chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Plus dizziness days and weeks after taking the shot.; I had every side effect listed on the CDC website; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 17:15 (Lot number: ER8737) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Azithromycin, reaction(s): "Drug allergy", notes: Known allergie- Azithromycin. The following information was reported: DIZZINESS (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Plus dizziness days and weeks after taking the shot."; ADVERSE EVENT (non-serious) with onset 09Apr2021, outcome "not recovered", described as "I had every side effect listed on the CDC website". The events "plus dizziness days and weeks after taking the shot." and "i had every side effect listed on the cdc website" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dizziness, adverse event.  Additional information: Facility where the most recent COVID-19 vaccine was administered was at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Patient took second dose of BNT162B2 on 24Apr2021 at 16:15 in left arm for covid-19 immunisation. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Narrative:  A 95yo male with PMH of Chronic Bronchitis, Glaucoma, Chronic arteriosclerosis, Chronic COPD, Benign Essential HTN, HL Hearing Loss Per nurse's documentation he received Covid-19 vaccine per policy and protocol without complication, First dose on January 22, 2021 and second dose on February 12, 2021 No ADE was reported the system showed this patient passed away on 03/14/2021
fever, crying, lethargy, and drowsiness. A week later he developed eczema on his hands, the backs of his knees and elbows, and his face. He also developed an allergy to milk/ casein that wasn't an issue before.  Bouts of nonstop crying and eventually crying himself to sleep.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L028664, expiration date 27-MAY-2017 (dose number and route were not provided) for prophylaxis. There were no adverse effects reported. Additional information has been requested.
Information has been received from a pediatric office manager concerning a female pt who was vaccinated with a dose of mumps virus vaccine live (Jeryl Lynn). It was reported that one month prior the pt had been vaccinated with a dose of measles virus vaccine live (Moraten) (MSD). Subsequently, the pt developed hard lumps on her thighs. It was noted that the lumps lasted for approx one year after they developed. The outcome was recovered. Unspecified medical attention was sought. No treatment was required. There was no product quality complaint involved. Additional information has been requested.
Patient spelt their first name without the 'h' in their first name on their paperwork and was put into our pharmacy system without the 'h'. The technician who gave the vaccine noticed the name was different after seeing the patients license and changed their profile to be correct. The paperwork that was filled out was overlooked and the fact that it said they had already gotten a COVID vaccine was missed, however it did not indicate what vaccine they had received. The patient had received Johnson and Johnson on 4/8/21 then received Moderna first dose on 7/26/21. They were due for their second dose of Moderna today and we checked data base and noticed they had received Johnson and Johnson back in April. Unfortunately, checking data base was not part of our daily routine at the time of their first dose but with the spelling of their name it wouldn't have shown. They were notified and will not be receiving their second dose of Moderna.
Onset of hives to right side of face 10 minutes post vaccination. Localized with no other symptoms.
Patient has had ongoing intermittent fevers of 99.5-104 for 2 months.  He was seen in the ER on 4/12 for this with a full lab workup done (including lyme which was negative). No other sick symptoms reported other than feeling fatigued from the fevers.  Tylenol will temporarily bring the fever down.   He has been fully vaccinated from COVID with Moderna, received both doses here, and states the fevers started with the first dose and have been present intermittently since then. He has not recently been tested for COVID since his second Moderna vaccine 2 weeks ago
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
He waited more than 36 days between doses; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 047E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (Shingles). On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved.            No concomitant medication reported. Patent family doctor gave him medication for the shingles. Patient reported to the Health Department as well.
2 days p/vax pt had localized swelling (approx 4"x2" area), pain, warmth & redness of same area. swelling subsided p/2wk & then small knot formed & is still present @ 3wk point
He was diagnosed with Covid for the second time in Nov2021; He was diagnosed with Covid for the second time in Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02095270.  A male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2020 (unspecified if ongoing), notes: Verbatim: First time he got Covid was sometime in Jan2020 and this was before he received the Pfizer Covid-19 vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "He was diagnosed with Covid for the second time in Nov2021".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient stated injection site is swollen and numb and she is having issues moving her arm around and doesn't know how shes going to work
Patient reaction felt by patient on 8/13/2013. Patient is stating itching and swollen, red and hot at the site of the injection.
