chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels sleepy; arm is sensitive; received the second dose 52 days after the first one; A spontaneous report was received from a consumer concerning a 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: received the second dose 52 days after the first one (inappropriate schedule of product administration), feels sleepy (somnolence), arm is sensitive (vaccination site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041120A) for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 001A121A) for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event received the second dose 52 days after the first one . On 24 Feb 2021, the patient experienced the events feels sleepy and arm is sensitive.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  On 23 Feb 2021 the outcome of events received the second dose 52 days after the first one was resolved. The outcome of events, feels sleepy and arm is sensitive was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 001A121A for the second dose) with associated AEs reported as sleepy and injection site pain 1 day after vaccination. 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. Further information has been requested
Under arm lymph node swelling on the same side as the Covid site injection; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 08:00 (Lot number: Ff2590) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Qw11111), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: N/a), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Under arm lymph node swelling on the same side as the Covid site injection". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Relevant medical history and concurrent conditions were reported none. Relevant past drug history were none. Reaction was allergy. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient received any other vaccines within 4 weeks was flu shot and the patient did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for adverse events. No hospitalization prolonged. No follow-up attempts are possible. No further information is expected.
Information has been received from a physician regarding an 19 years old male patient. On approximately 15-AUG-2012, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL, intramuscular injection, (Lot number was not provided). No other co-suspects were reported. No concomitant medications were reported. On 15-AUG-2012, the patient who had just received his second dose of GARDASIL, broke in hives soon after received the injection. The patient sought unspecified medical attention. The patient received an injection of BENADRYL as treatment for the adverse event. The patient's outcome was unknown. Additional information has been requested.
Pfizer vaccine was dilueted with 0.8ml NS rather than recommended 1.8ml NS-resulting in double dose vaccine.
vomiting; headache; stomach ache; generalized pain across the body; nausea; heartburn-like sensation; diarrhea; This is a spontaneous case is received from a contactable consumer (patient and patient's daughter). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Lot number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced heartburn-like sensation and diarrhea. On an unspecified date, the patient experienced vomiting, headache, stomach ache, generalized pain across the body and nausea. She would like to know if the heartburn-like sensation is normal and that is what worries her most. She was scheduled to get the second dose in 2 weeks. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021428556 same reporter/SD/AE, different patients.
low appetite; my body hurts; I feel horrible; I had COVID before but I feel like I am getting it back again; my arm is being swollen; headache; I have been all day with fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old female patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30145BA), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (Age at vaccination: 58-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included Blood pressure, asthma, covid-19 (had COVID before) all from an unknown date and unknown if ongoing. concomitant medications included medicine for blood pressure. Prior vaccinations were reported as none. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunization. It was reported that patient received booster shot on yesterday and today she had basically all of the symptoms that on paper, they told that from the Pfizer, you should get all the things, Because her arm was being swollen that what she had done and headache. It was also reported she feel horrible and had fever all the day, low appetite, her body hurts and she had COVID before but she feel like she getting it back again. Basically all this symptoms that are on this list with the exception of swollen arm or anything like that. she have everything else. The outcome for the events was reported as not resolved at the time of this report.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.
Vaccines provided on 01/24/2019 due to contact of acute hepatitis A. Patient died on 01/27/2019.
Swollen lymph node, left side of neck at the collarbone?stayed visibly swollen for 1.5 week?s after first dose. Swollen lymph node in left armpit for 1 week after second dose?uncomfortable, painful. Did not ovulate the month after the second dose (I use ovulation test strips). Had an unusual period that was kore painful than normal.
HBV (#5 - repeating series) (insufficient titer to 1st series) given on 7-23-12. 7-28-12 (early) broke out in hives over entire trunk of body. Took CLARITIN - rash disappeared for 23 hrs. Reappeared after CLARITIN wore off. Took a 2nd CLARITIN on Sat. 7-28-12; 2 Sun; and Monday. Seeing Dr. on Tues. 3PM.
