chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid test/result +/ date Apr2022; covid test/result +/ date Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: ER8730) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590, Expiration Date: 30Nov2021) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" (Apr2022) and all described as "covid test/result +/ date Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative, notes: 2 weeks from above.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;
Fever, body aches, joint aches, headaches,  fatigue.  I am drinking water and ate once in 24 hours
This spontaneous report was received from a healthcare worker concerning a 6 month old infant of unknown gender. On 22-MAY-2013, the patient was vaccinated with 0.5 milliliter (ml) of COMVAX (lot number reported as 0807Z), intramuscularly that had expired on 14-APR-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
No adverse event; total of 47 patients that received the vaccines after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2023, 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 05-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 05Jul 2023, 1 dose was administered at administration site 1. No treatment medication reported.   This case was for the 15th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccination details were added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Can't hear out of one of his ears after 2nd dose; Intense body aches after vaccine/ Intense body pains after vaccine; 2nd dose given sooner than 25 days after 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg amputation. Concurrent medical conditions included Diabetes, Blindness (nearly blind and has no legs), Cholesterol high and Physical disability (Patient has no Legs.).   On 28-Apr-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 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) (seriousness criterion medically significant) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose) had resolved. At the time of the report, DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications included, antihistamines were reported.   It was reported, the patient has no cough and his head is not stuffed up.   Treatment information was not provided.  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.; 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.
Shot was given approximately at 4:50.  I left the store after being watched at 5:15.  Went to pick up food for supper.  While waiting for the food, I was seeing spots (like when you have a photo taken with a flash).  This lasted for about 20 minutes.  This went away so I continued on my way home.  As I was driving I notice that my face was tingling and my eyes seemed to be really dry.  Both lasted about 30 minutes.  Then I had the headache, arm soreness and light headedness that are "normal" side effects.
SORENESS; PAIN AT INJECTION SITE; FEELS VERY TIRED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-APR-2021, the subject experienced soreness. On 04-APR-2021, the subject experienced pain at injection site. On 04-APR-2021, the subject experienced feels very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, pain at injection site, and feels very tired. This report was non-serious.
Large red circle at injection site, warm to touch and itching. Fever of up to 102 documented, muscle pain and weakness
Information has been received from a Registered Nurse (R.N.) concerning a 75 year old male with Spinal stenosis, allergic rhinitis and depression who at 11:00 am on 06-APR-2008 was vaccinated subcutaneously with the first 0.5 mL dose of ZOSTAVAX (Merck) (lot#659761/0157X; exp in February 2009) in his left deltoid. Concomitant therapy included TOPROL XL TABLETS, FORTEO, salsalate, LASIX and eplerenone. On the morning of 29-MAR-2011 the patient developed redness, itching and discomfort on left facehead, eyelid and scalp. On 30-MAR-2011 to 31-MAR-2011, the patient developed some lesions following nerve pathway on left facehead. On 02-APR-2011 and 03-APR-2011, the patient developed more lesions, discomfort and swelling of left eyelid. The patient saw a doctor and on 04-APR-2011, the lesions scraped and he started on KEFLEX, VALTREX. At the time of the report, the patient had not recovered from his adverse events. A lesion sample was collected on 04-APR-2011. The sample was swabbed from scabs. Rash and Herpes zoster were considered as other important medical event. Additional information has been requested.
Our patient received a Pfizer monovalent COVID vaccine on 9/1 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Menquadfi was ordered at pt's office visit on 7/14/23, but pt was given Trumenba in error.  Correct vaccine (Menquadfi) was then administered.
