chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction 9 to 10 days after 1st Moderna monovalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster). At the time of the report, ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 30ish. No concomitant medications were reported.  The patient reported a allergic reaction 9 to 10 days after 1st Moderna monovalent booster that required a trip to emergency room (ER) for treatment.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706654 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706654:Case for
Fatigue; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011KL20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On 16-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 18-Jan-2021, FATIGUE (Fatigue) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Telephone contact in attempt to obtain email address, reporter disconnected the call.
metastatic stage 4 breast cancer; diabetic; kidney dialysis; overweight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE. Vaccination history included: Bnt162b2 (Dose 3 (booster)), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: BREAST CANCER METASTATIC (medically significant), outcome "unknown", described as "metastatic stage 4 breast cancer"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; RENAL DISORDER (medically significant), outcome "unknown", described as "kidney dialysis"; OVERWEIGHT (non-serious), outcome "unknown". Therapeutic measures were taken as a result of renal disorder. Clinical course: Caller says she has had a total of four shots, with the first two of primary and two doses for boosters and said that she is already 70 years old and has metastatic stage 4 breast cancer, is diabetic, is overweight, and has kidney dialysis. Agent reports caller said someone told her she was qualified to get a fifth shot, and she got her last shot in April, so she wants to know if she is able to get a fifth shot this coming August and be eligible to get one in September or October for new vaccines for new variant for COVID. Caller says she loves Pfizer and gets her monthly Ibrance from Pfizer. She says that they are encouraging her at dialysis to get a fifth dose and she is reluctant to get the fifth dose since there is a newer one coming out in September or October that might be more important since Pfizer is coming out with one for the new variant. She says she is afraid to get one now since she would like to be able to get that one when it comes out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had well check on October 27, 2006 at 3:30 p.m. After being examined by MD the nurse gave him a DTaP vaccine. After receiving the vaccine the nurse and I (his mother) chatted for about 3 to 5 minutes. Patient began to get nausea but didn't say anything. He got up to leave and we walked a little ways when he began falling on me. I yelled for someone to help and the nurse ran over and helped catch him and lay him down. Patient seemed to have no color in his face. His lips were completely white. The doctor came out and began checking his pulse and the nurse was checking his blood pressure. His blood pressure had dropped to about 50 over something. I got cold paper towels and we began rubbing his face and neck with them. He began coming around. After a few minutes we walked him back into a room. He was given a sip of an energy drink, and he threw up. Just as the doctor and nurse left the room everything went black again, and they came back in. He was given a little more energy drink which stayed down. After a few minutes later his blood pressure began to come up. We were allowed to leave around 5:30 p.m. Patient was weak all weekend. He hardly set up. He had some soreness and redness as with most vaccines. (The doctor made reference to patient's passing out as thought it was from fright or because he had not eaten. He said he wasn't that worried about an injection. He had eaten breakfast, lunch and snacked in home living class. The time of injection was about 4:00 p.m.)
the first one was painful; did not shake the pre-filled syringe prior to administering with the first shot / the suspension was not uniform and hazy white; with the first shot / the suspension was not uniform and hazy white; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received HAB (Twinrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix adult. On an unknown date, unknown after receiving Twinrix adult, the patient experienced injection site pain, inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Twinrix adult.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported receiving two Twinrix vaccines and the first one was painful and the second one was not. The patient stated the nurse did not shake the pre-filled syringe prior to administering with the first shot, and that the suspension was not uniform and hazy white. The reporter did not consent to follow-up.
Lobar pneumonia; blood culture positive for H influenza type B; admitted to hospital p/rx by pediatrician w/Amoxicillin & APAP; appetite & activity dec; fever of up to 40C for 4 days; devel rhinorrhea, productive cough, & abdominal pain;
Previous Covid + physician with documented antibodies Symptoms started 17 hours post vaccine Fever x 36 hours Chills Rigors Malaise Myalgia Mild diarrhea, anorexia,
No adverse effects noted after vaccination.  Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed  SPO2 was 41%, pulseless with no cardiac sounds upon auscultation.  CPR and pulse was regained and patient was breathing.  Patient sent to Hospital ER  were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a adult male patient who received BEXSERO. On 14th August 2016, the patient received the 1st dose of BEXSERO. On an unknown date, several weeks after receiving BEXSERO, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. The reporter considered the Guillain Barre syndrome to be probably related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 18 years. The patient never received the second dose of BEXSERO. The patient became sick within a few weeks after the first dose. The Guillain Barre syndrome was confirmed with a lumbar puncture and the patient required eyelid surgery.
