chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Circular red mark, over an inch in diameter....not itchy, accompanied with swelling and mild headache. This dose is the only one that has done this.
Information has been received from a physician concerning a 32 month old male pt in good health with no known allergies, who on 07/03/02 (also reported as 07/31/01) was vaccinated in the left thigh with a 0.5mL dose of varicella virus vaccine live (Lot # 637977/1898K).  Concomitant therapy administered on the same day 07/31/01 included a third dose of Haemophilus B conjugate vaccine (manufacturer unknown) (Lot # not available). There were no other concomitant medications. No rash occurred at the site of injection post-vaccination. On 11/14/02 the pt was seen in the physician's office with a "classic presentation" of chickenpox all over and coming in crops at all stages. The physician described it as a moderate case. It was noted the pt did not have a fever at the time of the visit, but he was itchy and Benadryl was recommended. It was reported that the physician estimated that the onset of symptoms was 3 to 4 days prior to the visit (approximately 11/10/02), and resolution took another 3-4 days (approximately 11/18/02).  The physician confirmed there was no known exposure in this case. It was reported that the pt was seen again on 08/04/03 with a history of "rash for 7 days". The rash was a varicella form with over 100 diffuse lesions. The physician reported that the rash was again in crops at all stages, appearing all over except for the muccus membranes. The pt also had a runny nose and a low grade fever (100.1 degrees F by ear thermometer) and "gorgza". It was noted that "usual chickenpox care" was recommended. The physician reported that again there had been no known exposure for this case. It was noted the adverse event abated, and no treatment was required. There was no product quality complaint reported. The physician stated that he was puzzled that the child had received the varicella virus vaccine live 2 years ago and had had two apparent breakthrough cases of chickenpox. The physician indicated the pt was a normal host and he was not aware of any immune dificiency, either primary or secondary. The physician reconfirmed that the pt had no known exposure to varicella prior to either case of breakthrough. The physician also stated, "it's possible that the rashes are something other than varicella; however, the clinical presentation looked very much like chickenpox." On 08/08/03 a scab from a lesion for VZV identification was obtained. On 08/11/03 it was sent to the lab. On 08/13/03 it arrived in the lab. The VZV DNA was not amplified and the B-globin DNA was amplified. On 08/19/03 it was reported that the PCR analysis revealed that the specimen was negative for varicella zoster virus. Additional information has been requested.
raised bump that looked like a bulls eye/ it was red around the area; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of local swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced local swelling (Verbatim: raised bump that looked like a bulls eye/ it was red around the area).  The outcome of the local swelling was not reported.   It was unknown if the reporter considered the local swelling to be related to Arexvy.     It was unknown if the company considered the local swelling to be related to Arexvy.   Additional Information: GSK receipt date: 11-Sept-2023 The pharmacist reported the patient received a dose of Arexvy and had a raised bump that looked like a bulls eye and it was red around the area. The reporter consented to follow-up. The case had been link to the case US2023AMR124863, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR124863:same drug, same reporter US-GSK-US2023AMR124863:same vaccine, same reporter
lightheaded, sweaty, states he is a fainter around needles 100/60 HR 60 O2 100 Improved with food, juice and time in recliner
pt recvd vax 13OCT93 & started swelling has had inc swelling & erythema since then involving area from shoulder to elbow;
Fever of 102 for one full day after Full body and joint aches - severe Chills and shakes - severe Mild to Moderate confusion loss of equilibrium
Increase flow and length of menstrual cycle. 2nd dose was received 11/20/21- Pfizer FF2593  Over a year out from the last dose and menstrual cycle is still producing substantially more fluid, heavier menstrual cramps and a longer period, consistently, every single month.
03/05/2018: presented at PCP appointment with rash at site of Bexsero injection (administered 02/23/2018). Exam showed patch of 12-15 roundish red spots, size from 5-15mm. Ring-like appearance, center pale pink with no bullseye. Non-tender, non-blanching. Appearance suggestive of erythema multiforme except for no central bullseye. No treatment other than OTC hydrocortisone cream prn, with recheck in 2-3 days.
Caller states her aunt received the first dose of the Pfizer COVID vaccine on 18 FEB 2021. Caller states on 06 MAR 2021 aunt was diagnosed with COVID-19. Caller states on 19 MAR 2021 her aunt tested negative for COVID-19; Caller states her aunt received the first dose of the Pfizer COVID vaccine on 18 FEB 2021. Caller states on 06 MAR 2021 aunt was diagnosed with COVID-19.; This is a spontaneous report from a contactable other hcp.  An 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation.  The patient medical history concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test on 06Mar2021 and sars-cov-2 test was negative on 19Mar2021. On 06mar2021 patient was diagnosed with covid-19. Caller states on 19Mar2021 patient tested negative for covid-19. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity with only 1st dose of the vaccine.
