chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first two doses in 2016, third 28-JUN-2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (the patient received his first two doses of Twinrix in 2016).   On 28th June 2022, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:28-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Twinrix adult later than the recommended interval, which led to lengthening of vaccination schedule.
pt recv vax 13NOV97 & 14& 15NOV97 pt exp lymphadenitis;it was reported that the sx resolved w/in24hr to 7 days;
Red dots all over body; itchy lightly; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. 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 COVID vaccine. The patient did not receive any medication within two weeks of vaccination. On 21Apr2021 at 16:00, the patient had red dots all over the body which was started to appear on the 3rd day. It was the 5th day and the patient still had them. They itched lightly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the event red dots and itchy was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph node under arm; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph node under arm"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose Number: 3". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had no covid prior vaccination and it was unknown if patient was tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, chills, fever, nausea, vomiting, abdominal pain, fatigue, heart rate over 100 bpm. Muscle pain
Patient presented to emergency department from long term care facility on 12/15/2021 with shortness of breath. She was recently discharged from another hospital on 12/15/2021 for COVID-19 infection and condition worsened requiring additional care. Patient was treated with supplemental oxygen and dexamethasone. Patient was made comfort measures only on 12/18/2021. Patient expired on 12/22/2021
Itchy red circle on left arm at the injection site. Warm to the touch, skin is hard and firm at the injection site. Injection site is slightly tender. Reaction was exactly 1 week after receiving the 1st vaccine.
This case was reported by a consumer via interactive digital media and described the occurrence of asthma aggravated in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. Concurrent medical conditions included asthma.  On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthma aggravated (serious criteria life threatening). On an unknown date, the outcome of the asthma aggravated was unknown. It was unknown if the reporter considered the asthma aggravated to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that they had asthma also and she was just told by an pulmonologist that it was uncontrolled. The patient stated that last year, she took the flu and pneumonia vaccine. The patient thought that she was going to die and said that the vaccines triggered asthma. The patient reported that as a month before the time of reporting she got better.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. In approximately 2015 (reported as "on unspecified dates since 08-JUL-2015"), the patient was vaccinated with improperly stored dose of PROQUAD (Merck), lot # K022446, expiration date 13-MAY-2016 (dose, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Constant buzzing in head, tinnitus.  Everyday. Loudest when lying down and at night.  Doctor said to take Flonase and Zyrtec .  Has not helped.
Chills that lasted for over four hours; Diarrhea that is lasting over 12 hours; vomiting; This is a spontaneous report received from a non-contactable consumer, the patient. A 33-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 33-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure and obesity. The patient had a history of allergies to milk products. Concomitant medications included Lisinopril (MANUFACTURER UNKNOWN), water pill (MANUFACTURER UNKNOWN) (unspecified), vitamin d (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN), for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021 at 11:30, the patient experienced chills, diarrhoea and vomiting. Treatment was not received for the adverse 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 events chills (lasted for over four hours) and diarrhoea (lasted over 12 hours) was resolved on 21Mar2021 at 15:30 and 21:20 respectively, whereas event vomiting was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I started on the next day at 2AM with fever 102.5 degrees, muscle ache, exhausted and it felt like I had flu, I went 5 days with these symptoms. Before I used to walk 5 miles a day, I tried to walk 2 miles and I would get chest pain, shortness of breath, rapid heartbeat and my heart palpitations for a month. 1 month later I couldn't even walk down 3 houses and my chest was in pain. I felt dizzy and fainted and unresponsive for 45 minutes. At this point I went to the doctor's office, and I passed out in the lobby, and they called an ambulance and came with a diagnose of POTS (Postural Orthostatic Tachycardia Syndrome) my blood pressure was 257 over 127 so they were concerned and gave me temporary. When I got home the medicine was wore out and my heart was beating super-fast, I decided to have my son to take me to the hospital. I stayed at the hospital for 1 week because they were trying to control my blood pressure and pulse when I would stand up, still till this day I cannot walk/run my 5 miles. Now they have prescribed blood pressure metoprolol 25mg extended release, 1 a day for life. I'm still waiting to hear back to neurology and heart doctor to maintain me. With the tiredness there is a memory fog.
