chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of their lips 10 days after 2nd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (swelling of their lips 10 days after 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swelling of their lips 10 days after 2nd shot). At the time of the report, LIP SWELLING (swelling of their lips 10 days after 2nd shot) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  It was reported that patient had 2 moderna COVID shots and had some swelling of their lips 10 days after 2nd shot and it was unclear if it was related to the shot.  No treatment medication reported by reporter.   Reporter did not allow further contact
Fever < 104 times 24 hrs. watery stools. tylenol x 24 hrs. Rocephin 250 mle x 1 dose
Patient received vaccine at 1440. Patient eyes were opened but claimed to black out and was not responsive to his name. Nurse assessed and patient was clammy and pale. Patient was alert after 1 minute and stated he was dizzy. Medics were called on scene and patients blood pressure was 84/65, heart rate was 45. Medics started an IV with normal saline. Blood pressure 96/64. Patient was transported to hospital.
potentially tested positive for Covid after receiving the Pfizer vaccine; potentially tested positive for Covid after receiving the Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced potentially tested positive for covid after receiving the PFIZER vaccine. During the call, the caller mentioned that everyone in house tested positive and they all had the PFIZER vaccine. Everybody tested positive because someone may have been around that did not have the vaccine and got them infected. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test with result positive. The outcome of the events was unknown.   The report is cross referenced to report ID. Caller was calling on patient who tested positive for Covid-19 after receiving both doses of the Pfizer Covid-19 vaccine. During the call, the caller mentioned that everyone in house tested positive and they all had the Pfizer vaccine. Everybody tested positive because someone may have been around that did not have the vaccine and got them infected. This information could not be clarified further. Caller declined to complete report. Full details not obtained or provided.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: FL0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "turrets" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY taken for tourette's disorder (ongoing); FLU, administration date 2021. The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Diarrhea".  Additional information: Reporter is the mother and is calling to report that her two sons had diarrhea after getting the COVID vaccine shot on 14Dec2021 at 13:30-14. The patient Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no and Relevant Tests: No. No additional vaccines were administered on same date of the Pfizer suspect.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797861 Same reporter/drug/event, different patient.
Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The reporter reported that, electrocardiographist wife experienced rash.
ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE.  BY THE TIME I MADE IT OUT TO MY FIRE ENGINE I WAS RED AND BLOTCHY ON MY CHEST AND BACK THAT STARTED TO GO UP MY NECK.  ONE OF MY FIREFIGHTERS GAVE ME BENADRYL IM IN THE RIGHT ARM.  THE ITCHING STAYED THE SAME FOR ANOTHER 10 MINUTES UNTIL IT STARTED TO GET WORSE AND MOVE DOWN MY SIDE, STOMACH, LEGS AND ARMS.  I THEN STARTED TO DEVELOP BUMPS AND REDNESS TO MY NECK AND BEHIND BOTH MY EARS AND BOTH MY FOREARMS.  IN THE ARM WHERE I RECEIVED THE VACCINE IT TURNED RED WITH SOME SWELLING AND BUMPS.  MY PARAMEDIC THEN GAVE A DOSE OF EPI 1:1,000 IM ON THE LEFT ARM.  ABOUT 1 HOUR LATER THE MAJORITY OF THE BUMPS AND ITCHING WENT AWAY.  ABOUT 10 HOURS LATER THE REDNESS AND SWELLING ON THE LEFT ARM WHERE I RECEIVED THE VACCINE WENT AWAY.
tongue numbness/ Mouth numbness; pain at injection site; she was feeling bad; This is a spontaneous report from a contactable consumer (patient's daughter in law). A female patient in her forties received bnt162b2 (BNT162B2) via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient was taking an allergy medication prior to getting the vaccine. She stopped taking it after the second day. The patient experienced tongue numbness/ mouth numbness, pain at injection site, she was feeling bad (non-serious) on 02May2021. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Registered Nurse refers to a identifiable patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 12-SEP-2018 the patient was vaccinated with PROQUAD from lot N025718 by subcutaneous route instead of M-M-R II (product name confusion). Other suspect therapies included VARIVAX from lot R002056. Concomitant therapies included sterile diluent. No adverse events reported.