Her daughter developed a redness in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 17 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: I know she had covid , she got covid-19 2 months ago, that's why we waited to get her the shot. The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Her daughter developed a redness in her arm". Additional information: Her daughter got the pfizer covid 19 vaccine on Monday, and now the redness was going down her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
developed hives on her stomach and right leg 3 hours after administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 hrs after receiving Shingrix, the patient experienced hives (Verbatim: developed hives on her stomach and right leg 3 hours after administration). The outcome of the hives was resolved (duration 4 weeks).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The patient self-reported this case. In 2023, the patient developed hives in her stomach and right leg 3 hours after administration of the vaccine and it was resolved. The reporter did not consent to follow-up.
Fever, chills., muscle achyness in my back at base of lungs (hurts when I walk) area, knee joint pain
Headache same day, afternoon into evening. Ibuprofen helped.  Fatigue same day, but worse following day until around 1pm Soreness in arm (shot location) same day and day after.  Ibuprofen helped but never completely went away until 2nd day after injection.
Injection site started itching 8 days after vaccination (1/29) and on day 9 (1/30)  patient developed a raised red circle about the size of an orange at the vaccination site. She will go to a take-care clinic today if it doesn't resolve. She is not running a fever.
This spontaneous report was received from a 72 year old female patient and refers to herself. The patient was diabetic and had allergy to sulfur. On an unknown date in 2013 (reported as "about two years ago"), the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, route of administration, lot # and expiration date were not provided). The patient did not take concomitant medication. On 30-SEP-2015, the patient got shingles. She sought medical attention. On an unknown date in 2015, the patient was hospitalized. The patient had no lab diagnostics studies performed. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as no contact details were provided.
broke out in hives; I will just get tired, it seems like I need to go to sleep; mouth starts itching; I get a reaction in my eyes like they turn red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included allergic to fish. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot Number: EW0179) for COVID-19 immunisation and patient didn't get any reaction from the first one. The patient stated that patient was just not really, had second shot on Friday, patient think it was the 15Jun2021. The patient was allergic to fish and right now patient had this kind of complicated. The patient was super allergic to fish and fish odor and mouth started itching, patient got a reaction in eyes like they turn red and patient also broke out in hives yesterday (15Jun2021). The hive went away but the hive just return in last 30 minutes. The patient meant, their place today, patient had dinner around, fish or any fish odor (statement incomplete), patient did not know if it's patient sensitivity to things that patient might be allergic to changing because patient ate in a 'barb' with peanuts in it and patient could deal with Covid shots every once in a while. It would just hit patient. The patient would just get tired you know it seems like patient need to go to sleep, it might be hard to determine what it was, this hives would go away but it's still on the backside. Consumer stated that can't rule that one, patient don't think they are, but patient really didn't want to take a chance but patient had the second shot on 11Jun2021. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
About 5 minutes after the shot, patient tried to get up and knock on the door to the vaccination room but he fell to the floor. He was not responding when asked questions but was still breathing.  His hands had little tremors. Then after a few minutes patient was responding and talking to the staff. We still called 911 because patient was unresponsive again (second time). Shortly after patient was responsive again. Patient's spouse also came to the scene in a short time. His wife said patient had same problem previously when he had his blood drawn. Paramedics assessed that patient was stable and did not need further medical help. Patient left the store with his wife.  We recommended him to have second shot with primary care provider or at a facility with more medical assistance.
it blocked the effect of vaccine; patient did not have antibodies; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable nurse. This nurse reported same events for two patients (patient's mother and her son). This is the second of two reports.   A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 23Dec2020 at a single dose (lot number: EL1284) at a single dose and second dose on 11Jan2021 at a single dose (lot number: EL3246) for COVID-19 immunization; prednisone, via an unspecified route of administration from an unspecified date at 40 mg; famotidine (PEPCID), fexofenadine hydrochloride (ALLEGRA) and montelukast sodium (SINGULAIR), all via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included psoriasis, severe allergies and anaphylactic reactions. There were no concomitant medications. The patient's mother and the patient had a history of anaphylactic reactions so their doctor recommended to take a series of prednisone 40 mg for 3 days along with famotidine, fexofenadine hydrochloride and montelukast sodium, to prevent an anaphylactic reaction. Around 2-3 weeks after the first shot, the patient did not have antibodies; maybe it was the steroid (unspecified medication) and he did not have a reaction. He took the second shot this week Monday but he still had no antibodies. The patient's mother was wondering if the reason might be from the pre-medications as the patient was not on any other medications. He received the vaccine in the hospital. The reporter considered that the event was related to the medications that the patient took (prednisone, famotidine, fexofenadine hydrochloride and montelukast sodium), she guessed that it blocked the effect of vaccine and that was why it was not going up yet. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021029933 Same reporter, product, events, different patient
This spontaneous report was received from a pharmacist refers to a 81 year old non-pregnant female patient. She had no pertinent medical history and concomitant medication. She was allergic to aspirin and codeine. On 05-AUG-2016, the patient was vaccinated with ZOSTAVAX. On 09-AUG-26, the patient experienced "hives on her body and diarrhea". The patient sought medical attention by calling the pharmacist. The outcome of the events was unknown. The reporter did not provide relatedness of the events with ZOSTAVAX. Additional information has been requested.
