chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Restless sleep first evening following vaccine. When I woke up I noticed redness around injection site, swollen armpit/lymphnode, arm very tender. I had a fever of 100, experienced nausea, hot and cold chills through, fatigue throughout day following vaccine. Restless sleep, swollen arm, reddened area around site is still present 5 days later, other symptoms resololved after 2nd day following vaccine.
17 year 10 month old male given IM injection of Johnson & Johnson vaccine in right deltoid at 1 pm on 04/8/2021. Pt was observed for 30 minutes after receiving vaccine without  reaction observed . Mother was notified that child was younger than 18 years old. Mother verbalized that she thought he would be fine.  Mother was provided with Janssen fact sheet.
Right deltoid to axilla became extremely edematous, red, hot, hard to touch per grandmother's report.  Entire arm swelled to twice its normal size.  Client seen in ER. Given Prednisone and started on antibiotic per grandmother.
Menorrhagia.  Since I began menstruating at age 12, I have bled very lightly for 2 -3 days about 4-6 times a year. The period I got after my first moderna dose was heavier than I have ever bled and has lasted 7 days and is still ongoing but seems to be lightening up. This has never happened before.
Patient was underage  (16).  Patient had no adverse signs, symptoms during her waiting period (15 minutes).
30 yr/o male who presents with chest pain.  He states that symptoms have been present for about an hour.  He feels as if "somebody is punching me in the base of my heart."  He also notices a racing heart beat as well as some shortness of breath.  Symptoms are nonradiating and moderate to severe.
Patient reported to clinic to receive flu shot. Front desk staff reported to nurse that client here to receive covid vaccine. Asked if client had any reactions to the previous vaccines, did not specify COVID vaccines. Clients reported no issues with previous shots. Covid bivalent booster given. Client was eligible to receive vaccine, last dose was 12/13/2021. No known adverse side effects from vaccine noted as of yet.
Sore arm, nausea, tummy cramps, headache, fever, eye pain
Left side of throat was inflamed; Pain in let side of throat; Left buttock felt odd; Issues going to the bathroom; Feet felt swollen but she saw no visible swelling; Heart is palpitating more than normal; Experienced fatigue and had to stay home 3 to 4 days after vaccination because she was lying down most of the time; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Left side of throat was inflamed), OROPHARYNGEAL PAIN (Pain in let side of throat), FEELING ABNORMAL (Left buttock felt odd), ABDOMINAL DISCOMFORT (Issues going to the bathroom) and PERIPHERAL SWELLING (Feet felt swollen but she saw no visible swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PHARYNGEAL SWELLING (Left side of throat was inflamed), OROPHARYNGEAL PAIN (Pain in let side of throat), FEELING ABNORMAL (Left buttock felt odd), ABDOMINAL DISCOMFORT (Issues going to the bathroom), PERIPHERAL SWELLING (Feet felt swollen but she saw no visible swelling), PALPITATIONS (Heart is palpitating more than normal) and FATIGUE (Experienced fatigue and had to stay home 3 to 4 days after vaccination because she was lying down most of the time). At the time of the report, PHARYNGEAL SWELLING (Left side of throat was inflamed), OROPHARYNGEAL PAIN (Pain in let side of throat), FEELING ABNORMAL (Left buttock felt odd), ABDOMINAL DISCOMFORT (Issues going to the bathroom), PERIPHERAL SWELLING (Feet felt swollen but she saw no visible swelling), PALPITATIONS (Heart is palpitating more than normal) and FATIGUE (Experienced fatigue and had to stay home 3 to 4 days after vaccination because she was lying down most of the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
bilateral pedial neuralgia for the past 1 1/2 months; started 2-4 wks p/completion of rabies post exposure series; most prominent on awaking; disipates in 5 mins; during rest periods reoccurs w/pain proportionate to resting time;
pt recvd vax & 1 1/2 days p/vax all of pt's joints ached for 5 days & pt's knees cont to ache for 2 more wks;
This spontaneous report was received from a healthcare worker refers to a 30 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with a dose of M-M-R II (lot # unspecified) dose, route and location unspecified for vaccination by an unspecified physician. No concomitant therapy was reported. The patient was found to be pregnant with LMP of an unspecified date the first week of July. ON 22-AUG-2013 the patient received a positive pregnancy test. Date of conception was calculated by LMP plus two weeks as the third week of July. Trimester(s) of exposure was the first. No adverse effect reported. The patient had sought medical attention via office visit. No treatment was given for the events. At the time of this report, the pregnancy outcome was unknown. Additional information has been requested.
This spontaneous report as received from a physician concerning unspecified number of patients of unknown genders and ages who on an unknown dates had received their follow up doses of GARDASIL late. No adverse event reported. This is one of several reports received from the same source (other case number 1208USA009224). Additional information is not expected.