Had mild left arm rash that came on 1 day after vaccine and then lasted 3 days.  Fairly severe difficulty with eating x 3 wks (could only eat very little) despite no N/V/D.  He says it was hard to describe, but it was very bad and he barely recovered.   Self resolved after 3 weeks.   No fever, N/V, SOB.  +Fatigue.
normal arm soreness, then weakness, aches, chill, no sleep, night sweats, then no energy all next day. Continued aches, headache. Other aches and pains throughout body. about 10pm took Tylenol, some sleep night 2, - up at 11am, seemed ok, then later at 6pm started aches in joints again.  More Tylenol. went to bed and tried to sleep. FIled this info 1am Monday 15th
trouble sleeping; body was hurting from head to toe; This is a spontaneous report from a contactable consumer or other non hcp.   A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (Batch/Lot Number: EL3302; Expiration Date: Mar2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. on 17Feb2021 the patient experienced trouble sleeping, body was hurting from head to toe. Caller wants to know if she could be experiencing any side effects from the vaccine, States her second dose is scheduled for the 28Feb2021. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Itchiness; Light Headed; Hives; Feels Weak; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical Condition reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) 1 dosage form. On 25-Jan-2021, the patient experienced NAUSEA (Nauseous). On 26-Jan-2021, the patient experienced PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak). At the time of the report, NAUSEA (Nauseous), PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) was unknown.       No concomitant medications reported. No treatment information provided.
LIGHT HEADED; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced light headed, and chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from light headed, and chills. This report was non-serious. This case, from the same reporter is linked to.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a seven-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some  medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
at time of vaccination she became weak, hot, vision changes. Cold compresses given, feet up, water given. Waited 15 min. at the time she left  "able to go" visiting with family and staff. Mom called around 11 am.  Pt was vomiting, headache, arm swollen, fingers tingling.  Ice at site and pt rested.  When followed up she was doing well.  Woke at 3:30 this afternoon. Headache resolved, arm swollen at site only, hungry and tolerating food well.
Patient presented to the hospital for unrelated reasons and was tested for COVID on 8/29/21 which resulted positive. He reported he was positive 2 weeks ago with an at home test. Upon further investigation, his siblings in the house were COVID+ at the time and he had headache and loss of taste/smell so he used an at home test kit.
Patient's arm was red and swollen.  Hurt the evening of injection. Patient couldn't sleep.  Patient has limited arm movement. Painful, swollen, and red.
Bivalent COVID vaccine given after being declared no longer authorized. We didn't receive the email notification that it was no longer authorized until the evening of 9/12/23, after the vaccine was given. No issued for the baby after the vaccine was given.
Swollen lymph nodes at neck and armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 09:00 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN), administration date: 13Apr2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04May2021 23:45, outcome "recovering", described as "Swollen lymph nodes at neck and armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   Follow-up (03Aug2021): Amendment: This follow-up report is being submitted to amend previously reported information: Age at vaccination captured as 48.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea,  headache,  body aches,  chills, fever,  sore throat,  fatigue.   Took acetaminophen, ibuprofen,  Zofran.
Increased heart rate. Heart rate of 100 at all times after vaccine.  Excessive bruising on arms and legs.  Widespread inflammation and pain in muscles in joints. Fibromyalgia pain increase with little help by using medication . Never had to use medication to treat this condition prior to COVID-19 vaccine.
Stiffness, staring off, unable to communicate , unable to respond to commands,  unable to feed self, keeping left hand clinched in a fist, shuffling gait. Low oxygen
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: rash on lwer arms bot. red. pt self administered beandryl. applied vaseline and moisturizer
This case was reported by a consumer via digital media and described the occurrence of passed out in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the shot of Meningitis-B vaccine and it made her pass out. The nurse said it had happened to everyone she had given it to at that point and they would not recommend in its current form. The patient did not go back for the booster dose. This case was linked to the case US2018GSK109359, reported by the same reporter.
