chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a slight headache.; I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing it's just the pain comes and goes and it's very irritating .; It's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so it's very uncomfortable.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 28Apr2021, outcome "not recovered", described as "I had a slight headache."; ABDOMINAL PAIN (non-serious) with onset 28Apr2021, outcome "not recovered", described as "I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing it's just the pain comes and goes and it's very irritating ."; ABDOMINAL DISCOMFORT (non-serious) with onset 28Apr2021, outcome "not recovered", described as "It's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so it's very uncomfortable.". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated I had my vaccine. My first vaccine on Tuesday and I had a slight headache. I know those are the symptoms and from yesterday I am having this tummy ache like I don't need to go to the toilet or nothing but it's just the pain that comes and goes and it's very irritating like someone is sitting inside and squeezing my tummy. I am having it right now too so. It's very uncomfortable. I just took Tylenol yesterday because I had headache. Scheduled vaccination date for second dose: consumer stated: 18May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site was very sore after influenza vaccination. It continued and one week later I returned to asked pharmacy if it was normal. They said the soreness would go away. It did not and I can not raise my arm over my head now and the injection site is still sore to the touch.
I am experiencing what I believe to be a robust take on the back of my left arm at the site where I was vaccinated two days ago. There is a red, slightly raised area about 2"x4" and is warm to the touch. Yesterday I experienced what I believe was a small fever (less than 100F)  and have been experiencing muscle aches all day. I have no other symptoms
Upon giving flu shot, pt collapsed and fell onto face from exam table. Laceration to lower lip and 2 incisor teeth broken. 2 min after when she regained consciousness assessed by Dr. Pt to go to ER for evaluation.
fever; congestion; nausea; chills; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old female patient received 1st dose of bnt162b2 (Comirnaty,Batch/Lot Number: EL9264),via an unspecified route of administration, administered in Arm Right on 03Feb2021 14:00 ,at the age of 23 years old,as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever,congestion and nausea, chills on 04Feb2021.The patient had not received any other vaccines within 4 weeks.The patient had no known allergies.The patient had not received any treatment for the event.The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination.The outcome of the events was not recovered.The adverse events didn't resulted in patient visit to hospital or physician.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
2nd BI-VALENT BOOSTER GIVEN ON 12/16/22 1st GIVEN ON 09/21/22 MODERNA LOT # AS7162B NO ADVERSE SYMPTOMS NOTED
Headaches, Body Aches, Sore Throat Home Self Care (Pt is RN) Tylenol and fluid increase 5 days
Unsure whether it was the flu shot or a new lotion, but patient broke out with red bumps 3 days after shot.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On 06-JUN-2011 the patient was vaccinated with ZOSTAVAX (19400 PFU) (route not reported). The reporter stated that the patient informed him that on an unknown date the patient experienced neuropathy in his feet and the patient asked pharmacist if ZOSTAVAX can cause neuropathy. The pharmacist did not know the patient's medical history, or if the patient ever had shingles and also if the patient experienced any other adverse effects. The pharmacist declined to provide any additional information until after he speaks with the patient who was awaiting his return phone call. The outcome of neuropathy in his feet is unknown. No product quality complaint was involved. Additional information has been requested.
p/vax mom states child started vomiting later that day; carried to ER, had sz & adm to hosp 9/1/99;pt released 9/5/99;
Information has been received from a 51 year old female registered nurse with allergies to codeine and sulfa, who on 01-APR-2008 at 10:00 was vaccinated intradermally into the right forearm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included estrogens (unspecified) and zolpidem tartrate (AMBIEN), and unspecified over the counter medications. On 01-APR-2008 she was inadvertently vaccinated intradermally into the right forearm with pneumococcal 23v polysaccharide vaccine, instead of PPD Tuberculin. She stated it was human error only. She stated that she had extreme swelling 4 inches above the injection site and 4 inches below the injection site. She stated that her right arm was very painful and warm to the touch. She was vaccinated at 10:00 on 01-APR-2008. By 15:00 on 01-APR-2008 she experienced arm pain and by 17:00 PM the right arm was swollen. On 01-APR-2008 "last night," she developed aches and pains in her hips, neck, shoulders and she had a headache. She was seen in the office and was being monitored by her physician and was placed on prednisone, "40 mg today, 20 mg tomorrow, etc." At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Tested positive for COVID-19; A spontaneous report was received from a physician concerning a 54-year old, male patient who received Moderna's COVID-19 vaccine and tested positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient tested positive for COVID-19 after being exposed to the virus by a family member. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The history of patient being exposed to the virus by a family member confounds causality.