The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: alprazolam. On 05-MAR-2021, the subject experienced numbness from the waist down for 4 hours. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced emotional fatigue. On 06-MAR-2021, the subject experienced physical fatigue/exhaustion. On 07-MAR-2021, the subject experienced depression. On 07-MAR-2021, the subject experienced anxiety. On 07-MAR-2021, the subject experienced short term memory loss. On 07-MAR-2021, the subject experienced right hand not work properly, she cant hold things properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness from the waist down for 4 hours, was recovering from depression, and anxiety, had not recovered from physical fatigue/exhaustion, emotional fatigue, right hand not work properly, she cant hold things properly, and short term memory loss, and the outcome of body aches was not reported. This report was non-serious.
Patient received influenza and pneumonia vaccines around 10:30am on 10/25/07. At about 5:30pm, the right arm which had the pneumonia vaccine swelled up and was red and warm to the touch. The patient also developed a fever of 101 deg and took 600 mg of Motrin. After 4 hours, the fever went away and the swelling went down but the arm was still swollen and red.
Swelling, redness to site with pain, fever. Well 48 hours later after shot.
Cough; Body and muscle aches; Nausea; Fever of 101.8F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient used asthma inhaler and laid around).   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) Fever of 101.8F and 103 (High) Temp of 103 for 3 days.         No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR document received on 05 Aug 2021 and added lab data, vaccine dose number updated from dose 1 to dose 2.
I developed on my arm at the site a rash; Erythema; Hypersensitivity; Pruritus; A spontaneous report was received from a Non-Health Professional on 25-JAN-2021 00:00:00, which refers to a Female aged 74 Years who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity, pruritus, rash and erythema. The patients past medical history included: No adverse event. No concomitant drugs taken. On 14-JAN-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: 012LZOA) on her left arm for prophylaxis of COVID-19 infection and experienced hypersensitivity, pruritus, rash and erythema. On 22-JAN-2021, the patient experienced a delayed type of reaction, her arm was itchy and red, there was a circle about 4 inches around and there was a little raised area of rash. On 23-JAN-2021, the patient experienced that her arm was red and developed a rash at the injection site. No treatments were taken. Action taken with mRNA-1273 in response to the events was not reported. Diagnosis\Outcome- I developed on my arm at the site a rash - Unknown, red - Unknown, arm was itchy and red - Recovered/Resolved, delayed type of reaction - Recovered/Resolved.
Sweating, nausea, dizziness, aching joints.  Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine.  I have had extreme insomnia since vaccine.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD (lot # L030592, expiry date: 12-FEB-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L030592 (exposed at 10 degree Fahrenheit or an unknown time frame and for 300 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Arm soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix 5 months ago from reporting day since then patient had arm soreness. Till time of reporting arm soreness was not resolved. The patient's physician never heard of this happening. The patient was scheduled to get the 2nd shot on reporting day.
6 days after the injection (1/19/21) I got lymphadenopathy on my left underarm, it was painful but by today (1/21/21) it is smaller and not painful. On 1/20/2021 I noticed the site of injection is red, swollen, and a little hard, however, it is not painful at all.  The redness, swelling, and hardness didn't appear until the 20th of Jan, it was fine before then. I have been getting major headaches every day since I got the vaccine.
patient who received a pediatric dose of Engerix-B back in January 17th 2023; Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 86-year-old patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 17-JAN-2023, the patient received Engerix B pediatric. On 17-JAN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: patient who received a pediatric dose of Engerix-B back in January 17th 2023) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter did not provide patient initials and gender.  The reporter asked for recommendations on this situation. The reporter declined permission to store her contact information in our database. The reporter asked for information about a patient who received a pediatric dose of Engerix-B, which led to underdose and inappropriate age at vaccine administration.
3 ER visits/CAT scan/ colostomy/ MRI/ Flagyl med/ steroids/ 6 nights in hospital/ extreme bleeding from rectum/ immune system attacking it's self/ morphine giving for pain.
pain all over her body, worse at night, has been worsening for the past week, notes a radiating pain that spreads and is much worse now than before has a pending appointment with a doctor tomorrow, no treatments at home Symptoms of muscle and body aches are subsiding gradually. Patient taking Benadryl and Tylenol as directed. Recommended to follow up with primary provider if symptoms worsen.  I adv that given the onset time and duration may also be medical, especially if worsening rather than improving, agreed with dr visit given the current issues. Adv to try heating pad, can try any usual OTC pain relievers if desired as well according to recommended dosing. Adv to call back if issues worsen and we will FU on Wed. for outcomes of tomorrow's PCP appointment and to see if more history can be gathered.
Received an expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, ALLOPURINOL, LOSARTAN and SILDENAFIL for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired first dose). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
PATIENT RECEIVED AN EXPIRED DOSE OF PFIZER.  HE HAD A SORE ARM FOR 1 TO 2 DAYS.  HE WILL BE IN TO BE REVACCINATED
Have severe pain in left shoulder where shot was given, can not lift my left arm, has shooting pain and at times feels like its going to" pop", I have a yearly physical on 11/20/2015 and I am going to request xrays.