This is a spontaneous report received from contactable reporter(s) (Other HCP reported as a nurse). The reporter is the patient. A 63-year-old female patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 63 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 (Dose1, single), for COVID-19 immunisation. The following information was reported: CHEST PAIN (medically significant) with onset 24Feb2022, outcome "unknown", described as "Chest pain"; MYOCARDIAL INFARCTION (medically significant) with onset 24Feb2022, outcome "unknown", described as "thought patient was having a heart attack". Clinical course: The patient experienced chest pain. The pain began late Feb2022 or early Mar2022, within a few days of her second dose. Sometime around 24Feb2022, she had the first episode, stated should have tracked it better, stated it was either the same day as the second dose or a few days within getting the second dose. The patient stated that the chest pain sometimes persisting and sometimes it worsened, the pain was intermittent, has it in her sleep even, that's scary. Sometimes it was severe and sometimes it was not severe, sometimes severe enough to hold her chest, has not researched anything on any of the vaccines so she thought she was having a heart attack, thought it was weird because it was shortly after her vaccines. She stated that it was important to note that it was happening in her sleep. It was the first thing she wakes up to every morning. Some days, it was severe and some days it was not severe, but it was every day. It was intermittent throughout the day. She got both doses, her symptoms started after the second vaccine. She thought it was the lining of the heart but maybe it was the heart muscle itself or maybe it was both. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: A possible contribution role of vaccination with bnt162b2 to the onset of chest pain which was suspected as heart attack by the reporter, cannot be excluded. The case will be reassessed should additional information become 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.
9 hrs post dose stuffiness 12 hrs post dose severe chills, and fever with headaches.   These symptoms continued to occur for 24 hours and would subside a little with tylenol taken every 4-6 hours.
Pt reported possible swelling and discomfort in neck approx 5 min after immunization, blood pressure and pulse normal, medicated with 20 mL of Q-dry/12.5 mg/5mL -observed pt for > 30 min - No change, vitals normal.
Bell's palsy.   Earache began several days prior to diagnosis.  On 1/28 , woke up with a drooped left eye (couldn't close it fully), followed that day by loss of taste and sensitivity to noise.  The next morning (1/29), experienced drooling.  That afternoon, I went to the ER at NY, and was diagnosed with Bell's palsy.  Treatment was prednisone (50mg) and valacyclovir (1g) for seven days.  Symptoms were halted by the meds and now, three weeks later, have nearly disappeared.
I was standing in the grocery store, I thought I was going to pass out, light headed and nauseated, an hour later I felt bad . Happens more while I am standing. I had some other dizziness when I sit. Standing happened 4 or 5 times. Doctor - 7 sep2021. Put on Medication : Midodrine 0.25 milligrams twice a day.
Illness onset 11/13/2021 with symptoms of sore throat, loss of taste/smell, and difficulty breathing. Hospitalized on 11/29/21
Information has been received from a nurse reporting that there were about 25 pediatric patients who received pediatric RECOMBIVAX HB last year (in 2009) (lot number not reported) and had low titers. All 25 patients were revaccinated. The nurse clarified the office had received a pediatric RECOMBIVAX HB shipment 2 years ago in which the shipment was delivered to the wrong doctor office and later delivered to their office. The pediatric RECOMBIVAX HB was probably out of temperature range when their office received the shipment. The nurse confirmed the office never called Merck about this shipping issue 2 years ago. The office did not start using pediatric RECOMBIVAX HB until last year. It was unspecified if the patients sought medical attention. At the time of report, the outcome was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Redness, painful swelling all around the site, itching, bad headache, tiredness.
Approximately 2 weeks after vaccine administered, I started getting prickly, sore sensations in my feet and legs. Mostly feet. I asked my GP if it's possible that the vaccine could cause this. He said it's possible, but not likely. My feet became quite tender, almost like shingles     pain. Doctor gave me 6 day course of prednisone for my earache, and said "we'll possibly kill two birds with one stone". The prednisone helped with the ear problem, but not the prickly, stabbing sensations. So, I went ahead and got my second covid vaccination on 2/13/21 and the problem didn't get any worse or better.
Chills, muscle ache and fatigue, sharp abdominal pain, headache/migraine, shortness of breath, body aches, coughing, sore throat, dry throat