chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible enlargement of the lymphatic node (1) due to COVID-19 vaccination. No other abnormalities; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid carcinoma (post thyroid carcinoma/remission since 2016). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 137 mcg for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Jul2021, the patient had a preventative mammogram, called back for additional ultrasound on the left breast and experienced possible enlargement of the lymphatic node (1) due to COVID-19 vaccination. The patient did not have other abnormalities. The event resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event possible enlargement of the lymphatic node was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
PATIENT WAS VACCINATED ON FRIDAY AND WOKE UP MONDAY MORNING WITH A VERY SORE RIGHT ARM AND COULD HARDLY MOVE IT. PATIENT'S ARM WAS HOT TO THE TOUCH.
Pt stated that left arm was extremely sore, unable to move for 1 day and extremely sore for 3 more days.  Pain got better but 09/17/2021 she is unable to move arm again.
Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration at the age of 43-year-old administered in left arm on 24Mar2021 18:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. The patient previously took the first dose of BNT162B2 and administered in left arm at the age of 43-year-old on 24Feb2021 18:00 (Lot Number: EL9261) for covid-19 immunisation. Medical history included hypertension. No known allergies. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (ZIAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with bell's palsy on 06May2021 05:00. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Therapeutic measures were taken as a result of diagnosed with bell's palsy as treatment of antiviral and steroids. The outcome of the event was recovering.
p/vax pt rpt is now suffering from signs of multiple sclerosis;other medical event;
Immediately folloing administration of vaccine to left deltoid, patient had tingling and numbness in left arm.  Then left jaw pain and facial flushing.  She complained of feeling dizzy and faint.  EMS was called and patient was trasported to local emergency room for evaluation.
WEIGHT LOSS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced weight loss. Laboratory data (dates unspecified) included: Weight (NR: not provided) weight loss from 136 pounds to 125 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weight loss. This report was non-serious. This case, from the same reporter is linked to 20210724253.
On 6/22/00, felt jittery all over. Had muscle spasms in upper left arm and thigh that lasted a few hours. Left arm was very sore. On 6/23/00, same symptoms. On 6/25/00, was very sore and deep pain in left arm. On 6/29/00 and 6/30/00, upper lip area, left side under nose, twitched, non-stop. On 6/30/00-09/16/00, had deep aching pain in both arms and spasms, continuously; right arm most affected. Arms are very tired. On 9/16/00 to the present time, have spasms on and off. On 11/18/00, saw a neurologist. He said that he doesn't think there was long term changes.
Felt fatigued; High amounts of Inflammation; Crohn's disease flare up; This is a solicited report based on information by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4110252-00. A contactable female consumer (patient) reported a patient of an unspecified age received BNT162B2, intramuscular on 12Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at UNK (Citrate free) for moderate to severe adult Crohn's disease. Medical history included moderate to severe adult Crohn's disease. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported. The patient previously took BNT162B2 via Intramuscular route on 12May2021 as DOSE 1, SINGLE for COVID-19 immunization. On unknown date in 2021, the patient experienced Crohn's disease flare up and high amounts of inflammation. In Jun2021, the patient experienced felt fatigued after second Covid vaccine. The action taken in response to the events for adalimumab was dose not changed. The outcome of Crohn's disease flare up was not recovered while the other events was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt fatigued after second covid vaccine with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of high amounts of inflammation was not provided.  Causality for BNT162B2: Crohn's disease aggravated: Causality as per reporter (Drug/Vaccine): Not Related; Fatigue: Causality as per reporter (Drug/Vaccine): Possible; Inflammation: Causality as per reporter (Drug/Vaccine): Not Related.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Case will be further reviewed on follow up information  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
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 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:37 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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 66.57 for dose administered on 13-Feb-2021 and 66.66 for dose administered on 20-Mar-2021 .  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-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).
Beginning 3H after the flu vaccine; back pain, muscle aches, chills, fever, loss of appetite, head felt odd, excessive perspiration. Symptoms continued through the next day. Patient fainted at 10:00 AM morning after flu shot.
Thumb on right hand becomes numb, turns white with apparent loss of blood circulation, and becomes cold. Since April 10, 2021, this has occurred 3 or 4 times without any identifiable cause evident. On April 10, however, the numbness occurred a few hours after a capillary broke and discolored the thumb.  Though a capillary break in the fingers is not uncommon, the numbness is a new occurrence. It is not debilitating, though it is disturbing in that it appears my thumb is dying.The numbness dissipates in about an hour.  I am not diabetic. In 2002, I did have a mild transient ischemic attack.   During the week following the vaccination, cognitive processing was slowed remarkably but has returned to normal.
