chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vein appeared greenish and that it maybe clogged or a blood clot; the vein appeared greenish and that it maybe clogged or a blood clot; dizzy; his left leg started to hurt and when he looked at the leg, it had a vein popped out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 18Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VEIN DISORDER (non-serious), VEIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "the vein appeared greenish and that it maybe clogged or a blood clot"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his left leg started to hurt and when he looked at the leg, it had a vein popped out".  Additional information: Patient had his first dose of the Pfizer COVID-19 vaccine last 18Sep2021 and "got dizzy for a couple of minutes which may be an allergic reaction". Patient stated that "3-4 days later, he did some work at work and his left leg started to hurt and when he looked at the leg, it had a vein popped out, he couldn't walk, and the vein appeared greenish and that it maybe clogged or a blood clot". Patient wanted to know if "blood clots" had been reported as side effect of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I felt a little nauseous the first day after the shot. The next day I feel Dizziness fatigue, soreness, arm and elbow ache with a little headache.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant medication was not provided.  Treatment medication was not provided.
This spontaneous report as received from a physician refers to a 4 year old female patient with drug reactions/allergies to eggs and drug reactions/allergies to nuts. On 23-SEP-2014 the patient was vaccinated with PROQUAD. Lot number reported as K009891, expiration date unspecified. Other suspect therapies included DTAP (unspecified manufacturer) and IPV (unspecified manufacturer) date of vaccination 23-SEP-2014. Dose, route, lot number and expiration date were not reported. The physician reported that the patient left the office and while in the parking lot the patient began to vomit. The patient and her mother went back to the office and the patient then developed urticaria. The patient developed hives and angioedema and her face became flushed with the appearance similar to a sunburn (on 23-SEP-2014). The patient was given BENADRYL. Even though the patient had developed these symptoms the physician does not consider them to be life threatening. The outcome of vomiting, her face became flushed with the appearance similar to sunburn, angioedema and urticaria/hives was reported as recovered (on 23-SEP-2014). No lab diagnostics studies were performed. The patient sought medical attention. Additional information has been requested.
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 18-JUN-2013 (lot H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
Had two syncope events 10 minutes after receiving first dose. On day 8 (3/22/2021) I started to get a red itchy circle around the injection site which I am assuming is "COVID arm." Still have a red circle today (3/23/2021).
This case was reported by a pharmacist via call center representative and described the occurrence of taste loss in a 72-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, 1 hr after receiving SHINGRIX, the patient experienced taste loss and swollen tongue. On an unknown date, the outcome of the taste loss was not recovered/not resolved and the outcome of the swollen tongue was unknown. It was unknown if the reporter considered the taste loss and swollen tongue to be related to SHINGRIX. Additional details were reported as follows: The patient's husband reported this case. The patient received SHINGRIX vaccine on left deltoid. An hour after receiving the SHINGRIX, the patient reported losing her sense of taste. The patient also reported that her tongue feels swollen although it did not look swollen. The reporter did not consent to follow up. This case has been linked to case US2019GSK017156, reported by same reporter.
Pt came into be evaluated for a possible reaction to covid vaccine  that she received at senior center. Pt was experiencing left subzygomatic  cheek swelling (quarter sized area), Pt denies difficulty breathing, denies ever having facial dermal fillers. Pt on low dose of prednisone that has been previously prescribed by HCP. Pt took Claritin D. Pt was told to take OTC Benadryl at Dr. Visit with other HCP.
That evening I started feeling aches, fell asleep, woke up in pain, through out the day fever spiked,  also had cold sweat, chills, headache, diarrhea, nausea, muscle and joint pain, brain fog, muscle spasms.  I felt those symptoms for 3 days, on friday I was able to get up, the majority of the symptoms went away, I still have headaches, muscle and joint pain, shortness of breath, and muscle spasms.
