chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old patient received an additional Menactra dose after having prior dose in Aug 2019, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who an additional MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] dose after having a prior dose in Aug- 2019 (date unknown) (extra dose administered).  The patient's past vaccination  included Menactra on 21-Feb-2015 as prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  The patient did not receive any concomitant medications.   On an unknown date in Aug-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site and again on 09-Sep-2020 she received a 0.5 ml third dose of the same vaccine (lot U6565AA and expiration date: 28-Mar-2021) via intramuscular route in the left deltoid as prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency same day).  No adverse event reported at the time of reporting.  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.
Fatigue; Malaise; Mild headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 13:45 (Lot number: EN6205) at the age of 66 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Osteoporosis", start date: 2018 (ongoing); "Benign palpitations", start date: 1985 (ongoing). Family history included: "Herpes simplex 1", start date: 16Feb2021, stop date: 24Feb2021. Concomitant medication included: METOPROLOL SUCCINATE taken for palpitations, start date: 2011 (ongoing). Vaccination history included: Prevnar 13 (DOSE 1; arm), administration date: 08Jan2021, when the patient was 66 years old, for Immunization; Bnt162b2 (DOSE 1; Lot Number: EM9809; 14:30; left arm), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 immunization, reaction: "Herpes simplex 1". The following information was reported: FATIGUE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Fatigue"; MALAISE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Malaise"; HEADACHE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Mild headache". Therapeutic measures were not taken as a result of fatigue, malaise, headache.  Additional Information: With the patient's second vaccine, she instead had a mild headache and malaise upon waking on the day after her second dose, which resolved within a day. The events were considered non-serious. The patient provided information to the healthcare professional regarding the reported adverse events with the use of the product. The reporting healthcare professional considers that the Pfizer product had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021193300 Same patient and product; different events and dose
Immediately after receiving 2nd dose of Engerix B, patient experienced metallic taste in mouth. 45 minutes later metallic taste remained, accompanied by feeling of lightheadedness.  BP 140/90, pulse 90, resp 14. States feeling like she "inhaled bug spray."  Given 400 mg ibuprofen.  Symptoms continued for 1 hr, 15 min.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, chills Narrative:  1/12 4:00 fatigue and chills, 1/13 0300 freezing, temp to 99.5, body aches, headache, fatigue, nausea. Stayed in bed all day. 1/14 symptoms started to get better about 1:00 pm. Symptoms almost completely resolved by 6:00 that night. 1/15 felt normal.
Patient received Moderna vaccine on 06/05/2021 and received Pfizer on 06/29/2021
Vomiting & red rash on hands, arms & body. BENADRYL 12.5 mg given P.O. Client transferred by ambulance to Hosp. ER. in stable condition. Talkative & in no respiratory distress.
No adverse effects reported; 13 months later for her second GARDASIL 9; This spontaneous report was received from a physician and refers to a 13-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies were provided. On an unspecified date in 2018 (reported as at the age of 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N028567, expiration date 17-MAY-2019 (exact dose and route of administration were not provided) for prophylaxis. On 16-AUG-2019 (also reported as 13 months later), the patient was seen in the office for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
pain near belly button, on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain near belly button, on the right side) in a 24-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 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain near belly button, on the right side). At the time of the report, PAIN (pain near belly button, on the right side) outcome was unknown. Not Provided          No concomitant medication information was provided  No treatment product information was provided
A literature report was received on 03/24/2003 concerning a 62 year old female vaccinee who experienced recurrent uveitis 6 days after vaccination with virus influenza vaccine (brand unspecified) ON 10/12/1994. The vaccine was part of a retrospective study to investigate the possibility that influenza vaccination is a cause of recurrent uveitis in patients with a history of pre-existing ocular inflammatory disease. The vaccinee has a previous history of right eye uveitis in May 1994. On 10/18/1994, the vaccinee presented with recurrent uveitis in the right eye. Her best-corrected visual acuity was 6/12(20/40) in the right eye. There was a trace ciliary flush, few, fine keartic precipitates, and a 1+ cell and flare in the anterior chamber. Scattered inflammatory nodules were noted at the iris border. Laboratory tests of complete blood  count with/ differential. SMA 12, sedimentation rate, fluorescent Treponema absorption test (FTA-ABS) , Rheumatoid factor, and angiotension converting enzyme, which were all within normal limits. The vaccinee was treated with topical diclofenac 0.1% TID, atropine sulfate 1% every day, and prednisone acetate 1% QID. The vaccinee recovered in 2 weeks. The authors concluded that influenza vaccination may act as a non-specific stimulus of the immune system and thereby, reactive uveitis, The exposure to influenza vaccine triggered a recurrence of the ocular inflammation. Update1. 05/06/2003: A report was received from a health care professional indicating that the vaccinee had recovered without sequelae on an unspecified date. Cross Reference with: PJP200300141, PJP200300142, PJP200300146.
