chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has experienced fatigue, light-headedness, body aches, and sore and stiff joints.  The light-headedness resolved shortly after the patient resumed taking her prescription of allegra.  She presented to a physician on 4/9/03 and was given a 6-day medrol pack (4mg; 4/11/03-4/16/03).  The patient experienced no change in the severity of symptoms after finishing the medrol prescription.  Dr. with CDC was consulted on 4/17/03, and it was decided that the patient should be followed for 2 more weeks--at which point the patient would be advised to see a rheumatologist if the symptoms persisted. NOTE: When the patient originally became ill on 4/5/03, several of the patient's co-workers who had not received the smallpox vaccination were also ill with similar symptoms.  However, those co-workers' symptoms resolved after a few days, where as the patient's symptoms have now persisted for 2 weeks.
Low Grade Fever; Headache; Body Ache; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of   in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETAMINOPHEN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
develop RLQ pain, acute appendicitis requiring hospitalization 4/28/21 and surgery 4/29/21
Patient states that she has been feeling in her normal state of health until the last few days. She states that her baseline state of health involves intermittent chest pain that radiates to the left arm and which is non-exertional and non-pleuritic in nature and has a quality described as squeezing and/or stabbing. She states that she felt in her normal state of health until today when she woke up with severe "heart pain"--worse than her normal intermittent chest pain--and thought she was having a heart attack. She states that she walked to a nearby pharmacy to obtain some ibuprofen and, during the walk, initially thought that the movement was palliating her pain but states that she subsequently felt worse upon returning home and so is unsure of whether motion makes it worse. She notes that rest does not appear to palliate the pain; rather, she states that laying down in the supine position worsens the pain and that sitting upright relieves the pain. She states that she has not experienced any period of time where the chest pain entirely went away today; rather, she notes that it vacillates between a 3/10 and 8/10 in severity. She denies associated lightheadedness, syncope, shortness of breath, fever, chills, leg swelling, hemoptysis; regarding palpitations, she is somewhat equivocal and states that she has a sensation that her heart is "slowing down" but no other palpitation-like symptoms.   She notes that she was diagnosed with a presumptive UTI approximatey 2 days ago and has been taking ciprofloxacin 500mg BID as prescribed. She states that her UTI symptoms started ~4 days ago, involved back/flank pain and a temperature of 99.8F, and that her symptoms have improved significantly since starting the antibiotic.    Regarding her prior episode of pericarditis, she states that it was approximately 4-5 years ago. She remembers having an abnormal EKG at that time and was prescribed an anti-inflammatory drug for approximately 2 weeks, which she took; she states that the chest pain never really went away full and that the symptom she is experiencing today are similar to the symptoms she experienced at that time.   She was discharged after 3 days on colchicine and metoprolol and advised to avoid all exercise for 3 months.
Inappropriate route of vaccination; Arm bruised; Arm swelled; This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 9th September 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 9th September 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2019, the patient experienced bruising of arm and swelling arm. On an unknown date, the outcome of the bruising of arm and intramuscular formulation administered by other route were unknown and the outcome of the swelling arm was not recovered/not resolved.   It was unknown if the reporter considered the bruising of arm and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm, subcutaneously which led to an incorrect route of product administration. The patient's arm bruised and swelled.  The swelling was going down and the patient felt fine.  At the time of this report, the swelling has not completely resolved. The reporter agreed to recontact but said she was not always at the store.  Patient safety could call if details were needed. The reporter consented to follow up. In the XML document outcome of swelling arm was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
About 12-18 hours after vaccination, I experienced severe arthralgia, myalgia, and GI distress to the point of involuntary defacation multiple times.  I was unable to get out of bed all day Saturday aside from using the restroom due to all-over body pain.  I did not go to work Monday and I am going in late to work today due to stomach issues and lack of proper sleep.  Sunday, mid-day, possibly later in the evening, the pain started to lessen and the GI issues were not as prominent.  Monday was mostly exhaustion and mild GI distress, while today compromises of being tired and GI disturbances.
Headache and nausea 20 minutes after vaccine given - baseline history of nausea. Resolved after lying supine and a glass of water.
Patient complains of severe joint pain to the point where the patient can't go up or down stairs or get dressed without assistance.
itchy at injection site; red at injection site; looks more like a bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (looks more like a bruise), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CONTUSION (looks more like a bruise). On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, CONTUSION (looks more like a bruise), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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.
