chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in May/2022 (Three months ago), the patient died from an unknown cause of death and it was reported as "My brother died on Johnson and Johnson shot 3 month ago". It was unknown if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220806378-covid-19 vaccine ad26.cov2.s- Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2007 (reported as "about ten years ago"), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, route and dosing details were not reported) for prophylaxis. On an unknown date in 2009 (reported as "about eight years ago"), the patient developed shingles (Herpes zoster). The outcome of the event was unknown. Causality assessment was not reported. Product quality complaint (PQC) was not involved. No other information was provided.
Fatigue, headache, diarrhea, stuffy nose, loss of smell and taste, feeling a loss helplessness, can?t sleep, flu like symptoms.  This has been going on for five days.
high pitched cont crying;poor intake;pt poor feeder w/prob GERD;t102;pt observed in hosp overnoc;
In the weeks that followed I began to feel chest pain that would come and go and when I?m walking it?s like I need to breathe more air fast forward to now and I was in the store and it felt like I was having a heart attack but the left side chest pain went away it did scare me I?d never felt that before in my chest I do daily cardio and eat healthy so having chest pain?s really had me concerned  I primarily want to know what should I do or will this go away and if there are any dangers I should know about
Severe joint pain in back and hips.  Shortness of breath, dizziness. Pain and soreness when trying to take a deep breath.
Feels a little uneasiness; Little bit more sore than the typical flu shot; Joint pain that is similar to arthritical pain; Itching; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot), PRURITUS (Itching) and ARTHRALGIA (Joint pain that is similar to arthritical pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Patient felt  little uneasiness and it was a little bit more sore than the typical flu shot). Concomitant products included CORTISONE, CLOBETASOL and BACITRACIN.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot) and ARTHRALGIA (Joint pain that is similar to arthritical pain). At the time of the report, DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot) and ARTHRALGIA (Joint pain that is similar to arthritical pain) had not resolved and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains reporter Information and event(itching) added
Adult dose of HAVRIX was drawn up and only 1/2 was given as RN giving vaccine noticed the dose as she was administering. She is very confident that she only gave 1/2 of a dose or 0.5ml.   Mother is aware of incorrect dose given and that we would not expect any adverse effects.
Information has been received from a consumer a 28 year old nurse with latex allergy and a history of paroxysmal supraventricular Tachycardia (PSVT) who on 23-FEB-2009 was vaccinated with a first dose of GARDASIL (IM, dose and lot number not reported) and her second dose on 23-APR-2009 (0.5ml IM/SQ, lot number not reported).  Concomitant therapy included CYMBALTA (manufacture unknown).  No other vaccines was administered at the time of GARDASIL vaccinations.  The patient mentioned, that she received a portion of her second dose of the vaccine subcutaneous instead of intramuscularly.  The patient stated that when the nurse administered the vaccine there was a "giant lump on her arm and some of the vaccine leaked out" and the administering nurse pressed her arm so that the vaccine would be absorbed (on 23-APR-2009).  She also mentioned that after of the first dose of the vaccine, she developed soreness to the muscle of the arm later that the evening lasted for 3 days (on 23-FEB-2009).  She also mentioned that she began her GARDASIL series at the age of 28 years old.  No treatment was sought or required.  The patient indicated that she fully recovered.  No additional information was available.  Additional information has been requested.
Arthralgia, Fever, NauseaVomiting, chills Narrative:
slight fever; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. It was reported that the patient suffered from slight fever and chills on unknown date. The outcome of the events was recovered on unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/ drug, different patients/ events
Chills with violent shivering starting second night after vaccine and continued for 3 nights.   Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree.  Headaches.  Muscles ache and stiffness particularly in legs.  Slight loss of balance from time to time.  Loss of appetite.   Rash on chest possibly caused by sweating at night.   Increased severity when bruised.
The patient received a booster dose of Pfizer COVID-19 vaccine on 12/6/2021. He completed the 2 dose series of Pfizer on 6/20/2021. He tolerated it well. No symptoms at the time of this report. Notified his father. The patient is not immunocompromised therefore he does not need a booster dose at this time.
My chronic  migraines are out of control: lasting days and I am not being able to stop them myself. I have to go to ER. Already 4 times. Never happened before my vaccination.  My preventive migraine meds are not working as well as before.
