chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's wife stated he was experiencing arm pain for months after the injection.  States that it has improved at this time.  She could not give a better time frame
AFTER RECEIVING VACCINE PT. FELT LIGHT HEADED, SHE SAT DOWN AND APPROACHED PHARMACY AND ASKED IF SHE SHOULD FEEL COLD AND SWEATY.  SHE THEN PASSED OUT AND GINGERLY FELL TO THE FLOOR. PHARMACIST RAN OUT TO ASSIST, ELEVATED LEGS AND SPOKE TO HER, SHE WAS SEMICONSCIOUS.  PHARMACY WAS INSTRUCTED TO GRAB ICE PACK AND QUICKLY DID. ICE WAS APPLIED TO PT. WRIST AND SHE IMMEDIATELY REGAINED CONSCIOUSNESS. PT. WAS INSTRUCTED TO REMAIN ON FLOOR AND CONTINUED CONVERSATION TO MEASURE ALERTNESS. AFTER A FEW MINUTES SHE SAID SHE FELT FINE. PHARMACIST AND ASSISTED HER TO CHAIR, AND SHE REMAINED FOR 20 MORE MINUTES. DISCUSSED IF SHE HAD ANY INJURIED FROM FALL. SHE SAID SHE FELT FINE.  PTS LEFT WITH INSTRUCTIONS TO CONTACT PHARMACY OR SEEK MEDICAL HELP IF ANY REOCCURRENCE.
hypsarrhythmia; had a lot of rapid eye movements; This case was reported by a consumer via other manufacturer and described the occurrence of hypsarrhythmia in a 22-month-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hypsarrhythmia (serious criteria GSK medically significant) and eye movement disorder. On an unknown date, the outcome of the hypsarrhythmia and eye movement disorder were unknown.   It was unknown if the reporter considered the hypsarrhythmia and eye movement disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received Flu shot and experienced eye movement disorder and hypsarrthymia.
skin growth under and on my left armpit and arm; Rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced skin growth under and on my left armpit and arm and rash. The outcome of the events was unknown.
hot rash; swollen rash; chills; fever; fatigue; rash from shoulder to elbow; rash on arm; itchy rash on arm; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and RASH (rash from shoulder to elbow) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A or MRN4544) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (rash from shoulder to elbow). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) and RASH (rash from shoulder to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired). At the time of the report, FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-433568, MOD-2021-433968 (Patient Link).
My arm is in constant pain. I can not lift it at all or touch in the area where the shot was given. I can not lay on the side where the shot was given. I am experiencing pain all the way from the injection site now up to my collar bone. The pain is at a 7 when resting and at a 10 when raising the arm or touching/applying minimal amounts of pressure.
Strep. Flu-like symptoms (body aches, fever, headaches, chest congestion).
Dizzy spell; Right arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727/WCHD), via an unspecified route of administration in the right arm on 23Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included selective antibody deficiency(immunodeficiency), hypogammaglobulinemia, thrombocytopenia and arthritis. Concomitant medications included immune globulin (CUVITRU) and naproxen (ALEVE) taken for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Mar2021 at 10:00, the patient had dizzy spell within 10 mins and right arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the events dizzy spell and right arm soreness were resolved on an unknown date.    No follow-up attempts are needed. No further information is expected.
Left deltoid red, swollen approximately 24 hours after injection of DTaP, no fever.  Instructed parent to place cool wet cloth over swelling and given acetomenephen for pain and fever.
Patient reported red/swollen area at vaccination site. Family physician diagnosed cellulitis, prescribed antibiotic. Left arm, (ZOSTAVAX site).
Information has been received from a medical assistant concerning a 14 year old female with pertinent medical history reported as unspecified, who was vaccinated with a second dose of GARDASIL (Lot#, date, dose, and route unspecified).  Concomitant therapy included other unspecified vaccines normal to that age frame during the same visit.  It was reported that the patient developed appendicitis 2 - 3 months later, sought unspecified medical attention and recovered on an unspecified date.  No other details were provided.  No product quality complaint was involved.  Additional information has been requested.
