chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Fast heart rate; Sore arm; Hives in injection arm; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included VALSARTAN (DIOVAN), LEVOTHYROXINE and PRAVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Sudden nausea, overall larthagic feeling, very tired. Today, Sunday 5/30/21, symptoms returned strong. I am feeling very bad right now. Injection site stinging and arm very sore.
My symptoms started at the end of May 2021. I had to go to the ER July 7, 2021, because the pain that started in May just got more intense. I honestly thought I had pancreatitis or something with the liver. It was radiating and it was on going pain. I ended up going to the ER and they ended up doing a full body scan because I was in so much pain. They came back with my liver and pancreas all looking fine. They couldn?t determine where the pain was coming from. They gave me morphine for the pain. They found a hernia because of the scan in my abdominal wall. Then I went to my gastrologist because of the location of the pain that wasn?t going away after the ER. She said perhaps it was sensitivity or irritation. She prescribed OTC lansoprazole. It helps with irritation. But the pain would come and go. It wasn't all together gone. I started treating the hernia and had hernia surgery in November 2021. I started noticing that the pain was radiating to my back had stopped. But now when I sleep, the pain is right on top of my rib cage. If I sleep on the left or right side, it feels like something is hurting or tugging internally. I went to my PCP because the pain was still going on. She said perhaps I may have had COVID, and something happened. It was also on my left side, so she sent me to the cardiologist. They did an EKG, came back fine. They recommended me for a stress test, sonogram on heart. Everything came back fine. To date, I still have that pain right on top of my right abdominal area, under the breast. When I'm active during the daytime, I don't experience anything. It's only when I lay down and it's painful. I went back to my gastrologist and double check. They ordered an upper endoscopy and colonoscopy. They did that, and they noted irritation in my lining in my upper stomach lining. Was told to continue taking medication lansoprazole. That's where we are at now. Also, during the May 2022 timeframe, I started experiencing severe anxiety, depression, and panic attacks. It was impacting my personal life. I'm now seeing a psychologist. Had to be taken off work because that may have been triggering my anxiety. I've been on leave of absence for the past 6 weeks. I'm not sure if that instance is in relation to the vaccine. The pain that I'm describing also fluctuates or radiates back and forth between the left and right sides of my abdomen.
Patient received additional vaccines than were recommended or ordered. Was ordered to receive Pentacel, Prevnar 13, and Rotarix. Medical assistant drew up and administered an additional Hep B and Hib vaccine in addition to the ordered vaccines.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022. The vial did not undergo any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contain Non-significant information.
body aches, chills/sweats, severe headache, nausea (w/o vomiting), dizziness, fatigue
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 34 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
This spontaneous report was received from a pharmacist refers to a 34 year old male patient. The medical history, concurrent condition and concomitant medications were not reported. On 08-OCT-2015, the patient was vaccinated with RECOMBIVAX HB dose 1. On 08-NOV-2015, the patient was vaccinated with RECOMBIVAX HB dose 2. On 11-APR-2016, the patient had an unspecified tooth extracted. The outcome of the event was unknown. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. On 18th May 2018, 19:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site itching and injection site discoloration. On 18th May 2018, the patient experienced joint pain, tiredness, weakness and muscle pain. On an unknown date, the outcome of the joint pain, weakness, muscle pain, injection site pain, injection site swelling, injection site erythema, injection site induration, injection site itching and injection site discoloration were recovering/resolving and the outcome of the tiredness and injection site warmth were recovered/resolved. The reporter considered the joint pain, tiredness, weakness and muscle pain to be almost certainly related to SHINGRIX. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site warmth, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: On the same evening after receiving SHINGRIX, the patient began feeling very tired, developed joint pain, muscle pain and weakness and was asleep by 8:30 pm. The following day (on 19th May 2018), the muscle pain, joint pain and weakness were improving and she felt better, and again, at around 6:00 pm, the muscle and joint pain and tiredness recurred, and she again was in bed by 8:30 pm and slept 12 hours which was very unusual for her. On 20th May 2018, she felt much better and did not have the recurrence of her symptoms and did not have to go to bed early because of the tiredness. She received her injection on her left deltoid, and experienced pain, swelling, redness, and skin hot to touch at injection site. Presently, the site was hard, about 3 inches in diameter and discolored, but not black and blue. At the time of reporting, she stated that the injection site was improving and was now itchy. She was inquiring if the same thing would happen with the 2nd dose of SHINGRIX. Reviewed the PI including adverse reactions, how often they might occur with 2nd dose, and reviewed information from the clinical trials. The patient denied any fever or chills. The patient was planning to received the 2nd injection in a timely manner. She just wanted to be prepared on what to expect. The patient had denied permission to contact her physician.
