chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HYPOTONIA; STUPOR; DIARRHEA; FEVER; Initial information received regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 4 months old male patient who experienced stupor, hypotonia, fever and diarrhea while receiving vaccines ACEL IMUNE, HIBTITER, ROTASHIELD and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: Patient History Comments: Unknown Ongoing Disease (illness at time of vaccination): None    On 01-Jun-1999, the patient received a dose of suspect ROTASHIELD, HIBTITER and ACEL IMUNE not produced by Sanofi Pasteur and suspect IPV (VERO) (dose, formulation, strength, lot and expiry date: unknown) via unknown unknown administration site for prophylaxis vaccination.  On 04-JUN-1999 the patient developed a non-serious fever (pyrexia) and diarrhea (diarrhoea) (latency 3 days) following the administration of IPV (VERO), ROTASHIELD, HIBTITER and ACEL IMUNE.  On 08-JUN-1999 the patient developed a serious hypotonia (latency 7 days) following the administration of IPV (VERO), ROTASHIELD, HIBTITER and ACEL IMUNE.   On an unknown date the patient developed a serious stupor (unknown latency) following the administration of IPV (VERO), ROTASHIELD, HIBTITER and ACEL IMUNE.   Relevant laboratory test results included: Laboratory test - On an unknown date: [Unspecified blood work and tests: "normal" Blood chem.: CA - glucose SGOT - LDH, CBC, CT scan and EEG.]  (Other relevant tests included Unspecified blood work and tests: "normal" Blood chem.: CA - glucose SGOT - LDH, CBC, CT scan and EEG)  Action taken: not applicable for all suspects.  It was not reported if the patient received a corrective treatment for the events (STUPOR, HYPOTONIA, FEVER, DIARRHEA).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events (STUPOR, HYPOTONIA, FEVER, DIARRHEA).  Seriousness Criteria- hospitalization and medically significant for Stupor Hospitalization for Hypotonia  Additional information received on 19-Aug-1999 following changes were updated.  event onset date for pyrexia and diarrhoea updated and narrative amended accordingly.   Upon internal review on 04-NOV-2022, case 992130-1 (to be deleted) was identified to be duplicate of U1999-00529 (to be retained). Hence, all the information from the case 992130-1 (to be deleted) has been merged in the case U1999-00529 (to be retained); Sender's Comments: Sanofi company comment dated 04-Nov-2022: This case involves a 4 months old male patient who experienced stupor, hypotonia, fever and diarrhea while receiving vaccines ACEL IMUNE, HIBTITER, ROTASHIELD and IPV (VERO) [IPOL]. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
The IgG serology showed no titer response following a pneumococcal vaccination; This literature marketed report as received from the authors of a published literature article, titled as stated above, refers to a 49-year-old male patient with past medical history significant for mixed connective tissue disease, rheumatoid arthritis, and systemic lupus erythematosus.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumococcal vaccine) injection (dose, route of administration, anatomical location, lot # and expiry date were nor specified) for prophylaxis.  The patient's rheumatological symptoms were controlled by a combination of methotrexate weekly and rituximab every six months since 2008. However, the prolonged course of rituximab resulted in chronic pansinusitis which led to a diagnosis of acquired humoral deficiency. In 2017, the patient was referred by an otolaryngologist for an immunological evaluation because his chronic pansinusitis did not resolve with septoplasty and bilateral sinus surgery followed by several rounds of clarithromycin. His laboratory results revealed poor humoral function as demonstrated by peripheral lymphopenia with zero absolute CD19 count with an absence of IgA (<5 mg/dL) and IgM (<5 mg/dL), but a normal level of IgG (739 mg/dL). The IgG serology showed no titer response following a pneumococcal vaccination. His IgG subclass 1 was 599 mg/dL (normal), IgG subclass 2 89 mg/dL (low), IgG subclass 3 was 34 mg/dL (normal) and IgG subclass 4 was 13 mg/dL (normal).  The outcome of the event was not reported. The author considered the event to be related to the pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
Pt recvd vax & 3 days following vax pt devel elevated liver function tests;
4/15 day of injection went and worked out at gym per usual. 4/16 went to work but felt like she could not get warm, worked full day, home and to bed at 4:30 PM. Slept until next morning. Felt feverish for 2 full days. 4/20 Returned to clinic for assessment, erythema measures 18.5 cm by 11 cm; to be seen by Dr's partner.
