chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021). In September 2021, EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that dose of expired  was vaccine received  between 02-Sep-2021 and 24-Sep-2021.  Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received  contains non significant information updated reporter contact details. On 05-Oct-2021: follow-up includes no new information.
Pt et sister very nervous about vaccine. Pt became blotchy after injection et. M.D. was called to the room. At that time her skin was almost cleared up and she was calm. She was D/C  with her Mom et Dad at that time.
COVID-19; COVID-19; anaphylaxis shock; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient got anaphylaxis shock and COVID-19 on an unspecified date. Outcome of the events was unknown.  The Lot number for the vaccine BNT162b2 was not provided and will be requested during follow-up. Linked Report(s): US-PFIZER INC-202101281145 same reporter, different patient. US-PFIZER INC-202101281146 same reporter, different patient; US-PFIZER INC-202101281147 same reporter, different patient.
Patient reports significant Rt shoulder swelling and pain . Swelling located posterior shoulder area . Possible impingement syndrome
Sore throat; throat is constricted; thick tongue; Nasal burning; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (thick tongue), NASAL DISCOMFORT (Nasal burning), OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Drug allergy (Allergic to a bunch of antibiotics. ) and Food allergy (Shellfish).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TONGUE DISORDER (thick tongue) and NASAL DISCOMFORT (Nasal burning). On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted). At the time of the report, TONGUE DISORDER (thick tongue), NASAL DISCOMFORT (Nasal burning), OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
prolonged generalized seizure (approx 45mins) requiring treatment in ER including ativan and dilantin to arrest seizure activity, followed by 2 day admission in hospital; this event occurred at approximately 9am on the day following vaccination (vaccines were administered in the afternoon); temperature upon arrival at ER was 38.2C; following resolution of seizure activity and after a post-ictal perios the patients' exam returned to baseline
Thrush; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient that has received both dose of the Pfizer COVID vaccine and after both doses he has experienced thrush as a side effect on an unspecified date. Patient wanted to know if antibiotics will affect the vaccines efficacy. The outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Began with itching, progressed to severe coalescent hives over entire body surface. Oral swelling was present with headache accompanied by severe chills. Self treated with drinking water, Motrin 800mg and Benadryl 50mg PO. Hives lasted approximately two hours, headache is persisting. Mild disorientation was present during the event as was some difficulty speaking. Although I did not have difficulty breathing I had a sensation of swelling in the throat.
Headache, fatigue, swollen lymph node in the armpit of the arm injected
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
36 hours post vax, the patient developed a red, swollen area at the injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, fever and pain. On an unknown date, the outcome of the pain in arm, feeling unwell, fever and pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 87 or 88 years. The batch number and expiry date was unknown. The patient received vaccine in unknown deltoid. The patient's arm felt really sore after vaccination and she felt pretty crappy for a couple days. She might have had a bit of a fever, was achy, and did not generally felt well. She felt very crummy. The patient did not mention exactly when they started, she just kept mentioning the next day. The patient did not report exactly when they resolved.
Redness, hot - softball size. On 2nd day, mild flu symptoms, fever, chills.
Right ear stop functioning. Couldn't hear at all. Went to an audio dr and she confirmed that his hearing is gone.
Very severe pain in shoulder. Like a Charley horse but worse. Could not sleep one night, could not move arm for 5 days and still feel sore after 10 days and counting.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: having large bruising to left deltoid with pain and itching and burning with intermittent tingling down arm
Case number PHEH2015US019688, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 47 year old male patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
health issues; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The lot number of Shingrix was unavailable. The patient wanted to delay the 2nd dose of Shingrix even longer due to health issues and was having to go in for surgery. The reporting pharmacist had no further details regarding health issues or surgery. The reporter consented to follow up.
I had thrombosis.; I felt sick; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 25Apr2021 the patient felt sick and went to the hospital where she was told she had thrombosis. The patient didn't have any risks for this disease. The patient received blood thinners as therapeutic measure of the event thrombosis and the doctor told her not to combine them with other medications. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I had my Pfizer vaccine on March 16, 2021. On March 17th I had a headache, body aches and fatigue which I expected since I had Covid in November 2020. Most of these symptoms only lasted 3 days. After the 3 days I had a continuing headache and started having jaw pain. On March 22nd I started having dizziness and a severe headache with jaw pain, fatigue and nausea. On March 23rd I got up abruptly and felt extremely dizzy and almost passed out. I am having continued sporadic headaches, nausea, dizziness behind my eyes with fatigue and a metal taste in my mouth especially when my mouth is dry. As of March 30th, only side effects lingering are dizziness behind my eyes and nausea
That night my arm was very painful.  The following day it was very red around the area but didn?t bother me.  The pain from the vaccine lasted a few days.  About a week after the vaccine my arm began become super itchy,  was red, swollen (raised, felt hard to the touch), very warm to the touch.   I put hydrocortisone on it and took benedryl.
