chrisvoncsefalvay/vaers-outcomes huggingface dataset:
axillary lymph node swelling/neck lymph node is swollen; This is a spontaneous report from a contactable physician. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at the left arm from an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported hat the patient had axillary lymph node swelling. It was stated that the patient's neck lymph node is also swollen. This was the patient's first injection and clarified that it was given in her left arm. The outcome of the event was unknown.  Information on the lot number/batch number was requested.
Headache, Myalgia, NauseaVomiting, fatigue, general malaise Narrative:
NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received ustekinumab (form of admin and route of admin were not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The patient was recovering from not feeling well. This report was non-serious.
Two to three minutes post-vaccination, the patient stated her vision was darkening. Her eyes dilated, and then she became briefly unresponsive. Her fingers tightened, and her neck arched.  Her face changed color. First it was red, then pale-green, then pale. She was warm as well. All this went on over the course of about five to ten minutes. After about five minutes she was more aware of herself and stating she felt nauseous.  After eight to ten minutes she was completely back to normal except that she felt weak and nauseous still. She was taken by paramedics to a local hospital for follow-up treatment.
stroke of the 4th cranial nerve; Dizziness; double vision; This is a spontaneous report from a contactable nurse. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), intramuscular, in the left arm on 16Mar2021 at a single dose (at the age of 60-years-old) for Covid-19 Immunization; vaccinated in the hospital. Medical history included hypertension and allergies to sulfa. Concomitant medications were not reported. No other vaccine in four weeks. The patient had no COVID prior to the vaccination. On 16Mar2021, the patent experienced dizziness and double vision. He saw the eye doctor who stated that he had a stroke of the 4th cranial nerve. No treatment was given. The patient was not COVID tested post vaccination. The nurse assessed the events as non-serious. The patient was recovering from the events.; Sender's Comments: A contributory role of BNT162B2 to event a stroke of the 4th cranial nerve cannot be excluded based on limit information. Case will be reassessed when further information is available. 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.
Per Doctor, Normal neuro exam other than facial nerve testing. Flu shot Friday afternoon and symptoms started Sunday AM, possible correlation. Also very possible that this is viral. He is probably grade 3 on House-Brackmann scale, will go ahead and tx with steroid burst, VALTREX- advised of possible SE. Advised of importance of keeping eye lubricated and sun protection. Also discussed with optometry, no need for f/u from their perspective at this point. Will check labs and CXR considering airway exam. Pt will f/u Friday for re-eval. He was instructed to f/u sooner with any worsening or concerns or go to ED. Pt verbalized understanding and agreement with POC.
This is an initial report of an AE, received on 06Oct2015, for Protein Sciences FLUBLOK. A 23-year-old female received FLUBLOK intramuscular on 06Oct2015. On 06Oct2015, within 5 minutes after injection, the subject experienced local area reddened and raised, down her forearm to elbow. She was given BENADRYL orally at 12:30 pm. At 2:30 pm, she was observed to have mild edema and numbness to her fingertips, The rash was denser at the sight of injection and more intense. At the time of the report, the events of local area reddened and raised, down her forearm to elbow, numbness and mild edema were ongoing. Medical/surgical and concomitant medications were not reported. The company's assessment of the causal relationship between local area reddened and raised, down her forearm to elbow and FLUBLOCK is a possible relationship in light of the safety profile information that injection site reaction is an expected event, between numbness and FLUBLOCK is a possible relationship in light of the reported information that the event occurred hours after receiving FLUBLOK, and between mild edema and FLUBLOK is a possible relationship in light of the safety profile information that injection site reaction is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
101 Fever Severe Chills Body Aches Very similar to the symptoms of Covid from June 2020.  Shorter lasting.  Did not have fatigue or cough.  Fever was lower than when I had Covid, but the body aches were siimilar.   Symptoms were treated with OTC Extra Strength Tylenol
This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization, and to Prevent getting COVID. Medical history included sickle cell trait, diabetes and was obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On 06Apr2021, the patient experienced bleeding from the anus. Did colonoscopy and found that he had diverticulitis, sent home after 3 days in the hospital. On 11Apr2021, patient was bleeding from anus again where he went to ER that day and was admitted to the hospital. Basically, they haven't made any progress but his hemoglobin was 7 (hospital was talking about a blood transfusion). He had sickle cell trait, the hospital was fixed on diverticulitis. It was reported that patient was due to have another shot and was afraid it's going to start over again. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Hyperalgesia/Paresthesia to the to the arms and legs developed 4 months after the vaccine.  No motor changes.  Area of the vaccination became sore 4 months later as well (in October).  Symptoms are now resolving on their own.
