chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891215A, and A0891217A. Follow-up information was received on 09November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
body aches; extreme fatigue; upset stomach; diarrhea; extreme headaches; muscles aches/every muscle in her body hurts; knee pain/ joint pain/ can''t even touch her elbow where she got the shot because of the pain; muscle pain at the site; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 10Oct2021 at 15:30 (Batch/Lot number was not reported) at the age of 53 years old as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. The patient stated that this vaccine, there's no words for it. The patient was reporting to complain but she feels like she is wasting her energy, nobody is going to care, Pfizer doesn't care. The patient stated she is not yelling, agent is on speaker phone because she can't hold it up to her. The patient stated that it was her first dose, the first and last, she will never get it again. On 10Oct2021, the patient stated she was having body aches, extreme fatigue, upset stomach, diarrhea, extreme headaches, she is just fatigued to the point she can't even go to work, muscle aches, body ache, knee pain, joint pain, the elbow she had it put in she can't even touch that elbow because of the pain. The patient was missing work now for 48 hours. The patient stated the symptoms began 10 minutes after the vaccine and that it happened almost instaneously and confirmed all symptoms began 10Oct2021, are ongoing, have worsened, they are not getting any better, its actually scaring her. The patient got sent home from work because she's going to the bathroom and she's tired, having headaches. She states every muscle everything in her body hurts, she can hardly move, headache, fatigue, diarrhea, muscle pain at the site, muscle pain at every joint in her body. The patient stated that when she got the Pfizer vaccine, she was so sick, Pfizer should be sued, Pfizer is horrible, its like somebody injected her with poison. She has every side effect known to man, it's literally poison. She can't go to work, she's really upset. She states she would be happy to tell. This should not be on the market, the Pfizer Vaccine. The patient had not recovered from the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; Crohn's disease aggravated; Booster; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223921-00.  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for moderate to severe adult crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; IMMUNISATION (medically significant) with onset 31Aug2021, outcome "unknown", described as "Booster"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events (Crohn's disease aggravated, COVID-19) with the HUMIRA were not reported.  The reporter's assessment of the causal relationship of the events (Crohn's disease aggravated, COVID-19) with the PFIZER BIONTECH COVID-19 VACCINE were Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19, Crohn's disease aggravated cannot be totally excluded. The case will be reassessed when additional information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Headache & Myalgia Narrative:  1/21 to 1/22- fatigue; ha; chills
Headache, Fever, FATIGUE, CHILLS, SITE PAIN/SWELLING Narrative:
Upper lid on my left eye is black and blue, but no blurred vision and no bleeding. Hurts when I blink.
just lightly feels like my glands are swollen under my left arm; booster; the arm was sore; it was really sore and stiff; soreness in the injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2022 (Lot number: FE3594, Expiration Date: Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022, outcome "recovered" (Jan2022), described as "the arm was sore"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 05Jan2022, outcome "unknown", described as "it was really sore and stiff"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2022, outcome "unknown", described as "soreness in the injection area"; LYMPHADENOPATHY (non-serious) with onset 06Jan2022, outcome "unknown", described as "just lightly feels like my glands are swollen under my left arm".  Additional information: Reporter seriousness for The arm was sore but that went away so, last night it was really sore and stiff so, I had soreness in the injection area which was the left arm, just lightly feels like my glands are swollen under my left arm was Unspecified.
Pfizer 10/12/21, 11/2/21. Positive on 12/29/22
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 6:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 6:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided. Concomitant medication was not provided. It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.
Occured at off site vaccination clinic. About 15 minutes after vaccination patient complained about itchy throat. Gave patient diphenhydramine 25mg capsule and bottle of water. Called nurse to check pulse and blood pressure, both normal. About 5 minutes later she said the sensation felt worse. Gave her diphenhydramine 25mg liquid dose. Nurse called for Emergency Services prepared to administer Epi-pen if needed (was not used).  Patient felt she may  be getting short of breath. EMS showed up at that time and took over. They checked patients throat and she said she thought the shortness of breath was getting worse so they decided to transport her to the ER.
Three hours after receiving the 2nd vaccine I started getting cramps/pain in my lower right abdomen. The pain continued through the night and in the morning my husband took me to the emergency room. They did a cat scan and seen that I had an acute appendicitis. I had to have surgery that day to remove my appendix.. I had NO other symptoms related to an appendicitis except the severe pain. They kept me in over night after surgery. To this day, I am still recovering.
swelling of the whole left armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of LYMPHADENOPATHY (swelling of the whole left armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling of the whole left armpit). At the time of the report, LYMPHADENOPATHY (swelling of the whole left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
PATIENT CAME AND EXPLAINED THAT SHE GOT SWELLING AND PAIN AT SITE OF INJECTION ON THE DAY AFTER ADMINISTRATION DATE. DIAGNOSE CELLULITIS AND PRESCRIBED HER CEPHALEXINE 500 MG CAPSULES 1 CAP Q12 FOR 7 DAYS.
Received vaccine in am of 10-07-2010. Started pain same day. Chest pain, swollen arm started on Friday. Symptoms worse on Sunday chest pain, difficulty taking breath "hurts to breath" and fever of 101.5 degrees F. Was taken to an Urgent Care was pick-up by Paramedic and taken to hospital for observation.
-Patient received the correct fully concentrated Menveo vaccination along with Tdap during a well child visit. -After the appt., the pt. proceeded to our COVID Vaccination Clinic wherein he incorrectly received the powder portion of Menveo constituted with Pfizer COVID diluent.  Both the Menveo and Pfizer pediatric COVID vials have same colored top.   -Pt. observed for 15mins with no adverse event and/or outcome.  Pt will be advised to return to repeat COVID vaccine.