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 12-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Erythema and swelling around injection site emerged less than 24 hours after injection.  Erythema continued to increase, so patient presented to ED on 10/12/12.  Returned to ED on 10/13/12 when she developed a fever to 102 F in addition to worsening erythema.  Was admitted to hospital for presumed cellulitis and treated with antibiotics.
Information has been received from a consumer concerning his 74 year old wife with penicillin allergy and arthritis who in November 2009, was vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). Suspected therapy included HUMIRA. Concomitant therapy included methotrexate, prednisone and folic acid. In November 2009, shortly after the administration the reporter noted that the patient developed small spots all over her body-her arms, cheeks, legs, stomach and back. They had been to several physicians and no one had been able to figure out what was going on. Every lab test that was possible including bone marrow test had been done (results unspecified). The reporter thought there may be some issue with the shingles vaccine and the HUMIRA shots she got every two weeks. There were no pustules or open lesions. This was not an outbreak. At the time of this report, the patient had not recovered. Additional information has been requested.
Developed significant redness, warmth and swelling from injection site to left deltoid extending to shoulder and elbow with small patch of vesicles below injection site. Treated with antihistamines.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252181 and 2018SA252198 (same reporter). This case involves patient (age and gender not provided), who was vaccinated with expired dose of PENTACEL (lot number: C5384AA and expiry date: 30-JUN-2018) (dose, dose in series and route of administration were not reported) in the left leg on an unspecified date. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (Lot number, dose, route and site of administration not provided) on an unknown date. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
On day 3 after the vaccine I was very lethargic, I expected some reaction so I didn?t think much of it. However around day 5 the fatigue came back along with a lot of gastro intestinal discomfort.  Again, I didn?t think much of it, until last week I started putting the pieces together and decided by today this was worth reporting.  I have been extremely tired,  diarrhea 2-5 times per day, headaches, and nausea persistently. Since day  5 post vaccine.
A little over a week after the vaccine I begin feeling so tired because my back started feeling  so weard and fatigued feeling.  It was like my back was tired and the muscles were really tensed.   Moving helped but while sitting is when the issue back hurt worse.  I reached out to your Chiropractor on 3/31 who performed a few settings on my back to help with the tension but the pain went up and down during that time and seems as if the pain went away on it on.
pt got 2nd series of DTP/HIB/OPV on 18MAR93 & had 4 hr crying episode that afternoon; cry started out high pitched & would get nl p/mom tried to console; pt would settle down from 5-10mins & start crying again;
Patient is a 79 y.o. male who presents today with worsening shortness of breath and cough.  The patient has a pertinent medical history of chronic obstructive pulmonary disease on 3 L nasal cannula baseline per patient, systolic and diastolic heart failure with EF 54% in Dec 2020, coronary artery disease, PAD, hypertension, and hyperlipidemia.  The patient states his symptoms started roughly 3-4 days ago that included shortness of breath on exertion and cough.  The symptoms progressively have gotten worse over these previous days so he presented to the ER.  He was febrile in the ER and a code sepsis was started and he was given a 1000 mL fluid bolus.  He was requiring BiPAP support 12/6 100%. He subsequently tested positive for COVID so code sepsis was stopped.  Chest x-ray shows interstitial opacities at the lung bases.  Procalcitonin was 0.24.  He was vaccinated for COVID with Pfizer on 05/27/2021 and 06/17/2021.   The patient was admitted to the hospitalist team for further medical management.  He endorses fever, shortness of breath, cough.  He denies sputum production, nausea, vomiting, diarrhea, dizziness, lightheadedness, headaches, chest pain.  The plan will be to start dexamethasone and remdesivir for COVID pneumonia.  Will obtain a D-dimer at this time and can consider CTA of the chest if elevated.  Given her normal WBC and procalcitonin I have low suspicion for concurrent bacterial pneumonia.  He he is currently on BiPAP 12/6 at 35% with plan to wean to high-flow nasal cannula with assistance from respiratory therapy.  Given heart failure history and large fluid bolus in the ER, patient may need intravenous Lasix for hypervolemia and significant bilateral lower extremity edema.  I updated the patient on the plan of care and all questions and concerns were addressed
Pt states received H1N1 flu vaccine approx 2:15 PM 12-11-09, 15 min later arm, injection site, was hot and slightly red. By 12-12 AM upper arm sore-12-12 PM throbbing, 12-13 AM arm heavy, fell asleep with tingling down to fingertips. Numbness 12-13 dropped cell phone. 12/14, 12/15 and 12/16 continues to have tingling down arm into fingertips and throbbing in shoulder. 12-16 Pt reports hand slightly swollen. 12-16 pt into health unit, small bruise at injection site noted, grip slightly less in left hand. No redness or heat seen or felt in upper arms.
Patient had slight swelling and redness at the site in (R) upper arm, warm at site area also. Patient did see primary care physician 3-29-10 and was given a MEDROL dose pack for the inflammation.