chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 4 year old female brought by father presenting with drug reaction. On Saturday woke up at 8AM woke up with swelling on right leg.  By 2PM much more swollen and red from knee to hip. Gave motrin with some relief.  Tuesday evening had rash all over body with itching. Went to ER 1AM Tuesday where Rxed prelone and benadryl.  Hasn't started prelone yet.  Sleeping well, no fever, normal appetite and bowel movement . OBJECTIVE: BP 84/50 | Pulse 118 | Temp(Src) 97.3 °F (36.3 °C) (Oral) | SpO2 98%  Patient is alert and oriented , cooperative, cheerful Skin: urticaria on buttuck, both lower extremities and back Lips cracked, not swollen No rash on buccal mucosa Lungs clear Abdomen benign  ASSESSMENT: 909.5 ADVERSE EFFECT TO DRUG/MEDICATION  (primary encounter diagnosis) Comment:   Plan: CLARITIN 5 MG/5ML OR SYRP Use benadryl as second line antihistamine. Use every 4 hours as needed Take prednisolone for 3 days, then stop
Received the J&J shot on n20 July 2021.  Symptom of headache, stomach ache, no energy, groggy etc. started on 6 August 2021.  Went to hospital on 10 August and was diagnosed with Covid 19.
Eczema has gotten a little worse; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema has gotten a little worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Eczema.   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, 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 ECZEMA (Eczema has gotten a little worse). At the time of the report, ECZEMA (Eczema has gotten a little worse) outcome was unknown.            Concomitant medications details were not reported.  The patient stated that he felt that his eczema had gotten a little worse ever since he took the first two moderna COVID vaccine.  No additional information provided.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Patient came into pharmacy on 6/29/2016 at 8:30pm. She had a Large Red Area on her arm at the sight of the I.M. Injection on 6/24, reported it had been there since Saturday 6/25, and had seemingly gotten a little larger and itchier.  She asked if she should see her primary care physician, she was told that that would be a good idea, and she should probly take some Benadryl.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Seasonal Influenza vaccine. Concomitant products included clindamycin and MEPRON. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and cough. The patient was treated with Amoxicillin. On an unknown date, the outcome of the vaccination failure, influenza and cough were unknown. It was unknown if the reporter considered the vaccination failure, influenza and cough to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. During the follow up reporting of case US2015GSK103853 (same patient for adverse events following administration of MEPRON), the caller stated that she was taking MEPRON one tsp twice daily to treat Babesiosis, which was causing the chills and sweats from previous reports. She had been taking MEPRON together with clindamycin and she was getting better since starting that combination. She no longer experience the chills and sweats, which she had been experiencing since she was 22 years old. Recently the patient got the flu, even though she had received the flu vaccine, which had been causing her to cough. She had been taking amoxicillin and the flu was getting better. This case was considered as suspected vaccination failure since the time to onset of the events and the confirmatory lab test details were unknown.
muscle ache, sore arm, slight light headedness, upset stomach, difficulty sleeping the night of the injection
received two doses of Bexsero two weeks apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device , the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's comment: Nurse Practitioner reported a patient inadvertently received two doses of Bexsero two weeks apart. HCP did not have vaccine lot or expiry details, only had gender and age of patient (she called from her car to report). The reporter gave consent to follow up via email. Additional Supportive Information: Inadvertently received two doses of Bexsero two weeks apart, which led to drug dose administration interval too short.
Patient came in for catch up vaccination of Hepatitis A and Polio;  Both medication doses and type were verified prior to injection but during the documentation process it was noted that the vial expired on 10/03/21.  Patient guardian was notified after the fact by phone.
Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was initially stored in the refrigerator on 03-FEB-2022.  The vial was opened on 09-FEB-2022 at 10:00 am. the vial was not discarded and sat out in room temperature for a little over 24 hours.  Treatment medications was not provided.
No adverse event known, needle was 1 and 1/2 inch due to patient weight and after injection did not go directly into the safety shield, was off to the side, possibly went in to arm at slight angle, was still injected into the muscle of the patient.  Needle was pushed into the shield and put in sharps container with no harm.
I started having a sore throat and a bad headache and it felt like a migraine and then I had body aches, fever, runny nose, a little bit of coughing.  It lasted for 5 days.
Severe fatigue, fainting, vomiting, headache, seizures, chills, aches, brainfog
Redness of upper extremity below injection site extending to elbow. Very warm very tender, fever, circumferential edema of upper extremity. Pain with touch and movement. Has not improved since onset.
