chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate for about an hour after the second dose), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 008B21-2A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis and Dementia. Concomitant products included PREDNISONE for Rheumatoid arthritis. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (increased heart rate for about an hour after the second dose). On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 17-Apr-2021, HEART RATE INCREASED (increased heart rate for about an hour after the second dose) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Heart rate: increased (High) Increased heart rate and normal (normal) Heart beat became normal. Treatment information was not provided. This case was linked to MOD-2021-080357 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR added to case-denied further FU; On 09-Aug-2021: Significant Follow-up : Patient current condition (Dementia) was added.; Sender's Comments: MOD-2021-080357:First dose of vaccine case.
Swelling to left arm with erythema and warmth, on tender. Cap. Refill brisk. Pt awake, alert,playful, non toxic appearing.
I had pained at the vaccination site with swelling and redness.  I was fatigue, nausea, headache, chills, and body aches.  I also loss my sense of smell as well.  I was in bed for a few days after my shot.  I also had brain fogs.  I had swelling my lower extremities.  I got tress in my mouth for 3 times now.
From initial correspondence received at manufacturer on 3/24/03 it was reported that a 5 year old female patient received an IPOL vaccination on 7/7/98, lot number not reported. In December of 2002, exact date not specified, the patient experienced autism, fever, somnolence and a feeding problem. The outcome of this patient is unknown.
Bexsero expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.   On 22-AUG-2023, the patient received Bexsero. On 22-AUG-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Bexsero expired dose administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2023 The pharmacist reported that an expired vaccine was administered to a patient. The reporter asked what would be the next step and requested safety data. The patient received Bexsero vaccine beyond the expiration date, which led to expired vaccine used. The reporter consented to follow up.
Aura migraine headaches and chest pain started immediately.  Had 2 confirmed epileptic seizures.  27 July 2023 and 29 September 2023
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient was in the observation phase and stated he was not feeling well, that he felt a little bit of tingling. We asked if he had had any issues with the first dose he recieved on 9/3/21. He said he did not asked him to stay for an additional observation for at least 30 minutes. He began to say he was having difficulty swallowing - HCP told him we were calling 911 and to please sit next to the pharmacy. I called 911, came back to the patient. ambulance came admin epipen and took to ER
I had all the symptoms of severe allergic reaction; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; My face has been swollen, my lips, my tongue; I have been having rashes; Heart has been racing; Increased heart rate; Throat swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER8732) via an unspecified route of administration on 24Apr2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection lot Number ER2613) via an unspecified route of administration on 15May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had all the symptoms of severe allergic reaction, had swollen face, lips and tongue, had rashes, heart had been racing, increased heart rate and had throat swelling. It was reported that patient had multiple instances where patient had swelling, breakout in rashes and heart had been racing. My heart usually at night like I will get a fever, my heart will start racing. Patient was wondering what to do because patient knew that all the side effect from reading the paperwork and patient had been having this for over probably a month now, maybe it had been longer than a month. The patient underwent lab tests and procedures which included heart rate resulted as increased on an unspecified date. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
p/vax pt devel fever, initially low grade, then 104 by 11/29/99 AM;APAP q 4hr beginning w/vax;
Information was received from a pharmacist regarding his wife in late 60s (patient) as a part of market research. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2010 the patient was vaccinated with one dose of ZOSTAVAX. On an unknown date in 2015, the she experienced mild case of shingles after being vaccinated with ZOSTAVAX. Shingles only lasted two days. The patient recovered with sequelae from the event, three days after the onset, on an unspecified date in approximately 2015. The action taken was reported as none. The causal relationship between the event shingles and ZOSTAVAX was unknown. Additional information is not expected, as the consent was not given for further correspondence.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Immune system disorder.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours. Symptoms reported have She states that she felt horrific. She received Spikevax and felt nothing except a sore arm. In the past she has shown that she didn't maintain antibodies.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748891 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748891:Same Patient, Different dose
Around 3 pm on 4/14/21, I started to feel very tired and I started to get a headache. Around 6 pm, I started to experience lower back pain and my legs began to throb and my whole body became very sensitive to touch. I took tylenol or ibuprofen every 4 hours for the rest of the night. This went on until Thursday 4/15/21, when the dizziness and throbbing headache started. Every time I would stand up I would become off balanced and need to hold on to something. I was still experiencing the lower back pain, leg throbbing and skin sensitivity but the dizziness and headache became much more intense. Around 9:30  pm on Thursday, I felt like I was hallucinating and was experiencing euphoria along with a fever. I did not sleep the night of 4/15 into 4/16. I was sweating profusely with a throbbing headache that would cause spinning when I would stand up. Around 3 am on 4/16, I fell asleep until around 4:30 am when I woke up in a pool of my own sweat. The body aches, leg pain and skin sensitivity went away along with my fever. Throughout Friday 4/16, I had a throbbing headache and was dizzy with no relief. This continued into Sunday 4/18 when I started to feel some relief. My headache was pretty much gone but the dizziness is still very much there. I have also an experienced elevated heart rate and respirations throughout the last 5 days.
