chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woman received MENQUADFI while pregnant with no adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] in context of woman received menquadfi while pregnant with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE at 26 weeks of pregnancy, during third pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  The date of last menstrual period was reported as 22-Mar-2022. The estimated due date is 10-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancies.  On 19-Sep-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: unknown) Strength: standard at dose of 0.5ml total (lot number: U7447AC and expiry date: 20-Sep-2024) via intramuscular route in the left deltoid for Immunization and woman received menquadfi while pregnant with no adverse event (exposure during pregnancy) (latency: same day).  It was reported, she would like to know if she should be put on the registry? The patient was transferred to them for prenatal care. She received the vaccine at another clinic location.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown. Additionally, at time of reporting, the pregnancy is still ongoing.
Patient given wrong dose of flu.  0.5 ml instead of 0.25 ml.  Called CDC for instructions, give 2nd dose, 4 wks age appropriate dose.
She had swollen lymph nodes under her arm pit; I had like node under my armpit hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (not ongoing), notes: Not right now but I had it in 2017 at age 42.; "Blood pressure high" (unspecified if ongoing); "Cough" (unspecified if ongoing). Concomitant medication(s) included: ATACAND taken for hypertension; CELEXA [CELECOXIB]; TESSALON PERLE; LETROZOLE taken for breast cancer.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "She had swollen lymph nodes under her arm pit"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "I had like node under my armpit hurting". The events "she had swollen lymph nodes under her arm pit" and "i had like node under my armpit hurting" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, axillary pain.  Additional information: the reported stated from the first vaccine she had like node under her armpit hurting, to the first dose. It was painful under the armpits like lymph nodes under the armpits. She took Motrin and Tylenol for swollen lymph node.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2017, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Later in 2017, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache; Lymph swollen; Excess sweating; She could not put her pants on after first dose because she was just sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Jan2021 12:00 (Lot number: EL0142) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stress" (unspecified if ongoing); "sulfa" (unspecified if ongoing), notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid; "Penicillin" (unspecified if ongoing), notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Intolerant to certain medications", notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid; Dilaudid, reaction(s): "Intolerant to certain medications", notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid. Vaccination history included: Hpv vaccine, for Immunisation; Flu vaccine, for Immunisation, reaction(s): "headache ", "felt ill". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jan2021 08:00, outcome "not recovered", described as "Lymph swollen"; HYPERHIDROSIS (non-serious) with onset 09Jan2021 08:00, outcome "not recovered", described as "Excess sweating  "; HEADACHE (non-serious) with onset 09Jan2021 18:00, outcome "recovering", described as "Headache "; PAIN (non-serious) with onset 09Jan2021, outcome "recovering", described as "She could not put her pants on after first dose because she was just sore".  Additional information: Patient reported she is on birth control. Soreness started around 18:00 -19:00. Events did not result to emergency room and physician office visit  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse's aide refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient reported immunization injection occurred to high in the arm - feels like when into the joint space or close to the tendon. Experienced pain during immunization and has continued for the past 3 days, although less than on day of immunization. Shooting pain that goes into shoulder area and joint of left arm. Some weakness with grabbing objects noted evening of 5/21/2023 but not noticeable at time of report 5/22/2023. Additionally reports shooting pain from elbow to pinky in left arm on the evening of 5/21/2023 but again not noticeable at time of report on 5/22/2023.
Redness, swelling from injection site to elbow. Reported increased confusion/lethargy.
Information has been received from a physician concerning a 12-year-old female (previously reported as a male) with no pertinent medical history or allergies who on 27-AUG-2007 at 10:30 am was vaccinated subcutaneous in the left arm with her second dose of varicella virus vaccine live (Oka/Merck) (lot # 657944/1003U). Concomitant vaccine administered on 27-AUG-2007 at 10:30 am intramuscularly, in the left arm, included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot # U2370AA). There were no illnesses at the time of vaccination. On 04-SEP-2007 (also reported as 5 days after vaccination) the patient developed a "full outbreak varicella with over 100 lesions on her body". The patient was sent to the hospital with no other adverse experiences. On an unspecified date the patient recovered. Additional information has been requested.