RHEUMATOID ARTHRITIS FLARE; This spontaneous report received from a patient concerned a 6 decade old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced rheumatoid arthritis flare and was off humira while pandemic happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis flare was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210947413-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sometimes she begins to feel dizzy/lightheadedness; severe headaches, felt like meningitis; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Sometimes she begins to feel dizzy/lightheadedness), HEADACHE (severe headaches, felt like meningitis) and MYALGIA (Muscle aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 005C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, AMIODARONE, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) and HYDRALAZINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced DIZZINESS (Sometimes she begins to feel dizzy/lightheadedness), HEADACHE (severe headaches, felt like meningitis) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Sometimes she begins to feel dizzy/lightheadedness), HEADACHE (severe headaches, felt like meningitis) and MYALGIA (Muscle aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   SD text: A patient called that received the 2nd dose of the Moderna COVID-19 Vaccine in the left arm on 03Jun2021. The lot number of the 2nd dose was 048C21A. The patient states that since 24 hours after the 2nd dose, they have been experiencing severe headaches and muscle aches. Sometimes she begins to feel dizzy and lightheaded. They tried to treat it with tylenol for 2 days, but it didn't work, so they have been taking ibuprofen. She stated that the dizziness and lightheadedness seems to occur when the ibuprofen wears off, which is about 10 hours after. The patient said that the first day it felt like meningitis, but noted that they had never had meningitis. After the 1st dose, the patient had a rash, experienced tiredness and it hurt the next day. The first dose was administered on 06May2021 and the lot number is 005C21A.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. The patient described their symptoms as feeling like meningitis for the first day, but as there was no diagnosis of meningitis and as this perception is only reported as being on the first day, no event of meningitis is captured; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. The patient described their symptoms as feeling like meningitis for the first day, but as there was no diagnosis of meningitis and as this perception is only reported as being on the first day, no event of meningitis is captured
Didn't feel real great; Tired; Redness and itching; Itching; Didn't feel real great; soreness at injection site; Redness and itching; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Redness and itching), VACCINATION SITE PAIN (soreness at injection site), PRURITUS (Itching), the second episode of VACCINATION SITE ERYTHEMA (Redness and itching) and the first episode of FEELING ABNORMAL (Didn't feel real great) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Redness and itching), VACCINATION SITE PAIN (soreness at injection site) and the first episode of FEELING ABNORMAL (Didn't feel real great). On 08-Feb-2021, the patient experienced PRURITUS (Itching). On 09-Feb-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Redness and itching). On 10-Feb-2021, the patient experienced FATIGUE (Tired) and the second episode of FEELING ABNORMAL (Didn't feel real great). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Raised painful rash at injection site.  Has grown and spread  to approximately 4-5? in diameter in three days. Center of rash site has increased hardening and is warm to the touch.
Patient is fully vaccinate. 25 year old female with no pertinent medical history presents on 12/23/21 with a recurrent left labial abscess. Patient denies drainage, though reports a fever last night. Patient reported the cyst as being increasingly tender. No hemoptysis, dyspnea with exertion, chills, body aches, overt fatigue, chest pain, home oxygen use, tobacco use, dysuria, increased urinary frequency, or hematuria. Tested positive for COVID  on 12/21 after reports of a runny nose and exposure to friends. Positive for cough, congestion, rash, vomiting.  Patient admitted for IV antibiotic treatment for abscess. discharged home.
Significant vomiting and high fever.  Patient treated with hydration, observation, and Ibuprofen 200/5ml (2 ml dose).
Information has been received from a nurse concerning a 14 year old female who was vaccinated with all 3 doses of GARDASIL. That after the patient received her first or second dose of GARDASIL, she had fainted a "couple months ago". The patient felt dizzy and did not eat anything before her visit. The nurse did state that she did not faint when she received her third dose of GARDASIL. Not lot number was provided. Subsequently the patient recovered. The patient sought unspecified medical attention.
My head feels like weird; It feels light my eyes are sensitive to the sun; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided by the reporter.  Patient was not sure but received the first shot about a week ago.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013020A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term birth None complications) from August 2017 to 30-May-2018 and Alcohol use (Frequency of use: Rarely). Concomitant products included DOCUSATE SODIUM (COLACE) from 04-Dec-2020 to an unknown date for Constipation, METRONIDAZOLE (FLAGYL 250) from 26-Mar-2021 to 02-Apr-2021 for Gardnerella infection, VITAMIN D3 from 04-Dec-2020 to an unknown date for Vitamin D deficiency, PROBIOTICS NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, Pregnancy test: positive (Positive) positive. On 04-Dec-2020, Prenatal screening test: low risk male (normal) Test name is given as Panorama. Findings: Low Risk Male. On 28-Jan-2021, Alpha 1 foetoprotein normal: negative (Negative) Negative. On 28-Jan-2021, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-009143 (Patient Link).
fever; Pain in his left arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix in the left arm. The patient experienced fever that lasted for about 1.5 days and had pain in his left arm at the injection site.   For tolerances of 2nd dose, refer case US2020094353. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020094353:same reporter.
Big, swollen, red area, about 3-4 inches in size, but a couple inches away from the injection site. No itching, fever, ulcer, or disorientation.