chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient experienced hives all over body (legs/back/arms/stomach/face) but did not have any reaction around the injection site. Patient did experience tenderness at the injection site.
On Friday, April 1st at ~11:30AM I received the Shingrix vaccine. At 6PM the same day I started experiencing the following symptoms: Redness on my left cheek, and an ice pick headache. Over the course of the weekend the red blotch grew to what I thought was a huge skin infection and the ice pick headache was enhanced to include what can only be described as brain seizures/electric shocks which would last 1 second but were happening 3 or four times a minute. The pain in my face was and is excruciating; like getting burned with a blow torch. On Monday, after seeing the appearance of a cold sore on my upper, something I have never had in my life, I went to the Drs. office and was diagnosed by with shingles. I was prescribed an anti-viral; 1 gram Valacyclovir to be take 3 times a day every 8 hours for 7 days. At this point cold sores had started to break out on my upper lip. As of today, April 6th, 2022, I have boils on my upper lip, the strip of skin under the nose, on my nose and multiple on my cheek. The inside upper left gums are extremely sensitive making it super painful to eat or brush. The ice pick head and seizures continue although they are somewhat diminished. The area on my head where these are generated is extra sensitive to the touch due to the non-stop activity. The medication seems to be having a slowing effect as I do not see it spreading further. Other than 3 advils I have taken no prescription pain medication. The ?Vaccine Information Statement? I received from my Dr. did NOT include the risk that the shingles vaccine would trigger a shingles outbreak. Had I known this I would not have taken the vaccine. Hopefully my experience will help others make better informed decisions.
Two (2) staring spells: (1) 8/2/11 at 5:20 pm (2) 8/3/11 at 11:30 am. 9 1/2 cm x 6 cm area of erythema at site.
Pt reported in the Wednesday evening after receiving vaccine she developed chills fever and severe headache lasting thru Sunday, fever 102 on Thursday, fever broke Sat afternoon. headache lasted till Sunday. Saw Dr On Monday. Told no more pneumonia shots.
Patient reported leg pain and itchy throat about 30 minutes after receiving a Pfizer Covid vaccine. He did not seem distressed. After sitting in the observation area for 30 more minutes, he reported that his legs felt fine and his throat was getting better. Patient's mother opted to give him some diphenhydramine and take him home. Recommended close observation and that patient's mother contact his physician or seek immediate care if symptoms worsened.
Fever, diaphoretic, full body muscle aches, swollen and painful lymph nodes in the right side of the neck, muscle pain at the injections site in right arm, metallic taste in mouth, fatigue, headache.
Vaccination at 12:26 p.m. By 4 - 5:00p.m. I knew things were not going well. By 10:00 p.m. my temp was 100. Didn't really sleep; chills like I've never had before and general body aches, particularly major joint stabbing pains. By  the next morning my temp was 102.7. Temp broke during the next night and 3/18/21 by the afternoon I had a half moon shaped shingles rash on my arm at the injection site. About 4" wide and 2" deep with pain and itching. The rash lasted over a week.
In about 2016, I was diagnosed with stage 0 chronic lymphocytic leukemia. I was asymptomatic, and my situation has been closely monitored since then. Sometime in February 2023, I underwent a routine blood test that was used to monitor my condition. As soon as my oncologist got the results, he contacted me and informed me that my blood cell count was abnormal and that I needed to go to the hospital. On 2/17/2023, I was admitted to the hospital. My condition was stabilized without the need for a blood transfusion. They also started me on a new medication,  Brukinsa, which I was to take daily afterwards. However, I had very severe side effects (intestinal problems, bone and muscle pain) that were possibly caused by it. However, the Brukinsa was effective in bringing my blood cells to normal levels. I was in the hospital for five nights. I have now been off the Brukinsa for three weeks, and I'm awaiting to see if something could be done for the side effects.
Bruising spot near elbow on left arm 4 days after injection. Bruising still ongoing in same area.
This spontaneous report was received from a pharmacy intern, referring to a 9 month old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On unknown dates, the patient was vaccinated with the first and second doses of ROTATEQ orally, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On an unknown date, the patient missed the third dose of ROTATEQ.
Tested + 09Jun2022; Tested + 09Jun2022; sx of allergies ST; Runny nose; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 35-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EP6955) and on 16Apr2021 as dose 2, single (Lot number: EP6955) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Dec2021 as dose 3 (booster), single (Lot number: 067421A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 07Jun2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 07Jun2022, outcome "unknown", described as "Runny nose"; HYPERSENSITIVITY (non-serious) with onset 07Jun2022, outcome "unknown", described as "sx of allergies ST"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "Tested + 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Covid test type post vaccination: Nasal swab tested.  Clinical course: The patient was diagnosed with of allergies ST, runny nose and fatigue starting 07Jun2022 and then tested 09Jun2022. The patient did not had covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Information has been received from a RN concerning a 3 year old male who's 12 year old female sibling was vaccinated with a dose of varicella virus vaccine live on 05Dec2003. On 19Dec2003 the pt developed chickenpox. It was also noted that the disease was currently in the local schools and community. The pt's vaccinated sibling had no symptoms. Additional information was received from the RN which indicated that the pt broke out in chickenpox on 19Dec2003. The reporter indicated that the pt's pediatrician said that it was from the vaccines. It was noted that the pt and his sibling had no adverse events following prior vaccination. Follow up information was received from the RN who indicated that the pt did not received varicella virus vaccine live. The pt contracted chickenpox allegedly from his sister who received the vaccine. It was noted that the pt was never seen at the Doctors office. No further information is expected. The reporter also indicated that the pt's 12 year old sister had an adverse experience after therapy with varicella virus vaccine live.
