chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at the site of injection; overpowering headache in the afternoon and it went downhill from there, patient was in bed until night; also noted a very high level of body ache from head to toe; feels like having a flu but not stomach flu; feeling nauseous; they received a vaccine that is past the suggested used by date; patient was in bed until night,; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu) and NAUSEA (feeling nauseous) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,). At the time of the report, VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2nd dose: right arm given on: 1June2021 lot no.: 049C21A (not sure if 099C21A due to bad penmanship)   This case was linked to MOD-2021-209017 (Patient Link).
Patient developed left/unilateral tender lymphadenopathy of axilla w/o clinical evidence of cellulitis or breast pathology approximately 24 hours after receiving influenza vaccine in left deltoid.
29MAR2023  COVID-19 Test-Positive I went to see my Doctor as I was not catching my breath and my heart has mitral valve prolapse so I was wondering which condition it was They gave me cough medicine and Paxlovid but the Pharmacy di not have either one or an inhaler. On Friday 31MAR2023 I was not better and I went to the ER at the hospital. my oxygenleve was tested and in the eighties no Paxlovid was prescribed due to a conflict with current medicine I went home but got worse and then back to the hospital and stayed three days.
Erythematous, painful nodules developed on fingers.  Those subsided over the course of 10 days.  These reoccured more intensely after the second dose, involving all the fingers of my right hand at random intervals.  Each lesion lasts 8-10 days and is accompanied by swelling of the fingers, tenderness of the skin and stiffness of only the right hand.  The 2nd recurrence was 10 days after my second vaccine and has not yet abated.
She felt cold and her hands were clammy; She felt cold and her hands were clammy; may be due to low blood pressure; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 07Apr2021 (at the age of 63-year-old) at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she received first dose of the Pfizer covid vaccine on 07Apr2021 and had a reaction immediately after the vaccine. She felt cold and her hands were clammy, may be due to low blood pressure in Apr2021, caller wanted to know if it is safe to take the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician and described the occurrence of urticaria in a 6 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. On 3/15/05, the patient received the third dose of Pediarix in the left leg (lot AC21A008BA). On 3/15/05, the patient also received injections of Haemophilus influenzae type B conjugate vaccine and 7-valent pneumococcal conjugate vaccine. At an unspecified time following the administration of the immunizations, on 3/15/05, the patient experienced urticaria. The patient was seen in an emergency room and was treated with diphenhydramine hydrochloride. The patient was seen by the reporting physician on the morning of 3/16/05. The physician reported the patient still had hives, but no difficulty breathing or changes in tongue. The afternoon of 3/16/05, the mother of the patient contacted the physician. She stated to the physician that the patient's feet were purple and cold but no tongue swelling or difficulty breathing. The events were ongoing as of 3/16/05.
at 2000 developed nausea, stomach upset, and diarrhea. then chills, diaphoresis. around 2200 developed shortness of breath, wheezing, pharyngeal edema. presented to PCP clinic this AM for walk in visit. I sent her to the emergency room for IV steroids as she was unable to swallow pills due to the pharyngeal edema.
I am a pediatrician and was paged to ER to help with a 2month old coding.  Mom said pt had received his vaccines then on the way home had stopped breathing so mom stopped the car then saw and ambulance.  Paramedics found pt limp and brought him to Kaiser ER.  When I saw pt., he was already intubated and had received epinephrine, bolus.  Pt was coded for about 40-45 minutes and pulse never returned. I don't know where pt was vaccinated and I don't have any information on the vaccines given.  5/18/07 Received autopsy report which reveals COD as congenital heart disease (tetralogy of Fallot).  Findings at autopsy include: I. Congenital cardiac malformation (tetralogy of Fallot)    A. globular appearance to heart    B. malposition of great vessels w/an "overriding aorta"    C. mild subpulmonic valve stenosis    D. High membranous VSD    E. Right ventricular hypertrophy        1. pulmonary HTN        2. diffuse pulmonary congestion    F.  Large atrial septal defect    G. left superior vena cava that emties into coronary sinus    H. Juxtaposition of atrial appendages w/both atrial appendages lying on left side of great vessels.    I. Right sided aortic arch    J. Bilateral pleural serosanguineous effusions    K. Peritoneal serosanguineous II. Horseshoe kidney III. Postmortem blood toxicology    A. Acetaminophen 4.2 mg/L. IV. Postmortem metabolic profile unremarkable.
Aggressive red, swollen, dry, itchy, rash on hand of arm with site injection. Hive like puffy skin irration. Some have transformed into full blisters with secretion of clear/yellowish liquid.   Using antihistamine and hydrocortisone cream and monitoring need to consult doctor if further worsens.   In progress.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-NOV-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2016, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Approximately 24 hours after receiving the vaccine I felt like I had a mild flu with achy body and chills, I was tired and slept. This lasted for about a day. 48 hours after the vaccine my eye sight became blurry, my ears began ringing and my face became tingly around mouth and cheeks. The tingling is intermittent but the ear ringing and blurry vision has been fairly constant.
