chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Glaucoma; Uveitis; Difficulty in walking; Tissue adhesion; Pain localised; Ill feeling; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388643-00 (AbbVie).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 04Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years and on 28Sep2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 08Jan2018 (Lot number: 1155913) and second regimen since 02Mar2018 (ongoing) (Lot number: 1155993), all subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history included: "Covid-19", start date: 20Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GLAUCOMA (medically significant), outcome "not recovered"; UVEITIS (medically significant), outcome "not recovered"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "Difficulty in walking"; ADHESION (non-serious), outcome "not recovered", described as "Tissue adhesion"; PAIN (non-serious), outcome "not recovered", described as "Pain localised"; MALAISE (non-serious), outcome "recovered", described as "Ill feeling". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of glaucoma, illness with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of difficulty walking, uveitis was a reasonable possibility. The reporter's causality for the event(s) of covid-19 was not provided. Causality: Glaucoma (glaucoma), Ill feeling (malaise), Tissue adhesion (adhesion), Pain localised (pain): Causality as per reporter (drug/vaccine): not related, Difficulty in walking (gait disturbance), Uveitis (uveitis) Causality as per reporter (drug/vaccine): probable, Covid-19 (covid-19) Causality as per reporter (drug/vaccine): not reported.  The reporter's assessment of the causal relationship of "glaucoma", "uveitis", "difficulty in walking", "tissue adhesion", "pain localised" and "ill feeling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever, swelling at injection site of left arm. Throw up later of same day of vaccination. Fever is down from 104 to 100. Patient took TYLENOL for fever.
Patients reported on 4/07/21 she experienced a case hives at 3pm on 4/6/21 after receiving 2nd shot of Moderna covid vaccine  at 7am on 4/6/21.  Patient had taken Benadryl to get relief from hives.  The benadryl helped relieve and suppress the hives along with any itching caused by hives.  Patient didnt not require any medical attention as OTC benadryl is treating the case of hives.  Patient also stated she had hives a week after the(3/9/21) 1st dose of MOderna COvid vaccine but was not sure at first that it was covid vaccine that was the root cause for the first case of hives.
Patient stated she was extremely fatigued, light-headed. Her left arm was very red, swollen and warm to the touch. When she presented to our pharmacy she stated her arm looked much better than the day prior. She stated also that she contacted her doctor the day prior and the doctor told her to use cold compresses.
Pt immediately fainted after receiving IM H1N1 vaccine. Did not hit head. Spit up small amount of mucous (clear and scant).
PATIENT HAD AN EMESIS SHORTLY AFTER RECEIVING THE COVID AND FLU VACCINES ON OPPOSITE ARMS. HE SAID HE FELT TIRED AND COLD
losing her hair; 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 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included COVID-19 (unspecified if ongoing), she and her son had Covid-19 and were hospitalized. She was hospitalized for 11 days. The patient's concomitant medications were not reported. The following information was reported ALOPECIA (non-serious), outcome recovered. Therapeutic measures were taken as a result of alopecia.  Consumer said her 53-year-old son has a genetic urea cycle enzyme defect wherein he gets seizures if his proteins get too high. He is epileptic and is only allowed to have 21 ounces of protein a day. She mentioned that her son did not know he had a protein problem until he was 32 years old. He was hospitalized because of a drug-induced coma. She said the seizure was so bad. They had his hair tested and found out that he was loaded with protein. With that, consumer wants to know how much protein is in the Pfizer-BioNTech Covid-19 Vaccine. She said her son has not yet received any of the doses, and that only she and her husband received the vaccine. She also mentioned that before she received the vaccine, she had Covid-19 and were hospitalized. She took a lot of vitamins, and it took 05 months before her hair grew back. She said this also happened to other people. NDC number of COVID-19 Vaccine was not provided. Expiry Date of COVID-19 Vaccine was not provided. Other Products was not provided. Investigation Assessment was not provided. Consumer states his conditions are from birth, but they never found out until he was 32 years old because they didn't have DNA testing when he was born. He was in a medically induced coma because he had 100 seizures. Stated they tested his hair and it showed her son was loaded with protein. Caller really wants to get her son the shots because of the virus that's going around. State every one of the shots has protein in it. Even the Johnson and Johnson.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.  Follow up (13Dec2021) included this is a follow-up spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself that, other information was added in Narrative.
Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.). On 27-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their 2nd dose of the Moderna covid-19 vaccine 20 days after his first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.  This patient received 2 doses of the Moderna covid-19 vaccine by intramuscular injection to the deltoid. They have not reported any symptoms.
patient was sick; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 02Jun2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. Patient got the first dose of the Pfizer vaccine 02Jun2021. However, the patient was sick on unspecified date in Jun2021 and was not able to get the second dose. Reporter's daughter (patient) missed the second dose. Second dose was scheduled 23Jun2021. 21 days after the 1st dose. Caller wanted to know when patient can get the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Transverse myelitis.  Pt with sensory deficits including her perineum, left upper hand, and bilateral lower extremities.
On 12/20/2021 at about 9:12PM, patient had her first-ever seizure. It lasted about 4 minutes. She had follow-up care at the ER at Health Hospital, where she had a clean MRI and no indicators of infection or fever were found in her bloodwork. Patient then had her second seizure at about 5:00AM on 12/26/2021. She was unable to communicate or move her arms. We went to the ER at The Hospital. They did an EKG, and the results were normal. They recommended that she stay in the hospital overnight to undergo an EEG, but we had to decline, as our health insurance would not cover it. We had to arrange to take an emergency flight back home so she can receive follow-up care through the specialty system ER.
Received meningitis shot on 11/11, started having reaction overnight but was small, then yesterday midday started getting bigger, called mom abut 4:30.
Blurry vision, passed out, right leg jumping, tightness in chest, rapid heart rate, difficulty breathing, nausea all within minutes of receiving vaccine.  Nausea and delayed motor function for the duration of 5 days after receiving vaccine.
The site of injection is red and itchy. The injection site is still red on 02/21/2018.
Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very itchy and a little swollen, no redness. I felt achy and tired for rest of day.  On 3/21/21 I awoke and felt very, very tired and unwell. Became incredibly nauseous, dizzy at times and had a very strong headache which lasted all day, chills, face was slightly swollen, muscle and joint aches. Injection site still hurt.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 28th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage, accidental underdose and wrong injection technique. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose and wrong injection technique were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The HCP (healthcare professional) who was also the patient received a dose of SHINGRIX and during administration the patient hit a blood vessel. There was a lot of blood that came out. The patient felt as though he might not have received the full dose, which led to wrong injection technique and accidental underdose. The HCP would like to know if GlaxoSmithKline had data on whether or not he should be revaccinated.
A 55 year old woman was bitten by a stray dog. She was vaccinated with three doses of Rabipur IM, but rabies immune globulin was not administered. On 4/13/03 (11th day) the pt experienced a loss of consciousness and died due to cardio-respiratory arrest on 4/16/03. An autopsy was not performed.
24 hours after 2nd vaccine, I had one day oh fever to 104; headache; myalgia; chills; This is a spontaneous report from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:00 at a SINGLE DOSE  and second dose via an unspecified route of administration on the left arm on 07Jan2021 04:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none.  There were no concomitant medications. 24 hours after 2nd vaccine, the patient had one day of fever to 104, headache, myalgia and chills on 08Jan2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Hot arm; 2 inches size redness at the arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), INJECTION SITE ERYTHEMA (2 inches size redness at the arm) and VACCINATION SITE SWELLING (Swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), INJECTION SITE ERYTHEMA (2 inches size redness at the arm) and VACCINATION SITE SWELLING (Swollen arm).   At the time of the report, VACCINATION SITE WARMTH (Hot arm), INJECTION SITE ERYTHEMA (2 inches size redness at the arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
The vaccinating nurse did not administer IM in the deltoid, it was injected at an angle (that was not 90 degrees) into the acromion/bursa space. There were no immediate reactions to report at the time of vaccination other than shoulder pain/tenderness near the vaccination site.
Tinnitus.  Constant ringing in the ears and is intensifying.  Does not stop and is affecting sleep.  Have reached out for medical care.
COVID vaccine breakthrough case. Pfizer 3/5/21 EN6202, 3/26/2021 EN6207 and 11/15/21 FH8030
Brain fog; Memory problems; Concentration; Hard to speak; Severe headaches; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak) and HEADACHE (Severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (in left eye). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), GABAPENTIN, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and PREDNISOLONE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she seen a doctor and did some exercising for brain. The patient stated that she had surgery in left eye and believed that the medicine does not work well with the vaccine.
Just recently I had been in a full day physical class, I started getting muscle tenderness and I thought I pinched a nerve. Then it continued down the left side of my torso and leg, so I decided to call the doctor and i had notice what looked like flea bites. I started having the chills and the sensitivity , the bites started looking like blisters. My doctor diagnosed me with shingles. I'm on treatment now to help clear it up.