On December 15, 2021 left arm at the injection site  became  swollen, hard and painful with a small rash  approximately 30cm in diameter.  I took ibuprofen for the pain and took benadryl to combat the situation.  It cleared up on Tuesday, December 20, 2021.  On December 30, 2021 I woke up with blotchy large red welts on my body around waist and under breast and on right inside of arm in the deltoid region.  Currently taking benadryl 25mg  at the direction of the pharmacist.  Covering affected areas with cortizone 10 cream.  Really uncomfortable due to the itching.  I was diagnosed with Covid 19 back in November 2021 and was asymptomatic.  Shot #1 and Shot#2 didn't bother me.
I ended up w Covid in Jan2022; I ended up w Covid in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200230352 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I ended up w Covid in Jan2022". The patient initially received 2 doses of Pfizer in Feb2021. Boosters came out way later and I boosted in Dec2021. I ended up w Covid in Jan2022. I question whether the length of time between initially dosing, and booster was too long, and I am now in effect not fully covered (recent Covid antibodies aside). At what point do I re-vaccinate. 1. Advise caller that there is no information in the current PI ( Revised: 31Jan2022) on the maximum duration limit between the Pifzer BioNTech Covid-19 Vaccine second dose and booster dose. There is also no information in the PI that supports the booster dose is no longer effective if the duration from the second dose was too long. 2, Advise caller of the current vaccination schedule in the PI for booster doses (non-immunocompromised): 2.3 Vaccination Schedule Booster Dose. A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY to individuals 12 years of age and older. 3. Refer to HCP as Pfizer is unable to provide treatment recommendations for individual patients.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Painful canker sores found out on July 26th on left inside cheek Went to urgent care on 07/26/2022 and prescribed ibuprofen and triamcinolone Followed up with the PCP on 07/28/2022 As of 07/30/2022, canker sores still present (left and right inside cheek)
Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site with joint pain going distally on arm; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid], diphenhydramine hydrochloride (BENADRYL), ibuprofen and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient previously took cephalexin, ciprofloxacin, neomycin and macrobid [clarithromycin] and experienced drug allergies. The patient had first dose of  BNT162B2  (lot number: EK5730) via intramuscular in left arm on 19Dec2020 10:15 AM at single dose. On 10Jan2021 08:00 AM, the patient experienced redness, swelling and itching at injection site with joint pain going distally on arm. No treatment received for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Dose 1: Mild to moderate muscle and joint pains-localized onset 24-48 hr after dose. Dose 2: Moderate to severe muscle and joint pain, subjective fever, poor concentration-onset 48 hrs after dose lasting 4-5 days. No treatment.
Moderate to severe dizziness with vertigo. Comes and goes. Phenomenon fatigues after repeating the triggering event. Started at 5:45 pm-ongoing, Intermittently. 8:59 pm currently.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
adacel was supposed to be given, however daptacel was given in error,with no reported adverse event; DAPTACEL indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old female patient to whom adacel was supposed to be given, however daptacel was given in error,with no reported adverse event and daptacel indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Sep-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml (lot C582844, expiry date: 30-Mar-2023) via intramuscular route in the left deltoid for immunisation.  On 01-Sep-2022 the patient to whom adacel was supposed to be given, however daptacel was given in error,with no reported adverse event (wrong product administered) and daptacel indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event (product administered to patient of inappropriate age) same day latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 guidelines. 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.
Swelling and reddness on the left arm at the site of the DTaP vaccine.
Chills started about 9:30 pm not of vaccine.  Woke up about 1 am with pounding headache chills, fever, body aches.  Took ibuprofen 1:00 am. Symptoms still there tossed snd turned Until about 4:30 am.   Chills started again about 9am. Then super fatigued headache.  More ibuprofen - slept all day.  Woke up middle of night totally drenched at 3:00 am   Dull headache chills gone. Still fatigued
Hands became swollen; Precursor to hives; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that 5hours after taking the Pfizer covid 19 vaccine her hands became swollen which she recognize as the precursor to hives (on an unspecified date), she took some Zyrtec (treatment) and when she woke up this morning (on an unspecified date) the swelling was gone. The patient asked was it okay for to take the second dose to which she was replied yes, the Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart, if she receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, she should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series, these may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects might occur. Pfizer-BioNTech COVID-19, Vaccine was still being studied in clinical trials. The patient further stated that her doctor told to take Tylenol and Benadryl before the second dose will that be okay, in the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take fever-reducing medications and pain relievers. The patient considered that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. But, ACIP also states that these medications should not be routinely given before the vaccine to prevent these symptoms because the effects of the medications on mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) were not available at that time. Outcome of events was recovered on an unspecified date.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
pt expired (SIDS) on 15JUN92; pt did not awaken from afternoon nap; pt was not ill;
Bad case of shingles after receiving both doses/Suspected vaccination failure; Bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. After receiving both the doses of Shingrix, the patient got a bad case of shingles. Other supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible since contact details were not provided.
