chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in her neck; having pain in both arms,body aches is normal post vaccination; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), NECK PAIN (pain in her neck) and MYALGIA (having pain in both arms,body aches is normal post vaccination) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and MYALGIA (having pain in both arms,body aches is normal post vaccination). On an unknown date, the patient experienced NECK PAIN (pain in her neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), NECK PAIN (pain in her neck) and MYALGIA (having pain in both arms,body aches is normal post vaccination) outcome was unknown.            No concomitant was reported.
Facial numbness, hot flash, Sweating, increased heart rate, palpitations,  shortness of breath, Dizziness, faintness, nausea, headache, fullness in the ears, lightheadedness, stomach pain.
soreness initially; arm was very very hot to the touch; very very sore; nausea; fever; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea), PYREXIA (fever) and PAIN (pain). At the time of the report, PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea), PYREXIA (fever) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Moderna is currently indicated for 18 years and older.  The patient is 16 years old.
66-year-old lady with severe COPD on home 2L O2 (initiated 3/21), newly diagnosed SCC of lung (not currently on treatment), HFpEF, schizoaffective disorder, and recent COVID-19 infection (dx 4/6) who presented with shortness of breath on 4/16  in the setting of receiving first dose of Covid vaccine 1 week prior.  Found to have sepsis physiology w/ hypoxic respiratory failure from COVID-19 pneumonia.  CXR with multifocal pneumonia in the setting of chronic interstitial changes and required up to 6 L nasal cannula.  Started on IV remdesivir (x 5 days ending 4/20) and Decadron x6 days, ending 4/21.  Clinically improved and weaned to her baseline 2 L O2 and discharged on 4/21 to rehab
Patient reported to the ER one week post her first COVID vaccine complaining of tingling sensation on lateral aspect of the knee, and patchy lesions. Patient diagnosed with shingles.
Immediately after immunization was given pt developed a rash at injection site about 1 1/2" x 1". The rash was itchy. Pt felt fine other than those symptoms. She was given, diphenhydramine 25 mg capsule and requested to remain in the pharmacy for 15 minutes to make sure she felt ok. An outline was marked so pt could see if the rash grew or diminished. I requested she call us at the end of the day to let us know how she was doing. She was also told to call the dr if her rash continued to get larger.
Potential side effects; very sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache) 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 VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
I began having seasonal allergy type symptoms that I have NEVER had before. Congestion at back of throat was difficult to clear. Took OTC Loratadine 10mg to curb the allergy symptoms. Maintained the Loratadine regimen for 7 months until symptoms went away. I also had a reaction to consuming peanuts/peanut butter. I have eaten peanut butter several times a week for most of my life without any trouble, but after the vaccine I would get digestive issues after eating something with peanuts in it. I would have some cramping and severe diarrhea. I stopped eating peanut foods for many months then tried them intermittently until about 9 months after the vaccine I didn't have the reaction to consuming peanut foods anymore.
No strength on his left side, he can't walk; left side weakness; They found a small eye bleed, a retina tear; lost eyesight of his left eye; he has slurred speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8734) at the age of 64 years, in left arm and on 25Apr2021 as dose 2, single (Lot number: ER8736), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery both eyes" (unspecified if ongoing), notes: cataract surgery both eyes, over a decade ago, maybe 15 years. Concomitant medication(s) included: MORPHINE; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]. Vaccination history included: Flu vaccines (Flu vaccines always made him feel terrible. manufacturer unknown lot unknown. took one in 2015 and it made him feel terrible.), administration date: 2015, for Immunization, reaction(s): "feel terrible".  The following information was reported: WALKING DISABILITY (hospitalization, disability), outcome "unknown", described as "No strength on his left side, he can't walk"; ASTHENIA (hospitalization), outcome "unknown", described as "left side weakness"; RETINAL TEAR (hospitalization, medically significant), outcome "unknown", described as "They found a small eye bleed, a retina tear"; BLINDNESS (hospitalization, medically significant), outcome "unknown", described as "lost eyesight of his left eye"; DYSARTHRIA (non-serious), outcome "unknown", described as "he has slurred speech". The events "they found a small eye bleed, a retina tear" and "lost eyesight of his left eye" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (21Apr2023) Unknown results, notes: Result: Not Provided; Unit: Not Provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232941 Same product, patient, different AEs, different dose;
Pt experienced superficial cellulitis in the area of the right thigh. Pt is on antibiotics.
