chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cardiomyopathy; COPD; I had half my lung removed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONECTOMY (medically significant) with onset 2021, outcome "unknown", described as "I had half my lung removed"; CARDIOMYOPATHY (medically significant), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Therapeutic measures were taken as a result of cardiomyopathy and included Defibrulator (CRT-D) implantation; pneumonectomy was a therapeutic measure taken as a result of its cause (pending clarification). Clinical course: Patient stated, "I had half my lung removed last year and also have COPD well as Cardiomyopathy and a Defibrulator (CRT-D) implanted. I am age 61 and retired." Patient received 1st dose in mid February in 2021, 2nd dose in late March in 2021, Booster 1 in late August in 2021, Booster 2 in early February in 2022. Patient also stated, "It has been 5 months since my 2nd booster. Are 3rd BOOSTERS (5th shot) in the works for APPROVAL of the Pfizer vaccine for those who are immunocompromised like myself?" "Serious: No" was also reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Huge itchy rash at the injection sight; Huge itchy rash at the injection sight; Extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site itching, injection site rash and pain. On an unknown date, the outcome of the injection site itching, injection site rash and pain were unknown.   It was unknown if the reporter considered the injection site itching, injection site rash and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 6-Aug-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient was due for his/her second shingles shot next month. The first one was extremely painful and developed a huge itchy rash at the injection sight. He/she hope this was worth it. Follow-up could not be possible as no contact details were available.
Pfizer vaccination administered to a 15 year old patient. They indicated 16 years old on the consent form, but DOB indicated the child was 15.
Injection pain :sharp stabbing pain , throbbing in arm, Headache ,, increased in weird heart flutter
Pharmacist administered 100mcg instead of 50mcg as his booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 039K20-2A, 040A21A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist administered 100mcg instead of 50mcg as his booster dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Patient returned to pharmacy 72 hours post-vaccination with redness, slight swelling, redness and warmth on injection site.  Patient's provider who issued prescription for injection was consulted and requested patient to visit office for evaluation.
Shortly after my last vaccine I began experiencing muscle weakness in my face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). Also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy has recently been found to be an autoimmune disease sometimes caused by a virus or vaccine.
Tingling sensation in lips and tongue; Burning sensation in tongue; Could not sleep that night; She felt sick; Did not go for second dose; Headache; Fatigue; Low grade fever; Diarrhea; Elevated heart rate; Metallic taste; Burning sensation on lips; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Elevated heart rate), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling sensation in lips and tongue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ORAL DISCOMFORT (Burning sensation on lips), HEART RATE INCREASED (Elevated heart rate) and DYSGEUSIA (Metallic taste). On 27-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick) and PRODUCT DOSE OMISSION ISSUE (Did not go for second dose). On 28-Jan-2021, HEART RATE INCREASED (Elevated heart rate) had resolved. At the time of the report, ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste), PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick), PRODUCT DOSE OMISSION ISSUE (Did not go for second dose), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Start date for mRNA-1273 was updated to 25-Jan-2021 and Anatomical Location updated to left arm. New events, tingling sensation in lips and tongue, burning sensation in tongue, could not sleep that night, felt sick and did not go for second dose were added.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, fever and fatigue are consistent with the known safety profile of the mRNA-1273 vaccine
This spontaneous report was received from a physician concerning an approximately 3 year old male patient. At the time of this report patient was 6 years old. The patient had a normal vaccination history. On an unknown date, when the patient was 12 months old (approximately on an unknown date in 2008), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The child had no adverse reactions immediately postvaccination after VARIVAX (Merck) or other childhood vaccines. On an unknown date, beginning at age 3, the patient began to experience recurrent skin infections, including herpes simplex at age 3 (unknown date in 2010), another herpes simplex infection at age 4 (unknown date in 2011), and herpes zoster at age 5 (unknown date in 2012). These were each confirmed via diagnostic