Patient was accidentally administered a second bivalent COVID-19 vaccine. System did not flag that the patient already had the updated booster shot in September. Patient did not report any side effects.
LOW PLATELET COUNT; FATIGUE (NOT FELT GREAT); This spontaneous report received from a consumer concerned a 48-year-old female. The patient's weight was 155 pounds and height was 170 centimeters. The patient's concurrent conditions included non-smoker and abstains from alcohol. The patient had no underlying medical condition, no known allergies and had no drug abuse or illicit drug usage. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) 1 total, dose was not reported, administered on 05-APR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After vaccination, from an unspecified date in APR-2021, the patient's platelet count dropped dramatically to almost mid-20,000 (low platelet count) and visited physician's office for the same. Patient had no previous history of this condition. Patient did not experience any side effects except that, she did not feel great (fatigue) for few days, but, felt better afterwards. On 21-JUN-2021, patient had her routine physical and blood test and the test showed low platelet count (mid 20,000). On 25-JUN-2021, patient had appointment with hematologist. At the time of reporting, the reporter (patient's husband) did not have the vaccination card with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue (not felt great) on APR-2021 and had not recovered from low platelet count. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210648114-covid-19 vaccine ad26.cov2.s -Low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
3-4 days after vaccine noticed severe hearing loss in left ear, continued unabated. Also experienced ringing in left ear.  Days later  experienced several hours of almost total loss of hearing in that same ear.  Saw primary care physician  5/10/21 and was referred to ENT. Saw ENT for hearing test on 5/17/21 and for treatment on 5/18/21.
A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 03-Oct-2014. MA reported that they had a 10 year old child who inadvertently received 2 doses of FLUMIST a month apart. Patient has not reported any adverse effects. Patient received first dose on 03-Oct-2014 and received 2nd FLUMIST dose on 05-Nov-2014 which started on 05-Nov-2014. FLUMIST quadrivalent (intranasal) was discontinued on 05-Nov-2014. The outcome of the event of 10 year old child who inadvertently received 2 doses of FLUMIST a month apart is unknown. The report was considered to be non-serious.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of hive-like rash in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX. One day after vaccination with BOOSTRIX, the subject experienced hive-like rash on her forearms, back and legs that cleared (resolved) with BENADRYL treatment. It was noted that the subject called the reporter last week and reported her legs feeling heavy, welts on her body and tingling of her hands. At the time of reporting the outcome of these events was unspecified. The nurse practitioner stated that the subject reported that she went to see her primary care physician and the physician told the subject that this was a delayed reaction to the tetanus component of the BOOSTRIX vaccine; however, the nurse practitioner stated that they were still trying to pinpoint what had caused these symptoms in the subject (possible relationship to BOOSTRIX vaccine).
IMMEDIATELY AT ADMINISTRATION PT SAID INJECTION WAS PAINFUL AND WAS QUITE UPSET. SHE IS STILL EXPERIENCING PAIN TWO WEEKS LATER AND WANTS TO HAVE AN MRI DONE IN OCTOBER TO SEE IF DAMAGE WAS DONE AT SHOT ADMINISTRATION.
Tingling in left arm and left leg. Expressed numbness in left arm and leg. EMS called, and patient taken to ER.
On the 2nd of July I had blisters; Red and itchy with clear liquid, appear on both of my forearms and right ankle. I used Clotrimazole and Betamethasone Dipropionate cream USP, 1%/0.05% mixed with triple antibiotic ointment once a day in the evenings. I would clean the areas in the morning and use a herbal clay mixture. By the 4th the blisters on my forearms and ankle were healing and becoming scabs. On the 4th of July blisters; clear, itchy with sticky clear liquid, appeared on my left pinky and middle finger plus my right ring finger. I used the same treatment for these blisters. The blisters on my fingers cleared up by Monday the 12th.  On Wednesday the 14th the same blisters reappeared on my left pinky and right ring finger. As of today the blisters on my pinky are scabs again and the right ring finger are starting to scab again.