Pt developed a rash, 4 days post vax. It progressed to erythema multiforme and by 9/29/01 with arthralgia. It resolved by 10/4/01.
swelling on the inside of her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on the inside of her arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included CYCLOBENZAPRINE for COVID-19 vaccination, THIAMINE, MONTELUKAST, ATORVASTATIN, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, GABAPENTIN, FOLIC ACID, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), ALBUTEROL [SALBUTAMOL] and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on the inside of her arm). At the time of the report, PERIPHERAL SWELLING (swelling on the inside of her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Got a rash on my right calf; small amount of injection site pain; tiredness; fever; feeling unwell; some joint pain; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration on 05Aug2021 20:00 as dose 1, single (at the age of 58 years) for covid-19 immunisation. Medical history included renal disorder, type 2 diabetes mellitus and hypertension. Concomitant medications included furosemide; sacubitril valsartan sodium hydrate (ENTRESTO); dulaglutide (TRULICITY) and rosuvastatin. No other vaccine in four weeks. Other medications received in two weeks were Entresto, Trulicity, Rosuvastatin and Furosemide. No known allergies. The patient did not receive any treatment for the events. Patient not had covid prior and post vaccination. It was reported that, the patient experienced rash on his right calf, small amount of injection site pain, tiredness, fever, feeling unwell and some joint pain other than that he seemed to be ok on 07Aug2021 10:00. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I tested positive for COVID-19 on 12/28/22. I had body aches, cough, congestion, loss of taste, and a slight fever. I contacted my doctor and was prescribed 5 days worth of PAXLOVID. By the time I started taking PAXLOVID, I was already feeling better, so I don't know that it helped me at all. I am feeling better now.
Patient states shortly after receiving vaccine she felt dizzy. Then later that day nausea and vomiting. The world is virtually spinning when her eyes are open. Treatment = Meclizine 25 mg TID x 21.
Patient reported dizziness immediately post vaccination. Patient said "this kind of thing happens to me a lot." Patient asked for fresh air so was instructed to stand slowly while supervised by medical staff. Patient walk outdoors but was unsteady on their feet. The patient ended up becoming disoriented enough to lose their balance. Patient was brought to the ground by a nurse standing with them. Patient never lost consciousness and was provided with water. Patient recovered from the event after approximately 10 minutes. Patient was able to leave the clinic under their own power and no longer reported dizziness when they left.
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and race received PREVNAR13, (NDC number: 0005-1971-01, lot S15227, exp.date Feb2018) for immunization at 0.5ml single dose on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced rheumatoid arthritis, and a reaction in her arm where it's hot and swollen and painful. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
Excessive sleepiness starting 6 hrs after immunization until 24 hours post immunization (lasting 18 hours).
I had arm tenderness, body very weak couldn't walk, headache, nausea, muscle weakness, vertigo, redness the size of my hand on right arm at injection site started to get a raised appearance. I  was told by my doctor to use Benadryl lotion cream that helped clear the rash. I had a  fever 99.3. I'm still having headache off and on everything else has cleared up.
This spontaneous prospective pregnancy report has been received from a physician via a company representative referring to a 21 year old female patient. The patient had no medical history or drug reactions/allergies. On 30-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (injection, strength: 120 (unit not reported), lot # J015378, expire date 09-APR-2016, dose, frequency and route were not reported). There was no concomitant therapy. The patient became pregnant with conception date of 30-OCT-2014. The date of last menstrual period (LMP) was 16-OCT-2014 and estimated due date (EDD) was 23-JUL-2015. The pregnancy outcome was pending. Therapy with GARDASIL was discontinued. No lab diagnostics studies were performed. No treatment was given for the event. The patient sought medical attention via seeing the doctor. The outcome the event was reported as not recovered/not resolved. Additional information has been requested.
Approximately 13 months post vax pt developed hepatomegaly with fatty infiltrates. A small portion of the liver was normal.
HEADACHES, DIZZINESS, NAUSEA, BLURRED VISION, LIGHTHEADEDNESS, HOT FLASH TYPE SYMPTOM. ALSO I AM BREASTFEEDING MOTHER AND MY 3 MONTH OLD GOT SICK 2 DAYS AFTER I RECIEVED THE FLUMIST.