Newly diagnosed sweat gland envolvement for small fiber neuropathy. Started with tingling in toes beginning of March. By mid May in two fingers on left hand then by end of June all over body including around eyes. Turned into dulled sensation then to neuropathic itch then to neuropathic zings of pain all over.  Severe fatigue Night time sweating. Burned tongue feeling on top and coolness in nose. Symptoms have slowly improved to occasional zings of pain and more of the stocking glove pain. Fatigue has improved but not 100 percent better.  Burning tongue and coolness in nose remain. All blood test for autoimmune have come back negative. Had similar but much shorter illness 6 years ago after a very bad upper respiratory illness where I have numbness and tingling in fingers and toes and then in mouth. Resolved on its own after 2-3 weeks.
Began experiencing neuropathy, lasted 3 and a half months.  Diagnosed with Lyme disease (Lyme and Bartonella) that was dormant and doctor indicated that was old case that vaccine ignited.
Patient fainted after giving vaccinations -approx 5 min after, MA laid her down on table, she came to; MA gave crackers and juice - she felt much better within 5-10 min. Was accompanied by father.
A consent form was returned for this student to receive the COVID-19 vaccine at school. The form and letter stated it was for >12 year olds. It was signed and returned by parent. The vaccine was administered to student despite him only being 11 years old. He received a dose of the vaccine at the time when the vaccine is not approved for his age group. No known side effects or adverse outcomes at this time.
Initial symptoms of flu-like illness, cough, malaise, chills.  One week later developed slurring of speech, gait instability, disorientation.
18yo patient was given Moderna vaccine 0.25mL indicated for 6mo-5yo on 2/9/23. Pt came back on 3/9/23 to receive the correct Moderna vaccine 0.5mL indicated for 12+ yo. This is reported as an administration error. No adverse event occurred.
Approximately 10 days after the vaccine, my spouse noticed a welt like mark on the back of my left arm. The following day it had spread more. Prior to this showing, I was having persistent unexplained left sided stiffness. I was in physical therapy during this time so I assumed it was from that. Once the rash showed and I showed the physician, he agreed it did look like a reaction similar to shingles.
Patient was given a bivalent booster vaccine when he had only received 1 dose of covid vaccine previously and should have received a 2nd primary covid vaccine.
real bad headache; arm sore; really really tired; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (real bad headache), PAIN IN EXTREMITY (arm sore), FATIGUE (really really tired) and NAUSEA (nauseous) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Apr-2021, the patient experienced HEADACHE (real bad headache), PAIN IN EXTREMITY (arm sore), FATIGUE (really really tired) and NAUSEA (nauseous). At the time of the report, HEADACHE (real bad headache), PAIN IN EXTREMITY (arm sore), FATIGUE (really really tired) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I had the 1st vaccine on 1/26/21 and on 2/2/21 I woke up that morning and could not smell or taste anything.  I went and got tested, both rapid and PCR, and both came back negative.  I have no other symptoms at all.  Within 32 hours, my taste and smell have returned.
High blood pressure and went the emergency room twice.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Aug2021 10:30 (at the age of 44 years-old) (Batch/Lot Number: 3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies: Penicillin, covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Aug2021 22:00, the patient experienced high blood pressure and went to the emergency room twice. The patient underwent lab tests and procedures which included electrocardiogram: unknown results on an unspecified date, sars-cov-2 test: negative on 08Sep2021 Covid test type post vaccination=Nasal Swab  result=Negative. Therapeutic measures were taken as a result of high blood pressure and went the emergency room twice. (hypertension): IV fluids, EKG. Told to rest, excused from work. The outcome of the event was not recovered. The patient did not have COVID prior vaccination, and the patient was covid tested post vaccination.
long term decreased heart rate with daily spontaneous chest pain,  continuous  daily low blood glucose levels with decrease in daily sliding scale insulin
Information had been received on 11-JAN-2017 from a field employee who reported that a female patient (age unknown) who is the consumer reported to her that she experienced "redness, lump, fever, headaches lasting about a week" after receiving a dose of ZOSTAVAX for prevention of shingles at an unspecified pharmacy on an unspecified date. Outcome of events was unknown. No further information was provided. Additional information has been requested.
Lymph node swelling and tenderness in armpit, breast area - lasted about 5 days. Started about 5-7 days after shot.
Bad ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Bad ringing in both ears) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Bad ringing in both ears). At the time of the report, TINNITUS (Bad ringing in both ears) outcome was unknown. Not Provided          No concomitant medication was reported.No treatment information was provided.
