chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 84 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  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 expired vaccine used.  At the time of reporting, no adverse reactions were 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.  List of documents held by sender: none.
Initial report received on 05 February 2010 from a health professional.  Additional information was received on 08 February 2010.  A 48 year old male patient, who is an animal handler for a veterinarian, had never received rabies vaccination in the past.  He received the three dose series of IMOVAX Rabies (lot number not reported) on 08 June 2009, 15 June 2009 and 30 June 2009 as pre-exposure prophylaxis.  The patient was not immunocompromised.  He had no concomitant medications and no illnesses at the time of vaccination.  He had received no other vaccines on the same day and it was unknown if he had received any other vaccinations within the four previous weeks.  On 20 October 2009, the patient's titer level was less than 1:5, which was considered a sub optimal response.  Therefore the patient received a booster dose of IMOVAX Rabies (lot number not reported) on 30 November 2009.  On 25 January 2010, a repeat serum titer level was less than 0.1.
This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 14:00 (Lot number: FE3590) at the age of 38 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Sleep disorder" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ADDERALL. Past drug history included: Nuvigil, reaction(s): "Known allergy: Nuvigil". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eh9899, administration time 09:00AM, vaccine location: Left arm), administration date: 12Dec2020, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: El0140, administration time 09:00AM, vaccine location: Left arm), administration date: 07Jan2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: BREAST SWELLING (non-serious), PREMENSTRUAL PAIN (non-serious) all with onset 15Nov2021, outcome "not recovered" and all described as "left breast became swollen & painful 1 week prior to the menses to the week of, a total of 1.5 weeks each month since receiving the 3rd dose"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 15Nov2021, outcome "not recovered" and all described as "the period, which up till now had been regular, now was irregular, heavier and very painful". The events "left breast became swollen & painful 1 week prior to the menses to the week of, a total of 1.5 weeks each month since receiving the 3rd dose" and "the period, which up till now had been regular, now was irregular, heavier and very painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of breast swelling, premenstrual pain, menstruation irregular, heavy menstrual bleeding, dysmenorrhoea. Additional information: There was no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient had no Covid tested post vaccination. Follow-up attempts are completed. No further information is expected.
Patient reported dizziness.  Blood pressure 59/33 heart rate 53.  Patient instructed to lay down with feet elevated and 1 ammonia inhaled by patient.  Patient reported feeling better.  We alerted 911. We were instructed to give patient 4 chewable 81 mg aspirin.  Emergency responder arrived promptly and cleared patient . Vitals were taken : blood pressure , heart rate, oxygen  and blood sugar within normal. Responder ask if patient wanted to be transported to hospital, but patient refused.
Urticarial rash on left arm, erythema, swelling, warmth, fluid filled bullae.
needle bent-equipment failure 9/10/07-Friday in day care provided states slight elevated temp-administered ibuprofen. 9/11/07 Sat-erythema & edema of arm noted by mother-size of dollar bill applied ice-no c/o swelling 3 pm resorted to hospital x-ray of deltoid-Dx Cellulitis, allergic reaction Rx Cephalexin 250 mg 3 x day Benadryl, Motrin-1 tsp-swelling diminished @ hospital-left 7 pm 9/14/07 slight redness at site-"different shade" no swelling 9/16/07 skin tissue healed no swelling redness normal child behavior
Woke up this morning with right arm swollen and hot to touch, redness (105mm long  100mm wide)
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
p/ pt recv 1 dose varicella, 4th dose dtp, 4th dose hib conj & 1 dose MMR II vax on 10/97 then in 3/98 pt devel ``herpes zoster infect lasting approx 10 days.
Information has ben received from a nurse referring to an 11 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-DEC-2015 the patient was vaccinated with an expired dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015; dose and route not reported). No adverse experience had been reported. Additional information has been requested.