Profuse vomiting and diarrhea, syncope, chills, seizures.  ER visit received 3 bags of lactated ringers, 12 mg of IV zofran, 12.5 mg of IV phenergan, 2 CT scans.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient, without drug reaction or allergies and no pertinent medical history or current conditions reported. On 15-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, lot # K008881, expiration date 20-SEP-2015, subcutaneous in the right arm (deltoid). Concomitant therapy was not reported. On 17-OCT-2014, the patient who received the ZOSTAVAX experienced redness, swelling and heat at her injection site. The patient was unaware that she had any injection site reaction, but someone else noticed some redness on her arm. The patient told the pharmacist that the person asked her about the redness on her arm, and then she felt the injection site and noticed that it was swollen and warm. The patient did not sought any medical attention for the injection-site symptoms, so the seriousness criteria questions were not asked. No treatment was given for the adverse events. Varicella Zoster Virus Identification Program (VZVIP) offered to the pharmacist because the patient received ZOSTAVAX "two days ago," thought the patient was not exhibiting a rash. VZVIP packet was accepted by the pharmacist, and VZVIP packet would be faxed to the pharmacist. The outcome of a patient who received ZOSTAVAX experienced redness, swelling and heat at her injection site was unknown. Additional information has been requested.
After administration of both vaccines patient exhaled loudly and went unresponsive. Pale. Safely transferred from chair to floor. Remained unresponsive despite tactile and verbal stimulation. EPIPEN injected 0.3 mg left thigh at 1024. Responsive immediately after EPIPEN, however unsure of surroundings. Transferred to emergency room.
Patient received vaccine on 1/13 (unknown facility) and began developing rash, swelling of eyes, and itching 3 days later (1/16). Patient went to Emergency Room on 1/17 for treatment - - received injection of Decadron and was instructed to use Benadryl. Per documentation the rash had improved the next day, but then worsened and he returned to ER on 1/19 - - he was directed to increase his loratadine dose and was started on hydroxyzine and a course of prednisone.  He was seen in our office today (1/21) as rash continues - - hydroxyzine increased, directed to not taper down prednisone, and a consult to dermatology was arranged.
After receiving the 2nd dose of the COVID vaccine on Sunday  morning, Feb. 14, my left underarm began to hurt in the evening.  I was tired that day but no other symptoms.  Through the night I had chills and sweats.  In the morning there was a large lump in my left underarm.  Swollen lymph glands about 3 inches wide and 2 inches deep.  This has continued through Monday and now Tuesday morning it is the same.  No sign of it growing larger or smaller.
left arm hurt where shot was administered, shivers, cold, weak, headache, fever 98.5, don't feel well, in bed.  Moderna, 1st dose:3/23/21, second dose:4/20/21, booster shot: 11/20/21.
Swollen painful Glands in underarm of right arm, can barely stand to move arm, or raise it up.
Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient developed pain, fever, nausea and chills.   On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection.  On an unknown date, the patient had mild diarrhea and fatigue.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Information has been received from a certificated medical assistant concerning a 35 year old female with no known drug reactions/allergies who had a negative titer for mumps and was vaccinated with a dose of MMR II (lot# 664655/0640Y) on 14-AUG-2009 and on 21-SEP-2009. It was not known if the patient received it as a child. The titer was repeated on 30-NOV-2009 and was negative for mumps. The patient's negative titer of mumps persisted. The patient sought unspecified medical attention. Additional information has been requested.
