chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia Narrative:  Employee reported elevated Heart Rate for the last hour running in the 110's to 120's. Current heart rate is 124, with no other symptoms reported. Will continue to follow up with employee daily to check on status. Employee was reported to contact 911 or go to the nearest Emergency Room if symptoms worsen.
Dose was given after expiration dare. Expiration date was 07/13/2022. Dose administered on 08/04/2022.
Received smallpox vaccine on 7/25/05. Presented to local ER department on 8/2/05 with c/o elevated temperature (101.5) general fatigue and malaise with headache. Ibuprofen 600mg tid ordered and follow up at TMC in the morning. Follow up noted decreased temp (97.8) with continued general malaise and fatigue with headache. Released without limitations. Vaccination site not viewed at either visit (covered by bandaid). L axilla somewhat tender.
Patient provided a date of birth of 12/03/1998 on the electronic questionaire.  When patient arrive for 2nd dose, he provided his real DOB which was 12/03/2003 which means he was only 17.  Moderna is indicated for those 18 and over.  Moderna company was called and it was recommended to administer the 2nd dose.    There were no adverse reactions to the vaccination.
Flublock is for 18 years and old and at the time the patient was 17 years old.  Patient had no adverse reaction.
15 days post varivax, developed fever and T perianal T mm vesicle on erythematous base. Anterior cervical adenopathy. Brother got varivax same day and having similar reaction. Still has fresh vesicles today.
left eye got swollen; eye watery; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Patient did not have any relevant medical history. The patient had no known allergies. The concomitant medication was taken by the patient (birth control pill) within two weeks prior to COVID-19 vaccine. 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 patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 at 16:00, two hours after the injection, the patient experienced left eye swollen and watery. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and  emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events left eye swollen and watery was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative:  Upon arrival, found pt on floor c/o feeling ill and feeling faint. Pt clammy and diaphoretic. Pt had just received COVID shot and was two minutes from being discharged from the observation section when the pt collapsed in his chair. Writer was told that the monitor caught him and was lead to the ground. Pt became nauseated and began vomiting. Pt was helped up by several staff members and brought via chair stretcher to the clinic for further observation. He was taken to outside ER for evaluation and monitoring.
This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a patient who received Herpes Zoster (Shingrix) for prophylaxis. On 13th September 2021, the patient received Shingrix. On 13th September 2021, less than a day after receiving Shingrix, the patient experienced extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was unknown. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she  had the shot a couple of hours ago and feeling hot already. The patient wanted to know at what point might the patient start to feel side effects, within a couple of hours or 24 hours. The patient did not think that feeling hot on legs was an adverse event.
This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 24 year old female with stress, human papilloma 5B and cervical intraepithelial neoplasic I  who on 05-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (lot # 657617/0384U). Concomitant therapy included sertraline HCl (ZOLOFT) and amoxicillin. On 18-JUN-2007, the patient developed a red rash on her chest and back. The patient sought unspecified medical attention. No other symptoms were noted. At the time of the report, the patient was recovering. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Pt arrived to get her influenza vaccine and was given a 4 COVID vaccine. Patient reports feeling okay on the following day 10/7/21
Patient did not have initial series but started with the Bivalent Booster per parent request. MD ordered Bivalent Booster after discussing with patient's father.
Palpitations, fluttering, chest heaviness. Improved with Ibuprofen 600 mg  po Q8h x 4 days
Pain, redness, and swelling at the injection site. Muscle pain, Tiredness, Headache, Shivering, Upset stomach.
Admitted to the Emergency Room. Reason for visit: Allergic Reaction. Diagnosis: Adverse effect of drug, initial encounter.  Following issue addressed: High priority for COVID-19 virus vaccination. Three (3) hours in the emergency room. Short of breath/Yawning/Difficulty breathing/Trouble with breathing/Dried mouth. Blood pressure sky rocked. Muscles pain days after.  Due to my reaction, after first dose, Dr recommend me not to take the second dose of the vaccine.
Patient received vaccine today at 1500. Immediately after patient felt lightheaded, and was told by staff at vaccine sight she was pale. At home pt reports fever, syncope episode x 2 without hitting head, headache, N/V and chills.
Patient received an expired vaccine past 30 days in the fridge; A possible temperature excursion at her facility; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) had resolved.        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.   No concomitant medications reported.  No treatment medications reported.  Nurse reported that the vaccines were received on 08-Jul-2021 and was placed in the refrigerator, later was received to her on 30-Jul-2021 with the expiration label missing. The nurse was unaware that vaccines were placed in the fridge on 08-Jul-2021.The max temperature reached was 41.4F and min 40.6F. 4 vials (Lot# 038C21A)of them were affected and 3 of the vials were used to administer vaccinations to 9 patients over 3 days 09-Aug-2021 to11-Aug-2021.
Covid symptoms started right before the November holiday, tested positive at job with rapid test and also PCR that came back positive. Symptoms were cold-like symptoms and symptoms of common cold, runny nose, and throat pain. She also had balance issues after 2 months of having Covid and inquired with a doctor about it in March and also went to urgent care. They did an MRI and it was normal and she sees a neurologist this week.
Swollen and painful armpit, size of softball; Swollen and painful armpit, size of softball; Dose received: 3; This is a spontaneous report received from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 at 08:45 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing), notes: Rmmunocompromised. Concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Drug allergy", notes: patient drug name: IB Profen. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical site: left arm; Lot number: Unknown; Administration time: 09:00), administration date: 13Mar2021, when the patient was 41 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical site: left arm; Lot number: unknown; Administration time: 09:00), administration date: 17Apr2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 at 08:45, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 05Dec2021 at 21:00, outcome "unknown", and all described as "Swollen and painful armpit, size of softball". The event "Swollen and painful armpit, size of softball" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling and axillary pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included heat and appointment.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Urinary tract infection; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date: unknown) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced urinary tract infection. On the next day after vaccination, the patient got a call from the doctor that she had a urinary tract infection. They want to put her on ciprofloxacin. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
BODY HURT; DIZZINESS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 06-APR-2021, the subject experienced body hurt. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurt, fever, chills and dizziness was not reported. This report was non-serious.
fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.
