chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Patient had completed primary Pfizer vaccination series) on 03-Jun-2021 and Pfizer vaccine (Patient had completed primary Pfizer vaccination series) on 20-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series). On 16-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP mentioned that a patient received Moderna Booster dose within less than 6 months after completing Pfizer primary series. No concomitant and treatment information were reported by the reporter
Primary Reporter is Pharmacy intern. Intern called regarding ZOSTAVAX and a patient that had called the pharmacy and stated that  she "had itching on her chest and back since she received the ZOSTAVAX vaccine over s month age". She reported that there was no rash or redness, just itching. Once pharmacy intern checked to verify patient information she realized the patient had never been administered the ZOSTAVAX in that pharmacy. There were not patient records for the caller and therefore Pharmacy intern could not provide any patient information beyond the information given to her from the patient about an itchy back and chest with no rash or redness. Pharmacy intern had no specific patient information and therefore many questions have NA. No further information available.
12/21-Started getting occassional stabbing pains in upper right chest and -lasted 3 + weeks (no rash). 12/24-Chest pain and itch (no rash). 12-29-Chest Pain (occasional) and itch; soreness (no rash) hospitalized. 12-30- Hospitalized for stress test and rash 2-3" (on back only) present continued through 1/16/082/4/08-records received for DOS 12/29-12/30/07-DC DX: Very typical chest pain, doubt cardiac. Back dermatomal pain. Likely shingles.
fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (in March around 6 months ago) and Surgery (two lymph nodes were removed due to the cancer.). Concurrent medical conditions included Cancer. Concomitant products included GABAPENTIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that symptoms started maybe 12 hours after first and second shots. These symptoms went away after a couple of days.  Psychologist mentioned that around the time she got the first dose, she was recovering from surgery (two lymph nodes were removed due to the cancer).   This case was linked to MOD-2021-328294, MOD-2021-328319.
Severe Nausea/ Vomiting awoke me from sleep. By 8:30 AM severe nausea persisted and had severe ache in all muscles- could not get up out of bed by myself. During day severe nausea/ vomiting with serious aches. Difficult to walk.
Fatigue, headache, slight nausea, body aches over last three days, got the shot Saturday afternoon and it?s Tuesday night and I?m just now starting to feel a tad better. Just been alternating  Advil or Tylenol to help
After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.
non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a spontaneous report from a contactable consumer (reporting for herself).  A non-pregnant 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunizatio.  The patient experienced non-stop vomiting, headache, eyes hurt, cloudy feeling in my head and done nothing but sleep on 15Jan2021 14:00.  There was no treatment received for the events.  The outcome of the events was not recovered.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Pain in arm; Mild soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness of arm) and PAIN IN EXTREMITY (Pain in arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Mild soreness of arm). On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Mild soreness of arm) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications.  Patient gave verbal consent for safety to Follow-up.
Pharmacist told me he hit my bone with needle injection and my arm would be sore longer    I have not contacted anyone  It has been a week today.   Normal vaccine pain started about 1-2 hours after injection.  Pain continued to get worse. Could not sleep that evening. . Throbbing pain In Left arm going to shoulder and neck.   My arm is still sore at injection site. Throbbing pain is on and off with pain in shoulder and neck
Headache back legs hurt fatigued  9 hrs after  2 nd day severe headache fever 103.5 3 days of fever & headache  Two weeks later ear pain both ears
cardiomyopathy, myocarditis, s.o.b, chest pains started approx 6 hours post vaccine. benedryl taken 30min prior to vaccine as a pre caution. Heart issues have culminated to supraventricular tachycardia, tachy/brady syndrome, etc..
little weak overall; generalized body aches; felt like he was freezing; sweating of chest and neck area; too immobilized; probably had slight temperature; terribly weak; general muscle and joint pain; muscles and joints from neck down; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and MOBILITY DECREASED (too immobilized) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain), MYALGIA (muscles and joints from neck down) and CHILLS (significant chills/teeth chattering). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) ongoing since an unknown date for Adverse event, at a dose of 325 mg every 4-5 hours. At the time of the report, ASTHENIA (little weak overall), PAIN (generalized body aches), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain) and MYALGIA (muscles and joints from neck down) outcome was unknown and FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and CHILLS (significant chills/teeth chattering) had resolved.            No concomitant medications information was reported.   This case was linked to MOD-2021-402912 (Patient Link).
