chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Partial complex epileptic seizures, poorly controlled by medication. Epilepsy surgery in May 2000 did not stop seizures. Stopped speech development until surgery in May 2000. Severe hyperactivity and developmentally delayed. According to the parents, he was achieving his developmental milestones normally during his first year of age with walking alone at 11 months and starting to babble dada at 2 year old until he developed seizures the day after he had his MMR immunization at 1 year old. Hos parents noted that his communication (speech skills) have been significantly delayed because of intractable seizures with multiple medication changes. His parents note also that his motor development, however, has not been compromised. Medication changes were mostly due to side effects noted. His parents report that the patient has not had a major seizure for six months. His current medication, Topamax, seems to be doing well for him. Recently, he has been able to verbalize single words and repeat what he hears when prompted but still cannot form sentences and has also developed new words of his own. He has also recently begin labeling objects and expressing his needs. Pt reports the use of a few two words phrases. He reportedly is able to understand clearly everything that is said to him and mostly expressed himself using gestures or motions through pointing but no speech. His parents describe him as a happy and funny child who gets along well with others of his same age and his brother. He is said to independent and hardheaded at times and is sometimes prone to temper tantrums and seems active. No changes were noted in eating habits or sleep patterns. There were no significant changes in behavior from day to day or from situation to stuation.
itching all over, puffy eyes. started 1/23/21, still present 1/25/21. On 1/28/21, resident reports he has been short of breath since the vaccine, joint pain, body aches, swollen lymph nodes, and resident's right eye is visibly swollen. Injection was done on the right arm, which is the side all symptoms have been on. Resident going to see doctor.
1-2inch solid mass grew in my left arm, near my armpit starting a day after the injection; otherwise only general Muscle soreness.
Lethargy: difficult to wake and difficulty staying awake, 4/17/21 to current Worsening Depression: little motivation, lost interest in hobbies, zoning out, dwelling in negative thoughts
Unresponsive; A spontaneous report was received from a Reporter concerning a 25 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-DEC-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 01-JAN-2021, The patient became unresponsive and died which is serious.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 01-JAN-2021,  the outcome of the event unresponsive became fatal. patient died.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
About 24 hours afterwards I noticed pain in left breast and it is also very swollen. I also have pain from left side of neck down breast/chest to under armpit to back. Please note I have not yet been able to contact my doctor.
sore arm from injection time through 4/27, swelling near injection site, sore to the touch with redness
Information has been received from a physician, via a company representative, concerning a 23 year old female patient, with a sulfonamide allergy, who on 13-JUN-2007, was vaccinated with the second dose of Gardasil (Lot #0212U). Concomitant therapy included YASMIN and AMBIEN. Forty five minutes after the vaccine had been administered, the mother of the patient called the office to report her daughter was "violently vomiting." At the time of this report, the patient was recovering from the event. Additional information has been requested.
Pt has blisters on the same arm but not at injection site. The break out occurred on the same day as vaccination. Pt has an upcoming appt with physician.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 21-Jan-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.
Redness left deltoid.  Called parent, child is doing well.  No further problems.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Mild
Chills, sweats, fever, tiredness, muscle aches, injection site soreness.
L arm pain, body aches & pain, low grade fever, chills, nausea, malaise and other flu like symptoms
Inflammation of the face, jaw area extending from the left ear to the lower part of the jaw near the neck and to the middle of the cheek
Left big toe numbness with bruising; Left big toe numbness with bruising; vomiting; fever; severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 12:30 (Lot number: FC3180) (at the age of 59 years) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 30Jul2021, Administration time: 16:30, Dose number: 1, Vaccination location: Left arm, ), administration date: 30Jul2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), CONTUSION (non-serious) all with onset 21Aug2021, outcome "unknown" and all described as "Left big toe numbness with bruising"; VOMITING (non-serious) with onset 21Aug2021, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 21Aug2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 21Aug2021, outcome "unknown", described as "severe headache". Therapeutic measures were not taken as a result of hypoaesthesia, contusion, vomiting, pyrexia, headache.  Additional information: Facility type for vaccine was noted as pharmacy or drug store. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. Patient did not receive any other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
COVID breakthrough. Patient experienced extreme weakness at home on 11/29/21 and was brought to the hospital where she tested positive for COVID.
Tactile fever, fussiness,  decreased appetite on 7/11/2022. Rash on 7/9/2022 which worsened on 7/11/2022.
