chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an emergency medical technician refers to a 6-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient might have received following vaccines: diphtheria toxoid (+) pertussis acellular vaccine (reported as "DTaP"), pneumococcal vaccine, polyvalent (manufacturer unknown), poliovirus vaccine inactivated (reported as "IPV"), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "HIB"), the influenza virus vaccine inactivated (reported as flu shot) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). On 17-JAN-2017, the patient was vaccinated with his "6 month vaccines". It was unknown what the specific vaccines were but the parent's told the reporter that they thought he received diphtheria toxoid (+) pertussis acellular vaccine (DTaP) possibly his third dose, pneumococcal vaccine, polyvalent (manufacturer unknown), poliovirus vaccine inactivated (reported as IPV), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), hib conj vaccine (reported as HIB), maybe the influenza virus vaccine inactivated (reported as flu shot) and possibly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot# and expiration date were not reported) (dose regiments and route of administration were not reported for all vaccines) for prophylaxis. The reporter though that the parents must have been mistaken on the possibly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) because it was only for children 12 months old. On the same day, the child looked like he was having seizures, he was turning blue. It was reported that he might have been experiencing a vaccine reaction or a vaccine injury or he was just a normal six month old having a reaction. The patient was in need and in a crisis. While the child was on his way to hospital he might have received intravenous (IV) fluids as a treatment. When he was in emergency room (ER) the doctors told that it was not a vaccine injury, but probably like sudden infant death syndrome (SIDS) or "something like that". It was unknown if the patient was admitted to the hospital. The parents were adamant that the boy was administered the vaccines this morning. At the time of the report, he was near death, in the R. It was unknown if there was any relevant laboratory tests performed. The outcome of the events was not reported. The relatedness between suspect vaccines and the events was not reported. The reporter considered the events to be life threatening as the patient was near death at the time of the report. Upon internal review the event of probably SIDS or "something like that" was considered to be medically significant. Additional information has been requested.
i had it last year and was sick all winter; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown age and demographics who experienced i had it last year and was sick all winter after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event i had it last year and was sick all winter (illness) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (i had it last year and was sick all winter).  At time of reporting, the outcome was Unknown for the event i had it last year and was sick all winter.
Acute right central retinal artery occlusion. Total painless loss of vision right eye, subsequently about 85% loss persisted.
has history of SNHL post strep infection that had resolved with PO and IT steroids in 2016. SNHL recurred 2 days after covid booster and required PO and IT steroids again. had received prior vaccines with no similar issues.  no concurrent URIs. SNHL resolved with ENT management with steroids.
Patient was fine for 1 & 1/2 hours after receiving vaccine. Then experienced severe nausea.
Initial case was received from a non-healthcare professional on 05 February 2014. A 51-year-old female patient whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE (batch number U4698EA, dose not reported) in the right deltoid on 30 January 2014. On 30 January 2014, the patient experienced swollen, hard, red, itchy and hot to touch area of 2 inches around injection site; and lasted 3 days. On 03 February 2014, the toes of right foot started to feel numb. It was reported that numbness feeling has extended to entire right foot up to calf area and numbness has not affected the ability to walk. The patient can walk. No laboratory investigations or corrective treatment was reported.  The outcome of the event ws not recovered. The list of documents held by sender: none.
This spontaneous report has been received from a pharmacist, and refers to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date  in November 2016, reported as "one year ago" the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported). On an unspecified date, reported as recently, the patient had blood work for an unknown hospitalization (adverse event) that showed no immune response to pneumonia strains (Serology negative). There was not treatment given for the adverse event and the patient did not seek medical attention. There was not product quality complaint. At the time of reporting, the outcome of the events and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Patient reported experiencing itchiness in her throat 6 mins after receivng the vaccine. No redness or swelling at the injection site. Pt verbalized that she experienced this same reaction 4 yrs ago after recieving the Flu vaccine. Pt administered Benadryl 50mg IM to the L Deltoid area at 1710HR. Pt resting and being monitered. Pt is now reporting dizziness at 1730HR, face is flush, B/P 188/88, HR- 122. Pt reported that she has POTTS. Pt consumed sips of water and is continuing to rest. Pt moved to the sitting position @ 1755HR and HR is 98. At 1600HR pt is able to get up and walk without difficulty and reported feeling better. Pt encouraged to report to the hospital if symptoms worsen and to report incident to her PCP. Pt assisted out by her husband.
4/13/21- Uncontrolled runny nose, headache, left arm swelling,severe reaction ie. redness, left shoulder to forearm including pain. 4/14/21 - Headache ongoing,  fatigue,  nose dripping, began coughing with productive sputum which continues to date.  Developed chest pain, left arm pain and back pain. Shortness of breath. July 2021, diag: Nodules in left lung and possible cardiac problems. No significient problems prior to 4/13/21.  Pending lung surgery to remove nodules.