Within 1 minute of receiving vaccine there was a strong metallic taste in my mouth that lasted until the next morning.  There was also a slight dizziness and moderate nausea which dissipated after a meal. Eating did not eliminate the metallic taste. Sleep was disturbed on the night of the 3rd, restless body, and slight headache. The following days I experienced a light headed feeling.
At 1:00, arm was warm, painful, and swollen to elbow.  At approximately 5 PM, patient began to feel dizzy and sweaty like she was going to pass out.  At this time, her arm was swollen to wrist.  She was unable to talk and felt she was having a hard time swallowing and breathing.  Was taken to hospital via ambulance and treated with Benadryl and predinisone.  Was given a Medrol dose pack to complete at home.  As of 9-16-10 symptoms, including arm swelling were completely resolved.
Severe Rigors, Chills, muscle and joint aches, headache and significant fatigue.
upper arm was sore; body aches; Low grade fever; he was warm; just didn't feel good the next day; This is a spontaneous report received from a contactable consumer (patient's wife). A 73-year-old-male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6204) via an unspecified route of administration in the right arm on 05Mar2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient had no vaccinations in the 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9269) intramuscularly in the right arm on 12Feb2021 (at the age of 73-years-old) for COVID-19 immunisation. It was reported that the patient's upper arm was sore, he had body aches, a low-grade fever, was feeling warm, and just didn't feel good the next day on 06Mar2021. The following day, 07Mar2021, the patient felt fine and had recovered completely. The clinical outcomes of upper arm was sore, he had body aches, a low-grade fever, was feeling warm, and just didn't feel good the next day were recovered on 07Mar2021.
Pt reports that he received his first covid vaccine on 3/9/21 and that he had a "bad reaction". Pt reports he developed severe HA, watery eyes, body aches and chills. Symptoms lasted for about 18 hours and then resolved.  Pt was reading an article today that said if you have had covid in the past that you are more likely to have potential SE when you do get your first covid vaccine.  Pt would like provider to report this to the Vaccine reporting system, since he did have covid in December.  Pt did not do any reporting through V-Safe after getting his vaccine.
Initial and follow-up information has been received from a mother and 18 year old daughter who on 05-MAY-2007 was vaccinated with her first dose of Gardasil (Lot #, site and route not reported).  On 09-JUL-2007 the patient was vaccinated with her second dose of Gardasil (Lot #, site and route not reported).  "Sometime in August 2007", the patient missed her period and conducted a home urine pregnancy test which was positive.  The patient also reported that she also had a pregnancy blood test which was positive (not further specified).  In "January 2008", the patient delivered her baby.  The patient was hospitalized for delivery of the baby which she had by cesarean section.  No further information was provided.  The patient did not report any adverse reaction.  It was reported that there were "no complications for the mother or the baby".  Additional information has been requested.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 4/8/2021 and 5/6/2021. Hospitalized for COVID 1/11/2022 - 1/30/2022 tx'd w/O2, steroids, remdesivir, and antibiotics. Presented to ED 2/4/2022 w/weakness and SOB. Admitted for acute hyposic resp failure 2/2 Covid PNA c/b acute on chronic hypoxic resp failure, CKD3, T2DM. Tx'd w/O2, dexamethasone, antibiotics, pressors. Respiratory status continued to decline, intubated 2/11. On 2/17/2022 transitioned to comfort care and expired.
arm pain; fatigue; severe nausea; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. This Physician (patient) reported that the patient of unknown age and gender received bnt162b2 (BNT162B2, reported as Pfizer-BioNTech COVID vaccine), via unspecified route of administration on arm on unknown date at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were unknown. Physician reported arm pain, fatigue and severe nausea after receiving the Pfizer-BioNTech COVID vaccine. Patient is a HCP with no prior medical history. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.