Oropharyngeal pruritus, hoarseness/voice change - developed at 30 minute observation mark Monitored for additional 15 and then 30 minutes with improvement in symptoms
I ran a few errands after the vaccinaction and got home about 3:30pm.  All of a sudden I began to feel hot and dizzy.  Then the muscle aches started so I went to bed.  But this time it didn't go away!  Today is now 4/14/2021 and I am still having muscle ache in my right upper thigh and right side buttocks.  It is lessening but it also keeps me from getting a good night's sleep.  I've never had such a sensation.  Even after my hip replacement surgeries I didn't have this kind of discomfort.  I sure hope it ends pretty soon. For the past 2-3 years I have a routine of walking a minimum of 2 miles daily and that's during the winter as well since I'm up here in my state.  I'm strong and I'll get over this but I never expected this.  It feels like a "virus" has settled into the muscle tissue surrounding my right side hip implant.  I keep walking and doing my other exercises but it's very tiring.  Just wanted someone to know about this.  And, no, I did not bother going to the doc's with this.  Why would I?  The 'brainwashing' of the past 30 years about not bothering to go to the doc's if you have a cold because it's a virus and there's nothing we can give you for a virus has really worked.  I stay away from the doc's as much as possible!
On 2/14/01, varicella vaccine given in right deltoid area. On 3/7/01, fluid filled blisters noted on abdomen, torso and groin. Noticeable discomfort. On 3/12/01, vesicles fading.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 19:00 (Lot number: 40135BA) at the age of 36 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot Number: EH9889), administration date: 18Jan2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EK4176), administration date: 22Dec2020, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Fever of over 102.00 degrees"; CHILLS (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Body aches"; ARTHRALGIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Joint pain"; HEADACHE (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Headaches"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Large swollen lymph node under armpit of injection site"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Very sore arm"; LIMB DISCOMFORT (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Could not lift arm or support weight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, headache, vaccination site lymphadenopathy, pain in extremity, and limb discomfort. Additional Information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning an approximately ten-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Jan-2010, the patient received FLUMIST (expiration date 31-Dec-2009). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Rash is itching; rash under his arms from armpit to elbows underneath and on his sides below his belly button and in the groin area and on his buttocks; This is a spontaneous report from a contactable consumer (patient's wife). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the right arm on 02Jan2021 00:45 at a single dose for COVID-19 immunization. Medical history included hard of hearing, surgery to remove the cancer, cancer broke his arm and he had a reverse shoulder replacement (medical conditions predating treatment with Pfizer COVID 19 vaccination); kidney failure that is better, muscle (disorder), blood pressure (abnormal), anxiety and radiation. The patient was previously given oxycodone, Ativan, and Xanax to take as needed after his surgery, but he has not taken them since Oct2020. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety, amlodipine for blood pressure, metoprolol for blood pressure, tamsulosin hydrochloride (FLOMAX) from Sep2020 for kidney, carisoprodol (SOMA) from 22Oct2020 for muscle relaxant, ferrous sulfate, docusate sodium (STOOL SOFTENER), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were ongoing and other unspecified products. The reporter stated that she and her husband got the vaccine on 02Jan2021 and the husband has developed a rash under his arm from his arm pit to elbow underneath, on his sides, below his belly button and in the groin area and on the buttocks. Rash was itching on 06Jan2021. She wanted to know could the COVID 19 vaccine cause this 4 days later. The patient noticed the itchy rash four days later on Wednesday afternoon 06Jan2021. He took Benadryl 25mg tablet by mouth that night before bed and then in the morning and put over the counter itch relief cream on it so in the night around 0200AM not too long after taking the Benadryl, the rash went away, pretty much gone. Today it seems to have come back and now it was worse because he has it on his buttocks. He didn't have it there at first. Mentioned that the patient also took a cool shower before going to bed. Wife mentioned that she just looked the rash right now and it was improved. Asking should he continue taking his relief or stop and let the doctor look at it? Advised caller to consult HCP. He is planning to get the next vaccine 23Jan2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to physician office and ER. No prior vaccinations (within 4 weeks). No relevant family medical history. No relevant tests done. Outcome of the events was recovering.   Information on the Lot/Batch number has been requested.
A week and a day after receiving, left arm is itchy and red around the injection site area.
