chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient just got the Shingrix about an hour ago and already feeling neck muscle pain. The reporter asked was it possible that it already related to the shot.
Persistent headache; A spontaneous report was received from a consumer and concerning a 73 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a persistent headache and worried about a blood clot/thrombosis.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  Since 03 Mar 2021, the patient had persistent headache for maybe 12-14 days which were not getting better and was worried about a blood clot. No treatment information was provided. The event worried about blood clot was medically significant.  Action taken with mRNA-1273 in response to events was not reported.  The outcome of the event persistent headache was not resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. Headache is consistent with the safety profile of the product.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 at 19:00 as dose 3 (booster), single (Lot number: EW0198) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Past drug history included: Atorvastatin, reaction(s): "Allergy", notes: also take Atorvastatin, but have spotted taking it, while I am on the Paxlovid site to avoid interactions. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: patient received anti-viral Paxlovid treatment from 13Jun2022 for COVID-19.  Follow-up attempts are completed. No further information is expected.
pt recvd 2 doses of vax & exp elevated liver function tests; cholestasis was r/o;
Patient's wife reports a diabetic episode the morning after receiving the vaccine. The patient was fine going to bed the night before, but in the morning about 20 hours after receiving the shot the patient was unresponsive to wake up in the morning. He struggled to open his eyes, but was able to awake with some coaxing. His blood sugar was 175, but came down after taking measures to lower his sugar. He was able to get up and walk around, drive like normal within 2-3 hours after waking up. The patient's wife states the reaction was abnormal, nothing different occurred the night before, the only change was the vaccine administration.
Chills, malaise 24 hour after injection  High fever 103F  36 hour after injection  Near syncope 24 hour after injection  Low grade fever maintained until 48hr after injection Dry cough starting 36 hour after injection and continuing until 48 hour
Patient c/o itching all over, vitals stable. Patient given 50mg Benadryl. She felt fine after 30 minutes and discharged.
She got her vaccine, she started feeling real sick about 6:00 PM real woozy.  The next morning when she got up and started pulling herself together she rubbed her arm and felt the rash, really fine bumps on both arms.  These were new as the other rash she had just gotten over was in a different place.  She felt bad from her head to the toes, just dizzy, stomach upset and nausea.  She got up this morning to see what she should do.  She still has the rash on both her arms.  The only thing she took for the rash is Benadryl and is going to seek medical attention for it.
her arm is little sore; by mistake was givena dose of GARDASIL 9 instead if Tdap; 29 weeks pregnant/by mistake was given a dose of GARDASIL 9 instead if Tdap; 29 weeks pregnant/by mistake was given a dose of GARDASIL 9 instead if Tdap.; This spontaneous prospective pregnancy report was received from a consumer referring on herself a 30-year-old female patient. Her concurrent condition included high cholesterol; her medical history included abnormal Papanicolaou test; her drug reactions or allergies included morphine. Concomitant therapies included progesterone and prenatal vitamins. The patient's last menstrual period (LMP) was calculated at 14-NOV-2018 and the Estimated Date of Delivery (EDD) at 21-AUG-2019. The pregnancy outcome was pending.  For the past 3 or 4 years the patient's Papanicolaou test has been normal. It was reported that on an unknown date, a colposcopy was performed for the abnormal Papanicolaou tests.  On 04-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dosage form, in the upper arm (formulation, dose, route of administration, lot # and expiration date were not reported) instead of tetanus, diphtheria and pertussis (Tdap) vaccine (wrong product administered) (foetal exposure during pregnancy) (exposure during pregnancy); also, her arm was a little sore (pain in extremity). It was reported that the patient  spoke to physician's office.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration and pain in extremity occurrence was not provided by the reporter.
Pt received DTaP & Hib then eyes rolled back, held breath, went limp for a few seconds then woke & acted normally.
LPN calls FBVHC  on 29OCT09 re 23 y/o AD female SM who inadvertently received GARDASIL vaccine on 30SEP09 and the Live Intranasal Flumist vaccine on 08OCT09 before the SM knew she was pregnant. As of 29OCT09, when the SM's OB Intake/Registration was performed the SM was at 6 weeks, 3 days gestation / LMP 12SEP09 / EDC 19JUN2010. Age at first pregnancy: 20 years. Gravida 3, para 0 and 2 abortions/miscarrages one at 9 weeks and one at 5 months. No previous ectopic pregnancies. No h/o congenital malformations. No DES taken during pregnancy. Baby's father is 24 y/o. The SM currently denies any evidence of adverse events following immunizations received no spotting, cramping, pelvic or abdominal pain reported. Denies N or V. NKDA. The SM is scheduled to be seen at OB-GYN on 07DEC09 for specialty consult s/p vaccine exposure as noted above. SM advised to notify PCM of any new onset of spotting, pelvic or abdominal cramping or pain. Intractable N or B fever > 101F or any other changes in health status. FBVHC provided patient with online resources for MERCK GARDISIL PREGNANCY REGISTRY and will F/U with SM periodically throughout pregnancy to inquire re progress and reporting of any adverse events up through the delivery of the baby. Symptoms: Amenorthea.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Rebound of Covid exactly 5 days after finishing Paxlovid; (2022) Positive, notes: Symptoms same as before. Fever, cough, headache, and positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My symptoms have gotten worse or the past 2 weeks. I have had a headache every day since I got the vaccine. On 4/19/21 my symptoms worsened. I am currently experiencing chills, fever, fatigue, headache, and body aches.
