chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores. On 30th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th September 2018, 5 days after receiving SHINGRIX, the patient experienced cold sores. On 5th September 2018, the patient experienced tingling lips. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the tingling lips was unknown. It was unknown if the reporter considered the cold sores and tingling lips to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 69 or 70 years old. The patient received the SHINGRIX on an unknown arm. The patient stated she had a cold sore on the side of her mouth. She had no tingling before it appeared. The night before the date of reporting, 6 days after receiving the SHINGRIX, the patient felt a tingling in her lips and experienced another two cold sores on her lips. The patient sought reimbursement.
Guillain-Barré syndrome; This spontaneous case from was received on 29-Dec-2022 from a physician via Agency (reference number: SEQW22-06722), and concerned an adult, male patient. At the time of initial reporting, the patient was 68-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Dec-2014 (also discrepantly reported as 'Dec-2016'), the patient was vaccinated with influenza vaccine (brand not specified; dose, anatomical location, and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in May-2015, six months after receiving influenza vaccine, the patient experienced Guillain-Barré syndrome (GBS).  On an unspecified date in May-2015, the patient was admitted to hospital for treatment of GBS.   On an unspecified date in May-2015, the patient recovered from the event. Since then, in seven years, on recommendation, the patient had never had a flu shot again, and had not suffered anything like GBS, as reported.  On an unspecified date, the patient was discharged from hospital.  On an unspecified date in 2021, the patient was vaccinated with COVID-19 vaccine (brand not specified), and was fine, nothing like GBS happened.  At the time of initial reporting on 29-Dec-2022, the patient reported comorbidities like hypertension and obesity and wanted to know if it is safe for him to start immunization against Influenza again and if flu vaccine has any contraindications in people with a previous history of GBS.  The reporter assessed the event of Guillain-Barré syndrome to be not related to influenza vaccine. The reporter did not think the GBS was related to the flu shot because the event happened only six months after the vaccination.   The event of Guillain-Barré syndrome was assessed as serious due to the seriousness criterion of hospitalization, and additionally was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company Comment: An adult, male patient was vaccinated with influenza vaccine. Six months after vaccination, the patient experienced Guillain-Barré syndrome. Information regarding clinical course, relevant diagnostic findings and corrective treatment was not provided. Causal role of the suspect vaccine is assessed as not related for the event Guillain Barre syndrome, due to chronological implausibility. Agency criteria for the event Guillain Barre syndrome could not be assessed due to insufficient information.; Sender's Comments: An adult, male patient was vaccinated with influenza vaccine. Six months after vaccination, the patient experienced Guillain-Barré syndrome. Information regarding clinical course, relevant diagnostic findings and corrective treatment was not provided. Causal role of the suspect vaccine is assessed as not related for the event Guillain Barre syndrome, due to chronological implausibility. Agency criteria for the event Guillain Barre syndrome could not be assessed due to insufficient information.
Feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in an  unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patients experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. A pharmacist reports that she had had a number of patient complain that they feel sick for at least a day after receiving the Shingrix vaccine.  The reporter consented to follow up.  The pharmacist estimated 50 plus patients. When asked to elaborate on feeling sick she stated it was all the symptoms listed in the prescribing information.
MYELITIS 9/15/2021 HERPES ZOSTER  IDIOPATHIC TRANSVERSE MYELITIS 6/8/2021 HERPES ZOSTER         MYELITIS 9/15/2021 OSTEOMYELITIS  IDIOPATHIC TRANSVERSE MYELITIS 6/8/2021 OSTEOMYELITIS
Since 26 January he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, previously affected his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to his PCM on 28 January where he was treated with oral corticosteroids; he subsequently received two additional courses with benefit. He initially noted intermittent globus sensation (no difficulty swallowing or breathing) but since that time denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He reports that he had started taking Omeprazole two days prior to the onset of his symptoms but his symptoms persisted despite discontinuing this medication. He received his Moderna COVID-19 vaccine booster dose on 13 January, 13 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 19 (2, 3, 3, 1, 2, 4, 1, 3). No history of adverse reactions to prior vaccines.