Heart skipping  and racing for apx. 2 hours after vaccination.   Headache   Low grade fever  Body aches.  Pain in all  bone including ankles, fingers, and toes and arches
Patient present to ED for chest pain and fatigue. Per patient, she was gardening last week and developed chest pressure/SOB when moving around some mulch this lasted on and off for 3 days and then was followed by intense fatigue which persisted today so she came into ED. She was placed in observation for chest pain, and to rule out ischemia. Upon admission, a COVID-19 test was run for screening, and was positive. Other than fatigue and chest pain, she was not endorsing other symptoms and did not have hypoxia or coughing at all.  Although on admit, there was plan to get a stress test, given the COVID-19 diagnosis, this was deferred. She was discharged to home in stable condition on 5/5.
Information has been received from a registered nurse concerning a 24 year old female with latex allergy who on 19-DEC-2001, 01-FEB-2002 and 14-JUN-2002 was vaccinated with a three dose series of RECOMBIVAX HB (Manufacturer unknown). On 05-FEB-2007 patient's hepatitis B titer was found to be negative. On 08-FEB-2007 and on 08-MAR-2007 the patient received a two dose series of RECOMBIVAX HB. The titer was done on 11-JUN-2007 was positive. A product quality complaint was not involved. Additional information has been requested.
It left a huge knot in my arm and was extremely hot and red all around it for at least 3 weeks
rash on thighs, abdomen and back.   Large red spots.   do not itch.   do not break open.   just spots.    increased lethargy
pretty bad severe allergic reaction; Incomplete course of vaccination; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) (seriousness criteria hospitalization and medically significant) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination). At the time of the report, ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient received 1st dose of MODERNA COVID 19 vaccine in January 2021 , She had a pretty bad severe allergic reaction from the dose and was hospitalized. She was not able to get the 2nd dose due to severe reactions. She wants to complete the series to avoid discrimination and asking if she can have the 2nd dose as Pfizer. She spoke with the pharmacist and told her that she can still have the 2nd dose even if she had severe reactions   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.   This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact onset latency of the event severe allergic reaction relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient did not receive a 2nd dose of mRNA-1273 vaccine due to severe reactions with the 1st dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact onset latency of the event severe allergic reaction relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient did not receive a 2nd dose of mRNA-1273 vaccine due to severe reactions with the 1st dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical.
arm hot and red; Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day; low grade fever of 99; sore arm; an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling; arm hot and red; accelerated pounding heart beat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day) and PYREXIA (low grade fever of 99) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A-2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), PYREXIA (low grade fever of 99) and MYALGIA (sore arm). On 11-Feb-2021, the patient experienced ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm hot and red). On 15-Apr-2021, PYREXIA (low grade fever of 99) outcome was unknown. At the time of the report, FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (arm hot and red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication was provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-133172 (E2B Linked Report). This case was linked to MOD-2021-133049, MOD-2021-133270 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133172:Case for patient first dose
It was reported that a 38 year old female patient received a JE-Vax vaccination on 02/12/01 at3:05 pm. Reportedly, 5 minutes after vaccination in the left deltoid, the patient complained of headache and feeling "foggy head". The doctor was notified. Blood pressure 107/71, pulse 92,and color slightly flushed. Tylenol 325mg tablets two per oral STAT at 3:17 for headache .At 3:20 pm,  blood pressure 134/66, pulse 96.color less flushed. Patient states she felt better . Slight headache 3:50 pm blood pressure 129/71, pulse 96. Patient states slight headache, feeling better. Ok to discharge per doctor. Reportedly the patient recovered from this experience.
Superficial thrombophlebitis right arm ( same arm as administration of vaccine and iv site)
My menstruation became lighter after the 2nd Pfizer dose. Then, in the Autumn my menstruation completely stopped.  My menstruation has not returned.
Availability issues with the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eosinophilic asthma. Concomitant products included covid-19 vaccine (Covid Vaccine).   In NOV-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue (Verbatim: Availability issues with the vaccine). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt date: 09-MAY-2023 The patient was self-reported this case. The patient called in regarding a question about starting Nucala. Upon discussion, the patient reported he had taken 2 doses of Shingrix but that he had a couple of years between the first and second dose due to availability issues with the vaccine. The Patient did not recall dates of the Shingrix vaccines or the sites of the injections.  He received a covid vaccine on the same day as his second Shingrix dose sometime in November 2022. The patient received second dose of Shingrix late than recommended period due to availability issues, which led to product supply issue. The reporter did consented to follow up.