After first dose:  swelling of lymph nodes behind left knee; arm soreness; slight headache; slight fatigue After Second dose:  arm soreness; slight headache; sore throat; overall body aches; fatigue; fever; dry eyes; muscle weakness; rash and itching at injection site
Note: Pt was told by his Spouse's doctor to report these symptoms. The day after receiving the vaccine, the patient developed body aches, headache, and fatigue for about 48 hours. The symptoms resolved since then.
Pt stated that after receiving the flu vaccine on 2/4 that she started having nausea and vomiting the evening of 2/5/19. Pt states today she is still having nausea and vomiting. Pt also states that this morning she woke up with a red rash to the right side of her face with some swelling and her throat burned. Pt denied any itching, difficulty swallowing, or fever. Pt did appear to have a rash on the right side of her face with very small non-raised red spots. Pt stated swelling went away and that her rash had gotten better throughout the day, but is concerned that it was an allergy to the flu vaccine.
4 to 6 wks p/having vax given pt failed to convert; 1 pt barely converted & 3 pts converted well;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Alleve, reaction(s): "Known allergies; Alleve". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Oct2023, outcome "recovered" (25Oct2023), COVID-19 (medically significant) with onset Oct2023, outcome "recovered" (15Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Negative, notes: Home antigen testing; (26Oct2023) Positive, notes: Home antigen test showed clear positive on 26Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for the events from 17Oct2023 to 22Oct2023.  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.
Veteran reported tachycardia and diaphoresis. Vitals show BP: 144/98 Pulse: 98-103 02: 96% RR: 18. Veteran denies pain. Code Assist called, veteran was evaluated and declined further evaluation in the ED. Recheck of vitals showed BP: 137/90 Pulse: 99 02: 97% RR: 18. Veteran monitored for 30 minutes.
Low-grade fever (100.4 F), chills, myalgia, headache. Onset ~8 hours after vaccine administration. Resolved ~48 hours after vaccine administration.
Three days after receiving my second dose of the Moderna COVID vaccine, I had a sudden onset of tinnitus. I've never had tinnitus symptoms before with any other vaccine or in general (aside from acute tinnitus after rock concerts), much less sudden onset tinnitus. Once the normal, published side effects (aching, sore arm, fatigue) subsided, I immediately began noticing a constant ringing/buzzing in my ears. The left ear is more prominent, but I have it in both ears. I also experience a higher sensitivity to loud sounds. As of 4/2/2021, I still have mild-moderate ringing in my ears, especially in quiet situations.
Relapsing Polychondritis woke up and I?m deaf now in right ear.
Patient experienced menstrual bleeding that started shortly after she received the vaccine. The bleeding has continued and is still going today (3-14-22, about 29 days).
swollen feet and hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) 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 : 01), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 04May2021, outcome "unknown", described as "swollen feet and hands".  Additional Information: Today morning her son had extremely swollen feet and hands, that's why would like to know if this is a normal symptom / side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart pain  palpitations shortness of breath extreme fatigue lethargy vision issues pounding heart skipped beats dizziness elevated BP brain fog weakness insomnia
felt very tired; Minimum pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 11:45 at a single dose for COVID-19 immunisation. The patient's medical history included crohn's disease. The patient was not pregnant at the time of vaccination. Concomitant medications included azathioprine (IMURAN) and multivitamins. The patient previously took the first dose of bnt162b2 in the left arm on 03Feb2021 11:45 at the age of 42 years old for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 23Feb2021 15:00, the patient felt very tired and experienced minimum pain at the injection site. No treatment were received for the events. Outcome of the events was recovering. The events were considered non-serious.  Information on the lot/batch number has been requested.
Massive MCA Stroke. Inoperable. Emergency craniectomy within 24 hours. Numerous blood clots were found in the lower extremities. No prior blood clots - ever. Right brain stroke, affecting left side mobility.  Morning of the stroke, he had extreme nausea, said it felt like food poisoning. Dry heaves and then threw up. Stroke followed immediately after.
vertigo when getting up. Occasionally during the day dizzyness and tunnel vision. No improvement after 6 days.