Developed malaise and palpitations, and a feeling of "irregular heart beat". Experienced these same sxs after receiving 2014's influenza vaccination. She was given only 1/2 dose this year and still had the same sxs. Underwent a cardiac workup in early 2015 which showed atrial and ventricular ectopy (PVCs and PAcs) for which cause is unknown and usually harmless. When she received the influenza vaccine, however, the sxs greatly increased. Possible myocarditis? According to myocarditis definition one may not have chest pain but have palpitations only.
The patient may have been administrated PROQUAD, who was over the age of 12 years old; This spontaneous report has been received from an office manager via a company representative, concerning a patient over the age of 12-year-old, of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, previously drug reactions and or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, as prophylaxis (concentration, formulation, dose, dose number, frequency, anatomical location were not reported; route of administration, lot number, and expiration date unknown by the reporter, however it was reporter that the patient was over the age of 12-year-old (product administered to patient of inappropriate age). A sterile diluent was used.
Increased blood pressure by at least 10 points (top and bottom numbers); extreme ringing in the ears that lasts for several hours, ringing goes away and returns --- a cycle.
After waiting 15 minutes after vaccine administration, pt states she felt very warm and stopped by the bathroom that is when she noticed her face was very red. Patient was examined and had a red rash on her cheeks, nose, and chest. Patients vitals were obtained BP 110/70, HR 66 and O2 sat 98. Emergency anaphylaxis kit was obtained and pt was given 50mg IM Benadryl per protocol. Patient was observed for an additional 30 minutes. Rash had lightened in color. Patient left facility and drove herself home.
Red eyes, swollen eyelids, and swollen face. My son stated his head felt weird like he was almost floating. The next day the arm that received the injection was swollen under the right axilla, and my son complained it was hurting.
Inadvertently gave Fluvirin 0.5ml. Contacted CDC (#1-45356717), CDC states expects possible minimal side effects, which should resolve, such as those stated on the V IS for influenza.
The patient received his first dose of the COVID vaccine.  The father states as they were walking out, the pt complained or "not feeling well".  He describes this as feeling of dizziness and nauseaous.  The father asked is he could come back to an urgent care room to lay down which is where he had a n episode of emesis.
This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 07-NOV-2015, the patient was vaccinated with a dose of GARDASIL, intramuscular (lot # and expiry date were not reported) for prophylaxis. Other co-suspect or concomitant medications were not reported. On 07-NOV-2015, the patient felt faint (dizziness). The patient did not seek medical attention and did not receive any treatment. The outcome of dizziness was reported as recovered/resolved on 07-NOV-2015. The physician did not rate causal relationship. Additional information has been requested.
Itching in the rest of the body; thinks she had an allergic reaction; stuffy nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching in the rest of the body), HYPERSENSITIVITY (thinks she had an allergic reaction) and NASAL CONGESTION (stuffy nose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (Itching in the rest of the body), HYPERSENSITIVITY (thinks she had an allergic reaction) and NASAL CONGESTION (stuffy nose). At the time of the report, PRURITUS (Itching in the rest of the body), HYPERSENSITIVITY (thinks she had an allergic reaction) and NASAL CONGESTION (stuffy nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment information includes Benadryl was provided.
pt recv vax & pt devel erythema multiforme;It was noted that pt had no serious consequences;MD had no further information because event occurred 1yr prior to the pt visiting office
After receiving flu vaccine returned back to office training room. States not feeling well returned to room where injections given, sat at table and has a possible vaso vagal response fell from chair to floor. Hit chin on table causing laceration. EMS activated and sent to ER for evaluation.
Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia episode; body pains; headache; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunisation. Medical history included fibromyalgia and asthma. On 19Jan2021 16:00, the patient experienced triggered mild asthma attack, wheezing, continued pain at injection site, triggered a fibromyalgia episode, body pains, headache, fatigue, and dizziness. No therapeutic measure was taken as a result of the events. Clinical outcome of injection site pain was not recovered while for the other events was recovered on Jan2021.
Dehydration; Nausea; Throws up everything he eats even water; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), NAUSEA (Nausea) and VOMITING (Throws up everything he eats even water) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced DEHYDRATION (Dehydration), NAUSEA (Nausea) and VOMITING (Throws up everything he eats even water). At the time of the report, DEHYDRATION (Dehydration), NAUSEA (Nausea) and VOMITING (Throws up everything he eats even water) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On 12 Jun 2021, the patient went to the ER (Emergency Room) and received an unknown IV (intravenous) fluid.