This is a spontaneous report from a contactable pharmacist communicated to a sales representative. A male patient in his 50's received on an unspecified date (reported as several months before the report) PREVNAR 13 intramuscular, at single dose, for prevention of pneumococcal pneumonia (immunization) and tetanus vaccine (trade name unknown), for immunization. Both vaccines were administered in the same arm. Medical history included bone marrow transplant. The patient was immunocompromised. Concomitant medications were not reported. On an unknown date the patient developed an injection site reaction with a large lump and swelling of the arm at the injection site. The events resolved within one week, on an unknown date. His experience was not painful. He was going to receive other injections or products on that day, but he did not due to his experience after he received PREVNAR 13 injection.
Pt stated day after vaccines area around injection site reddened and sore. Area has spread further below injection site (day 2). Pt to take Clarinex and apply hydrocortisone cream. Will call if worsens.
Armpit on injection side began to form a lump.  Swelling progressed into my Left breast.  Went into my clinic 2/25/2021 and was examined- was told this was a very common side effect of the vaccine.
The day after immunizations, right arm swelled from collarbone past elbow, was hot and tight. Given Tylenol and Benadryl. Pt received MMR and IPV on right arm.
The next day upper arm had a large swollen red area at injection site, painful to the touch and when moving the arm, continuing for 4 days.  Muscle and joint pain, pain standing and walking, difficulty getting up from sitting or kneeling. Joints stiff and painful upon waking in the morning. This discomfort and pain continued until today. 2 weeks after the injection and has only started to alleviate in the last 24 hours.
He just told me yesterday that the day after he got his second moderna injection both feet swelled up. Severely ! He complained of not being able to move his toes etc. There is no pain or trauma. just ironically it happened the day after his injection. He will not go see a doctor yet because he thinks it will go away. He started wearing compression stockings the day before  last and it has helped.  I am worried that he has a blood clot but he  thinks that it woudn't be in both feet. Not sure if it matters but he is a 61 year old man .  with no known co morbities. Is this a side effect that has been recorded? I am concerned but dealing with a stubborn man.
Redness at site, irritability. BENADRYL and TYLENOL given.
This spontaneous report as received from a health care worker refers to a 16 week old female patient. On 03-SEP-2013, the 16 week old patient was vaccinated with a first dose of ROTATEQ (Lot number and expiry date were not reported) 2 milliliter (ml), orally. No adverse effect reported. Additional information has been requested.
29OCT93 devel aching, chills, & cough seen by MD later that day; dx as viral illness & cough medicine w/codeine prescribed; 8NOV cont to have same sx spoke w/MD today; no change in treatment ordered;
This spontaneous report as received from a nurse (who is also the patient, her age was reported as "early 20's") via company representative. In approximately 2011 (reported as "about 4 years ago") the patient was vaccinated with the first dose of GARDASIL (dosage schedule and route of administration were not provided). The patient completed the series of vaccinations on an unknown date in approximately 2012 (reported as "about 3 years ago"). In approximately 2012 (reported as "about 3 years ago") the patient was diagnosed with cervical cancer after getting GARDASIL (the patient mentioned that she was diagnosed with cervical cancer approximately a year after she had completed the series of shots). The patient explained it was almost an exact year from the time she initially received her first dose of GARDASIL. It was explained that she received the full 3 shots when she was 18. On her 19th birthday, she was diagnosed with cervical cancer. The outcome of cervical cancer was unknown. Patient sought medical attention. The relatedness between cervical cancer and vaccination with GARDASIL was not reported. Upon internal review cervical cancer was considered to be medically significant. Additional information has been requested.
