chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called 8/24/2020 to report 24 hours of "severe"pain in left deltoid and inability to move her arm after this injection. Reported swelling of upper arm without redness or excessive warmth x 24 hours after injection. Spontaneous resolution of symptoms with exception of mild tenderness at injection site following first 24 hours after injection. Denies any other ill effects.
temp up to 102-nausea/vomiting;soreness over entire body;pt recovered on 6MAY96
Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Diarrhea; Vaccination adverse reaction; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Clostridium test: negative (Negative) Negative.         This case was linked to MOD-2021-239141 (Patient Link).
Severe pain in left shoulder especially when lifting arm or moving it behind. Went to pharmacy next day and was told to take TYLENOL which helped; however, I still experience some "residual" ache after 13 days.
Legs have been hurting; Neck hurting; Feeling 'off' after the vaccine; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included valaciclovir hydrochloride (VALTREX). On 01Apr2021, the patients legs had been hurting, neck hurting and feeling 'off' after the vaccine. Patient reported that she had the first dose of Pfizer's COVID vaccine on 01Apr2021 and she hadn't been feeling right since 01Apr2021. She knew it was not a common side effect. Her legs had been hurting and neck hurting. Her neck started hurting immediately following the shot. She had to do physical therapy for it, but it was getting better. It was almost instant from the time they put the needle into her and the pain shot up her neck. She was wondering if there had been reports of feeling 'off' after the vaccine and caller was concerned on how the second shot might feel. She stated she did speak with the doctor and they said to give it some more time before receiving my second shot. They said to give it a couple more weeks to let her body respond and then go get the second dose. Patient had been taking Valtrex and was wondering if that will be a problem with the vaccine. The outcome of legs hurting and feeling off was unknown and outcome of neck hurting was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Erythema about 14x7cm distal to vaccination site noted 11/28/07, resolving by 29Nov07.
This spontaneous report as received from a company representative refers to a 67 years old female patient. On 17-JAN-2013 the patient was vaccinated with a single dose (dose 1) of 0.65 ml live ZOSTAVAX (19400, subcutaneous injection, lot number not reported). On 18-JAN-2013 (the next day after vaccination) the patient experienced induration at the injection site with redness from the elbow to shoulder. On 19-JAN-2013 the patient went to a walk in clinic and the patient was told she had hives. On 22-JAN-2013 the patient went to her primary care physician, who diagnosed chicken pox. At the walk in clinic the patient was prescribed with prednisone as treatment, but the patient did not take it. The outcome of chicken pox, had hives and induration at the injection site with redness from elbow to shoulder was reported as not recovered/resolved. The relatedness for chickenpox, had hives and induration at the injection site with redness from elbow to shoulder was unknown for live ZOSTAVAX. Additional information has been requested.
told mom to wait 5-10 minutes make her she does not have a reaction as I (MA) was leaving she got really flushed and fell over. She did not hit anything off the floor, mom caught her. I (MA) ran to get provider to come check on her. Spo2 was taken 97 and blood pressure was taken 88/60  gave water/juice/and a snack  had her lay down
Patient came in after 3 days of minor fever and rash on the side of the face that spread through stomach and over back and arms/leg
Pt. stated experienced SOB, dizziness after first Pfizer vaccine. Pt. had taken methotrexate prior to vaccination. Juice and water provided to pt. Pt. states feeling better after ingestion. Pt. offered to lay down, pt refused. Vitals signs taken, all stable. Pt. educated on food and hydration before and after future vaccinations.
Pt presented with uti and covid with possible aspirtation pneumonia. treated with remdesivir and dexamethasone. cefriaxone given for uti. Related to patient's advanced age and physical decline, the decision was made to transition to hospice.
Patient experienced facial itching approx 5 minutes after vaccination. Denies swelling in throat, mouth. BP 141/90, Sp02: 98%. RRT called and patient refused ED transport. Sat for approx 30 minutes in obs area before leaving on her own. Airway assessed by RRT and no concern for respiratory compromise.
