chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hurts/neck hurts/painful; on the left side of my neck / I have first it looks like it was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (on the left side of my neck / I have first it looks like it was a little swollen) and NECK PAIN (hurts/neck hurts/painful) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced SWELLING (on the left side of my neck / I have first it looks like it was a little swollen). On 04-Nov-2022, the patient experienced NECK PAIN (hurts/neck hurts/painful). At the time of the report, SWELLING (on the left side of my neck / I have first it looks like it was a little swollen) and NECK PAIN (hurts/neck hurts/painful) outcome was unknown.            No concomitant medications were reported. Patient had the booster the Moderna booster on Tuesday morning. Last night on the left side of her neck, which, by the way, she got the shot on her left arm. Patient had first it looks like it was a little swollen, in this morning It did not look like it was swollen. But her next side of her neck hurts. And if you push on the area, it was somewhat painful. And patient was asking Could that be a side effect of the injection. No treatment medications were reported.   Reporter did not allow further contact
chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Caller states she received her first vaccine on 4/18@ 12 noon,  Noted today a red rash at injection site and another rash directly under the injection site.  Denies swelling, fever or pain at site.  Encouraged to  apply cold compresses, Benadryl for itching if applicable, and if symptoms worsen, contact PCP or go to ER for evaluation.  , RN
Patient has already received one dose of bivalent moderna vaccine on 10/29/22. Patient was not due to receive another dose but did not tell the pharmacy she had already received the vaccine until after another dose was administered on 1/19/23. No adverse reactions have been reported.
Initial and follow up information has been received from a physician concerning a 42 year old white female with fibromyalgia, sjogren's syndrome and systemic lupus erythematosus who on approximately 12-DEC-2007 was vaccinated into the right deltoid with a first dose of ZOSTAVAX (Lot "14114").  Concomitant therapy included hydroxychloroquineS04 (PLAQUENIL), alprazolam (XANAX), duloxetine hydrochloride (CYMBALTA), acetaminophen/hydrocodone bitartrate (LORTAB), pramipexole dihydrochloride (MIRAPEX) and "xanaflex".  Subsequently the patient developed a shingles outbreak after being given ZOSTAVAX.  The patient had contacted the physician and sought medical attention.  The physician also noted "questionable neurontin and hydrocodone reactions".  The patient was reported to be recovered on 21 DEC 2007.  It was noted that the patient had not yet returned to the clinic despite repeated requests.  There was no product quality complaint.  No further information is expected.
itching; swelling; dizziness; coughing; sneezing; agitation; nausea; diarrhea; trouble breathing; This is a spontaneous report from a contactable other hcp (Patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ww0171) via an unspecified route of administration (age at vaccination 42-year) in Arm Left on 24Apr2021 at 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included PCOS; Hypothyroid; allergies to Soy, Gluten, Fish; COVID-19; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took sulfur and byetta, and experienced allergies. Historical vaccine includes first dose of BNT162B2 (Lot number=ew0153) administered in left arm on 03Apr2021 at 09:15 AM as single dose for COVID-19 immunization. Reported vaccine facility type was Pharmacy or Drug Store. The patient received no other vaccine in four weeks. The patient had COVID prior vaccination. The patient not tested COVID post vaccination. On 24Apr2021 at 11:00 AM the patient experienced itching, swelling, dizziness, coughing, sneezing, agitation, nausea, diarrhea, trouble breathing. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events; treatment received with clariten, singular, benadryl, lorazepam, prednisone. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Day 8 after vaccine, patient developed redness, swelling and itching at injection site.  Notified nurse and was told to take what she normally takes for pain, to use Benadryl for itching (if not allergic) and to use ice packs on the site.
At 12:30pm approximately 30 minutes after having vaccine the patient had a generalized tonic clonic seizure.  The patient went to the Emergency Department.  Shortly in her Emergency Department stay the patient spiked a fever.  The patient recovered well and was discharged.
Child received vaccine on 11/14/03 Fri., to ER 11/15/03 with the following symptoms: left thigh red, hot, swollen area. Received Decadron 4mg IM. F/U visit in office 11/18/03: site had improved, no redness, no temp.
headaches for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 3-4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches for 3-4 days). At the time of the report, HEADACHE (headaches for 3-4 days) outcome was unknown.            Treatment information not given, concomitant medications were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
After I took the second vaccine I went to the doctor for my follow up office visit and the doctor discovered I had AFIB, following the AFIB I had another doctors appointment and later discovered I developed prostate cancer.
Patient's primary series were given on 9/29/2021 & 1/24/2021. Patient was not due until 6/24/2022 for the 3rd dose, or 1st booster. No adverse events reported, however geriatric center will monitor the patient and update us with any issues.
