chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. About a day after receiving SHINGRIX, the patient experienced pain at the injection site. The 50 something female stated it felt like they had been pushed into a corner to describe the pain. The patient went on to state out of all vaccines she has received, this was the most painful. The pain resolved after about two days.
Severe muscle/joint pain in left arm/elbow since 6/11/2015. Limitation of left arm movement and use. Reported to pharmacy and PA at practice. No treatment sought since told symptoms would abate within 40 days according to Pfizer. Symptoms remain to date (8/29/2015).
The college student reported she experienced" a lot of pain" at the injection site; This spontaneous report was received from a pharmacist, via a company representative, referring to a female patient of unknown age, who was a "college student". Information regarding medical history, concurrent conditions or concomitant medication was not provided.  On an unknown date (reported a many years ago), the patient received a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (route of vaccination, dosage information, lot number and expiration date unknown by the reporter)   On an unknown date (also reported a many years ago), she experienced" a lot of pain" at the injection site. It was unknown if treatment was given for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of injection site pain was unknown. The causality assessment was not provided.
Metallic taste in mouth immediately following the injection. About an hour later I had throat swelling, coughing, trouble breathing. It felt like something stuck in my throat.
Approx 10 days after vaccine a red, raised rash appeared around injection site. Area was swollen, painful, warm, and itching. The rash continued to spread and almost completely wrapped around the entire arm. She also experienced heavy vaginal bleeding, and was not due to begin cycle. Last cycle ended 1/5 and bleeding began on 1/23, and she also experienced abdominal pain on 1/25. When rash was at its worst, she was extremely fatigued.
bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.
12/25/22 presents to ED for "cough, SOB". PMHx of "HTN, HLD, SSS s/p PPM"
Information has been received from a physician concerning a 5 year old female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy that day included a dose of tetanus toxoid. Subsequently the patient experienced syncope approximately 15 minutes after receiving the vaccinations. The patient has since recovered, but was never revaccianted with Hepatitits B virus vaccine rHBsAg(yeast). No other information was provided. Unspecified medical attention was sought. There was no product quality complaint provided. Additional information has been requested.
redness and pain in a large area on the injection site; redness and pain in a large area on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and pain in a large area on the injection site that lasted for almost three weeks. The reporter consented to follow up.
Swollen arm. Pink in color. Warm to touch. Cannot lift arm due to pain.
Immunization site red. Infant crying hysterically. Tylenol every 4 hours and warm compress.
High heart rate, increased muscle weakness, muscle twitches, tingling in hands and feet, insomnia
High fever, reached max to 103.4; Chills; Body ache; Headache; Nausea; Loss of taste; Feel of bitter taste; Dry cough; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 04May2021 at 13:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included dust allergy and cockroach allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 13Apr2021 at 18:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 01:15, the patient experienced high fever that reached maximum to 103.4 (unspecified units), chills, body ache, headache, nausea, loss of taste, feel of bitter taste and dry cough. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). The clinical outcome of the events high fever that reached maximum to 103.4 (unspecified units), chills, body ache, headache, nausea, loss of taste, feel of bitter taste and dry cough was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Systemic: stuffy nose for 1 week then altered taste/smell-Mild, Additional Details: Patient reports a stuffy nose that last 1 week after the vaccine then had alterned taste and smell since the congestion resolved. He reports everything having a chemical smell or taste.
getting the booster dose; after getting the booster dose COVID-19 vaccine got COVID; after getting the booster dose COVID-19 vaccine got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "getting the booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "after getting the booster dose COVID-19 vaccine got COVID".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Bruising at site of injection. Possible minor infection at site. Treatment: Neosporin topical-covered with bandage for 2-3 days.
Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sniffle. This morning woke up about 4:30 a.m., has some nausea but did not vomit. Had some lightheadedness. Has had vertigo in the past.
Explosive diarrhea around 10am on 8/15/2021 (48 hrs post-shot) Vomiting around 11:30 am on 8/15/2021
Mother brought child to PHN office on Fri, 10/12/12 approx. 1545 to have child (Lt) thigh assesses & report ?affected area which mom reported had blister like on outside of approx. 3 1/2 inches x 3 inches darkened, tender area which she noted on 10/6/12. The blisters like were dry but area darkened, non tender at this time. Also, mom reported fever NOC of 10/2 only & flu like syms. x2 days only.