After cutting my finger slicing vegetables, I went to the ER for stitches.  I was given a tetanus shot at 7:00 PM on Dec. 31, 2003. The following day, around 5:00 PM, I started to feel slightly nauseous, with tingling and a 'zinging' sensation throughout my body. I was sensitive to loud noises and sudden movements, which caused more of the 'zinging' (adreniline-like) sensations and an overall nervous feeling.  I felt feverish, but did not feel warm to the touch.  My husband put me to bed and tended to our toddler's bedtime needs.  Every noise they made was amplified and nerve-wracking. I felt like screaming. The vaccine site on my right arm was painful, with the pain radiating down to my hand. My muscles in my right arm, back and neck were tight and tingly. After a while, my husband felt my forehead and I was hot (although I did not take my temperature, I would estimate that it had been slightly elevated). I experienced terrible back pain throughout the night.  In the morning (1/2/04) I felt slightly nauseous, but after drinking some hot tea felt better. As of 1/2/04, the vaccination site is still extremely painful and slightly red and swollen. I am achy all over, particularly in my neck and lower back.  The zinging is still present, but much less frequent and less intense.
I received a heavy menstral cycle two days after receiving the second shot.  This was a week and a half earlier than I normally have my menstral cycle.  And have not had one since.  I normally should have started my cycle 8 days ago and have been on the same cycle every month for the past 22 years!
Patient was waiting outside in hot climate and felt syncopal and fainted.  Regained consciousness after few seconds, legs raised and cold pack applied to back of neck and felt better.  Received water and snacks.  Patient seen by doctor and discharged home ambulatory few minutes after this.
Pt received this vaccine in his right arm and he has been sore in this arm, no redness no swelling, can't see where the injection was given; pt is sweating, he feels listless, he has body aches and is concerned that he has never had this kind of reaction from a a vaccine before-pt feeling better today (6/23) than the night of the vaccine (6/20). States he is not sleeping and feels that is why he feels the way he does.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 38.05 for dose administered on 13-Feb-2021. No concomitant medications were reported.  Batch number 031L20 A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Numbness and tingling started on the soles of the feet and continued upward.  Within days the numbness went  over the tops of the feet, ankles and daily would advance until it was up over the knees.  Fingers and hands also began to have numbness and tingling.  While this process continued I had lethargy, insomnia, and became depressed and emotiona.   I had all the symptoms of GBS.    After I figured out what happened, it took over a  year to detox and return to somewhat formal function.  Currently I struggle with some return of the symptoms and have to do a detox regime again.    So many people have the same issue after these injections or others and no one tells them they are connected to the vaccine.  They just give them a new diagnosis and some new prescriptions and send them on their way.     I find this unacceptable!
Given 3rd dose of tetanus (Td) 23 days too early, will need to repeat 3rd dose. (primary series for 33 year old is 0-1-6)
Weakness in right side of face, couldn't smile  Couldn't shut eyes. Pain in right ear.
I developed Chronic Idiopathic Urticaria 2 weeks after my vaccination. I have had it for 8 months now. I was treated with steroids, 2 antihistamines a day with no sucess. I will be starting Xolair to treat this condition for the next year. I am very hesitant to get the booster, as my family physician could not even advise me on getting it as wel,l as she has seen over 3 cases of Urticaria.
A large patch of redness and bruising approx 4" below the injection site.  Patch developed into a patch 4" x 5" by day 4 after receiving the vaccine.   The patch is warm to the touch.  A bit of aching in the arm.
Got the vaccine and they had her pull over as she had already had a reaction to the first one.  All of a sudden she felt like her lip was swelling, and her tongue swelling, her face was a little red.  She then had trouble breathing, and thought it may have been anxiety.   She also has had headaches which have lasted for about 11 days, and depression.  Her breathing was getting worse and the nurse came over and told her that she was having problems breathing and started coughing.  She had Benadryl with her and she was advised to take that, and took 2 puffs of her inhaler.  She stopped coughing as much, and was able to drive home within 10 minutes.  She went home and realized that she was hyper, advised to take more Benadryl.  It did not make her sleepy and did help with the allergic reaction.  A friend saw her and told her that she was wired.  She keeps having the coughing fits and breathing problems, and was thinking she was going into anaphylaxis.   She also has had some confusion.  She then went to the doctor on 3/25/21 due to urinary symptoms and had a UTI.  Within the first couple of days she was having coughing bouts and was wondering if she should go the UC or not, wheezy type feeling.  Her doctor gave her antibiotics and told her to use inhalers.  She went back to the doctor on Monday 3/29/21, did a chest x-ray which was clear.   She still thought that she was wheezy and ordered a new inhaler which she has been using, and still having coughing fits even today.  She has been taking Benadryl every night since the vaccine which has not made her sleepy.   The antibiotics seem to have helped the chest symptoms, but she is still coughing.
Generalized prurtic maculopapular rash, on trunk, arms,l egs and scalp.
