chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH FLU; CHEST PAIN UNSPECIFIED; SHORTNESS OF BREATH; EKG SINUS TACHYCARDIA, LOW VOLTAGE PERIODICAL, UNCONFIRMED DIAGNOSIS; DIZZINESS; SLEEPING 14 HOURS; LARGE NODULE AT INJECTION SITE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS/PAIN AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (following vaccination), the patient's area around the injection site was swollen, a large nodule formed, it was red, sore and painful. These local symptoms lasted for a week then disappeared. The patient felt very fatigued, and reports sleeping 14 hours that night. On 10-APR-2021 the patient experienced headache and felt like his head was in a vise around each cheekbone. The fatigue and headache was gone on 11-APR-2021. On 19-APR-2021 the patient had vomiting and diarrhea for about 16 hours. The local symptoms swelling, redness, pain at injection site reappeared. On 19-APR-2021 the patient was very fatigued and took Pedialyte (calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate) to get rehydrated. On 21-APR-2021, the patient visited the emergency room as new symptoms appeared stomach pain, chest pain, shortness of breath and dizziness and her blood work and electrocardiogram(EKG) was done. The health care professional(HCPs) ruled out heart attack and told patient nothing in the symptoms or blood work warranted a scan for blood clots. The patient received anti-nausea intravenous (IV) medication, diagnosis of stomach flu and was sent home. The patient reports that her blood pressure readings were 144/104 and a pulse was 119. The emergency room health care professional instructed the patient to follow up with doctor and discharge diagnosis was made as chest pain unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at injection site, redness at injection site, soreness/pain at injection site, and large nodule at injection site, had not recovered from chest pain unspecified, shortness of breath, dizziness, and EKG sinus tachycardia, low voltage periodical, unconfirmed diagnosis, and the outcome of stomach flu, high blood pressure and sleeping 14 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210443030-covid-19 vaccine ad26.cov2.s-Stomach flu. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Injection site (arm) is killing her; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in arm, on 19Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine this morning (19Mar2021). On 19Mar2021, the patient's injection site (arm) was killing her (as reported) and she was advised not to take paracetamol (TYLENOL) unless she had severe symptoms and would like to know if she can take something for her sore arm. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Began with severe aches in neck and head. On Friday morning 12/3 I had a fever of 101. and my arm in the location of the shot was swollen to the size of a grapefruit and hot to the touch. I was dizzy and my body ached all over, particularly in my joints. This lasted approximately 24 hours. The shot location is still swollen and red. (5 days post shot) I was still feeling weak with slight aches this morning.
5 days after patient given MMRV (PROQUAD). She developed swelling left side of face (mumps like swelling of left parotid gland 5 x 6 cm in size). Had fever 2-3 days prior.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist was the vaccine coordinator for pharmacy in her area. The age at vaccination was not reported. The patient had no history of shingles. This case has been linked with the case US2018166388, reported by the same reporter.
24 hours after booster patient's tongue was coated with a thick, white film that could not be removed by brushing.  Decided that dehydration could be the cause.  Rehydrated for 48 hours before tongue began to look normal.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapy or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# K021581 with expiration date 24-OCT-2016; lot# K026531 with expiration date 15-APR-2017; lot# L042846 with expiration date 15-SEP-2017; lot# L003193 with expiration date 10-NOV-2016; lot# L010595 with expiration date 12-NOV-2016; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe body/muscle aches approximately 19 hours after injection, accompanied by minor dizziness. Moderate fatigue. Took Tylenol to relieve side effect symptoms. Mild to moderate shakiness and shaky sensations then set in 24 hours after injection, most noticeable when trying to sleep and waking up.
On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022; No adverse event; We gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19.    On 16-Aug-2022 at 4:14 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Aug-2022 at 4:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022).    Concomitant medication information was not provided by the reporter.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  The vial did not undergo any temperature excursion.  Treatment information was not provided by the reporter.
Hearth fells weaker; Blood pressure went really low; Pulse rate double; Felt really weak/Weakness; This spontaneous case was received on 24-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04950) and concerned a 79-year-old, male patient.   The patient's concurrent conditions included blood pressure. The patient's concomitant medications included amlodipine and lisinopril, both used for unreported indication for several years.  On 07-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient's blood pressure went really low, he stopped taking pill. The patient experienced weakness, his pulse rate double and hearth felt weaker.   On 24-Oct-2022, the patient recovered from the events of 'cardiac discomfort', 'blood pressure low', and 'pulse rate increased'.   At the time of the initial reporting, the patient had not recovered from the event of 'asthenia'. As reported, the patient was still feeling weak.  The reporter did not provide a causality assessment.  Company comment: A 79-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient experienced hypotension, increased heart rate, asthenia and cardiac discomfort (reported as hearth fells weaker). Information regarding the related diagnostic findings was not provided. The patient's concurrent conditions included blood pressure, as reported. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 79-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient experienced hypotension, increased heart rate, asthenia and cardiac discomfort (reported as hearth fells weaker). Information regarding the related diagnostic findings was not provided. The patient's concurrent conditions included blood pressure, as reported. Based on plausible time relationship, causality is assessed as possibly related.