BODY ACHES; CHILLS; EXTREME HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, extreme headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, extreme headache, and fever. This report was non-serious. This case, from the same reporter is linked to 20210534648.
itchiness on side of abdomen below underarm of left side on side shot was given 3 hours after shot lasting through night, severe vertigo-congestion and both ears ringing 24 hours after shot which continued for 3 days, congestion lasted 10 days, 2 1/2 inch in diameter raised hot welt around injection site lasting 10 days with arm very sore the entire time,  intermittent low grade fever day 3-5,
on awakening 11-6-21 presence of itching red Rash on back of arms and upper thighs, spreading. ORal benadryl and topical benadryl used without change. Cortisone injection (tennis elbow) received 2 days prioR to boosteR. 11-8-21 Pruritic/petechial papules on both dorsal forearms and anteRior thighs. 11-8-21, Hematology assessment: Adverse drug reaction. Therapy, triamcinolone ointment.
0.3ml of dose given initially and error discovered in need for additional 0.2ml and 0.2ml dose Moderna same lot administered
Symptoms include fatigue, headaches, redness, tender, itchy, welted, warm to the touch.
PEDIARIX given instead of PENTACEL with HepB. Patient given HIB.
A report has been received from a health professional concerning a 7 month old, female patient, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the FLUMIST Quadrivalent was given to a 7 month old patient, which was started on 17 OCT-2014. The outcome of the event of administration to 7 month old is unknown. The report was considered to be non-serious.
Patient called on 3/20/2021 stating that he broke out in hives at 1am following his second dose on 3/19/2021, he took benadryl and tylenol and the hives went away . Patient stated he had no other issues since the dose of Benadryl.
P:  Hypersensitivity reaction Patient received covid vaccine at 835  in covid clinic ( 3rd floor west auditorium).  Due to her h/o multiple allergies she was asked to stay for 30 min instead of 15.  About 10 min post vaccine she c/o feeling light headed and hot.      Did not have dyspnea, itching in throat or mouth, itching at inj site, no sensation of throat/face/mouth swelling.    O:  845:   bp 118/82, p 145, o2 sats 99%.    No respiratory distress, appeared anxious, HEENT:   flushed with redness to cheeks and forehead no facial swelling Mouth:  No swelling, pharynx without redness, no swelling to lips or tongue Neck: no redness, no increased warmth, no swelling Lungs:   lungs clear in all lung fields no wheezing or stridor both anterior and posterior CV: tachycardia with reg rhythm. No murmur  Given water, and ordered po benadryl 50mg  8:48:  C/o increased lightheadedness and feeling flushed,   Skin:  Urticaria to chest, neck and visible spreading of urticaria into face and scalp during observation.  Continues with stable respiratory status and airway, no stridor, no angioedema Due to rapid progression of hives, pt was given epi 0.3mg IM  EMS activated for transport to ER  8:52  Bp 122/82, p 150, o2 sats 99%.  Pt shaky and anxious, teary, calm after reassurance that this is normal reaction to epi and stress of situation for her.  9:00am EMS arrived and report given to EMS who then transported pt to ER.  A:  Hypersensitivity reaction to covid vaccine, possible more related to anxiety   1pm Patient called clinic to give a status update.  She was held in the ER and given additional benadryl, prednisone, zyrtec and then some ativan She did not have further hives after the initial epinephrine dose.  She was discharged with 5 days of prednisone and zyrtec as well as an epi pen.  Reports she feels tired and drained but no other symptoms.
Pt given 36month+ dose of flu vaccine in error, 0.5mL instead of indicated 0.25mL. At time parent was notified on 10/30 PM, pt had no notable side effects or adverse reactions.
My extremities tingling; My face gets red; A warm feeling; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Atrial fibrillation. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, CARVEDILOL, RIVAROXABAN (XARELTO), LOSARTAN and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued). At the time of the report, PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued) had not resolved.            No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Pt experienced dizziness during vaccination. Has hx of DM2 & high cholesterol but unsure of medications. BP 169/85; HR 80; RR 16. Given Benadryl, released from site. Pt's significant other drove pt home. Pt stablet to release from site per MD
Had varivax vaccine on 10/24/1997. Chickenpox exposure at daycare the week of 3/22/01. Seen on 3/26/01 with many vesicles, papules, URI symptoms. Rash very itchy.
This spontaneous report was received from the patient's father via company representative, referring to a 5 year old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 10-SEP-2017 (also reported as "10 years ago"), the patient was vaccinated with PROQUAD (strength, dose, route of administration, lot number and expiration date were not provided) which was diluted with sterile diluent, for prophylaxis. The patient also received a dose of an unspecified flu vaccine (manufacturer unknown). Subsequently on unspecified time, the patient developed "a fever and swelling on the left side of her cheek and neck"; no further clarifying information was provided. The patient was seen by an unspecified healthcare provider on 20-SEP-2017, in regards to the reaction and was diagnosed with a viral infection of the salivary glands. At the reporting time, the outcome of the patient was not reported. The reporter did not assess the causality between the event and PROQUAD. Upon internal review the event of sialoadenitis was considered to be medically significant.
