chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient felt sick 15 hours after the vaccine shot; muscle pain; some fever; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 53 year old adult female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt sick 15 hours after the vaccine shot, muscle pain leading to myalgia and fever on an unspecified date with outcome of recovered.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Initial report received from a pharmacist on 03-Oct-2013. A 83-year-old female patient had received FLUZONE HD (batch number: U4759AA, dose number not reported and site of administration deltoid right) on 02-Oct-2013. The patient's medical history was none. Concomitant medication was unknown. On 03-Oct-2013, the patient developed 10 cm swollen, erythematous, tender area, and the size of a softball. There are no other symptoms and no fever. She was prescribed antihistamines, compresses. Laboratory tests and corrective treatments were unknown. Outcome of event ws unknown. List of documents held by sender: None.
A fast heartbeat that lasted for a few hours; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 18:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), ANXIETY (non-serious) all with onset 13Dec2021, outcome "unknown" and all described as "He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety"; HEART RATE INCREASED (non-serious) with onset 13Dec2021 20:00, outcome "recovered" (Dec2021), described as "A fast heartbeat that lasted for a few hours". The events "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety", "a fast heartbeat that lasted for a few hours" and "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (13Dec2021) fast heartbeat.  The clinical course of events was as follows: An 11 year old male patient received his first dose of Pfizer Biontech covid 19 vaccine on 13Dec2021 at 6 PM and at 8 PM he developed a fast heartbeat that lasted for a few hours. He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety. Caller seeking information if the patient should get a his second dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, it is not clear if myocarditis was diagnosed. The reported symptom of fast heartbeat was possibly due to anxiety. Additional information has been requested. The case will be re-evaluated if more information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subject adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth of redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023; No adverse event; I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) 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 (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  Reporter work for an organization and a patient was administered a Moderna vaccine that was expired by a few days. The HCP explained that the vial expiration date was still good, but it was beyond the storage guidelines. The vial should have been pulled out on 12-Jan-2023, but a dose was given on 17-Jan-2023. The patient did not report any adverse reaction. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 14-Dec-2022. No treatment information was provided by the reporter.
received expired dose that had been left out/vaccinated beyond the 12 hour use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.  A patient received expired dose that had been left out in room temperature past the 12 hours.
chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021.  The patient was recovering from all the events.
Flu like symptons, aches and muscle pain, headache, tiredness, reddening at site of the injection, pain at site of the injection,
Pt recv vax on 1/28/99; 15 min post vax pt exp stuffy right nostril, runny nose, sclerae red, eyelids puffy
Itching rash upper body (stomach, back, shoulders, neck). Had an appointment with dermatologist 1/29/21. Cannot take Benadryl, took Zyrtec with some relief.
tingling & sl burning sensation & abn taste in mouth,then numbness on the lt side of face,not including forehead;seen on 31OCT94 & condition was stable as described;no motor deficit,only sensory;no local sx or other systemic;
This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included bad back, and concurrent conditions included high blood pressure, high cholesterol, intolerant to statin, non smoker, and non alcohol user, and other pre-existing medical conditions included on medication for high blood pressure and high cholesterol and no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced burning sensation in both legs and feet. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from burning sensation in both legs and feet. This report was non-serious.
Up all night 3/7. 3/8 Complained of welts on legs, tightness in chest, hard to breath, bottom of feet stinging, sore and swollen. Hands also swollen. Physician prescribed Zyrtec.
Skin surrounding the injection site was red and warm to touch. Sold patient some generic BENADRYL tablets to take and CORTAID cream to put on area.
pt recv vax & devel twelve red spots on stomach & leg on 26MAY95 following vax 25MAY95; also reported son devel 5 lesions on back & fingers on 26MAY95 following vax; 14JUN95 pt & son broke out a 2nd time; pt w/35 lesions, son w/5 lesions;
After first vaccine dose in March 2021, menstrual cycle began 5 days early with unusually heavy bleeding and cramps.   After second dose in April, heavy, painful cramps marked the onset of menstrual cycle 8 days early.   Menstrual cycle normally runs very regularly, between 26-28 days with 4 days of bleeding.
Patient received the vaccine on 6/21/18 and presented back to the pharmacy on 6/27 reporting of a really red, warm-to-the-touch area. She was in no pain. However, there was a small amount of itching. She was told it was a injection site reaction. She went to the walk-in providers to be seen. They also confirmed it was a injection site reaction.
