chrisvoncsefalvay/vaers-outcomes huggingface dataset:
client  became diaphoretic  shortly after getting vaccine. did not lose consciousness; slid from chair onto floor by vaccination staff, pale color. client reports this has happened before with vaccinations. client reported no fluids or food prior to getting vaccination. provided freezer pop, water and moved by wheelchair to medical tent and attended by EMS team. additional food provided, candy, juice and water. monitored with VS and cardiac monitor for 45 minutes.  once recovered.
Moderna vaccine #1 administered at 17 years old. Consulted legal team and determined that patient to receive second dose today due to previously receiving first dose and proximity in age to lower limit.
developed progressive SOB and DOE about 2-weeks after booster. Ultimately, came to the Emergency Department where he was diagnosed with bilateral pulmonary emboli and required oxygen 2 liters. Diagnosis was <1 month from his booster.
Information has been received from a registered nurse concerning a 26 year old female patient with psoriasis and allergy to animal dander, who on unspecified dates when she was a child was vaccinated with two doses of MMR II (Lot # not reported) (manufacturer unknown) and on 04-NOV-2008 was vaccinated with a 0.5 ml dose of MMR II (Lot # 659705/0356X). A MANTOUX SKIN TEST was also administered on 04-NOV-2008. The nurse stated that the patient had a negative measles titer in November 2008, and received a dose of MMR II (Lot # 659705/0356X) on 04-NOV-2008 (after the negative measles titer). This patient again had a negative measles titer on 18-OCT-2010. Titers for mumps and rubella were within normal limits both times that titers were drawn. The patient visited an office for blood test. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Within 2 hours of receiving flu vaccine felt (L) upper arm swelling 10/18/17. Woke this AM and (L) upper arm swollen, redness and was itchy. Seen in Employee Health.
Urticaria 2-3 hours following FLUZONE vaccination. In 24 hours have widespread urticaria, rash, and upper neck and facial flushing occurred.
Information has been received from a physician concerning a pt who "this week", in September 2003 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01722, 0209USA01724, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Patient presented for well child exam. Patient was due for #2 Menveo and #1 Bexsero. Patient was given Bexsero and MMR instead of Menveo.  No adverse reactions noted.
Information has been received from a male nurse of unknown age concerning himself. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date when he was a child, he was vaccinated with one dose of M-M-R II (lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2013, he got tested for titers and came up negative. On an unknown date in 2013, he got another dose of M-M-R II (lot# and expiration date were not reported) and sterile diluent (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis, and his titers were still coming up negative. The outcome of the events was unknown. The causality between M-M-R II with the events was unknown.
Fever; lamp with bruise; lamp with bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (lamp with bruise), VACCINATION SITE MASS (lamp with bruise) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003621A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE BRUISING (lamp with bruise) and VACCINATION SITE MASS (lamp with bruise). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE BRUISING (lamp with bruise), VACCINATION SITE MASS (lamp with bruise) and PYREXIA (Fever) had resolved.            Patient applied ice on lump for 2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Significant FU received on 17-JUL-2021. contains AE outcome updated
she felt like she was getting the flu; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she felt like she was getting the flu), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (she felt like she was getting the flu), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 05-Mar-2021, INFLUENZA (she felt like she was getting the flu) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
After immunization, the patient fainted and fell to the floor. There were also upper body spasms. EMS was called and evaluated the patient on site. She regained consciousness and EMS gave her an okay to go home. (
Was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/myasthenia gravis" required physician office visit. Clinical course: Reporter mentioned that she knew someone who had the same experience with her after receiving the vaccines and booster. She knew of another person that was around her age in (City withheld) (State withheld) that was diagnosed with this around the same time.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201185389 same reporter/product, different patient/event;US-PFIZER INC-PV202300186632 same reporter/product, different patient/event;US-PFIZER INC-PV202300186639 same reporter/product, different patient/event;
p/vax pt exp rash that was raised approx 1/4inch & a red, hot to touch, induration w/pain @ the inj site;pt recovered, w/o med;
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on an unknown date. It was reported that patient had administered with expired dose of FLUMIST on 20-Mar-2013. The outcome of the event of administered an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
feeling faint and dizzy after vaccination, lasted about 15 minutes. Resolved with time without medical intervention.