Booster was received on 2/18/22. I became sick on 2/19 with fever, chills, headache, body aches, joint pain, generalized weakness, and extreme fatigue. I also had an extremely swollen lymph node under my left armpit that required ice for approximately four days before the swelling began to subside. On 2/21 I began to have chest pain and a racing heartbeat, hammering heartbeat, and shortness of breath. I went to the emergency room where I was sent for testing to rule out a Pulmonary Embolism. I was tachycardic and hypertensive. two days later i went back to the emergency room for the same symptoms as well as an irregular rhythm. In addition to the tachycardia and hypertension I was also having PVCs. They were able to get the PVCs to subside for the time being. A week later I again went to the emergency room for the ongoing chest pain, hammering heartbeat, and racing heartbeat. two days later I went to the emergency room again for the same symptoms and the PVC rhythm again as well. on 3/11 I was finally evaluated by a cardiologist. I had bloodwork done and was placed on a Holter monitor for 10 days. On 3/21 I had an  Echo performed. On 3/25 I had a treadmill Cardiac stress test performed and was put on 12.5 mg of Metoprolol daily. The medication did not help and the physician increased the dose to 25mg daily. It seemed to help for a little under a week until i overexerted myself for a very short period of time and the symptoms returned to the original intensity. The physician has since increased my dosage to 50mg daily. I have been out of work since the onset and it has drastically affected my daily life. I am unable to do any physical activity lasting more than a couple minutes without becoming lightheaded, short of breath, dizzy, and afterwards having the chest pain and PVCs increase drastically.  Even the most menial tasks such as laundry, washing dishes, and generalized housework have become impossible tasks. This has also lead to me being unable to be intimate with my husband without feeling as though I may pass out and afterwards having the pounding heartbeat and increased PVCs and inability to catch my breath.
Loss of taste in the left side of the mouth; Weakness; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Lungs felt heavy and Pain in the lungs; Body Ache; Headache; Join Pain; Nausea; A spontaneous report was received from a consumer concerning a 62-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, loss of taste in the left side of her mouth/ageusia, shakiness only the left side/tremor,  fast heartbeat/heart rate increased, shortness of breath/dyspnoea, weakness/asthenia, lungs felt heavy(pain the lungs)/pulmonary pain, headache/ headache, joint pain/arthralgia, body aches/pain and nausea/nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received the vaccine and experienced loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, lungs felt heavy, pain the lungs,  headache, joint pain, body aches and nausea. Treatment for the events included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, headache and nausea were not resolved. The events, lungs felt heavy, pain the lungs, joint pain and body aches were resolving.
Patient received Tdap immunization IM in (L) deltoid. Ten minutes after immunization was administered patient stated that arm was numb and could not feel it. Able to feel pressure the next day at 10:00 am patient was able to feel sharp and dull sensation in arm and reported arm was sore, but able to do ADLs.
12 hours after vaccine was given patients injection sight began to itch and swell. Over the next 48 hours swelling increased until entire thigh was swollen, painful, hard and hot. Dr. prescribed Zyrtec and antibiotics. Child refuse antibiotics but too Zyrtec with no change in symptoms. Hotness stop after 3 days but symptoms of swelling and pain persisted for 7 days. 15 days after injection sight continues to slowly heal - currently gray and rock hard the size of a grapefruit.
diagnosis of Pityriasis Rosia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PITYRIASIS ROSEA (diagnosis of Pityriasis Rosia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heartburn, Blood pressure abnormal and Blood cholesterol abnormal. Concurrent medical conditions included Osteoporosis. Concomitant products included AMLODIPINE for Blood pressure abnormal, EZETIMIBE for Cholesterol, DEXLANSOPRAZOLE (DEXILANT) for Heartburn, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN and METOPROLOL for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PITYRIASIS ROSEA (diagnosis of Pityriasis Rosia). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (diagnosis of Pityriasis Rosia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Specialist consultation: pityriasis rosia (abnormal) diagnosis of Pityriasis Rosia. On an unknown date, Biopsy: pityriasis rosia (abnormal) Underwent biopsy of the red lesion.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PITYRIASIS ROSEA (diagnosis of Pityriasis Rosia) to be not related.    On 24FEB2021, the patient noticed red spots over the wrists, both legs, upper thigs, stomach and back since 24Feb2021. On 28FEB2021, she developed red spots on her arm. On 14MAR2021, the patient went to receive the 2nd dose and the vaccination center did not give the 2nd shot after patient showed the red spots on her arms and was advised to consult the HCP. Patient did consulted the HCP and did some blood work and reports came back normal and HCP mentioned as no idea what are those red spots and where they came from. Patient then consulted the dermatologist , who prescribed hydrocortisone cream and the red spots did not get better, so 2 weeks later she underwent biopsy of those red lesion and  report came as diagnosis of Pityriasis Rosia. Dermatologist said that it could be related to Moderna vaccine. Also mentioned that, it would take 3 months more to disappear .   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Initial additional document added: event details were added.
