chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cramps were more intense; period almost 20 days out of the month/ periods were heavier; My menstrual cycle is only 10 -12 days. I am spotting by and on my period almost 20 days out of the month.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Jan2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's menstrual cycle was only 10 -12 days. On 01Feb2021, the patient experienced spotting by and on period almost 20 days out of the month, cramps were more intense and periods were heavier and none of this was how cycles were prior to the COVID-19 vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events spotting by and on period almost 20 days out of the month, cramps were more intense and periods were heavier was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
red blotch around injection site approximately 5" in diameter.  Not itchy but warm to the touch.
1455 Tdap - RUA. C/O pain stinging above and in shoulder. C/O being sick. Sat down. Then went to DR emetic. Rash over arms, ankles, back down. 1507 Stated she had had diff. breath - numbness in front neck. BP 130/100. BENADRYL 50 IM, H20. BENADRYL 50 mg IM RA.
Admit to hospital for acute COVID-19 infection in patient with severe COPD. Hypoxic.
On 04/26/2000, pt developed an injection site reaction characterized by redness and small red bumps at site.  This is 1 of 2 pts from this facility who experienced this event.
I have an 8cmx4cm welt at injection site. Swelling noticed 28hrs after initial injection, but could have began prior. Welt is warm to touch, tender, and slightly raised. Itching began 2 days after injection. No prior history to adverse reactions from other types of vaccines.
experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug), Hypothyroidism, Type 2 diabetes mellitus and Obesity. Concomitant products included TRAZODONE, IBUPROFEN (ADVIL [IBUPROFEN]), METFORMIN, BUPROPION, MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion) was resolving.            It was reported patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported patient had previously received a COVID-19 Vaccine. COMPANY COMMENT: This is an spontaneous case concerning an 51-year-old female patient with  medical history of Drug allergy, Hypothyroidism, Type 2 diabetes mellitus, Obesity, Concomitant products included TRAZODONE, IBUPROFEN, METFORMIN, BUPROPION, MULTIVITAMINS, LEVOTHYROXINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, PAXLOVID for COVID-19 treatment from 18-May-2022 to 23-May-2022 who experienced the unexpected event of COVID-19 (AESI) 205 days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 51-year-old female patient with  medical history of Drug allergy, Hypothyroidism, Type 2 diabetes mellitus, Obesity, Concomitant products included TRAZODONE, IBUPROFEN, METFORMIN, BUPROPION, MULTIVITAMINS, LEVOTHYROXINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, PAXLOVID for COVID-19 treatment from 18-May-2022 to 23-May-2022 who experienced the unexpected event of COVID-19 (AESI) 205 days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This study case was received from the investigator in a trial on 16 July 2013. A 20-year-old male subject with a no past medical history was found to have encephalitis following immunization procedures 10 days after the subject had received the following vaccinations on 25 May 2010: an injection of ACAM2000 (lot number, route and site of administration not reported), an injection of Anthrax (manufacturer, lot number, route and site of administration not reported) and an injection of TYPHIM VI (lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
discomfort; vertigo; dry heaves; dizziness; hot flashes; chills; nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT, VERTIGO, RETCHING, DIZZINESS, and HOT FLUSH in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included METOPROLOL, NEXIUM, DITROPAN, Losartan/ HCTZ, METHENAMINE, REPATHA, JANUVIA, VITAMIN D3, and VITAMIN C for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DISCOMFORT, VERTIGO, RETCHING, DIZZINESS, HOT FLUSH, CHILLS, NAUSEA, and FATIGUE. On 04-Feb-2021, DISCOMFORT, VERTIGO, RETCHING, DIZZINESS, HOT FLUSH, CHILLS, and NAUSEA had resolved. On 06-Feb-2021, FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included none.
Patient was admitted with loss of appetite and wheezing. Patient received 6 mg daily for 8 doses from January 20-January 27.
Diagnosed with Peyronie's Disease in November, 2021 after experiencing symptoms in October, 2021.
