chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had received Johnson and Johnson vaccine on 3/24/21, but inadvertently received a dose of Moderna vaccine on 9/13/21 (today). No immediate adverse effects noted. Patient currently incarcerated and will be monitored for adverse effects. Patient reported that he had not been previously vaccinated with any formulation of the COVID vaccine, and staff did not perform due diligence in reviewing administration history. We are reporting this as error as it constitutes an administration error.
I had pain from the left shoulder to my right shoulder; pain up to my ear for 2 weeks; it was stiffness with the pain before; My heart beats very fast sometimes and it would last 6 to 10 seconds; My anxiety seems to be agitated; I started getting more pain throughout my whole body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I had pain from the left shoulder to my right shoulder"; EAR PAIN (non-serious), outcome "unknown", described as "pain up to my ear for 2 weeks"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "it was stiffness with the pain before"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "My heart beats very fast sometimes and it would last 6 to 10 seconds"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety seems to be agitated"; PAIN (non-serious), outcome "unknown", described as "I started getting more pain throughout my whole body".  Additional information: The patient had pain from the left shoulder to my right shoulder and pain up to my ear for 2 weeks and it sort of went away. And it was stiffness with the pain before. My heart beats very fast sometimes and it would last 6 to 10 seconds. My anxiety seems to be agitated. In 2021 when I got my 2nd shot, I started getting more pain throughout my whole body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
early onset of menstrual cycle; very heavy very painful periods; very heavy very painful periods; only received one dose of Moderna COVID-19 Vaccine; spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting), MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting). On an unknown date, the patient experienced MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine). On 03-Feb-2021, INTERMENSTRUAL BLEEDING (spotting) had resolved. At the time of the report, MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods) and DYSMENORRHOEA (very heavy very painful periods) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pregnancy test: negative (Negative) negative.     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 were not reported.  No treatment information provided by the reporter.  The patient reported, she has not had the second dose and was unsure if she should get a second dose or if she needs to start over or try a different type of COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated patient details (initials), events and reporter demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Around 24 hours after my first dose I had pain all over my body with aching and brain fog for about a week. It then subsided but I then continued to have pain that settled into both knees, ankles, and my feet. It still was present up until my second dose. I thought it was just body doing it's thing. I thought it was just a normal reaction and did not seek medical care.
both ears constantly feel full and like they need to 'pop,' tinnitus, muffled hearing, feeling of pressure in ears {previous symptoms are constant since September 12, have never had any of these symptoms before and symptoms have not let up at all}
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ew0158), in left arm, on 02May2021 as dose 2, single (Lot number: ew0173), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: 33026bd), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hashimotos thyroiditis" (unspecified if ongoing); "allergy related asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ESTRADIOL; PROGESTERONE; VENTOLIN HFA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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 outcome: She completed 5 days of Paxlovid last night from 13May2022 to 17May2022 and she still testing positive for covid this morning.
I had a sore throat first and then coughing, runny nose and sneezing. Eventually loss and taste and a low-grade fever around 100.0. I tested on Saturday morning after the symptoms plus congestion. I also had exhaustion on Saturday but that has improved. The test was positive. I contacted my doctor's office and the doctor on call prescribed Paxlovid on 10/22/2022. My sore throat is gone, congestion is much less than before. My sense of taste has not come back fully.  I am still recovering. I did start taking Vitamin C, Vitamin D3 and Zinc. I also take Tylenol at night.
Case number PHEH2015US020113, is an initial spontaneous report from a health care professional received on 07 Oct 2015. This report refers to a 44-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157004) intramuscularly on 07 Oct 2015. On the same day after vaccination the patient experienced itching at the injection site. Final outcome, seriousness and causality were not reported
large mass  2in x 2in in L axillae on the side his injection was given.  no pain or redness, just fullness
feeling sick/ has not been feeling well at all; health is declining/body has started failing; lost 50 lbs; has no energy; can barely walk across the road; He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy) and GAIT DISTURBANCE (can barely walk across the road) in a 41-year-old male 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 was provided by the reporter.    In February 2021, the patient received second 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. On an unknown date, the patient experienced ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it) outcome was unknown.            Concomitant medication included thyroid medication. Patient went through lab data but results were not provided.  Patient consulted with his doctor but they did not provide any treatment, they were not able to figure out what was going on with patient and they do not knowhow to treat the reaction to COVID shot, especially for the ones dying like him.
Patient received AREXVY on the Left arm and Spikevax on the right arm on 9/29/23.  Patient reported  on 10/02/23 that the next day post vaccination, on 9/30/23 that her left arm (AREXVY ) had redness,  swelling and warmth. Patient returned to the pharmacy to fill an antibiotic on 10/02/23 and stated that her doctor diagnosed her with cellulitis.
Patient more shakey, weakness, and unsteady on feet. On Neuro checks due to a fall from the symtpoms. By 7/02/22 patient symptoms improved.
Hospitalized 1/31/22-2/5/22 weakness, hypokalemia, malaise, decreases appetite,
Pt experienced hives and red papules on her face, cheeks and chin bilaterally. Describes them as itching and mild burning sensation. Pt states it happened 24 hours after receiving second dose of covid vaccine. Pt came to urgent care and was treated with oral prednisone and hydrocortisone.
