 06-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # L020189 with expiration date of 03-JUN-2017), administered subcutaneously, for prophylaxis (dose was not reported); which was diluted with sterile diluent (MRK INJ). No adverse effects were reported. No product quality complaint was involved.
01/22/2021 EKG WHICH WAS NORMAL. EYE PROBLEMS  03/12/2021 EKG DONE HEART WAS IRREGULAR. 03/29/21 HEART MONITOR, NOT NORMAL 28% OF THE TIME, HAD MONITOR  FOR TEN DAYS. 04/7-8/2021 ER VISITS HEART RATE 29 BEATS PER MINUTE HEART ABRASION SURGERY 06/18/21
Body aches,  chills, diarrhea, fatigue, operate arm pain, sweating, malaise. Lasted about 4 hours.
parents states pt broke out w/rash all over body;rt leg swelled & was red;pt was seen in ER w/fever of 102-crying alot
Patient had the Jynneos vaccine too early, 18 days after the first dose, the second dose was administered.; Second dose of Jynneos administered at dose of 0.1 milliliter intradermally.; Case reference number US-BN-2022-003280 is a spontaneous case report initially received on 23-Sep-2022 from other health professional via Company (reference number: USBAV22-1519) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.  On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00016), at a dose reported as 0.5ml, subcutaneously, for monkeypox prophylaxis.  On 30-Aug-2022, 22 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00016), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked with US-BN-2022-003274 and US-BN-2022-003278 due to the same reporter.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, on the day 22 after the first dose, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Case number PHEH2014US024249, is an initial spontaneous report received from a pharmacist on 04 Dec 2014. This report refers to a 27 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1412601) intramuscular on an unknown date. On 04 Oct 2014, 1-2 days after vaccination she experienced skin discoloration at the injection site. The patient stated that the color of the skin looked like it was bleached where the injection was given and became worse over time and the area had become bigger about the size of a dime (the area looks lighter than the rest of her skin). The pharmacist stated that she saw the patient's arm last week. The patient stated that it was about quarter size now and the patient was seen a dermatologist. Nothing was prescribed by the dermatologist and the dermatologist stated they had not seen anything like this before. Outcome of the event was unknown. Seriousness and causality assessment was not reported.
Patient c/o feeling warm on left-side, legs shaking upon standing, balance issues per patient report. Shortly after, patient c/o of itching. BP 198/77. Patient transferred for further observation.
Chills, nausea, vomiting, fatigue lasted for 2 days. Pain and swelling in armpit area/lymph node in arm where injection given is still persisting.
Redness, itching and swelling worsening over time. Redness getting larger.
Severe itching in arms, legs, feet, and hands 11/2 weeks following injection.  Also, stomach upset starting on same day.
PATIENT HAD AN EPISODE OF UNCONTROLLED SHAKING FOR 30 MINUTES DURING WHICH HE WAS NOT RESPONSIVE TO THE MOTHER. tHE DESCRIPTION OF THE EPISODE WAS SUGGESTIVE OF A SEIZURE.
pt recv vax DEC95 & in JAN96 pt exp non-specific flu-like sx & devel an explosion of lymph nodes;MD reported that pt had swelling in the carotid & unilateral parotid swelling;biopsy in occipital node revealed hyperplasia;
bumps are hardening; Rash; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (bumps are hardening) and RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INDURATION (bumps are hardening) and RASH (Rash). At the time of the report, INDURATION (bumps are hardening) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
I started having random lip swelling, eye puffiness, and hives every few days just under 3 months after receiving 2nd dose of Pfizer vaccine. Symptoms worsened over time. Saw allergist who performed blood tests and I am now diagnosed with Chronic Spontaneous Urticaria with Angioedema. I now take a daily antihistamine. I am told this disease may last more than 5 years since I have angioedema as well.
"Client received Johnson & Johnson vaccine on 3/19/21 and started with symptoms on 3/21/21, he assumed it was a reaction to the vaccine."  Client admitted to Hospital on 3/29/2021.  Per hospital 3/30/2021: Presented to the ER with SOB and low oxygen saturations that started on 3/30. The patient did not have any complaints of shortness of breath up until that morning. He received the Johnson & Johnson vaccine on 19 March, then developed fevers, fatigue the Wednesday after his vaccine and tested positive for Covid on March 26. Patient does complain of fevers of 103 at home. He resides at home with his wife who is also sick with Covid.  He was admitted with Covid pneumonia and new oxygen needs. Tested positive on 3/26.
