chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, ethnicity and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient have had reported the event antibody low after vaccination (suspected immunological vaccine failure).  Laboratory data (dates unspecified) included: Antibody test revealed antibodies becomes very low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210645530-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279742, 2018SA279746, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 59-years-old male patient who was vaccinated with a 0.5 mL dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not provided any information confirming whether the patient experienced any adverse event. 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. List of documents held by sender: none.
This study report was received from an unspecified source, as part of a marketing research study refers to a Caucasian female patient (age reported as 30). Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown) (dose and route not specified). Subsequently, the patient experienced injection site pain. At the time of the report the patient was recovering from the injection site pain. The investigator considered that injection site pain was related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown). Additional information is not expected as there is no consent to contact the patient nor the doctor.
Pt states that minutes after she received the vaccine she started to "feel nausea, lightheadedness and itching at the injection site".  She did not inform clinic staff about this until she was just about to go home after her 15 minute wait.  Vital signs were taken at 14:45 BP 136/106 P 105 SpO2 = 99%.  Temp 99.5.    VS @ 14:52 BP 144/70 P 104 O2 98%.  14:59 BP 146/71 P101  o2 98%.   15:08 BP 137/78 P103 O2 98%.   Skin was cool and dry the entire time.  Nausea subsided after pt drank a bottle of water.  At 15:10 patient stated she felt "spaced out".  Pt was taken to the ED by RN who spoke to the ED MD and ED PA.  While briefly waiting for the triage nurse to bring her back pt described that her "entire left arm was starting to hurt".  Pt remained alert and oriented all the time, without any other complaints.  Respirations sounded normal without a stethoscope, pulse was regular.
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient experienced lightheadedness. Vital signs include BP 121/54, P 78, O2 99%. Cetirizine 10mg PO administered at 08:28. Before leaving clinic, patient felt comfortable with no additional or worsening symptoms.
Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 18:00, the patient experienced fever (102.5F), headache, muscle pain, fast heartbeat. On an unknown date, the patient underwent body temperature measurement and the result was 102.5F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of the event fever (102.5F), headache, muscle pain and fast heartbeat was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
admitted 11/15 for acute respiratory failure requiring BiPAP 2/2 COVID with superimposed Strep pneumonia. Patient was initially admitted to hospital and discharged on oral Azithromycin, Augmentin and Prednisone. She stated that, however, she started feeling worse the following week and was found by cleaning lady over the weekend sat at 72%, and EMS was called. Patient Tested positive for Covid on 11/15. Admitted to ICU for acute hypoxic respiratory failure requiring NIPPV. Started on Remdesivir (11/15- 11/20), Dexamethasone IV (stop date 11/24). Urine positive for Strep Pneumonia 11/15. Patient was initially started on Zosyn but was subsequently de-escalated to Levaquin 750 mg (stop date 11/25) for community-acquired superimposed bacterial pneumonia. Patient continued to improve and transferred to step down on 11/19. PT/OT evaluated the patient recommended SNF. Plan to continue to wean oxygen as tolerated. She at the time of discharge is requiring BIPAP overnight and her baseline 5L during the day. Her hospital course was complicated by hypocalcemia and hypomagnesemia. Workup for her hypocalcemia demonstrated only a low Vitamin D which was also replaced. She is being discharged on Ca, Mg, and Vit D replacement.
issues breathing; pressure in the chest; I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose). At the time of the report, DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does had COVID-19 history, nor myocarditis/pericarditis history.   No concomitant medication was provided.  No treatment information was provided.
pt. vax'd /w 3 doses of Hepatitis B vaccine, subsequent lab evaluation revealed positive HBsAG.
Right arm pain after injection x 1 month. Treated with course of Prednisone.
Patient hospitalized within 6 weeks of receiving COVID vaccination. First hospitalization was 4/19/21, then 5/4/21. On 5/11/21 patient presented to the ED and was subsequently hospitalized for 16 days with decompensation of cirrhosis of liver.
I experienced extremely red cheeks, almost like a sun burn. It hurt to the touch. It started the evening of 4/3/21, but on the morning of 4/4/21 it was worse. By the morning of 4/5/21 it had disappeared.
Excessive crying, irritability on day of vaccine. Vomiting x 3 on 5/10/2011.
Patient admitted to hospital with covid symptoms (shortness of breath, fatigue, and fever 103) after receiving covid vaccination.
Extreme headache rot. Side of head,  extreme back pain in left wing one ,   Runny nose,   Chills  took Tylenol and napped for hrs for two days.       2 heavynosebleeds right nostril  one wk later.     2nd shot on 2-21-2021,    Hot, 4 nights of night sweats,    Two more bloody noses right nostril.   Tired
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic biliary cholangitis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: URSODIOL; MYRBETRIQ; LEVOTHYROXINE; RISEDRONATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 03Nov2022 to 07Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient returned to pharmacy today with redness on the right arm at injection site and spreading to lower upper arm. Red areas were warm to the touch. Pt also complained of arm pain.
sore arm / couldn't lift it; very sore arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 62 or 63 year. Exactly 2 months back from 6th June 2020, the patient received the 1st dose of shingrix. The patient experienced very sore arm, It was so sore she couldn't lift it. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR113970, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR113970:Same patient, 1st dose
Hives on trunk 2-3 hours after hpv admin left eye swollen next day after vaccine given.