Chest pressure; funny feeling in face, tongue and throat; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 54-years-old) as dose 1, single for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing. The patient previously took morphine and experienced allergy.  Concomitant medication(s) included amlodipine benazepril hydrochloride (Amlodipine and Benazepril Hydrochloride) taken for an unspecified indication, start and stop date were not reported; trazodone (Trazodone) taken for an unspecified indication, start and stop date were not reported; Lexapro (escitalopram oxalate) taken for an unspecified indication, start and stop date were not reported; Omega 100 (carbinoxamine maleate) taken for an unspecified indication, start and stop date were not reported; D (colecalciferol) taken for an unspecified indication, start and stop date were not reported; Tizanidin (tizanidine hydrochloride) taken for an unspecified indication, start and stop date were not reported. The patient experienced chest pressure and funny feeling in face, tongue and throat on 05Mar2021. Therapeutic measures were taken with medications administered via IV as a result of event chest pressure. The outcome of event was resolved.  Amendment: This follow-up report is being submitted to amend previously reported information: Event " Chest pressure " upgraded as serious--Medically significant checked as assessed by DSU only and not from reporter, patient's name added in general tab and patient tab, patient's address added in patient tab,  Allergies to medications, food, or other products: morphin coded as Past Drug Event: Morphine,  Vaccine Facility Information added, Concomitant drug amlodepin w/ben coded as Amlodipine and Benazepril Hydrochloride, Trazadone coded as trazodone, omega coed as Omega 100,  Emergency Room Visit and Physician Office Visit ticked and leading sentence updated to a contactable consumer.
Patient was lethargic moaned and maintain a fever in excess of 103 degrees for six hours.  Unable to fully wake up.
Disorientation; Severe cramps; Muscle ache; Fatigue extreme; Muscle chills; Nausea; This is a spontaneous report from a contactable consumer, the patient.  A 67-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 1, single (age at vaccination 67 years) for covid-19 immunisation. Medical history included grover's disease. Concomitant medication(s) included vitamin c; ergocalciferol (VIT D); vitamin b complex since an unknown date, about 5000 each. The patient reported that the side effects did not start 24 hours after the injection. They lasted for initially 3 and a half days where he had severe cramps and muscle aches, extreme fatigue, disorientation, nausea and muscle chills on an unknown date in 2021. And nausea went away on day 4 but the fatigue and the chills lasted 12 days. The patient had lab work done, last Thursday, on 18Feb2021, he went to the hospital so they did a lot of lab work there can tell you because he thought he was having a heart attack. The patient did not receive any treatment for reported events. The outcome of the events was recovered on an unknown date in 2021 for fatigue, muscle chills and nausea and unknown for the rest.  Follow-up attempts completed. No further information expected.
Approximately 30 minutes after receiving vaccines, the patient became very pale, vomited, and was unable to retain fluids for 3 hours. The patient developed a fever of 101-102F for 5 days. The patient was treated with ibuprofen. The fever was resolved on day 5. The patient's appetite was normal.
After all previous shots, patient had a hard time lifting her arm; After all previous shots, she had a little arm pain; First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm), VACCINATION SITE PAIN (After all previous shots, she had a little arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 054A22A and 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm) and VACCINATION SITE PAIN (After all previous shots, she had a little arm pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm), VACCINATION SITE PAIN (After all previous shots, she had a little arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-724185 (Patient Link).
