chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty breathing; eye started hurting; pressure in her right eye was higher; felt like she was having flu; strange feeling like she was going to have some kind of illness coming; had chills for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), EYE PAIN (eye started hurting), OCULAR DISCOMFORT (pressure in her right eye was higher), INFLUENZA LIKE ILLNESS (felt like she was having flu) and FEELING ABNORMAL (strange feeling like she was going to have some kind of illness coming) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M23A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided) since an unknown date.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing), EYE PAIN (eye started hurting), OCULAR DISCOMFORT (pressure in her right eye was higher), INFLUENZA LIKE ILLNESS (felt like she was having flu), FEELING ABNORMAL (strange feeling like she was going to have some kind of illness coming) and CHILLS (had chills for 2-3 days). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. At the time of the report, DYSPNOEA (difficulty breathing), EYE PAIN (eye started hurting), OCULAR DISCOMFORT (pressure in her right eye was higher), INFLUENZA LIKE ILLNESS (felt like she was having flu), FEELING ABNORMAL (strange feeling like she was going to have some kind of illness coming) and CHILLS (had chills for 2-3 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
approx 12 hrs p/vax noticed reddness, edema, pain & warmth to inject site; following day c/o sore throat w/achy joints; states did not feel well; c/o back pain w/severe indigestion; itching;
No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 18-MAY-2021, the patient (reported as adult and over the age of 13 years) was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis (inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003760: US-009507513-2106USA003761: US-009507513-2106USA001912:
swelled up the size of a grapefruit, red, warm, body aches, body chills, fever of 100.1, pain/sore
Dizziness, headache, (on day of injections) Fatigue (day after injection) red raised circle around injection site (4.5cm diameter), weak and tired forearm (day after injection)
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the agency at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Within 5 mins of injection tingling between shoulder blades and face, came in waves.  Within 20 mins of the injection throat tightness, dysphagia.  50mg Benadryl PO, 20mg Pepcid PO, 2 puffs of Albuterol.  Throat tightness resolved within the following 30 mins.  The next day body aches, itching of arms, and swelling in the left axilla (same side as injection). 48 hours after injection rash and itching on the upper back, chest, and both arms resolved with 50mg Benadryl.
Early periods; Severe headache; Nausea; Vomiting; Debilitating body aches; Nose bleed; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had allergy to shellfish. Concomitant medications included paracetamol (TYLENOL) once from unknown date for unknown indication and melatonin (MANUFACTURER UNKNOWN) once from unknown date for unknown indication . The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 04:00 the patient experienced severe headache, nausea, vomiting, debilitating body aches, nose bleed and it lasted 24 hours. On 8Apr2021 the patient got her period one week early. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe headache, nausea, vomiting, debilitating body aches and nose bleed was recovered on 26Mar2021; while that of got her period one week early was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years).    No concomitant medication information was reported. The nurse reported that they had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years on 09Dec2022. They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation. These were the patient's 1st doses. No adverse events had been reported by the patients. No treatment medication information was reported.
breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown", described as "breast tenderness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. No medical history was reported. On an unknown date, unspecified number of patients were vaccinated with GARDASIL (dose, route, and frequency unspecified) which was improperly stored since 01-FEB-2014. No concomitant medications were reported. Nurse did not have any patient specific information. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. reported nausea and vomiting and lethargy for days after the shot.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: neck swelling-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Medium
This is a spontaneous report received from a contactable other-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced product dispensing error, administered poor quality product, administered expired product (dose administered past the 6-hour time) and product temperature excursion issue (patient received the product after the excursion), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt states she received shot around 10:00am (10/29). Pt started having chills, fever 101, tight chest, hoarseness around 2:30pm. Pt denies any SOB. Pt states she went to her bed to sleep and felt better by 10:00pm yesterday (10/29/08).