During recent patient hospitalization, it was discovered that patient has received multiple doses of the COVID vaccine. Patient received COVID vaccines from January 19, 2021 to February 19, 2021:   Moderna Dose on 1/19/2021:    Pfizer Dose on 1/24/2021:    Pfizer Dose on 1/28/2021:  Moderna Dose on 2/16/2021:    Pfizer Dose on 2/19/2021:
Chills, skin sensitive to the touch, sharp pains here and there, stiff neck and tired on Friday.  Late Friday night chills again low grade fever, sensitive to touch and swelling in one finger  and sharp pains in legs and body. Weird feeling at times.
ADVERSE EVENT DID NOT OCCUR. PATIENT GIVEN VACCINE THAT MAY CONTAIN LATEX AND PATIENT REPORTS LATEX ALLERGY.
DX about 1 month ago with a specific language impairment by SLP.  She is unable to repeat certain words. Cognitively she is fine.  Unable to process specific information. Can't speak in sentences with more than 4 words.  Hearing test WNL per audiologist.  Spoke fine prior to vaccination with H1N1.
This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of haemorrhage (1st dose received on an unknown date, refer case US2018GSK179164). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hemorrhage (serious criteria GSK medically significant), general body pain, headache and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the hemorrhage, general body pain, headache and chills were recovered/resolved. It was unknown if the reporter considered the hemorrhage, general body pain, headache and chills to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The reporter said that the patient had headache, body aches and chills after dose of SHINGRIX. He did not have any symptoms after the 1st dose. The symptoms lasted about 1 day. The patient noted that he bled more after the 2nd dose compared to the 1st dose of SHINGRIX.
Day 4 following vaccination patient experienced 12 hours of chills. Day 9 patient experienced muscle aches which progressed to severe joint pain and severe swelling of wrists, hands and knees. This subsided on Day 12 following vaccination.
Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot) had resolved.            Concomitant product use was not provided.   Treatment information was not  provided. now the patient cannot get second dose.
I felt very bad that evening. I couldn't eat. I felt a little nauseated. my arm was sore across my shoulders and down my left arm. I had fatigue, headache (I felt like my head was going to explode) , muscle pain and general pain all over. My heart rate was 96 and my BP was 62/36. I felt Dizzy, weak. 03/16/21 I went to the ER  Still feel hazy and foggy. I feel like my limbs are disconnected and dont respond as easily as they should.
patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported the same event for seven (7) patients. This is the fourth of the seven (7) reports.  A patient of unspecified age and gender received the 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 consumer reported that seven (7) coworkers/ patients tested positive for Covid on an unspecified date after receiving the first dose of the Pfizer Covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same reporter/drug/event, different patient.
I started getting symptoms of flu like symptoms except no fever. I took an at home COVID-19 test that was positive. I contacted my doctor and was prescribed molnupiravir. My symptoms were weakness, loss of appetite, and fatigued. My symptoms lasted for 4-5 days.
One week after receiving the shot, my arm developed a red, itchy welt (approximately 2 inches long) around the injection site.  Over the next few days, the rash  started to spread down my arm, losing the welt and becoming pink instead of red. After one week, the rash is splotchy and starting to go away in places.
15 x 16 slightly indurated mildly to moderately inflamed area of left upper arm surrounding immunization site -  no odenitis, not tender, no fever, no systemic symptoms (pt not concerned).
Macular, erythematous, rash, started on trunk and spread to involve entire body except face at time of exam. No fever or other symptoms.
Client called c/o upset stomach d/t lactose in the typhoid oral medication. States he is lactose intolerant and can't have nay lactose at all.
Same day post vax, the pt experienced left foot pain, then left hand and finger pain. On 4/10/00, the pt developed right jaw pain with difficulty closing jaw and pain to neck on 4/11/00. On 4/14/00, the pt experienced left shoulder pain (unable to lift arm). Pt was seen by MD and treated with Vicodin. He also had a temperature of 100.5 with chills.
On 10/29/99, pt. had inflammation extending 4-5 inches above and below site of injection.  Inflammation did not extend around the arm.  Pt. reports area was sore.  Dr. does not feel area needed treatment.