chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Several months after zoster vaccine live (ZOSTAVAX) vaccine was administered, on 01-OCT-2018, the patient presented to a hospital and was diagnosed with shingles. On 03-OCT-2018, he presented to his primary care doctor who told him that the vaccine likely caused his shingles outbreak. He was prescribed gabapentin and acyclovir. As a result of vaccination the patient sustained personal injuries. Further, as a tragic consequence of vaccination the patient suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has suffered and incurred damages, including medical expense and other economic and non-economic damages. The outcome of shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested
she faint twice after her second dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (she faint twice after her second dose of Moderna vaccine) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (she faint twice after her second dose of Moderna vaccine) (seriousness criterion medically significant). At the time of the report, SYNCOPE (she faint twice after her second dose of Moderna vaccine) outcome was unknown.            Patient is worried about the booster dose.  No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred right away after receiving the second dose of mRNA 1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The reporter assessed the events as related to the product.; Sender's Comments: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred right away after receiving the second dose of mRNA 1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The reporter assessed the events as related to the product.
Fever followed by urticarial rash that lasted 5 days following DTaP and IPV.
Woke up morning of 10/11/2022 with a sore throat and fever. Took an at home rapid COVID-19 test, which was positive. I had a tele visit with my doctor that day who prescribed PAXLOVID. Took full course of PAXLOVID. Fever fluctuated between normal temperature and 100.7. This lasted until 10/14/2022. Sore throat lasted just 10/11/2022. Noticed a blister on abdomen that itched. This diminished in size slowly until being mostly gone as of 10/25/2022.
Generalized body aches, malaise, fatigue, and right facial swelling and itching.
Nerve pain down the arm; Lymph node swelled up like hard mass. Its still their I can feel it.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain down the arm) and LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced NEURALGIA (Nerve pain down the arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Nerve pain, at a dose of 1 dosage form. On 17-Jun-2021, NEURALGIA (Nerve pain down the arm) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) outcome was unknown.            Laboratory data included Ultrasound Biopsy. No Concomitant medication details was provided. No treatment medication details was provided. Patient will be getting  surgery scheduled in July to remove his lymph nodes (supraclavicular lymph node removal left side of the collar bone).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226030 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
during our covid site visit on 12.15.22. it was discovered that we had a pfizer batch in the frig that was past BUD date. during the investigation they went back through all the covid injections that were given and saw this patients lot number was given past the BUD date. patient has been contacted and revaccination was offered . manufacture was notified and reports were filed pending outcome.
Fluzone High-Dose Quad 2020-21 (PF) 240 mcg/0.7 mL IM syringe  Within 15 mins I was dizzy. The rest of the first day was a feeling of vigilance, a buzz. By night I could not sleep then severe pain developed in my gluteus maximus muscles which lasted for three days. Painful to walk. This, along with clogged sinuses and swollen tonsils. General misery. Did not sleep for three days. By Day three symptoms abated somewhat.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information was received regarding the pt's medical history, concurrent conditions and concomitant medications. On or about 02-OCT-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a certified medical assistant refers to a 47 year old female patient. In November 2013, the patient was vaccinated with a 0.5 ml dose of PROQUAD (Merck) (Lot # reported as J006868, expiration date 14-DEC-2014) subcutaneously. No adverse effects were reported. Additional information has been requested.
Fever of 101 and severe soreness/stiffness.  Skin sore to the touch and muscles sore with any movement.
Any data on risk of waiting after 6 weeks from first dose?; Dizzy; sore; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 25Aug2021 18:15 (Lot number: FC3183) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose , Batch/lot number: Pfizer EM9810), administration date: 04Feb2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Aug2021, outcome "unknown", described as "Dizzy"; PAIN (non-serious) with onset 25Aug2021, outcome "unknown", described as "sore"; ASTHENIA (non-serious) with onset 25Aug2021, outcome "unknown", described as "weak"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Aug2021 18:15, outcome "unknown", described as "Any data on risk of waiting after 6 weeks from first dose?". The events "dizzy", "sore" and "weak" were evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
I waited the obligatory 15 minutes after receiving the injection, with no noticeable side-effect, but a few minutes later on the drive home I began experiencing numbness and tingling of my lips.  I did not discern any swelling or difficulty breathing. This slowly dissipated over an hour or so, but almost 24 hours later I still feel slight tingling, like when you get novocaine  at the dentist and it's almost all worn off.  This was my 2nd dose.  I did not experience any side-effects after my 1st dose, given on Mar 10, 2021.  I have never had lip fillers, by the way.