fever/she had a fever of 104/ Monday morning her temp was 101 yet; chills; swelling; she was tired; she didn't feel good; she couldn't stop shaking; This is a spontaneous report from a contactable consumer.  An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6200; Expiration Date: 21Feb2021), via an unspecified route of administration on 20Feb2021 (at the age of 83-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included weight decreased (patient was going to say her weight is 135 but she has lost some weight so it may be less than that) from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 21Feb2021 patient had a fever, chills and some swelling after the first dose of the pfizer COVID-19 vaccine. Sunday patient had a fever of 104 and patient was tired. Fever was 104 and patient did not feel good and chills, they were so very bad patient could not stop shaking. Trying to see if patient continue go ahead and have the second one plan mark down 13Mar2021. Patient wanted to know if this was a reason not to get the second dose. Possible duplicate AE. Patient stated the efficacy of the vaccine was after two doses and it was a good thing we have this vaccine. Patient was worried that reaction might be worse after the second dose and was wondering if patient should get the second dose. Her children said they thought patient should go to the ER but anyway, it all worked out at home. Patient said the fever was resolved, Monday morning temp was 101 yet, so it probably went away Monday afternoon or evening, the chills went away Monday as well. Patient has an appointment coming up. The patient underwent lab tests and procedures which included body temperature: 104 on 21Feb2021 and body temperature: 101 on 22Feb2021. The outcome of the events pyrexia and chills were recovered on 21Feb2021 while other events were unknown.  No follow-up attempts are possible. No further information is expected.
A lump on her arm; Lump is sore; Patient now has a lump on her arm which has swelled to the size of a golf ball; Fever; Patient received her Covid-19 vaccine less than 26 days between doses; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (A lump on her arm), PAIN (Lump is sore), PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her Covid-19 vaccine less than 26 days between doses). On 05-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN MASS (A lump on her arm) (seriousness criterion medically significant), PAIN (Lump is sore) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) (seriousness criterion medically significant). On 03-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her Covid-19 vaccine less than 26 days between doses) had resolved. On 05-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, SKIN MASS (A lump on her arm), PAIN (Lump is sore) and PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, Lump on arm, Pain, Peripheral swelling and Pyrexia a causal relationship cannot be excluded. Causality for the event Inappropriate schedule of product administration is not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Lump on arm, Pain, Peripheral swelling and Pyrexia a causal relationship cannot be excluded. Causality for the event Inappropriate schedule of product administration is not applicable
Large blurry areas in vision, flashing light on right side, dark tiny dots in center of vision, difficult to read. Cold sores left lip, left upper lip, numbness left face. Treatment wait and observe, symptoms unabated.
Arm hurts; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 18-Apr-2021, PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-080544 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080544:1st dose of vaccine
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/ allergies were reported. On 11-NOV-2015, the patient was vaccinated with first dose of VAQTA (strength, dosing details, anatomical location, lot# and exp date unknown). On 27-APR-2016 the patient was vaccinated with a booster dose of VAQTA strength 25/0.5 (unspecified unit), (lot # L036300, Expiration date 04-NOV-2016, dose 2) (dosing details and anatomical location unknown), which was earlier than 6 months after the initial dose of VAQTA. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Started to feel pumping heart 12 hours after injection. 24 hours later, felt the arm pain, feel cold, tight chest, short breath, 48 hours later, starting having diarrheas, lower abdominal pain, sharp nerve pain on the leg here and there, one morning experienced super fatigue left leg. 3 hours later, the feeling was gone. After 48 hours, start feel sharp pain from chest, one and off. cannot sleep. slightly swelling legs and fatigue for the legs
Patient called from home. Reports of Redness, warmth, itching at site of injection. Border reaction site with skin marker to monitor Area, heat packs, Antihistamine. Patient Never returned f/u call. Resolved?
strong covid sysmtoms; fever; chills; body ache; This is a spontaneous report from a contactable consumer (Patient herself). A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6205), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:00 (age at the time of vaccination was 50-year-old) as single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing i have had covid already (11 days) so it was exact same,. Other medications in two weeks Concomitant medications included bupropion hydrochloride (WELLBUTRIN); fluoxetine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. The patient has no other vaccine in four weeks. The patient has no covid test prior vaccination. The patient has no covid test post vaccination. No treatment for AE. On 14Mar2021 02:00 The patient experienced strong covid sysmtoms, fever, chills, body ache. The outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse via a company representative regarding a 65 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2016 (reported as within last two weeks), the patient was vaccinated with M-M-R II dose 1 and dose 2 (dose, route, therapy type, lot # and expiry date unknown) within last two weeks. On 09-SEP-2016, the patient presented with shingles. The outcome of shingles was unknown. Causality was not provided by the reporter. No product quality complaint was involved. Additional information has been requested.