1st dose 13Sep2022, 2nd 09Mar2023; Can't lift arm; Injection site tenderness; Warm to touch; This non-serious case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   Previously administered products included Menveo (received one dose of Menveo on 13th September 2022 at an out state pharmacy).   On 09-MAR-2023, the patient received the 2nd dose of Menveo (left deltoid). On 09-MAR-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 1st dose 13Sep2022, 2nd 09Mar2023). In MAR-2023, the patient experienced injected limb mobility decreased (Verbatim: Can't lift arm), injection site tenderness (Verbatim: Injection site tenderness) and injection site warmth (Verbatim: Warm to touch). The outcome of the injected limb mobility decreased, injection site tenderness and injection site warmth were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site tenderness and injection site warmth to be related to Menveo.     It was unknown if the company considered the injected limb mobility decreased, injection site tenderness and injection site warmth to be related to Menveo.   Additional Information: GSK receipt date: 14-Mar-2023 The registered nurse had a patient complaining of injection site tenderness, warm to touch, could lift arm.  The patient was not aware at the time of injection that patient also received dose in September 2022. No records in electronic medical record or with state immune registry.   The patient received vaccine out of state at a pharmacy.  The patient asked that how long should a patient be experiencing any potential injection site reactions from Menveo. The reporter showed a documented dose of 27th July 2016 and 9th September 2023.   After vaccine was given, patient family called back to the office stating same vaccine was given 13th September 2022 at an out of state pharmacy. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received 2nd dose of Menveo, which led to extra dose administered.
Patient fell ill and was transported to the ER via ambulance after a presyncopal event on the toilet with diarrhea. She developed hives within 24hrs of this event. Although she has a strong history of environmental allergies, this was her first episode of urticaria.
About an hour after he was given the Hep A shot his throat started hurting and it was getting harder to breathe. He took 2 BENADRYL and his inhaler for asthma. Symptoms went away in about an hour after that. The next day he was fine.
Injection site itching; Rash; Injection site rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (Injection site rash), INJECTION SITE PRURITUS (Injection site itching) and RASH (Rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 INJECTION SITE RASH (Injection site rash). On 28-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching) and RASH (Rash). On 23-Jan-2021, INJECTION SITE RASH (Injection site rash) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site itching) and RASH (Rash) outcome was unknown. Not Provided      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.   Treatment included itching cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI- Patient denied further follow-up.
Tuesday April 13, 2004 at 9:30 pm infant stopped breathing for 15-20sec. This kept occurring every 5 mins for 1 hour with duration of apnea decreasing as the hour passed. Crying in between. No fever. Cyanotic lips during apnea.
Pharmaceutical product complaint; Invalid case- The only event pharmaceutical product complaint for rubber stopper of Shingrix vial.
headache, nausea, severe myalgia -cervical/thoracic; pt had to take  Tylenol and when that didn't work she had to take hydrocodone to get some relief.
Patient is pediatric emergency physician. Reports onset wheezing & coughing about 20 minutes after flu shot administration. Self rx with albuterol inhaler & eventually resolved. Similar reaction last year now reported but states onset several hours later & less severe.
Pt developed flu-like symptoms that included a low-grade fever. Pt then developed a few pimples with blistering. Pt was treated with Motrin. The pt "was part of a vaccine study done at that time" in 1995. Additional information has been requested.
Information has been received from a nurse concerning a friend of a friend's 13 year old daughter who was vaccinated with a dose of HPV rL1 11 16 18 VLP vaccine (yeast). On an unspecified date the patient developed "Guillain Barre". The outcome of the patient was not reported. The patient was seen by the physician. Upon internal review, "Guillain Barre" was determined to be an other important  medical event. Additional information has been requested. 11/17/08-records received from Clinic-2/12/08-seen for C/O sore throat and fever. Rhinorhea and nasal congestion, belly pain, headache, fatigue and not eating as much. DX: Strep pharyngitis. Received HPV vaccine. Office visit 7/16/08-C/O muscle weakness times 1 month in arms and legs getting worse over last month. 7/30/08- DX infect polyneuritis. 8/1/08-suture removal from back of head. Headaches times 1 week.7/16/08-C/O knee and thigh pain and weakness times 6 weeks becoming worse some weakness in arms times 1 month. 7/16/08-Seen for Guillain Barre syndrome diagnosed 3 weeks ago and hospitalized. 11/26/08-records received for DOS 7/23-7/25/08-DC DX: Subacute demyelinating polyneuropathy. Presented with 2 month history of progressive bilateral extremity weakness worse in lower than upper extremities. First noted bilateral knee pain 2 months ago progressed in ascending manner. Difficulty climbing stairs, falling a lot. Few days before onset of knee pain had a URI with rhinorrhea and productive cough lasted 3 days. Received Gardasil in February. Treated with IVIG.
administered a dose that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a medical assistant administered an expired dose of Bexsero, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The Healthcare professional did not have the patient's identifiers. The reporter did not consent to follow up.
severe tremor shakes; Neurological symptoms; throat & mouth began to swell; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (throat & mouth began to swell), TREMOR (severe tremor shakes) and NEUROLOGICAL SYMPTOM (Neurological symptoms) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Jan-2021, the patient experienced PHARYNGEAL SWELLING (throat & mouth began to swell). On 28-Jan-2021, the patient experienced TREMOR (severe tremor shakes) and NEUROLOGICAL SYMPTOM (Neurological symptoms). The patient was treated with CLONAZEPAM for Tremor, at an unspecified dose and frequency; VALPROATE SEMISODIUM (DEPAKOTE) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; OMEGA-3 NOS at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency and VITAMIN E NOS at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (throat & mouth began to swell), TREMOR (severe tremor shakes) and NEUROLOGICAL SYMPTOM (Neurological symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication was not provided.