This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN9581, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 01:00 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3302, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, on 18Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. It was reported that no additional vaccines administered on same date of Pfizer suspect. No AE(s) follow prior vaccinations. On an unspecified date in Feb2021, the patient experienced soreness in back and injection arm, has a few itchy spots on his legs and a couple on his arms, on 15Feb2021, the patient experienced rash on both arms, on 16Feb2021, the patient experienced rash went down to his legs, on 17Feb2021, the patient experienced ankles and big toes were slightly swollen. Patient received treatments for events (rash on both arms, rash went down to his legs, has a few itchy spots on his legs and a couple on his arms) with hydrocortisone cream on his arms to keep the itching down. Reported that take second dose on 11Feb2021 and Thursday and Friday acted like he didn't even have the shot. Over the weekend his back and are was real sore. Last night, ankles and both big toes were slightly swollen and has a question about it. On the day of reporting it was reported that, has a few itchy spots on his legs and a couple on his arms. Big toes and ankles are still swollen. He is not talking drastic swelling. Wants to know if it would hurt to take a Benadryl. Doesn't know if that was right or not. The outcomes of all reported events were unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
NO Adverse reaction.  Client received only 0.1 ml in the Rt arm,  due to syringe plunger issues.  Advised by Supervisor to give full dose in opposite arm. 0.3ml was given in left arm and Client tolerated well.
GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. Patient was a healthy man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on OCT-2021 for prophylactic vaccination (Dose number series 1). The batch number was not reported and has been requested. No concomitant medications were reported. After receiving the vaccine on unspecified date in OCT-2021, patient experienced Guillain Barre syndrome. He was in hospital (admitted on an unspecified date) for 8 days and was in ton of pain. Physician said that it would take patient 2 to 3 years to be back to normal. Patient looked older than his 92 years old father. He walked with a cane or walker. He experienced horrible life at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211264251-COVID-19 VACCINE AD26.COV2.S-Guillaine Barre Syndrome. This event(s) is labeled per RA and is therefore considered potentially related.
A consumer report has been received. The report concerns a 5 year old, Male consumer, Height: 110.0 Centimeters, Weight: 40.0 Pounds, who had been receiving FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent started on 12-Oct-2015. The patient experienced complained of a cough which stared on 15-Oct-2015, complained of a sore throat which started on 14-Oct-2016, her son had a fever on Tuesday morning which started on 13-Oct-2015 and had a headache Tuesday evening after administration of FLUMIST. FLUMIST quadrivalent was discontinued on 12-Oct-2015. The outcome of the event of her son had a fever on Tuesday morning, complained of a sore throat, complained of a cough and had a headache Tuesday evening after administration of FLUMIST is unknown. The report was considered to be non-serious.
Headache; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache was unknown.
Syncope after receiving immunizaions. Pt. placed in supine position with legs elevated.
This case was reported by a nurse via call center representative and described the occurrence of headache in a 12-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 4 hrs after receiving BEXSERO, the patient experienced headache, vomiting, fever and nausea. On an unknown date, the outcome of the headache, vomiting and fever were recovered/resolved and the outcome of the nausea was not recovered/not resolved. It was unknown if the reporter considered the headache, vomiting, fever and nausea to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced headache began vomiting and got a fever after vaccination with BEXSERO. It was reported that, the patient was no longer experiencing a headache, vomiting or fever at the time reporting, but was just a little nauseous. No further information was provided.
Pt. c/o Numbness and tingling of lips. Having a metallic taste in mouth.   Took allegra 180mg at 2:30pm. Vital signs:  2:15pm 125/90 82 14 O2 96%;  2:30pm 130/90 84 14 O2 97%;  2:45pm 130/82 77  O2 97%;  3:35pm 125/90 78 O2 98%;
After shot(pneumococcal polysaccharide) my husband had swelling at the sight and red and very hot.The redness and swelling went down the inside of his arm. He ran a fever and it was very painful. This lasted 5 days and then disappeared. No treatment was given
Gave water and crackers.  Patient felt very dizzy after waiting the 15 minutes.  She laid on the floor with her legs elevated. Came back to the medical center to be monitored and symptoms improved. Patient's vitals remain stable through observation. She had 2 waters  and some crackers and tolerated well. Patient felt well enough to leave.  Patient was wheelchair to the front door.
Two weeks after receiving dose 2, I developed a rash, first on my chest. Rash then appeared on arms, legs and later the neck, but the rash was worst on the chest. It was not painful, but the itching was severe enough that I began waking in the night - at first once or twice, but after about 5 days I was waking up 4 or 5 times/night. Finally on day 9 I went to my GP who gave me a Cortisone shot and a prescription for Triamcinolonge Acetonide Cream. The itching began to subside in a few hours and was stopped almost entirely after about 24 hours.