02Nov90 pt vax w/ hepta B; 09Nov90 exp itching, + on 10Nov90 exp rash dx as erythema multiforme.
Pt was seen on 9/9/00 with symptoms of swelling of left arm from top of arm to elbow. Injection site is pale and markedly swollen. Erythema also at injection site. Some erythema over scapula. Full range of motion. Afebrile.
Information has been received from a medical assistant referring to three patients of unknown age and gender. On unknown dates of 2015 the patients was vaccinated with a dose of PNEUMOVAX 23, (injection, lot # J013345, expiration date 11-JAN-2015, dose, route and strength were not provided). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected as the reporter didn't want to be contact.
230PM pt awakened from nap screaming-unable to console called clinic told to call MD; called MD told to inc APAP dose & bring pt in if sx got worse; 530PM settled down-ate p/fitful periods of crying, t99.6;
pain in the intestines; fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN and PYREXIA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B4A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 02-Apr-2021, the patient experienced GASTROINTESTINAL PAIN and PYREXIA. At the time of the report, GASTROINTESTINAL PAIN and PYREXIA outcome was unknown.
7 hrs after vaccine (~ 11 pm) I started to have body aches and then chills.  It got worse after a few hours and I woke up with a 103+F degree fever that lasted a few more hours despite taking ibuprofen, acetaminophen and applying ice packs.  Eventually by 4-6-21 at 5 am I was able to sleep. Today I woke up with no fever but just exhausted.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Passed out for less than a minute-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient passed out less than 10 minutes after receiving Moderna vaccine. stated he felt fine after initially receiving his vaccine but felt dizzy while using the rest room.While having a seat in the immunization area, the patient passed out for less than a minute. 911 was called right away. was monitored by his immunizer, & myself and remainded concious as we awaitied the arrival of the EMT's. Patient was able to walk out but is unknown if with Emts
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Guillain barre syndrome (previously had experienced when she was 19 and 40 years old). Patient was with a group of 14 whom all tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-SEP-2021, patient experienced sore throat. On 06-OCT-2021, she lost her taste and smell and received the regeneron monoclonal antibody (IV treatment). On an unspecified date, she tested positive for covid-19 infection (coded to suspected covid-19 infection) and also experienced suspected clinical vaccination failure but was not hospitalised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196465.; Sender's Comments: V0: 20211015230-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211015230-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Swollen lymph nodes (happened with all 3 doses, first dose was most severe, completed vsafe survey on it but did not get a call like this time) congestion, mucous buildup
Information has been received from a health care professional concerning a 66 year old white male with no known allergies who on 1/8/02 was vaccinated in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy included Manair, albuterol, Advair, and Flovent. On 1/10/02 (previously reported as 1/9/02) the pt developed a red, swollen, hot and painful left arm from two inches above the wrist to two inches below the armpit. Unspecified medical attention was sought. Additional info has been requested.
Patient's left arm went numb for about an hour following vaccination. pt was given Benadryl. after an hour feeling (along with pins and needles sensation) came back
Injection was given 3/12/02 around noon. By 4 pm, I had such rash , I looked sunburned and was feeling extra tired. At 2:30 am on 3/13/02 I woke up, hurting in all my joints and it hurt to breathe, as my lungs felt like I had ingested drain cleaner. By morning, I had a high fever and even my skin hurt. By 3/15/04, I was sicker, my throate was broken out mud raw, had a rash on my upper body/ legs, and persistent fever >100 even with Tylenol. That fever lasted 6 days. Off wrk 3/13/02-3/24/02. Then Diagnosed with asthma in December. Not without adverse chronic complications.
6 1/2 x 3 cm area of raised erythema to left upper arm.