Information has been received from a consumer concerning her 45 year old husband with asthma and penicillin allergy who on 21-NOV-2008 was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (unspecified) in the physician's office. Concomitant therapy included "SIMBACOURT" and LESCOL XL. On the same day, "about a minute after receiving PNEUMOVAX 23 vaccine", the patient went into full blown anaphylactic shock. The patient's blood pressure went to 40/0, he did not have a pulse, his face was swollen and red, he had shortness of breath and had the shakes. Since this happened at the physician's office, the patient was kept on IV drips for 3.5 hours, given epinephrine (manufacturer unspecified), BENADRYL (manufacturer unspecified) and another steroid (name and manufacturer unspecified). Once the office gave the patient these medications, the patient's carotid pulse was good and his blood pressure came back up. The patient did not have to be hospitalized and he did not go to the hospital, but he was monitored at the physician's office and went home later that day. The physician's office gave the patient an EPI pen to take home with him. The consumer reported that the patient recovered on 22-NOV-2008. The patient went to see an allergist on 24-NOV-2008 who did some blood work. But the allergist stated that they could not test him for any allergies regarding PNEUMOVAX 23 vaccine. Upon internal review, anaphylactic shock was considered to be other important medical event. Additional information has been requested.
Patient reported nausea and shortness of breath after 15 minute observation period. VS checked in clinic. ER MD assessed patient and asked patient be taken to ED for further evaluation and assessment.
Dizzy, nausea, sweating, fainted! 911 was called and I was transported to the ER. I had low blood pressure at that time.  Headache afterward.
Dizziness, nausea - Injection sites swollen, pink, warm to touch. Both arms where Tdap and meningococcal were given.
On July 13,2017 we reported a temp spike in the refrigerator 60.6 freezer is unknown on for 12.10 Hours on July9.
Diarrhea; 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 unspecified route single dose for COVID-19 immunization on 14Jan2021, 3 o'clock (unspecified in am or pm). Medical history and concomitant medication were not reported. The patient went swimming next day (15Jan2021) for an hour without stopping and did water aerobics and nothing hurt. The patient was doing great but came down with a little diarrhea, Friday, Saturday, and Sunday (from 15Jan2021 to 17Jan2021). The patient woke up this morning (17Jan2021) and stated probably had it during the night. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the batch/lot number has been requested.
On 11/24/21, I received the 3rd Pfizer vaccine, the booster. On 12/2/21, I began coughing and had a sore throat.  As of today, 12/7/21, I am still coughing with a sore throat. Could this be caused by the covid vaccine booster?
got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines; she woke up today felling sick to her stomach; she has been sleeping all day; She has a fever of 102; every time she get up to go to the bathroom she throws up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "got the Pfizer vaccine and the flu shot (Unspecified Flu shot); she got the 2 vaccines"; NAUSEA (non-serious), outcome "unknown", described as "she woke up today felling sick to her stomach"; SOMNOLENCE (non-serious), outcome "unknown", described as "she has been sleeping all day"; PYREXIA (non-serious), outcome "unknown", described as "She has a fever of 102"; VOMITING (non-serious), outcome "unknown", described as "every time she get up to go to the bathroom she throws up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Yesterday my daughter got the Pfizer vaccine and the flu shot (As name of vaccine could not be clarified hence captured as Unspecified Flu Shot) (withheld) at our pharmacy and she woke up today felling sick to her stomach and she has been sleeping all day. She has a fever of 102 and every time she get up to go to the bathroom she throws up. I just wanted to know if its normal or may be she had a virus yesterday we didn't know about before she got the two vaccines. When probed to clarify if patient got the Pfizer COVID-19 Vaccine and Flu Shot on the same day, Reporter stated, Yes.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female adult patient of unknown age concerning herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported). On an unknown date the patient got bad cellulitis from injection site, down to elbow. The outcome of the event was unknown. Someone told the patient that she should get her blood level checked. Causality was not reported. Additional information has been requested.
suspected vaccination failure; got shingles; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jun-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient took the vaccine and got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Pain in left ear and jaw a few days after first injection for a few days. Moderate pain in left ear and jaw a few days after second injection. Went to urgent care and was prescribed antibiotics. Doctor was not able to look into my ear very well because it was very painful when she tried, so I didn't let her. I thought it was an ear infection and didn't make a connection to the vaccine until a friend of mine told me she had the same reaction. The pain lasted a few days (I can't quite remember now).
After administration of vaccine the injection site immediately formed a wheel the size of a peanut (no shell). Pt stated no complaints a s/s from injection.
Patient complained of redness and soreness. Went to urgent care and they prescribed a steroid and antihistamine.