Soreness 5" below and toward front of arm in 3" diameter circle after injection.  My husband did exactly the same way.  I however, 3 days later got in a tanning bed and the round circle of soreness turned red and itched.  I think the tanning bed aggravated the soreness.
This spontaneous report was received from a nurse practitioner concerning a female patient who would be currently 24 year old at the time of this report. The patient had no medical history, drug reactions/allergies or concomitant medications. On 13-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N023952 with expiration date of 12-JUL-2020, intramuscularly as vaccination (dose not reported). On 04-JAN-2018, the patient went to the pharmacy and reported that since 13-DEC-2017 (reported as since the receipt of the vaccine), she experienced pain at the injection site, which was radiating up towards her shoulder. The reporter stated there was also a bump at the injection site (injection site mass). At the time of the report, the patient did not recover from pain, injection site mass and injection site pain. The causal relationship between the event and therapy with GARDASIL 9 was not reported.
Rash and joint pain.  Subsequently diagnosed as serum sickeness.  Currently on steroid therapy and with joint pain.  Most likely had same adverse event in 2011 - misdiagnosed at that time as JIR vs JRA vs Strep induced arthritis. Pt completely recovered after tonsillectomy and case of serum sickness with Omnicef.
Heartburn immediately upon waking the morning after the shot that will not go away. I have never had heart burn before.
POST VACCINATION DAY #8 PATIENT WAS HOSPITALIZED 15NOV2003  AT HOSPITAL WITH FEVER, SWELLING IN LEFT ARM, GENERAL MALAISE, AFTER SUCCESSFUL VACCINATION. PATIENT WAS DISCHARGED ON 18NOV2003. PATIENT STATES ONE LARGE ULCER ON THE LEFT DELTOID.
ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. Big pharma is; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. big pharma is after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had ended up with guillain-barre; she never recovered and her life was very limited with the neurological disease. big pharma is (guillain-barre syndrome) received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer, lot number not reported in unknown administration site for Immunisation with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Not Recovered / Not Resolved for the event.  Seriousness criteria: medically significant for guillain-barre syndrome.; Sender's Comments: Sanofi company comment dated 23-Nov-2022: This case concerns a patient who has received Influenza vaccine and experienced guillain-barre syndrome. There is no evidence to suggest a causal role of the suspect product hence the event has been assessed as unrelated to the product. There is no pharmacological plausibility of the patient to develop guillain-barre syndrome after receiving Influenza vaccine, hence the benefit risk profile of product is not affected by this report.
High fever for 4, fussy for 4 days, swollen eyes on day 3,
I had my vaccination on 11/10/2022. On 03/06/2023 I felt like I was coming down with a cold. I tested COVID-19 positive 03/06/2023 and I contacted my physician office. I had a telehealth appointment and was prescribed PAXLOVID on 03/08/2023. I feel fine on 05/15/2023.
3PM pt began crying & mom noticed abd distension & flatus;330PM pt began to hold head while in a seated position as if in pain & preferred lying down;during the course of these events pt would laugh, eat & play as long as reclined;
Fever; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1980, Hypertension since 2004, High cholesterol since 2004, Prediabetes since 2015, Drug allergy (allergy to local Anaesthetics), Allergy to antibiotic (allergy to sulfa) and Allergy to venom (Bee wasp venom). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA) for Hypertension, LEVOTHYROXINE for Hypothyroidism, METFORMIN for Prediabetes, VITAMIN B COMPLEX and VITAMIN D NOS for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 10:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 milligram. On 28-May-2021, PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-100659 (Patient Link).
Severe headache, unable to sleep, elevated temperature in morning, muscle aches, arm soreness
headache; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Mar2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a scheduled appointment for a second dose due on 21Apr2021. This past Sunday, her granddaughter tested positive for COVID. On an unspecified date in Apr2021, the patient experienced headache. The patient asked whether it will affect her second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The day after receiving the vaccine I developed redness, itchiness and some swelling at the injection site.  That went away after a couple of days.  However on Day #8 redness and itchiness developed again at the injection site and is still present now on Day #10.