After 1st dose, fatigue, headache and muscle soreness in the left arm first 2 days after vaccination. After 2nd dose, first few days was low grade fever, muscle soreness and fatigue.  3rd day after small bruise developed at injection site and muscle aches and pains.  The bruising on the arm has gotten progressively larger and much worse for the last 7 days.  The bruise now extends from just below the shoulder where the injection was given down to the elbow and all the way around the entire arm with moderate swelling.  Joint pain in the right shoulder and unable to lift arm more than 6 inches. Bruising keeps increasing everyday.
Pt broke out in a rash at approx 6pm and went to the ER. Rash progressively got worse while in ER. ER gave pt Benadryl, Zantac and prednisone.
Moderna covid-19 vaccine EUA Hour after shot, body broke out in hives with itching and elevated heart rate. Lasted about 15 minutes.
My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; I'm having trouble walking; got up every 15 minutes after that with frequent urination/ I got up 5 or 6 times and even could not get bathroom fasten up and couple of occasion is very unusual for me; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose in the arm for COVID-19 immunization. Medical history included atrial fibrillation, diabetes and a heart attack 30 years ago. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) for A-fib, empagliflozin (JARDIANCE) for Diabetes, metformin hydrochloride (METFORMIN ER) for Diabetes. It was reported that the patient had no after effects the day he had the shot. In the morning of 16Jan2021, he got some things going on but he was not sure if it is connected with Pfizer or not. Usually he wakes up and go to the bathroom once in middle of a night. Last night he got up 5 or 6 times because he had to go and couple of times, he did not even get to the bathroom on time so he really had to urinate. Stated this is very unusual for him. And when he woke up this morning, her joints do not look physically swollen up but they feel, stated "how do I describe it, they feel very (incomplete sentence)". His knee joints and elbow joints felt very stiff and felt as if they were swollen but they're not. Stated that he's having trouble walking. Stated that it may be totally unrelated. The patient stated, "The only thing I had was, every year they make me go to a lab and make sure I have no issues with Pradaxa because it is a blood thinner. I have that lab. Work done couple of weeks ago. I have not gotten the answers yet". Also stated that he had lab test because he has acid. The outcome of the events was unknown.
severe shakes, fever more than 2 degrees, excessive sleeping 16 hours, unable to stay awake
1st dose I had fever, body and arm pain. 2nd dose I had arm pain and swollen lymph nodes, 3 days later I lost smell and taste.
Pericarditis: inflammation of heart's lining; Stabbing pain shooting from upper-mid back through to sternum; Fever; Overall weakness; Severe pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (lot number: EW0175), via an unspecified route of administration in arm left on 26Apr2021 15:30 at single dose for COVID-19 immunisation. Medical history included endometriosis, no recent issues. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included estradiol, progesterone, and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis:  inflammation of heart's lining, stabbing pain shooting from upper-mid back through to sternum, fever, overall weakness, and severe pain on 12May2021 10:00. Facility the most recent COVID-19 vaccine administered was in hospital. Adverse events resulted in emergency room/department or urgent care. Patient was hospitalized for these events. Treatments included morphine, colchicine, and indomethacin. Outcome of the events was not resolved. Patient also received the second dose of BNT162B2 (lot number: EW0169) on 17May2021 15:45 in left arm.  Follow up needed, further information has been requested.
I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; extremely itchy from head to toe; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation. The patient medical history was none. No family medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). No prior vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced extremely itchy from head to toe and rash almost like, patient didn't know if it's hive or as rash on body and on face which patient never gotten in life especially where patient scratch to itch. And patient started menstrual cycle 2 weeks sooner than it should started and the menstrual cycle had a lot of blood clots, clots coming out. Treatment in response to event included diphenhydramine hydrochloride (BENADRYL). The patient had a blood test (Jun2021) done just to check level of like vitamin D, vitamin b, full blood panel. Just a regular full blood panel. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt was seen at local hospital ER for swelling on (L) thigh from groin to just below knee. Spoke with mom on 8-7-07 and pt has completely recovered.