Musculoskeletal pain, fever, fatigue, nausea/vomiting       Onset of fever, fatigue & muscle pain that evening, nausea and vomiting next day
Constant muscle pain, muscle weakness, especially in legs.  Initially, no pain in arms or feet.  all other muscles affected; lower back, upper back, chest, abdomen, groin.  Eventually, tingling in finger tips & toes then numbness in hands and feet, and pain in arms.
Information has been received from a nurse concerning a male patient who on 24-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza virus vaccine (unspecified) in the other arm.  Subsequently the patient experienced redness, swelling and warm to touch at the injection site.  The patient sought unspecified medical attention.  The patient took ibuprofen for the symptoms and recovered in less than 24 hours.  Additional information has been requested.
I had the usual stiffness for a day and nothing for about one week.  Then I noticed it hurts to raise my arm over my head.  Anytime I move my arm, it hurts.  I've tried stretching it with Yoga but to no avail.
This health authority case was initially received on 09-May-2016. The case report was received from a(n) Health Professional and concerns a(n) 58 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 19-Sep-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unspecified date, the patient experienced intermittent numbness, burning and tingling since receiving the vaccine in Sep-2015. The outcome was not recovered. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches; Skin reaction to booster is hot; Skin reaction to booster is red; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 039K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 02-Nov-2021, the patient experienced VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red). At the time of the report, VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Cardiac arrhythmias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001179 (Novavax).  A female patient in her 40's received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Cardiac arrhythmias".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Seizure, started at approximately 4:30 pm; recovery/post ictal state started approximately 5:00pm. Will report to practitioner tomorrow (03/31/2022)
REDNESS, SWELLING, RED PATCHES ON THE SKIN; LASTED FOR 3 DAYS.
Persistent crying and misery starting around 2 days after vaccine and lasting 7 days. 3 days after vax dx ADM but recheck 7 days after vax ears normal and baby miserable.
Mild discomfort at injection site; mild fatigue; mild muscular pain; lymphadenopathy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN62B1) via an unspecified route of administration in left arm on 21Feb2021 at 09:00 (at the age of 58-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient was not reported. Patient had no known allergies. Concomitant/other medications in two weeks included Atenolol 25mg once daily, Pravastatin 20mg once daily both taken for unspecified indications. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 22Feb2021 at 01:00, patient experienced mild discomfort at injection site, mild fatigue, mild muscular pain, lymphadenopathy. Patient did not receive any treatment for adverse events. Outcome of the events were resolved on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Headache, Myalgia, FATIGUE Narrative:  Other Relevant History:
Had been to MD week of 10/18 with normal well child exam. 10/19/2004 slight cough, chest clear temp 99.8 in our office. To MD office 10/21/04 - Dx beginning pneumonia. Antibiotic inj. given and sent home. 10/22/04 Rapid progression of pneumonia at ER. Blood sugar 700+ Dx: Diabetic Ketoacidosis. Life flight to Hosp. Brain stem swelling. Pt died 10/24.  Added code of dehydration from Death Certificate rec'd 06/13/2005.  From discharge Summary rec'd 06/21/2005, added terms are polyuris, lethargy, weight loss, tachycardia, dehydration, irritable, bradycardia, hypoventilation, pain, hyperventilation, pallow, and hyponatremia.
Every bone in body ached; Experienced a reaction where it was very nasty; Could hardly move; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness). At the time of the report, BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness) outcome was unknown.            No concomitant medications was reported. The patient received the Moderna booster vaccine in October or September. It was reported that for couple of times the doctor held off her dose for a week due to low levels then continued it a week later. Drug-drug interaction (DDI) check showed category D between Ibrance and Xgeva and Ibrance and Omeprazole.  No treatment drug details was reported.   Reporter did not allow further contact
1/26/14 - Mom called pharmacy to inquire as to which vaccine patient provided. Said over 9 days patient had extreme leg/arm pain, loss of strength in legs. Flushing and irregular pain at injection site with no visible signs of reaction 1/26/14 unable to walk; taken to MC.
Generalized Headache; severe at times with ear pain, bilat.  On day two dizziness, nausea and loss of taste and smell for a few hours with "brain fog".  Headache continues today the third day.
Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications.  The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be.  Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax;the inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/receiving the above lot number