chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported.; The pharmacist stated that the patient received VARIVAX shorter than recommended interval. The patient received first dose of VARIVAX on 5/1/2022 and second dose on 5/27/2022.; This spontaneous report was received from pharmacist and referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided.  On 01-MAY-2022, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) /dose, lot number u016065, expiration date: 20-MAY-2023 administered subcutaneously for prophylaxis (anatomical location was not provided).  On 27-MAY-2022, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/dose, lot number u016065, expiration date: 20-MAY-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) (inappropriate schedule of product administration).  No adverse event (AE) was reported.
Information has been received from a physician concerning an 18 year old female, with a history of cardiac irregularity detected during an athletic physical, who on 08-APR-2008 was vaccinated with second dose of GARDASIL (lot # not reported). Concomitant therapy included HAVRIX, administered on 08-APR-2008. Blood work taken on 09-APR-2008 showed elevated liver enzymes were positive for mononucleosis. AST (SGOT) level was 129 and her ALT (SGPT) level was 223. Her only symptom was fatigue. The patient sought unspecified medical attention during an office visit. The patient's elevated liver enzymes and mononucleosis persisted. Additional information has been requested.
Atypical Reactions: Swollen lymph node above my left collar bone began three days after injection and continues to be swollen and tender currently (11 days post injection), tingling in hands and feet, depression and severe fatigue continues as well. Typical Reactions: Sore arm for one day, swelling for 3 days, redness for 6 days, hard knot at injection site for > 7 days, headaches and nausea > 10 days.
Swelling left knee, slight erythema, pain. Began evening 12/7/10. Does not want to flex (L) knee, favors when walking. Came to office 12/9/10 without sx. Placed on oral KEFLEX.
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week,  had to stay in bed on and off all week, no energy, forced myself to eat,  severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21.  was most severe Thursday 4/8-Firday 4/9    Could not concentrate all week, even watching tv.
Immediate cold chills, headache, skin color appearing pale, sensitivity to light, racing pulse, erratic heartbeat, stroke-like facial drooping, unable to use fingers on both hands (stiff paralysis)
Erythema Multiforme  Fever 2 seizures within a 3 week time period
Initial fever and chills overnight,  persistent neuropathy in right arm, inability and difficulty in raising arm,  numbness in right hand and difficulty in lifting and doing work with right arm.  I contacted my Dr after a few days over my concerns and was told to wait a few more days and see if the symptoms faded.  When the symptoms persisted I sought an appointment with my GP.  He recommended further evaluation and physical therapy.  I am currently participating in a therapy program, but I have limited use of my right arm and after three months I see little progress to full recovery.
pt recv vax 7MAR97 & same day pt passed out for 2-3 min & exp a decreased heart rate;
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L21A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety.Concomitant products included CLOFIBRATE (FIBRATE) for Triglycerides. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping). The patient was treated with LORAZEPAM (ATIVAN) for Anxiety, at an unspecified dose and frequency; ZOLPIDEM TARTRATE (AMBIEN) for Adverse event, at an unspecified dose and frequency; ESZOPICLONE (LUNESTA) for Adverse event, at an unspecified dose and frequency and TRAZODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping) 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.Concomitant medications used were Supplements and antibiotic for bladder infection. 3 other medications were used as treatment medications.Sleep studies were done on patient and the result was negative for sleep apnea. This case was linked to MOD-2021-387074 (Patient Link).
uncomfortable itchy feeling; chills; body aches; overall itchiness; Headache; hives; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches), PRURITUS (overall itchiness/ uncomfortable itchy feeling), HEADACHE (Headache) and URTICARIA (hives) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seasonal allergy, Drug allergy (allergy to Levofloxacin) and Drug allergy (allergy to  Keflex).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced URTICARIA (hives). On 17-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), PRURITUS (overall itchiness/ uncomfortable itchy feeling) and HEADACHE (Headache). On 19-Mar-2021, URTICARIA (hives) had resolved. At the time of the report, CHILLS (chills), MYALGIA (body aches), PRURITUS (overall itchiness/ uncomfortable itchy feeling) and HEADACHE (Headache) had resolved. 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.