"She is reporting reaction following 45 minutes after receiving the vaccine, nausea lasted several hours, right arm soreness and entire biceps muscle with swelling and firmness at injection site, tender to touch, lightly touching even causes pain.  Pain from elbow to fingertips and radiates into shoulder and into neck. The pain moves around right shoulder blade and chest/ribcage. Turning head to right painful and stiffness. She describes as burning and paralyzing pain. Difficult picking her up off of the pillow in the left arm last. "
arm hurt for a week and a half; throbbing; broke out like a rash a couple of days later; pain, same as when I had my first dose; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm), PAIN (throbbing), RASH (broke out like a rash a couple of days later), LIMB DISCOMFORT (arm hurt for a week and a half) and PAIN (pain, same as when I had my first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (pain in arm). On 07-Apr-2021, the patient experienced PAIN (pain, same as when I had my first dose). On 09-Apr-2021, the patient experienced RASH (broke out like a rash a couple of days later). On 12-Apr-2021, the patient experienced PAIN (throbbing). On an unknown date, the patient experienced LIMB DISCOMFORT (arm hurt for a week and a half). At the time of the report, VACCINATION SITE PAIN (pain in arm), PAIN (throbbing), RASH (broke out like a rash a couple of days later), LIMB DISCOMFORT (arm hurt for a week and a half) and PAIN (pain, same as when I had my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient takes medication for Blood pressure (unspecified) No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075005 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075005:
After the first vaccine the patient went to the hospital on Jan 25th bc she had pain her abdomen. She was given a CT scan that showed kidneys and stomach. Some of the blood clots was removed and patient was placed on blood thinners. In April patient started having problems with her kidneys. She was having a lot of protein in her Urine. Her antibodies are attacking her kidneys.
Myalgia, Arthralgia, Fever, Arm pain and swelling Narrative:  Missed 1 day work
redness & swelling to rt arm w/o pain to area on 27FEB97;arm painful w/further swelling & discoloration on 1MAR97;
I started having symptoms on July 25th.  I had trouble eating and swelling.  My face started to droop.  I thought it was a stroke. I went to the ER.  They treatment me four hours.  They did a CT scan and blood test.  I had migraines.  I was diagnosed with Bell palsy.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported on behalf of physician. A 18-year-old female patient received, on an unknown date, TRUMENBA in the arm, at 0.5 ml, single dose and MENACTRA in the arm, both for immunization. The vaccines were given in a different arm. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced nausea and had a fever for a couple of days. She also reported feeling depressed and would start crying when talking to people. She was most concerned about the emotional effect she felt the vaccine had on her. The patient recovered from nausea and fever; while clinical outcome of the other events was unknown.
Vaccine was given to patient who is 16 years old.  Current EUA is for 18 years and older.
4 month old male patient received Adacel instead of indicated DAPTACEL with no reported AE; 4 month old male patient received Adacel with no reported AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819249).  This case involves a four month old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported, Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DAPTACEL) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller states that today her sister took her 4 month-old son to the doctor for his 4 month immunizations, but he was given ADACEL rather than the indicated Daptacel".  At the time of reporting, no adverse event was reported.    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.  There will be no information available on the batch number for this case.
Pfizer on 3/5 and 4/2. Positive 8/8. admitted on 8/16/21 to current. in ICU
Intermittent cramping the size of a ball; This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation .  The patient medical history and concomitant medications were not reported. The patient experienced intermittent cramping the size of a ball on an unspecified date with outcome of unknown.    The information on the lot number has been requested.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (fell of the chair) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell of the chair). At the time of the report, FALL (fell of the chair) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that, patient didn't have a reaction but fell of the chair after receiving the vaccine. No treatment information was provided by the reporter.
Timeline illness 11/5/21: 3rd Moderna shot. Fevers, headaches, lethargy  12/26/21 Covid: significant neuro s/s. HA, uncoordinated, memory loss Neuro symptoms began (unclear if post vaccine or post Covid as timeline was similar ) right foot numb. Fingers numb. Progressed to R leg below the knee. Mobility issues. Started wearing sneaking only. Difficulty suturing. Slight tremor hands with procedures 2/2022 Neuro. Neg mri. Neg vsp, ssep. 5/2022 Flu; unstable pneumonia, syncope.  High dose steroids, abx 5/23/22 hospitalized for the week. Inappropriate sinus tachycardia: 120 rest, 170 standing. Microvascular clots in hand/fingers Left>right Autonomic symptoms Rashes Dx: POTS dysautonomia, long Covid  Meds: cardizem 120 ER 6/3/22: neuro Dr. Started on midodrine 2.5mg am/lunch 6/2022 heme. Labs, abdominal Sono. No monoclonal gammopathy. No thrombotic risk noted. Testing: Emg arms, Autonomic testing (abnl) Confirmed dystautonomia Emg neg for large fiber neuropathy 6/2022 difficulty walking. Profound muscle weakness. No stairs. Exhaustion. Autonomic s/s. Difficulty using hands. Lost fine motor skills. R leg worse. 7/2022 started driving again. PT bid x 3 mos. R leg weaker. 1/2022-9/2022Progression of neuropathy in glove/sock fashion. Right leg more significant. Loss of temperature sensation hands. Up to thighs. Arms to shoulder, left armpit, chest wall 8/2022 anti mag  antibody+. HCF (a cidp-like disorder)  Early sjogrens positive Gait analysis abnl  Increasing weakness R leg since PT d/c'd Variable mobility issues. Tremors worse when fatigue Autonomic symptoms Fatigue variable
Rectal bleeding; Extreme tiredness; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and FATIGUE (Extreme tiredness). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) and FATIGUE (Extreme tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided by the reporter.   Treatment information was not provided.; Sender's Comments: Limited information regarding these events has been provided at this time. Further information has been requested.