High fever 102.7 for 24 hrs then started to break. Chills almost to conuations for 6 hrs Elevated heart beat-burning ears and eyes vomiting and weakness
After receiving the 2nd dose I felt like death later that afternoon, I couldn?t think straight was very disoriented and immediately passed out and slept from 7pm until 7am I didn?t move that entire time. Then a week after my lower back was inflamed I was unable to stand up from a sitting position with out  feeling tremendous pain to my lower back.  My spinal nerves were inflamed and my lower lumber was compressing the nerves
I got my first Pfizer booster for COVID-19 on 2/24/2022. On 6/13/2022, I woke up and got a text message informing me that a friend had tested positive for COVID-19. I felt really run-down, so I decided to take a home test. The home test yielded a positive result in the form of a faint line. I called my doctor's office, and they recommended that I go to a pharmacy to get a PCR test, which I did on 6/15/2022. The PCR test also yielded a positive result. During the period between 6/13/2022 and 6/15/2022, I felt horrible. I was very fatigued and had a fever that ran between 99 and 101. I also had body aches, headache, nasal congestion, sore throat, and a cough. I took Advil at this time, but it wasn't very helpful. Although I hadn't yet gotten the results back from my PCR test on 6/15/2022, I called the doctor's office to see if I could get a prescription for Paxlovid. Thankfully, they approved the prescription, and I began taking it later that day.  They also prescribed Tylenol 3 with Codeine and Robitussin to treat my cough. While I took the medication and was dealing with the virus, I had major insomnia. On 6/16/2022, I started taking Benadryl, and that helped ease the nasal congestion and insomnia. I continued to take Robitussin and Advil during the day and Benadryl and Advil at night, and the medicines helped. However, I stopped taking the Tylenol 3, because I suspected that was the cause of the insomnia. The Paxlovid left a metallic taste in my mouth, so it overpowered the flavors of the foods I ate; the aftertaste finally abated about 4 days after I finished taking the Paxlovid. After I finished taking the Paxlovid for 5 days, I felt very weak and lethargic. Even though I was dealing with a lot of discomfort, I at least no longer had a fever, because the fever had abated after 6/16/2022. I didn't begin to feel well again until about 6/26/2022 or 6/27/2022. At that point, I almost felt normal again, though I still had fatigue and general malaise. During my illness, I worked just a few hours a day from home. On 6/22/2022, though, I was again able to do my full workload from home.
SHARP SHOOTING PAINS GOING FROM INJECTION SITE TO FINGERTIPS WHILE BEING INJECTED.  THROBBING SHARP PAIN PROGRESSIVLEY GETTING WORSE AS THE DAY WENT ON. NEXT DAY WEAKNESS IN ARM INJECTED AND SEVERE PAIN EVERY DAY. TODAY IS 10/07/2009 AND I STILL HAVE PAIN LIKE I DID THE SECOND DAY
Chills; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; HEADACHE (non-serious), outcome "recovered", described as "Headache". It was unknown if therapeutic measures were taken as a result of chills, headache.  No follow-up attempts are possible. information about lot/batch number cannot been obtained. No further information is expected.
7/10 level pain in left shoulder at approximate location of proximal biceps tendon origin.  Weakness L arm.  Four days duration then spontaneous resolution.
Pt c/o a heavy period, started same day as vaccine, abnormal large clots, last 4days then done for 2 days and then restarted period, stated I have to the day when I will start and its the 1 or 2 every month so this was not normal
In early AM hours of Apr 23 I began to feel very weak. At around 3:15am when I got up to use the bathroom, my eyes clouded over and I passed out on the bat Herron floor. I regained consciousness after almost 10 minutes. Luckily I was not injured. But I was practically bedridden all day Apr 23.
Patient was vaccinated on 4/6/21 at 9:05 am.  Report received that patient was in the car on the way home from the vaccination and had chest pain and shortness of breath.  Patient called their primary care doctor who requested reporting to the nearest emergency room immediately.  Patient became unresponsive in the car.  Patient arrived in cardiac arrest (arrival time noted to be 4/6/21 at 10:54 am, CPR began. Patient was intubated in the ER, and received epinephrine, amiodarone, and was defibrillated several times per ACLS protocol.  Patient did not have return of spontaneous circulation and was subsequently pronounced. Per report, it was noted that patient was short of breath prior to receiving vaccination earlier in the day.
Body rash, itchy, with sun/heat exposure. Looks like measles.  Rash from neck to knees. Treating with benadryl. Occurs every time I'm outside 30 minutes. This began happening after my second vaccine.
I went for a run/jog and and I was short of breath and hives on my face and lips. The shortness of breath was scary as I was really unable to breath; I went for a run/jog and and I was short of breath and hives on my face and lips. The shortness of breath was scary as I was really unable to breath; This is a spontaneous report received from a contactable consumer (Patient). A 20-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), Solution for injection, via an unspecified route of administration on 08Apr2021 (at the age of A 20-year-old) as single dose for covid-19 immunisation. Medical history included asthma and nuts allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 19Apr2021, the patient went for a run/jog and she was short of breath and hives on her face and lips. The shortness of breath was scary as she was really unable to breath. Patient received children's Benadryl as a therapeutic measure to treat adverse event. The events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Severe dizzy spell about 5-10 following injection, helped to the floor, this lasted approximately 30-40 minutes after start of symptom.  Hot flashes and visual disturbance lasting into following day.