Pain and tenderness on injection site beginning in the hours following injection that lasted approximately 4 days accompanied by redness swelling and hardness.  The maximal area of swelling was approximately 4 inches surrounding the injection site.  The tenderness and sswelling resolved over approximately 4 days  without treatment or sequelae.
tachycardia (especially when lying down); irregular heartbeat; dizziness, fatigue, difficulty breathing, blood pressure fluctuations; low oxygen levels, general debilitation
Left arm red, swollen 2 days after vaccination of KINRIX and MMRV.
The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 dose. She is in the hospital with left sided weakness, facial droop and speech changes. She is receiving blood thinner and therapies.
Site: Pain at Injection Site-Medium, Additional Details: Pain when lifting left arm persisting for over 1 week. Also it is difficult for her to make a fist with her left hand
rash diffuse over body reported by mom 9/30/99 sen by MD same day;sx started 9/29/99 w/fever to 100.2;rash started around face & ears;
Myalgia, Fever, congestion, sore throat, fatigue, headache, chills Narrative:
The second dose lot number is 011a21a.  I have had ringing in my ears ever since a couple of days after my second dose.
Diagnosed with vertigo, sensorineural hearing loss in left ear, and tinnitus after hearing test, MRI of head with and without contrast, and VNG test.  Precursor to sudden onset of acute vertigo was pressure and echoing in ear which began 12/4/2021.  Acute vertigo followed 5 days later on 12/8/2021 followed by a month or more long illness. Prior to 12/4/2021 I had periodic "zingers" in my ear.
Initial information has been received from a 52 year old female registered nurse reporting on herself, with Graves disease and a history of drug reaction/allergies to fluorescenin angiogram dye. On 21-JAN-2013, the patient was vaccinated with 0.5 ml PNEUMOVAX23 (lot # H014282, expiration date: 09-APR-2014) intramuscular injection. No other co-suspects were reported. Concomitant medications included SYNTHROID, estradiol, spironolactone and pantoprazole. On 22-JAN-2013, the patient experienced the following adverse reactions after receiving PNEUMOVAX23: fever, chills, malaise, headache, back pain and injection-site soreness and tenderness. On 22-JAN-2013, her fever was 103.3 degrees Fahrenheit. She spoke with the physician, who advised that she take ADVIL (unspecified manufacturer, strength and frequency) and BENADRYL (unspecified manufacturer, strength and frequency) to alleviate the symptoms. As of 25-JAN-2013, her fever has gone down to 99 degrees Fahrenheit. Lab diagnostics studies were not performed. No further information was provided. At the time of the report, the patient was recovering. Additional information has been requested.
on 10/02/21 Noticed redness, swelling lump size of tennis ball at injection site. Had fatigue and body aches
Fell sick fever morning of 12/15 - started with nausea stomach pains fever rise within hours to 104.5, went to er where was told blood pressure was 88/40, hard to breath.  Was in septic shock- small intestine full of infection which moved to kidneys, liver and appendix,  fluid on lungs . Was in hospital 4 days and duscharged on the fourth . They said it wasn?t bacterial infection mite viral and couldn?t really pinpoint what the cause was but said it was enteritis
Client has cerebral palsy and received vaccine during a visit. Client is non-verbal. Saturday evening (4/17/21), Mom noticed rash on daughters legs (groin). She stated it looked flushed red. On Sunday she noticed her face was flushed as well. She gave Tylenol on Sunday at 3:50 pm. Mom has been putting hydrocortisone cream on her face for the past week and  states the rash is mostly resolved. Mom states Saturday and Sunday she was very irritable and "moody." She states as of today, 4/28/21 she is not irritable any longer and the redness from her face has mostly resolved.
Could barely talk; husband had to take her to the bathroom; Trouble breathing; Pressure in the chest/Pressure on chest comes and goes; Brown Urine; Could barely move; Itchy Bumps on both legs; Tiny Bumps on both legs; Rash on both legs; Fever 103 F; Vomiting; Severe Nausea; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move) and PRURITUS (Itchy Bumps on both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2021.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache). On 22-Jul-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes). On 17-Sep-2021, the patient experienced SPEECH DISORDER (Could barely talk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SPEECH DISORDER (Could barely talk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 103 (High) High. On 22-Jul-2021, Echocardiogram: normal (normal) normal.     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.   Lab data included ECG, cardiac test, cardiac enzymes. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-21: DOB added and age updated.
Post vax, the pt developed edema/ecchymosis at injection site. Treated with Vantin.
pain in arm approx 6 weeks, contacted MD, xray showed infection of bone or covering over bone? at skin injection site. MD: mri shows scar tisswue on bone/periosteo change/osteomyelitis? therapy recommended: physical therapy.
DOSE #3 OF COMIRNATY, PFIZER COVID VACCINE GIVEN 4/14/22, LOT # C-FK9893; pt had a positive COVID test at home; was told by PCP (name unknown) to go to ED for Remdesivir; over hospital course, pt became hypoxic and her condition worsened; respiratory failure; ICU; eventually became unresponsive; status changed by family to DNR and she passed away in the hospital
Mom called and reported child ran slight fever for 8 hours and then 35 hours after receiving vaccine child developed a rash from breast bone to umbilicus.  Lasted for 2 days.