Large left arm swelling at injection site.  Stiffness, upper arm pain left arm.  Headache.  Fatigue.  Too painful to use left arm.  Slept most of day 10/20/2019.  Tried acetaminophen for relief, not helpful, for headache or arm pain.  Still very sore left arm and mildly fatigued on 10/21/2019 but improving.
mild anaphylactic reaction; Throat felt funny; Throat felt swollen; couldn't breath properly; coughing; wheezing; lip got swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (mild anaphylactic reaction) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to sulfa) and Asthma.   On 28-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 28-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (mild anaphylactic reaction) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen). At the time of the report, ANAPHYLACTIC REACTION (mild anaphylactic reaction), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen) was resolving.            No relevant concomitant medications were provided.  She used inhalers and other at home treatment and thought her Asthma is acting up. She went to her Doctor who told her that she might had the mild anaphylactic reaction from the Vaccine. He gave her prednisone and diphenhydramine to use and she is feeling much better now.  Action taken with mRNA in respect to the events was not applicable.   This case was linked to MOD-2021-100620 (E2B Linked Report).; Sender's Comments:  MOD-2021-100620:dose 1 case
It made my upper right-side pain, chills, fever. I was feeling really sick. I now have stage 4 cancer of the liver. I had pain in my breast as well. I have fluids that build up in my liver. I had to go to the hospital, and I just got out. I now have to see a chemo doctor.
A non-serious, spontaneous report of nosebleeds, tired and hungry has been received from the patient's mother concerning a 12-year-old male patient subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. On 22-Oct-2009 at 3:00pm, the patient received FLUMIST. The next day, 23-Oct-2009, the patient developed nosebleeds. At 12:05 PM, the patient had a nosebleed lasting 25 minutes (first 10 minutes, mostly clotted blood was present). At 2:15 PM, he had another nosebleed and then one more 30 minutes prior to receiving the report from the mother. She indicated the patient also felt tired and hungry. The outcome of the events was not reported.
On the day of my booster vaccine my left arm was more swollen and sore than any prior vaccines or flu shots etc. I woke up shortly after falling asleep freezing cold, shaking and unable to do anything else but grab another blanket which provided no help. I was too cold to move. In the morning the severe chills were gone and I tried to get up from my recliner I had fallen asleep in. I could not get up and felt unstable. After many many attempts I was able to get up but couldn't stand or walk without tipping over and falling. I had to hold onto walls to make it to the bathroom before I wet myself and to grab a thermometer. Upon returning to my seat I felt dazed and out of it.  I took my temperature with 2 types of thermometers. One in ear was 100.7 and one that rolls across your hear 99.8. The rest of the day and part of the next I felt dazed and unsteady, I'm still having random twinges of dizziness but very minor and maybe a few times a day
This medically confirmed spontaneous report (initial receipt 11-JAN-2011) concerns a female patient. On an unknown date the patient received a flu vaccine injection (brand name unspecified). Within a short time the patient experienced 'closing of her throat'. The patient recovered from the event. The reporter considered event serious (life-threatening).
Patient claims the injection was given too high on the shoulder and in the shoulder joint or tendon.  It caused immediate pain and reduced use of her right arm which has failed to resolve.
Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with rash on 01/27/2021, rash is located on the center of her back. She began with pain on 01/26/2021 in the morning, reports her pain is located beneath her armpit radiating both toward the front and back
Throwing up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up). At the time of the report, VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  and treatment medications were reported.
Awakened with headache, nausea, chills, Lf. upper arm swollen, red & painful (size of palm of hand). temp 102po & chills that evening. Ibuprofen q6h 10/14, 15 & 16. Lightheaded 10/18, swelling improving. Today, 10/19, feels fine, arm slightly swollen, red & warm.
This spontaneous case, initially received on 28-Nov-2017 from other health professional (nurse), concerning a 25-year-old, adult female patient. The patient current condition included: depression, migraine and hypertension. The patient concomitant medications were Nortriptyline, Melatonin, ZOFRAN, labetalol and naproxen for migraine. On 08-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195249, expiry date: Jun-2018). On 09-Dec-2017 (not sure), the patient was feeling more depressive after receiving the flu vaccine. At the time of the report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 09-Feb-2018: Follow-up for this case is not being sought as reporter information is not available". Hence this case is considered as lost to follow up.