This spontaneous report was received from a doctor of pharmacy concerning his 11 month old nephew (male). On 19-MAY-2011, the grandmother of the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). On an unknown date, approximately in February 2013 (about a month ago), the patient experienced whole body rash of unknown origin and he was hospitalized on an unknown date for about 5-6 days. A lot of testings (unspecified) were done and thought that rash could be related to HSV1 (herpes simplex virus 1). He was prescribed acyclovir and rash completely resolved on an unknown date. Approximately on 14-MAR-2013 (a week ago), the patient experienced lesion of rash on his thumb. The pharmacist described current rash for his nephew as blistering rash. Pharmacist did not known if rash of his nephew was ever diagnosed as chickenpox rash. The outcome of lesion of rash on his thumb was unknown. The pharmacist suspected the possibility of secondary transmission from vaccine virus from ZOSTAVAX that his mother received or from shingles breakout that his mother had. The reporter considered the events whole body rash and blistering rash could be related to ZOSTAVAX. Varicella Zoster Virus Identification Program (VZVIP) packet faxed. This one of the two reports from the same source. Additional information has been requested.
I got my first dose of Shingrix 11 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 11 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 02-JUN-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient enquired that he/she received 1st dose of Shingrix 11 months ago, so was it too late to get second dose and asked what he/she could do. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately January 2016, reported as on multiple unspecified dates following a temperature excursion reported on 15-JAN-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# reported as L039268, expiry date 05-APR-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. The reporter stated that the doses of PROQUAD (Merck) were exposed to the temperature of 6.1 degrees Fahrenheit for 48 hours, 5.5 degrees Fahrenheit for 72 hours, 6.8 degrees Fahrenheit for 15 hours, 6.6 degrees Fahrenheit for 120 hours Fahrenheit for 72 hours, 5.2 hours Fahrenheit for 16 hours and 6.1 degrees Fahrenheit for 70 hours- on unspecified dates). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her 13 year old son who had asthma and a grass allergy who on 8/20/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and fluticasone propionate. The patient's mother reported that on 8/31/04, 11 days after being vaccinated, her son developed a mild case of chicken pox. The mother indicated that her son had pox marks on his face, neck, back, stomach, and legs but they were not closely spaced together and were few in number (approximately three on his face, three on his neck and six on his back). Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
Gradual onset of dyspnea on exertion that began approximately 2 weeks post-vaccination.  Symptoms progressed over 6 months until had syncopal event on 8 Oct 2003.  Work-up revealed large bilateral pulmonary emboli.  No other etiology has been found to date after an extensive work-up.
This spontaneous report was received from a certified medical assistant and refers to 4 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2016, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M012495, expiration date 09-OCT-2017, route of administration defaulted to oral (dose and frequency were not reported). The patients' concomitant therapy was not reported. The administrated dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient left the pharmacy after standard 15 minute observation with no issues. Husband returned the next day reporting that patient felt palpitations and anxiety starting the morning after her shot. Advised that patient to check temperature, keep hydrated, and monitor for signs of allergic reaction.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinate with an expired dose of M-M-R II (lot # 0649AE, expiration date 27-MAR-2014) (rHA status not provided) 0.5 ml subcutaneous. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Constricted airway, unable to breathe, weak, loss of speech, increased heart rate, fatigue, loss of balance
asthma exacerbation responded to pred burst & inc of asthma inhalers;
Dizziness in the morning that wore off, followed by late night nausea, vomiting lasting 2 hours.  Nausea still present but improving.
premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a 16-year-old female patient. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed premature ovarian failure. No details were provided. The patient sought medical attention, however it was unknown, if she received any treatment. The outcome of the event was unknown. The causality assessment was not provided.
Severe swelling of thyroid, pain radiating to right ear, pain in neck and throat area, exhaustion, malaise
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/27/2021 and 02/24/2021. They presented to Emergency Dept on 11/02/2021 after about a week's worth of illness with symptoms of shortness of breath, low O2 stats, dizziness, cough, and nasal congestion. They were admitted to hospital and tested positive for COVID-19 via antigen test upon admission. They were found to be experiencing complications of hypoxemic respiratory failure, Strep pneumoniae positive blood culture, acute on chronic kidney failure, acute on chronic heart failure, episodes of non-responsiveness, possibly a seizure (not confirmed), a probable aspiration event, and increasing oxygen demand. Their condition continued to deteriorate and aggressive symptom management was ended. The individual remained hospitalized until their death on 11/12/2021.