chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/13/13- No reaction 15 min. after injection (R) upper thigh red (swollen). 9/14/13 - 9pm - Went to E/R. Dg with cellulitis. Prescribed BACTRIM BID X 7 days and Ibuprofen TID. 9/15/13 - 11am - Went to another E/R - Redness and swelling (R) ant upper thigh. Given ROCEPHIN 1000mg IM and Cephalexin 250mg QID x 10 days. 9/16 - F/u w Dr. Redness 10 x 10 cm - no cellulitis. Reaction to vacc. Cool compress.
Patient's wife reported that he broke both of his shoulders four days after his first vaccine. He had a seizure and fell off the bed breaking his shoulders. No hx of seizures, TBI or stroke. His wife stated they were told by the PCP he could get the second dose of the vaccine.  None of these records are accessible by the vaccinating site. No known ED visit or hospitalization related to the event.
Patient stated prior to vaccination that she becomes light headed with every immunization she receives. Approximately three minutes after vaccination, patient began to experience vasovagal symptoms. She stated she was lightheaded,dizzy, and feeling hot. Patient did not lose consciousness, remained laying down for approximately 25 minutes, drank juice, BP at time of occurrence was 98/76 and HR 78. After 25 minutes, patient slowly sat up, BP re-checked and was 100/76. After approximately one hour of observation, patient stated she felt much better and ready to leave. All symptoms resolved.
Bloodwork taken on June 22 showing thyroiditis. Ultrasound done to confirm. Second blood test taken.
pt recvd vax & 24hrs later exp tender, hot, swollen arm;applied cold compresses & took APAP w/o relief; seen in clinic 11JUL95, arm is swollen & very warm & tender;seen by MD who recommended see pvt MD cont cold compresses & take Advil
feeling better but not back to normal; all the possible side effects being reported; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (all the possible side effects being reported) and FEELING ABNORMAL (feeling better but not back to normal) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE for GERD.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (all the possible side effects being reported). On 17-Mar-2021, the patient experienced FEELING ABNORMAL (feeling better but not back to normal). At the time of the report, VACCINATION COMPLICATION (all the possible side effects being reported) and FEELING ABNORMAL (feeling better but not back to normal) 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.   Patient stated that as part of the questionnaire prior to receiving the vaccine she was asked if she had ever been diagnosed with Covid. She was sick in december but wasn't sick enough to see HCP and get tested. Patient was wondering if in fact, she could've had Covid, and if so, if it was okay to receive vaccine. Patient inquiring if it was wise to get 2nd dose since she experienced all possible side effects.   This case was linked to MOD21-056062 (Patient Link).
Constant tingling of both arms and hands occurred the day after I received the Covid-19 Janssen Vaccine. Cerebral hemispheres which (per read) most likely represents vasospastic phenomena of migraines vs. small vessel ischemic changes in a patient with appropriate CV risk factors.  As well there is partially empty sella, which is a benign finding, but is occationally reported to be associated with headaches.  Given no structural abnormalities to explain patient's symptoms, temporal relation to his vaccination, and newer reports associated with the J and J vaccine (though patient does not have, but isolated sensory dysfunction) there is possibility that patient's symptoms are a vaccine side effect.  Discussed the importance of documenting his symptoms in VAERS so that further investigation can be done.
4 hours after vaccine patient started with fever and chills. Fever got up to 102.3 degrees F (8 hours after vaccine). About 20 hours later, the patient's blood pressure dropped to 86/62 (normal for him 110/70).
right leg paresthesia; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer COVID 19 vaccine and experienced right leg paresthesia on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
All my chest is swollen and my arm; The inflammation in my axilla is still present; All my chest is swollen and my arm; Chills; My right axilla is swollen; Fever; Body pain; Headache; Very intense right arm  pain; Body is cold; Bone pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Body is cold), BONE PAIN (Bone pain), PERIPHERAL SWELLING (All my chest is swollen and my arm), INFLAMMATION (The inflammation in my axilla is still present) and SWELLING (All my chest is swollen and my arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and CREATINE, INULIN, LEVOGLUTAMIDE, LYSINE, PROTEINS NOS, SPIRULINA SPP., TAURINE, VITAMINS NOS (VEGAN PROTEIN) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced FEELING COLD (Body is cold), BONE PAIN (Bone pain) and PAIN IN EXTREMITY (Very intense right arm  pain   ). On 16-May-2021, the patient experienced SWELLING (All my chest is swollen and my arm), CHILLS (Chills), LYMPHADENOPATHY (My right axilla is swollen), PYREXIA (Fever), MYALGIA (Body pain) and HEADACHE (Headache). On 17-May-2021, the patient experienced INFLAMMATION (The inflammation in my axilla is still present). On an unknown date, the patient experienced PERIPHERAL SWELLING (All my chest is swollen and my arm). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) (oral) at a dose of 500 gram twice a day and IBUPROFEN (oral) at a dose of 800 gram twice a day. At the time of the report, FEELING COLD (Body is cold), BONE PAIN (Bone pain), PERIPHERAL SWELLING (All my chest is swollen and my arm), SWELLING (All my chest is swollen and my arm), PAIN IN EXTREMITY (Very intense right arm  pain   ), CHILLS (Chills), LYMPHADENOPATHY (My right axilla is swollen), PYREXIA (Fever), MYALGIA (Body pain) and HEADACHE (Headache) outcome was unknown and INFLAMMATION (The inflammation in my axilla is still present) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Shortness of breath that began after receiving COVID vaccination 12/10/2021. Noted HR elevates with mild exertion. Denies any chest pain at this time, but states she did have chest discomfort both times after receiving her COVID vaccination (1st time she was very anxious, 2nd time she was not). She states both episodes of discomfort was about 20 minutes after administration. Feeling extremely thirsty lately.   shortness of breath and a butterfly sensation in her chest. She's had two episodes both associated with the COVID injection. Symptoms started approximately 20 minutes after the injection. The first episode lasted about 20 minutes. The most recently epidsode comes and goes and symptoms are worse. She developed shortness of breath with mild exertion. She takes 10 minutes or more to recover after just brief exercise. She had an epiosde today where pulse went to 124 with ambulation on a flat surface and up to 150+ after walking just two stairs. She feels pressure on her chest and as if she cannot take a deep breath. She feels she is breathing faster than usual. She denies fevers and chills. She has a chronic cough. She's noticed wheezing.