Dose 2 was at 1100AM on 2 Apr2021.  at about 630pm same day, started to get heat flashes and chills, temp was 100 degrees. took Tylenol at 9pm.  Slept till 130 am 3 Apr.  Woke up in sweat and temp at 102.1.  Took another Tylenol about 145am 3 Apr.  Slept till 9am 3 Apr 2021.  Woke up with temp at 100, felt run down and cloudy.  Took IB and napped off and on till 6pm 3 Apr.  Temp at that time was down to 99.  Went to bed at 1100 pm 3 Apr, took IB, slept till 6am 4 April.  Temp 98.6 the rest of day. Arm was still sore, yet no other symptom was observed.  aches and pains went away, temp was back to normal, 98.6.  5 April, normal, temp 98.2.
This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 50 year old female with HIV disease, hypertension, shellfish allergy and sulfonamide allergy who on 26-JAN-2006 was vaccinated (route unknown) with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 27-JAN-2006 the patient developed swelling at the injection site, a red 1.25 inch area, tenderness, firmness, and induration after vaccination with pneumococcal 23v polysaccharide vaccine. The patient's present status was reported as not recovered. Registered nurse also indicated that the patient was able to lift her arm but that it was very sore. The patient was still able to perform her activities of daily living. The nurse did note consider it to be a serious/significant disability. Additional information has been requested.
Patient received 2nd dose vaccine and came to the EC for shortness of breath and loud wheezing, patient has significant history for bronchial asthma (last hospitalized for bronchial asthma exacerbation 2/2020).Patient states she had been wheezing for about a week, but more noticeably in last 1 day.
Patient developed flu like symptoms.  He  tested positive for COVID on May 6.  He was not symptomatic at the time of the first dose of the Moderna vaccine
Approximately 30 seconds after giving injection- patient became pale and diaphoretic with high response. I encouraged to sit down lower her back slowly breathing. Approximately 10 seconds later she flared her head up and her body started  to jerk hands contracted inwardly to her body and eyes rolled back. I rushed out to call 911 and office staff promptly called. After body ceased convulsing checked pulse- strong at reg 88. She would not respond to voice commands until I applied pressure to upper arm.  Continued to feel dizzy upon standing up.
This spontaneous report was received from a Registered nurse regarding a 18 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Jan 12, I noticed a small reddened area about an inch and some swelling. nurse told me to draw around the border of it. It progressed over to a bigger area on the 13th - and spread more - it ended up being 3 or 4 inches. Spreading, red, and warm, and swollen. It didn't affect use of arm.  Swollen glands on the 14th. doctor (workman's comp dr) - on 15th of January - gave me some Prednisone - so Saturday, 16th, I had sore throat, swollen glands and worst headache I had in my whole life -  I had taken one Prednisone and the evening I stopped taking Prednisone because I thought the headache was result of it.  Original spot was fading on the 15th.   I started to get shooting pains on sternum area and clavicle. Evening of 18th,  I noticed rash on left shoulder and a little tiny blister on my sternal notch. I  had I talked to Dr  on 19th and he thought it was Shingles. I saw my regular  health dr - my regular PCP Dr on 20th of January  - He prescribed - Acyclovir and Gabapentin - for shingles. I had a very wicked case of singles. I contacted Moderna about  and February 3rd, 2021. Shingles was still happening at time of second dose.
on 01/09/2021 I had an immediate reaction with an itchy rash all over my body that lasted 3 days. I controlled it with Benadryl and ranitidine. on 01/30/2021 I took Benadryl before getting this dose and I had a lenticular rash from the chest up for 1 days.
This is a spontaneous report from a contactable consumer. A female patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at unspecified dose. Relevant medical history and concomitant medications were not reported. After a couple of hours from vaccination the patient was not looking too good and was super nauseous. Outcome of the events was unknown at the time of this report. Follow-up (10JUL2015): Follow-up attempts completed. No further information expected.
He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.; He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) in a female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.). At the time of the report, INFLUENZA LIKE ILLNESS (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) outcome was unknown and ABDOMINAL DISCOMFORT (He states that he felt like he had the flu and was sick on his stomach for 8 hours that day.  And the other person said they had the same thing.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
On an unknown date, the patient was vaccinated with a third dose of GARDASIL (Lot No., dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, afterward of vaccination, the patient experienced fever (pyrexia), aching muscles (myalgia) and his left eye was "blood shot" (ocular hyperaemia). The outcome of ocular hyperaemia, myalgia and pyrexia was unknown. Additional information is not expected due to no contact details for perform follow up.