chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse for the pregnancy registry for GARDASIL, concerning a 25 year old female patient with anxiety disorder and papanicolaou smear abnormal in 2007 resulting in a loop electrosurgical excision procedure, who on 28-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 658558/1061U), on 30-OCT-2007 was vaccinated with the second dose of GARDASIL (lot# 659964/1978U) and on 02-MAY-2008, was vaccinated with the third dose of GARDASIL (lot# 659437/1266U) while pregnant.  On an unspecified date, a non stress test was performed (results not provided).  Concomitant therapy included LEXAPRO and PREVACID.  The nurse reported that the patient who had completed the HPV vaccine series was hospitalized for delivery and delivered a healthy baby on 31-DEC-2008.  The patient had a post partum fever.  On 31-DEC-2008, the patient recovered.  Additional information has been requested.
Information has been received from a physician concerning his daughter who was vaccinated with first and second dose of GARDASIL. Subsequently she was diagnosed with reactive arthritis. It was unknown if patient sought medical attention. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a physician concerning his daughter who was vaccinated with first and second dose of GARDASIL lot #653735/0688F. In follow up telephone call the physician indicated that his daughter's arm (same arm as injection site) was worse and was "not functional" at that time. She was evaluated for the possibility of fasciitis and had tissue and bone biopsies on 26-SEP-2007. There was also concern about osteomyelitis. She was reported as chronically ill.  No other information was available. It was reported that patient's chronic illness was so excruciating, that she had to take MORPHINE.  The outcome was unknown. The physician was requesting a lot check for the GARDASIL lot his daughter was given. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.  Follow-up information was received which reported a cardiologist and his wife, a rheumatologist, opted to have their 17 year old daughter vaccinated.  It was a desicion they now regret.  Following vaccination, their teenage daughter began showing signs and symptoms of an autoimmune disease.  The cardiologist said:  "She went from being a healthy, active teen running, playing lacrosse and participating on swim team to becoming a chronically ill patient".  Additional information is not available.
sore arm at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm at the site of the injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 012M20A, 039D21A, 0661221A and 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack (before the vaccine), Lung cancer (2x (2019, 2021 not sure if after the first dose) and was radiated.) and Radiation therapy. Concurrent medical conditions included COPD (before the vaccine), Blood pressure high (before the vaccine) and Osteoporosis (diagnosed few months ago.).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (sore arm at the site of the injection). At the time of the report, VACCINATION SITE PAIN (sore arm at the site of the injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748633 (E2B Linked Report). This case was linked to MOD-2023-748624 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748633:Husband's Case (Monovalent)
Upper torso muscles locking up to the point where  can't rotate neck, left arm, and eyes; Upper torso muscles locking up to the point where I can't rotate my neck, left arm, and eyes; Upper torso muscles locking up to the point where I can't rotate my neck, left arm, and eyes; Pain very severe; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 07May2021 at 08:45 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19, hysterectomy for endometriosis and known allergy to sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and estradiol (ESTROGEN) for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 09:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 08May2021 at 00:00, the patient experienced upper torso muscles locking up to the point where patient could not rotate neck, left arm and eyes, pain was very severe accompanied by extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upper torso muscles locking up to the point where patient can't rotate neck, left arm, and eyes and pain very severe, accompanied by extreme fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patient's medical history was not reported. ON an unknown date, the unspecified patients were vaccinated with 8 doses of GARDASIL Idose, frequency, and route were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for GARDASIL. This case is linked to 1409JSA012424 and 1409USA014919 (same reporter link). Additional information has been requested.
