chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable consumer. A 15-month-old female patient of unspecified ethnicity received single doses of PREVNAR, diphtheria, tetanus and acellular pertussis, haemophilus influenzae b and measles, mumps and rubella, all administered via unspecified routes of administration, on unspecified dates. The patient's medical history and concomitant medications were not reported. On an unspecified date, the mother of the patient reported that her daughter was severely injured by a reaction to the diphtheria, tetanus and acellular pertussis at 15 months of age (when measles, mumps and rubella, haemophilus influenza b and pneumococcal 7-valent conjugate were also given). The mother reported that the patient had a vaccine reaction and just spiraled out of control; onset dates unspecified. On unspecified dates, the patient's fever spiked to 105.7 and she began screaming. The patient also experienced seizure disorder; she stared blankly and developed seizures on an unspecified date. Then she experienced shaking episodes at night and repetitive behaviors, including arm flapping and spinning; onset dates unspecified. She developed a measles-type rash on an unspecified date. Things went from bad to worse; the patient experienced damage and suffering. A neurologist noted on unspecified dates, that the patient had staring spells and an abnormal EEG. Another diagnosed the patient with encephalopathy characterized by speech delay and probable global developmental delay that occurred in the setting of temporal association with immunization as an acute encephalopathy. The patient's mother filed for an encephalopathy table injury in 2003 unaware that the patient would be diagnosed with PDD-NOS, a form of autism spectrum disorder (ASD) on an unspecified date. Relevant lab data on an unspecified date included an EEG and an MRI, which indicated that everything was consistent with encephalopathy, post-vaccination. The clinical outcomes of fever spiked to 105.7, screaming, seizure disorder, staring spells/stared blankly, shaking episodes at night, repetitive behaviors, including arm flapping and spinning, measles-type rash, abnormal EEG, encephalopathy, speech delay, probable global developmental delay and PDD-NOS, a form of autism spectrum disorder (ASD) were unknown. No follow up attempts possible. No further information expected.
This infant had left leg erythema 3 cm, 2 cm induration. No treatment.
High grade Fever, headache, chills, body aches, sore throat, foggy and dizzy feeling
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number-L018001, expiry date- 19-MAY-2017, lot number-L026408, expiry date- 15-JUL-2017 and batch number-L026407, expiry date- 15-JUL-2017, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaints (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
Confirmed breakthrough case  COVID-19 (Moderna) 1 03/09/2021 Health Center - Moderna 036A21A   COVID-19 (Moderna) 2 05/20/2021 Health Center - Moderna 047C21A   COVID-19 (Moderna) 3 01/13/2022 Health Center - Moderna 084J21A
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later   Headache waxes and wanes - at times feels like vice squeezing my head  11:50 heartburn sensation  12:00 localized swelling/ knot at injection site   12:04 wave of nausea/ mild heartburn  Headache continues off and on  3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest   16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78   Hives for several hours.  Hives gone by morning but still intermittently itchy.  Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years)  Very mild cough started in evening  12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache  22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists  12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on  9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing  Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97  12/21 Itchy/ hives on face, neck, upper chest  By 12/21 afternoon, itchiness and hives abated. No further symptoms
2:05 started complaining of abdominal pain. 3:00 started wheeze and subcostal retractions. Pulse Ox 88% -> Albuterol ATROVENT neb and O2. Started EPI PEN Jr given at 3:05 3:10 facial swelling started 3:15 EMT arrived to hospital.   11/24/09:  Primary Care records received for dates of service 11/17/05 to 11/2/09  Assessment:  Developed wheezing, abdominal pain, subcostal retractions, inspiratory and expiratory wheezing, SaO2 88-89% with HR 171.  Epi pen administered and supplem ental oxygen given.  Transferred by ambulance to ER.  12/22/09 MR received for DOS 11/02/09. DX: Allergic reaction. Pt developed fever, difficulty breathing, rash to back and wheezing after vaccination. Tx: Epi, O2, Benadryl. Pt discharged home in good condition.
Patient felt dizzy, ringing in ear, headache within receiving COVID-19 Pfizer vaccine (first dose) within 5 minutes. Ambulance arrived to take patient to hospital.