Information has been received from a pharmacist concerning a 69 year old male patient with high blood pressure, high cholesterol, thyroid issue, penicillin and latex allergy who on 30-SEP-2009, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23, intramuscular route- left arm (lot # 664871/1142Y). Concomitant therapy included TOPROL, SYNTHROID, lisinopril, omeprazole, simvastatin, LASIX and XANAX. On 30-SEP-2009, two hours after vaccination, the patient developed muscle soreness "all over" his body, it lasted 2 or 3 days and then subsided; however, the patient still had pain and discomfort in his upper left arm and it was painful to lift it. The pharmacist reported that the patient received a previous dose of PNEUMOVAX 23 about 10 years ago. A MRI has been ordered but it has not been done yet. At the time of the report the patient had not recovered. Muscle soreness, pain and discomfort were considered to be disabling. Additional information has been requested.
Patient is complaining of range of motion issues with his right arm. He cannot raise it much past his hip.
8/11/05 - 7 days post vaccines, developed varicella type generalized rash. 8/15/05 - 11 days post vaccines, developed temp 101.2 Rectally- Motrin 1 tsp. q. 4-6 hr. 8/17/05 - 13 days post vaccines, fever subsided. 8/18/05 - 14 days post vaccines, rash subsided.
Covid arm & blisters on hands, feet, & back of neck. Dr gave antihistamine + 40 mg steroids daily. Stll on meds. Blisters went away but arm is still red/not swelled anymore. Dr. said not to get 2nd shot.
ULCERATIVE COLITIS FLARE UP; PRIMORDIAL CYST BECAME INFECTED; LOOSE STOOLS; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant), INFECTED CYST (PRIMORDIAL CYST BECAME INFECTED) and DIARRHOEA (LOOSE STOOLS). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) outcome was unknown, INFECTED CYST (PRIMORDIAL CYST BECAME INFECTED) had resolved and DIARRHOEA (LOOSE STOOLS) had not resolved.            No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of PRIMORDIAL CYST BECAME INFECTED, LOOSE STOOLS and ULCERATIVE CLOITIS FLARE UP with Humira was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (medically significant) event of ulcerative colitis an unknown time after the third dose of mRNA-1273. The event was described as a flare up. Ulcerative colitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (medically significant) event of ulcerative colitis an unknown time after the third dose of mRNA-1273. The event was described as a flare up. Ulcerative colitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Tested positive for Covid on December 26.  At home test was negative but positive two days later.  Very mild symptoms - more like a cold for about 4 days.   About a month later had shortness of breath and dizziness.  My doctor did an EKG and then sent me to a heart doctor.
Vaccine 8/09/07;   Swelling under left clavicle 8/11/07;    left supraclavicular lymph node swelling  8/14/07;      Dr appt. lymph node measured 2cm, chest xray and blood work done--neg 8/16/07;   8/18/07 noticed tightness and swelling below left clavicle over left clavicle and up into left neck;   8/21/07 Mammogram ordered due to left lymph nodes and aching on left side;    8/23/07  Dr's appt, cough begins  lymph node gone down,  more bloodwork--neg   9/6/07 2nd mammo and ultrasound due to question on upper left breast--neg    9/14/07 Dr's appt, extreme cough, dr suspects pertussis not kowing of the pertussis vaccination August 9,2007--  9/19/07 See general surgeon due to continual swelling and discomfort of left clavicle area.  9/21/07  blood work shows possitive for pertussis;  CT scan scheduled for 9/27/07; ntibiotics given for pertusis
After receiving the vaccination, patient was advised to sit for 15 minutes in the designated waiting area. Approximately 5 minutes while sitting in the waiting area, patient's father noticed his daughter was about to fall over but caught her without her falling to the floor.  The patient was conscious, has a pulse and was breathing the whole time.  Pharmacist on duty called 911 and within 10 minutes the paramedic arrived.  They checked her BP, heart rate and blood sugar.  Both her BP and blood sugar were within normal range, while her heart rate was out of range. The paramedics suggested to the parents that their daughter needs further monitoring. The parents agreed and left wit the Paramedics.
No adverse symptoms reported; the patient was vaccinated with expired VAQTA (R021233 exp 9/5/2019); This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-SEP-2019, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated(VAQTA) lot# R021233, expiration date 05-SEP-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse symptoms reported.  The nurse stated that hepatitis a vaccine, inactivated(VAQTA) did not have any temperature excursions prior to vaccination.
Perfectly healthy going into the ped for shots and less than 24hrs after vaccination she woke up in the morning and could not breathe properly: coughing, wheezing, difficultly breathing. I took her back to the ped and after 2-3 breathing treatments the ped could not control breathing and  called an ambulance. Ambulance took her to a hospital who diagnosed with an ?asthmatic reaction to a virus?. She had many indications of inflammation after these shots and has since had several asthmatic episodes and was diagnosed with asthma. 6-7weeks after the vaccinations she also developed a rare auto inflammatory disease: SJIA which we believe is related to the inflammation caused by the vaccination.
