chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on both arms where she had her 1st and 2nd shots; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, 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 experienced PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots). At the time of the report, PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-404628, MOD-2021-404746 (Patient Link).
This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD injection (lot # M018638, expiration date 11-OCT-2017 and lot # M017335, expiration date 05-OCT-2017) 0.5 ml (route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Dose 1 my face and lips became tingly the back of my tongue swelled but sideways like it was in my teeth other then that nothing  Dose 2 same as dose 1 but a bit more of my face then about 5 hours later my chest became red with bumps went to the ER received Benadryl went home  Booster shot : my lips were tingly my tongue swelled the back of my throat felt itchy I could not swallow due to my Achalasia so they called a Rapid Response on me took me to the ER gave me IV Benadryl and Epranehrim got discharged after awhile and took Benadryl.
Patient with history of dementia.   Patient brought to the ED by EMS on 10/26 for bilateral hip and back pain after she lost her balance and fell. Patient has had multiple falls recently. She was admitted 10/26-10/28 for evaluation of recurrent falls. On admission (10/26), patient tested positive for COVID-19 by PCR. Per chart review, provider notes recurrent falls could be related to COVID-19 infection.  Patient has been vaccinated with COVID-19 primary series and one booster.
Approximately 9:00 PM on 10/16/17 associate began to feel nauseated, heart began racing, Chest felt heavy. Facial itching and swelling began approximately 9:15 PM. Benadryl 1 pill by mouth and one puff of albuterol Inhaler taken @ 9:30 PM. Symptoms subsided approximately 10:00 PM. During the nigh she woke up a couple of times. Facial swelling had subsided but itching continued. Chest continued to feel achy, heart racing had subsided. This morning 10/17/17 Chest slightly achy, facial itching minimal.
Cellulitis left anterior thigh approx. 4cm around injection site of DTaP. Put on Keflex.
On March 22, I went to the hospital because I had gotten something in my eye causing severe scratches. I was given a tetanus/diphtheria shot about 4:00 PM. I have had them before and knew there would be some swelling, heat, and tenderness at injection site. By the next day it was very hot and swollen the size of a large egg. Three days later it was very hot and red with streaking over the entire upper arm and shoulder. I ran a low grade fever for about four days. It took almost three weeks for the swelling to go down and I still have a knot the size of a large grape. I noticed tonight that the muscle about three finger widths down is swollen and sore still. My sister-in-law is a nurse and said that I should report it. Is this something that I should be concerned about in the future when I get another tetanus? I have had at least three as an adult and never reacted like this before. This shot was given very high on my shoulder at the very top and I didn't know if that might be why it was such a bad reaction.
Severe headache for 10 days still Fevers Severe sinus pressure/pain Increased blood sugars
Redness, swelling, warmth, pain at injection site. Pain extending from shoulder cap to elbow.  Redness about 1.5 inches across.
Swollen calves, ankles; red spots; Swollen calves, ankles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen calves, ankles), ERYTHEMA (red spots) and PERIPHERAL SWELLING (Swollen calves, ankles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swollen calves, ankles), ERYTHEMA (red spots) and PERIPHERAL SWELLING (Swollen calves, ankles). At the time of the report, JOINT SWELLING (Swollen calves, ankles), ERYTHEMA (red spots) and PERIPHERAL SWELLING (Swollen calves, ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Patient experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced side effects). At the time of the report, VACCINATION COMPLICATION (Patient experienced side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.   Reporter did not allow further contact
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Date the vial was initially stored in the refrigerator: 19Nov2021  Patient experienced no signs or symptoms of any distress.  No Treatment information was reported.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received on 23-Nov-2021 and Reporter details  added and Patient demographics added.