Vaccine was to be given to patient. Needle was inserted IM in left deltoid but the needle was not on secure resulting in the vaccine leaking out the side of the syringe. Another shot was given on the same side afterwards.
No additional adverse events; Expired dose of M-M-R II was administered to patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 29-NOV-2021 (reported as: yesterday), the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 1 dose (lot # S037502 has been verified to be a valid lot number, expiration date was reported and established as 20-NOV-2021; exact dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported), as prophylaxis. It was confirmed that the dose was properly stored up through the time of administration. No additional adverse events were reported.
Muscle aches and general tiredness with no other side effects. I am currently pregnant and was at the time of the shot, with a due date of 12/18/2021.
had tiny pimples in my arms, chest; reddish color on my face; rashes; general malaise associated with fibro is increasing; weak; puked; general malaise associated with fibro is increasing; fatigue is worsening/feel totally drained; can't even walk without feeling the necessity to rest; have a headache that feels like something is pumping in my brain; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168), via an unspecified route of administration in right arm on 14Jun2021 at 12:00 as (at the age of 46 years old) single for covid-19 immunisation. Medical history included fibromyalgia, don't have a thyroid and have high blood pressure. The patient had allergic/not common side-effects to around 30 medicines, food allergies, dust and other allergies. Concomitant medications that patient received within 2 weeks of vaccination included levothyroxine sodium (EUTHYROX), 75 microgram, lisinopril 7.5g total, others. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 14Jun2021, at 12:15, 15 minutes after of receiving the first dosage, she had tiny pimples in her arms, chest and reddish color on her face. This kind of allergic reaction she had in the past and normally develops in short breath and other symptoms. At that point she took 2 pills of desloratadine 5 mg. Since then (today is 24Jun) fatigue is worsening. She can't even walk without feeling the necessity to rest. She also feels totally drained after eating, her rashes come and go during the day and general malaise associated with fibro is increasing. She feels very weak. Since last night she has a headache that feels like something is pumping in her brain. Today she puked. She is asking how long these symptoms will last. The adverse event resulted: Doctor or other healthcare professional office/clinic visit. The patient received treatment due to the had tiny pimples in my arms, chest, reddish color on my face and general malaise associated with fibro is increasing. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Headache, Fever, Diarrhea & Nausea Vomiting Narrative:
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for dementia, hyperlipidemia, obesity. Per note 5/5/21 only received one dose of Pfizer covid vaccine. Was under the care of hospice. Recently fell and dislocated hip requiring surgery at outside entity. Continued to decline post surgery. No documentation or medical records from hospital visit available. Deceased 5/23/21
Pt. received shingles shot on 9/16 and then developed shingles.
The day following my vaccine I had the expected side effects of achey muscles, headache, chills, and fatigue. The second day after, the chills had stopped by I still felt achey. In the afternoon my stomach began to hurt, it got significantly worse over night and persisted at that level for 12 hours. My stomach currently still hurts but not as much as it did over night. I have not been able to identify any action/medication to alleviate the pain.
congestion; mucus; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son) that.  A male patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration and unspecified date as dose 1, single for covid-19 immunisation. The medical history and concomitant medication was not reported. The parent reported that the active drug substance name as COVID 19 Vaccine, mRNA. Parent stated that her son has already received the 1st dose of the Pfizer Biontech Covid vaccine but was not able to get the vaccine on the recommended date due to congestion and mucus on an unspecified date. Caller asked if her son was still eligible to receive the 2nd dose. The outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I has a bilateral attack of narrow angle glaucoma,  seeing colored halos around lights. Had a headache and mild nausea,  but attributed that to known vaccine side effects. I had never experienced anything like that. Went to opthalmologist the next morning and pressures were elevated with some reduced visual acuity. Was given drops, sent home, returned for a check that afternoon, which were in acceptable range.
Sore Arm  Throwing up 3 times Fever Chills  Tired  Weak   It has been 3 days and I'm slowly recovering. I've never got this sick from any shot before. I will not take the booster as sick as I've been the last 3 days.