Janssen COVID-19 Vaccine EAU.  Side effects in order of occurrence:  sudden onset of severe headache, chills, uncontrollable shaking, nausea, muscle aches. Following day - low grade fever, dull headache, fatigue, lethargy.  36 hours following injection feel back to normal.
sore throat, body aches, febrile, eyes burning, headache X 2 days
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
Pfizer-BioNTech COVID-19 Vaccine EUA 12 hours after injection: fever (up to 100.5), muscle aches, joint pain, headache, fatigue, nausea lasted 24 hours and then ended abruptly
Muscle pain, severe.   Large muscle groups, legs and arms only.  Also tender to touch.
Headache; 16 years old received vaccine; A spontaneous report was received from a patient concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and 16 years old received vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the patient experienced headache for a couple of days. Treatment for the event included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache and 16 years old received vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error  Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with event of headache.Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Intense neck pain; Overall aches; Low fever; Painful sore throat/ears; Painful sore throat/ears; Injection site is still painful and red; Injection site is still painful and red; Injection site is still painful and red w/large sub-dermal knot; Sharp/stabbing joint pain (wrists, elbows, shoulders, knees, hips); This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included cutaneous lupus and Sjogren's syndrome. The patient was allergic to nickel. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), ascorbic acid  (VITAMIN C), sambucus nigra (ELDERBERRY), melatonin (MANUFACTURER UNKNOWN) and help hair (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 20:00, the patient experienced continuous changes of intense neck pain, overall aches, low fever, painful sore throat/ears and injection site was painful and red with large sub-dermal knot. On an unknown date in Apr2021, the patient experienced sharp/stabbing joint pain (wrists, elbows, shoulders, knees, hips). On an unknown date in Apr2021, 1 week later, the events were still present along with the most recent joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense neck pain, overall aches, low fever, painful sore throat, painful sore ears, sharp/stabbing joint pain (wrists, elbows, shoulders, knees, hips) and injection site painful and red with large sub-dermal knot were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt had seizures which increased with frequency and severity. She also was tested for metal poisoning which showed elevated levels of mercury. 11/22/00-11/25/00 possibly related breathing problems. Will be tested for autism in January. Doctors did not give a diagnosis. Nurse follow up on 05/14/04: hypotonia, hyporesponsive, viral illness.
Patient was given Moderna booster from a vial that expired one day prior to the date it was given.  Patient is not known to have any ill affects of the vaccine
swollen arm ( COVID arm); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm ( COVID arm)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm ( COVID arm)). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 06-Feb-2021, PERIPHERAL SWELLING (swollen arm ( COVID arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include The omegas, rosacea medications     This case was linked to MOD-2021-163465 (Patient Link).
Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Havrix. On 07-MAR-2023, an unknown time after receiving Havrix, [the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The patient received Havrix pediatric expired dose, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2023035936, reported by same reporter.; Sender's Comments:  US-GSK-US2023035940:Same reporter
Patient was in his car in the vaccine administration area. Approximately 7 minutes after vaccine administration, patient waved at RN and expressed not feeling well, feeling "strange". RN called for help. Went unconscious and arms rigid, but breathing 12-15 with pulse  60-65, regular. Provider team arrived and patient was coming too, breathing well and pulse remains 60-65. Color pale, clammy though in the car and sunny outside. No rash or itching, no difficulty breathing or swallowing. Patient knew name and date of birth, two minutes until he remembered where he was. Nauseated and vomited x 4 intact food. Able to stand and pivot to wheelchair to get into a cooler site. Cool cloths applied to neck and head. Continues to vomit, although now smaller amounts. Wife called. EMS unit arrives; vital signs 90-94/60-64. Pulse ox 90%'s. Remains heart rate 60-65. CBG 111. EKG sinus bradycardia, regular rate and rhythm. Complains of severe head ache and briefly severe chest pain. EMS transport to hospital       Patient was discharged hoe at 9/16/21 at 0200 per hospital.
Systemic: rapid heart rate-Mild, Systemic: Tachycardia-Mild, Additional Details: Customer experienced a rapid heart rate. Husband called 911.
3-4 days before having adverse event at night there was a unpleasant smell from my mouth which shocked me. The adverse event started on 01/2023 in the afternoon- evening. Over the course of the day I wasn't feeling well. I felt weak. I went to bed just to lay down since I was feeling dizzy even though I laid down it wasn't helping so we went straight to urgent care.   In the urgent care they diagnosed me as having dizzy/ Getty. I was like what this is so weird. I know I have asthma and it makes me to react but where did the dizziness came from. The doctor wasn't sure what to do with me. So I decided to go home. I spoke with my doctor and my doctor referred me to a Cardiologist. I haven't gone to the cardiologist yet. As of now I am just trying to figure out if this is an ongoing issue then I can decide. It hasn't happened yet. As of today I did recovered from it.
104-105 degree fever intermittently for 5 (five) days. Inability to raise arms for 10 (ten) days above the shoulder. Severe swelling at injection points grapefruit-sized swelling! Could not touch arms above elbows or would induce screaming and crying. Lethargy and trouble sleeping.
patient developed indurated, sollen, erythemous area at injection site on RLE along with vomiting & 3 day history of fever.  Fever developed approx 3 hours of immunization, vomiting began 24 hours post & erythema developing 48 hours post injection.