She is experiencing a large area of redness under where the shot was given.  She is also complaining of swelling & experiencing pain in her arm both below & above the injection site. She states that the ice pack is what soothes it the best.
Extreme bouts of vomiting, which lasted for about 8 hours. I was unable to keep down fluids or liquids until the vomiting stopped, quite late into the night. I had a fever and alternating hot flashes/cold chills.
Left deltoid pain, swelling, redness, decreased ROM. Advised ALEVE BID, pending MRI.
No further AE information available; dose of PNEUMOVAX 23 that expired on 10/1/2023 was given to a patient on 10/10/2023. Lot: W021636 EXP: 10/1/2023; This spontaneous report was received from physician to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W021636 expiration date reported as 01-OCT-2023 (dose and route of administration were not reported) for prophylaxis (expired product administered). No further adverse event (AE) information was available (no adverse event).
Patient reported wounds to his BLE that were not healing and was found out to have DVT where he needed stenting. Patient already high risk for clotting/ blockages due to history of CABG.
Pt received vaccine about 1045 am, and complained of chest pain, throat closing and dizziness at 1055 am.  Pt taken to urgent care.  Pt d/c to home at 1113 in stable condition.
Patient received first Moderna dose on 9/19/21 from pharmacy then presented to Hospital Emergency room on 9/24-25 with several days of Chest Pain, and dx'ed with acute idiopathic pericarditis  Dr. was contacted by patient on 10/08 via telephone and discussed recent ED visit after 1st dose; seeking guidance on if she should try to obtain a 2nd dose given ED visit after 1st - advised patient to discuss with Cardiology prior to scheduling a 2nd dose
Rash; High blood pressure; Ringing in ears; Wheezing; Fever.
fever, migraine, nausea, fatigue, body aches. Major illness for 24 hours, migraine remains 3 days later (10/8/21)
h/a, severe myalgia, nausea & vomit x 24hr;also inc heart rate 88 w/skips 9 3-5 beats;
I had a mildly sore arm at the injection site for a day. I started feeling symptoms on 08/28/2022 with a terrible headache. On 08/29/2022 the headache was worse with a fever and body aches. I tested with a home test for COVID-19, and it was positive on 08/29/2022. I had a telehealth visit with my insurance company and talked with a provider. I was concerned that it would be moving into my chest. I was advised to load up on vitamin C and vitamin D and oranges. A couple of days later I was feeling better. I tested negative within six days.
left arm pain; Chills; extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 21Aug2021 13:30 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=FA7484, brand=Pfizer lot unknown=False, administration date=31Jul2021, administration time=06:45 PM, vaccine location=Left arm,, dose number=1), administration date: 31Jul2021, when the patient was 12 years old, for covid-19 immunization, reaction(s): "1st dose sore left arm and sore right arm per patient (muscle aches) only", "muscle aches"; Tdap (Other vaccine 4weeks details , Other vaccine 4weeks product=Tdap, Other vaccine 4weeks vaccine date=12Jul2021,, Other vaccine 4weeks vaccine location=Left Arm), administration date: 12Jul2021, when the patient was 12 years old. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "left arm pain"; CHILLS (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "extremely tired". Therapeutic measures were not taken as a result of pain in extremity, chills, fatigue.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No known allergies. No other vaccine in four weeks. Other medications in two weeks were reported as none. AE resulted in none of the above. 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 treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd DTP/HIB @ 130PM & @ 7PM mom reported that pt had sz & fever of 102; Seen in the office the following morning; Pt had a fever of 104, bulging fontanelle & was listless; Seen in ER & is currently receiving workup for illness;
Patient had mild reaction (itchiness) to COVID vaccine second dose on 8/25/2022.  Patient came into vaccine clinic on 1/6/23 for COVID booster.  Patient and mother were advised that same reaction may occur.  Mother aware and wanted patient to receive booster dose.  After less than 5 mins was given patient complained feeling like throat was closing.  Diphenhydramine 50mg liquid was given to patient who was observed for 40 mins without further symptoms.
c/o post nasal drip about 20min after injection. Reports history of post nasal drip, takes Zyrtec daily. States drip feels thicker than usual this time.  Denies, SOB, chest pain, headache, rash, itching, palpitation, blurred vision. No other complaints. BP: 149/79 Sp02: 98% Room air HR: 80  Seen and cleared by EMS