5AUG97 PC from MOC states pt lt arm is swollen, warm to touch & hard;pt was taken to hosp;DPH & cool packs;
got second shot today (7 days early); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable  No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-102912 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102912:
4/25/21   Morning started with fatigue and brain fog, body and mental fatigue lasted all day, cold sweats began around 3pm and temp was taken at 4:30 and was 99.8
Seizures; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 5 months after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received the first dose of Shingrix and experienced a seizure. The reporter did not consent to follow-up. The reporter refused to provide patient and product details.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck), lot number L023111, expiration date: 24-DEC-2016 and lot number reported as L050907, expiration date 14-JUN-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
on 10/20/2022 had minor heart attack, on 11/03/2022 had major heart attack resulting in 100% blockage required 2 stents, now have pericardist, heart damage
Ringing on the ear; This spontaneous case was received on 13-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04476) and concerned a 72-year-old, male patient.  The patient's concurrent conditions included heart bypass. Concomitant medications included clopidogrel, metoprolol, vitamin B3 and pantoprazol, all used for an unreported indication.  On 13-Oct-2022, in the morning, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, indication, route of administration and anatomical location: not reported). The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced ringing in the ears.  On 13-Oct-2022, the patient recovered from the event.   The reporter did not provide a causality assessment. However, the reporter was wondering is ringing in ears a rare side effect of the Flucelvax.  This case was assessed as non-serious.  Company comment: A 72-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed tinnitus. Information regarding the related diagnostic findings was not provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The reporter did not provide a causality assessment. However, the reporter was wondering is ringing in ears a rare side effect of the Flucelvax.; Sender's Comments: A 72-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed tinnitus. Information regarding the related diagnostic findings was not provided. Based on plausible time relationship, causality is assessed as possibly related.
Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Pt received Shingrix around 11:30am on 4/4/22. She called the pharmacy on 4/5/22 reporting she had body aches and a rapid heart rate that woke her up in the middle of the night while sleeping.  She said she currently still has a higher (95bpm) than her regular resting heart rate. She spoke to the pharmacist who told her to call her MD immediately. On 4/7/22, the pt called the pharmacy saying her primary care MD told her to call her cardiologist. Her cardiologist determined the tachycardia was from the vaccine.  She said her heart rate is now back to normal, but she had severe body aches. She has a follow up appointment with her Cardiologist in 2 weeks or so.
Received COVID vaccine 01/12/2021 and 02/02/2021 Tested positive for COVID 19 08/09/2021 Asymptomatic
Patient states she began experiencing leg pain around 10pm on the day of vaccination.  It progressed to numbness. Patient states she lost all feeling and was "paralyzed" on her right side from the pelvic area down her leg.  She stated that she had to drag her leg as she was unable to move it.   The loss of feeling continued until Thursday morning, 6/9/22, approximately 36 hours after symtpoms began. Patient also states she had a fever of 102 degrees and chills the night of vaccination. Patient did not contact her MD, or go to the hospital to seek treatment of any kind.  Patient only reported symptoms to pharmacy where vaccine was administered after all symptoms had ended.
Patient and mother came into clinic searching for catch up vaccines required for school. Nurse reviewed vaccine record and determined that the needed vaccines included Hep B, Tdap, IPV, MMR, and Hep A. System also prompted the need for all stated vaccines and wre verified. Nurse prepared, administered and monitored patient through the visit and showed no vivibe signs or symptoms of distress. Nurse reviewed the vaccine history and realized that Hep A was given at a 4 month interval, instead of the required 6 months. Nurse made supervisor aware and called patients father 8/8/2022 to explain the situation. Father was given the oportunity to ask all questions and all were answered. Nurse recommended a later date to administer Hep A with a correct interval.
Bell's Palsy Left side-3/08/2021 Seen at Emergency Room and was given treatment of Prednisone, ValAcyclovir, and ointment to left eye at night. She experienced severe left sided neck and left ear pain on Saturday 3/06/2021 and then got drooping of left mouth and left eye around 3 pm on Sunday, 3/07/2021, and was seen at healthcare Clinic and Emergency Room 3/08/2021 2 Doses Pfizer given: #1 on 1/21/2021 and #2 on 2/11/2021
Post vax, the pt developed redness with induration 45 mm on left upper outer arm. No other side effects.
Maderna Shot #2 - headache 1 hr after shot, very tired as of 4pm date of shot, very bad chills as of 11pm date of shot and low grade (99.9) fever
pt recv varivax 5/21/97 & on approx 5/6/98 pt recv 2nd dose of mmr & on 5/21/98 pt presented in ofc classic zoster. f/u from MD revealed pt had painful, raised right, T3 distribution w/no addl lesions p/ 5/14/98
Gave Pfizer dose for age 5-11 years instead of Pfizer dose for 12 years and older.
After receiving infusions I usually take it slow for the day. I was resting and when I went to reach for something on end table I felt sharp pain followed by an inability to move my arm and a steady throbbing from behind my right ear down my arm to my fingers.
Fatigue; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the arm left on 31Mar2021 at 11:30 hours (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications included LARISSA, ADVIL, magnesium (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 14:00 hours, the patient experienced fatigue and slight headache. The adverse events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue and slight headache were recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
I felt pain on the right side of my abdomen on June 4th. I see a bruise on the site on June 7th.