11/30/2021 - I felt general malaise, achey; 12/1/2021 - I became Short of breath with minimal exertion,  felt like my heart was pounding, and diaphoretic.  These symptoms resolved completely with rest. At the time of this report, 6 days post booster shot,  I remain short of breath with minimal exertion , along with the diaphoresis and heart pounding. I was hospitalized on 12/1/2021, discharged 12/2/21. Admitting doctor and 2 consults all told me they believed my symptoms to be due to the covid booster.
12/5/2021 - In ED via EMS for weakness/fall. Vitals WNL except RR 24, Temp 94.3. Admit for pneumoperitoneum/sepsis.Covid negative on admit and until 12/24.  12/24 - Patient pending discharge to extended care facility in am following neg covid swab. Found now to be Covid positive and asymptomatic. Started Decadron, Lovenox. Not a candidate for Remdesivir due to AKI. Discharge held for 10 days. Vitals WNL 12/28 - Sodium level that has been an issue that resolved has resurfaced - now 148, serum osmality 345. Increased free water plus hydrochlorathiazide. Increased BUN-93- d/c decadron and IV Flagyl. 12/30 - d/c Losinipril per Nephrology consult 1/2/ -covid test negative. Preparing to discharge in am 1/3 - HgB 7.6 and BUN elevated again. GI consulted.  1/5 - received 1U PRBC. Lovenox d/c. started A-fib with controlled rate. Had previous episodes short term.  1/9 - Potassium elevated 6.1 - question etiology- started Kayexalate, D 50 and insulin, calcium gluconate. Later on patient went into cardiac arrest and expired @1616.
Redness on the shoulder from the injection side; Swollen shoulder; A spontaneous report was received from the consumer,79 years old female has developed redness on the shoulder from the injection side, as well as the swollen shoulder from her 1st dose of Moderna.Patients medical history was unknown. Patients concomitant medication was unknown.S he has received  COVID-19 Vaccine on January 13, 2021.She wanted to know whether it will impact her ability to get her 2nd dose of COVID-19 Vaccine.The event has not recovered.
Fever treated with acetominophen Cold chills Severe bone pain Sensation like being stung by wasps headache severe fatigue
Pain in arm continues. I cannot sleep on it. On occasions I cannot raise it without pain.  Visited my GP recently, told her about the pain and she thought it was muscle damage.
Hives on entire body the morning after the flu shot was given, severe itching. Patient took antihistamine and symptoms were relieved.
Two days after my initial dose, I experienced a bad Lupus flare with horrible widespread pain that was difficult to manage, weakness and extreme fatigue; I could not function ie: bathe, cook, etc. It took me roughly 5 days to recover. It is reported that the side-effects with the 2nd dose of the COVID vax are even more severe. And honestly, I felt so horrible the 1st time around that I am scared to experience it again and at a more severe level, especially since my husband will be working outside of the home at a new job and cannot be available to care for me.
Edges of my lips are red and itchy; Edges of my lips are red and itchy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 15:30 (Lot number: EW0182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; TURMERIC [CURCUMA LONGA]; MELATONIN; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose: 1, Administration date: 05Apr2021 , Administration time: 12.15 PM , Lot number: ER8729), administration date: 05Apr2021, when the patient was 41 years old, for covid-19 immunization, reaction(s): "with the first vaccine I had vaginal irritation", "with the first vaccine I had vaginal irritation, redness,", "the skin started to peel". The following information was reported: LIP PRURITUS (non-serious), LIP ERYTHEMA (non-serious) all with onset 04May2021, outcome "not recovered" and all described as "Edges of my lips are red and itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip pruritus, lip erythema. Additional information: he patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The treatment was given with Allegra and AZO.  No follow-up attempts are possible. No further information is expected.
Patient reported that she started to get vertigo the day after the vaccination. She claims that her symptoms come and go but she is still feeling the effects of the vertigo now, which is weeks later.
Gradual onset of altered taste 2/24/21.   .   On 2/27/21,  he noticed that his right eye could not squint like his left. He was diagnosed with Bells Palsy by his PCP and started on Valacyclovir.
Pt.'s mother states that after receiving the 2nd dose of Moderna 07/31/2021, started experiencing symptoms 07/31/2021 of chest burning, heartburn, headache, and dizziness lasting 19 days. Primary visit 08/26/2021, recommendation to follow-up if symptoms worsen. Mental "Breakdown" stated son has shown signs of Anxiety and Nervousness. Still continuing to experience symptoms.
This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose and route were not reported, lot # L039659, expiration date 15-MAR-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On an unknown date, the patient was inadvertently administered a dose of ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) diluted in sterile diluent (DILUENT MRK) injection (dose, lot number and expiration date were not reported) instead of an intended dose of VARIVAX. The pharmacist reported the error occurred because both vaccines were varicella vaccine and it was believed that they were interchangeable. No dose of VARIVAX was administered. No adverse effect was reported. No additional information provided. No product quality complaint. Additional information has been requested.
expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-403798, MOD-2021-403791, MOD-2021-403794, MOD-2021-403796 (Patient Link).