Pain in her back is worse; extends from lower back to sciatic nerve; Pain extends into her lower legs; Headache flared up; Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired; General dragged out malaise; Sleeping later than used to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), MALAISE (General dragged out malaise), HYPERSOMNIA (Sleeping later than used to), PAIN IN EXTREMITY (Pain extends into her lower legs) and HEADACHE (Headache flared up) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in 2015.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (General dragged out malaise), HYPERSOMNIA (Sleeping later than used to) and FATIGUE (Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired). On an unknown date, the patient experienced BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), PAIN IN EXTREMITY (Pain extends into her lower legs) and HEADACHE (Headache flared up). At the time of the report, BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), PAIN IN EXTREMITY (Pain extends into her lower legs), HEADACHE (Headache flared up) and FATIGUE (Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired) had not resolved and MALAISE (General dragged out malaise) and HYPERSOMNIA (Sleeping later than used to) outcome was unknown.            The patient reported requiring extra pain medication (not specified) due to aggravated back pain.     This case was linked to US-MODERNATX, INC.-MOD-2021-083531, MOD21-079646, MOD21-091983, US-MODERNATX, INC.-MOD-2021-149581 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New event of headache added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083531: MOD21-079646:cross linked id MOD21-091983:cross linked id US-MODERNATX, INC.-MOD-2021-149581:
This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-JAN-2017, the patients were vaccinated with an improperly stored dose of ROTATEQ, orally, with lot # M019691 and expiration date on 02-NOV-2017 for prophylaxis. The reported stated, that ROTATEQ, was exposed to a temperature of > 46 °F but < 77 °F, for 7 hours and 39 minutes. Data logger was reported. Furthermore, it was reported that, on an unknown date, ROTATEQ was exposed to a previous temperature excursion of 32 °F and 36 °F for 78 minutes. Additionally, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007859:
I waited at the pharmacy for 20-25 minutes after I got the first dose. I have a history of reacting to almost every medication I have been given. When I have been vaccinated in the past I haven?t had any reactions. Within the first few minutes of getting the first dose I was itching over my entire body. After an hour, my breathing began to be restricted. Over the next two days the itching got worse, no rash, but my breathing was terrible though my oxygen levels were above 90. The pharmacy suggested I contact my allergy doctor so I got in to see Dr. on Thursday of that week I believe. She put me on steroids for 10 days. The steroid didn?t help my breathing so I ended up doing breathing treatments for 10 days. The first week I did the treatments every 4 hours during the day and after that I was able to get by with 1 treatment until I felt ok. It was suggested that even though my reaction was severe, it was immediate and I couldn?t get the second dose.
The patient said he felt bad the evening after recieving the vaccine. The patient woke up on 1/18/15 at about 3am and felt bad. later in the morning patient reported headache, stiff neck, and felt exhausted, felt tired and reported he just felt like he was getting sick. Patient said he felt better the evening of 1/18/15.
Profound and persistent lethargy & joint aches, still going on 11/05/2015. Bruising below injection site (down towards triceps, also starting 2 days after injection, still visible today.
Diffuse pruritus within minutes of vaccine administration. No wheezing, stridor, oral-pharyngeal edema, or urticaria. Not tachycardic. Saturating 99% on RA. Given Benadryl 25mg PO. Transported to Medical Center via EMS
Dramatic increase in tinnitus, continuous, unresolved; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 10:00 (at the age of 49-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0121) via an unspecified route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), endometriosis, and tinnitus which was ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received mepivacaine hydrochloride (CARBOCAINE) from an unknown date for an unknown indication and experienced drug allergy. On an unknown date in Apr2021 at 20:00, the patient experienced a dramatic increase in tinnitus, continuous and unresolved. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dramatic increase in tinnitus, continuous, unresolved was not recovered at the time of this report.