immed following saline diluted varivax 4/20/98 pt devel ``some local reactions''
The patient came into the pharmacy 10 days after the injection to let us know she had experienced an adverse event from her shot on 12-2-19. She said she woke up the next day and her arm was swollen, red, and hot. Her skin was blotchy with a rash and she had a small bruise but it was not at the exact spot of the injection site. She told me she called her doctor to discuss it because she thought she was just having an adverse reaction to the shot. She said she only had the flu immunization once before and it was last year with the mist. She also had two children immunized the same day and they did not have any problems at all.
Patient received both Flu & Pneumo vaccine. Reported very sore arm where Pneumo vaccine given. Did not feel well. Had to lay down. Overused arm while cleaning.
No adverse event but patient received the incorrect vaccine.  Should have received the Pfizer Bivalent booster instead
Fatigue,  Body aches,  Dizzy,  light headedness,  nausea,  tremors in hand, Arms and legs Trouble breathing, Headaches
This spontaneous report was received from a 51 year old male consumer referring by himself. The patient's medical history and concurrent conditions were not reported. On 03-FEB-2017, the patient was vaccinated with the 1st dose of VARIVAX parenteral injection in the left arm (lot # and expiry date were not reported) to prevent chicken pox. On the same day, he was also vaccinated with a dose of influenza virus vaccine (unspecified) (flu shot) in the right arm. The patient was using Unspecified concomitant medications. On 03-FEB-2017, the patient developed an injection site rash in the arm where VARIVAX was administered. Afterwards, the patient felt chilled (feeling cold) and tired (fatigue). The rash persisted for three days so, he was treated with diphenhydramine hydrochloride (BENADRYL). He felt better now and the rash was gone but he was still tired. He suspected that he might feel tired as a result of depression. The patient said he has no recollection of ever having chicken pox or a vaccination against chicken pox and suspected that was why he was administered VARIVAX and not ZOSTAVAX (wrong drug administered). He was still considering taking his second dose of VARIVAX but had not made the final decision at this time. The outcome of feeling cold and fatigue was reported as covering/resolving. The outcome of depression and wrong drug administered was unknown. The outcome of injection site rash was reported as recovered/resolved on an unknown date. No causal relationship was rated between the events and the VARIVAX therapy. Additional information has been requested.
I receive my second dose on April 9 2021 at 10:00am I had pain in the arm at 4:30 am I star having chills, joint pain muscle pain headache, fatigue and fever of 101.9 it last for 3 days. fever only 1 day I still have headache and my arm is getting red and swollen with pain.
Erythema, edema and tender at injection site of DTaP- (L) upper arm. BENADRYL given x3 days.
This is a spontaneous report from a contactable medical assistant calling on behalf of a nurse. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA, (lot number: R56652, expiry date: 30Sep2017, NDC number of TRUMENBA: 00005010010), in the physician's office via an unspecified route of administration at right deltoid on 06Oct2017 16:23 at a single dose as needed vaccine for college. Medical history included mild asthma, anemia, chronic tinnitus and tonsillectomy. Concomitant medication included 8th dose of influenza vaccine (manufacturer: GlaxoSmithKline, Lot Number:PN75E; Expiry Date:31May2018) intramuscular at left deltoid. On 06Oct2017, TRUMENBA that had been expired for 6 days was given to a patient. A day after the vaccination, on 07Oct2017, the patient experienced headache and slight fever (described as the patient was warm). The outcome of the events was unknown.
(L) arm swelling pain, redness, itching, joint aches, skin sensitivity nausea.
A itchy; Had like a little rash in her back and expand to her legs, arms and  thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A itchy) and RASH (Had like a little rash in her back and expand to her legs, arms and  thighs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a, 020b20b and 016c21a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (pills for arthritis), Cramps (pills for cramps) and Acid reflux (oesophageal).   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (A itchy) and RASH (Had like a little rash in her back and expand to her legs, arms and  thighs). At the time of the report, RASH PRURITIC (A itchy) and RASH (Had like a little rash in her back and expand to her legs, arms and  thighs) outcome was unknown.     No medical history was provided by the reporter.  Relevant concomitant included Pill for cramps, pill for arthritis and acid reflux.  No treatment information was provided.
