chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received the third/booster dose of BNT162b2.; Vaginal bleeding (light); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration on 03Nov2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included chlorphenamine maleate/dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride (THERAFLU) taken on an unknown date in Oct2021, two weeks before vaccination for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on 12Apr2021 (at the age of 32-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 03May2021 (at the age of 32-years-old); both as single doses for COVID-19 immunisation. On 03Nov2021, the patient experienced vaginal bleeding, which was light. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event vaginal bleeding which was light was not resolved at the time of this report.
She woke up the next morning (approximately 14 hours after injection) complaining that she was having difficulty breathing. I?m an RN so I checked her sats  and pulse. Sats were ok at 99% but pulse was 150. Mild fever of 100.5. Gave her water and rechecked pulse but it was still 140-150.  Called her doctor
administration of Boostrix vaccine intravenously to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: A pharmacist asked for information about the administration of Boostrix vaccine intravenously to a patient. The reporter did not provide information about the patient and the vaccine administered.  The reporter consented to follow up. Additional supportive information: The patient received Boostrix intravenously, which led to intramuscular formulation administered by other route.
Adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 reported medical history).    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 VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Patient woke up with spots on tongue, later same day spots red & purple on legs. Went to Urgent Care told to go to ER immediately. Admitted to Hospital, Platelet count drop significantly. Receive 2 Units of Platelets placed on steroids.
Trouble sleeping during night,  achey legs started around 6am and continued throughout day along with some chills, fever of 100.6, headache. Fully better by next morning.
Information has been received from a NP concerning a 61 year old white female who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. via the right deltoid. On the same day, she also received an influenza virus vaccine. Subsequently, the pt experienced injection site reaction described as swollen arm with redness (injection site arm). Also, she developed significant flu symptoms. It was noted that the pt had no previous reaction to flu shots. Pt was presented to a physician and treatment with hydrocortisone cream and Benadryl was initiated, but despite the treatment, the arm redness persisted. Therapy with Decadron was recommended. Subsequently, the pt recovered. No further information is available.
Resident started having emesis at 0400 on 10/11. Seemed to improve throughout the day. On 10/12 fasting blood glucose was 390, was sitting at the lunch table and had another emesis followed by projectile vomiting. Blood Glucose was 530. Called 911
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient has fainted after a flu and bivalent COVID shots give. patient recovered in a minute. 911 was called and showed up about 20 minutes later. patient has filled better and does not want to check out. tried to contact patient today 9/19/22 but no response.
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling, feeling numb on left arm post 2nd dose Pfizer vaccine
Pt reports bilateral arm pain that started 4 days ago around 2 and 1/2 weeks after vaccination, feels "like in the bone" rates 7/10, tried advil with only mild improvement, no redness, no swelling, no injury other other symptoms
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Additional information: patient was asking about how long to wait before taking the booster after recently being positive for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
On the morning on the 13th I woke with a rash and hives on various places on my body with serious itching. I occasionally felt chest tightness, sore throat and muscle pains in my upper body which came and went for a night. I went to a telehealth visit the next day. The dr. diagnosed me with an allergic reaction and prescribed me prednisone and hydroxyzine HCL.
w/in a few minutes p/inject in the lt thigh, erythematous area covering the lt thigh appeared; there was aslso a 4mm area of ecchymosis around the inject site; cold pads was applied & p/20mins erythema was minimal;
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact.
I had an extreme amount of congestions. There was at least 2-3 days straight that I could not get out of bed. I had headaches and extreme fatigue. I had 4 negative COVID tests. I went to the clinic and had a blood test that showed my antibodies increased and that it indicated that I did have COVID. Quantitative IGG against S increased. Qualitative IGG against N increased 1.8 to 8.48.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Shingles; rash on her chest /down the arm; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date unknown) for prophylaxis.   Concurrent medical conditions included upper back pain. Concomitant products included paracetamol (Tylenol).   On 16th January 2020, the patient received the 1st dose of Shingrix. On 18th January 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient came to physician's office with pain in upper right part of her back. The thought it may have been from a work out. The physician told patient to take a Tylenol and she started to feel better. She asked HCP if she had the shingles vaccine. The patient was given Shingrix. The patient developed a rash on her chest and on 18th January 2020, called the doctor and emailed a picture of the rash. On 20th January 2020, the patient returned to the office and was diagnosed with shingles. The rash was down the arm and the right upper side of back, as per HCP it was classic shingles presentation and not an allergic reaction. The physician could not be sure if patient was already in a pre-clinical presentation of shingles due to the original pain the patient discussed. The patient was prescribed Valtrex. The reporter gave consent for follow up.
9/14/21: Patient arrived at the ER due to complaints of productive cough x 1week, body aches and chills. Patient stated that her daughter is a flight attendant and also was not feeling well and her test results for COVID came back positive 9/13. Patient tested positive for COVID on 9/14/21. Patient currently diagnosed with acute COVID-19 infection, with fever and systemic inflammatory response.  Patient received first dose Moderna vaccine on 1/31/2021 Lot # 012M20A and the second dose on 2/28/2021 Lot # 012M20A
69 expired doses administered; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.   This case was linked to MOD-2022-449369, MOD-2022-449432, MOD-2022-449470, MOD-2022-449496 (Patient Link).
