chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suicidal idealization; felt bad; tongue swollen; Mental health issues; bad tingling in mouth; Face is red; mind is spinning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (Suicidal idealization) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Generalized anxiety disorder and Gastric bypass in June 2020. Concomitant products included DIAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ALPRAZOLAM (XANAX) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal idealization) (seriousness criterion medically significant), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning). At the time of the report, SUICIDAL IDEATION (Suicidal idealization), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning) had not resolved.            Treatment included benadryl.  Patient mentioned he went to urgent care, his covid test was negative, psych evaluation recommended help for side effects only.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Company Comment - 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-2021-073680 (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.
Itching began sacral area and back of legs, extending over few days to front of thighs, mid-back, and arms. No hives, no redness, tiny pale to red bumps only, non draining, no scabs. No change in diet, laundry, personal care items. no UTI or yeast, no bug bites, OTC remedies minimal help.
Muscle aches; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2019) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced muscle pain and influenza-like symptoms. On 20th April 2019, the outcome of the muscle pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the muscle pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the left arm. The pharmacist on the line reported that the patient experienced flu like symptoms and muscle aches, starting the day after the injection and then resolving two days later. The patient did not want to get the second dose. The reporter consented to follow up.
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received HAV (Havrix) (batch number 95EJ7, expiry date 06-FEB-2023) for prophylaxis.   On 15-MAR-2023, the patient received Havrix. On 15-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was office manager. The reporter consented to follow up. The reporter reported an expired dose of Havrix was administered to a patient, which led to expired vaccine used.
pt recv vax AUG95 & w/in 1 wk post vax pt exp lesions scattered over arm & trunk;pt was found to have atrophoderma;lesions cont to devel as of 14MAR96;
Rash all over back and some on trunk. A little in leg. Like hives. Itchy
1 1/2 hrs p/vax (630) pt felt hot; eyes looked spacey; fell asleep several minutes a/could arouse 715PM; taken to ER more alert; t102 R; APAP given; lethargic, shaking, chills; convuls
Rash, hives, swelling of eyes (mild) within 30 minutes of receiving vaccine listed below. No problem breathing. Benadryl orally given once, followed by DEPO-MEDROL 40 mg X 1 IM. Hives started to fade. Patient left in stable condition.
Symptoms of Shingles started two days after vaccination. The symptoms started with skin pain on abdomen which spread around to back over next two days. At 5 days after vaccination, a rash started and progressed over next 3 days also around back. I visited an Urgent Care at 7 days after vaccination where the Nurse Practitioner diagnosed Shingles. Started anti-viral at 8 days after vaccination (6 days after initial skin pain, and 3 days after rash started). The rash does not appear to be spreading further but is still in-progress toward blistering, etc...
Fiery red patch on upper left arm where pneumonia vaccine was administered. Also prominent swelling at infection site.  Pt was administered the vaccine on 10/31/02 at 11 am and started having symptoms at about 11 pm that night.  She has generalized body aches and a fever of 103.
This spontaneous report as received from a treating physician via a company representative refers to a 24 year old female patient. On an unknown date (in the past, while under the care of another, unspecified Medical Practice) the patient was vaccinated with at least one dose of GARDASIL, injection, (lot #, expiration date, dose, route unspecified). It was unclear if the patient had received only one, or multiple doses of GARDASIL. On an unknown date the patient experienced hives afterwards. Therapy with GARDASIL was reported as discontinued. The patient had not sought medical attention. The event was improved after stopping therapy. On an unknown date, the patient went to her new treating physician for an initial appointment, for an unspecified reason. Additional information has been requested.