red swollen itchy lumpy area 2 - 3 inches in diameter at injection site on day 9 after injection
Swelling; Lethargy; Joint pain; Allergic reaction/bad reaction to the second shot; A spontaneous report was received from a patient on 24MAY2022.  The male patient (unknown age) developed "allergic reaction/bad reaction to the second shot" (PT: Hypersensitivity) which included joint pain (PT: Arthralgia), swelling (PT: Swelling) and lethargy (PT: Lethargy) following immunisation with BioThrax (anthrax vaccine adsorbed). It was reported that around 1999 to 2000, the patient received 2 shots of Anthrax vaccine (lot number: FAV037 and FAV44). It was reported that the patient did not have a reaction to the first shot however he had a bad reaction to the second shot. He developed allergic reactions. The reactions he had to the product included joint pain, swelling, and lethargy which were persisted for months. Thus, he was given pain management medications for treatment, and it was confirmed that these issues were no longer existed.  Action taken with BioThrax with respect to the reported events was not applicable.  The patient had recovered from the reported events at the time of this report.  It was reported that the patient believed that he was allergic to polyethylene glycol and or polysorbate 80 and he believed that Anthrax vaccine may have either of these components.  Additionally, the patient stated that after receiving the Anthrax vaccine, he believed that his allergies were started but he was trying to establish that.  No additional information was reported.  Company comment: A consumer received BioThrax and developed allergic reaction/bad reaction (hypersensitivity) which included joint pain (arthralgia), swelling, and lethargy. This patient had recovered from these events at the time of reporting. Considering the case information, the role of BioThrax cannot be ruled out and the causality of hypersensitivity, arthralgia, swelling, and lethargy is assessed as possible with BioThrax.; Sender's Comments: A consumer received BioThrax and developed allergic reaction/bad reaction (hypersensitivity) which included joint pain (arthralgia), swelling, and lethargy. This patient had recovered from these events at the time of reporting. Considering the case information, the role of BioThrax cannot be ruled out and the causality of hypersensitivity, arthralgia, swelling, and lethargy is assessed as possible with BioThrax.
I had the Moderna Vaccine on December 6th and within a short time, my arm swelled from shoulder to elbow and stayed hot for a couple weeks. I also developed chest pain the first day at about 6-12 hours after and it was severe enough that I thought I was having a heart attack and started taking baby aspirin. This was severe for some time and when I went in for the second shot, they said I needed a medical evaluation to receive a second dose. I developed High blood pressure and have been put on BP meds 2x daily to keep it in a safe but not great range. I see a doctor and they don't have time for the patients and sent me to urgent care and then really nothing to assure me that I will be okay or that I can get help for the issue I am dealing with ever since the vaccine. I am sure they have not reported it to anyone because  they treat me like I am an anti vaxer and minimize my life changing issue.  I used to be a runner and worked out every day. I can not anymore but do walk again but can not run any longer as my bp goes up too high.  Who should I report this to or do you even care as the rest of the medical people I have been treated by if you can call it that.
rashes in passing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (1st dose received on an unknown date, refer link case US2020205664).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced rash in passing after receiving dose of Shingrix. Health care professional did not have any additional information about rash. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205662:same reporter US-GLAXOSMITHKLINE-US2020205664:same patient (1st dose)
Fever Injection site pain Narrative:  First Vaccine: injection site pain x 2 days. Second Vaccination 2/1: 2/2: Fatigue; 2/6: Fatigue; 2/7: Lymphadenopathy, fever and fatigue.  Other Relevant History:
During response testing for an outbreak in a homeless shelter, patient tested positive for COVID-19. She had no symptoms.
The patient began to itch all over her body roughly 15 minutes after inject. Shortly after she started having a "burning" sensation in her throat that she compared to a past history of when her throat did start closing due to an allergic reaction. The itching became progressively worse. She was given 50 mg of liquid diphenhydramine. Roughly 15 minutes after administration of diphenhydramine, she stated that her throat was improving. She stated at that time the itching was still continuing. She was given an additional 25 mg of liquid diphenhydramine at that time. I continued to observe the patient for another 15 minutes and she stated the itching was improving. At that time, her husband arrived to drive her home. The patient carries her own Epinephrine pen and is experienced in using it, as is her husband. Myself, the patient, her husband, and the other pharmacist on duty all agreed that she could leave with her husband given the fact that the situation was improving and both the husband and patient are knowledgable in using an epi-pen.
Five days after first dose a red rash 8 cm diameter developed at the injection site.  Several small red raised bumps as well.  No warmth or swelling.  No bruising.