1. Moderate exacerbation of Eczema condition 3 months after 2nd dose of covid19 vaccine. Control at then with topical steroids. 2' Severe  exacerbation of Eczema 1 month after 3rd dose of covid19 vaccine. At present uncontrolled , in spite of multiple attempts with topical medication and moisturizing creams. 3. oral prednisone to be started
The patient said she experienced redness, swelling, warmth, and pain in her right upper arm underneath the injection site. The reaction lasted 4 days.
Vertigo; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U25620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VERTIGO (Vertigo) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo) and NAUSEA (Nausea) 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.; 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, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Healthcare Worker via field representative refers to a 58 year old male patient. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007826, exp. date 03-FEB-2016) injection, 1 dose/once, intramuscular (IM) for chronic risk factors. Concomitant therapies included FLOMAX, atorvastatin, ALEVE and VARENICLINE. On 20-OCT-2014, the patient experienced body aches, cough and fever after receiving PNEUMOVAX 23. The patient also had received an unspecified flu shot on 20-OCT-2014. The outcome of cough, fever and body aches was reported as not recovered/not resolved. It was not report whether the patient sought medical attention. This is one of several reports from the same reporter. Additional information has been requested.
After vaccine, pt became "a little lightheaded". Pt. was given TDAP (BOOSTRIX) pt asked to remain seated for approx 10-15 min. Dr came in to evaluate pt. before leaving. Sxs lasted approx 15 min.
New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thighs developed stiffness (R>L) in morning with AM stiffness for 1/2 day, and finally wore off day before second shot. Then, got 2nd shot 5/17/21, with fever first day, body aches starting the next day. After few days, felt better. However, Friday morning 5/21 woke up with pain in biceps, triceps, could not abduct arms above 7 o'clock position due to severe pain -- bedridden 4 days, felt like someone beat him up or got hit by a car, then improved sligthtly. 1 week later, developed stiffness in low back, hips, and thighs. Also with night sweats few nights.
From initial information received on 01MAY2003 from a nurse regarding an adverse event occuring in the USA, it was reported that a 62 year old female pt received TD ADS ADULT given inramuscularly in the right deltodi and TUBERSOL 5 TU, given in the right forearm on 22APR2003. On 29APR2003, the pt experienced a local reaction of redness, swelling and itching from the deltoid down to the elbow. The pt was evaluated by a physician and diagnosed with cellulitis. She was prescribed cortisone, Keflex and Zyrtec. It was reported that the events were resolving as of 30APR2003.
I had a headache, runny nose, swelling and redness at injection sight, pain and swelling in left armpit, back ache, fatigue, general uneasiness.
39-y-o employee received an influenza vaccine on Wednesday 26 SEP reports experiencing pruritus, erythema, and urticaria around the site of injection and by early evening this reaction spread to her neck, chest, abdomen, bilateral arms and upper thighs.  When she arrived home from work, the employee reports she took Benadryl 25mg, Claritin 40mg, and Zantac 300mg with some relief. This morning, she reports taking the same doses of medications.  On 27 SEP, she reported that most of her hives have subsided, but she still is experiencing pruritus especially around the injection site, lips, and hairline.  Employee reports that she has not experienced a prior reaction to any vaccine. She denies exposure to any known allergy during this time period.  She reports that she feels like this after she has received morphine, which is a medication allergy for her.  After phone interview, employee was briefly visited at her work area.  On physical exam: calm, A&Ox3, no signs of emergency/immediate threat to life; noticed employee occasionally scratching arms, legs, eyebrows, and areas close to her mouth during conversation. HEENT: no erythema, no swelling of tongue or pharynx; chest and neck: erythematous anterior without urticaria. L deltoid: noticeable erythema at injection site with an erythematous, 4 mm diameter, raised wheal.  The area approximately 2 cm away from the injection site also was erythematous.  Employee has continued taking Benadryl, Claritin, and Zantac, and was prescribed a low dose burst of prednisone.  She reports symptoms have improved.
