chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local reaction to left thigh after DTaP. Verified that 1 inch needs was used. Fever 100 degrees for 2 days.
Patient had inconsolable crying, would not eat, upon examination, right thigh swollen - no increased redness. Left thigh ok. Temp WNL 97 degrees tympanic. Re exam done at 1730 - TMS clear, pink good cap refill. Pt calm in mom's arms, resting quietly with eyes close. Nursing successful.
Blotchy macular eruption close to site of administration. Rash was painful. Treated with oral antihistamine. (Rash was nearest to site of FLUZONE vaccine).
Patient admitted for pulmonary edema and suspected COPD exacerbation in the setting of previously undiagnosed COPD with advanced emphysematous findings on chest CT and TTE demonstrating normal LVEF findings compatible for severe COPD. She likely has underlying chronic diastolic heart failure as well. Discharge once COPD exacerbation resolved. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
ZOMBIE AFFECT/ FEELING VERY TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced zombie affect/ feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of zombie affect/ feeling very tired was not reported. This report was non-serious. This report was associated with product quality complaint 90000217685.
extreme abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN (extreme abdominal pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 024M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE and AMLODIPINE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL PAIN (extreme abdominal pain). The patient was treated with DOMPERIDONE (PERIDIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (extreme abdominal pain) outcome was unknown.        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.
I received the vaccine the next morning a rash had appeared on the left arm and  two days later it spread to my right arm. I went to the Dermatologists and they gave me  sluocinonide for that rash, and it went away in a bout a week. Then a few months later I had a post menopausal cycle. I went to the gynecologists and they did a uterine biopsy and it came back negative, they said that I will need to watch it and if I start to bleed again i will need to see them immediately.
Pain at injection site; severe headache soon after injection; severe lower back pain; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 08Feb2021 14:45 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. Medical history included Diabetes and asthma from an unknown date and unknown if ongoing. The patient received unknown concomitant medication. The patient previously took BNT162B2 (Lot number: EL3248) on 19Jan2021 at 02:45 PM administered in Right arm for covid-19 immunisation and also patient took DEMEROL and experienced drug Allergies. The patient experienced pain at injection site, severe headache soon after injection and severe lower back pain on 08Feb2021 15:00. The patient did not received COVID tested post vaccination and COVID prior vaccination. The patient did not received treatment for the events. The outcome of the events was reported as recovering.
Cellulitis; Left arm redness/pain/swelling 8cm worse after 3-4 days; Left arm redness/pain/swelling 8cm worse after 3-4 days; Left arm redness/pain/swelling 8cm worse after 3-4 days; This is a spontaneous report received from a contactable physician. A 72-years-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6207), intramuscularly in Arm Left on 19Mar2021 (at the age of 72-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and erythromycin and experienced drug hypersensitivity. The patient previously took first dose of bnt162b2 (Lot: EN6207) on 25Feb2020 at 12:00 PM (at the age of 72-yesr-old) in the Left arm for COVID-19 immunisation. The patient experienced cellulitis and Left arm redness/pain/swelling 8cm worse after 3-4 days, on 20Mar2021. The event Cellulitis assessed as serious (medically significant) and while others was non-serious. Treatment was received for the events as antibiotic- Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient visited doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as unknown.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product Comirnaty  to the reported 'COVID 19' cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Developed cold sore on lip with 5 pimples below it. Treated with Abreva. Cold sore resolved, but pimples still there and still treating with Abreva. No medical treatment to date. Pt did receive unknown name of Flu vax in early October.
Throat tightening. Patient states it's how she feels when she has an allergic reaction. Pt. has used her Epi Pen for this before in the past. Patient airway is able to breath, drink and have a conversation.
Pt states that a few weeks after receiving the vaccination, her arm began to hurt and she had difficulty lifting it.  She did see an urgent care doctor in January 2020 and she states that he informed her that she has Tendonitis caused by the flu shot given in September
Information has been received from a licensed practical nurse concerning a 13 month old male patient who on 19-JAN-2009, was vaccinated with a dose of VARIVAX, on 06-FEB-2009, was vaccinated with the first dose of MMR II (lot # not reported), on 08-OCT-2009, was vaccinated with the second dose of MMR II (lot # not reported). On unspecified dates the patient was also vaccinated with a dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown) and a dose of Hib conj vaccine (manufacturer unknown). The nurse reported that "3 month ago" (approximately in 23-MAY-2011), the patient discontinued chemotherapy treatment for Cystic Astrocytoma (onset date not reported). The nurse also questioned if the child needed to be revaccinated with all the childhood vaccines again. The nurse stated that the child was current and up to date on all the childhood vaccines, and confirmed that the patient was vaccinated on 23-AUG-2011, with a dose of PREVNAR 13. At the time of the report the patient's outcome for cystic astrocytoma was not reported. It was unspecified if the patient sought medical attention. Upon internal review cystic astrocytoma was considered an event of cancer and an other important medical event. Additional information has been requested.