Seriously affected my work and life; Dizziness continued until now; Started to have a headache; knee cramps and pain; knee continued to ache; 04/20 First dose and Second dose on 05/28 Covid-19 Modena vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04/20 First dose and Second dose on 05/28 Covid-19 Modena vaccine), DIZZINESS (Dizziness continued until now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Seriously affected my work and life), ARTHRALGIA (knee cramps and pain; knee continued to ache) and HEADACHE (Started to have a headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04/20 First dose and Second dose on 05/28 Covid-19 Modena vaccine). On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (knee cramps and pain; knee continued to ache). On 16-Jun-2021, the patient experienced DIZZINESS (Dizziness continued until now) and HEADACHE (Started to have a headache). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Seriously affected my work and life). The patient was treated with Manual therapy (Acupuncture) for Arthralgia. On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04/20 First dose and Second dose on 05/28 Covid-19 Modena vaccine) had resolved. On 14-Jun-2021, ARTHRALGIA (knee cramps and pain; knee continued to ache) had resolved. At the time of the report, DIZZINESS (Dizziness continued until now) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Seriously affected my work and life) and HEADACHE (Started to have a headache) outcome was unknown.            Concomitant product information was not provided. The patient received acupuncture on 08 June 2021. The pain was relieved, but two hours later the knee continued to ache.  Treatment information also included Chiropractic and massage, but nothing worked. On 12 July 2021, the patient had an appointment for an MRI.
A non-serious, spontaneous report of sore throat and fever was received from a physician, concerning an 11 year-old male subsequent to FLUMIST. The patient's past medical history includes ADHD and behavioral problems, without diagnosis of neurologic disease. The patient also has staring episodes and was worked up for seizure disorder although no diagnosis was made. No concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Oct-2008 for influenza vaccination. The patient was brought to his doctor four times in October 2008 for sore throat and fever, although no fever was documented by the physician. On 30-Oct-2008 the patient was seen for his fourth medical visit of the month for sore throat and fever. The patient recovered from the events.
Mother describes bumps on childs trunk, legs and arms as hives & welps. Temp 99.9. No swelling to injection sites noted by parent. PCP confers reaction to immunizations. Parent instructed to give Benadryl. No report of breathing difficulty or respiratory involvement.
7 days post Proquad - temp 104 in ER. Had episode of shaking x 6 mins. Postictal x 6 min. Exam not focal.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 08-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
At first I felt fatigued, trouble getting up and down stairs, feet and ankle swelling, knee swelling. My hands have gotten stiff, a lot of inflammation throughout my body. Joint pain and breathing issues My primary put me on CELEBREX 200 mg once daily and before that I took 15 days of prednisone. My eyelids get puffy and swollen. If I go outside and sun hits my chest it burns, not on my face or arms just a sensitivity to my chest.
Had upset stomach on 14JUL92 until noon the next day 15JUL92 felt hot, never took temp was also nauseated; no one in family w/similar sx;
pt received an expired single dose. Spoke with the provider and he states it should be fine we can administer at a later date being that the potion may have decreased. Attempted to contact the manufacturing  facility but they are closed. Pt was given shots in our office today at aprox 1:30pm.
Received 2nd shingrix vaccination 1/8/21. On 1/9/21 my arm was sore but I had sever generalised body aches lasting 24 hours. Treated with ibuprofen and Tylenol. 2months earlier after the first vaccine I just had fatigue and a sore arm
COVID 19 Treatment; COVID 19 Treatment; Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2; Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6201) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 03ZHZ1A) for immunisation. The patient's relevant medical history included: "controlled HTN" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Moderna Dose Number: 1, Pfizer / BioNTech Dose Number: 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 09Jul2022 and treatment stop date was 13Jul2022, Indication was Treatment of Covid-19. AE treatment: Starting another course of Paxlovid. Patient had no Known allergies: NKDA (No Known Drug Allergy)  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
On 5/15/2007, 16 week old infant givent first dose of rotavirus oral vaccine. On 7/20/2007, infant returned for six-month old immunizations but not given further doses of rotavirus due to starting first dose after recommended starting age of 12 weeks. No adverse effects identified by parents of baby regarding first dosage of rotavirus.