Narrative: COVID infection following COVID vaccine series 01/14, Pfizer, dose #1 02/04, Pfizer, dose #2 08/10 pt cc: exposure: unknown 08/10 COVID swab, result: detected 08/10 SARS-COV-2 LINEAGE result: B.1.617.2 08/10 SARS-COV-2 CLADE result: 21A
J18.9 - Pneumonia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) K92.2 - GI bleed
Patient had a accidental vaccination today08-08-22 at 9:30am with the expire day08-05-22, patient never had any reactions to any of the covid19 vaccinations.
pt recvd vax & was noted to be weak for 1 hr following dose 1 which was administered w/a 1-inch needle;
NO ADVERSE EVENT, Patient was given the vaccine outside of the proper storage of 2 weeks in the freezer unit.
This spontaneous report was received from a pharmacist who was informed by another unspecified pharmacist and refers to a female patient of unknown age. On 06-SEP-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date the patient experienced small red bump at the injection site which resolved within 1-2 days. No further information was provided. The outcome of small red bump at the injection site was reported as recovered/resolved. Additional information has been requested.
after 5 minutes of the patient's 2nd dose covid vaccine, i heard that this patient fainted and when i look at him he was sitting on the floor. i asked him what happened and if  he had a vaccine and he said yes. he said he fainted and said he bumped his head. and he mentioned that everytime he has a vaccine he sometimes feel dizzy. but he said on his 1st vaccine he did not faint. he seems fine so i ask him if he wants to seat down and he said he's fine. we told him one of the employee called paramedics.
COVID-19 - cough  started 10/07/2021. Tested negative for COVID that day.  Fever, chills, aches, and pains developed that night. Tested positive the next day. Treated with albuterol inhaler and fever reducers (Advil and Tylenol).  Fever lasted 5 days, up to 103.5 every day. Cough, congestion, and exhaustion continue (now on day 12).
Fever, vomiting, not able to keep any solids or fluids down, not even ice chips or pedialyte freezer pops. Lasted about 24 hours before able to keep anything down.
I developed an inflamed lump in the front upper part of my arm that was tender to the touch (a bit larger than the size of a quarter). It formed the day after my second dose and although it felt better over time, the lump remained for 5 more weeks (today) and is still a bit tender to the touch.
After I left the facility to drive home, ~25 mins after the injection, I could feel my face getting hot, and feeling a bit "off."  When I looked in the rear view mirror, I was completely flushed, and red as a cooked lobster! >  Everything passed in another 30 minutes or so, and I haven't noticed any other symptoms.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). On an unspecified date the patient developed a zoster-like rash at site of injection. The patent sought unspecified medical attention and was given antiviral medication (name unknown) for treatment. Upon the time of the report, the patient's present status was unknown. No further information is available.
Just letting you know it felt like a bad flu shot, sore enough to avoid sleeping on, but it went away after a few days :) thank you for your hard work, let?s hope after Jan 20 you can do your jobs without restriction.
Narrative:  Resulted in patient fall and skin tear to left  elbow. Required Xray to rule out fracture.
Patient began having migraines day after following second dose- did report to Emergency Room, has been having continuous episodes of migraines since event, cannot identify any other changes in routine outside of vaccination.
t105.4 occurred 13JUN91 3 days p/vax administration-associated w/otitis media;
Fever 102.5, 9 cm area warmth/erythema induration.
I got the shot and immediately started feeling shooting pain down my arm. It was given at high angle and higher on the arm than I have ever gotten a vaccine. I have had severe shoulder pain shooting down. my arm and into my wrist since then, lost 80% mobility without pain, and have trouble sleeping. I went to the ER where an ultrasound showed nothing. I went to my PCP four hours later, then my occupational health clinic an hour later. I took a ton of steroids which helped slightly, but the pain has returned.
Aprox. 2-3 hrs after injection. Pt was at home after nursing he screamed, eyes rolled back in his head and then he had his head on mom's shoulder. Per mom he was cool to touch but did respond to verbal stimuli by visually tracking her; but no further cry. She took pt to ED, he was evaluated and sent home.
Second dose given on 1/20/22. Began menstruating 1/31/22.
Case previously recorded as MA2009-4497.  Initial case report received from a nurse, via agency on 20 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 101327) i.m., on 20 NOV 2009.  No adverse event was reported.  Administration to a child under 4 year-old is an off label use and unexpected for FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008675.
I had fever, headache, fatigue, nausea, swollen glands, my throat was so inflamed I could hardly talk, I was coughing so bad I couldn't sleep, and had terrible chest congestion. I did a steam inhalation to break the congestion up. I was so sick I could hardly get out of bed. My relatives insisted that I go to Urgent Care. I tested negative for COVID-19 on 10/22/2022. When they listened to my lungs, they knew that something was wrong. They did a chest X-ray on 10/21/22 and it showed that I had Pneumonia. I have to go back in 2 weeks for another chest X-ray. I will be taking antibiotics until 11/1/22.
Behavior changes including fussiness towards bath water, speech regression to none and glossy eyed staring with lack of smiling and responsiveness to cues.