chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Thick skin; she is in pain; the bones on her chest are hurting; Rash is Itching; injection site on the left arm is still sore; Torn rotator cuff; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis, ehlers-danlos syndrome and rotator cuff repair (had three rotator cuff surgeries). Concomitant products included tofacitinib citrate (Xeljanz).   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and capsaicin, the patient experienced rotator cuff tear. On 6th March 2020, the patient experienced shingles, skin thickening, pain, bone pain, itchy rash and injection site pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir), capsaicin, trolamine salicylate (Aspercreme) and steroids nos (Steroids). On an unknown date, the outcome of the shingles, skin thickening, pain, bone pain and rotator cuff tear were recovering/resolving and the outcome of the itchy rash and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin thickening, pain, bone pain, itchy rash, injection site pain and rotator cuff tear to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix in left arm and when she went to a store and tried to pick up a heavy bag of potatoes and tore her rotator cuff. Then she went to the orthopedic physician who gave her a steroid shot in the arm.  The patient had a history of Ehlers-Danlos syndrome and that makes her prone to tendons tearing easily hence she did not think the rotator cuff injury was related to the Shingrix vaccine. The patient said that by Friday or Saturday of that week, she was breaking out with a rash on her back and went over the right side of her body and in between her breasts. The patient had thick skin and rash but no blisters. The patient stated that she went to urgent care on 9th March 2020 and that she was told she has shingles. The patient was in pain and that the bones on her chest were hurt and that the rash were itching. She stated that she had an electrocardiogram performed after this happened and it came back negative. The patient stated that the injection site on the left arm was still sore but she had range of motion. The patient had history of rheumatoid arthritis for which she takes Xeljanz. The patient received Valacyclovir to treat the Shingles and Capsaicin and Aspercreme for the itching. The reporter consented to follow up.
Muscle spasms, weakness, hot/flushed then cool/clammy, anxiety.
Red welted rash on inside elbow of injected arm; Red welted rash on inside elbow of injected arm; Headache; Chills; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 17:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 08:00, within 15 hours, the patient experienced headache, chills, fatigue, joint pain. On 08Apr2021 at 17:00, 48 hours after, the patient experienced red welted rash on inside elbow of injected arm and lasted for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of events headache, chills, fatigue and joint pain was recovered on Apr2021, while that of red welted rash on inside elbow of injected arm was recovered on 13Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
After IM administration in the left deltoid, Pt exhibited a racing pulse. We attempted several times to capture an accurate blood pressure reading; the reading was in error a few times, but we also got a readings of 232/127, 185/131, 169/112,71/55, 180/110, and 179/93, BP was clearly elevated. Pt was also nauseated. 25mg diphenhydramine was administered. 911 wasn't called per Pt request as she was awake and aware and could breathe properly. She contacted her sister to pick her up to go to the hospital. Pt was mobile and was taken to the hospital for evaluation by her sister.
High fever 103 + severe headache Transported to Hospital by ambulance, now having memory loss.
no adverse effects; The administration of an one separate dose of an improperly stored vaccine, PEDVAX HIB, to one separate patient; This spontaneous report was received from a nurse, regarding a identify patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.   On 19-APR-2019, the patient was vaccinated with with improperly stored stored doses Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, intramuscular in the thigh, lot number N000238, and expiration date 25-OCT-2019 (dosage was not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion and time frame of 35.7 for 0 minutes and 35.9 for 0 minutes. There was previous temperature excursion of 34.7 Fahrenheit  for 2 hours and 30 minutes. Data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1904USA010692:
Erythema multiforme. Facial and body lesions appeared 4 days after vaccine. No oral lesions, low grade fever (99.7). Patient comfortable, happy, eating well. No treatment required. Case discussed with pediatric allergist.
tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid-19) 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. In January 2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported. No treatment medications were reported. It was reported that patient had tested positive for COVID 19 in the past week of January 2022.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recvd vax & devel urticaria, facial edema, & a fever that lasted 7-10 days; pt has since recovered;
injection site pain, tiredness, headache, chills, nausea, muscle pain, joint pain,  feeling unwell
REDNESS AT INJECION SITE (UPPER ARM AND EXTENDED DOWNWARD FROM INJECTION SITE), ITCHING AT INJECTION SITE, FEVER.
After one week of taking the first shot, I feel the area of the injection spot being firm or stiff, hot, red, paining and itchy. It has been one full day of this symptom. I read it online and saw that it may be COVID arm but in my case, it seems to be milder. It feels like I developed muscle where the injection was administered.
Janssen COVID 19 vaccine administered to a patient under the age of 18. Patient had no symptoms.