Shoulder and hip joint pain Minor headache, difficulty regulating body temp, General achy and fatigue
Complaint of 102 degrees temp, chest congestion, coughing, muscle ache.
missed period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (missed period) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (missed period). At the time of the report, MENSTRUATION DELAYED (missed period) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left sided weakness and heaviness, macular rash on bilateral ankles, neck pain, headache, chest pain, shortness of breath, throbbing in her head, head fullness started the day after vaccination.  Headache at the base of occipital area remains today.  Weakness is better, rash almost resolved.  Patient advised to see her Health Care Provider.  Has appointment to see today.
This 37 year old  female received the Covid shot on  4/7/21    and went to the ED on 4/9 /21  with the following diagnoses listed below. U07.1 - COVID-19
Fever 102; swelling/redness/bruising to leg; won't walk on leg.
I FELT LIKE I COULD FIGHT someone OR TWO; CHILLS; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced I felt like I could fight someone or two. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and tired on APR-2021, and the outcome of I felt like I could fight someone or two was not reported. This report was non-serious. This case, from the same reporter is linked to 20210435862.
Headache, Myalgia, chills, Pain in (injected) arm Narrative: Per nursing report: " c/o took 2nd Moderna vaccine yesterday [3/29]. C/o headache,chills, neck and right arm pain"  Other Relevant History:
Headache, Myalgia, Arthralgia, NauseaVomiting, Localized pain: chills, fatigue Narrative:
Swollen welts at injection sight turned black and blue. Nausea, Vomiting & Diarrhea starting at 3:30 PM.
Rash is non pruritic, erythematous macules and papules that are well defined. Arm rash slightly scaly, rash about 1 cm in size around trunk,  bilaterally mid arms, and bilateral proximal legs. Rash for 3 weeks,  2-3 days after 4th covid vaccine.
Pain in arm radiating to hand ans pinky and ring finger. Tingling pain in fingers, arm pain making it hard to use arm. Getting worse over time
Haven't eaten since Friday, severely tired and grouchy. Developed cellulitis, high fever, have to take 2 different antibiotics and PHENERGAN, severe nausea, arm doubled in size and I am still sick and very grouchy 5 pain, days later. Bumps under arm from elbow to shoulder.
Diagnosed with episcleritis following vaccine admission.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 12:30 (Lot number: EW0161) at the age of 32 years as dose 1, single and administered in arm left (Lot number: ER8736) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: EPISCLERITIS (non-serious) with onset 03May2021, outcome "recovered" (2021), described as "Diagnosed with episcleritis following vaccine admission.". The event "diagnosed with episcleritis following vaccine admission." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of episcleritis.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since and post the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient received medication within 2 weeks of vaccination was Prenatal vitamins and treatment for adverse event was CT Scan, steroid eye drops, anti inflammatory meds.  Follow-up attempts are completed. No further information is expected.
Right thigh with 3"x4" redness, warmth, swelling within 24 hour after receiving vaccines. Child also had diarrhea and fever 102.
Pt's R arm became red, hot and swollen. Was seen by physician (was on vacation) 3 days post injections were given. Treated with Keflex, Ibuprofen and ice. R arm measured 8 1/2", L arm measured 7 1/2".
Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests; Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "migraines" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: DYMISTA; HYDROXYCHLOROQUINE; METFORMIN; NORVASC; PROAIR [SALBUTAMOL SULFATE]. Past drug history included: Amoxacillin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovering" and all described as "Completion of course on 21May2022 and on 25May2022 developed sore throat again, and rapid antigen positive; after 2 negative rapid antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
they administered an old formula of Pfizer covid-19 vaccine booster dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "they administered an old formula of Pfizer covid-19 vaccine booster dose". Additional information: Pharmacist said they have a patient who wanted to get the Pfizer covid-19 vaccine, bivalent but they administered an old formula of Pfizer covid- 19 vaccine booster dose. Caller asked how long they should wait before giving the Pfizer covid-19, Bivalent booster dose to the patient.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
My arm was sore immediately after the shot and remained sore for several weeks. Then my arm was sore if moved in certain positions. It remains sore in certain positions to this day. I am now attending exercise classes at a local gym. The exercise has helped a small amount.
This spontaneous report as received from a pharmacist refers to a female patient between 50 and 60 years old. The patient's medical history and drug reactions/allergies were not reported. The patient was vaccinated subcutaneously with ZOSTAVAX on 15-OCT-2012. The dose and lot number were not reported. No other co-suspects were reported. No concomitant medications were reported. While on ZOSTAVAX the patient developed a small rash on 17-OCT-2012. No treatment was given for the adverse experience. No laboratory tests were performed. At the time of reporting, the patient's outcome was unknown. Relatedness was not provided. Additional information is not expected.
Pt has been crying since left clinic; parents unable to pacify pt; currently being seen by MD; MD's office called to report case @ 1240PM;
high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to HYPERTENSION. At the time of the report, HYPERTENSION (high blood pressure) was resolving. The patient initially was scheduled for cataract surgery but was hospitalized for high blood pressure      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient takes blood thinners from an unknown date.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2021-077862 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded MODERNATX, INC.-MOD-2021-077862:
T 36.5, BP 123/74. 19 cm by 19 cm area of erythema on arm that received vaccine noted on 3/2/17. Warmth of area. No trouble breathing or other swelling/redness. Prescribed cetirizine 10 mg in am, BENADRYL 25 mg in night x 4 days.
Starting approximately one hour after injection pt developed a rash on neck and arms that was quickly spreading.  Reported tingling in feet.  Pale and diaphoretic.  Some SOB and chest pain.  Was taken to ER via ambulance.
3 days sore arm that spread to upper shoulder 01/22-01/24  01/24/21 at 6AM my left side of my face was swollen from eye to ear to mouth, under my neck, and swollen lymph nodes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 13:00 as dose 5 (booster), single, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Hives began on 07-10-04 with chills and fever.  Took Benadryl po and began Vistarel po 7-11-04. Hives increased and continued fever and chills with tightness across chest.  Went to ER tx's with Vistarel steroids and tagament. Requested Drs report from client 9-15-04 no physicians report received. patient continues to recover.
Flushing, hives, vomiting, diarrhea 4 hours after injection
Body aches; Chills; Headache; Pain at injection site; poor appetite; fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular (left arm) on 11Jan2021 (16:45) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EL1284) on 21Dec2020 (05:00 PM) intramuscular (left arm) for Covid-19 immunization. The patient's medical history included diabetic and heart disease; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, headache, pain at injection site, poor appetite, and fever on 12Jan2021. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
1/15/2021 0600 Upon awakening noticed hot, red, blotchy, swollen area at and around injection site. 1/18/2021 This area has extended to 10cm x 8 cm Serious adverse reaction CRITERIA: LOCALIZED GRSDE 3 ERYTHEMA TO INJECTION SITE  Occasionally will have vertigo after flu vaccine
Patient called in and informed nurse his arm was very sore, involving the entire shoulder. He canceled his usual activities due to this pain. Advised to use ice/cool therapy at site, and could take OTC mild pain reliever