chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to an approximately 12 month old female patient, who had none pertinent medical history, drug reactions, allergies or concomitant medications. Concurrent conditions were not reported. On an unknown date in June 2002, the patient received the first dose of RECOMBIVAX HB (dose, frequency and route of administration were not reported). Then, on an unknown date in March 2003, the patient was vaccinated with the second dose of RECOMBIVAX H 5/0.5 mcrg/ml (dose and frequency were not reported) intramuscular, also for prophylaxis. It was stated that the patient never received a third dose of the vaccine. The reporter stated that due to school requirements, the patient had titers drawn on 24-AUG-2015, which showed she was negative for immunity to hepatitis B. It was stated that no intervention to prevent serious criteria was necessary, that the patient did not die, that the adverse events were not life threatening and did not cause significant disability or incapacity or hospitalization. At the time of the report, the outcome of hepatitis b antibody negative was unknown. The relatedness of RECOMBIVAX HB with the adverse events was not reported. Additional information has been requested.
Headache, fever, soreness at injection site, fatigue  beginning at 0100. Managed with rest, fluids, and ibuprofen.
10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Paralysis of left side of face.  Seen at ED and diagnosed with Bell's palsy and placed on steroids.
Bell's Palsy 09Feb2021 dx 12Feb2021; This is a spontaneous report from a contactable Physician. An 89-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, intramuscular on 23Jan2021 at 13:15 (Batch/Lot Number: EL3247) as single dose (at the age of 89 years-old) for COVID-19 immunisation.  Medical history included high blood pressure, spinal stenosis, kyphosis and known allergy to sulfa-hives. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included donepezil, methadone, sertraline, hydrocodone, metoprolol, alprazolam (XANAX), nifedipine, mirtazapine, hydralazine, and spironolactone; all taken from unknown dates for unspecified indications.  On 09Feb2021 the patient experienced Bell's palsy (diagnosed on 12Feb2021). The event resulted in emergency room visit. Therapeutic measures were taken as a result of Bell's palsy and included steroids and acyclovir. The patient was recovered from Bell's palsy on an unknown date. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 28Feb2021 at 14:15 (Lot number EN6203) for COVID-19 immunisation. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported  Bell's palsy and the use of BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Had both shots, and still got them/suspected vaccination failure; still got them; 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: Had both shots, and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots of the new vaccine and still got shingles, not as bad but he/she could not imagine any worse pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
expired dose of Adacel was inadvertently given to patient/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is related to case- 2019SA133619 same reporter.  This case involves a 52 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) on unknown date.   On 04-May-2019, the patient received a Booster dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5656AA, expiry date 02-May-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose of Adacel was inadvertently given to patient.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Patient did not experience any symptoms. NO Additional adverse effect reported.; 19 year old patient was administered a dose of pediatric VAQTA; 19 year old patient was administered a dose of pediatric VAQTA; This spontaneous report was received from a nurse referring to a 19 years old patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.      On 25-NOV-2019, the patient was vaccinated with a dose of pediatric hepatitis a vaccine, inactivated (VAQTA) (lot # S002506, expiration date 04-APR-2020; dose and route were not provided) intramuscular for prophylaxis (incorrect dose administered and product administered to patient of inappropriate age). Patient did not experience any symptoms. No additional adverse effect reported.
about two hours after injection,  I experienced headache,  then mild dizziness,  then extreme dizziness,  then sudden overwhelming fatigue,  then swollen eyes and eyelids,  then chills and elevated heart rate,  with pounding.    I had to cancel the class I was supposed to teach,  because I would not have been safe to drive to campus.  I slept from approximately 2:30 pm on March 8 until 8:30 am today,  March 9,   all symptoms continuing,  with bathroom breaks, a couple of short reports to family members who were watching out for me,  and one  2-hour window during which I ate a small meal,  went back to bed,  and read part of a book.    During bathroom breaks I took more antronex,  some milk thistle,  and some glutathione,  which seemed to at least temporarily reduce dizziness and eye/eyelid swelling.  At one point I took some hawthorne tincture because I was concerned about the heart pounding.    Today I woke up feeling symptom-free,  but by 2 pm I was compelled by sudden fatigue to take a two-hour nap.   After that I felt better,  and I think I am now fine,  at 7:45 pm on 3/9/21.    I am happy to have gotten the Janssen vaccine,  because it is one and done!
doses administered after excursion; No adverse event; Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Patient had a 2 minute febrile seizure 24 hours after a Flu-zone flu shot and was brought to Hospital. Lot UT35678A, Exp June 2011
Patient received the vaccine on 9/1 and on 9/2 the mother noticed redness in the left upper arm (site of vaccine). At baseline patient has a skin rash (keratosis pilaris) on both upper arms and legs.  The redness seemed to be on top of the keratosis pilaris and the keratosis pilaris seemed worse.  He also developed a cough and cold on 9/6/22.  He was seen in the clinic on 9/8 and rash had improved. Rapid COVID test was negative.
Diarrhea 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea 3 days after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea 3 days after vaccine). At the time of the report, DIARRHOEA (Diarrhea 3 days after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter. No treatment medication provided by reporter.