In December 2021 I noticed I had pain developing in my chest on my right side just slightly above my breast. It feels like it is inside my body beneath ribcage. I would only develop during exercise and when I would go up hill. It was not painful just uncomfortable. Within a month it became a pain. Within two months I could no longer go up the hill without stopping to relax totally. I began seeing a cardiologist because I was concerned. By July 2022 I had two events where the pain was so excruciating that it felt like my chest was going to explode. I've seen the pulmonologist. I am on a high-powered inhaler. The pain continued and has stayed on the 8-9 of the pain scale. I am no longer able to walk up severe hills. I am only able to go up slight inclines. And even then, I still need to take a break.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Localized lump and rash at injection site. Mildly tender one week after injection.
Had a COVID exposure from a family member and COVID positive 09/12/2021, tested positive and rapid PCR. Lose of taste and smell, head aches and then mild cough, a few weeks, last two or three quarantine directives. Mild shortness of breath  lasted a few weeks, last two or three quarantine directives.
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  No temperature excursion was reported.  No treatment medication was provided by the reporter.
Patient received Shingrix vaccination, however 2 days later she noticed redness and swelling few inches below injection site. After icing the affected area, she visited her doctor and it was diagnosed as Cellulitis.  Patient's doctor prescribed antibiotic for it.
On 7/01, sore right arm, aches, redness. On 7/02 nausea, headache and chills
Patient rarely cried for any reason until this vaccine. When I got him home I nursed him and laid him down as usual. He awoke after a short while with a high-pitched squeal/screech/scream that was non-stop for two days, accompanied by diarrhea and fever. The sound was so unusual and alarming I panicked and called my doctor, even told him I thought it was the vaccine because he had never really cried and certainly never cried like this before. I had never heard ANY child cry like this, with the exception of a newborn's screams. I spoke with a nurse who told me the doctor said it was not the vaccine, to keep an eye on him, "wait it out" and if it didn't get better in a couple of days bring him in. If it got dramatically worse that day I could opt to take him to the ER. He cried almost non-stop all day for hours on end, lessening late that evening and starting again with subsequent bouts of bad diarrhea.
Pt states she developed throat tightness, tongue felt swollen, and had a find rash that started right after injection at 1715. She told the clinic staff about this and at 1743 she was given 50 mg benadryl and at 1746 she was given an Epi-Pen. At 1800, EMS noted she had a hoarse voice and cough, given Duoneb with improvement of symptoms.  On exam in the ED at 1845, pt was asymptomatic and had not findings of throat, lip, or tongue swelling.  She was breathing normally with no wheezes or stridor.
Rash and swelling/cellulitis. Acetaminophen 1-2 tab prn, Cephalexin 500 mg BID, Prednisone 20 mg every day.
Patient was inadvertently administer 2 dose of Covid Vaccine Lot number 8057658 on 09/28/2023.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:13 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Patient experienced a sharp, shooting pain beginning Sunday evening. The pain was located in the arm that the Pneumococcal vaccine was administered (left arm).
Arm sore at injection site and in muscle, radiates down to elbow with certain movements and is still having issues 4 weeks later.
Swelling, redness 1 1/2" x 1 1/2" Rt deltoid (1/22/2013.)
The infant was given the first dose of Rotavirus after the age of 15 weeks which is not recommended. The infant did not have a reaction or adverse outcome from the medication error.
Gave Patient Afluria seasonal flu shot on 11/3/10 at 10:20am.  Patient called me around 3:30 pm with concerns about a possilble allergic reaction.  Stated that around 1pm he started feeling unusual.  He experienced headache, bloodshot eyes, general soreness around stomach area particularly on his sides, described stomach as feeling tight, stuffy nose, when swallowing he would feel like something was stuck. After questioning patient, he denied chest tightness or difficulty breathging. I advised he seek medical attention, in which he did.  Physician concluded he had a type of allergic reaction and was given IV steroids and Benadryl.  He was sent home with prednisone and a cough medicine.  Patient stated to me that he felt much better after being treated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Jul2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (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 "recovered" (21Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 15Aug2023 to 19Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headache, chills, very slight fever 99.4 (my normal temperature runs around 97.1) terrible body aches, weakness, unsteady walking,  upset stomach, vomiting.  This lasted for 12 hours.