4/22: Swelling at injection site 4/23: Swelling is worse with redness, seen by MD- dx. with cellulitis - treated with antibiotics
hair started falling out again like it did first shot/my hair falling out like crazy; Numbness in both arms; ringing in ears(still have); sever pain in arm that lasted for 3 months after shot; Very swallow lymph nodes underarm.; Day 5 my scalp started to feel like it was on fire; Messed up period cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 (Lot number: Er8732) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair started falling out again like it did first shot/my hair falling out like crazy"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovering", described as "Numbness in both arms"; TINNITUS (non-serious) with onset 2021, outcome "recovering", described as "ringing in ears(still have)"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sever pain in arm that lasted for 3 months after shot"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Very swallow lymph nodes underarm."; SKIN BURNING SENSATION (non-serious) with onset 2021, outcome "recovering", described as "Day 5 my scalp started to feel like it was on fire"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Messed up period cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, hypoaesthesia, lymphadenopathy, skin burning sensation, menstrual disorder. Therapeutic measures were taken as a result of tinnitus, pain in extremity.  Additional information: Patient had no known allergies and no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Numbness in both arms that lasted about 3 months, hair started falling out again like it did first shot. Patient's hair was still recovering. Therapeutic measures taken for the event included Chiropractor & getting messages, and salt float ta. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Vaccine facility type was reported as Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
lump near my left collar bone; tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 03Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 06:00, the patient experienced lump near left collar bone and was tender to the touch. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the lump near left collar bone and tenderness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 01/24/2023, approximately 02:30PM, I experienced high blood pressure. Prior to that, a few days prior, I had had mild heart palpitations. I saw my doctor on Friday and my blood pressure was still elevated. She wants me to monitor it and see her again in 4-6 weeks. Today it was 132/74.
patient was given expired Daptacel on 31JAN2020/ no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 month old male patient who was vaccinated with an expired dose (0.5 mL, fourth dose in series) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5367AA, and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 31-Jan-2020.  Medical history, medical treatment, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used.   It was reported that patient was given the DAPTACEL vaccine, which was expired on 30-Jan-2020.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Muscle pain, chills, injection site pain and stiffness, feeling unwell, swollen lymph nodes, arm pain.
My COVID-19 symptoms started on 03/27/2023 in the afternoon. I had a slight fever of 100.01 and felt achy. On 03/28/2023 I tested positive. I felt feverish, achy and tired. On 03/29/2023 I developed sore throat along with preexisting symptoms. On the same day I did a telehealth with a doctor through telehealth from my doctor's office. He didn't prescribe me PAXLOVID because he said I was healthy and I didn't need it. He recommended to treat my symptoms as a cold. I used over the counter medication such as TYLENOL and cold & flu medication. I quarantined for 5 days before returning to work.
Parent had not consented to daughter receiving COVID19 vaccine. Vaccine was ordered in error by provider, then given by clinical support staff member. No adverse reactions noted. Parent and patient made aware of error.
administered inj on 19OCT95 pt woke up on 20OCT95 c/o lt shoulder & lt sided neck pain (inj was in lt deltoid) couldn't move extremity w/o it hurting
Severe body aches started 16 hours after injection and lasted for approx 30 hours.  Specifically in back and legs.  Difficulty walking due to pain.  Severe exhaustion started 16 hours after injection and lasted for 40 hours.  Moderate exhaustion for the 24 hour after that.   Mild exhaustion continues at this time (120 hours after injection). Loss of appetite began 16 hours after injection.   Vomiting with empty stomach (water only) began about 36 hours after injection and lasted for 6 hours.
Case number PHEH20114US023192, is an initial spontaneous report from a health care professional received on 17 Nov 2014. This report refers to a 21-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: unknown) subcutaneously from a multidose vial on 13 Nov 2014. On the same day, after vaccination, the patient experienced redness and swelling at injection site. Outcome of the events was reported as unknown. Seriousness and causality of the events was not reported.
1/13/21 body aches, HA, sore at arm.   1/27/21 Sx of chills, flushed, moderate to severe dizziness.  Dizziness subsides within 10 min of rest.   No resp diff noted.  No coughing.  No PCP or Urgent care eval was done.  Pt got some relief with ibuprofen OTC
Case number PHEH2014US015693 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 29 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
significant reduction in herpes simplex outbreaks after the Pfizer COVID reduction of outbreaks around 50~70% less than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) intramuscular, in arm for COVID-19 immunization. The patient's relevant medical history included: "Herpes Simplex" (ongoing), notes: Herpes labials HSV-1 Herpes HSV-2, Onset date: around 1978. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "significant reduction in herpes simplex outbreaks after the Pfizer COVID reduction of outbreaks around 50~70% less than normal".  Additional information: Family medical history relevant to Adverse Events (AES): N.A. It was noticed that a significant reduction in herpes simplex outbreaks after the Pfizer COVID vaccination(s). Reduction of outbreaks around 50 -70 percentage less than normal, if there was a herpes simplex outbreak the duration and severity was lessened. Patient's lifestyle and diet was the same prior to and after the vaccination and very beneficial side effects. Specific relevant test for thromboembolic events with thrombocytopenia was none. Note: for thromboembolic events with thrombocytopenia include specific relevant test above: N.A.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200123893 Same reporter/patient/event, different vaccine dose.;
6 days after MMR was administer, client had high fever of 102 and lasted 4 days along with a red rash.  Parents took client to ER and he was tested for possible problems.  Pediatrician informed family that fever and rash were related to MMR vaccine.