I noticed a slight ringing in both ears weeks after my first JJ shot. The shot made me terribly sick for a day and I felt awful for two days. Pounding headache, convulsing while curled into a ball with chills and sweats. I suspect neurological or nerve damage by whatever was going on. Booster shot (Moderna) made the ringing worse possibly doubled the noise just days later 1-3 days. Both ears now ring loud enough to hear while walking outside or in the office at work. I also hear a fluttering or pulsing sound almost like pressure or heartbeats, usually fast but sometimes pressure sounds from my actual heart beat which is not as bothersome as the ringing. A doctor prescribed me 250mg of oral steroid pills for 4 days which made my face and eyes puffy, vision really blurry and made it hard to sleep. The pills did nothing at all.  The doctor stated that I don't have any hearing loss and thought it might be stress But I have not been under any stress ever. So if the ringing is not stress related, nor caused by hearing loss and happened within 24-72 hours of the shot, I'm suspecting the shot caused the tinnitus.   Previously, I was not on medications and nearly never on medications my entire life.
Administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product details were provided by the reporter. No Treatment information was provided.  Linked to master case: MOD-2021-315260
12jan90 pt vax hepta B. 13jan90 pt ex dizziness, nausea. next morning, pt devel. urticarial rash on face w/ slight swelling of eyes.  pt recovered.
Pt experienced an injection site reaction which included swelling @ site of injection & down the arm within 24 hrs p/immun.
Customer states she is experiencing a new shingles outbreak.    Rash appeared on the back of her leg beginning on 3/31/20 and  6/13/2020.    Customer visited Dr. on 3/28/20.    Her 2nd rash appeared 6/13/20; but she has not yet made an appointment to see her regular doctor.   The pharmacy placed a call to the office for a refill of Acyclovir 800 mg #10, (1 bid) today.
Started with red rash which progressed to being warm to the touch. Initially managed by hydrocortisone cream and antihistamine. By day 3, progressed to whole arm swelling, rash, and hit to the touch. No pain. Went to ER for fear of cellulitis. IV vancomycin and ceftriaxone given (3 doses and 2 doses respectively). Discharged on oral doxycycline and cephalexin.
pt does not do well with any types of shots. Pt almost fainting was not abnormal. evaluated by EMT before release. no medications were given during observation.
This spontaneous report as received from a licensed vocational nurse refers to a 4 year old male patient. The patient had no illnesses at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 09-AUG-2015 at 10:38 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) (subcutaneously, in right thigh, lot # L010145; dose and expiration date were not reported) that was improperly stored. On 09-AUG-2015 at 10:38 a.m., the patient was also concomitantly vaccinated with the second dose (reported as #1 given elsewhere) of HAVRIX (intramuscularly, in left thigh, lot # C7392; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.
Less than 24 hours after shot, I will briefly descirbe adverse reactions as follows: 1.  shiver which turned into shaking uncontrollably until I could grab my hand with another and steady to take ibuprofen 2.  extreme exhaustion 3.  severe blisters inside mouth, gums, lips approx. 4 days after injection 4.  blisters outside of lips same as above 5.  severe face pain and headache before blisters appeared 3 days after injection 6. 6 days after injection, diagnosed with severe read sore throat, severe left ear infection, given antibiotics 5.  blister on left side of face ( appears to be shingles) No illnesses known more than 60 days prior to injection--My general health is very good and I am very active.
Pain and redness in arm, entire body had sever muscle aches, high temperatures, short of breath, muscle weakness, struggle to walk, White blood count elevated. Patient states he came to clinic to be evaluated two days after in a wheelchair, and was short of going to the Emergency room.