Got 2 Shingle shots, Got shingles/Suspected vaccination failure; Shingles all over body; left toe turned blood red; left toe swole up; 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.   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: Got 2 Shingle shots, Got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles all over body), erythema of extremities (Verbatim: left toe turned blood red) and swelling of feet (Verbatim: left toe swole up). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the erythema of extremities and swelling of feet were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, erythema of extremities and swelling of feet to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, erythema of extremities and swelling of feet to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The patient's physician talked him/her into getting the Shingles vaccine. The patient had 5 brothers and 5 sisters, none of them have ever gotten shingles.  After the second injection, the patient started with shingles all over body.  The patient's left toe turned blood red and swole up, like he/she had gout.  The patient looked up the side effects of the vaccine and had them. They tried all sorts of meds, and the stuff cleared up except on my arms. The patient had to out up with this everyday. The patient stated to beaware as there were side effects for people. The patient wished he/she had never gotten it. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PT RECEIVED MODERNA COVID VACCINE ON 1/16/2023 TO RIGHT DELTOID AT 0930 AND THEN BY 1300 NOTICED LUMP PRESENT TO RIGHT AXILLARY, THEN ON TUESDAY HAD INCREASING PAIN AND BURNING WITH PERSPIRATION. DENIES ANY DECREASE ROM.
4 hours after my tongue swelled up; throat in my left side swelled up; 12 hours later left arm hurt; 24 hours later numbness on my spine middle section; nausea; dizziness 1-4 days; period texture and color change-black and chalky texture; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the left arm on 03May2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seafood allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 21:15, 4 hours after the vaccination, the patient's tongue swelled up and throat in her left side, 12 hours later left arm hurt, 24 hours later numbness on her spine middle section, nausea, dizziness 1-4 days, period texture and color change-black and chalky texture. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events patient's tongue swelled up and throat in her left side, left arm hurt, numbness on her spine middle section, nausea, dizziness, period texture and color change-black and chalky texture was resolved with sequelae on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: en6198), in right arm, on 03May2021 as dose 2, single (Lot number: ew0170), in right arm and on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: Nasal Swab.
Nausea; Chills; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at an unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was sick for about four and a half days. The patient had nausea, chills, and diarrhea. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flu like. Body/head aches. Chills. 102 fever. Took ibuprofen. Lasted approx 24 hrs.
Pfizer Covid-19 shot - The lymph node in my neck swelled up and is tender, along with a lymph node on the front of my shoulder, which usually just gets sore.  It is swollen and sore with this shot.  The lymph node in my neck gets swollen and sore for a few days after I have a flu shot.  This is typical for me.  However, I was advised to report this if it is different in any way.  The difference is 2 swollen lymph nodes.
Headache, Fever, Diarrhea, Malaise and Pain at Injection Site, Abdominal Pain Narrative:
Ten day post vax, pt experienced posterior auricular adenopathy and a rash. No further information is available.
Patient in office with Grandmother on 6-7-18 stated that 3 day after vaccine she started with back pain, neck pain and headache.
Swelling arm Soreness arm Redness arm Arm is hot Vomiting, diarrhea and chills for about 2 hours on night of vaccine
Migraine headache; cold chills; body aches; cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 15:00 (Lot number: FC3184, Expiration Date: 30Jan2022) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "had a stoke 3 years ago" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number FA7484;exp:30Sep2021, administration time 05:00 PM, vaccine location Left arm), administration date: 16Aug2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: MIGRAINE (non-serious) with onset 08Sep2021 18:00, outcome "not recovered", described as "Migraine headache"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 08Sep2021 18:00, outcome "not recovered" and all described as "cold chills"; PAIN (non-serious) with onset 08Sep2021 18:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of migraine, chills, pain, nasopharyngitis.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified prescription medicine within 2 weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19   No follow-up attempts are possible. No further information is expected.
Feels weak; No appetite; Short of breath/Winded going up and down stairs; This is a spontaneous report from a non-contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 24Mar2021 as a single dose (at the age of vaccination 39-years-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, it is unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced short of breath (2 days after shot, felt short of breath, after moving equipment, had to sit for 10 mins and just catch breath) and on 28Mar2021, the patient was feeling weak, winded going up and down stairs and did not have appetite. Considered going to hospital for IV fluids. It was unknown if the patient had received any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events short of breath/winded going up and down stairs, feels weak and no appetite was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lost taste  and smell, body aches, headaches, nauseous, throat hurts, diarrhea
I had my Moderna booster on 11/9 and broke out in hives in the middle of the night on 11/19  incredibly itchy around my hairline and upper back and couldn?t go back to sleep. The next two weeks were miserable, constant hives that travelled everywhere, but mostly on my hands and legs and neck. I landed in the Dr twice during that time (once for the hives, once for a full day of vomiting from the prednisone dosage that I had to go to urgent care because I couldn?t keep water down.) I would describe my hive pattern  as redness,  splotchy, not raised, travels everywhere, including inner ear and genital region. They?re mostly itchy but sometimes just feel ?hot.? I notice them mostly at night, or during the day if I?m very stressed. They have slowly gotten objectively better over the weeks from 24/7 severe hives with no alleviation from meds to wake up every few nights with them and a high dose antihistamine will kick them for the night.  Initially did not report as 10 days seemed delayed for a rxn. No history of hives, and no known history of Covid dx
Woke up this morning with golf-ball size hard lump at injection site.  It is raised, red, and just a little itchy.  I have not sought any treatment.