This spontaneous report as received from a registered nurse refers to an 8 weeks old male patient with esophageal reflux. The patient had no drug reactions or allergies. The patient was vaccinated with the first dose of ROTATEQ (lot number reported as H012975; expired date 30-JAN-2014) orally on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-NOV-2012 the patient experienced vomited about 30 seconds after receiving his first dose of ROTATEQ. There was no treatment given for the adverse event. The patient was recovered on 16-NOV-2012. The therapy was continued at the time of report. The patient had sought medical attention as the adverse event happened in office. Additional information is not expected.
About 1 minute after receiving 2nd vaccine, PREVNAR-13 patient sat down in waiting room chair and said she felt hot. I went out to observe her and could see a flushing on her neck and chest. She said her left ear felt hot. I had her sit behind privacy screen and went to pharmacy to call 911. Tech made call and I brought emergency bag to patient. I observed pt. for worsening symptoms, asked pt. if any throat, lip involvement. Patient had one year old child with her. We talked about her family while I was observing her. EMS arrived and took over medical care. They talked to and examined patient. They said they could take her to hospital. She declined. They advised 25 mg diphenhydramine. She took that and left. EMS told her to call them if anything got worse as it could get worse for about 8 hours. I called and spoke to patient at 8 PM. She said she felt tired, light-headed and had approximately 100 degree fever, but was giving kids a bath.
Pt was administered a expired Pediarix. Child has no symptoms and parents were informed and child is scheduled to come back for repeat vaccination as instructed by provider and nurse at office.
Vomiting; Uncontrollable Shivering; Terrible Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia). At the time of the report, VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  The patient was going on day 2 of incapacitating illness (vomiting, uncontrollable shivering, terrible myalgia) from Moderna shot.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Updated the report type from Invalid case to Spontaneous. Added reporter and patient details. The country of incidence, reporter and event country was updated from unknown to (country name). Suspect product coding and narrative was updated.
large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Agency. The reporter is the patient. A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 16:00 (Lot number: EW0176) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19, Brand: Pfizer, Lot number: ER8737, Administration time: 02:00 PM, Vaccine location: Left arm), administration date: 06Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "large, swollen, hot, painful lump at the site of the injection".  Additional Information: Previous dose details: Dose number: 2, Product: COVID 19, Brand: Pfizer, Brand unknown: False, Administration time: 04:00 PM. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. There was no Known Allergies. Adverse event: After the second dose i had a large, swollen, hot, painful lump at the site of the injection. After 3 dose (booster) i have been experiencing large painful boils and lumps in my armpits and under breasts  Follow-up attempts are completed. No further information is expected.
had it ... DID get vaccinated/suspected vaccination failure; had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and had shingles. The reporter had a couple of friends who got the vaccine and had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case has been linked with US2021AMR241238, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241238:same reporter
She experienced fever, body aches, headache and chills that continued to worsen throughout the night but had alleviated by the next morning, although she did have a headache still.
Patient reported level 5 chest pain 5 minuted after receiving 2nd dose of covid 19 vaccination. Patient denied LOC, resp. diff. or other symptoms.
a major dizziness spell and leaned against a wall; very cold in bed and took a nap before feeling better; feeling abnormal; exhausted; feeling sort of crummy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling sort of crummy), FEELING COLD (very cold in bed and took a nap before feeling better), FEELING ABNORMAL (feeling abnormal), DIZZINESS (a major dizziness spell and leaned against a wall) and FATIGUE (exhausted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PREGABALIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING ABNORMAL (feeling sort of crummy) and FATIGUE (exhausted). On 19-Feb-2021, the patient experienced FEELING COLD (very cold in bed and took a nap before feeling better) and FEELING ABNORMAL (feeling abnormal). On 20-Feb-2021, the patient experienced DIZZINESS (a major dizziness spell and leaned against a wall). On 20-Feb-2021, FEELING ABNORMAL (feeling sort of crummy), FEELING COLD (very cold in bed and took a nap before feeling better), FEELING ABNORMAL (feeling abnormal), DIZZINESS (a major dizziness spell and leaned against a wall) and FATIGUE (exhausted) had resolved.            Treatment details included None.  Action taken with mRNA-1273 in response to the events was not applicable..
Pt had soreness in the injection site day after injection.  No swelling, no redness.