10 year old patient came in with his mother to get a Pfizer dose. Vaccination was administered and patient and mother waited for the 15 minutes after the vaccination with no side effects during this time. As patient and mother was leaving to pay by the front registers of the store, mother stated that patient briefly fainted. The mother came back to the pharmacy to tell me. She stated that it was most likely due to anxiety, as the patient was anxious and he usually reacts from anxiety (i.e. vomit, faint). I advised the mother to sit with the patient for another 30 mins just to be safe. Patient was given water and stated that he was feeling better.  Called pt's mother in the afternoon and mother stated that the patient was doing well.
Open sores on joints (right knee, various knuckles, toes), got infected, received antibiotics twice, didn't heal them up completely.  New sores kept forming until September 2021.  No current open sores, just scar tissue now.
headache, fever, fainting. all during the night. fever and headache lasted from about 10 pm until about 8 am
This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 70-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb 2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that had the Pfizer COVID-19 Vaccine three weeks ago (in Feb 2021) and Two days ago (12Mar2021) woke up with severe vertigo and took blood pressure started out about 152 and then it went up to 205 within 3 hours, and that was systolic but the diastolic 112. It was also reported that patient do not have high blood pressure and blood pressure is usually around at most 140, generally it is 126/76 and this was very scary. Patient took Aspirin because, was worried about the stroke and questioned can that be contributed to vaccine? It was 19 days later. Outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Woke up on 11/17/21 and had terrible pain around the left side of my chest and arm pit area, entire area was swollen and dark in color, similar to a bruise. I have limited movement on that side of my body as the pain has not subsided as of this evening, 11/18/21.
pt recv vax w/sl-moderate nervousness noted;955Am slumped in seat & slid to floor- pt fainted;unresponsive to voice;eyes closed;pulse weak & rapid;diaphoretic;tonic/clonic activity;bronchitis;arched back;pale;
pt recv vax 6-8AM & on 28OCT98 pt vomited 10min later felt bad;went home & cont c/o not feeling well next day;drove husband to work & when arrived in parking lot lost consciousness & stopped breathing;
This spontaneous report as received from a physician via a company representative refers to an over 70-year old, female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown, date the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced large swelling at the injection site. The outcome of large swelling at the injection site was unknown. The relatedness between the adverse event and PNEUMOVAX23 was not reported. Additional information is not expected, as there was no consent to contact the physician.
Pt developed shingles L4 dermatome right leg, VZV PCR (+)
Myalgia, CoughWheeze, FATIGUE, RUNNY NOSE, REALLY TIRED Narrative:
Mom states: slept 6 hrs post vaccines, then started screaming much of the time for five days. No illness symptoms. Fever of 99.0 degrees, no resp. symptoms. "Inconsolable." Fed poorly for five days. Seen in ER on 12/8/02 for L eyelid puffiness which resolved without treatment. Mother didn't notify me: excessive crying until the 2/5/03 well visit.
Extremely high frequency noise in my ears. Visited my family doctor who prescribed a steroid; however, high frequency noise continued after medication. Immediately visited with an ENT who basically said that I had an adverse reaction to the vaccine known as tinnitus and their is no cure. ENT scheduled a hearing test that day to start monitoring my hearing loss from my tinnitus. On a level of 1 to 10, my condition remains anywhere from 8 to 10 with no relief. After months of suffering , I visited with an audiologists for advise on how to live with this condition, which has ruined my life. This high pitch sound is 24-7 and unbearable.
ADACEL being administered to a patient under 10 years of age with no adverse event; patient was given TDAP instead of the ordered DTAP with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid non-serious case received via health professional. Agency number: 01238843  This case involves a 15-month-old male patient who reported to have Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered to a patient under 10 years of age with no adverse event and patient was given tdap instead of the ordered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] (dtap) with no adverse event.   Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2022, the 15-month-old patient received suspect Adacel vaccine of the ordered Daptacel at dose of 0.5ml once via intramuscular route in the right thigh (lot U7528BA) Immunization (product administered to patient of inappropriate age and wrong product administered) at same day latency.  Action taken: Not applicable for both suspects.  At time of reporting, the outcome was Unknown for both 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 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.
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity.  Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
On 4/22 I experienced a heavy post-menopausal period that lasted 4 days
Patient's arm (deltoid muscle) where injection was given is very swollen, red, and tender. Swelling/redness is about the entire size of the patient's deltoid muscle. She ahs been icing the area to help with the pain and swelling so far.