Had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth,; Strange to eat and drink at the back of his throat; He can eat, but it's painful; High fever for 4 days/severe fever; Dehydration; Deliriousness; Lost 12 pounds in weight; Blisters and ulcers in mouth; Blisters and ulcers in mouth; Could not eat; This is a spontaneous report from a contactable consumer. A 59-year-old male consumer (patient) reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0170) intramuscularly in left arm on 29Apr2021 (at the age of 58-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FP6955) on 27Mar2021 (at the age of 58-year-old) at single dose (left arm) for COVID-19 immunisation. Both doses were given in the morning. Other relevant medical history was none. Concomitant medications were not reported. After second vaccination, the patient had high fever for 4 days, dehydration, and deliriousness. He said he was rushed to the emergency room, was given fluid and was stabilized. He also added that he had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth, and had clusters of them inside his mouth. He said it was strange to eat and drink at the back of his throat. He also said it happened last April (24Apr2021 for fever, 28Apr2021 for dehydration and 24Apr2021 for blisters and ulcers in mouth), but the sores returned at the beginning of August, and was not subsiding. He said he can eat, but it's painful. He also mentioned that he lost 12 pounds in weight. Clinical course was further reported as follows. The first stage for him after the second dose of the Pfizer COVID vaccine was a severe fever, he was in bed for 4 days, he then got dehydrated and had to be treated in the emergency room (was not admitted) and was treated with 1.5 liters of saline to stabilize him because they were worried about his organs. He also started to get blisters and ulcers in his mouth, stated the ulcers were canker sores on tongue and inside of mouth, not in his throat, got so bad he could not eat. The patient spent three weeks trying to eat and drink using a syringe in the back of his throat, states he lost 12 pounds. He saw the doctor about his symptoms, it was recognized he had chicken pox as a kid and wondered if this vaccine triggered that dormant virus, he was concerned because the ulcers were returning to his gums and he was concerned about ongoing ulcers in his mouth. Fever resolved 4 to 5 days after onset (exact date unknown). Outcome for delirium, weight decreased, dehydration and could not eat was unknown, other events were not resolved.
Fever; Arm pain/arm hurt; nausea; vomiting; Visual changes; Labored breathing; almost hypopnea RR: 9; Arm pain that shoots down arm interfering with daily activities and sleep; Arm pain that shoots down arm interfering with daily activities and sleep; Stridor; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Bexsero (left deltoid). In JUN-2023, 1 hr after receiving Bexsero, the patient experienced fever (Verbatim: Fever), pain in arm (Verbatim: Arm pain/arm hurt), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), visual disturbance (Verbatim: Visual changes), labored breathing (Verbatim: Labored breathing), hypopnea (Verbatim: almost hypopnea RR: 9), activities of daily living impaired (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep), sleep disturbance (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep) and stridor (Verbatim: Stridor). The outcome of the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor were not reported.   It was unknown if the reporter considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 09-AUG-2023 A physician reported that patient received 1st dose of Bexsero and immediately following dose, patient complained that arm hurt and went home and slept.  Within an hour patient experienced nausea, vomiting, fever, visual changes (saw rings in field of vision) Stridor, labored breathing, almost hypopnea RR: 9. No rash or tongue swelling, patient says she just felt "out of it", lasted about 6 hours, did not need to go to ER. Arm pain that shoots down arm interfering with daily activities and sleep. Revisit with physician 6 days later due to persistent arm pain, patient had full range of motion, no redness, swelling or erythemia, Physician and patient agree to not receive Dose 2. The reporter agrees to follow up.
Seosory peripheral neuropathy in feet up to mid-calf extended to over knees after vaccination.
Pt w/ hx of allergy to Erythromycin Base (arrhythmia) and "walking corpse" syndrome in 2015.  No additional PMH or medication hx available to this writer. 10mins post vaccination pt c/o palpitations and SOB. Pt abulated to triage area.  Vitals:13:38 BP 150/83, HR 153, RR 16, O2Sat 99% -- > 13:43 111/67, 107, 99%. Pt A&Ox4, denies sxs N/V, headache. NP recommended rest and water and continued to monitor. 14:00 pt c/o chest discomfort and a cold sweat.  NP recommended to call 911. 911 Called @14:02.  EMS arrived 14:15 and report was given to EMS.  EKG showed sinus tachycardia. Pt was taken to Kaiser via ambulance, VSS at the time of departure.
partial complex sz occurred 8 days following MMR vax; anticonvulsant therapy (dilantin)
Prolonged menstrual cycle lasting longer than seven days. Prolonged ear infection lasting six months or more.
