chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer via a Pfizer colleague(consumer is Pfizer colleague's uncle). A male patient in his early 80s received PREVNAR 13, on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications. The patient experienced pain in the arm after the administration of the vaccine. Event worsened. Due to the event the patient went to emergency room and then he was hospitalized for a day or two and after he was transferred to the long term care facility (which was a part of a hospital). Patient will be getting vancomycin and ROCEPHIN for the next 3 weeks. Surgical procedure to drain his arm was done on an unknown date. Final outcome of the event was not recovered.
Information has been received from a nurse concerning an 8 year old male with asthma and hypersensitivity who on 23-DEC-2002 was vaccinated with the first dose of VARIVAX (Merck) (lot number unknown). On 24-JUL-2009 the patient received the second dose of VARIVAX (Merck) (lot number 663308/0094Y). Concomitant therapy included montelukast sodium (MSD). On 24-JUL-2009 the patient felt "weak, tired and puny" after receiving the second dose. On 27-JUL-2009 the patient  developed a rash from poison ivy contact on his left side of his face and neck. He had periorbital swelling. The rash was described as erythematous clear fluid filled blisters. The patient still felt "puny". At the time of the report the patient had not recovered. Additional information has been requested.
Patient had shortness of breath, heavy feeling in chest, large knot approximate size of a large orange and erythema. Patient seen by provider the following Monday (11/22/2021) after administration on Friday (11/19/2021). Provider administered Kenalog 1mL.
Strong sneezing; Coughing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, administration date 02Oct2021. The following information was reported: SNEEZING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Strong sneezing"; COUGH (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Coughing". Therapeutic measures were not taken as a result of sneezing, cough. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No
Redness, edema, to (Rt) & (Lt) thighs; low-grade fever; rash; vomited x2. 1-2 days post immunizations.
Hospitalization due to COVID-19 Reported per Moderna COVID-19 Vaccine EUA
Ankylosing Spondylitis; Ankylosing Spondylitis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "Ankylosing Spondylitis". Clinical course:  The patient stated "I suffer from ankylosing spondylitis. I have never taken biologics. I have taken two shots and a booster of the Pfizer COVID vaccine. It seems to have an effect on my illness."  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145008 same patient/vaccine, different dose/event
Has some diarrhea on day before she had the second shot; This is a spontaneous report from a contactable consumer(parent) reported for a female patient (daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated the patient (daughter) last night (incomplete sentence), she found out later that patient had some diarrhea on day before she had the second shot of the Pfizer Vaccine on 30Jun2021. So, they don't think it's anything with the vaccine but talked to our pediatrician to report that up and she gave us the number to call. Upon follow up, consumer also stated that the case got serious and required antibiotics. About LOT#: Reporter stated, "Yeah it was a, two different numbers I guess it looks like 'P'W0179 (Not appropriately clarified, hence not captured in tab) and EW01 looks like 177 for the second dose." The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
FLUZONE HIGH-DOSE doses were administered from the frozen shipment with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Agency (under the reference 00815032).  This case is linked to case 2021SA345065 (same reporter).  This case involves a 71 years old male patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 29-Sep-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.7 ml, total, lot UJ716AA and expiration date: 30-Jun-2021) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product storage error temperature too low (latency same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  At time of reporting, the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt. received Varicella vaccine 1/12/09. RTC today 20 to reddened area 11X10 CM @ site of vaccine.
Severe heart attack, taken to hospital.  Stent surgery performed. Discharged from hospital 08-19-2021.
Occurrence 12/07/2005 approx 24 hours after shots. 2-3 seconds low amplitude shaking left hand when excited. Recurrence 3-4 times over the following 48 hours. No loss of consciousness, no change in color, no other changes. Patient is on orajel for teething uses once daily average. Neurologic exam normal.
Site: Pain at Injection Site-Mild, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
GARDASIL injection was administered in left arm. No immediate reaction. The following morning a severe rash the size of a baseball was apparent. The rash lasted approximately one -1- week. This was the first injection of the series. Informed by pediatrician NOT to continue with the series.
Pt. in on 05/25/2021 "presents with altered mental status. Per EMS, her nursing home stated that she was minimally responsive during breakfast"; "Laboratory results notable for 4+ bacteria in urine."; PMH significant for DM, CKD, CHF, HTN.