Possible administration of the Shingrix vaccine reconstituted with sterile water; Possible administration of the Shingrix vaccine reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the possible administration of the lyophilized portion of the Shingrix vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was not sure if the vaccine was administrated or not because they were only missing the powder portion of the vaccine. No further information reported. The reporter consent to follow up.
She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster; She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster; received the Pfizer covid vaccine booster 05Nov2021; Weakness; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation; cortisone (CORTISONE), since 15Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j covid-19 vaccine (Dose 2), for COVID-19 immunization; J&j covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster"; IMMUNISATION (non-serious) with onset 05Nov2021, outcome "unknown", described as "received the Pfizer covid vaccine booster 05Nov2021"; ASTHENIA (non-serious) with onset Nov2021, outcome "unknown", described as "Weakness"; DIZZINESS (non-serious) with onset Nov2021, outcome "unknown", described as "Dizziness". The action taken for cortisone was unknown. Additional Information: The caller received her booster shot 5Nov2021 and had a few side effects from the shot, including dizziness and weakness. 10 days after she had the booster shot, she went to her knee doctor, because she has knee problems, and he gave her a cortisone shot. She had the same type of symptoms. She was wondering if the Cortisone and the booster shot were similar. The caller has been referring to the Pfizer booster shot. She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster. Clarified that she was referring to the Pfizer Covid booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up. .
Type 1 Diabetes, Diabetic Ketoacidosis.  I was not a diabetic prior to this. After receiving these vaccines I almost lost my life in November 2021. Diagnosed Type 1.
he patient presents with difficulty breathing.  The course/duration of symptoms is 61-year-old female asthmatic presents with increasing shortness of breath.  Patient diagnosed at home 1 week ago with coronavirus.  Patient states she did get the Johnson & Johnson vaccination back in March or April.  Patient states that she went to have the outpatient autoimmune immunoglobulins given however her O2 sats were below 90 and she was instructed to go to the hospital.  In triage on room air her O2 sat was 86%.  She denies coughing up any sputum she does complain of shortness of breath with any exertion.  She has had some body aches.  She has had no fever.  She has had some nausea but no vomiting.  She states her whole family at home has coronavirus.  She does work in daycare..  Degree at onset mild.  Degree at present severe.  The Exacerbating factors is exertion.  The Relieving factors is oxygen.  Risk factors consist of asthma.  Prior episodes: none.  Therapy today: none.  Associated symptoms: cough and nausea.
felt extremely hungry; severely fatigued/felt extremely fatigued; dizzy; needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours), HUNGER (felt extremely hungry) and FATIGUE (severely fatigued/felt extremely fatigued) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Congestive heart failure, Heart attack and Surgery. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Sep-2022, the patient experienced DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours) and FATIGUE (severely fatigued/felt extremely fatigued). On 12-Sep-2022, the patient experienced HUNGER (felt extremely hungry). At the time of the report, DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours), HUNGER (felt extremely hungry) and FATIGUE (severely fatigued/felt extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Blood pressure measurement: Normal.   They went to an urgent care where he had his vitals checked, which were very normal. No fever, his O2 levels were normal, and his blood pressures were normal..  He currently takes Eliquis and other medications  No treatment information was provided.
Symptoms include rash/swelling. It is of severe intensity.  This is the first episode.  The typical duration of an episode is the majority of the day.  There are no obvious aggravating factors.  Symptoms are relieved with steroids and antihistamines.
pt was brought to ER dead on arrival; initial cause of death was attributed to sudden infant death synd;
The patient had a seizure in the pharmacy waiting room while waiting her 15 minutes.  EMS was called and the patient was taken to the hospital.
Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
I had gotten my vaccination at around 6pm on 10/5 and the following morning, I had taking my medication 100mg Spironolactone in the morning. Around 10am that morning I passed out after feeling faint and lightheaded and then I went to the doctor that day. The doctor did labs and said it was likely due to my blood pressure dropping due to my medication. There was also fatigue (body soreness) that day after my vaccination (like the previous doses) and I don't know if the fatigue had anything to do with my blood pressure dropping.
Information has been received from a consumer referring to her husband of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, lot number, expiry date, route, dosage were not reported). On an unknown date, the patient was vaccinated with the second dose of ZOSTAVAX (strength, lot number, expiry date, route, dosage were not reported). Additional information is not expected as there was no correspondence information available.