The evening she got her shot, patient reports headache, fatique, sore arm, red spots and itchiness on arm
shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Itching/Rash to bilateral arm, legs/torso/ back; This is a spontaneous report from a contactable nurse.   This 51-year-old female nurse (patient) received second dose (Lot Number: EL3248 expiry date was not reported) dose 2 via intramuscular route of administration at Arm Left on 27Jan2021 06:30 as 2ND DOSE, 0.3 ML SINGLE for covid-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection first dose 0.3 ml (Lot Number: EL3248 expiry date was not reported) via an intramuscular route of administration at Left Arm on 09Jan2021: 06:30. Medical history included asthma from 01Jan2007 and ongoing. Patient received DTAP on 09Dec1981 at the age of 12 years and Tetanus Booster at the age of 25 years. Concomitant medication(s) included paracetamol (TYLENOL RAPID RELEASE GELS) taken for an unspecified indication from 09Jan2021 to an unspecified stop date. Patient did not have Prior vaccinations (within 4 weeks). On 27Jan2021 17:00 the patient experienced itching and rash to bilateral arm, legs/torso/back. Patient received Benadryl PO 25 mg due to event. Patient did not visit to physician office or emergency room due to event. The outcome of the event was resolving.
Patient got Td and Varicella on the right arm yesterday. At the location of Varicella (not Td) today he developed redness and mild swelling No fever. No headache. No med was given. On the red arm at the location of pervious varicella immunization there is swelling and redness about 4 cm. Not fluctuant. No discharge. Normal distal pulses on the right arm and normal sensation and motor function. No sign of neurovascular compromise.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 08-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Longitudinal extensive transverse myelitis; This is a literature report.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovering", described as "Longitudinal extensive transverse myelitis". The patient underwent the following laboratory tests and procedures: Imaging procedure: was consistent with acute onset longitudinally ext, notes: ensive transverse myelitis (LETM); broad autoimmune workup: all of which was non-diagnostic; all of which was non-diagnostic; all of which was non-diagnostic; all of which was non-diagnostic; Magnetic resonance imaging spinal: he was found to have edema and heterogenously hype, notes: rintense T2 signal involving the entirety of the spinal cord, most marked in the cervical and mid thoracic segments. The imaging was consistent with acute onset longitudinally extensive transverse myelitis (LETM). Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Myelitis transverse.
Received call from mom sts" my son got shots there on the 21st and he has a lump on his thigh since the 22nd and it won't go away, and he won't let you touch it."  Mom questioned as to whether or not the child has or ever had a fever sts "no", mom encouraged if uncomfortable to follow up with doctor.
p/vax w/in 24hr spiked fever @ 103-104 w/duration of 5 days of  fever;irritable 5-7 days;
Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via intramuscular route of administration on 08Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021, the patient experienced itchy rash on bilateral elbow. The patient did not receive any treatment for the reported event. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.
Bells Palsy 11/17/07.  Treatment Prednisone, Doxycycline, Valacyclovir.  Lyme titre negative.  4/8/08 Reviewed PCP medical records of 10/12/07-3/25/08 which include consultant's evaluations. FINAL DX: acute left Bell's palsy, slowly improving. Records reveal patient experienced usual state of good health on day of vax.  Seen in ER 11/7.  Initially upon awakening noted right side bell's palsy which resolved then developed left side bell's palsy within short time.  Tx w/steroids, antiviral & antibiotic.  Facial droop, paralysis, numbess & fatigue increased.   Unable to close left eye, unable to smile, unable to drink liquids w/o dribbling.  Referred for MRI & consults to neuro & ophtho.  Ophtho 1/15/08 revealed Bell's palsy & mild corneal drying.  Neuro consult 2/8/08 revealed flat left nasolabial fold, unable to whistle, unable to completely close left eye, unable to raise eyebrow or furrow forehead on left.
Low grade fever - 99.9, reduced with Tylenol after about 4 hours Headache - lasted approx. 24 hours Extreme nausea - lasted approx. 16 hours Body aches - lasted approx. 36 hours
I am allergic shellfish, the nurse ask me if I was allergic and I told her shellfish only. She gave me the shot anyway, that night I had chills, fever, and diarrhea. The next day I was ok but the following day I noticed my memory started to decline. It got worse where I develop a speech problem and my blood pressure was high. I also noticed that I had an unexpected limp. I went to urgent care and they performed a CT scan of my brain to see if I had a stroke. The results were negative. I wasn't getting better so they wanted me to go straight to the hospital to get an MRI. The hospital performed the MRI with contrast dye to get images of my brain (stroke). Results are neg,
Dermal filler injected in October 2020 into chin.  36 hours or so after shot, my chin (where the dermal filler was injected) is now swelled up and hard to open mouth. The first 2 vaccines I had 0 reaction here or anything other than sore arm.  This time, I have had severe body aches, fatigue,  and pain in armypits.