Pain at Injection Site, Shoulder Pain, Headache, Fever (102+), Body Aches, Muscle Weakness
This spontaneous report as received from a registered medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the multiple unspecified patients received doses of improperly stored VAQTA (dose, route and site of administration were not reported) lot# K012457, expiry date 04-JUN-2017. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
He was in the ER for depression, and while he was there he received the vaccine as they informed him he could not go places without a vaccine card so decided to get it.   After the vaccine he had pain in his back, wasn't too sure if it was in his back or legs.  He was diagnosed with lower back sciatica.  He went to his PCP for his pain and she referred him to a neurologist, pulmonary vasculature.  He was diagnosed with MS but are awaiting to get an MRI to rule out that diagnosis.  He had an x-ray for a TB test, which showed pulmonary vasculature and they suggested the MRI, and is waiting to get that done which is scheduled on 6/22/22.    He has a hard time walking, and has a hard time urinating whether it's bladder or kidneys but will be determined once he gets the MRI.  He will then perhaps to see a neurologist.  He did not have these symptoms prior to the vaccine.    His records indicate that he is diagnosed with an undiagnosed STD from about 7 years ago and feels that this may be something to do with the chain reaction of events that he has had in his life.  He is going to be going to a disease specialist to see about this.
Approximately 19-20 hours following immunization, the patient was swinging on the playground at school and her shoulders locked up and she couldn't move them for a few minutes. Later that day, she yawned and had her jaw lock up for a few seconds. The jaw locking occurred twice. She has not experienced any other symptoms.
Patient presented to the ED, per provider notes: Patient presented to the emergency room with hives to bilateral hands and feet one on her right upper thigh and some on her right arm. She reports on 7 April she received her initial covid vaccine. She notes on April 15 she started to develop hives around the injection site and down her right arm.
This spontaneous report as received from a nurse refers to an approximately 8 years old male patient. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, when the patient was 1 year old, he was vaccinated with the first dose of VARIVAX injection (dose, route of administration, lot#, expiration date were not provided). The patient received the second dose of VARIVAX injection (dose, route of administration, lot# and expiry date were not reported), on an unknown date, when he was approximately 5 years old. On an unknown date, when the patient was approximately 8 years old, he experienced a mild case of chickenpox, possibly transmitted to him by another child at school. The patient recovered from the event of chickenpox on an unspecified date. The relatedness VARIVAX and the adverse event was not reported. Additional information is not expected, as there was no consent to contact the reporting nurse.
her lips became dry and the corner is a little dry.; She states her lip is also discolored, being a little darker than usual.; some tingling and a little burning; some tingling and a little burning; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported for that a 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: EW0161), via an unspecified route of administration in left arm on 06May2021 at 11:00 (at the age of 67 years old) as dose 1, single for covid-19 immunisation; levetiracetam (KEPPRA), oral from Oct2020 (Batch/Lot number was not reported) and ongoing, at 500 mg, 2x/day, 1 tablet twice a day by mouth for seizure. Medical history included seizure from Oct2020 and ongoing, multiple sclerosis from 1998 and ongoing. The patient's concomitant medications were not reported. The patient previously took keppra for seizure. The patient not had history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks. She received first dose of the Pfizer BioNTech Covid 19 vaccine last Thursday. Late Saturday afternoon, on 08May2021her lips became dry and the corner was a little dry. They are also having some tingling and a little burning, and still ongoing today. She stated her lip was also discolored, being a little darker than usual. In the corner of her mouth, she thinks she may be developing a cold sore, but she gets those once or twice a year. She also has been on Keppra since October, and she got dry hands from the Keppra. Her second dose was scheduled for 27May2021. He stated late Saturday night the patient started having dryness and itchiness on her neck and she wonders what the problem with this was. She clarified it was not the neck. Stated she has dryness on her lips and a little darkness in the corner of her bottom lip. Therapeutic measures were taken as a result of her lips became dry and the corner was little dry, she states her lip was also discolored, being a little darker than usual with lubricating with vaseline Lip Therapy Tube. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. The action taken in response to the events for KEPPRA was unknown. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
The next day my arm was very sore.  I got a painful, red, itchy rash at the injection site.   It was also very hot to the touch.  Today is Sunday and it?s pretty much better.  Still a little sore but the rash is mainly gone and it?s no longer hot.  Other than the rash I got a headache, tiredness, and muscle aches on the following day after injection 03/10 but those only lasted that day.
Pt was 17 at time of vaccination. Parents contacted and would like individual to receive does two even though it is outside of the EUA
This case was reported by a physician and described the occurrence of about to pass out in a 43-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 23rd September 2014, the patient received FLUVIRAL. On 23rd September 2014, less than an hour after receiving FLUVIRAL, the patient experienced about to pass out (serious criteria GSK medically significant and clinically significant/intervention required), feeling nauseous abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep. On an unknown date, the patient experienced product complaint. On 24th September 2014, the outcome of the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep were recovered/resolved. On an unknown date, the outcome of the product complaint was unknown. The reporter considered the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep to be probably related to FLUVIRAL. Additional details received: The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia  symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.