Patient was administered flu vaccine shortly after received vaccine, patient appeared to lose consciousness and was slumped over. After approximately 20 seconds patient regained consciousness. Paramedics were summoned and cleared patient. It should be noted that patient had reported previous incident of syncope after immunization.
Arm was bad; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was bad) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Cholesterol, Penicillin allergy, Allergy to vaccine (Tetanus shot.) and Ragweed allergy. Concomitant products included ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm was bad) and FATIGUE (Very tired). At the time of the report, LIMB DISCOMFORT (Arm was bad) and FATIGUE (Very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received contain additional second dose events and associated lab data added; no significant information for the first dose case On 02-Jul-2021: Follow-up received on 02-JUL-2021, contains patient demographic details, patient medical history allergic information, concomitant medication information and first dose date
shoulder & chest lt side were itching, discovered area numb when trying to scratch area, c/o SOB, numbness, denies numbness in neck afebrile advised to contact physician to r/o cardiac problems
very large size redness surrounding the injection site along with swelling; very large size redness surrounding the injection site along with swelling; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A 75-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in Oct2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced very large size redness surrounding the injection site along with swelling on an unspecified date in Oct2019 with outcome of unknown. Doctor had a picture of the sight which displayed the reaction. Patient was re-seen a week after injection on 08Oct2019.
Pt developed > 10 cm swelling, redness after 1st and 2nd shots that lasted longer than 3 weeks. No systemic symptoms.
Patient received the vaccine at 2:55pm and returned 30 min later stating soreness at the injection and having headache and tongue is tingling. RXM gave her 2 Benadryl and water.
The day after my vaccine ( Thursday) my stool was bright green, I evacuated twice that day and both stools were bright green. On Friday I evacuated once and my stool was a darker green; This is a spontaneous report from a contactable consumer. A 73-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:00 (Age at vaccination 73 years) as 1st dose, single for covid-19 immunisation. Medical history included Asthma mild, Renal Calculus, mitral valve regurgitation, prediabetes, hyperlipidemia, liver mass, Allergies to medications, food, or other products: Penicillin. Concomitant medications included simvastatin; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after vaccine 04Feb2021 08:00 (Thursday), patient stated her stool was bright green, she evacuated twice that day and both stools were bright green. on 05Feb2021 (Friday) she evacuated once and her stool was a darker green, as green as spinach. She had no eaten or drunk any food that would cause her stool to green. Patient visited physician office for event, she wanted to know if she should go ahead and take a second dosage in 3 weeks. Patient did not receive any treatment for events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
The patient began to feel light headed/ dizzy and nauseous. Within minutes she lost color in her face became very sweaty and passed out. The paramedics were called .All of her vitals checked out. The patient chose to go to hospital for further evaluation. The patient reported that she had only had breakfast that day. We gave her some water as well as some juice .
A report received from a Health Professional concerning a 4 year old, female patient. The patient medical history and concomitant medication were not provided. The patient had received nasal FLUENZ TETRA (intranasal) on 12-Feb-2016. Caller stated she had given a FLUENZ vaccine which was out of date to a child. Action taken with FLUENZ TETRA was unknown. The outcome of the event of given FLUENZ vaccine which was out of date was unknown. The company physician assessed the event given a FLUENZ which was out of date to be non-serious.
Both arms red & hot. No fever. Both arms swelling. If redness improving & no fever, then OK to observe, OK for ice/heat.
And injection site pain (mild, but noticeable).; muscle ache; fatigue; chills; fever (101.8 degrees),; headache; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 10:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose 4 (booster), single, lot: unknown, route of administration: unknown), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster), single, lot: unknown, route of administration: unknown), for Covid-19 immunization; Bnt162b2 (Dose 2, single, lot: unknown, route of administration: unknown), for COVID-19 Immunization; Bnt162b2 (Dose 1, single, lot: unknown, route of administration: unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 08Sep2022 at 10:45, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "And injection site pain (mild, but noticeable)."; CHILLS (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; FATIGUE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; PYREXIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "fever (101.8 degrees),"; HEADACHE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; MYALGIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "muscle ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of off label use, vaccination site pain, myalgia, fatigue, chills, pyrexia, headache.  Additional information: It was reported that Approximately 8 hours after receiving the vaccine, the patient was hit pretty hard and fast with symptoms: muscle ache, fatigue, chills, fever (101.8 degrees), headache. And injection site pain (mild, but noticeable). That was unusual since he had never experienced such symptoms with any of the previous 4 vaccines (all Pfizer). The symptoms lasted into the night but were mostly gone (except for mild fatigue) by 8:00am the next day. There was no covid prior vaccination. Covid was tested post vaccination. He had no allergy.   Follow-up attempts are completed. No further information is expected.
Skin peeling around injection site and a 3 to 4 inches away from injection site.