Pain / tightness at injection site starting mostly the second day, progressing to swelling in under arm area down toward breast.  Gentle massage, elevation and gentle exercise.
Pt was registered and given the 1st dose of the Pfizer vaccine.  Pt did not disclose previous vaccination on registration form.  When vaccine was entered into database, it was found that the patient received J&J back in March.
Two red rings surrounding the circular shot band aid like used (not allergic to it, had std flu shot via same method. I have a picture available.  CV19 03/18/21 J&J exp 05/25/2021 lot 1805022  FLU 10/21/20 Fluzone High dose quadraband   CV19 01/18/22 Pfizer Booster unknown lot number
for a root canal; bad allergy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the vaccine on 23Feb2021 (yesterday afternoon), and she was going to a dentist for a root canal on an unspecified date. The patient said she will take ZYRTEC as therapeutic measure (for bad allergy which started on an unspecified date in between doses and was asking if it was okay since she was also scheduled for a 2nd dose. Therapeutic measures were taken as a result of the event tooth disorder. The outcome of events was unknown.
PEDIATRIC DOSE 2 WAS GIVEN AT 2 WEEKS RATHER THAN 3 WEEKS
Very high white blood cell count; This case was reported by a consumer via interactive digital media and described the occurrence of increased white cell count in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced increased white cell count. On an unknown date, the outcome of the increased white cell count was unknown.   It was unknown if the reporter considered the increased white cell count to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient reported that had vaccine and 2 days later had bloodwork done.  The reporter want to know if there was a correlation with the vaccine and very high white cell count. The follow-up would not possible as no contact details were available.
101 F temperature, Higher temperature chest/stomach area, joint/muscle pain, chills, nausea, injection site pain.  Started about 1:15am, woke up with severe chills, fever and the pain.  Took Advil for fever and pain.  Went from chill to hot and back again throughout the night.  By morning, even drinking water was generating nausea.  Symptoms decreased in the late even, but second night still had chills but much reduced.  Next day, only the soreness in arm has remained.
Patient felt lightheaded almost immediately after receiving vaccine. She was walking with her parents to the lobby and they reported pt "jerking" then becoming unconscious. She woke up right away. She was nauseous and pale for another 20 minutes or so. We called 911 and paramedics determined it to be a vasovagal response.
This spontaneous report as received from a pharmacist and pharmacy intern refers to unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 19-DEC-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 or lot# L019298 with expiration date 22-JUN-2017 (dose, route, lot # and expiration date were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
11 days after taking the vaccine he begin to exhibit Bell's Palsy symptoms. He began to have facial paralysis on the right half of his face he went to see his NP and he was diagnosed with Bell's Palsy. His right eyelid does not close and his eyeball curls upward into the skull. He had swelling of the face, inflammation in jaw and cheek all on the right side.
Patient received the Shingrix vaccine, and approximately at 12 hours later, she developed red lumps around the injection site. Since then, it has gotten worse to a section of her upper left arm is now itching, inflamed, and very warm to touch. The patient is not in pain other than the site itching. She is also not experiencing a fever. She has used cortisone cream for the itching.
Fatigue, fever, ear ache, arm ache, migraines. Second shot caused rigors, vomiting, dry heaves, dehydration, fever, intense all over body pain including bone aches, teeth, ears, neck, spine, everything on me hurt.
From initial information received on 19Dec03 from manufacturer, regarding an adverse event occurring, it was reported by a physician that a 46 year old female pt received a dose of Fluzone SV 2003-2004 USP on an unspecified date. Sometime later, the pt developed lump at the injection site. The pt recovery status was not reported. From additional information received on 30Jan04, from another manufacturer (no reference number provided), it was reported by the pt's physician that the pt experienced a swollen arm one day after receiving the injection. The specific vaccination date was not provided. The physician reported that the pt called the office and stated that she had to take pain medication because of the swollen arm. The pt's recovery status was not provided. The adverse event coding for this case was updated to include arm swelling and injection site pain. Further information is not anticipated, this case is considered closed.
Patient developed mild lightheadedness and tingling of the lips. No SOB, CP, swelling of the throat or lips, or rash. Patient was observed for one hour from vaccine administration. She was given water and crackers. Symptoms improved at 60 minute reevaluation. Vital signs stable. Discharged to home.