On 12/6/99, the pt experienced welts on the torso. She also experienced redness and itching at the site of injection which spread out over the entire body during the next four hours. The urticaria continued after treatment with Benadryl for 4-6 weeks. A visit to a physician was required.
pain at injection site, fatigue, nausea,headache, congestion, fever, achy joints, cough, body aches all over, chills
Child was given DTAP, IPV, Hep B in (R) leg had induration and erythema. Doctor examined and determined normal reaction.
Patient states that she has numbness from chest down that is more prominent on right side. Patient characterizes pain as "1,000 out of 10". Patient was not able to walk.
Lungs feel odd. I can breathe fine. I can exercise. Just a different feeling  than prior to the vaccine.  Still have the weird feeling. Sceptic about getting second dose.  Also, had very swollen arm 9 days after the vaccine. I understand this is normal for older women.
Haven't felt well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2023AMR011214   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had not felt well since got the shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact details were available. For tolerance of 2nd dose of shingles vaccine, refer case US2023AMR011214.; Sender's Comments:  US-GSK-US2023AMR011214:Same reporter
Headache, Thrombocytopenia & Purpura Narrative: Thrombocytopenia a few days after 1st and 2nd dos of COVID vaccine (Moderna). Platelet count was 175K on 1/7/2021 and 2/4/2021, but dropped to 56K on 2/8/2021 and has been unstable or below normal since that time.
One day following vaccine injection, intense pain and stiffness arose in patient's left shoulder - not at site of injection but entire left shoulder. Symptoms consistent with SIRVA do not dissipate. Instead, pain and stiffness intensify and migrate over the following days/weeks/months to the neck, right shoulder, torso, lower back and hips. Symptoms are most intense in morning hours upon waking from restless and very uncomfortable sleep periods or other periods of inactivity.  It was extremely difficult to move while in bed or to get out of bed, extremely difficult to get dressed, bend over or down, difficult to run, often impossible to sneeze because patient was unable to sufficiently expand his lungs. Following a period of misdiagnosis, patient is diagnosed with polymyalgia rheumatica (PMR) and is prescribed 12.5mg/day of prednisone on 10/18/2021. Pain and stiffness in all areas improve substantially and prednisone dosage is tapered down to 10mg/day on 11/12/2021. Today (01/25/2021), patient continues to take 7.5mg/day.  Physical function equivalent to pre-vaccination has not been restored. Atop the immune suppression associated with prednisone use, patient was advised not to receive a vaccine booster. Despite careful attention to Covid precautions, he became symptomatic and tested positive for Covid on 01/22/2022.
History of Present Illness     89-year-old female with past medical history significant for osteoporosis and hypothyroidism, who initially presented to ER on March 2 due to lower extremity weakness and right knee pain after a recent fall.  Patient lost her balance and suffered a mechanical fall on February 22.  Patient developed right lumbar and hip pain radiating down her leg.  She saw Dr from orthopedics on February 26 who recommended offloading knee and wearing a knee immobilizer.  Patient was admitted to hospital on March 2 due to worsening knee pain and was incidentally found to be positive for COVID-19.  Patient had received her second Moderna COVID-19 vaccination on February 26.  Patient was evaluated by neurology during that hospital course, who recommended outpatient EMG, physical therapy, and pain management.  No evidence of Guillain-Barré or viral induced neuropathy.  Patient's lower extremity weakness did improve, and she was successfully discharged home with family and home health on March 5.   Patient reports doing well at home with family initially, was making improvements with her strength and was able to stand and take a few steps with walker and assistance.  On March 8, patient was in bed and she attempted to turn onto her right side, and as she was turning she felt a pop and a pain in her right hip that radiated down her right leg.  Since that time, patient reports having severe pain with movement, rates pain as 8/10 severity.  Denies falls or new trauma since her previous fall from February 22.  Patient was unable to control pain at home, so she came into the emergency department for evaluation.  Initial hip x-ray series revealed questionable greater trochanteric fracture.  CT of right hip subsequently revealed fracture.  Orthopedics consulted.  No significant laboratory abnormalities.  Foley catheter was placed in ER.  Patient was admitted to hospital service for management.  On my interview, patient reports that right hip pain is under good control as long as she does not move, but has 7/10 pain severity over her right lateral hip with movement.   Patient reports following Covid isolation protocols at home with family.  Reports that her Covid isolation will be completed on March 12.  Denies upper respiratory symptoms.  Patient has oxygen saturations of 100% on room air.