Received first dose in arm on 4/13/2021 at approximately 1 A.M. on 4/14/2021 woke in pain all over, freezing chills (shaking),extremely weak, nauseous , went to bathroom a lot---lots of gas. Did not want  to eat or anything. Stayed in bed. By 4/16  was a little better, couldn't eat much, still weak. Was better on 4/17/2021. I tried to report to medical , they didn't seem to think it was  important.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 60-year-old patient who received SHINGRIX. Co-suspect products included SHIGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, chills, injection site pain, injection site swelling, general body pain and exhaustion. On an unknown date, the outcome of the fever, chills, injection site pain, injection site swelling, general body pain, exhaustion, circumstance or information capable of leading to medication error and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, general body pain and exhaustion to be related to SHINGRIX. Additional details were reporter as follows: This case was reported by the patient who was a retired nurse. The patient was in general good health. The patient received a dose of SHINGRIX vaccine two days ago from the date of reporting. The patient stated that, the side effects were terrible. The patient experienced fever, chills and site pain with significant swelling. The body aches were more than aches and quite painful. At the time of reporting, the patient was on day 2, and although the patient was not bedridden that day, continued to suffer from exhaustion and pain. The patient felt that, GlaxoSmithKline misrepresented the level of side affects. Since the patient was a retired nurse, the patient would understand the importance of vaccine, and was very aware of the discomfort and implications of the disease. The patient was concerned and asked what level of immunity can be expected with 1SHINGRIX vaccine, as the patient would not be receiving a 2nd dose, which could lead to or information capable of leading to medication error and incomplete course of vaccination.
stomach pain. pt presents to the ED for severe abdominal pain x 8-10 hours, pt states she has left flank pain that radiates to her upper back, chills, denies N/V/D, denies any recent stools and endorses frequent eructation. 26 yo f w/spouse at bedside c/o ongoing intermittent episodes of diffuse abd pain/cramping (hypogastric > epigastric) w/additional nausea w/o vomiting x 2wks, worsening over past 24-48hrs, states latest onset largely R-sided in nature x8hrs; Pt denies any fevers/ns/chills, urinary sx's, vaginal bleeding/discharge, prior hx of abd trauma/surg/procedure
At 15 min mark after receiving vaccine: sudden loss of hearing (extremely muffled, underwater sounding), profuse sweating, and then lost vision and passed out entirely when attempted to stand up for help. After laying down, quickly regained consciousness and felt better. After effects and soreness have been minimal. Have not fainted during/after vaccine before.
Painful injection when given. Pt took ibuprofen & TYLENOL. Pt had arm pain. Described as intense pain. No external sign or swelling at injection site. Pt doing physical therapy. Pt went to doctor one month later. Immediate pain felt.
Pt recv vax on 11/3/98; on 11/4/98 pt exp urticaria x 48 hr; tx=Benadryl
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 of herpes zoster, also known as shingles and other complications. On or about 11-NOV-2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. 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.
some hot flash type symptoms that she has not experienced before; This is a spontaneous report from a contactable Nurse reported for herself. A 44-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About ten days after her first dose of COVID vaccine, she started experiencing some hot flash type symptoms that she has not experienced before. Event took place after use of product. Pregnancy at vaccination time was No. Event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Pt received Varivax 1/10/08. Woke up with swollen red area around injection site 4cm x 4.5 cm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-MAY-2014, the patient was treated by a Physician Assistant for a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and hydrocodone for management of her painful symptoms and chronic pain. 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No additional AEs or PQC reported; Product preparation issue (Inappropriate reconstitution technique); expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous report was received from a nurse concerning a patient of unknown age. No information about the medical history, concurrent condition, or concomitant therapy was reported.   On 22-NOV-2021, expired sterile diluent (MERCK STERILE DILUENT) (lot # S002625, expiration date 09-NOV-2021; dose and route were not reported) was used to reconstitute vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U007478, expiration date 08-MAR-2023; dose and route were not reported) that was administered (expired product administered and product preparation issue). No additional adverse event was reported.  ; Sender's Comments:  US-009507513-2112USA004666: US-009507513-2112USA004629:
Information has been received from a nurse practitioner, concerning a 16 years old patient of unknown gender. Patient's historical condition, current condition, concomitant medication, previously drug reactions and allergies were not reported. On 04-MAR-2019, the patient was administered with a dose of PROQUAD subcutaneous injection for prophylaxis (anatomical location, lot number and expiration date were not reported) (product use in unapproved population). No adverse effects were reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1903USA002536:
pt recvd vax & 2 wks post vax exp general aching & pain in joints,especially finger joints,& gen fatigue;these sx lasted 2 days & resolved completely;pt decided to discontinue the vax series;
Injection site reaction. Redness/swelling, pain.  Likely superimposed cellulitis. Treated with a course of antibiotics and warm compresses.
Approx. 24-36 hrs. after vaccines listed below patient developed rash across her back and thighs bilat. Mtr. called ER at hosp on 7/10/11 (Sat) soon after & they told her to give child BENADRYL and rash quickly resolved.
Pt waited ~15 minutes after receiving half dose of flu vaccine and left. After leaving pt reports feeling itchy and achy. Pt decided to rest and take a nap and woke up at 5:30 PM feeling like her throat was swelling and general malaise. Pt then took a Benadryl and states symptoms were resolved.