received a Shingrix /had a sore arm / is common side effect.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The reporter initially called to inquire about the components used in the making of Shingrix vaccine, then she mentioned about her husband who received a Shingrix vaccine and experienced a sore arm.  The reporter inquired if the sore arm was common side effect. The reporter told that she had an appointment and therefore she must leave.  The reporter ended the conversation, therefore, unable to collect the following information, patient's initials, patient's full mailing address, lot/expiry date, route and date of administration, first or second dose, left or right arm, when did the symptom started, and if the symptom has been resolved or not. The reporter did not gave a consent to follow-up with health care professional, therefore, did not collect health care professional contact information.  The reporter mentioned that safety may reach out to her if there are any follow-up questions.  The reporter provided her email address. The reporter did not consent to follow-up.
Patient is said to have started with fever immediately after the vaccines were given and was given motrin without improvement. The baby had two febrile seizures ( first seizure at 7pm and the second was later that night) observed and described as shaking and loss of consciousness. The baby was admitted to PICU at Hospital and released on 7/24/2019.
Prior to receiving the vaccines, I was in perfect health at 66 years of age! About three and a half weeks after receiving my first dose, I woke up and my knees were stiff and swollen. It felt funny to walk. My ankles were swollen also. I still went and got my second dose on 03/16/2021. On 03/17/2021, first thing in the morning, I tried to get out of bed and I had to call my husband because I could barely walk. I called him to take me to the hospital. I decided to shower to before going to the hospital, and when I got out of the shower I started to feel dizzy/lightheaded and nauseous. I lay on my bed, because I was feeling faint and called my husband again to see if he could come get me right away. I went to the hospital, and had to be put in a wheelchair because I could barely walk. I had x-rays on both knees and blood work. I was given a low dose steroid at first to help with the swelling, but it did not help. I told the doctor about it not helping and was prescribed a stronger steroid. I was on steroids for about four to five months. I was also having swelling and pains in my hands and wrists to the point that I couldn't hardly use them. It looked like I had a big lump on both hands. After seeing the Rheumatologist, I was told that I had the rheumatoid antibody. As of today, I feel better because of the Plaquenil and Methotrexate that I was given. As of three weeks ago, my white blood count was low so now I'm only taking Plaquenil. I go this week to have a blood test performed to see if my white blood count has improved. I'm doing well, without the Methotrexate. I wasn't able to walk well, for a few weeks, and I still have a little swelling on the bottoms of my feet. My wrist and fingers are doing better. The swelling has gone down on them.
Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
Patient had pain, redness, swelling and itching. pain was only on night 1 and is resolved. At day 7 she has only itching per pt.
Chill, pain all over the body and a large area of the arm swelled, red and painful.
1st dose: day after had extreme headache for over 4 days, loss of appetite, anxiety 2nd dose (6/8/2021): day after had extreme flu-like symptoms (headache, body aches, fatigue) for over 4 days and lingered on. On 6/19, after inadvertently ingesting soy in food, had more severe reaction than normal to this date (6/23). Went to Urgent Carer (6/22).
Information has been received from a physician concerning a 11 year old female who on 24-JUN-1998 received her first dose of VARIVAX (Merck) (lot # not provided) and on 02-OCT-2008 received her second dose of VARIVAX (Merck), 0.5ml, subcutaneously (lot # 661651/0989X). There was no concomitant medication. The patient had no medical history or drug allergy. On 03-OCT-2008 the patient experienced redness, swelling, induration and vesicular lesions at the injection site of the right upper arm. The patient sought medical attention and was prescribed a course of AUGMENTIN. On 06-Oct-2008, follow-up exam revealed the symptoms resolving. Additional information has been requested. This is one of several reports received from the same source.
After the shot I got all the expected side effects, malaise achy, fatigue, which lasted 3 days. Then as soon as they went away, I developed a migraine that lasted the better part of 6 weeks. This was distinctly different from my baseline migraines that were well controlled at the time of my vaccine, which includes location intensity and frequency.  Shortly after migraines resolved I was diagnosed with a sensory neuropathy.