Very swollen, painful lymph node under left arm beginning a day and a half after injection. Even more painful the following day after onset of pain (day 3 after injection).  Pain is just beginning to decrease a little on day 4 after injection.
Absence seizure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (159558).   A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 11:20 as dose number unknown (booster), single (Lot number: GJ3277, Expiration Date: 31Jul2023) at the age of 14 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset Sep2022, outcome "unknown", described as "Absence seizure". The patient underwent the following laboratory tests and procedures: Blood test: (24Sep2022) Unknown results, notes had his blood taken out today, blood drawn today for the lot purpose.   Clinical Course: The caller said that they have gave the Bivalent vaccine confirmed as COVID-19 Bivalent Vaccine to a fourteen-year-old patient and it looks like the patient is having some absence seizure. When paraphrased the concern: Pharmacist stated Yes so after receiving the vaccine patient looks like he is having absence seizure is that one of the listed side effects. Pharmacist stated they said they had his blood taken out today blood drawn today for the lot purpose. No not within the past two-week no.  ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Petit mal epilepsy 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 RAs, Ethics Committees, and Investigators, as appropriate
Information has been received from a consumer concerning her husband, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). The consumer stated that the patient had experienced pain and swelling at the injection site after being vaccinated with PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. No further information is available.
After approximately 10 minutes from vaccination, the patient lost consciousness in the waiting area of the pharmacy.   He fell out of his chair and hit his head, and 911 was immediately called. Employees tended to him and he regained consciousness within a minute or so.   We kept him lying on the ground until paramedics arrived.  I witnessed him losing consciousness again when he was helped back into the chair.  He was taken to local hospital for treatment
47 Year old female received Moderna COVID-19 vaccine first dose on 01/28/2021. Adverse reaction occurred within 10 minutes which included SOB, Hives on neck and upper back, and a feeling per client statement, ?filter in my throat.? Benadryl 50 mg PO administered to client at HCF in observation room. Client?s symptoms improved during the 30 minute observation and was able to drive home. Upon day 3-4 left lymphnode in neck began to swell for a week and remained swollen for 4 months post vaccine. Client background: August 2020 found out allergy to IV Fluorescein (reaction: vomiting & hives) and treated with Benadryl. Then client found out from this incident she was severely anemic (Hemoglobin 6.7) and was prescribed iron supplements. Sept 2020 had Sx for hysterectomy. Dec 2020 Sx for Colonoscopy. Oct 2021 had another Colonoscopy. Client followed up with PCP MD and second MD whom is a blood chemist specialist (per client) who was already monitoring client after receiving Moderna vaccination and at that time Janssen was not yet available. Both MD?a would not recommend moving forward with MRNA vaccine. Client does not currently have any diagnosed medical conditions (has recovered from all previous surgeries and medical conditions) and is not taking any medications.
A father reported that his 2 month old daughter received Rota Shield, Hib-Titer, Tripedia, Engerix B and IPV on 6/23/99. In 10/99 she experienced a grand mal seizure and a petit mal seizure. She was seen by a MD who prescribed phenobarbital. The caller reportes that the infant develops a "blank look" on her face at times. This event is considered medically important.
It was noted after the vaccination was received that the booster was given at the 4 month mark and not at the approved 5 month mark.
I entered Hospital on the evening of September 30, 17 days after having the Pfizer Covid vaccine.  I was diagnosed with a mild stroke.  I was treated with blood thinners and perhaps other things.
fever of 101, myalgia, headache, weakness, diarrhea, lethargy
Systemic: Abdominal Pain-Medium, Systemic: Nausea-Medium