I went to bed earlier than usual the night I received the vaccine( Friday). The next day,(Saturday) I was tired and had muscle aches and pains, I didn't feel like doing much. Later in the evening I started to develop a headache and took some Advil.  On Sunday I was much better - not tired and no muscle aches.. Today (Monday) my wife pointed out that I had a few red blotches where I had the injection. Not sure when that started.  I did have some soreness around the injection site from Friday afternoon through Sunday afternoon.
Leg pain, pressure headaches and chest tightness resulting in ER visit 4/12. Attending physician noted no visible signs of clots. Occasional shortness of breath and brief bursts of dizziness and nausea (not necessarily together) persist, as do minor headaches.
Worsening fatigue, rash on right hand, crying spells, increase in anxiety, pure panic that lasted 2 months, upper back pain, increase in noise & light sensitivity, major personality changes (on the verge of psychosis), more weight loss (10lbs in one week), worsening insomnia, carotid/jugular/temporal  vein inflammation, cramping and hotness to shoulders, facial swelling, stomach rashes, brain zaps, near-syncope. Allergies  From August to November 2021
A spontaneous report has been received from a Health professional concerning a 53 year old, female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient had been received FLUMIST (intranasal), 0.2 millilitres, once/single administration started on 19-Nov-2015 for flu vaccination. The patient experienced given to patient over 49 yo and gave whole dose in one nostril which started on unknown date. The outcome of the events of given to patient over 49 yo and gave whole dose in one nostril was unknown. The company physician considered the events of given to patient over 49 yo and gave whole dose in one nostril to be non-serious.
No adverse event. Client was given J&J at 17 yrs, when J&J was not approved for 17 yrs at the time. Despite EAU information being given and signs posted that it was for ages 18 years and older. PHN did attempt to contact patient via phone and left message, but did not receive a phone call back.
Rash, redness, and itching on the front and back of the torso. I took pictures.
heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "heart inflammation". Clinical course: A review of the Prescribing Information for Pfizer BioNtech Covid vaccine failed to find any information regarding finding a facility and a cardiologist.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored oral, ROTATEQ (dose, lot # unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative: He reports having experienced nausea after the initial vaccination. This started a day afterwards and resolved without treatment or intervention within 3 days (no therapies were tried). He denied other common adverse effects including vomiting, abdominal pain, and rash. He did not feeling hotter than normal during that time, but did not have a thermometer. He was able to eat and drink.
10 days post vaccine increase itchy rash red.  No evidence infection 30 cm diameter circular. No rash other area.  No joint pain.
4MAY t103 dx tonsilitis Cefzil given; 6MAy t105-ER ATB; 6MAy changed to Erythromycin-APAP supp; fine rash on face also dx roseola? react to vax;
Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensation, chest tightness, pain radiating into left arm and left leg. Tx: diphenhydramine 50 mg orally every 10 min until symptoms lessened/resolved.  Aprox 300 mg over 30 min  All symptoms resolved within 60 min
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that there were two different lot numbers involved in the incident: 047C21A and 23C21A   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up appended On 05-Nov-2021: Follow-up received on 08-Nov-2021 contains Non-significant information.
Patient received vaccine on 1/4/2021.  He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk.  On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.  No localizing neurologic findings.  He was too lethargic to get up in chair.
04/24/05 7am During diaper change, Mom observed child twitch, shake & child's eyes rolled back. Temp. had been elevated night before but not recorded. Taken to local ER by ambulance. No further seizure activity noted. Temp 101.6 ax Tylenol supp. given. Child alert. Sent home. To Pediatrician 04/25/05
Dizzy, wheezing, loss of appetite, very pink cheeks. Fever of 103.7 on 8/26/2013 at 8:30 PM. Still wheezy and clammy with no appetite on 8/28/2013.
Patient had pain spread from injection site to elbow and back shoulder blade. Injection site was inflamed and hard.
Chills; Headache; Fatigue; Aches; This is a spontaneous report from a non-contactable consumer reported for a patient. A 33-year-old female patient of received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose (at the age of 33-years-old) for COVID-19 immunisation. The medical history of the patient and concomitant medications was not reported. On an unknown date, the patient experienced chills, headache, fatigue and aches. The clinical outcome of the events chills, headache, fatigue and aches was resolved on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Narrative leading sentence updated to "This is a spontaneous report from a non-contactable consumer reported for a patient." Narrative ending sentence updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained."
ON MORNING OF 9/18/2021 PATIENT WAS OUTSIDE WORKING AS A PHOTOGRAPHER.  PATIENT REPORTS SHE BEGAN TO FEEL FLUSHED AND REDNESS AND SWELLING IN HER FACE. SKIN IS PEELING PER PATIENT.
Left thigh redness/swelling/tender 4 hours after injection.  TYLENOL/BENADRYL/cool compress resolved in a hour after TYLENOL/BENADRYL
Area felt bruised but wasn't bruised.  Vaccine received on a Sunday.  On Thursday, I developed an oval red area; the injection site felt  hard and hot.
Tingling, numbness, pins in needles in hands and feet. This has been going on since vaccine