DIARRHEA, SWOLLEN TONGUE, TONGUE SORES, FEVER, CHILLS, ACHES, HEADACHE, TONGUE SWELLED MORE THE NEXT DAY AND SORES WERE BECOMING INTOLLERABLE. MAJOR FATIGUE. HEART PALPITATIONS, WEAK LEGS. EVERYTHING SEEMED FOGGY.
As soon as the needle was put in I felt pain. He had to push very hard to get it to go in. The first few days the arm was sore then it started to get where daily I had pain. It will wake me at night. The are things I can't do without sharp pain. The doctor said it could take 6 months to go away. I'm in the 6th month and its not going away.
Skin peeling on the face right after vaccination. Patient reports now having new skin in the areas of peeling.
soreness; redness; bruise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and bruising of arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and bruising of arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and bruising of arm to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on an unknown arm and his arm was very sore after getting the first dose of Shingrix. The patient also had a big red mark on his arm and there was a bruise. The patient thought that the symptoms lasted for about 1 week. The patient gave consent to be followed up. In the narrative outcome of all events were reported as resolved with sequel, however in structured field it was reported as resolved.
28 yo female with a known h/o vasalvago s/p injection reactions presents with a c/o of feeling lightheaded and like she is going to pass out. Mother states that it happens frequently and after a drink and sugar she feels better.   Lightheadedness, vasovagal response, hypotension
1. Injection site reaction-red and raised, approx. 1 inch in diameter. 2. Mild case of hives-head-to-toe, equal to or less than 12 at any given time that came and went-lasted approx. 24hr.
Patient had light swelling and a rash extending from the injecting arm around the tricep wrapping around to the front of the arm, none on the deltoid, rash was itchy and mildly red. Reported this to her doctor who gave her a prescription for Keflex just incase it was an infection however he said it was probably an allergic reaction and told her to get Benadryl. Doctor told her to report it to the pharmacy so we could report it to VAERS.
Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened; Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1685), single dose via intramuscular route of administration in the left arm between 5:30-6pm on 15Jan2021 (at the age of 49 years-old) for COVID-19 vaccination.  Relevant medical history includes ongoing nervous bad anxiety attacks, spinal stenosis (diagnosed 2-3 years ago), two stomach surgeries, so she had problems going to the bathroom and experienced bloody discharge, hiatal hernia surgeries (one surgery was 4 years ago and the other was 3 years ago), appendix taken out 3 years ago, ongoing insomnia diagnosed 10-11 years ago, shellfish allergy to lobster, pinched nerve and nerve issues and took Krill pills and had an allergic reaction. Relevant drug event  included increased anxiety and her hands would fall asleep when she took trazodone and quetiapine (SEROQUEL). The patient did not receive any concomitant medications. On 17Jan2021, the patient experienced rash at the injection site.  On 18Jan2021, the patient experienced a fever of 101 and more anxiety each day after the shot. Anxiety was reported as worsened. On an unknown date the patient experienced rash. The patient was treated for rash with diphendydramine (BENADRYL). The clinical outcome of fever was recovered on 19Jan2021, recovering for rash at injection site, unknown for rash and not recovered for anxiety.
Headache within an hour of injection, by evening, severely ill: Fever, Severe shaking and chills, Spinal pain, Stomach pain, cold to the bone, especially feet, exhaustion, pain at injection site, in bed for three days.  Cold, off and on for weeks and still experiencing waves of exhaustion. Within those first few days of being sick, other symptoms arose and still experiencing:  Pain in arm with lump, arm goes completely numb if any pressure applied to it while in bed...can not even lean a little to my left side less alone sleep on left side. Spinal pain, bottom of feet pain, pain radiates from injection site to neck and shoulder, muscle cramping, swelling on left side of body, shooting, stingy pain in eyes, all joints are very stiff and feel arthritic, waves of exhaustion. Swelling of lymph nodes on left side of neck, that when touched severe pain shoots up to my ear and ear turns red and warm, very painful. After being completely healthy, I now feel crippled since this vaccine.
It did not manifest in a normal way- I started coughing and needed my inhaler, proceeded to feel as if my legs were covered in fire ant bites and swollen, the skin all over my body itched to the point that I broke the skin, my face became bright red and hivey, and my throat began to tighten as if someone were choking me. The only reason I did not use my Epipen was the fact that I could still breathe through this, even if it was a bit labored. I should add that my reaction began 1.5 hours after I was vaccinated. I?ve been managing having life threatening allergies since I was a child, but this reaction resembled nothing I?ve ever experienced.  After using 50 mg of Benadryl, my symptoms were manageable. The pain at the injection site lasted for five days and caused intermittent numbness to my pinky finger and up my neck.
Pain & Tightness in right arm 6/22/21 & red swollen arm & heated 6/23/21 with tightness & pain