After 2nd dose immunization by my tech, I asked patient if she had significant side effect after first dose.  She said she had palpitations for an entire month.   She was seen by her prescriber, Dr, and she was told to continue with her 2nd dose.   She reports no heart palpitations or signs & symptoms of anaphylaxis after her 2nd dose.
Patient states that after receiving the 3rd dose of Pfizer 09/21/2021, started experiencing symptoms 09/24/2021 of muscle aches, fatigue, joint pain, and weakness. Periodically comes back lasting 3-4 days. Primary communications/no recommendations. Patient still experiencing symptoms.
only the adjuvant portion was given to patient; only the adjuvant portion was given to patient; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2021, the patient received Shingrix. On 19th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The reporter informed that, the patient had received an incomplete dose of Shingrix and was vaccinated with only the adjuvant portion (diluent), was given to patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. After noticing this, a valid dose was given on the other arm, on the same day. The reporter also mentioned that, this complete dose was given too soon as per IAC (Individual Accountability and Conduct) guidelines. The reporter declined any patient information and just requested to have the recommendations mentioned. No other data was collected. The reporter consented to follow up.
Arm swelling and red - began the day of the vaccine - stable after 1 day. No treatment.
Chills, fever, dull headache, vomiting, dizziness  Began 24 hours after dose.  Lasted for 18 hours.  Then began again 7 days later and lasted for 48 hours.
MOTHER REFERS THAT THE CHILD PRESENTS IN BOTH ARMS REDNESS, PAIN, HOT TO THE TOUCH WHERE IT WAS VACCINATED.
Information has been received from a licensed practical nurse concerning a 17 year old female patient with no drug reactions/allergies and a history of anaemia who on 08-SEP-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (Lot # 666929/0331Z). Concomitant therapy included multivitamin with iron. The nurse stated that on 08-SEP-2010 the patient experienced headache and burning of the eyes. The patient had been in the office for twenty minutes after receiving the dose of GARDASIL and did not experience these symptoms until she got home. The duration of the symptoms were not specified to the office nurse. The patient did not receive the second dose of GARDASIL due to the patient's mother's concerns about the side effects that her daughter experienced with the first dose. On 10-SEP-2010 blood work was performed, results were not provided. The patient did not seek medical attention. At the time of the report the patient's outcome was recovered. Follow up information was received from a licensed practical nurse who indicated that the student with no illness at the time of vaccination and no pre-existing allergies or medical conditions was vaccinated with a dose of GARDASIL in her left arm. The patient went on 09-NOV-2010 to the reporter's office for her 2nd dose, then her mother reported her symptoms. The symptoms were not right away nor did they last long per the patient's mom. The patient's mother refused to receive the 2nd dose to this date. No relevant diagnostic or laboratory studies were performed. Additional information is not expected.
vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Event updated sore arm to arm pain. No new information was reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
tenderness; heat at the site of injection; swelling; Extreme fatigue still persist; This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, injection site swelling and fatigue. On an unknown date, the outcome of the injection site tenderness, injection site warmth, injection site swelling and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, injection site swelling and fatigue to be related to Shingrix.  Additional details were provided as follows: The physician reported they had a patient who on day 4 after the vaccination still had significant swelling, tenderness and heat at the site of injection. The patient also still had extreme fatigue. The reporter did not consent to follow up.
Vaccine was administered 2 days after the expiration date.  Medical Director notified immediately, and MERCK contacted.  Per MERCK Case Number the stability of the vaccine 2 days past expiration with no temperature excursions is acceptable.  Medical Director notified and no revaccination needed as valid dose per MERCKS guidance. Patients physician reported to us was also notified and agrees with decision.
6 year to 11 year Moderna Booster was given to an adult who needed Moderna bivalent dose.
Tested PCR positive for COVID on 9/28/21 after being fully vaccinated.
MILD GUILLAIN-BARRE SYNDROME; BLEEDING UNDER THE SKIN; EPSTEIN-BARR VIRUS; This spontaneous report received from a patient concerned a 61 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: physical therapy, and acupuncture, and concurrent conditions included: shoulder rotator cuff injury. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2. s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 01-MAY-2021 for prophylactic vaccination. On an unspecified date in 2021, post the vaccination, the patient experienced side effects and lingering pain was gone (dose number in series: 1). The outcome of side effects was not reported and lingering pain was gone was recovered. On 25-OCT-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient reported really, really sick, bleeding under the skin, mild Guillain-Barre Syndrome (GBS) and very serious Epstein-Barr Virus (EBV) (dose number in series 2). The patient stated to be in a good health. The patient's doctor had mentioned to him that bruising was normal when old and had discontinued some of patient's medications including ibuprofen. The patient had undergone numerous tests within a period of 3 months post vaccination. Laboratory data (dates unspecified) included: Bone marrow biopsy was negative for blood cancer, and unspecified tests indicated diagnosis of very serious Epstein-Barr Virus (EBV) and mild Guillain-Barre Syndrome (GBS) (dose number in series: 1). The patient's symptoms were pointing to blood cancer before the test results had arrived. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding under the skin, epstein-barr virus, and mild guillain-barre syndrome. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220511951.; Sender's Comments: V0:20220513079-covid-19 vaccine ad26.cov2.s- Mild guillain-barre syndrome.. This event(s) is labeled per RSI and is therefore considered potentially related. 20220513079-covid-19 vaccine ad26.cov2.s-Bleeding under the skin. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.