Eye irritation in both eyes. Eyes became irritated, red, and swollen. Irritation went away 1 week after receiving 1st dose. Eye irritation repeated after 2nd dose and stayed for 1 week. Several weeks later eye irritation still occurs from time to time.
Facial swelling of the right cheek/sinus area. Moderate to severe pain around location of sinus cavity extending to gums, visible swelling/puffiness with tenderness. Sinuses and gums feel significant amounts of pressure, gums are swollen, red, pain and tenderness. Symptoms began the morning after 1st dose, day two after 1 dose swelling still persists without relief from Ibuprofen 800mg or over-the-counter sinus medication.
Patient received Moderna on 9/11/21. Came to Pharmacy on 9/18/21. Presented left arm with a severe bumpy rash where his vaccine was given. He said as week progressed it just kept itching and getting redder and uncomfortable. He said it was "weeping" and he was worried about if if had "staph" in it. Referred to local Urgent care or hospital.  He had been taking Benadryl by mouth on topical and it didn't relieve for very long at all.
Positive result for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive result for Covid) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced COVID-19 (Positive result for Covid). At the time of the report, COVID-19 (Positive result for Covid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 at 07:30 as dose 1, single (Lot number: EK5730), in left arm, on 06Jan2021 at 10:00 as dose 2, single (Lot number: EL3246), in right arm and on 20Sep2021 at 16:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Treatment of COVID-19 included Paxlovid from 22Jun2022 and 27Jun2022.; Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that the events are  related to  BNT162b2 cannot be excluded.
PT BECAME PALE, DIAPHORETIC, AND ALMOST PASSED OUT.  B/P WAS 88/40 AND HER PULSE WAS 84.  SHE RECOVERED WITHIN ABOUT 20 MIN.
about one-half hour later, she experienced a minimal sore arm; minimal soreness is off and on and ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing). At the time of the report, PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) had resolved.            No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: FU-1 is added and the outcome of events are updated.
As Tdap vaccine was being administered, I got horrible chills, nausea, dizziness, weakness.
In August, I had rash that spread through out my body.  It then began to bluster and legion up.  I went to ER.  I was hospitalized for 8 days.  The did blood test and urine test.  They diagnosed me with Stevens Johnson syndrome.
Mild/Moderate Anaphylaxis. Hives all over body, slight swelling in mouth, throat, nose. Breathing remained normal and unlabored through mouth. Decided 2 hours after vaccine to go see a doctor just in case. Doctor gave injection of steroid and also prescribed over the counter Benadryl. Hives and swelling cleared up that night prior to bed. However sleep did not come easy due to increased heart rate from the steroid and slight fever from the vaccine.
Complained of soreness of injection arm, red hot swollen from site to wrist, worse the next morning with muscle spasms to ER received steroid injection.
Noted swelling on Left deltoid area, warm to touch, no open skin noted. No c/o pain, itchiness. Encouraged  warm compresses and pain meds PRN. Pt will come back if worsens.
Information has been received from a Licensed Practical Nurse referring to an unspecified number patient of unknown age and gender. Since 02-DEC-2016, the patients were vaccinated with doses of improperly-stored VARIVAX (lot# reported as M032495, expiration date: 06-JUL-2018; strength, dosage, frequency and route unspecified) for prophylaxis.  No adverse effects were reported. Temperature and time frame was reported as 40.7 F for 16 hours and 34 minutes and there was no previous temperature excursion. This case is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005014:
This case was reported by a nurse and described a 30 year old male patient who did not respond to the Hep-B vaccine.   On unspecified dates in 2004, the patient received three doses of Energix-B.  Subsequently on 18 OCT 2004 a hep-B surface antibody titer was negative.  The nurse considered the event to probably by related to the use of Energix-B
From initial information received on 10/15/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 66 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1266AA, administered intra-muscularly in the left deltoid on 10/10/03. Four days later, the patient developed radiating pain in the left arm and shoulder. She was seen in the emergency room and treatment included Celebrex and a heart attack was ruled out as per the reporter. Reportedly, the patient's recovery status is currently unknown.
Office visit for rash 12/29/12 determined to be likely from VARIVAX received at physical 12/20/12.
IRREGULAR HEART BEAT; TREMOR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included slight murmur, diabetes, chronic obstructive pulmonary disease, alcohol user, and non-smoker, and other pre-existing medical conditions included patient have no known allergies and there was no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced tremor. On 02-APR-2021, the subject experienced irregular heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tremor, and irregular heart beat. This report was non-serious.
Spots of face, neck, arm pit, and groin. Some raised with pustules, Temperature 99-100.4 degrees Fahrenheit.
A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning a male in his mid thirties. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 16-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 21-Mar-2012: reporter's information and the reporter was not aware of the patient experiencing any adverse events.