The pt complained of arm felt "weak" right after appointment. Next day he developed pain. Tylenol was given. The pain persisted, then the mother gave him Motrin but it didn't help much. On 03/27/2002, arm was better but still painful.
Patient began feeling achy on 11/9/23 after recieving the vaccinations. The spot on the arm where the RSV shot was administered became red and swollen. The patient also developed an upset stomach and was not feeling well until the morning of 11/12/23 but they did not feel like they were 100%. They just felt a little bit better.
Dizziness, headache, weakness onset less than 24 hours after vaccine. Patient reported similar symptoms with nausea and vomiting after first dose .
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Received the Vaccine Shot, waited 15 minutes with no issues.  Went home, in about 15 minutes had extreme chest pain. Quickly moved to emergency room.   Was given nitroglyercin paste on chest, Asprin to chew, Heprin and cardiac cautherization.  Cautherization showing no real issues.  Eventually the pain was gone. Cardiac doctor mentioned heart possibly being highly stressed earlier. I have some thoughts that it may have been a temporary blood clot, but not proven. Chest pain was very bad until emergency room starting getting it under control. never had that much pain before with previous heart attacks in 2004-05
Left deltoid pain, swelling, redness, warmth;  Swollen, painful, left axillary lymph nodes  ?diagnosed with cellulitis 1/18/21 and given keflex every 8 hours x7 days.
Pt is a 26 yo M with a documented allergy to Amoxicillin (rxn: Rash; severity: Not Specified; since 01/19/2018). On 04/08/21, pt presented to clinic for immunization. At 0834, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #207A21A; Exp: 6/23/2021; NDC #59676-580-15). After injection, pt became diaphoretic and dizzy. Pt reported similar reaction with blood draws. Pt was placed in supine position, given water and ice packs were applied to his neck. Pt evaluated by MD with no new orders given. After 10 minutes of observation, pt reported symptom resolution and return to baseline. Vitals assessed as BP: 126/81, P: 77, O2 sats: 97%. Pt discharged in stable condition.
Nausea and vomiting began 7/31/15 - 8/3/15.
This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's medical history included hysterectomy about 22 years ago and acute pancreatitis due to congenital defect. On 18-SEP-2009, the patient was vaccinated with a dose of ZOSTAVAX, (Lot # reported as NDC 00649630). Concomitant therapies included estradiol, LORTAB and ADVIL. On 03-SEP-2013, the patient experienced shoulder fracture. On 08-NOV-2013, the patient woke up with a stiff neck with shooting pain up. This was followed with a rash and blister started on the 18th. She went to the doctor on 19-NOV-2013 and was diagnosed with shingles. The patient also reported that she still had blisters that keep coming out on her hairline and ear on left side of the scalp, neck and ear area. She said she was also experiencing sharp pains in her ear. The patient was treated with an antiviral medicine. An MRI was performed on 16-OCT-2013 (results nor provided). An X-Rays were performed on 02-OCT-2013, 06-NOV-2013 and 16-NOV-2013 (results nor provided). The outcome of the events (shingles and ear pain) was reported as not recovered/not resolved. Additional information has been requested.
Tinnitus. No available treatment. Taking vitamins that lessens the ringing.  My sister had the same adverse event.
Got 3 vax for shingles, got shingles/Suspected vaccination failure; Shingles in eye; Got 3 vax for shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and extra dose administered. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient's friend reported that the patient got 3 vaccine for shingles then got shingles in his eye. The reporter stated no thanks. Additional supportive information: The patient received 3 shingles vaccines, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pfizer-BioNTech COVID19 Vaccine  Vomiting, diarrhea, stomach aches
2nd day - chills, fatigue numbness 3rd > 6th days  - increasing numbness ... left face, left finger, left foot 4th & 5th days - stumbling on left side, all symptoms serious enough for me to get doctor consults (3 doctors)
Developed supraclavicular lymphadenopathy, followed by general lymphadenopathy and persistent fevers.  Has continued to have persistent fevers and lymphadenopathy since.  Currently ill with multiple medical problems related to frequent infections, hemodynamic compromise, renal failure over the past few months.
Pt requested FLUZONE HD and PNEUMOVAX 23 vaccines in same arm on 12/14/15. The vaccines were administered approximately 1 inch apart in left deltoid. Pt complained on 12/16/15 warm area and puffy red area. She went to PCP on 12/16/15 MD thinks maybe area of cellulitis treating w/penicillin.
Sudden onset severe vertigo, nausea and emesis 10/5/21 upon wakening.  Virtual MD appt that morning. dx: vertigo.  Anti nausea and anti vertigo meds prescribed.    Symptoms resolved over following 1-2 days.