This spontaneous report was received from a physician via company representative refers to several patients of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date was unknown). On an unknown date, the patients failed to seroconvert with RECOMBIVAX. The outcome was unknown. Additional information is not expected.
Awoke with blister on leg; began to hurt in lower left quadrent; pain got more under left rib; sharp pain under left rib cage (3rd day); at Dr. x-ray no visable signs of pain; day 4 began showing blisters on left side; Day 5 broke out laft abdomen around to spinal column; Day 7 Dr. gave anti-viral pills for 1 week; Day 8 blisters began leaking.
Injection site red; Injection site inflamed; Injection site hard; Lymph node swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 16:15 (Lot number: Ff8839) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6293, Location of injection: Arm Left), administration date: 01Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Left), administration date: 08Feb2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site red"; VACCINATION SITE INFLAMMATION (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site inflamed"; INJECTION SITE INDURATION (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site hard"; LYMPHADENOPATHY (non-serious) with onset 03Oct2021, outcome "recovering", described as "Lymph node swollen". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site inflammation, injection site induration, lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This case was reported by a 23 yr old medical assistant who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The medical assistant reported that she received three doses of Engerix B on 07Jul03 (lot ENG5379A4), 08Aug03 (lotENG5390A4) and 09Feb04 (lot ENG5507A4). Engerix B was administered on a 0, 1 and 7 month schedule rather than the recommended schedule of 0, 1, and 6 months. On an unspecified date in May 2004, a hep B surface antibody titer indicated that the medical assistant was non-reactive.
I continued to have my period since the vaccine. I was on day 6 or 7 of period when I received the second COVID 19 vaccine.  I am currently on week 3 with continued abnormal uterine bleeding. I have only had a day or two break twice during the last 3 weeks but every time, my period restarts. Currently still bleeding and waiting to see an OB-GYN specialist. I have always had regular monthly periods prior to the vaccine.  I am a physician myself. I completed pregnancy test and it is negative. Waiting on further studies and evaluation.
Shot site tender, redness, itchy, slight swelling, bumpy and  sore to the touch.  A bit more fatigued than usual.  No special treatment.  Keeping check on the injection site.
After the vaccine was administered, the injection site was more sore than how a regular flu shot feels.  The third day after the vaccine was administered the injection site and the area around it began swelling.  The swelling went away a few days after that.  The redness faded to a dull pink.  Around the 10th of January I again had redness around the injection site accompanied by major itching.  The redness had almost a perfect circle around the injection site that began about the circumference of a golf ball.  The next day (the 11th), the circumference of the rash increased to the size of a baseball.  The rash is now spreading down and around my arm.  The itching is not nearly as bad.  I've been taking my temp and it has ranged from 97.9 to 98.3.  I haven't had a fever or any other symptoms since my injection day.  I went to a free-standing er/clinic (last night, 01/12/2021), and the doctor there told me to watch for swelling of my lymph nodes and also for a red line or red streaking to go up my neck.
patient received second dose early for 2 dose GARDASIL 9 regimen; This spontaneous report was received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 16-SEP-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, early, on 30-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown).
entered clinic with red bull energy drink, spouse reported Patient drank a soda earlier, skin appeared pale, reported he did not do well with vaccines as a child in the past, still wanted to proceed with vaccine. Had seizure for 2 mins, family reported past history of fainting.  EMS attended, responded to questions appropriately, fainted a second time, monitored, pt was released home with spouse
2 weeks after injection, pt states he noted discomfort in muscle just above elbow. Pain with reaching backward and lifting, when reading vaccine. Info sheet given. He decided to call. States he is improving, recovering.
8/26 Day of vaccine arm soreness and had flushing on body (arms and chest). 8/28 -9/5 Arm soreness at site of injection. 9/7 Scalp severe itchiness and welts like allergic reaction which i have never had before. 9/10 Still mild injection site tenderness 9/23 Still having itchiness and notice sore joints at times which never had before
7pm on 11/5/19 - Hot to touch, Red, swollen, raised 11/6/19 - Hot, red, swollen and itching, raised saw OCC. Health N.P. 11/8/19 - F/U w/ OCC Health N.P. Still itchy, pink in color
Pain near injection site (right arm) for 40 hours; pain in left neck and shoulder for 36 hours; general feeling of malaise for 36 hours; headache for 36 hours; insomnia during two nights.