Received second dose of vaccination at approximately 4:50 PM. Awoke at 2:30 AM with mild fever, body aches, chills, and  nausea. Got out of bed for to drink fluids; after walking around for approximately 10 to 15 minutes I experienced a blood pressure drop resulting in me passing out on my bathroom floor. Prior to passing out attempts to regulate breathing and placing head between my legs failed to keep me conscious. Unknown duration of time spent passed out on floor; eventually was able to walk back to bed upon waking and lying on floor for additional 5 minutes (conscious). Awoke again at 8 AM with mild fever, chills, and body aches, while experiencing mild drops in blood pressure (no nausea). Symptoms ceased the following day of 1/16/2020.
3 x 4 cm - local reaction, mild erythema, slight tenderness right deltoid.
Itching on arms back. Severe reaction to bug bites, mosquitos ants flea bites etc. Never had allergies to bug bites before!
This spontaneous report was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
CALLER KNOW PEOPLE WHO HAVE EXPERIENCED AE AFTER RECEIVING THE VACCINE/SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced caller know people who have experienced ae after receiving the vaccine/side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caller know people who have experienced ae after receiving the vaccine/side effects was not reported. This report was non-serious.
BREAKTHROUGH INFECTION:  vaccinated 2/23/21 and 3/23/21 with Moderna. Went to ER via ambulance 11/25/21 with c/o dizziness x 1 week and shortness of breath. Was admitted to hospital that day.
20JUL devel acute severe GBS; presently on ventilator day 55, no motor activity; in hosp 21JUL to present;
3" x 4" area of erythema left thigh. Post immunization on 10/01/2004
Approximately around 10:10am, patient was screen for contraindication, and stated that he had allergic reaction to Covid Bivalent vaccine. Patient stated that he had mild itchiness and broke out in hive. He was given Benadryl but unsure of the dosage. Other than allergic reaction to Covid 19  Bivalent vaccine (Moderna) patient has no known history of allergies.  10:20am, patient received typhoid vaccine to left deltoid 1mL. Given history to previous reaction to Covid 19, patient is aware that he will be kept for 15 minutes observation. Approximately, about 10:25 patient began scratching his head. LVN observed that the patient was clearing his throat and ask if he was alright. LVN also noted that the patient face was flush. Patient show no sign of difficulty breathing nor urticaria. 10:27 patient stated that he felt itchy and asked for Benadryl. Diphenhydramine 25mg capsule was given orally.  10:30am patient stated that he felt better and wanted to leave. However, LVN kept patient for another 10 minutes observation. 10:40 patient left the exam room ambulating independently, alert and oriented with no sign of distress.
Injection therapy for prostate cancer. This infusion was within 6 weeks of receiving the COVID vaccine.
approx 3yrs p/vax pt devel full blown chickenpox w/@ least 30 lesions on face & hundreds over rest of body.
Headache, 101.1 fever, chills, and fatigue on 7/6/17 at 3 AM. Patient took acetaminophen at 3 AM and naproxen sodium at 4 PM. Patient seen in office on 7/7/2017 for this issue and was prescribed methylprednisolone 4 mg tablet therapy pack.
This spontaneous report as received from a pharmacy technician concerning a currently 42 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with VARIVAX lot #J005416; expiration date: 02-MAY-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Blood pressure to 185/109 within 10 minutes.  Potassium level (serum) drop.  Pulse at 51 bpm.  Typical BP is 110 / 75.   Followed over course of 48 hours with extreme muscle weakness and near flaccid paralysis, irregular heartbeat and gripping headache (not a common occurrence for me) with "brain fog"; slept approximately 16 hours over the next 36.  Second reaction better than first dose because we prepared better based on first reaction.
swollen lymph nodes; trouble with breathing; trouble swallowing; headaches; low fever; felt sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VAC-CINE, solution for injection, Batch/Lot Number: EM9802) via an unspecified route of administration, administered in arm right on 18Feb2021 11:00 (at the age of 76-year-old) at dose 2, single for covid-19 immunisation. Medical history included ongoing thyroid. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid via oral route from an unspecified start date and ongoing. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration, ad-ministered in arm left on 28Jan2021 11:00 (at the age of 76-year-old) at dose 1, single for covid-19 immunisation and experienced rash 5 hrs later on 28Jan2021, received treatment and got resolved. On 18Feb2021 the patient experienced swollen lymph nodes, trouble with breathing, trouble swallowing, headaches, low fever, felt sick. Narrative description of the sequence of events hives after first vaccine this to dermatologist after second vaccine and had symptoms of swollen lymph nodes, trouble with breathing and swallowing, headache and low fever for about a week felt sick and had similar symptoms in 2020, which lasted for months, and never got tested and didn't want to be hospitalized. Onset time: next morning. Adverse events resulted in physician office visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.