Narrative:  Pt is a 38 y/o female with PMH significant for migraine, sleep disorder, obesity, back pain, major depression/personality disorder, GERD, bipolar disorder, and asthma. Pt received COVID-19 vaccine #1 on 3/25/21 and COVID-19 Vaccine #2 on 4/15/2021. Per 4/21/2021 Primary Care Secure Messaging, pt reports c/o rash down her arms, neck, and left check bone describing sxs similar to exposure to poison ivy after receiving second COVID vaccine. Pt also informed 1 week after receiving her first COVID vaccine, she experienced a rash all over her arm. Per 4/22/2021 sameday clinic note, pt currently takes loratadine for allergies. She took Benadryl for pruritis and OTC hydrocortisone cream to help with sxs from rash in which she noted some improvement but did not completely resolve rash. Pt was prescribed hydroxyzine 25 mg TID prn for pruritis and triamcinolone 0.1% cream BID. Per 4/29/2021 nursing outpt tele note, pt reports cold sxs of productive cough, headache, sinus and congestion, slight fever, with sore throat/runny nose, however, pt does not think this is related to the COVID vaccination given son and husband also are experiencing similar sxs. Per pt, body rash was resolved a few days before cold symptoms started. Upon chart review, no other sxs related to rash noted.
The pts parent reported that the pt had a very bad reaction following vaccination with Prevnar. The vaccine was given in the deltoid muscle along with another unspecified vaccine.
Developed full case of Chicken pox approx. 100 fluid filled vesicular lesions. Temp max. 99.0 F, macular rash started evening on 3/19 and developed into full body (face/head, limbs, trunk) 18 days following vaccination. Started on Valacyclovir on 3/20.
PATIENT HAS PAIN IN ARM AND CLAIMS VACCINE WAS GIVEN TOO HIGH IN THE ARM AND STATES SHE HAS SIRVA AND "THE PHARMACIST MUST HAVE HIT A JOINT"
Myalgia, Arthralgia, BURNING AT INJECTION SITE Narrative:  Other Relevant History:
they received a second dose instead of waiting for 30 days or more with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 months old patient of unknown gender who received a second dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of waiting for 30 days or more with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection) (lot: UT7744NA ) (expiry date: 30-JUN-2023) (strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient received a second dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of waiting for 30 days or more with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
She complained of red and warm arm from her left deltoid down to her elbow, more on the lateral side which lasted for days. She never had a reaction like this from the first two doses in the series. The pharmacist counseled her to take some oral ibuprofen and if it does not help to come to the pharmacy for an anti inflammatory gel. She continue to monitor and take ibuprofen as needed.
Pt's mother called pharmacy to ask us about jaw and lower neck pain after receiving flu shot. I suggested she contact the MD as soon as possible. Pt went to PM pediatrics and received a diagnosis of possible Bell's Palsy. Upon further discussion mom also mentioned pt received meningitis vaccine from pediatrician on 8/10/16. The physician at PM pediatric informed pt that she may have possible Bell's Palsy from either vaccine. Pt went to pediatrician for second opinion and was told not Bell's Palsy, to take Ibuprofen for pain and to consult neurologist.
Patient had PREVNAR and FLUAD on 11-14-16. On 11-17-16 patient experienced severe muscle aches. She saw physician on 11-28-16 and was given naproxen 500 mg. She still had severe aches. Saw physician on 12-15-16 and was given alprazolam 0.5 mg. Patient contacted me on 1-3-17 and said muscle ache severe - I contacted MD on 1-3-17, MD notes show pain is from fibromyalgia and doesn't mention vaccination reactions.