A 28 year old female was hospitalized on 5/13/01 for Guillain-Barre-like symptoms. She was bitten by a rat on 3/15/01, in her house; the rat escaped. Her 3 month old dog was bitten by a rat (maybe the same one that bit the pt) and the dog died. No biopsy on the dog was performed, so the cause of death was unknown. The pt received her first dose of RabAvert on 3/20/01 and 9.5ml of human rabies immune globulin. She received subsequent RabAvert doses on 3/23/01, 3/28/01, 4/5/01 and 4/18/01 with no notable adverse drug reactions. On 5/13/01, the pt was hospitalized with numbness, weakness and tingling in her legs, and numbness in both hands. There was no weakness in her upper body. She was unable to walk and was falling to either side. A computed tomography scan of her head was negative. She had no history of pain. The pt was transferred to another hospital and her symptoms remained the same. She was positive for descending hypesthesia in both legs and toes. Her CSF was normal and creatine phosphokinase (CPK) lever was normal. The pt was dx'd with Guillain-Barre-like symptoms. She still had her reflexes present. No medications were given to treat the adverse events. Follow-up information was received on 5/31/01. The pt received RabAvert on 3/15/01, 3/20/01, 3/23/01, 3/28/01, 4/5/01, and 4/18/01. She received 9.5ml of BayRab (human rabies immune globulin) on 3/15/01. On 5/12/01, she went to the ER due to increasing numbness and weakness in both legs. She was unable to walk and tended to fall on either side. She was admitted, but transferred to another hospital on 5/15/01. Physical exams from 5/12/01 to 5/17/01 showed a variable decrease in lower extremity strength, otherwise the exams were normal. The pt was dx'd with possible conversion disorder and discharged on 5/17/01. The pt had agreed to undergo psychological evaluation and she is currently being referred for psychological treatment.
pt recv vax & 30min post vax pt broke out in hives, itchy & had some swelling;ER or MD visit was required;tx DPH;swelling dec 3hr later but pt was itchy for about 24hr;
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279268, 2018SA279273, 2018SA279275 and 2018SA279276 (same reporter). This case involves a four years old patient of an unknown gender who was vaccinated with a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (batch number UT6259KA and expiration date 30-JUN-2019) via unknown route in unknown administration site on an unspecified date.  The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to vaccine underdose. It was reported that the patient received FLUZONE QUADRIVALENT of 0.25ML that needed the 0.5ml. No Adverse Events have been noted at time of the call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
10/31/21 Faiting, seizure-like episode, temporary paralysis for 12 hours. Hospitalized overnight for observation. Head CT scan, neck CTScan, MRI of brain, EEG, EKG, various bloodwork.  Upon discharge,  Referred to Primary Care Physician, Neurologist, ENT (For possible fungal ball in septum).  Weakness in all limbs, nerve pain and severe fatigue have continued to present day.  Neurologist appointment not until 12/23/21. PCP prescribed Gabapentin 300mg 3 times per day for nerve pain while awaiting neurologist appointment.
Soldier is 6 weeks pregnant. Was administered Hepatitis B vaccine Lot AHBVB131AA Exp. 12/09/06.
Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 vaccine (lot number 663888/0627Y or 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 vaccine ranging from fevers of 102F to 103F and cellulitis." Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 vaccine was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 vaccine that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 vaccine in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23 vaccine. This is one of several reports received from the same source.
periodic headaches; It is like a heaviness in the head; It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations; Her height is decreasing  and she has lost weight.; Her height is decreasing  and she has lost weight.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 09:51 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 87 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE; ATENOLOL; LOVASTATIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch number: EN6200), administration date: 16Feb2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch number: EN6206), administration date: 10Mar2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch number:FF2589), administration date: 28Sep2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch number:FK9893), administration date: 11May2022, when the patient was 86-year-old, for COVID-19 Immunization; flu vaccine (Dose Number Unknown, Single, manufacturer: Unknown), administration date: 17Sep2022, when the patient was 86-year-old, for Immunization.  The following information was reported: BODY HEIGHT DECREASED (non-serious), WEIGHT DECREASED (non-serious) all with onset Nov2022, outcome "unknown" and all described as "Her height is decreasing  and she has lost weight."; HEAD DISCOMFORT (non-serious) with onset Nov2022, outcome "unknown", described as "It is like a heaviness in the head"; PALPITATIONS (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations"; HEADACHE (non-serious) with onset Nov2022, outcome "not recovered", described as "periodic headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Other Conditions: No, Investigations: No, Other Products: No. She had no reactions after first two primary or first two boosters. She was taking high blood pressure pills, but she has taken those for years. There were no emergency or physician office room visit. Prior Vaccinations (within 4 weeks): flu vaccine but weeks apart. maybe 3-4 weeks before administered on 17Sep2022.
Discharge Provider: DO Primary Care Provider at Discharge: MD   Admission Date: 2/14/2023 Discharge Date: 2/16/2023  PRESENTING PROBLEM: Hyponatremia [E87.1] SOB (shortness of breath) [R06.02] Hypothyroidism, unspecified type [E03.9] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 85 y.o. male with history of mild left ventricle outlet obstruction, hypertension, well-controlled asthma, chronic dyspnea, hypothyroidism, history of prostate cancer status post chemoradiation, who presented to hospital with one week of weakness, malaise and flu-like symptoms. He felt so "crummy" that he presented to the ED. In the emergency department, he was positive for COVID 19 infection. No oxygen requirement.  His sodium is 122, baseline is normal, 140 in March 2022. He was treated with 1 L of normal saline in the ED.  The patient will be admitted to the Hospitalist Service for further management. His electrolytes and weakness improved with management. His vitals were normal. He was breathing, eating, drinking, eating, and moving bowels with no problems.  He was discharged him in stable condition on decadron, sodium chloride and high dose acetaminophen. He will follow up with his PCP. Return precautions were discussed
Covid arm (rash, then red area around injection site, warm to the touch). Started 5 days ago, 8 days after the shot. I've read about this and it doesn't seem to be a concern, but what I said encouraged us to report it to you, so I am. I have not reported it to my family doctor at this point. I feel completely fine except a little arm pain at the injection site.