Moderna monovalent for 12+ that was given to a four year old for a second primary dose.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.).    No concomitant medication was reported. No treatment information was provided.
since I was vaccinated,haven't had a single further outbreak of herpes, even when by all rights I should have had an outbreak; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (since I was vaccinated,haven't had a single further outbreak of herpes, even when by all rights I should have had an outbreak) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex NOS (Patient had Herpes 2 virus in his system, since very long time. He usually had outbreaks, when he ran down and overly tired).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 THERAPEUTIC RESPONSE UNEXPECTED (since I was vaccinated,haven't had a single further outbreak of herpes, even when by all rights I should have had an outbreak). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (since I was vaccinated,haven't had a single further outbreak of herpes, even when by all rights I should have had an outbreak) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
pt recv vax 29OCT97 & 31OCT97 pt devel chickenpox & a fever;arms, neck, torso & scalp were covered w/chickenpox;5NOV97 pt exp swollen lips & hands;exp poss angioedema & urticaria;
osteomyelitis; foot infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 85 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "dementia", start date: 2015 (unspecified if ongoing); "cognitive age related impairment", start date: 2017 (unspecified if ongoing); "subdural hematoma" (unspecified if ongoing); "horrible twisted feet/ bunions and are torched to the side" (unspecified if ongoing); "foot infection" (unspecified if ongoing). Concomitant medication(s) included: PREDNISOLONE taken for localised infection; ARICEPT taken for dementia Alzheimer's type, start date: 2021. Vaccination history included: Bnt162b2 (dose 1), administration date: Mar2021, when the patient was 85 years old, for COVID-19 immunization, reaction(s): "Alzheimer's disease"; Bnt162b2 (dose 2), administration date: Apr2021, when the patient was 85 years old, for COVID-19 immunization, reaction(s): "she had fecal incontinence", "was unstable on her feet", "had a loss of appetite", "fell", "lethargic", "leptin lymphocytic meningitis", "mother would scream when you touched her", "UTI", "West Nile Virus and had encephalitis from it". The following information was reported: LOCALISED INFECTION (medically significant) with onset Jan2022, outcome "unknown", described as "foot infection"; OSTEOMYELITIS (medically significant), outcome "unknown", described as "osteomyelitis". Therapeutic measures were taken as a result of localised infection and osteomyelitis: the patient was prescribed clindamycin for foot infection. Foot Infection: reporter's parents used to have help that would come to their house after her mother had West Nile but they no longer have that help so the caller has to rely on report from her father. She calls multiple times a day and he didn't say anything about her mother's foot. Her mother in general has horrible twisted feet, they have bunions and are torched to the side, they look horrible. She has areas that protrude and any shoes that she wears no matter how soft and stretchy they are cause rubbing. She believes it is her mother's left foot and on the small toe over that toe joint. It began a concern when the caller first heard about it which she thinks was around the week of 17Jan2022 and then her mom saw the doctor on 20Jan2022. The caller's dad didn't tell her about her mother's foot until either 17Jan2022 or 18Jan2022 and then the caller took her to the doctor on 20Jan2022. The doctor started the clindamycin because she concerned about it being over the joint and she was worried that they could be looking at osteomyelitis at some point. It looks much better according to her dad.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: The events localized infection and osteomyelitis are considered as intercurrent conditions and unrelated  to product bnt162b2 (BNT162B2). ,Linked Report(s) : US-PFIZER INC-202200133054 same patient/drug/different event/dose
Sore arm 3 days, Nauseous,  vertigo, brain fog,  Aches- all for 3 days.  Later a hacking cough
7 days following 1st vaccine started with aches and pains in muscles and joints. At 9 days following 1st vaccine started having numbness/tingling and pins and needles in tips of toes and fingers. Over the next week this progressed into my feet and hands and is now up to my ankles and wrists. The aches and pains slowly got better, but did not resolve and worsened following second vaccine 2/4/21
Two days after COVID vaccination I began feeling nauseous, with feelings of panic attacks and impending doom., brain fog and physical weakness. It is now 8 days after my shot and the symptoms have not eased. I have never experienced anything like this   feeling.
Arthralgia & Fever Narrative: chills, fatigue, body aches. still has fatigue but able to work.
KINRIX was given to a 4 mo. old child as part of her routine 4 month vaccines. It was chosen because it contained Dtap and IPV - and not Hep B. It was realized a few days later that KINRIX is routinely used for 4-6 year old - kindergarten shots. I call GlaxoSmithKline and talked to pharmacist. She told me that KINRIX has the same antigen dose and that it was a valid dose of Dtap and IPV for this patient. Thus the patient is immunized as stated. There is no treatment.