On day 8 I developed pain, redness, swelling at the vaccine site. This has continued to increase over the last three days.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of GARDASIL (lot # J006850, expiration date 31-MAR-2016; lot # K006117, expiration date 14-JAN-2017, dose and route were unknown) which were exposed to temperature outside of the recommend range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
had her very first period (more spotting than an actual period); had her very first period (more spotting than an actual period); had her very first period (more spotting than an actual period); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 16:30 (Lot number: FK5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE. Vaccination history included: Bnt162b2 (DOSE 1, lot number=FK5127, administration date=12Nov2021, administration time=04:45 PM, vaccine location=Left arm), administration date: 12Nov2021, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: PREMATURE MENARCHE (non-serious), MENSTRUATION IRREGULAR (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 05Dec2021, outcome "unknown" and all described as "had her very first period (more spotting than an actual period)". Therapeutic measures were not taken as a result of premature menarche, menstruation irregular, intermenstrual bleeding.  Additional information: Reporter stated that her daughter had her very first period (more spotting than an actual period) on 05Dec2021, which was 2 days after she received her second Covid-19 shot. She will be 11, so it isn't that drastic, but they suspect her period came 12-18 months early due to the shot. The patient did not receive any other vaccine in four weeks.  Follow-Up (13Dec2021): Follow-up attempts are completed. No further information is expected.
Ringing/static sound in ears, noticeable when things are fairly quiet. Always present for the last 3 months.
Vaccine administered on Feb023 9:00 AM. Reaction started approx 3: PM same day with headache. At 6:   PM 101 degree fever, muscle aches, uncontrollable shivering with slight disorientation during the night 4:00 AM symptoms start to recede.
Pt came to ER c/o RUQ pain x 2 days with nausea and vomiting.
Can the Shingrix vaccine cause itching all over?; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced itching all over after vaccination. The patient asked could the Shingrix vaccine cause itching all over.
raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead; Rash itched bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included a topical corticosteroid, and to use a cold rag for rash. No concomitant medications were reported. Patient visited dermatologist. She received her second shot on 09-Mar-2021 (batch lot 006M20A) in right arm.
Information has been received from a consumer via poison and drug center (MFR#USIS-027832) referring to her daughter a 13 year old female patient. The patient's relevant medical history and past drug history were unknown. In 2014, one year ago, the patient started her first dose of GARDASIL (1 injection, once, route strength, lot# and expiration date were unknown). Concomitant medications were unknown. Since starting the first injection, the patient had had headaches daily. It was unknown if there was any relevant laboratory data. The patient never completed the series. As of the report time it was unknown if the patient would receive a GARDASIL again and she had daily headaches. The relationship of the event and GARDASIL was not reported. Additional information is not expected as the reporter refused any safety report information.
Light-headed/I woke up very light headed/Dizzy; arm got sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunisation; rivaroxaban (XARELTO), (Batch/Lot number: unknown) for anticoagulant therapy. The patient's relevant medical history included: "blood thinners" (unspecified if ongoing), notes: I am on blood thinners. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light-headed/I woke up very light headed/Dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm got sore". The action taken for rivaroxaban was unknown.  No follow-up attempts are possible. No further information is expected.
Patient up to date on vaccinations with last COVID vaccine on 10/22/21 who admitted to hospital for infected hardware found to have COVID detected test.  Asymptomatic for COVID throughout stay.  Provider discharging note below:  "69-year-old woman who had PMHx of T2DM on Metformin, Morbid obesity s/p sleeve gastrectomy, Permanent A-fib, HTN, HFpEF, underwent a right total knee arthroplasty In 2014.  The patient did very well with both her right and left total knee arthroplasty until several days ago when she experienced some fevers and chills and then began to notice severe right knee pain.  She was sent for laboratory studies that showed a dramatic rise in d-dimer, C-reactive protein, and sed rate.  Arthrocentesis of the right knee demonstrated A streptococcal pathogen and she is taken to the operating room for right knee arthrotomy liner exchange and thorough irrigation debridement of the right knee. Patient found positive with COVID, however, asymptomatic. After surgery, metformin held and add SSI, A1c returned unremarkable. ID consulted for antibiotics recommendations. D-Dimer trending down. Patient SBP on the soft side and her Losartan held. Bcx return negative. Eliquis resumed after surgery. PICC line placed   Patient is seen and evaluated at bedside. Patient AOx4, good mentation. Pain of the right knee is tolerable. Patient is able to passing urine freely.Breath comfortably in RA. Patient is otherwise no other complaints. Patient will be discharged home with home PT/OT and home infusions for 8 days and transferred to infusion clinic after COVID isolation terminated. Patient will need to have ceftriaxone infused until 3/1/21 and amoxicillin thereafter for bacterial suppression. Patient will need to follow up with ID, orthopedics and PCP regarding the right knee, Losartan use. "