Fever 102.24 ,shivering ,aches, HA ,extreme tiredness , mild nausea at times, joint pain, slight coughing (dry)
Patient recieved Fluzone influenza vaccine on 10/04/2011 IM right deltoid. Called health department on 12/09/2011 to report has been experiencing pain in right arm from shoulder to elbow ever since flu vaccine 2 months ago.  Reports no redness or swelling after injection.  Reports has seen two doctors and had an MRI done which did not show anything that showed thickening at injection site. Said doctor told patient that body's immune system had attacked the flu vaccine and it was an immune reaction which would take time to heal.  Has been treated with a round of steroids, which patient reports made the pain a little better.  Reports arm hurts daily and takes ibuprofen every day.  Has tried both hot and cold compresses.  Encouraged patient to call doctor to let doctor know it is still hurting.  Patient says not using the right arm much and thinks the muscle in the right arm looks like it is smaller than the muscle in the left arm. Has recieved yearly doses of Fluzone vaccine since at least 2007 without any problems.
Left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a weird little side effect where the left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes and then completely resolved. The patient asked when giving the second one should the patient expect a similar response.  The information on the batch number has been requested.
Approximately 1 day post injection right upper arm developed local injection reaction with induration approximately 5.5 X 8 cm, erythema, tender, increased warmth, 1st seen here 6/4/05, follow up evaluation 6/7/04 with minimal improvement approximately 5 X 7 cm with same signs. No shortness of breath/throat swelling/ respiratory signs. None known prior injection reactions.
right arm is red and itchy and has a bump where shot was received. mom is using an ice pack and benadryl to relieve symptoms.
Myalgia; Fever 100.6; Chills; Migraine; Nausea; Severe fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular, administered in Deltoid Left on 22Dec2020 10:00 (Lot Number: EJ1685) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. Medical history included lupus (prior to vaccination), HPTN (hypertension) (prior to vaccination), and sleep (disorder). Concomitant medication(s) included trazodone (TRAZODONE) taken for sleep (disorder), start and stop date were not reported; losartan (LOSARTAN) taken for HPTN, start and stop date were not reported. The patient previously took ibuprofen and experienced allergy (allergic to ibuprofen). It was reported that the patient experienced myalgia, fever 100.6, chills, migraines, nausea and severe fatigue on 23Dec2020 00:30 (resolved with sequelae on 24Dec2020), then on 13Jan2021 21:00 (resolved with sequelae on 15Jan2021). It was reported that patient was allergic to ibuprofen, thus, she took Tylenol for symptoms. Therapeutic measures were taken as a result of the adverse events which included paracetamol (TYLENOL), taken from 22Dec2020 (as reported) to 24Dec2020, then from 13Jan2021 to 15Jan2021. Outcome of the events was first resolved with sequelae on 24Dec2020. The reporting nurse assessed the events as non-serious. It was reported that the patient received the second dose of (BNT162B2), intramuscular, administered in Deltoid Left on 21Jan2021 11:00 (Lot Number: EJ1686) as DOSE 2, SINGLE for COVID-19 immunisation. The patient also received a third dose on an unspecified date.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored PEDVAXHIB (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003603: US-009507513-1708USA003015: US-009507513-1708USA003604: US-009507513-1708USA003605: US-009507513-1708USA003607.
Small 2-3mm lump LUA, not brought to our attention until 3/15/13.
Had a slight fever that developed overnight, aches at lymph nodes and fatigue.  Felt normal but tired at about 11am.  Also the expected arm soreness at the injection site.  I had the same symptoms with the first shot but more intense and lasting all the next day.  For the first shot I had just gotten over a cold earlier that week.  Also on the second shot I made a point of drinking a lot of Gatorade the night of the injection and another the morning after. Otherwise I did things about the same for both.