On 1st and 2nd dose...flu like symptoms. Painful joints. Headache. Appeared 6 hours after injection. Took ADVIL and rested!
A 9-year-old boy who is with a complex history today relating to a flu shot. Since receiving his flu shot, within 12 hours, mom has noticed him to be highly anxious and worried unnecessarily so. He has had tic-like behaviors, which have included mouthing at clothing, being excessively fidgety, as well as habitual coughing. He had an episode like this back almost two years ago, and mom stated it came right after a flu shot as well. Going back through the records I see that he had a flu vaccine on 11/12/03. This time, his mom said that within a week he was ill, and he had a viral-like syndrome where he took some prednisone. Shortly after this, within a month, he developed obsessive-compulsive disorder symptoms and high anxiety including tics with habitual coughing, head tilting, and a need to smell objects habitually. He was seen by doctor in play therapy which did not result in a tremendous amount of improvement. He was ultimately put on Zoloft to help with his high levels of anxiety and OCD symptoms in January of 2004, but this was apparently  "a disaster," according to mom and he became very naught and misbehaved. He was therefore taken off of the Zoloft and switched over to Prozac, which was helpful for him, and he took it until May or June of 2004. At which time, he had discontinued it, and he really had not had any return of any symptoms until  his recent flu shot. To complicate matters, he did come back in, in the middle of January, and he had a strep screen at that time which was positive. It was thought that he might have PANDAS syndrome, and he was treated for strep, although he continued to have residual symptoms for several months thereafter. He is in today with no sore throat, fever, cough, or other symptoms, although his strep screen actually comes back and is positive today as well. He has continued to exhibit OCD symptoms, anxiety, and tics since his flu shot was given on Friday, and there has been no general improvement up to today.
48 hours after my second shot of the Moderna vaccine in my left arm, I developed a red rash approximately 4x4 inches about 3 inches below the site of injection.  Warm to the touch and slightly raised and itchy.  24 hours hours after the second vaccine, also had slight fever and fatigue.  Had no side effects from the first shot on 2/9/21.
allergic to some or all of the ingredients; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced severe side effect from the Shingrix shot. The patient stated that he/she must be allergic to some or all of the ingredients. The patient asked that what were the ingredients. The follow-up could not be possible as no contact details were available.
phlegm had blood within; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 19Feb2021 10:15 AM (at the age of 67-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication; start and stop dates were not reported. The patient previously took clarithromycin (KETEK) and experienced allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced phlegm had blood within on 20Feb2021 08:00AM, the morning after first vaccine. No treatment was taken for the events. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 4th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever and shivering. On 7th July 2018, the outcome of the fever and shivering were recovered/resolved. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported, but it could be 74 or 75 years. Limited information was provided. The patient experienced the above side effects.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot# L020015 and expiration date 16-AUG-2017, lot# L018351 and expiration date 11-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Initial consumer report received from the patient's son on 18 Mar 2010: This patient on Trileptal since 2003 and restarted using it from 2008 for an unspecified indication. Dosage regimen and therapy dates were not reported. In Oct 2009, this patient was vaccinated with H1N1 vaccine (manufacturer unknown). On an unspecified date, reporter stated that "a day after the vaccination this patient would blink his eyes, get dizzy, hold on the wall as if he was riding a ship, would get exhausted and fall asleep for about hour to an hour and a half." The reporter further mentioned that when the patient woke up she was fine or back to normal but this would happen 45 to 60 minutes after the patient would take the medication. The reporter added that changing the time when the medication was administered did not help. This patient was also on Lamictal, unspecified dose, duration and indication. On an unspecified date, patient experienced "motor ticks in the head." The outcome of the events were reported as unknown.
RN gave a 1st dose of Hep B Recombinat to a 35yrs old pregnant lady with about 4 weeks, pt. had no adverse reaction or any complains and symptoms
Within a day or 2 of receiving shot #1, I had a headache . . This headache  persisted  and within days  became a unilateral left sided migraine  whic after a 2-3 weeks became right sided. Both impacted neck to scalp (new symptom), behind the eye, nose, and even hard palate at times. All have  persisted daily since approx 2/18/21.  Tried not to take meds initially, since 18 yrs ago had ulcer rupture due to Excedrine use. Then began Excedrine and Naratriptan  (2x day) for weeks. Naratriptan has always been a successful med and would wipe out a migraine in hours. Then I was fine for weeks or months. Not the case this time. It dulled or temporarily relieved the symptoms, but they would come back that day. Still have daily headache migraine, down to 1 Excedrine a day.