3mins 1st febrile sz, 12 hrs p/onset of t104; exam consistent w/non specific viral synd; 2 days later devel a measles like rash x 1-2 days;
Patient received vaccination that was expired.   Description per error reporting system:  "Patient was given a Pfizer booster immunization and clinical staff realized the vaccine was expired (out longer than 6 hours) This event was reported to me by clinical team member. Patient was contacted and informed that a repeat does would need to be given." No additional reaction or issues reported in patient EHR.
Patient received the vaccine around 8am without incident.  The patient returned to the pharmacy at around 3pm later that day.  She reported that a few hours after her vaccine she broke out into hives.  At the pharmacy she had small red hives visible behind both arms and redness across her chest.  The patient denied difficulty breathing and reported that she was breathing just fine.  The patient was counseled to take otc antihistamines and to seek medical attention if it worsens.
Have been losing weight (25 Lbs)  without trying and always feel lethargic.
She developed redness and swelling of her upper right arm. Some itchiness. Dr is proactively treating her for cellulitis.
Crying, fussy, area around injection site edematous; mom gave TYLENOL at 1:20pm; ice pack applied in office which did reduce swelling.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 28-FEB-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness/ light-headed; Feeling shaky; Nauseated; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via intramuscular route of administration on 12Feb2021 at 14:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and known allergies to shellfish. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN) and sumatriptan (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 12Feb2021 at 14:30, post vaccination approximately 20 minutes, the patient experienced dizziness, feeling shaky, nauseated, and light headed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events dizziness/ light-headed, feeling shaky and nauseated was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
hoarse voice; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "hoarse voice".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced immediate dizziness of most concern, pt experienced an immediate rxn of a bluish/purple bump about 1/2 cm high x 2 another pt has experienced almost exact rxn.
Patient reported soreness and rash at injection site extending 1-2 inches out from the injection site. She noted swelling and a round hard lump under the skin. She called her physician, who recommended NSAID therapy to reduce inflammation. She responded well to Aleve and the adverse effects have resolved.
Started to develop a rash around injection site after about 5 minutes.  She also said her stomach was a little wonky, Treated with benadryl, she stayed in our lobby for about 2 hours. No further symptoms developed. She than left the pharmacy.
Patient received the Phizer Bivalent Booster originally on 9/30/22. Patient received a second dose on 10/18/22.
Noted lt. arm soreness at 3 a.m. ( more than dose 1), noted chills at that time and body aches. Got up at approximately 8 a.m. and walked to the bathroom but felt nauseous. Sat on toilet, had diarrhea and felt like I  was going to faint. I knew I needed to get my head down inorder to feel better. I stood up to pull my pants up and passed out. My husband heard the clunk as I hit my left forehead on wall  - he came rushing in - I was face down on the tile which actually felt cool but good on my face.  he helped me  sit up while sitting on the floor but I still felt faint and needed to keep my head down. I quickly  felt another bout of diarrhea  before he and I could get back up to the toilet.  I was able to wash up with him handing me washcloths and towel and clean lower extremity clothing - still felt nauseous.  Had gatorade which improved how I felt quickly - temp was 96.5. rested most of the day. Completely fine on 4/2/2021. Bruise on left forehead about size of quarter and small bruise left side of nose.
Myself, the medical assistant, in preparing shots for patient gave patient PEDIARIX, KINRIX, and ROTATEQ resulting in a double dose of DTaP and IVP. I immediately called the state in which they said it is still valid and I needed to inform the family and submit a VAERS.
Child passed out 2 minutes after immunizations given. Eyes rolled into the back of her head. Child lost control of bladder, face turned bluish color, area around mouth was white. Child became conscious approximately 1 - 1 1/2 minutes after incident. Arms were rigid and hands turned outward.
Fever 24 hours,diarrhea 2 days,severe severe headache 2 days  joint Nd muscle pain2 days Severe fatigue 5days
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. Not Provided. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported. This case was linked to US-MODERNATX, INC.-MOD-2021-080387 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080387:husband case.
received the first dose / on 31-Dec-2019 but have not received the 2nd dose; it may have beed COVID-19 or influenza; respiratory tract symptoms / respiratory tract symptoms in february 2020; it may have beed COVID-19 or influenza/ suspected Influenza; This case was reported by a nurse via call center representative and described the occurrence of suspected covid-19 in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In February 2020, between 1 and 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced suspected covid-19, respiratory tract disorder and influenza. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the suspected covid-19, respiratory tract disorder and influenza were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the suspected covid-19, respiratory tract disorder and influenza to be related to Shingrix.  Additional details were provided as follows: The reporter was a consumer but who was also a nurse. The patient experienced upper respiratory tract symptoms in february 2020 after the first dose of Shingrix (the patient did not have the lot numbers). The reporter thought it might be COVID-19 or influenza. Outcome was reported as fully recovered. The age at vaccination was not applicable for the 2nd dose of Shingrix.  The patient had not received the 2nd dose till the time of reporting, this led to incomplete course of vaccination. The reporter consented to follow up. The case has been linked with the case US2020206902 reported for husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206902:same reporter
experience swelling; pain at the injection sites; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included lidocaine hcl (LIDOCAINE HCL), hyaluronic acid (JUVEDERM VOLUMA), hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLBELLA WITH LIDOCAINE), hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLIFT WITH LIDOCAINE), all taken for an unspecified indication, start and stop date were not reported. Reported as, the patient was injected approximately 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLITE. Treated with Telfast and betacorten steroidal ointment. Symptoms resolved. This record captures events relating to the injection with Juvederm VOLITE. The patient experienced experience swelling, pain at the injection sites on an unspecified date. Reported as, patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the Covid 19 Pfizer vaccine. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.