I started with a dull ache in my right upper arm about a week after the injection.  I did not think there was any correlation between the shot and the arm pain.  It was not in the joints.  It traveled to the lower arm.  I could not lift heavy things.  The pain is not constant, but it continues at night when I am relaxed to a throbbing type pain.   After 2 weeks it went to my left upper arm and then has just been in the elbow joint of the left arm.  It only aches when I move it around a lot or lift.  The pain has continued until today with no improvements in either arm.  I am not in excruciating pain, but I have a hard time lifting objects with my right arm, and turning it a certain angle is more painful at times. I did not strain my arm in any way that I can remember around the time I first experienced pain.
No additional AE reported.; Customer called and reported that a dose of MMR-II expired on 18AUG2022 and was administered on 13SEP2022. Customer reported that the MMR-II had no temperature excursions through date of administration.; This spontaneous report was received from the customer and refers to a patient of unknown age, and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 13-SEP-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), recombinant Human albumin, subcutaneous injection, lot #T027937, expiration date: 18-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided). The suspect therapy had no temperature excursions through date of administration. No additional adverse event was reported.
Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-side chest pain.
Received PCV-13 on 5/19/15. On 5/20/15 started with itchy rash (L) lower abdomen. Seen on 5/27/15 for rash: large macular plaque (L) lower abdomen, red and warm to touch with surrounding area of pink with erythematous papules at midline-also, noted same rash at top of gluteal crease bilaterally.
noticed PM 9OCT redness of rt deltoid then 10OCT AM arm more red, swollen & sore;redness from deltoid down to with 2" of elbow;knot in deltoid approx 10x10mm;NOS;
SOB / midsternal CP 20 minute after H1N1 vaccine. Progressed to malaise -HA
Chills, fever, headache, body aches, and nausea beginning about 4 hours after injection.
tissue infection in right arm with severe pain, weakness, redness, swelling, stiffness, hot-to-touch.  severe (sinus) headache, fever, body aches, fatigue, dizziness, loss of appetite.  infection traveled down arm to wrist/hand and up to neck/head over the course of several days.  started the evening vaccination was given with unusual eye irritation and then flu-like symptoms.  seemed to progress very quickly.  following morning, awoke with intense pain throughout right arm, up through the neck and in head.  arm was painful to touch as well as the slightest movement.  initially given Norco for pain at ER on 11/19 and also at student health on 11/20.  continued worsening over the weekend and then given Septra (for 10 days), more Norco and an arm sling at student health on 11/23. improvement began within one day of starting antibiotics. still recovering.
pt recvd vax & exp lower extremity aching w/fever (100.5 to 102) & noc sweats which lasted 2 1/2months;neg work/up for infect agents ensued;recvd tuberculosis triple therapy & vancomycin & gentamicin as part of protocol for fever unk origin
This spontaneous report was received from a medical assistant and refers to 4 unspecified patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies provided. On unspecified dates between 08-AUG-2017 and 11-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD, unspecified dose (lot # reported as N10114 with the expiration date of 24-SEP-2018, route of administration and albumin status were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion of minus 2 (-2) Celsius degrees for 68.5 hours. Digital data logger was not involved. There were no previous temperature excursions reported. Additional information has been requested.
SkinRash, Rash & EDEMA; RASH TRIAMCINOLONE 40 MG ONCE
On 10/27 my husband tested positive. Then on 10/28 in the morning I began not feeling well and my eyes felt funny. Also, developed post-nasal drip. Woke up on 10/29 still not feeling well and tested positive on at home test. Woke up in the middle of the night of 10/29 and was up most of the night with terrible headache. The head was in my forehead, temples, and lower back region of my head. Nothing I tried at home eased the pain. Called PCP's office on 10/30, and was prescribed CELEBREX for the headache. Began CELEBREX after call with PCP and headache was almost gone by afternoon. Still having sinus pressure and congestion treating with OTC meds and warm compresses.
In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days; I was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives, reddening and swelling of skin after contact  (rubbing, scratching, etc.) rash at clothing lines (sleeves, waistband, etc.)
pt woke up screaming;rt leg very red & swollen to foot & into groin; temp not taken;advised to call MD 29NOV95;mom reports pt was seen by MD & is nl happy self today; slept 9 hrs last noc
Nosebleed, 19 hours after vaccination, lasting about 2 minutes, pinched and held nose to make bleeding stop
This spontaneous case was reported by a patient and describes the occurrence of LIP BLISTER (blister on upper lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced LIP BLISTER (blister on upper lip). At the time of the report, LIP BLISTER (blister on upper lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment or concomitant medications reported.
injection to pediatric patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injection to pediatric patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injection to pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injection to pediatric patient) had resolved.        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.   In events they reported as updated contact information. No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: fallow up received , updated contact information