Alpha strep intermittent pneumonia, empyema, liver abscess, hepatic vein clot. 07/17/06-records received from Maine Med Ctr the receiving hospital for transfer of patient. DOS 5/11-5/19/06 DC Principal DX: Alpha strep intermedius pneumonia and bacteremia. DC Secondary DX: Empyema                             Liver abscess                             Hepatic vein clot                             Constipation                             Fact V Leiden heterogeneous deficiency Reason for Admission: Beginning symptoms present on 4/20/06 at time of hepatitis B vaccine. Three days later he developed fever, cough and vomiting and three days later PCP DX viral syndrome. Symptoms persisted included 7-10 pound weight loss and CXR revealed pneumonia. BC positive for alpha strep. Presented at ED for c/o persistent cough, abdominal pain and diarrhea. Admitted to ICU. Transferred to Maine Med Ctr. C/O SOB attributed to drainage of empyema. Hospital Course and Treatment: Ceftriaxone, gentamicin, heparin, enoxaparin .  DC included IV home therapy, enoxaparin sc. krk
as vaccine being injected, pt leaned forward, pale, almost cyanotic, holding breath, (+) jerky movement all lasting 30 seconds. Pt. rested for few minutes -> felt weak, couldn't wake. After 15 min -> pt recovered
This was a booster dose - it should have been given 28 days after the initial influenza vaccine given 9/18/2020 - but was given after 20 days.
The tingling only lasted for a few minutes, and it felt warm, very warm.; face started to tingle on left side; Facial swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 87-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 11:00 (at the age of 87-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing arthritis diagnosed about 20 years ago, blood pressure from an unknown date and unknown if ongoing. The patient got the first dose yesterday. After she was home about an hour, her face started to tingle on the left side and started to swell and on the right side of her face it was also a little swollen on 05Aug2021. Reports that almost any medication that she takes she cannot take because it makes her face swell up. She was hesitant about getting the second dose in three weeks and was afraid she will swell and her throat will swell. She does not have high blood pressure or high cholesterol but does have arthritis. The tingling only lasted for a few minutes, and it felt warm, very warm. Her face was still swollen. She wears a mask and it cannot be seen. She does not take blood pressure medicine because it makes her face swell. She controls her blood pressure by not eating salt and using no salt. The patient underwent lab tests and procedures which included her body height shrunk an inch on an unspecified date. Patient declines any treatment. The outcome of the event face started to tingle on left side was recovered on 05Aug2021, facial swelling was not recovered while the outcome of remaining event was unknown.     Information about Lot/Batch has been requested
Sore arm the day of shot and several days after.  The next day headache, fatigue, chills, fever of 101.2, nausea - only lasted the day.  The next day felt fine.  The following day was tired.  Then reaction was over.
The pain from the injection has never gone.  It?s spread into the side of my left bust and shoulder.  I have numbing in my left arm that?s spread down into my fingers and now numbing at the front of my right leg.  I feel fatigue and like my memory is blurred.
Developed blood clots after the second dose/got blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant products were reported.  Reporter and 8 other women all age 60 and above presented with blood clot post their second dose.  Women's in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No treatment information was reported by the reporter.  Company Comment: This is a spontaneous case concerning  a  7-decade-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Thrombosis, Cerebrovascular accident. The events occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine which was received on an unknown date. The events outcome were reported as unknown at time of report. No treatment information was reported by the reporter. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566808, MOD-2022-566718, MOD-2022-566814, MOD-2022-566821, MOD-2022-566839, MOD-2022-566828.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow up received with added reporter information, verbatim for event thrombosis and new event stroke.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  7-decade-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Thrombosis, Cerebrovascular accident. The events occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine which was received on an unknown date. The events outcome were reported as unknown at time of report. No treatment information was reported by the reporter. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis.
Mom called on 7/31/ to report that patient had high pitched screaming and fever following vaccines yesterday- child seems fine today per mom
This is a spontaneous report from a noncontactable consumer (patient). A 46-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 46, via an unspecified route of administration, left arm, on May 5, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food or other products. Concomitant medications included Drospirenone/ethinyl-estradiol and trazodone 25mg; both from unknown dates for unspecified indications. Prior to the vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 8, 2021, at 01:30, patient experienced vomiting. No therapeutic measures taken as a result of the event. The event did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of vomiting recovered on an unknown date in May 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Initially felt only soreness in left arm.  Following morning started to have lower limb muscle aches with both calves. Started to feel chills.  Bundled up and went to bed about 8:30 am.  I was so cold that I had several layers to keep me warmish.  2:30 pm I was gonna take a shower to try and feel better but then decided to take my temperature.  It came up as 101.0F
Patients received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  On 31 Aug 2021, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursion.  No Treatment medication reported.   This case was linked to MOD-2022-534284.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Non significant information received.
COVID -19 VACCINATION MODERNA WAS GIVEN TO A 13 YEAR OLD.