Swollen & red at injection site 9-7-12 gradually spread  & worse till made Dr appt 9-10-12, Dr diagnosed with chicken pox.
Felt bad; Arm pain; Sweating; Cold feet; Slurred speech; Elevated blood pressure; Stuttering; Body ache; Headache; tremors; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt bad), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweating), PERIPHERAL COLDNESS (Cold feet) and DYSARTHRIA (Slurred speech) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2001, the patient experienced TREMOR (tremors). On 21-Jan-2021, the patient experienced FEELING ABNORMAL (Felt bad), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweating), PERIPHERAL COLDNESS (Cold feet), DYSARTHRIA (Slurred speech), HYPERTENSION (Elevated blood pressure), DYSPHEMIA (Stuttering), MYALGIA (Body ache) and HEADACHE (Headache). The patient was treated with LORAZEPAM (intravenous) 21-Jan-2021 for Adverse event following immunisation, at a dose of 2 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 21-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency and STEROIDS on 21-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. In February 2021, FEELING ABNORMAL (Felt bad), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweating), PERIPHERAL COLDNESS (Cold feet), DYSARTHRIA (Slurred speech), HYPERTENSION (Elevated blood pressure), DYSPHEMIA (Stuttering), TREMOR (tremors), MYALGIA (Body ache) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Blood pressure measurement: 183/90 (Inconclusive) Inconclusive. On 21-Jan-2021, Computerised tomogram head: normal (normal) CT of brain was normal. On 27-Jan-2021, Magnetic resonance imaging: abnormal (abnormal) abnormal  flare signal regions in the brain which may signify early microvascular ischemic changes, a demyelinating process, vasculitis, or sequelae for migraines. On 05-Feb-2021, Magnetic resonance imaging: normal (normal) indicated no acute intracranial abnormalities, no diffusion evidence of acute ischemia, no brain parenchymal edema, hemorrhage or mass effect, no enhancing intracranial mass or suspicious intracranial enhancement, multiple scattered punctate foci of unenhancing white matter, signal alteration which are nonspecific but unchanged in comparison to 27 Jan 2021..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. In addition to the ones reported above , stroke alert was also performed in Emergency room.
ARM SORENESS; ARM REDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 06-OCT-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm soreness, and arm redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness and arm redness was not reported. This report was non-serious.
Hives noted at 5:45 pm on 1/16/19 on entire body - scattered. Mother gave BENADRYL 1 dose and by evening only a few hives remained. AM on 1/17/19 had hives again mother gave a dose of either CLARITIN or ZYRTEC before patient went to school. In the evening of 1/17/19 mother states "had spots on her arms and stomach that looked like bite marks". Mother gave a dose of BENADRYL at that time. Friday AM 1/18/19 rash/spots were completely gone. Mother stated that patient had redness and swelling at the (R) thigh injection site that lasted through Saturday 1/19/19. Patient had a previously scheduled physical appointment with her PCP on 1/21/19. Immunization reaction was discussed at that time.
This spontaneous report as received from a physician refers to a 17 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot#, expiration date not reported). The patient experienced syncope about 12 hours later. The patient did not seek medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt called today, 10/06/2021, to report her symptoms that are ongoing. States that the day after receiving her second dose of the Moderna series (09/12/2021) that her whole arm became very swollen, there was a red rash about 2 inches underneath the vaccination site, and she developed a "kink" in her neck. She reports there have been painful tingling sensations down her whole should, arm, and near her breast. Her thumb, index, and middle finger have all become numb, and the tips of her ring finger and pinky are beginning to go numb. She states her left arm is very weak and she cannot use it well. She has only been getting 3 hours of sleep each night since 09/12/2021 due to being so uncomfortable. Pt states all of her symptoms are progressively getting worse. I advised her to go to an urgent care to have a medical evaluation as she has not been evaluated yet.
Patient is a 78-year-old gentleman with prior history of dementia, stroke, debility chronically, who presented from the nursing care facility with reports of acute mental status changes and fever.  See admission note for full details on his presentation.  He was found to be positive for COVID-19 and was treated with stress dose of his prednisone and fluids for acute kidney injury.  In 24 hours of hydration and steroid dose, his mental status returned to baseline.  He unfortunately was depressed and had some confusion and was failure to thrive here in the hospital, refusing medications on a regular basis and taking a p.o. poorly.  The family elected not to do a remdesivir, so he was just treated conservatively for the COVID-19.  His O2 sats remained stable.  Had just very mild bronchitis but was stable on 2 L O2, which is similar to his previous baseline.  The patient remained resistant to taking his medication and family was concerned about his continued decline.  They wish to have a rasp for a hospice evaluation and consultation.  They elected for home hospice care with more palliative care approach going forward.