chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; This is a spontaneous report from a non-contactable consumer. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. Other medical conditions, not even cold, no diabetes, no cancer. The patient had a stroke. He was 63-64 (not further clarify). He had 2 strokes. The reporter didn't know, what kind of thing' but had not had any symptoms experienced as immediately, lost in a week. The reporter meant within 48 hours this thing happened. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given 10/8/04 at 13:15. Approximately 18:45 hands became hot and itchy. Few hours later feet became hot and itchy. Woke up 10/9/04 and was "blotchy" all over. Went to MD and received Zyrtec for itching.
for 12 hours the flu-symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms). In April 2021, INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-399927 (Patient Link).
woke up next morning p/vax, runny nose, achy, low grade fever-now has chest congestion hast talked w/PMD & ATB have been prescribed;
Pts mom explained pt leg was red form his knee to groin area. There was mild swelling. Put cool packs and gave tylenol was told to call back in 1 day if no improvement. Pt did not call.
Felt weak after booster; Not hungry at all  after booster/Forced herself to eat after booster; Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 009C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose). On 02-Dec-2021, ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.
After vaccine felt fatigue, then woke up next morning at approx 9 am on 1/31/21, lip itchy/swelling and eye swelling and went to emergency room.  Treated with IV Benadyl, Zofran and fluids.
No additional AEs reported.; expired VAQTA was administered; This spontaneous report was received from a medical assistant, referring to a 6-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 24-AUG-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (lot # T008698, expiration date 04-JUN-2021, dose, strength and route were not provided) for prophylaxis (expired product administered).  No additional adverse event reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2109USA005216: US-009507513-2109USA005193:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose: 03), for Covid-19 immunization; Moderna vaccine (Dose:02), for Covid-19 immunization; Moderna vaccine (Dose: 01), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "it doesn't make me feel comfortable"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller mentions that she has a sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown".
Right arm edema and rash around the injection site, with associated throat itching, right arm soreness and pruritis that began 7 days after vaccine administration. 8 days after the injection I awoke with severe nausea, lightheadedness and diaphoresis that lasted 30 minutes. The rash took 4 days to resolve.
Patient spiked a fever and chills within hours of vaccine.  BY 6pm she threw up and had a febrile seizure while in urgent care, turned blue and was rushed to the ER by ambulance
Seizure lasting 7+ minutes. This occurred 1 day after receiving DTaP + Hib vaccines. ER eval. Pr=stable. Discharged home. No fever noted.
Initial report was received on 11 February 2011 from a consumer, who is also the patient's parent. A six week-old male infant with no reported past medical history, received a Pertussis vaccine (manufacturer, lot number, route, site and date of administration were not provided) and was reported to be grumpy later that same night. The next morning he became uncontrollably upset. The reporter stated that the infant completely quit making noise, was struggling to breathe, and then wasn't breathing. He vomited what was described as bright red jelly. The mother felt that the infant was having an allergic reaction. The patient began to convulse and CPR was started by a family member. Paramedics were called to the home and the patient was reported to be DOA (dead on arrival). The patient was then resuscitated with the use of electric defibrillator. The patient was transported to the hospital and spent one week in isolation connected to heart monitors and life support (unspecified). No further treatments were reported. The patient is now 17 years-old and according to the reporter he has lasting complications from the event including ADHD, ODD, and learning disabilities. At the time of this report, the patient was described as a young man who enjoys the life of a typical teenager. Documents held by sender: none.
Patient reported flu like symptoms about 12 hours after receiving the shot. She said she had flu symptoms after her first dose and already reported that, and called to tell us that the symptoms occurred this time again after having the second shot. She has fever and chills.
Patient received 3rd dose of Pfizer vaccination on 8/26/2021 and developed LLE redness, pain and swelling on 10/8/2021. Patient was evaluated on 10/11/2021 and sent for LLE u/s to rule out DVT and a D-dimer was drawn for shortness of breath (mild).
Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse reported that the patient went into the office 3 weeks later with an infected injection site reaction. At the time of the report the patient's outcome was unknown. The patient sought medical attention (was seen in the office). Follow up information has been received from the nurse who reported that on 21-OCT-2009 the Medical Assistant vaccinated the patient with the first dose of GARDASIL (lot # 662304/1013Y), intramuscularly in the right deltoid. It was reported that the patient developed a small lump on the right deltoid with some redness. The patient was seen in the office on 13-NOV-2009 and was treated with BACTRIM DS 160 mg/800 mg, twice a day for seven days. It was stated that the patient went back on 02-DEC-2009 and the right deltoid was completely healed. No further information is available.
Patient received the Pfizer Bivalent shot at our pharmacy on 1/13/2023, around 5.45 pm.  She developed redness , pain under the injection site .  Redness was spreading down  to bicep & around with fullness & tightness when the time goes.  She spoke to her Doctor office & started taking Cephalexin & Advil per Doctor instruction. She has appointment tomorrow(1/18/23) to see her Doctor.  Advil helps her for the pain.
Menveo + administration of liquid portion only; Menveo + administration of liquid portion only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA723Z, expiry date 31-AUG-2023) for prophylaxis.   On 21-JUL-2023, the patient received Menveo. On 21-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo + administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Menveo + administration of liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-JUL-2023 The Clinical manager reported that patient received only the liquid portion only of Menveo and asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received only the liquid portion only of Menveo , which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
No adverse events but Hep A was given at 3 mo interval instead of 6 mo.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 9/11/2021 HX OF NON ST ELEVATION MI I95.9 HYPOTENSION 6/1/2021 HX OF NON ST ELEVATION MI
My wife suffered ovarian failure as a result of the Pfizer Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVARIAN FAILURE (non-serious), outcome "unknown", described as "My wife suffered ovarian failure as a result of the Pfizer Covid". The lot number for bnt162b2 was not provided and will be requested during follow up.
sever headache, chills, fever starting about 12 hrs after administration and lasting for 6 hrs
arm soreness; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm soreness) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm soreness) and CHILLS (chills). At the time of the report, MYALGIA (arm soreness) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Pt C/o Red itchy rash on face , Chest and Blotchy rash on hands. Denied SOB. Had same reaction in 2001 from Flu Shot. Gave PT 25 mg Benadryl PO and Pt stayed with Husband who is an MD until sx were improving. Pt Left with Husband when she stated her sx were improved.
Patient has swelling and increased warmth at injection site/local reaction. Patient rubbing scratching area alot per caregiver.
pt states he started getting nauseated, got the chills, sweating, body aches and pains.  He says it made him very shaky and his teeth were chattering.  He went to bed and suffered w/ his symptoms.  On 3/25/2021 he says his symptoms seem to be improving. Pt sent his PCP a message about his symptoms.
Significant hair loss, hair thinning on scalp and scalp tenderness. Have begun now using hair regrowth products with no significant improvement.
Patient reported for 2nd dose of Covid 19 vaccine.  RN, administered Pfizer when the patient should have been given Moderna.  Patient had no adverse side effects.  Patient was observed for 20 minutes post vaccination.  Will monitor patient and have continued contact to document any symptoms possibly associated with adverse event.
I developed a Urinary track infection, body ache, fever, fatigue, these were the only symptoms incurred.