Intense itching, raised redness about 3? in diameter lasting about 12 hours. Took Benadryl po. Used ice pack at site.
Vision loss for 15 minutes. Cause unknown. Diagnosis by exclusion is ocular migraine.  Waiting for echocardiogram to rule out possible stroke.
A spontaneous report was received from a consumer who was  73-year-old female patient who received the Moderna COVID-19 vaccine and felt very bad at night, shivering, fever, headache and body aches. Patient's medical history not provided. No concomitant medicines taken by the patient. On Jan 14, 2021 (approximately one day prior to the onset of the symptoms), patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On Feb 11, 2021 patient received their second of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On Jan 14, 2021, patient felt very bad at night, shivering, fever, headache and body aches. The symptoms is ongoing. Rechallenge is positive. No treatment taken by the patient. Action taken with mRNA-1273 not reported. The outcome of the events, felt very bad at night, shivering, fever, headache and body aches considered not recovered.
Site of vaccination is red bumpy, swollen, warm and itchy.  Notice throat congestion and notice tired after short walk, itchy all over arms, back of neck, called Dr.'s office and told to take Benadryl and see if that helps, if not go to hospital to get help.
Patient is a 60-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient has history of smoking and elevated blood pressure. No history of allergies. At 11:14 am, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 11:30 am, patient notified EMT that she was experiencing numbness in left fingers. EMT assisted patient to anti-gravity chair. Patient states she has not eaten. Patient was given a granola bar and water bottle. Patient remained A&Ox4 and talking to EMT. Lead RN was notified of reaction. RN requested vitals Q5 minutes for 30 minutes. At 11:33 am: BP of 137/91, HR 88. At 11:35 am, patient states numbness is ?improving?. At 11:40 am: BP of 132/99, HR 77, SPO2 99%. At 11:44 am, patient states numbness in fingers is ?almost gone?. Patient denies any additional adverse symptoms, such as dizziness, lightheadedness, and shortness of breath. At 11:50 am, patient sat up with a BP of 152/94, HR 80, SPO2 99%. Patient states she is "feeling better" and requested to leave facility. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 11:52 am, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's husband drove patient home.
AFTER 2nd MODERNA VACCINE THIS PT HAD BODY ACHES, HEADACHE AND LETHARGY. PATIENT STARTED ITCHING THAT EVENING AND WAS ITCHING FOR 5 DAYS THEN DEVELOPED HIVES.  WHICH SHE HAS HAD SINCE 3/6/21 THE DATE OF HER VACCINE. SHE ALSO DEVELOPED A RING AROUND THE INJECTION SITE
5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021 at 9:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021 at 9:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 20-Sep-2021 at 9:54 AM, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was stored in refrigerator on 09-Sep-2021 and initially punctured on 16-Sep-2021 11:45 AM. Vial was stored in fridge after used in room temperature at 8 to 25 degree Celsius. and vial did not undergo any temperature excursion.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Patient felt dizzy right after the administration of the vaccine. She was asked to sit down and BP taken at that time was 139/99. Patient sat and drank some water and about 5 minutes later, BP was 135/95, and she said the dizziness improved a little. About 10 minutes later, patient said her hands were tingling and she felt nauseous. Patient was offered to drink and after a few sips, the nausea subsided. BP was retaken and it dropped to 125/94. Patient said she does not take any BP med but forgot to take her Flecainide dose for the evening. Patient claimed she felt much better after another 10 minutes and preferred to go home to lie in bed. Her husband accompanied her and said he would continue monitor her BP at home.
Per patient she went home and her arm hurt and was hot to touch. (This happened Monday). She said she put ice on it after church and at 3am Thursday morning she couldn't get out of bed. She believed she had some kind of reaction to SHINGRIX. She stated she was given a steroid and she felt fine now.
Pin-like needles in my chest, back, and upper arms that itch very much. This only happens after exercising or anything that fatigues me. It lasts for about ten minutes any the subsids.
I received my first dosage on 2/16. Approximately 7 days later I broke out itching on my chest , neck, arms, legs and stomach. I was advised then to take Benadryl to relieve the itching.  I was told to take benadryl the night before and the morning of my 2nd shot which I did. 2nd dose was given on 3/12. On Monday 3/15, I again got the say rash , this time on chest and next. Took Benedryl and Dr. Prescribed Prednisone for 5 days
Had them and had the vaccine/suspected vaccination failure; Had shingles; Writhing in pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (single shot vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had them and had the vaccine/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shingles) and pain (Verbatim: Writhing in pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received dual shot of shingles vaccine. The patient experienced shingles for over a month. The patient was writhing in pain and wanting to scream. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
She just started feeling very tired and achy. Then it progressed to flu like symptoms. Started getting nausea and headache. She also had severe body aches all over. Severe exhaustion. She called her doctor. He told her to take the normal over the counter ibuprofen and sudafed. And drink lots of fluid and rest. It took 4 days to get better.