chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/22/01, pt developed a varicella-like rash of approximately 20 to 30 lesions distributed over her entire body. Slight fatigue was also noted. Conservative care was provided including antihistamines and oatmeal baths. The duration of the lesions was approximately 5 days before they crusted completely. Unspecified medical attention was sought. The pt recovered from these events. No further info is available.
4 days after had a small itchy area after soreness lessened, then at day 9 and 10 noticed a small area at injection site of red, itchy, swollen red patch in same area of injection site.
Patient states she started not feeling well 2 days ago.  She is unsure of when she was exposed to Covid.  Patient states over the past 2 days she has become progressively weak and having difficulty ambulating due to weakness of her lower extremities and extreme fatigue.  She also reports that she has had diarrhea x2 days.  Complains of abdominal pain.  She complains of intractable coughing and states that she has coughing until her ribs have become sore.  She is vaccinated and received Johnson & Johnson vaccine in February.  CT of the chest did not show pneumonia.   Patient with acute exacerbation of COPD.
Fatigue after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after first dose). At the time of the report, FATIGUE (Fatigue after first dose) outcome was unknown.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Within several hours after vaccine - vomiting, severe headache, chills, weakness, aches and fatigue. Symptoms improved within 24 hours except for headache and fatigue.
L deltoid injection, 2 hours later L arm red and worn from site down to L hand.
Tenderness noted at site of injection the night of the injection. Noted redness and swelling at injection site today at about 8:00 am. Redness and swelling continued to increase in size to approximately 1 1/2 inch diameter by 2 1/2 inches.
red rash w/1 1/2 x 4 1/2cm indurated area, somewhat teardrop shaped, on top of a  2 1/2 x 5cm area of erythema;firm & sl warm to touch rt thigh;
You can get it from the vaccination! That's how I got it./Suspected vaccination failure; You can get it from the vaccination! That's how I got it.; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
I experienced COVID-19. I had runny nose, congestion, cough, body aches and headaches. I did a home test on 04/08/2023 and it was positive. I am still recovering and I am taking Advil and Paxlovid.
Side effects from vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects from vaccine) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects from vaccine). At the time of the report, ADVERSE EVENT (Side effects from vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
6 X 10 cm warm light pink lesion to left deltoid with a reddened firm area approximately 2 cm x 3cm and 2 cm from the top of the inflammation no tenderness, blanchable, warm but not hot to touch.
Extremely Sick; Had a fever of 104 for 4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely Sick) and PYREXIA (Had a fever of 104 for 4 weeks) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely Sick) and PYREXIA (Had a fever of 104 for 4 weeks). At the time of the report, ILLNESS (Extremely Sick) had resolved and PYREXIA (Had a fever of 104 for 4 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 High.         The reporter stated her son-in-lawhad the Moderna vaccines and was fine with the first one, but with the second shot, he came down with a 104 fever for 4 weeks. He was extremely sick with the Moderna vaccine. He is fine now as far as they know. Caller declined safety report. Caller declined email. Concomitant medications and treatment was not reported.   Reporter did not allow further contact
Generalized raised urticartial rashes all over body started 2 hours after vaccine.  It started one week high fever and seizure 4 days after vaccine. 02/27/07-records received and reviewed for DOS 10/28/06-DX:Seizure with fever Temp in ER 104.5. Erythema multiforme. Received Tylenol and prednisolone Temp 102 (R).
Fever 101-102 degrees 24hr after got FLURIX vaccine and PNEUMOVAX. Rash at site of injections. Diffuse malaise. Seen in office on 11/15/08.
On 11/26/00, around 19:00, I was feeding her and after she finished, she rolled her eyes in an upper right position; deviated to the right and stared for a few seconds. Had 3 episodes, total.
Information has been received from a RN concerning a 30 year old white female with allergies to codeine, aspartame, and bee stings, and history of three week duration of muscle stiffness and pain at age 21 following a tetanus toxoid vaccination, who on 2/12/03 at 16:00 pm was vaccinated by IM injection in her right deltoid with a first dose of hep B vaccine (641694/1534L). It was noted a few minutes later (also reported as immediately after injection at 1600), the pt began feeling a tingling sensation in the right arm that radiated down into her forearm and then into all five fingers. It was noted she also developed some weakness in the right hand and right arm which lasted six hours. It was reported that she was still able to hold a pen and write, but her strength was not the same in both hands. At the time of this report on 2/13/03, the reporter noted the pt still has some tingling in the arm, and "all of her joints ache." Follow up info from a RN noted that 12 hrs after the injection (04:00 02/13/03) the pt developed stiffness, ache in arms, and she reported all "joints ache." The reporter noted the pt's ache in her arms, and joint ache in her shoulders and wrists lasted six hours. The joint ache in the pt's hips resolved after eight hours, knees resolved after 11 hrs, and ankles resolved after 14 hrs. It was noted that no laboratory or diagnostic tests were performed, and the pt had no illness at the time of vaccination. It was reported the pt recovered. No additional info is expected.