pt recvd vax & had pain since inject; swelling; redness; fever; warm to touch in the last 2 days; tx w/warm to cold compress
patient received less than half the dose; experienced a needle and syringe detached; A spontaneous report was received from a physician concerning a patient who experienced a needle and syringe detached and patient received less than half the dose.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Patient received MCV4 on RD during time of visit arm was swollen and large circle was appeared on injection site. Patient was prescribed Benadryl, Hydrocortisone, Keflex. No other action was taken.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JAN-2019, the patient was vaccinated with a dose of VARIVAX, via the intramuscular route in error (lot# and expiration date were not reported) for prophylaxis, and during the same visit, he or she was inadvertently given a dose of RECOMBIVAX HB 10/1.0 microgram/milliliter injection, lot # R015160, expiration date 09-NOV-2020, via the subcutaneous route. No adverse effects were reported in the patient.
SHINGRIX vaccine given at a different facility in the morning of 12/31/2018. Subsequently patient felt ill with malaise, aches and chills throughout the rest of the day. He went to bed and woke up at 1:30 am on 1/1/2018 and had a seizure.
I had swelling and pain and rash at the sight of the injection early on, I thought it was just a minor reaction and I had a flu vaccine at the same time and it was in both arms, but it was in the left arm first, and then I took BENADRYL because the rash had spread over every inch of my body for over the last 4 weeks. It is red and raised and it's a lot, I went to the Dr. office and the gave me cetirizine, and famotidine, to help with the symptoms and it helps some but it is still going on.  It is still going on and there is puncture mark where they did the injection it's like a dark spot on my arm like it is scared.  There have been a consult to my allergist but I have not seen anyone yet due to them believing that I am having an allergic reaction to a different medication that I am taking.
I went to the doctor on November 4 because I had two lumps, one on the inside of my left leg and one on the outside of my calf. He said they were small blood clots. He said they were superficial blood clots and not deep vein. He gave me a strong dose of ibuprofen, Naproxen, and that was the first time I went to the doctor, and he sent me home after that. On the 13, I started not feeling well. I was feeling tired and having chest pains. I had the 13 and 14 off so I took those days to rest. On the 15, I felt horrible. I couldn't breathe, I was sweating, there was chest pains. I couldn't catch my breath and I just felt horrible and cried. I called to make an appointment with my doctor, and they couldn't get me in until 11/19/2021. My doctor called me and told me to go to the ER. I went to the ER in the city. I was there for 8 ½ hours and they did a bunch of blood work and x-rays. They did a CAT scan with contrast dye, and they also did an ultrasound, and it came back that I had a large blood clot in my right lung and a smaller one in the lower left one. They sent me home with shots for 5 days in my stomach (Enoxaparin) and after that I was put on a prescription to take every day (Pradaxa). On 11/20 someone called me and told me they found a lump on my left breast and needed to go get a mammogram for that as well. When I got the mammogram, they couldn't figure out what the lump was, so they also did an ultrasound as well. I went to go to work on 21st or 22nd and they sent me home because I couldn't breathe, and I went to the urgent care, and they took me off of work for a week because I couldn't breathe. I went to get the mammogram done and the radiologist said that that they're finding lumps in the breast of the side women get the shot in. Taking the medication my doctor gave me and I also did a follow up on 11/24 on the phone and have another follow up in the next month on February 11, 2022, to see if I can go off the blood thinners. Still coming up short of breath, but chest pains are no longer ongoing.
after getting injected, patient complained on filling  dizzy and lightheaded, wanted to lie down I asked him to sit down and put his head between his knees,  also said that he feels pressure behind the eyes, was sweating and after 15-20 minutes said he feels nausea, he refused medical help (calling 911) ,  40 minutes after the shot he said he is feeling ok and wants to leave. He had female companion with him. I just left him message 24 hours later but got no response yet
my ears are blocked / Like talking in a cave; had some vertigo; This case was reported by a consumer and described the occurrence of vertigo in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced sensation of block in ear. On an unknown date, the outcome of the vertigo was recovering/resolving and the outcome of the sensation of block in ear was not recovered/not resolved.   It was unknown if the reporter considered the vertigo and sensation of block in ear to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had vertigo, which was better. The patient's ears were blocked which were still there at the time of reporting. The patient stated that, it was like talking in a case. The patient was asking as was that an issue of the injection or just weird timing.