Aches and Pains all over the body a few hours after bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Aches and Pains all over the body a few hours after bivalent booster) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced MYALGIA (Aches and Pains all over the body a few hours after bivalent booster). At the time of the report, MYALGIA (Aches and Pains all over the body a few hours after bivalent booster) had not resolved.            No concomitant information provided. Reported that patient received 5 doses of Moderna COVID-19 vaccine so far, 2 primary, 2 Monovalent boosters and 1 Bivalent Booster. After Bivalent Booster patient started with Aches and Pains all over the body last night and she had them. This time she was not sure if it will go away after 24 hours. She stated that she went away for work and has not exercised for 5 weeks. Yesterday she decided to exercise again. She was not sure if the pain was from the exercise or the vaccine or both. No treatment information provided   This case was linked to MOD-2021-076249, MOD-2021-109926, MOD-2022-656445 (Patient Link).
I felt very sick about a second after the injection. Cold extremities, pale, like I was going to faint, shaking, nausea, head tension, and a feeling of the world disappearing. My symptoms have changed a lot over the course of my illness. Some of them are: gastrointestinal issues like frequent urination, diarrhea, difficulty fully emptying bladder. Tachycardia upon standing. Pulse during tilt table test was 60-126. HR is frequently 150+. Blurred vision. Headaches. Nerve pains. Lack of appetite and difficulty eating. Cramps and random muscle pains. Throat tightness. Tension in my head like there is too much pressure. Fatigue. Exercise intolerance. Confusion and memory issues. Difficulty absorbing information. Irritability. Difficulty swallowing. Chest pains and palpitations. Intolerance to heat. Difficulty breathing. Cold extremities. Like I was upright when lying down. Pins and needles.   I have gotten better and my symptoms constantly change. The most consistent symptoms are fatigue, lightheaded, blurred vision, tachycardia.  The two week following vaccinations I had very long (multiple hours) episodes that were very severe. One day I lost the ability to get up from my bed despite trying. This went away after a few minutes. I took 0.25-0.5 mg lorazepam as needed. Doctors thought it was anxiety at first but were confused because it was very atypical.   I have no treatments since there are none for POTS.   I felt better in April but am a lot worse now again in May. Gets almost unbearable when I?m on my period.  My doctor suspect I had an adverse reaction to the spike protein which then developed into POTS. I passed out twice with my second vaccine despite no history of fainting. I was not scared of needles. I had the flu vaccine in October/November with no issues despite being anxious after my experience with the second COVID vaccine. My doctor says I have a textbook case of POTS (Postural Orthostatic Tachycardia Syndrome). I feel so unwell and have dropped out of college.
pt recvd vax; devel arching of the back, stiffening of both legs; jerking of both arms approx 3 1/2 hrs p/ tetramune/opv vax;lasted 30sec-1 min;had 2 more episode next 3-4 hrs; to er;ibuprofen given;MD visit next am nl-exam;
pt became lifeness; pale ; crying off & on since receiving vax; crying became progressively worse; same day lasting 3-4 days fine red rash; temp 104; given APAP;
vaccine in am. That night had back pain. left hip pain and when walking felt like dragging left leg. Ice to injection site due to discomfort also.
Syncope. about twelve hour later she  developed some chills and fever and dizziness which was not unexpected.  Overnight into Saturday morning 3/27/2021 however she fell a few times and believes that she did pass out.  She injured her face in the fall but no other injury and the injuries or not severe.  By our appointment on 3/29/2021 She is feeling a little bit fatigued at this point but otherwise back to her normal self.
On 1/10/01 the pt went to the ER with a rash and shortness of breath, fever of 100.4 was told to stop Amoxil. On 1/12/01 the rash is still present, pediatrician consulted referred to an allergy specialist. Specialist is unsure is rash is due to PCN reaction, vaccine reaction or viral infection.
Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED.  Patient reported back to baseline after 1.5 hours.
I gave a newborn RSV vaccine meant for pregnant moms. Reported to Dr and Dr. Spoke to infectious disease doctor regarding adverse symptoms to watch for.
Pt called with dizziness and shortness of breath. Went to ER and was admitted for observation.
Patient developed dyspnea/wheezing/shortness of breath while working in her yard. On examination, she was noted to have Bronchospasm, wheezing, hypoxia  requiring supplemental o2, steroids, duonebs. Troponin peaked to 3.Could be demand ischemia vs true NSTEMI. Going for LHC at Hospital on 4/22. Incidentally we also found Tick on her.  Not sure if her respiratory symptoms triggered by allergy or related to recent vaccine dose. Clinically improved. CT chest negative for PE/Pneumonia,COVID 19PCR neg, antibody positive.
Patient has complaints of hives all over her body and itching. Patient has not taken any medication as of right now,
1 hr p/receiving OPV pt vomited; Had t102-103; h/a, sore leg on 7AUG91 finally sleeping @ 530AM; No further vomiting on 8AUG; resolved by PM 8AUG;
About 32 hrs after injection = swelling, redness and pain at injection site. Day 2 - Localized rash and itching, increased pain spreading to (R) side of neck. Day 3 - ZYRTEC 10mg after increased symptoms. Day 5 - Redness in (R) side of face. Treated with Triamcinolone 0.1% cream TID. Day 9 - Decreased swelling, decreased redness, no itching, no rash. Still slight tenderness at injection site.
sneezed a few times; slight sense of impending or incipient headache; felt a bit achy all over/body achy; left arm started feeling tender or sensitive/Arm still sore at injection site/left arm was sore/Arm sensitive if touched; This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (sneezed a few times), VACCINATION SITE PAIN (left arm started feeling tender or sensitive/Arm still sore at injection site/left arm was sore/Arm sensitive if touched), MYALGIA (felt a bit achy all over/body achy) and HEADACHE (slight sense of impending or incipient headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Occasional), Hypercholesterolaemia (no recent change in status of chronic condition) since 15-Oct-2018, Allergy to plants (cedar) and Ragweed allergy. Concomitant products included ATORVASTATIN for Hypercholesterolaemia.   On 01-Jan-2021 at 10:43 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left arm started feeling tender or sensitive/Arm still sore at injection site/left arm was sore/Arm sensitive if touched). On 10-Feb-2021, the patient experienced MYALGIA (felt a bit achy all over/body achy). On 10-Feb-2021 at 5:36 AM, the patient experienced HEADACHE (slight sense of impending or incipient headache). On 11-Feb-2021, the patient experienced SNEEZING (sneezed a few times). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD & FLU) on 10-Feb-2021 for Vaccination site pain and Myalgia, at a dose of 325 milligram and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD & FLU) on 10-Feb-2021 for Vaccination site pain and Myalgia, at a dose of 325 mg. On 12-Feb-2021, SNEEZING (sneezed a few times), VACCINATION SITE PAIN (left arm started feeling tender or sensitive/Arm still sore at injection site/left arm was sore/Arm sensitive if touched), MYALGIA (felt a bit achy all over/body achy) and HEADACHE (slight sense of impending or incipient headache) had resolved.            On 09-Feb-2021, the left arm started feeling tender or sensitive about 6 hours after shot. On 10-Feb-201, arm was still sore at injection site in the morning and felt a bit achy all over. The patient's arm was sensitive if touched but started feeling much better around 7:19 p.m. on evening.  The patient stated that the sneezing could have been allergies due to a cold front that was blowing in. On 11-Feb-2021, the patient felt better throughout the day and by 12-Feb-2021, the patient felt great.   This case was linked to MOD-2021-005495, MOD-2021-005495 (Patient Link).