Information has been received from a physician concerning a 11 month old female with a history of premature birth (28 weeks), respiratory failure requiring endotracheal support, pulmonary hypertension and no allergies reported who on 02-OCT-2009 was vaccinated with 0.5ml a dose of VARIVAX (Merck) (lot number 664708/1020Y, route not reported) in the left thigh. Concomitant therapy included PULMICORT, ferrousSO4, albuterol, vitamin D (unspecified), sildenafil citrate, calcium carbonate, lansoprazole and "Neutrophos" vitamins. On 19-OCT-2009 the patient experienced respiratory failure, liver enzyme elevation, chronic varicella zoster infection and rash in the face , upper trunk and a few in her extremities with approximately >100 lesions. There was no recent exposure to chicken pox or herpes zoster. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with Merck vaccine VZV strain. The sample of the lesion was collected on 23-OCT-2009. The sample was taken from: vesicular lesion and endotracheal aspirate. The PCR results indicated : adequate specimen, vaccine strain. At the time of the report the patient was not recovered. The patient sought medical attention by seeing her physician.  A lot check has been initiated.  Additional information has been requested.
Rash on top of both feet after both shots 1 & 2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 57-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 01Apr2021 at 21:00, (after both shots 1 and 2), the patient experienced rash on top of both feet. 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 event rash on top of both feet after both shots 1 and 2 was recovered on an unknown date in Apr2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I received a Hep A and B shot, one in each arm. The Hep A shot gave me reactions such as weakness in my arm, fatigue, and disorientation.
Patient had a spell of dizziness the evening after receiving the vaccine, the day after she also had a spell of dizziness, and today 10/30/19 she is experiencing dizziness again along with increased heart rate.
temp to 104, rash, hair loss seen that noc in ER-DPH/APAP given;
2/16/11 - Pt states she noticed redness & swelling in Lt arm at injection site on 2/14/11 also noted neck was swollen 2/16/11 painful to touch. Lymph node swollen in neck as well. No SOB - diff swallowing or fever - 4mm soft movable cystic area consistent w/possible node given Cephalexin 500mg BID #20.
Couldn't get out of bed; fever; Tremendous headache; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (approximately 8 days later started getting better.) on 17-Dec-2020. Concomitant products included SIMVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS). On 30-Jan-2021, ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
"a really swimmy head"/dizzy; changes in vision, she said she was reading her bible and the words on one side of the page were blue, and the other side was black and white/TV was blurry/blurred vision; developing "an excruciating headache"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:00 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 64 years as dose 2,0.3ml single for covid-19 immunisation. Relevant medical history included: "Chronic lymphocytic leukemia" (unspecified if ongoing), notes: she was diagnosed approximately 12 years ago; "Asthma" (unspecified if ongoing), notes: She has had asthma since childhood; "Diabetes" (unspecified if ongoing); "over weight" (unspecified if ongoing); "polycystic kidney disease" (unspecified if ongoing), notes: She also has polycystic kidney disease and stage 4 kidney failure.; "stage 4 kidney failure" (unspecified if ongoing), notes: She was in stage 3 kidney failure prior to COVID stuff. She went into stage 4 kidney failure a few weeks ago. 13Apr2021 was when she had the test that showed she was in stage 4.; "Covid-19" (unspecified if ongoing), notes: She had COVID back in December. The patient took concomitant medications. Vaccination history included: Bnt162b2 (first dose, First dose administered time:10AM, Vaccination site: right arm, lot number: EN6204), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Didn't feel good", "Achy". The following information was reported: HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "developing "an excruciating headache""; DIZZINESS (non-serious), outcome "recovered", described as ""a really swimmy head"/dizzy"; VISION BLURRED (non-serious), outcome "recovered", described as "changes in vision, she said she was reading her bible and the words on one side of the page were blue, and the other side was black and white/TV was blurry/blurred vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a consumer who reports developing "an excruciating headache" a few hours after her second dose of the Pfizer-Biontech Covid19 vaccine on 31Mar2021. She reports that she has a high pain tolerance stating she "didn't use Novocaine when I had my wisdom teeth pulled". Her head-ache has been ongoing since receiving her second shot. Additionally she reports symptoms that arise for 2-3 days then resolve, such as "a really swimmy head" and changes in her vision. As examples to her changes in vision, she said she was reading her bible and the words on one side of the page were blue, and the other side was black and white; she also reports that the TV was blur-ry and she had to move to a different seat to make the blurriness go away. She has been seen by her HCP and had a CT scan done, and they "can't find anything wrong".  No follow-up attempts are possible. No further information is expected.