Patient came back to the pharmacy on 10/11/18 to have the pharmacist look at the adverse reaction she was having to the vaccines she received. Her arm from her shoulder to elbow appeared to be red and inflamed. Patient said the pain was pretty severe the previous day. It was to the point where she could not move her arm. At the pharmacy the patient was instructed to apply ice and to use BENADRYL to help with the itching.
Injections given on 8/8/08. Meningitis/Pneumonia (RUA). 8/10/08 Pt called with red, swollen upper arm - raised 7" across. Pt chilled/no thermometer. Pt was previously on Keflex for toe infection. Hydrocortisone 1% cream and ibuprofen, ice, Benadryl. If no response in 24 hours to call back.
Polymyalgia rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) outcome was unknown. Not Provided          The patient was taking prednisone he is following up with the doctor on 16 Apr 2021.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD21-072303 (E2B Linked Report). This case was linked to MOD-2021-071546 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. MOD21-072303:
This spontaneous report was received from a patient's mother and refers to a male pediatric patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the pediatric patient was accidentally vaccinated with an unspecified dose of ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). The patient had no adverse effects at the time of this report. Additional information is not expected because no contact details were provided.
The patient was administered the incorrect COVID 19 Pfizer Bivalent vaccine according to his age. Patient received the Pfizer-BioNTech Covid 19 vaccine Bivalent Age 12 years & older.  I reached out to the patient's parents on 10/20/2022 after receiving a call from the regulatory authority to notify their son had received the incorrect vaccine. The parents reported their son had no adverse effects after getting the COVID vaccine. However, they did mention their son felt mildly ill with a fever after getting the Flu shot the following week on 10/15/2022.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 40-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021; got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) 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 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021). On 05-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) and INCORRECT DOSE ADMINISTERED (got a full first dose of the Moderna vaccine on 07May2021, then got half a dose on 05Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
I have never had hives or swelling, and this was the first flu shot I've ever had.  I developed chronic urticaria idiopathic, chronic angioedema idiopathic, and chronic swelling of other body parts.  I have been through extensive allergy testing and autoimmune testing and have found no known allergies or specific auto-immune diseases.  These symptoms can be debilitating when on my feet (can't walk) and in my hands/wrists (can't drive/hold items in my hands).  Again, I have never experienced these symptoms and they occurred within weeks of having my first ever flu shot.  I have been on copious amounts of antihistamines including, Zantec, Zyrtec, Allegra, and Singulair, all of which have helped but not alleviated my pain/swelling/hives completly.  The next treatment is a very expensive drug called "Xolair" which if my insurance refuses to pay, I cannot afford to get.  I was admitted to the hospital once when I woke up in the middle of the night and my face was extremely swollen, eye swelled shut, hives over entire face/scalp, neck, shoulders, back and chest.  I was also on 3 different prednisone tappers trying to get rid of the hives and control the swelling in my face, hands and feet.
Patient reports local swelling and discomfort the night she received the vaccination, followed by chills and subjective fever that resolved by the following morning. Patient reports this several days later on 11/28/17. All symptoms have resolved.
This spontaneous report was received from a registered nurse, concerning a currently 14 year-old patient of unknown gender. Information regarding no concurrent conditions, medical history, drug reactions or allergies or concomitant medications was unknown by the reporter. On 25-FEB-2002, 16-MAY-2002 and 18-SEP-2002, the patient received a doses of Hepatitis B vaccine (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported) for Hepatitis B prophylaxis; and on an unspecified date, the patient had insufficient titers for Hepatitis B (hepatitis B antibody negative). On 18-JUL-2016, the patient received a dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported), and on 04-JAN-2017, the patient received another dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M000442 with expiration date of 31-MAR-2018; both for hepatitis B prophylaxis, which had been exposed to temperature 32 F, for a time frame of 24 hours. No previous temperature incursion was reported. The outcome of the event, and their relationship with suspect therapy was not reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
Pt given rotavirus as forecaster listed on immunizations due. No s/s reported as a result.