Patient presented to Nurse Triage with concerns due to redness surrounding Pneumo Conjugate injection site received on 04/24/2023. No complaints of pain or itching. Patient presented with no difficulty breathing and has no prior history of allergic reaction to vaccines. Patient was seen by on-site physician Dr. and RN. No bleeding, discharge, ulceration, or infection noted by physician, Dr.
second dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion). On 21-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) 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.   No concomitant medications reported. No treatment reported   This case was linked to MOD21-146513, MOD21-146835, MOD21-146840, MOD21-146854, MOD-2021-329506 (Patient Link).
Fussy at first as usual, fussy increased, inconsolable, wouldn't eat until next day. More cooperative.
PT WAS RECEIVED 2 FLU SHOT BY ACCIDENT-- CALLED PAT LATER THAT DAY AND HE WAS FINE
she had rashes on the side of her body and under her arm on the side; This is a spontaneous report from a contactable consumer (self reported) and received from a sponsored study. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration on 08Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on unspecified date in Mar2021, she had rashes on the side of her body and under her arm on the side where she received the injection for the 1st dose. Patient was due for her 2nd dose of our COVID-19 vaccine on 29Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Fever, chills, chest tightness, cough, sore throat, headache, loss of appetite, arm soreness, body aches, arm rash/redness near injection site. Lasted 72 hours.
Pt recvd vax on 21FEB92 around 315PM; parent state that @340PM body shaking & hands turned blue; called paramedics; to ER; pt had fever 102, poss otitis, ? febrile seizure; given ATB
p/recv vax pt exp redness, pain & warmth at inj site; pt recovered 6/5;
No adverse reaction seen or reported.  Contacted manufacturer and the vaccine is still viable. Revaccination not needed.
Information has been received from a registered nurse concerning her son who on approximately 21-FEB-2008 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included AMOXIL. It was reported that the patient developed a rash from head to toe in approximately February 2008 from measles virus vaccine live (Enders-Edmonston (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was unknown if the patient sought medical attention. As of 06-MAR-2008, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
rash on my abdomen; chills; aches; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my abdomen), CHILLS (chills), MYALGIA (aches) and HEADACHE (headache) 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 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced CHILLS (chills), MYALGIA (aches) and HEADACHE (headache). On 31-May-2021, the patient experienced RASH (rash on my abdomen). At the time of the report, RASH (rash on my abdomen), CHILLS (chills), MYALGIA (aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
I was given the HEP B vaccine, shot #2.  About 2 hours later, I experienced the same pain from the shoulder blade up through to my head that I did from the first shot of the HEP B vaccine.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 5 days.  The most severe pain was at the top of my spine just before my head just like with shot #1.
Generalized varicella rash (11 vesicles) vesicle on torso, face and extremities
Adverse effects began day after first shot.  Both hands stiff, sore and hot.  Right shoulder was immobile.  Right side more effected than left.  Pain became increasingly worse and debilitating.  Unable to complete common tasks easily such as brush teeth and feed myself.  Took 2 months to get into primary doctor.  Ordered blood draw.  First tried Diclofenic and Tizanidine.  Pain continued to progress. Refereed to specialist in Rheumatology.  Re conducted blood draw.  Diagnosed with Rheumatoid Arthritis.  Prescribed Prednisone, Folic Acid, Methotrexate, Hydroxychloroquine, Alendronate,  Able to move about more freely on medication.  Able to sleep again
This was my booster (first two shots were Moderna  4/1/21, 4/27/21). The injection was high in the upper left arm. My injection arm felt throbbing sore for the first 24-36 hours as expected and then began subsiding. However, I have a lingering sharp pain that does not seem to be getting better nearly 30 days later. I do not feel it if my arm is in normal position, but I get a sharp stab during certain shoulder rotations and movements, especially if they are weight bearing (propping myself up in bed, lifting a grocery bag).
I had 2 doses of Moderna/ I get the Pfizer booster; booster; I had 2 doses of Moderna/ I get the Pfizer booster; heart attack; I have never been so sick in my life; Pain was so intense in my chest; I am so freaking cold; My face is so hot like if it is going to burn up; My whole body just hurts it aches so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "cholesterol" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: GLIMEPIRIDE taken for diabetes mellitus. Vaccination history included: Moderna vaccine (First Shot: Consumer stated, "031L20'A'.), for COVID-19 immunization; Moderna vaccine (Second Shot: Consumer stated, "001B21A), for COVID-19 immunization, reaction(s): "I ended up with that underarm pits syndrome where your (word not clear) swelled up under the arms". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 2021, outcome "unknown" and all described as "I had 2 doses of Moderna/ I get the Pfizer booster"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "heart attack"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have never been so sick in my life"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain was so intense in my chest"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "I am so freaking cold"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "My face is so hot like if it is going to burn up"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "My whole body just hurts it aches so bad". The patient underwent the following laboratory tests and procedures: blood test: unknown. Therapeutic measures were not taken as a result of myocardial infarction, illness, chest pain, feeling cold, burning sensation, pain.  Follow-up attempts are completed. No further information is expected.