1 WEEK AFTER RECEIVING INJECTION - INJECTION SITE BECAME RED, SWOLLEN, WARM AND ITCHY
Pt received the H1N1 injection was observed for 15 min, and went back to class. He c/o feeling dizzy, so he was sent back to observation area. His color was fair skin warm and dry. He was placed in a recumbent position until school nurse transported him her clinic via wheel chair.
Approx 12 days after receiving my first dose of the vaccine my right arm was sore to the touch, a little itching. By 2/28 it is hot to the touch, swollen, red and hurts. I will be going into the doctor to have them take a look at it since it has been 2 weeks since I received the vaccine as of today 3/1.
This spontaneous report was received from a registered nurse referring to a 6 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1712USA010085: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Patient report feeling pain in all body, headache and minor fever. Also pain in arms. Patient took 2 TYLENOL and next day feeling better. Pharmacist gave counseling to patient.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with diabetes. Drug reactions/allergy to BACTRIM. Pharmacist reported that on 04-SEP-2013 patient developed itchy, red, raised uncomfortable rash on the back of the arm at the injection site after a 0.65 dose of ZOSTAVAX (lot # J003806, expiry date: 03-JUL-2014) subcutaneous at the back of the arm vaccinated on 03-SEP-2013. The rash was hot to the touch and about 4-5 inches in diameter. Concomitant therapies included  furosemide, hydrochlorothiazide, irbesartan, meloxicam, NOVOLOG, PRILOSEC, PRISTIQ, VALTURNA, WELCHOL, and ZETIA. The patient has sought medical attention via pharmacist visit. No lab diagnostics studies were performed. BENADRYL and cortisone cream were given for treatment. At the time of report, the outcome of the events was not recovered,  Additional information has been requested.
Swelling upper left arm, erythema, extreme soreness- 3 hrs. post injection. Shortness of breath and nausea.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site). At the time of the report, ARTHRALGIA (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Information has been received from a registered nurse concerning a male who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles along the sciatic region. At the time of the report the patient was debilitated with pain. The patient's shingles persisted. The reporter considered shingles to be disabling. No further information is available.
patient experienced immediate light headedness and dizziness---was given water and ginger ale---was observed for a full 45 minutes---medical professionals (EMT's) checked her out for her safety
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and  pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She has one big toe that is arthritic and it does not seem to want to bend; More like her balance does not feel right/Still feels a little off kilter; Dizziness; Hard time focusing her sight; Neck and toe stiffness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 around 13:00-14:00 at single dose for covid-19 immunization.  There were no medical history or concomitant medications. The patient got the vaccine this week on 06Jan2021 right after lunch/early afternoon. She had no issues. In the afternoon of 07Jan2021, she started getting a little dizzy and had a hard time focusing her sight. The patient also had neck and toe stiffness on 07Jan2021. She did not think about the vaccine until last evening of 07Jan2021. The hospital called to see how she was doing, and then it dawned on her. After, she took her blood pressure which was 126/68 with 81 pulse. She slept well last night of 07Jan2021. This morning on 08Jan2021 she had breakfast but still felt a little off kilter. It is like dizziness, not really dizzy, but more like her balance does not feel right. She was focusing better on 08Jan2021, but not like normal. The dizziness hit her on 07Jan2021 about 15:00. It had improved. She felt more at the time of the report, not really dizzy, but more like her balance did not feel right. It was earlier on 07Jan2021 around 14:00 she was on the ladder taking down her Christmas bows. She had no dizziness whatsoever. For neck and toes stiffness, she had one big toe that was arthritic and it did not seem to want to bend. She had been doing neck exercises which had helped. The outcome of dizziness, hard time focusing her sight, neck and toe stiffness were resolving, outcome of rest events were unknown.   Information on the lot/batch number has been requested.
2nd Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was taken out of freezer on 8-Sep-2021 and was administered on 22-Oct-2021.
About 7 hours after booster vaccine I started having a headache, this was followed by nausea and dizziness. I also had a low grade fever through the night. These symptoms continued through 11/9/21 until approximately 8pm