low-grade fever; mild to intense headache; muscles soreness; fatigue; chills; mild soreness at the injection site; on and off sweats; difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EL3247) at the age of 26 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BLISOVI 24 FE oral taken for contraception, start date: 2018 (ongoing). The following information was reported: CHILLS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; INSOMNIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "difficulty sleeping"; FATIGUE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered"; PYREXIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "low-grade fever"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild soreness at the injection site"; HEADACHE (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "mild to intense headache"; MYALGIA (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "muscles soreness"; HYPERHIDROSIS (non-serious) with onset 04Mar2021 at 10:00, outcome "recovered", described as "on and off sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, myalgia, fatigue, chills, injection site pain.  Additional information: the effects lasted more than 24 hours; the patient  took Acetaminophen as recommended, and recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069389 same patient, different dose/event;US-PFIZER INC-2021336635 same patient, different dose/event;
A report was received from a health care professional on 11/18/2003 concerning a 45-year-old female pt who developed transverse myelitis with numbness and weakness in the lower extremities, and paralysis from the waist down approximately 12 days after receiving Fluvirin on 10/14/2003. On 10/26/2003, approximately 12 days after vaccination the pt began to experience symptoms of numbness and weakness in the lower extremities. This progressed to the point of paralysis from the waist down. The pt was hospitalized on an unspecified date. A spinal tap and a magnetic resonance imaging scan failed to reveal an infection or any other process. The attending neurologist diagnosed the condition as transverse myelitis. The pt had not recovered at the time of the report, and remains hospitalized. There was insufficient info to determine the reporter's causality assessment. The reporter indicated that the attending neurologist informed her that she (the neurologist) would be reporting this event to CDC. Follow up pending.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (Had right leg, hip, testicles removed), infection, testicular operation and accident. Previously administered products included Antibiotics and Shingrix (1st dose received on 30 December 2019). Concurrent medical conditions included paraplegia, bedridden and bone cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The pharmacist called to report that a patient had a first dose of Shingrix in 2019 and had not received a second dose yet. The reporter mentioned that patient had been in bed over a year paraplegic after a motorcycle accident and had right leg, hip, testicles removed because of bone cancer from a dead sore.  The reporter was unsure if patient was immunocompromised but mentioned had a history of a lot of infections treated with antibiotics in the last 6 months. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility is the same as primary reporter for 1st dose. No lot number reported. The reporter consented to follow up via email.
Severe shortness of breath during activities such as walking up or down stairs flat land long distance. Take a while to get my breath back. Inhaler don?t even help. Never experienced any of these issues until after the vaccine.
Auto-immune flare up; Lichen Sclerosus and had a flare up 2 days following shot; This is a spontaneous report received from a non-contactable other HCP (patient herself). A 38-year-old female patient received second dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 17Feb2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient medical history included Lichen Sclerosus ongoing from an unknown date. The patient has not allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 27Jan2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient had no other vaccine within four weeks. The patient was not tested for COVID-19 prior to vaccination and not post vaccination. Two days after her second dose of vaccination, on 19Feb2021, the patient had flare up of Lichen Sclerosus over the weekend and had a flare up 2 days following shot. Treatment medication was given Clobetesol. The outcome of the events was recovered.   Follow up Information on batch/lot number was requested.
Fainted/lost consciousness while still at doctors office, remained pale, clammy, shaky and cold for a while.  Remained at doctors office until he felt better.
In my yearly physical it shows hearing loss one ear is worse than the other, feels and sounds like I'm submerged had clogged ears. Since it started have had a high pitched wine tinnitus and a crackling sound as well it's comes and goes. There were no other significant events I can think of that may have caused this issue.
Pt recv vax on 3/30/99; on same day pt exp shortness of breath & rash; tx=Epinephrine
A pink, itchy, non-raised to slightly raised rash approximately 4cm x 6cm around injection site on left thigh. It was not tender to palpation and blanched. Treated with topical steroid and oral antihistamine.
Pt was a low responder p/ 3 doses of hep B vax on a 0,1 & 6 months schedule.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with RECOMBIVAX HB (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015. No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was available. This is one of the several reports linked with the same reporter link. Additional information has been requested.