It started with a fever, chills, headaches, and a sore arm. He has tremors that causes shaking in his arms. His head feels like it's in a cloud. He has tightness in his throat and chest. He has numerous complaints of constipation. He had a bladder infection. His neurologist thinks he has Parkinson's disease. He has been to the ER 2 times. He was dehydrated and had more symptoms of Parkinson's. His neurologist gave him a neural block in his head and nortriptyline, but he can't take the medication because it makes him too drowsy and unable to function properly. He is severely depressed because he doesn't know what's wrong with him. He used to be very active, but now he is not able to do anything anymore. I don't even feel comfortable with him driving anymore. This has all been present within the last 4 or 5 months. Next Tuesday he is going for a MRI. He doesn't have a final diagnosis yet. He has tried to start Parkinson's medication but he cant tolerate it. He started off trying to take Rytary, but he couldn't tolerate it. Then he was put on a neupro patch rotigotine, but he wasn't able to tolerate that either. I can't leave him alone because he can't function properly, and he can hardly walk.
Information has been received from a medical assistant concerning an 8 year old male with an allergy to amoxicillin who on 06-OCT-1998 was vaccinated in the right arm with a first dose of Varivax (Lot# 626970/0850H) (diluent LOT # 627257/0926H). There was no illness at the time of vaccination. On 11-SEP-2006 the patient had no fever. It was reported that "several classmates" were sent home with chickenpox. On 20-SEP-2006 the patient recovered. No further information was available. Additional information is not expected.
After first shot (4/19/21), roughly 6 hours later, I got a numb patch on my head that wrapped from one temple over the top of my head to other temple.  It wend away after approximately 48 hours. After second shot (Monday 5/10/21), roughly 6 hours later, my entire face had a numbing and tingling sensation.   By Weds 5/12, mid afternoon, it went away on the right side of my face only.  Left side of face, Nose and mouth still had the sensation. Thurs and Friday the sensation was getting weaker.  On Saturday 5/15, the sensation became stronger, still on the left side of face, nose and mouth, but now also moved down the back of my neck, my entire left shoulder, arm and hand. Also, by saturday afternoon, I had a series of blisters on the inner edge of my upper lip.  I do not get blisters in my mouth.  The blisters were gone within 2 days. I have not lost feeling at all, just an annoying numbing/tingling sensation.  I did see my family Dr, and she ruled out Bells Palsy, as there is no weakness, and did routine testing to verify it is not neurological.  Her suggestion was to wait for 6 weeks, to see if it just goes away.  It has now been 3.5 weeks and is no better, or no worse.  I am not comfortable just sitting and waiting 6 weeks.  My online research shows that during testing of this, other people had the same reaction.  I would love to know how they treated it.
No adverse events reported. ERROR on administering a vaccine past beyond used date of 4/14/2022. Patient was informed of error. Pfizer vaccine was re-administered on 4/20/22 @5:58pm.
Per patient's mother, at 7 AM on 8/25/2020, infant had "diarrhea" stool and fever of 101.9.  Was noted to be sleepy, but easily aroused.  Was nursing vigorously intermittently.  Had another "diarrhea" stool. Fever was treated with acetaminophen and tepid bath with temperature declining to 99 degrees.  At 11:40 AM on 8/25/2020, infant awakened and temperature measured 100.9 in left ear that was against bedding and right ear that was not against bedding temperature was 98.6 degrees.  No further "diarrhea" stool.  Infant had fully recovered the morning of 8/26/2020 with normal temperature and no abnormal stooling.  Continues to feed well and other wise doing well.
Information has been received from a medical assistant (also the site supervisor) referring to unspecified number patients of unknown age and gender. On an unknown date in March 2015 or April 2015, the patients was vaccinated with improperly stored PNEUMOVAX 23 (dose number, dose, route and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
Medical Assist reconstituted the Hib component of PENTACEL with normal saline, administered it to a patient/DTaP-IPV portion of PENTACEL was not given to the patient, this is how they discovered that only the Hib portion was given with no reported ae; Initial information received on 02-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient whose medical assist (assistant) reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (adverse event) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Sodium Chloride (Normal Saline).  On 06-Jan-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , once, (formulation, strength: unknown) lot UJ502AA via intramuscular route in unknown administration site as Immunisation.  On 06-JAN-2022 the medical assist reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
coughing; congestion; , sneezing; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HEADACHE (headache) and COUGH (coughing). 18-Aug-2021, the patient experienced NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever). On 26-Aug-2021, HEADACHE (headache), COUGH (coughing), NASAL CONGESTION (congestion), SNEEZING (, sneezing) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test positive: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.     This case was linked to MOD-2021-296717 (Patient Link).
one week after the shot patient had warmth , itching  and a hard knot at the injection site , Dr . called it Covid arm
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received Tdap on 6/18/21. Patient called our office on 6/24/21, reporting five days after receiving the vaccine she developed increased pruritus and redness to her left arm that has not resolved. Pt states erythema has expanded to the back of her upper arm, does not go below her elbow. Patient applied Benadryl ointment and has been taking Ibuprofen. She states site is warm to touch and throbs at times. She states site is sensitive, especially when her sleeve touches the area; feels similar to a sunburn. Pt reports full ROM in her arm. She denies any fevers, tongue swelling, difficulty swallowing, or sob. Pt was seen in our office for cellulitis and prescribed cephalexin and prednisone.
82-year-old female with PMH of hypertension, CKD stage 4, anemia in chronic disease, recently diagnosed with diabetes  sent in from infusion center for low Hb level , in ED CBC showed Hb 9.3 , and BMP back with K level 6.5 , Creat 1.96 , pt seen in ED and states she feels weak  will admit for hyperkalemia and AKI  7/28/2021 tested positive 7/28/2021: patient discharged.
patient experienced dizziness and tingling and was responding slowly around 5 minutes after receiving his dose. once he was moved to the floor and legs elevated, he regained consciousness and coloration and stated that he felt better.  he was monitored for around 20 minutes after the reaction and was told to seek medical care if he started to feel any other symptoms