Returned to emergency room 10/16/11 with severe lower back pain. Was sent home with pain pills/muscle relaxers. Returned to emergency room 10/17/11 with weakened left leg and having to use a walker. A CT scan was done to check for stroke. Sent home. Returned to emergency room 10/18/2011 at this point left leg was completely paralyzed and the right leg was going numb. I was admitted and diagnosed with acute transverse myelitis. They said it was idiopathic. I was treated with steroids and physical therapy.
Rash from head to toes.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash from head to toes.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash from head to toes.). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash from head to toes.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
fever of 102.5, rash devel on ankles;mom states pt has chills & trembles;mom reports episode lasted 15min;
Patient came to the pharmacy for an additional covid vaccine dose, she did receive Moderna for her first 2 doses earlier in the year. Patient had marked off she was over 65 years old on the attestation form, but Moderna is currently not approved for this population at the moment. The 3rd additional dose of Moderna was administered. Patient is not experiencing any side effects from the third dose.
pt recvd vax 27oct94;on 28oct94 pt admitted to hosp due to respiratory distress; fever of 103 & severe swelling at inject site; pt discharged on 30oct94 w/ no probs;
1/6 18 days after the vaccination I woke up with floaters in my right eye.  Much more developed throughtout the day.  The next day Thursday I had a visual deficite in my eye along with the floaters.  By Friday evening I went up to see the eye doctor while at work and was advised I had 5 tears to the retina of my right eye and was advised it needs to be repaired immediately. On 1/9 I had a vitrectomy and the tears in the retina were repaired as well.  I was advised the surgery had an 85% success rate but advised I will develop a cataract in the eye within 6months but within 6 weeks it developed. 2/22 I had the cataract removed  and a lense replaced in my right eye.
Immediately after seasonal influenza vaccine (preservative free) notice some tingling in lips - took 50 mg Benedryl gradually over next few hours eyes started feeling itchy and watery, some shortness of breath and some mild nausea. At 1:00 PM took another 50 mg Benedryl and by 1:30 PM went to Emergency Room due to increased shortness of breath, wheezing, nausea, light headedness, increased wateriness and mucous from eyes with puffiness and some puffiness and tingling of hands. Epinephrine given twice and Solumedrol given in ER. Discharged on Prednisone, Benedryl and Pepcid.
Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing; Sneezing; Not feeling the same, but also not feeling worse; has not been feeling good; Achy; Stress from not receiving Letairis; upset with Letairis shipment; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy) and STRESS (Stress from not receiving Letairis; upset with Letairis shipment) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included WARFARIN SODIUM and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 16-May-2011, the patient TREPROSTINIL SODIUM (TYVASO) (Nasal) dosage was changed to at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (Nasal) microgram four times per day. In 2021, the patient experienced SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired). On 22-Sep-2021, the patient experienced DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing). At the time of the report, DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  The current dose for IH Tyvaso was reported as 18-54 µg (3-9 breaths), four times a day (QID) via inhalation (IH) route.  The patient received Flu shot(Influenza vaccine) on 22-Sep-2021
chills on and off for 2 days, with temperatures of 99-101.5 started on 2/18/2021; cough and exhaustion started on 2/21/2021, urine turned dark, symptoms lasted for 3 to 4 days; cough is ongoing, but it is intermittent and may be due to pollen
Patient given FLUMIST and GARDASIL and subsequently noted urine HCG was positive.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about  09-APR-2014, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
Irregular menstrual cycle after shot Menstrual cycle started  again 1 week after the last and lasted almost 10 days
Symptom onset 10 -15 minutes after receipt. Symptoms included pruritis, shortness of breath, perhaps CP. HE does not recall urticaria, oral/facial/throat or tongue swelling, red/watery eyes, wheezing,  n/v/d. He was treated with 50 mgs benadryl and observed for one hour. There was no recurrence. Event documentation is very consistent with his report and documents VS R 60-75 SPO2: 98-100 with metal status of A&Ox4.
bone pain/ unbearable femur pain; awoke with fever; nausea; dizziness; could not keep it down; Feel odd; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid over thanksgiving weekend) in November 2020.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING ABNORMAL (Feel odd). On 02-Feb-2021 at 1:00 AM, the patient experienced BONE PAIN (bone pain/ unbearable femur pain). The patient was treated with BENZYL NICOTINATE, CAMPHOR, GLYCOL SALICYLATE, MENTHOL, METHYL SALICYLATE (SALONPAS TOPICAL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; 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.
Has increased swelling and redness, warm to touch left deltoid muscle where Dtap injection was given.
Chest pain; Chest pain; Chest pain, unspecified type; Pleural effusion on left
Information has been received from a female consumer who on 07-DEC-2011 was vaccinated with a dose of RECOMBIVAX HB (Route, dose and lot number not reported). The patient called to report she experienced extreme fatigue, shaking, headache and nausea after receiving the RECOMBIVAX HB. It was unspecified if the patient had sought any medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.