PATIENT EXPIRIENCED LEFT ARM REDNESS, WARM TO THE TOUCH AND SWELLING. DIAGNOSED WITH CELLULITIS AND WAS TREATED WITH BACTRIM.
Swollen lymph nodes near and in armpit. Soreness and stiffness spreading through back. Has lasted for 3 days so far.
About two weeks after vaccine symptoms began, fatigue, shortness of breath.  Second dose 3/14/21. Body aches began about 7 hours after vaccine for the next 24 hours.  Fatigue and shortness of breath continued and began to have pain when taking deep breaths.   3/23/21 went to Urgent Care and had chest x-ray which was negative.  Feeling worse later that night went to the Emergency Room. Had EKG , blood work up and covid test.  Covid test was negative.  Troponin levels elevated  0.74, 0.130, 0.97.  I was admitted to the hospital for observation and further tests.
I had swelling in my feet, legs, hands, and abdomen. I had bad pain in my joints and especially in my sacroiliac joint. I had burning in my throat and difficulty swallowing. My blood pressure have been variable. It goes up and down. I also have burning sensations in my hands. I was also going to the bathroom a lot. I was prescribed Macrobid for the bacterial infection.
Crying off and on. Rash on entire body including face. Tem. 101.7.
never had any problems with flu until I took a flu shot. Had it twice in 3 weeks; Initial information regarding an unsolicited valid non-serious case received from a patient via social media on 11-Dec-2020.  This case involved patient with unknown demographic who experienced flu (Influenza) (I never had any problems with flu until I took a flu shot in 1965 with football team. Had it twice in 3 weeks), while he/she received influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitants were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site  On an unknown date, following the administration of influenza vaccine, patient developed flu (Influenza).  No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for influenza.  There will be no information about batch number.  No further relevant information was provided.
Patient received only received the IPV and DTAP and not the HIB portion, while patient received a first dose of PENTACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via Agency (Reference number- 00577561) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 2 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: U6842BA, expiry date: 05-Jul-2021 and other dosing details were not reported] on 06-Apr-2021 for prophylactic vaccination (product preparation issue).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box.   It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial.   At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not.   Reporter said one option was to do titer but not sure they will be accurate, but the patient was only 2 months old, so reporter prefer not to do a blood draw.   At the time of report, 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 the 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.
The lymph nodes in my neck have swollen. I have been experiencing a very sore throat.  It is hard to swallow. I was diagnosed today with strep throat and prescribed amoxicillin-clavulanate to address the strep throat.
Rash on his neck, chest and back - all over his body; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on his neck, chest and back - all over his body) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced RASH (Rash on his neck, chest and back - all over his body). At the time of the report, RASH (Rash on his neck, chest and back - all over his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment information were not provided
Increased right hip pain especially in the morning. (12/01/2021) First went to Urgent care and was started on a course of Medrol dose pack and gabapentin. Was given steroids, as well. After about three days, (12/04-12/05) went to ER and had a MRI done. By this time pain was so much that took me 2 hrs. to get out of bed. Was given a steroid injection on 12/10. As of today 12/13 still ongoing issue.
I took Advil when I went to bed at 9:00 pm. Woke up at 1:10 am with a fever of 100.7, body aches and chills. I took Advil again at 8:30 am and the fever broke by 10:30 am. Body aches were minor by this time and the chills were gone.
Patient was vaccinated with the Pfizer vaccine in early February.  On February 19th, she was diagnosed with Acute Myeloid Leukemia
Injection site wheal -  Information has been received from a health professional concerning an 18 month old male with an allergy to eggs who was vaccinated in October 2000 with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  The injection site started to develop a wheal and the doctor did not inject the entire dose.  Unspecified medical attention was sought.  The reaction resolved within 24 hours.
full dose instead of a half dose; Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021; Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 004M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021). On 29-Oct-2021, EXTRA DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was present.  No treatment medication was present.  We had given a couple of doses of Moderna for the booster shot today. The first 5 patients we gave a full dose instead of a half dose. We were told that the dose was expired. These patients are not knowingly immunocompromised. None of the patients have reported any symptoms, and no treatments have been attempted. Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today, 29Oct2021, after being in the refrigerator starting on 8Sep2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up contains: reporter fax information and event details were added.