doses /5 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7F, expiry date 10th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th May 2021, the patient received the 2nd dose of Shingrix. On 11th May 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix 5 weeks after 1st  dose, earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
p/vax pt loss consciousness & had convuls x 2-3seconds;spoke to nurse then loss consciousness a second time x 5-7min;pale, lips cyanotic, diaphoretic;hyperventilating;BP 100/60, P80, 911 called;
Admit Date: 4/19/2021  Discharge Date: 4/23/2021 S/p 2nd COVID vaccine on 4/17, developed dyspnea on 4/18. COVID PCR+ on 4/19. CRP >200.     Patient is a 22 y.o. female with lupus, hx of class IV lupus nephritis on multiple immunosuppressing medications who presented with dyspnea in setting of 2 months of chest pain. Pt reports chest pain, substernal, R sided x2 months. Seen as outpatient previously (February), CTA negative, no effusions at that time. Since then progressively worsening. Yesterday had new and progressively worsening dyspnea. Upon my interview, denies pleuritic pain, not clearly positional, sometimes better with sitting forward, sometimes better when supine. Upon my interview she is very tachypneic so obtaining hx is challenging. She denies anxiety at this time. Denies relief with ativan in the ER. Of note, she received her 2nd COVID vaccination on 4/17, day prior to onset of dyspnea
Patient reported no vaccines in the past 14 days on his consent and at time of review.  I saw the patient end of day and he reported his "arm is really sore since I got my flu shot yesterday too."  Upon further investigation, it was determined that he had gotten a flu shot the day before in Employee Health.  Patient reports no reactions other than soreness in the arm.  I contacted Employee Health and was advised that he will need to work and massage the R deltoid muscle to help disperse the medication for the next week.  I relayed this information to the patient.  Employee Health also advised he should contact Employee Health if he develops any issues.  I also relayed this to the patient, who verbalized understanding.
Systemic: Diarrhea-Medium, Additional Details: Customer reported that he started to have diarrhea 1 day after the date of Moderna Bivalent vaccination, but he thought it was from the salad that he ate.  He changed his diet to brat diet. He had about 7-8 diarrheas within 11/22 to 11/25.  He took pepto bismol but it didn't help. He went to pharmacy on 11/25/22 to report the adverse reaction.
Patient waited in clinic for 15 minutes post vaccination. About 15-20 minutes after vaccination pt reported to clinic window complaining of dizziness and tunnel vision. Brought back to clinic room for about 30 minutes with continued dizziness. Started having complaints of numbness in hands.
Dermatitis on the right lateral side of the deltoid the following day after the vaccine was given. Rash continued to expand, swollen shoulder, was red, and sore. Rash eventually went away after 5-7 days without any topical creams/ medication. Arm soreness went away after 2 days.
noticeable bruising by 3-4wk p/vax;1MAY96 dx w/ITP w/platelet count @ life threatening level was hosp;
Facility was providing pre-exposure Rabies vaccine for employees of animal hospital.  Injection on 05/11/2005 was #2 for her.  No problem with 1st injection, after #2 injection developed vomiting, temperature of 102, chills, headache, muscle soreness. Symptoms lasted 72 hours.
Received both doses of Moderna Vaccine while pregnant; Arm soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of Moderna Vaccine while pregnant) and PAIN IN EXTREMITY (Arm soreness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Mar-2021 and the estimated date of delivery was 23-Dec-2021. On 09-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of Moderna Vaccine while pregnant) and PAIN IN EXTREMITY (Arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 09-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of Moderna Vaccine while pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
He became dizzy and nauseous after about 10 minutes of sitting following the shot. Blood pressure and pulse were stable he was given water and a granola bar and his feet were put up. He was fine after 10 minutes and went home with his mother.
The week after receiving the vaccine, I began to experience sever pain, stiffness, and swelling in my fingers, knees, and toes.  At times I am unable to write and often experience trouble walking.
Dramatic increase of ringing in ears, loudest in right ear. Loud enough to affect daily life, mental health. High pitch sound with no cessation in 3 weeks.
Rash, itching. 7-8 papulo-vesicular lesions on trunk and legs.
stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient got Shingles shot and week later stroke. The reporter wanted to know if there was any connection. The follow-up would not be possible as no contact details were available.
No additional AE reported; an expired vaccine was administered; This spontaneous report was received from Office Manager and refers to a 16-month-old child of unknown gender.The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided.  On 18-APR-2022, the patient was vaccinated with an expired dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #S030966, expiration date: 14-APR-2022 (expired product administered) (dose, route of administration and injection site were not provided) for prophylaxis.
like something stuck in the back of my neck on right side; something stuck in the back of my neck on right side and push through now that side of my head; face feel funny I happen two times 30 seconds apart; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart). At the time of the report, MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
12 hours after vaccination I started chilling and had intense body aches, terrible joint pain. I do have arm soreness but nothing worse than with other vaccinations. These symptoms have continued for 24 hours after the injection