Numbness and tingling to left side on arm, jaw and hand,  and left sided swollen tongue.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 14-year-old female arrived with parents. Discussed her nervousness; stated last shot was flu shot (painful). No history of "passing out." Had patient  stay in seat for 2 to 3 minutes prior to moving to observation area. About 3 to 5 minutes later, she was weak and leaning with eyes closed over mom's shoulder. Called 911. She reported seeing spots; had her move from chair to floor. She was able to sit-up straight and keep eyes open. Vitals every 5 minutes, 92/49-100/72mmHg, 68-93bpm at 15:25-15:40. EMS arrived. Patient went home.
C/O tingle/itch on the right arm and right neck after getting vaccine. No rash noted. Small amount of swelling at injection site.
LEFT SHOULDER AND DELTOID 3" IRREGULAR TENDER FROM MIDDLE RED. LOCAL REACTION TO VACCINE
Developed a lymph node in her neck; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPH NODE PAIN (Developed a lymph node in her neck) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A. and 025J20A.) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Developed a lymph node in her neck). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, LYMPH NODE PAIN (Developed a lymph node in her neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-068351 (Patient Link).
2 hours later she felt something dripping down her arm and it was some clear liquid at the same shoulder she got the shot; Experiencing swollen hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 18:30 (Batch/Lot number: unknown) as dose number unknown, single 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) with onset 2021, outcome "unknown", described as "Experiencing swollen hands and feet"; VACCINATION SITE DISCHARGE (non-serious) with onset 30Apr2021 20:30, outcome "unknown", described as "2 hours later she felt something dripping down her arm and it was some clear liquid at the same shoulder she got the shot".  Additional information: Caller stated, my daughter got your shot and she was experiencing swollen hands and feet, it was the weekend she cannot consult with here primary care physician and also when she got the shot about 2 hours later she felt something dripping down her arm and it was some clear liquid at the same shoulder she got the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Fever, Injection site pain, chills Narrative: Chills, fever myalgia injection site pain for 2 days after #2 days after #1 dose injection site pain
MenA lyophilized conjugate vaccines component(vial 2) mixed with sterile diluent and given to patient.    Men CYW-135 liquid conjugate vaccine component(vial 1) not given.
Extreme dizziness not resolved by vertigo medicine, abnormal ekg, nausea, vomiting, high BP
Swelling of the left eye and development of hives on the arms hands and legs about 2 hours after injections, around 9pm. Next morning left eye was swollen shut and left side of face was swollen. Hives deloped on stomach hips and butt. Took benadryl around 9am. Didn't help. Hives continued to spread down face, into nose and mouth. Hives continued to spread on extremities. Went to urgent care around 2pm. Was given a steroid injection and prescribed oral steroids. Hive spread has now stopped.
Information has been received from a pharmacist concerning a multiple unknown patients. The patients pertinent medical history and concurrent conditions were not provided. On multiple unknown dates the patients were administered a dose of ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), in the deltoid areas in the back of the arm (which was outside of the recommendations per the product information. Concomitant therapies were not provided. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008349). Additional information has been requested.
Swollen arm, couldn't move it for a couple days, fever, pain, took a couple days off work. Pt. called MD, no treatment was given.
Redness, soreness, and swelling at injection site, with mild, red, raised rash on stomach and back (some itching). Swollen glands behind the ear/neck region. Symptoms began today, in the am. Reported at 9:15 a.m. Afebrile at this time. No treatment at this time.
Information was received from a pharmacist regarding a 83 year old male patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-JUL-2017 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M038351 expiration date 06-DEC-2017 (dosage and route unknown). The STERILE DILUENT used had lot # M034763 and expiration date 22-APR-2019. It was reported that "one or two days" later the injection site was red and warm to the touch. There was no rash. The outcome of the events was not recovered. Causality assessment was not provided.  Additional information has been requested.