testing. The child was treated each time with unspecified antiviral therapy and recovered from each episode. In addition to those 3 skin episodes, he also developed atopic dermatitis, eczema, asthma, eosinophilia, pneumonia and pneumatocele on an unknown date. The patient subsequently had an immunological workup and was found to have a rare disorder called DOCK8 immunodeficiency syndrome which was confirmed via genetic testing (date of diagnosis was unknown). It was reported that DOCKS disorder results in severe immunodeficiency. In addition to severe eczema, staphylococcal skin abscesses and pneumonia, patients with this syndrome may also develop cutaneous viral infections with human papilloma virus (HPV), molluscum contagiosum, herpes simplex virus (HSV), and varicella zoster virus (VZV). He indicated that most children with this immunodeficiency do not live past the age of 10 years old. On an unknown date, the physician consulted the patient due to his having neurologic symptoms and being hospitalized (date unspecified). The patient was subsequently diagnosed with VZV vasculopathy. His cerebrospinal fluid (CSF) contained a high level of VZV antibodies. Polymerase chain reaction (PCR) analysis of the CSF revealed it was positive for Oka vaccine strain VZV. The child did not have any skin lesion. A magnetic resonance imaging (MRI) of the brain revealed multiple cerebral infarctions and large cerebral arteries. The patient was treated with unspecified antiviral therapy, and within 1 week, he was completely better. He had no neurologic sequelae and a repeat brain MRI was significantly improved. The patient discharged from the hospital (date unspecified). At the time of reporting, he continued to be very well and fully recovered. The relatedness for the events was unknown for VARIVAX (Merck). Additional information has been requested.
Next day post vax, the pt's right arm had a raised welt approximately 30 mm at injection site. Light heat to touch. Pt states slight tenderness to touch.
Vasovagal faint and brief (< 30 secs) tonic-clonic seizure blood glucose = 94.
3 hours later developed mucus in throat, coughing, trouble breathing, red eyes. Went to urgent care and they called 911 and sent to hospital. Kept overnight and treated for reaction. Had a follow up a week later that she cancelled because she felt better.
pt recv vax 19NOV97 & pt exp immed rxn of redness & swelling;reportedly the rxn resolved in 10 to 15min;
On Sunday, December 3th, I have suffered difficulty breathing, strong weakness, fever, loss of sleep, loss of appetite. I was taking to "health" facility morning of Monday 4th. After checks and tests I was released. These signs of a sever body reaction continued. I was taking to the Emergency room (ER) on 12/06/2017 for the same symptoms stated above. At the ER, I went through all required tests and then I was released after few hours. I suffered from the difficulty breathing for weeks. I have visited my primary doctor care where I done more tests and I wear a device to monitor my heart for few days. I traveled outside of the country Jan 07/2018 and on Jan 29/2018 I suffered again most of symptoms stated above. I visited a doctor office where I done cardiac test and I was given antibiotics and vitamins and 1 weeks to rest. When I returned home on the 02/07/2018 I do feel occasionally short breathing and weakness. I have lost lot of work days due to this issue. In addition to large amount of medical bills. I have all doctors visits documented.
pt recv vax 2APR90 & 8APR93 lab eval revealed rubella antibody to be negative;
Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had been sick for like 3 days. I had a fever, I felt nauseous, and I had a headache that nothing would touch. On 07/10/2021 I passed out. I had to be taken to the emergency room by an ambulance because my blood pressure dropped so low. I wear glasses and I felt forward, and my glasses cut into my eye. I had to have my eyes stitched. They did blood work, EKG, x-rays, and CT scan. They came back normal. I went to the cardiologist, and he thinks it was just dehydration. He did a heart monitor, and everything was normal.
10am, shot was administered. 9pm pain in my arm started. 10pm pain became worse and arm began to swell. 11pm body aches began and fever of 100.6, 12am chills began, 1am, headache (mild). Throughout the night I had fevers ranging between 101 and 102.4 I sat at 101.7 for a few hours (without the use of Tylenol). Got up for work by 9am. Did not sleep at all through the night. Body hurt a lot, fever of 100.7, arm is hard, hot, and red. Spot around injection site is growing. Took too Tylenol around 10am to make it possible for me to work. Chills became mild and temp dropped to 99.6 for most of the time I was taking Tylenol. 24 hours after the symptoms started they went from severe to moderate (without the use of Tylenol). Was able to sleep last night. No chills but still had a low fever 100.6 woke up today and my body hurts. Temp was 99.3 at 10am. By 4pm 2 days after getting the vaccine my are is still very hot to the touch, red, and hard. It does not look better. Back to normal temp 96.6 and body hurts in the mild range.