Technician was giving a vaccine to a pt. and after administration the pt. bumped the Tech causing her to stick herself.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not reported.  Nurse reported that patient received bivalent booster from vials that were put in the fridge and after that refrozen and thawed again. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP. HCP wanted to know if the vaccine was ok or if they should be revaccinated.  This case contains information for the 4th of 100 adult male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
30 minutes after vaccine patient experience localized itching to left supraclavicular, b/l neck and behind the ears with mild flushing of the associated skin without development of hives, normal vitals.  given 50mg of benadryl by mouth, monitored for 30 minutes, decrease in itching in this time and was released to self-care.
InjectionSitePain,InjectionSiteSwelling Narrative: Approx. 2 inch circular raised red area with heat and aching at injection site. Iced area and took Benadryl.
legs swollen 24 hr after; severe leg pain in my calf muscle; I sick of the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "legs swollen 24 hr after"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "severe leg pain in my calf muscle"; ILLNESS (non-serious), outcome "unknown", described as "I sick of the pain".  Additional information: Patient reported that I got your Covid shot at a my legs swollen 24 hr after along with severe leg pain in my calf muscle , I called a company and your site had no warnings about this when I seen a video from 2021 you Company knew about it. What is causing it, I need to know what to ask my physician to look for. I'm a CNA this affects me 24hr a day nothing helps. I sick of the pain I'm 37 what is causing it so I can have my physician look.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Felt very sick; This is a spontaneous report from a non-contactable consumer (patient's parent). A male patient an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was felt very sick. The outcome of the event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT WANTS US TO REPORT ONLY, PT WILL RECOVER FROM "COVID ARM"  SWELLING, REDNESS, PAIN
Pt had VARIVAX at 1 year (unknown lot #) and now has herpes zoster. Never had clinical varicella.
52 days interval between the doses; Fatigue/tired; Joint pain; Light fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses), FATIGUE (Fatigue/tired), ARTHRALGIA (Joint pain) and PYREXIA (Light fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease from 26-Feb-2021 to 04-Mar-2021 and Open heart surgery on 08-Mar-2021. Concurrent medical conditions included Colon cancer since 20-Nov-2004, Blood pressure high since 2006, Borderline diabetes since February 2020 and Latex allergy. Concomitant products included AMLODIPINE, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ATORVASTATIN, FERROUS SULFATE, SIMETHICONE, METHIMAZOLE, METFORMIN, ASCORBIC ACID, PARACETAMOL (TYLENOL), MULTIVITAMINS [VITAMINS NOS], LISINOPRIL from 2006 to an unknown date, VITAMIN C [ASCORBIC ACID] and METOPROLOL TARTRATE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses) and PYREXIA (Light fever). 26-Mar-2021, the patient experienced FATIGUE (Fatigue/tired) and ARTHRALGIA (Joint pain). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses) had resolved. On 28-Mar-2021, FATIGUE (Fatigue/tired), ARTHRALGIA (Joint pain) and PYREXIA (Light fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Patient is concerned about effectiveness and efficacy of Moderna Covid-19 vaccine given 52-days apart. He wans to be part of clinical trials.   This case was linked to MOD-2021-061224 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 12-May-2021 .Patient demographics were updated, vaccine facility details were added, concomitant medications were added, event stop date was added, chronic long standing conditions were updated. On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains No New information.
Anxiety, dry mouth Narrative: Patient received her #2 COVID-19 Immunization and while in the observation area about 10 minutes after receiving her vaccine she offered a complaint of rapid heart rate, dry mouth, itchy (R) arm (location of vaccination). Vitals were obtained and patient was moved to the observation stretcher. Patient complained of feeling dizzy during ambulation and nausea. Will attach observation room provider to this note. 2 minutes post vaccine patient noticed itching at injection site and was worried about angioedema, hx of angioedema with antibiotics and need for epi. VSS and transferred from chair to stretcher via two nurses. Nausea began 4 minutes post vaccine and she was given an emesis basin and cold wet towels around her neck and we removed her sweatshirt d/t feeling hot, vitals taken again all stable. Itching worsened and she felt like her tongue was starting to itch and swell, no eye or lip edema and we trialed a PO benadryl which she spit out and we then injected IM benadryl 50 mg and called 911, paramedic and EMTs arrived and report was given and she was transferred to ER for higher level of care, IV fluids, Zofran, Solu-Medrol. Her daughter was here with her, she drove her knowing a reaction would take place like after her 1st COVID vaccine. History of allergies and anaphylaxis to Penicillin, Morphine, Amoxicillin, Cephalexin, Cipro, Bactrim, Gatifloxain. No pertinent labs available. Blood pressure of 131/57 at 8:37A, 3/20/21. Patient was contacted by facility provider on 3/22/21 after ER visit. Patient told facility provider she is feeling much better and all side effects had resolved expect the fatigue. Treatment given to patient at ER is unknown.
In the afternoon of April 1, 2021, my head began to itch. It was very uncomfortable. I noticed welts were formed on my head. They soon were on the back of my neck and upper back with itching. The welts on my neck and head were very large. My daughter put Benadryl cream on my head, neck and back. I took one generic brand Benadryl. Before I went to bed, we applied more Benadryl cream on the welts and I took two Benadryl type tablets. The next day, the welts weren't as bad but there were some new ones on my neck. They have eventually all gone away with some residual itching that may or may not be associated.
PATIENT WAS ADMINISTERED VACCINE PAST THE ROOM TEMPERATURE EXPIRATION TIME OF 2 HOURS.