Very strong rash on the whole body.  Muscular involuntary movements that still going on today, more than 3 weeks after the shot.
Received vaccination early morning (around 7 am). Headache started approximately 5-6 hours post vaccination and continued off and on for 72 hours. Explosive diarrhea approximately 18 hours post vaccination.
I received the 1st dose of the Moderna COVID-19 vaccine on January 29, 2021.  On Sunday, January 31, 2021, I began having really bad headaches.  I took Tylenol and Ibuprofen and benedryl to try and get my headache to go away.  I initially thought maybe it was a sinus headache.  The headache never went away.  It would ease up some and then it would get really bad to the point I was sick to my stomach and was crying in pain.  On Saturday, February 5, 2021, I had a family member take me to the emergency room.  I was seen by the emergency room doctor for the headache.  The doctor indicated that this could be a side effect from my vaccine.  She mentioned that she knew of others who had suffered with headaches.  She treated me with multiple medications in the emergency room and said that I should report this to my work.  I did report it to my contact person at work and they in turn said that I needed to fill this form out.  I had a headache for 8 straight days after having my first vaccine shot.
Initial report received from a healthcare professional on 06 February 2014. A 69-years-old female patient, whose medical history and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number: UH674AA) in the right deltoid and received intramuscular dose of TYPHIM Vi (batch number: J0520-1) in left deltoid and received intramuscular dose of Hepatitis B (manufacturer: unknown, batch number: AHBUC104AA) in right deltoid, all on 23 January 2014. On 23 January 2014, the patient presented red area at injection site approximately 3 cm, tender at site. Corrective treatment and laboratory data were not reported. As of 06 February 2014, the patient had not recovered from the event. Documents held by sender: None. Follow-up information received from healthcare professional on 03 April 2014. It was reported that, the patient received YF-VAX in right upper arm. On 23 January 2014, the patient also received TDAP, batch number: C4347AA (route and anatomical site of administration were not reported) in right deltoid. The patient did not receive any other vaccination within 4weeks prior to vaccination. It was reported that, the arm was recovered within 2 weeks to normal appearance.
Generalized blisters with erythematous base, malaise, nausea/vomiting, diarrhea for 3 wks duration. Resolved with rash. Slight fever.
Reports tinnitus described as high pitched constant squeal that lasts about one hour about 2 times a day, usually occurring upon waking then again in the afternoon. This occurs on most days.
Patient reported feeling shaky and hot. Patient was assessed and her BP was elevated (172/90, 182/94, 188/94)
Hot, sweating. Ice cold freezing, body aches, slight headache. For about 12 hours
I was fine for the first couple of days, then I developed  hives, headache, fever, nausea, sore throat, fatigue, coughing and nasal drainage.  My PCP put me on Prednisone and Augmentin.
This literature report (initial receipt 10-Apr-2012) concerns a 71 year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 1 week after receiving H1N1 the patient developed his first symptom of Guillain-Barre syndrome (GBS). The patient reached nadir within 1 week. Sensory symptoms included perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx and ataxia. Motor symptoms included the rapid progression of ascending quadriparesis after admission. A neurological examination revealed reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally). Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours after admission. Deep tendon reflexes (DTRs) diminished to 1+ throughout and worsened to areflexia. Bladder and bowel control were normal at admission but progressed to complete bowel incontinence & urinary retention. The patient's cerebrospinal fluid (CSF) protein was 82mg/dl which was considered elevated. 12 days after receiving H1N1 electrodiagnostic findings were normal, however at 17 days electrodiagnostic findings were absent of F responses, A waves in all four limbs, sural and peroneal responses which were suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. After the first course of IVIG there was an improvement in motor strength but unchanged sensory loss. Two weeks later the patient relapsed manifesting as right facial palsy in addition to increasing limb weakness. On day 50 during the relapse, electrodiagnostic findings revealed severe axonal sensorimotor polyneuropathy. The patient received a repeated course of IVIG 0.4kg/day for 5 days. Motor strength in arms significantly improved but sensory loss, bowel incontinence, and leg weakness improved very slowly. After 8 months the patient was non-ambulating with bowel incontinence. 1 year after the initial illness the patient remained non-ambulatory. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 4:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 4:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer, refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Syncope 30 secs after injection and vomiting about 15 min. after injection.