09/04/22 presents to ED for "shortness of breath". PMHx of "A. Fib on AC, PE, DVT, asthma"
On 8/16/07 during routine vaccination screening, Public Health Nurse questioned client and clients mother to see if she was possibly pregnant, and client stated no.  Nurse Administered HPV & MCV 4 to Client. Client then presented to Clinic on 8/21/07 with mother for pregnancy test and was positive.  Public Health Nurse phoned CDC information line and was encouraged to complete VAERS form and have Client to register with HPV Pregnancy Registry.  Client not to receive the followup doses of HPV vaccine until completion of pregnancy.
After receiving Pfizer Covid Vaccine, Patient reported, disorientation, flushing, pain in chest numbness in left arm.  Patient accepted water, refused EMS , Cold Compress , and diphenhydramine  Wife picked up patient and patient advised to seek care at urgent care.
pt developed nodules on breast, swollen nodes, dime sized lesions which opened and then subsequently healed, but leaving a acar at the 11 o'clock, 12 o'clock, and 3 o'clock
Redness on left arm below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on left arm below injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included unspecified supplements.  After first dose, the patient had redness on left arm below injection site and than it disappeared.   This case was linked to MOD-2021-317610 (Patient Link).
Initial pregnancy report received from a healthcare professional on 06 May 2013. A 33-year-old female patient had received an intramuscular dose 1 of ADACEL (lot number U4612AA, anatomical site of vaccination not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 August 2012 and the expected date of delivery is 22 May 2013. Prenatal tests were not done. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as not applicable. As of 06 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
COVID arm. An oval shaped swelling at the vaccine site. Pinkish and itchy.
pt recv vax 18DEC96 & on 4JAN97 pt devel varicella lesions which were not yet vesicular;f/u was recv from MD which indicated that on 4JAN97 pt devel bumps which devel into vesicles & crusted ulcers;pt seen by MD on 9JAN97 w/in 6-8 lesions;
Prevnar 13 administered around 9:00 AM, at 7:00 PM Resident's L deltoid - red, raised, firm, circular, warm, itches, 3.25 inches diameter area, no pain, full range of motion to L arm, no treatment, just monitoring.
Period cycle 2 weeks early , severe cramps and heavy menstuation Headache, fatigue, mental fog,
6/27/2022 Woke up with back hurting and neck stiff. That night I felt bad, whole body aches. 6/28 at home COVID 19 test positive. Ear soreness; headache; shivering/chills; Increased sensitivity temperature and pressure; Deep depression feelings. Tele visit with doctor on 6/28. Doctor prescribed PAXLOVID. Got a PCR COVID 19 test, also positive. 6/29 symptoms got worse, and coughing increased. Sputum from coughing still clear. 7/5 symptoms improved noticeably, but not fully recovered.
Rash devel on back of neck & both shoulders upper back 2hr p/vax;small red-non itching;no diff breathing or other sx;lt arm had circle w/rash around it, about size of nickle;
8/2/21: Patient arrived at the ER due to hypoxia secondary to COVID-19 infection. Patient notes his symptoms started 3 weeks ago with sore throat and fatigue. Patient tested positive for COVID-19 on 7/28/2021.  Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure Please note: Patient received First dose of Pfizer COVID-19 vaccine on 1/23/2021, followed by the second dose on 2/15/2021 (confirmed through DOH)  8/9/2021: patient discharged
Started with redness & swelling at the site of injection (the size of my hand) that night. Next day flu-like symptoms (severe aching & low-grade fever) that kept me in bed the next 3 days. Used Advil for the aching which helped. Redness & swelling on my left arm that slowly spread down my arm continued for almost 2 weeks. Hot to the touch & itched badly. Within 5 days of the shot tiny red bumps (about 6 or 7) on my left arm that itched like crazy for almost 3 weeks.
hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Bleariness, slight brain fog, not steady, legs feel like that they're not attached to body.
Mother called Pt. crying, unable to console X90 min. Tylenol given - phone call 4/17/09. Pt doing better, cried for 2 1/2 hrs. and is fine today- had low grade fever
Patient was given PFIZER when the other two doses were moderna. NO symptoms or signs reported by the patient.
autistic; Seizures; bad reactions after injections; This spontaneous report was received from a patient's mother and refers to an 18-month-old male patient. It was reported that the patient was adult at the time of the report. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not provided.  On an unknown date, the patient experienced bad reactions and seizures after injection. It was also reported, that the patient was autistic from an unknown date. The outcome of the events was unknown.   The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided. It was reported that the events occurred due to thiomersal (reported as thimerosal).  Upon internal review, the events of autism spectrum disorder and seizures were considered to be medically significant.
Within 10 minutes of receiving immunization child developed red, itchy feet, palms of hands, scalp, ears. Blotchy cheeks with pink papules. Within 45 min of giving Benadryl symptoms subsided.