I had a little reaction to the second Shingrix shot. Injection site was sore soon after receiving it; about 6 hours after injection I noticed stiffness in hips and ribs. During the night I awoke to flu-like symptoms including overall muscle soreness and joint stiffness/pain. I stayed in bed for next 10 hours. In the late morning, checked my temperature = 99.2F. Took 2 tylenol which reduced discomfort and continued with that.  Better the next day but still somewhat sore and tired. Back to normal the day after that.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 23-OCT-2015, the patent was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Itching Whelps (various sizes), primarily on head and upper back,  spotty tingling entire body.  Taking antihistimine which is helping.
Burping; Intestinal gas; Ongoing burping and intestinal gas -since first dose but worse after 2nd; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included ongoing sinus disorder for decades. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of COVID- 19 vaccine, names were unspecified. On 20Mar2021, the patient experienced ongoing burping and intestinal gas - since first dose but worse after second. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02Jul2021, the patient underwent NACR (SARS COV-2 test; Nasal swab), and the result was Negative. The clinical outcome of the events ongoing burping and intestinal gas was unknown at the time of this report.
This spontaneous report as received from a pharmacist refers to the mother. On 27-JAN-2013 the patient was vaccinated with live (Merck) VARIVAX (lot number, dose, route and site not reported) in error. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Additional Details: while patient was waiting out in the waiting area for their 15 minute monitoring session the patient passed out and fell to the floor. The patient did not injure himself with falling to the floor and woke up immediately after he passed out. We immediately put ice packs on him and had him drink a bottle of water while sitting on the floor and made him stay in the waiting area until his color came back in his face and felt fine to go home. He was extremely nervous about getting the vaccine.
Felt like throat closing, lip & facial swelling. Tx: BENADRYL 25 mg IM ZANTAC 150 mg PO DECADRON 10 IM.
Initial arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication reported  No treatment medication reported   This case was linked to US-MODERNATX, INC.-MOD-2021-083307 (E2B Linked Report). This case was linked to MOD-2021-083307 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083307:Case for dose 1
a one year old received both the PROQUAD and VARIVAX injection; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 09-SEP-2020, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (lot # T009930, expiration date 16-SEP-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T010311, expiration date 24-MAR-2022) (both strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (inappropriate schedule of product administration).
No additional AE reported; administered following temperature excursion; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 23-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA, lot # U009260 (lot # was determined as valid), expiration date was provided and also validated as 19-SEP-2022 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (improper storage of product in use). It was stated, that the vaccine before administration was stored at the temperature of -10.7 Celsius degree (C) for 192 hours. It was not provided, if data logger was involved. No additional adverse event (AE) reported (no adverse event). The reporter provided permission to follow-up regarding the report.  This is one of the two linked reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA007542:
10/29/2021 Patient was given Moderna booster dose of 0.25ml instead of Janssen 0.5ml primary dose.  Patient requested Janssen vaccine only. IMM66 reviewed by volunteer nurse. Janssen vaccine removed from cooler by IPC Nurse. J&J vaccine verified by volunteer nurse and patient. Volunteer nurse administered a pre-drawn dose of Moderna 0.25ml booster vaccine instead of first dose of J&J. Error noticed when Janssen vaccine was given to IPC nurse to place back in cooler; vaccine had not been opened. Volunteer nurse and clinic charge nurse notified of error 10/29/2021.  Reported to IPC Nurse / Supervisor on 11/01/2021
had side effects - started Friday with achyness and then onset of fever. Then onset of shoulder pain with Pain and swelling above clavicle and in axilla without redness. Has difficulty moving arm and unable to lift arm. Significantly impacting getting dressed and other ADLs. Took tylenol on Friday for fever, but has not used medication since that time.  Recommend conservative treatment with NSAID (discussed dosage and recommendations in detail), passive range of motion exercises of shoulder, warm and/or cool compresses. Letter provided for work, she may return when discomfort is abating and improved functionality of upper extremity.