A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Very swollen arm immediately after vaccine and worsened throughout the day, inflamed and painful joints, tightness in chest
Information has been received from a nurse concerning a 19 month old patient who on 04-OCT-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 01-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several repots from the same source. Follow-up information received from the registered nurse revealed that on 04-OCT-2011 was vaccinated with a first dose of VARIVAX (Merck) (lot# unspecified, also reported as historical). It was mentioned that on 01-JUN-2012, the patient with no pre-existing allergies, birth defects or medical conditions, no illness at time of vaccination and unknown past medical history went to the clinic for a rash described as a generalized vesicular and maculopapular rash, greatest of arms and legs, excoriation, scattered dry and crushed lesions, new small vesicles scattered as well, no scaling, edema, petechia. The patient was diagnosed with varicella. No relevant diagnostic and laboratory tests were done. At the time of the report, the patient's outcome was unknown. This is a several reports form the same source. No further information is available.
Patient appeared to be due for pneumococcal vaccine. Ordered the vaccine using the ADULT IMM smartset and not the other Smartset New guidelines state for those who have not previously received any pneumococcal vaccine, CDC recommends you give 1 dose of PCV20. For those who have only received PPSV23, CDC recommends you: May give 1 dose of PCV20. PCV20 dose should be administered at least one year after the most recent PPSV23 vaccination. An additional dose of PPSV23 is not recommended since they already received it.
discoloration of her arm; has problems with her brain; both her hands and palms were "beet red"; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in right arm on an unspecified date at 12:00 (as per patient) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had received both doses of the Pfizer Covid-19 vaccine (unsure of dates, Spring or Summer) and after the first dose of vaccine both her hands and palms were "beet red", the first shot it was beet color she was describing it as, like beets, the vegetable, root, plant, reddish/purplish and both of her hands went red and it just spread through her blood and both of them became red. The patient experienced her arms were a strange red color and she has problems with her brain and she has discoloration of her arm and her arms and her palms, hands became a very red color, like beet root color. Patient informed it happened immediately after she was vaccinated. The patient informed that the vibrant color, the beet-root color was gone and she still has a little bit of redness, but its fine, she actually has it from "#", the redness. The patient has recovered and informed "no its not from the vaccination, the blood vessels, its a norm from her, its from school." The outcome of event erythema was recovered while the outcome of events problems with her brain and skin discoloration were unknown.  Information about Lot/Batch number has been requested.
Had flu vaccine on (N) shift. Within 6 hrs stated he developed achy in joints, nausea, sore throat, loss of appetite. Within 24 hrs had bilat ear pain with itching, chills & "sweats". Symptoms resolved within 48 hrs.
Woke up with severe convulsive chills and shaking. Heartrate 100 or more. Next day intense facial bone pain and sinus pain. Extreme dry nose. Leg pain. Arm pain. Pain back of neck. Constant nausea. Third day better but with abdominal cramping.
Received the vaccine in dominant arm and approximately 3 hours afterward I had to write something and was unable to hold a pen. This continued for a day in a half. I'm not almost 2 weeks post vaccine and my rheumatoid arthritis in my hands have gotten progressively worse
This case was reported by a healthcare professional via a distributor and described the occurrence of cellulitis in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, details unknown). The lot number and expiration were unknown. At an unspecified time after vaccination with FLULAVAL, the subject experienced cellulitis and flu-like symptoms. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887616A, A0887617A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial.
Soreness at place of injection, lasting for 24 hours. Started feeling tired and weak about 6 hours after the injection. Nausea, stomach cramps - all starting 7 hours after the injection, lasting for 30 hours. Diarrhea, fever (mild)/chills, lack of appetite, general discomfort, aches, and back pain - all starting 9 hours after the injection, lasting for 50 hours. Vomited once about 16 hours after injection.   Fully recovered 3 days after injection.