Patient was feeling very shaky, dizzy and nauseous 2 minutes after the shot. Patient said she felt like she was going to pass out. We laid her on the ground and gave her water and orange juice. Patient stabilized after a couple of minutes. Paramedics came out and double checked on her, but mom said she did not need to go to hospital. Patient walked away fine. Most likely nerves that caused this incident.
Alopecia areata at the base of my neck upward approximately 3 inches on each side discovered by my hairdresser on 11-24-21.  I had been to the hairdresser on 10-15-21 and had no hair loss.  No previous hair loss at any other time in my life!
2nd dose- tired.  9 pm diarrhea followed by low grade fever and extreme chills and sweats. day 2- very stiff, achey, headache, low grade fever, extreme chills and sweats.  Barely could stay awake. day 3-  exhausted achy, headache, low grade fever, extreme chill sweats.  day 4- woke up feeling a bit better but after a hour or two low grade fever followed by a full day/night of the most extreme sweats and some chills.   Day 5- woke up feeling okay but since there have again had low grade fever and sweats.  (no chills yet.)
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with doses of ROTATEQ (lot# K016261 and expiry date: 23-JUN-2016) (dose and frequency were unknown), which were exposed to temperatures outside of the recommend range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient had Adverse reaction to vaccine. Felt light headed- seems to have been brought on my anxiety. Had some sweating and nausea. Gave patient water and Benadryl and told him to sit and relax. Patient started feeling much better and left within the hour.
PATIENT CAME TO RECEIVE VACCINE AT THE PHARMACY, AFTER GETTING THE VACCINE PATIENT PASSED OUT WHITE SITTING ON THE CHAIR FOR OBSERVATION
Pneumonia; arm soreness; This is a spontaneous report from a contactable consumer (patient's boyfriend). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient experienced arm soreness after first dose. And she was prescribed azithromycin (ZITHROMAX) and amoxicillin/ clavulanic acid (AUGMENTIN) to take because she was just diagnosed with pneumonia. And it's due for her second dose "tomorrow" 26Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Breakthrough case admission after 4 vaccines Moderna 3/1/21 Lot# 010A21A;  Moderna 3/29/21 Lot# 007B21A;  Moderna 11/7/21 Lot# 039F21A;  Pfizer 8/23/22 Lot# FJ4991
A non-serious spontaneous report of fever of 102 and sore throat has been received from a parent/consumer concerning his six-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 19-Nov-2009, the patient woke up with fever of 102 and sore throat. The outcome of this event was unknown.
Immunization reaction to COVID Vaccination: Vasovagal response  Pt had his first Pfizer Imm today and was sitting down for 15 mins observation and at 1142 pt stated that he is feeling dizzy. On observation pt was diaphoretic and feeling dizzy. He denied shortness of breath and chest pain or difficulty breathing. As I am talking to him he started to faint. Pt had quick syncopal episode with few seconds of LOC. Quickly he gained his consciousnes and was alert and oriented x 3. Pt stated he feels better.  He was given water to drink and crackers to eat. He was able to eat and drink without any difficulty swallowing.  Vital signs:   11:45am : BP--84/36 sats:100% HR:55  11:55 am:  BP: 103/62  Sats: 96% HR: 76 1210:          BP: 120/73  Sats: 97% HR: 76  Pt was able to walk and was able to go home without any complications in stable condition at 1220.
- High and persistent fever of 103 degrees lasting far more than 24 hours - Severe body aches and shooting pains down both arms
Tinnitus occurred 48 hiurs after the 2nd dose of Moderna vaccination; patient experienced ringing in her right ear and reduced hearing for 24 hours. Patient has never had Tinnitus before. The hearing came back to normal after 24 hours.
After my second dose of Pfizer when I woke up the next morning, I had regular symptoms (body aches) which were eased my ibuprofen. However, I also had low circulation in my left leg. This continued for a few days, and resulted in pain in my left calf, and some in my hamstring. There is no redness or swelling, but my calf muscle hurts when flexed or stretched. I continue to have circulation issues. It feels like the blood is having a difficult time flowing through.  Symptoms are worse when lying down or sitting. I have not seen a Dr about this yet.
Information has been received from an office manager concerning a female in her late teens who was vaccinated with Gardasil. Subsequently, the patient received a dose of Gardasil and felt sick. The patient went to the emergency room. The reporter felt that felt sick was not related to therapy with Gardasil, but a viral infection. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), exposed to -11.8C for seven hours. No adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.