Patient presented to primary care physician's office on 7/17/06 with a 3d history of fevers, chills and headache and a 1d history of left testicular swelling and pain. Exam remarkable for mild-moderate swelling and tenderness of left testis.
Muscle aches back of thighs, both legs  Symptoms started after my 2nd Pfizer booster. Currently stopped statin drug to see if that?s the problem rather than vaccines
Information has been received from a consumer concerning his 7-year-old daughter with asthma and a history of hepatitis A, who at one year of age, on approximately 30-NOV-1999, was vaccinated with a dose of Varivax. On 01-OCT-2006 the patient developed "bumps under her arm" which was diagnosed as breakthrough chickenpox. Unspecified medical attention was sought and she was treated with acyclovir. No diagnostic or laboratory studies were performed. Subsequently, the patient recovered from breakthrough chickenpox. No product quality complaint was involved. Additional information has been requested.
Pt reports severe pain at site of injection, throbbing and tingling on surface of left hand.
After the first shot I felt very fatigued and tired; fall asleep while working; This is a spontaneous report form a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 16:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation (age at vaccination: 50 years old).  Patient was not pregnant. Medical history included arthritis. Concomitant medications included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN).  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 01:15, after the first shot patient felt very fatigued and tired.  That never seemed to go away.  She would be working and just fall asleep while working. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-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 medication information was not reported  Treatment information was not reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vial Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021.   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received on 28-OCT-2021 contains included no new Information.
sore; swelling; marks on leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    Concurrent medical conditions included Thrombosis leg (Blood clots in legs) since July 2020.   In July 2020, the patient started PREGABALIN (LYRICA) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg). At the time of the report, PAIN (sore), SWELLING (swelling) and CONTUSION (marks on leg) outcome was unknown.            Treatment information not reported.  No concomitant medications were reported.
Initial report was received on 28 September 2011 from a health care professional, which involved a cluster of two male patients who experienced adverse events after receiving FLUZONE HIGH-DOSE, lot number UH444AB. This case captures one of the male patients. The other patient has been captured in case number 2011-09381. A male patient (age 65-80, exact date of birth not reported) who had no illness at the time of vaccination had received on an unspecified day in September 2011 an intramuscular injection of FLUZONE HIGH-DOSE, lot number UH444AB (site was reported as left, right deltoid) and an unspecified amount of time later, experienced site pain and soreness. The patient was evaluated by a physician. He was diagnosed with cellulitis and was treated with antibiotics. The needle size used for vaccine administration was 5/8", 25 gauge. No additional information was provided at the time of the report. Outcome was reported as unknown. The reporter for this case is the same as for cases 2011-09381, 2011-09382 and 2011-09383. Documents held by sender: none.
This spontaneous report as received from other health professional as part of a marketing research program, refers to a 62 or 63 year old female patient. On an unknown date approximately in 2012 (reported a 1 year ago) the patient was vaccinated with a dose of ZOSTAVAX (lot # and dosing regimen was not provided) administered once for herpes zoster vaccination. On an unknown date the patient developed shingles (mild) after receiving the vaccine. The patient recovered with sequelae from the event on an unknown date. Reporter's causality was not provided. Additional information has been requested.
Had a first dose on 1/23/2021 with no adverse reaction other than some pain near injection shot.  The second dose was on 2/20/2021.   I experienced a  fever of  (101.7) and weakness later in the day.  The next day on 2/21/2021 in addition to feeling weak with a slight fever of 99.5 I broke out with a bad rash all of my body.  I went to the emergency room at 9:30 p.m. and was there for two hours. They gave me an IV which included Pepcid and a dose of Benadryl.  The ER doctor prescribed Prednisone 20 MG for five days, Famotidine 20 MG for five days and an Epi pen just in case I needed it.
got the first dose of Covid 19 vaccine a week ago (22Mar2021) and tested positive; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 22Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first dose of Covid 19 vaccine a week ago (22Mar2021) and tested positive (assessed as Mar2021). The outcome of the event was unknown.
This spontaneous report as received from a physician refers to a  69 year old female patient who on 14-FEB-2013, was vaccinated with PNEUMOVAX 23 dose 1, intramuscular (lot #: H014561 Exp date: 21-MAR-2014) (dose not provided. No concomitant medications were reported. The physician stated that on 14-FEB-2013, a patient, who was administered PNEUMOVAX 23, developed a 5-6 cm area of pain, swelling, and induration at the injection site. The patient was evaluated at a local emergency room and prescribed Doxycycline, BENADRYL, and topical hydrocortisone cream. The patient recovered in 36 hours. The relatedness adverse events was unknown for PNEUMOVAX 23. This is one of several reports from same source. Additional information has been requested.