Patient note that she had no side effects until she was sleeping that night, and switched sides, and noted warm, puffy, painfully red arm. Tried Tylenol and ice on affected site with no help. Told patient to go seek care by PCP, or another medical doctor to assess site.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route of administration were not provided). No concomitant medications were reported. On an unknown date, the patient complained of pain after injection of GARDASIL. The outcome of the event was unknown. The relatedness between the event and the vaccination with GARDASIL was not provided. Additional information has been requested.
received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is 3rd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for COVID-19 immunisation. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD/AE, different patient
Crohn's aggravated; This is a solicited report from a non-Pfizer sponsored marketing program, based on the information received by Pfizer. A contactable consumer (patient) and physician reported that a 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose (Citrate Free) for moderate to severe adult Crohn's disease. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, the patient received 1st dose covid-19 vaccine manufactured by Pfizer intramuscularly for covid-19 immunization at age of 66 years old. The patient experienced crohn's aggravated in Mar2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown.   The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Crohn' disease aggravated and the suspect drug.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Red, warm area around injection site. Advised treatment, cool packs, and Tylenol or Motrin, PRN.
I woke up at approximately 9:30 AM the morning of Sunday May 2nd 2021 the day after getting my covid vaccine and had to rush to the bathroom. I proceeded to have blood and blood clots come out my urethra very urgently. I had abdominal pain and pressure. I proceeded to need to urinate blood and blood clots for approximately 4 hours urgently. I could not go far from the bathroom without having to return quickly to the toilet. I wet myself several times. The clots stopped coming around 1:30 PM. I proceeded to have to have no control over urination urge and could not leave the bathroom. Around approximately 2:00 PM I could leave the bathroom without fear of wetting myself. I continued to have a small amount of a mix of blood and normal urine passing for another hour or so. I have a picture of the blood and clots that came out of my urethra. I continue to have dull pain and pressure in my abdomen.
Received DTaP, VARIVAX to (L) arm on 8/18/11. On 8/20/11 pt with erythema (approximately 8cm x 6cm) to (L) arm with bruising (approximately 0.5cm x 2 bruises). Positive warmth. SUTTP. MAEE. Positive distal grip positive 2+ radial pulse. Also had fever Tmax 101 & emesis x 1 on 8/19/11.
After receiving her vaccine, client states she felt dizzy and confused, then lost consciousness.  Vital signs BP 136/84, O2Sat 99%, HR 100. Client was alert and awake.  Client advised to be transported to the ER.  Client refused.  Client went home.
Report received from an Emergency Medical Technician (EMT) at Plasma center on 22-Oct-2008:  A female employee received AFLURIA (CSL influenza vaccine) on 21-Oct-2008 at 10:00 AM.  AFLURIA lot # 03549111A, exp date 30-Jun-2009.  The patient developed headache, nausea, chills, muscle aches, and fever 100.2F starting 2 hours after receiving the shot (12:45 PM).  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Information derived from the AE report does not change the current safety profile of the product.  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event report.
2 weeks post vaccine developed thoracic pain, now 6 weeks later  (8 weeks post vaccine) treating for post herpetic neuralgia (zoster sine herpete)
This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) in 2008. The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) in 2009. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot not reported) in 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
My medication stopped working a week and 3 days after receiving the vaccine. I received the vaccine May, 5th, 2021. I told my doctor about this and she suggested trying a different medication.  That did not work.  I was still feelings symptoms of my medications not working.  On June 29th, 2021, I went in for a follow up appointment with my doctor at noon to address the medications, as well as discuss neck pain I was feeling that day. She sent me for x-rays after my appointment. At this point I was experiencing some moderate tremors but tried to continue my appointment.  I was unable to sign my paperwork without holding my hand, began having difficulty walking and by 3:40pm I was experiencing severe tremors I could barely walk.   I went to the emergency.  The doctors gave me lithium because my levels were low and sent me home.  By July 2nd I was back in the emergency.  The doctors told me I was crazy.  That this was all in my head and sent me home.  By July 5th, 2021, I could no longer speak without struggling.  I am now currently still shaking uncontrollably sometimes, cannot speak properly at all, and have pain all over my body.