recovering from lung cancer.; Have copd; This spontaneous case was reported by an other health care professional and describes the occurrence of LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Lung cancer.    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 LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) (seriousness criterion medically significant) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Have copd). At the time of the report, LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) was resolving and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Have copd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment drug information was provided.  Company comment: This case concerns a 62-year-old, patient with unknown gender with concurrent medical condition of COPD and Lung cancer, who experienced the unexpected serious event of Lung neoplasm malignant (seriousness criterion medically significant) which occurred on unknown date after the (not specified) dose of mRNA 1273 Vaccine and outcome was reported as unknown. Patient's concurrent medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, patient with unknown gender with concurrent medical condition of COPD and Lung cancer, who experienced the unexpected serious event of Lung neoplasm malignant (seriousness criterion medically significant) which occurred on unknown date after the (not specified) dose of mRNA 1273 Vaccine and outcome was reported as unknown. Patient's concurrent medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On November 18, 2021 I developed severe itching in my palms and feet.  This spread over several days into a rash and itching throughout my entire body unrelieved by Benadryl.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Joint pain; Muscle pain; Nauseated; pain of lower abdominal; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization, and patient had received medication include paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced joint pain, muscle pain, nauseated and pain of lower abdominal. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Violent chills for 4 hours, fever of 102 for 1 1/2 days, sweats, dizziness, diarrhea for several days, nausea for 4 days.  Red and swollen left arm for 4 days, arm slightly red and swollen now (4/3).
Body aches; Joint pain; Fever 100.4; Nausea; Chills; Severe headache; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 10May2021 at 12:45 (at the age of-58-years-old) as a single dose for COVID-19 immunisation. Medical history included foramen ovale patent (PFO), sleep apnea, hypothyroidism, migraines, arthritis and COVID-19, diagnosed prior to the vaccination. The patient had known allergies (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and butalbital/caffeine/paracetamol (FIORICET); all for unknown indication from an unknown date and unknown if ongoing. On 11May2021 at 23:00, the patient experienced body aches, joint pain, fever 100.4, nausea, chills and severe headache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, joint pain, fever 100.4, nausea, chills and severe headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Customer called today at 4PM saying her legs have been sore since Tuesday 6/15.
p/vax pt exp breakthrough chickenpox;the reporting nurse practitioner noted 100 lesions & a rash on pt trunk;
Muscle pain in shoulder at sight of administration hot sensation as well for 2 weeks & still hurting.
I received my Pfizer booster for COVID-19 on 9/29/2021. In the early morning of 6/24/2022, I woke up with nausea and chills. I took a home test for COVID-19, which yielded a negative result. I also took some Tylenol and then went back to sleep. I then woke up at about 7 or 7:30 AM feeling very fatigued.  Later on that day, I went to an urgent care and underwent a PCR test, which yielded a positive result. I became feverish that day. My temperature was 101.3 at the highest. I also had fatigue, muscle aches, and headache. I did not contact my doctor. Instead, I just went home and self-isolated.  On 6/25/2022, I developed a cough, which I treated with Robitussin DM and cough drops. I saw a doctor about a week to a week and a half later, because my cough was persistent. The doctor prescribed me prednisone, which helped. The doctor also told me that I had some wheezing. I took the entire course of prednisone, and by the second day of taking it, my cough had subsided. I later took two more home tests, the second of which was on 7/15/2022, and they both yielded a negative result. I would also like to note that I missed my period in July and found out shortly thereafter that I was pregnant. At the time of this writing, I have no more COVID-19 symptoms. I have undergone extensive prenatal tests, including one for chromosomal defects, and thus far, my doctor says that my baby is developing normally. My baby is due on 4/1/2023, so at the time of this writing, I am 14.5 weeks pregnant.
Initial reaction on the evening of 03/25/2021 was a sore arm, headache and achy around neck and shoulders. Took two ibuprofen prior to going to bed. Next day still had a sore arm and later in the evening felt a slight itchiness around injection site and redness. Today, five days after the vaccine, itchiness and redness persists and no other symptoms.
Patient had nausea & vomiting x1, weak, felt nervous. Instructed to go to ED if feeling worse (N/V), fainting, shortness of breath/chest pain. Patient stable, released from vaccination site.
Circular rash and inflammation about 4in diameter around the injection site. It is slightly warm to the touch and feels a little itchy. No major pain. Slightly tender.