99 degree temperature through out 12 hour period Bad headache through out 24 hour period Brief period of  shivering Lightheadedness throughout 12 hour period Treated all with Advil
kind of unconscious; his heart is barely working; water in the lungs; he got so sick; This is a spontaneous report from a contactable physician.   A male patient of (33 or 34 years old) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 1, single and via intramuscular on an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 2, single for COVID-19 immunization. On an unspecified date in 2021 patient experienced kind of unconscious, his heart was barely working, water in the lungs and he got so sick. It was reported that after the patient received the third dose he got so sick he was hospitalized. The patient had been in the hospital for 6-7 days. What does Pfizer recommend. Had anything happened with the safety of the Pfizer covid booster vaccine. Had one had a severe reaction like this. was there an antidote. The caller understood the doctors in Australia were giving good care to the patient as the patient was in Australia. was there someone in Australia from Pfizer who could help the caller's sister. Caller was asking what Pfizer recommends for anaphylactic shock. Seriousness of the kind of unconscious, his heart was barely working was hospitalization and medically significant and events water in the lungs, he got so sick was medically significant. It was reported that as soon as the patient had the third dose he slept and then they took him to the emergency room. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the causal association between the events loss of consciousness, heart failure, pleural effusion and illness with the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once detailed information is 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.
The first thing I saw was a very black bruise - it was at the site of the injection. I can still see the residue today from it. It is three or four inches wide and an inch and a half or two inches long - right now I can still see that. It was startling dark at the time - extreme bruise. I have not had that experience with injections in the past. A day or so later, after the bruise showed up, I had swelling - 3x3 inches below that injection bruise - it was swollen and had almost like a rash on it. It felt like it was warm as if it was a bee sting or spider bite. It was puffy and large and I couldn't sleep on it. It didn't go down for 5 days to a week. Even now, it's not real dark, but I can still see where it was. A person could look and see it. I did call the hospital and they told me to report it. Another thing that has happened, last week, probably on Wednesday, I called a dentist because I had so much swelling underneath my left jaw. I thought a tooth was infected. The dentist could not locate anything that is wrong but I do have crowns. She suggested that I have me ear and throat get checked out. I went to an Urgent Care and they found nothing. Underneath my jaw, I still have a little tenderness and that it still hadn't gone away. I called my doctor - and they said it could be related to vaccine but we don't know. It seems today like it's a little better today. It's the same side of body as shot - it's the lymph glands under the left jaw. They are still somewhat painful - not as painful as last week. I got a flu shot in October, 2021 - but I don't know the exact date. I got it injected in the left arm. Pharmacy
Oct 30, 2021...approximately 2hrs after receiving the Moderna booster, became diaphoretic and nauseous, heart rate elevated to 205 bpm on Applewatch.  Pulse was too rapid and thready to palpate.  911 was called. Heart rate was 228 on  paramedics O2 sat monitor.  ECG reveled Supraventricular tachycardia. 12 mg Adenosine administered, heart rate decreased to low 100s.   Transported to closest ED.  No prior cardiac abnormalities.  Heart rate has remained in the upper 90's/low 100s since the event.
Suspect vaccination Failure; Nowhe is in the hospital with a very bad case / Had them in mouth, ears, throat; In hospital very ill; Unable to eat; Difficult to swallow; Difficult to / breath; Side of face and head swollen big time; Side of face and head swollen big time; Excruciating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included AD26 COV2 S VACCINE (COVID-19 VACCINE JOHNSON & JOHNSON) for prophylaxis.   The patient's past medical history included shingles (5 years ago from the date of reporting lasted about a month).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE JOHNSON & JOHNSON. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), unwell (serious criteria hospitalization), unable to eat (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), facial swelling (serious criteria hospitalization), swelling (serious criteria hospitalization) and pain (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. On an unknown date, the patient received the Johnson and Johnson shot. After receiving Shingles shot and Johnson and Johnson shot, the patient had shingles in his mouth, ears and throat. The patient was in the hospital with a very bad case. The patient was unable to eat, had difficulty to swallow and breath. His side of face and head also swollen for big time. The patient was very ill and had excruciating pain. It was unknown if the reporter considered the shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to COVID-19 VACCINE JOHNSON & JOHNSON. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient received IM vaccination in left arm. About 6 hours after receiving vaccination, he experienced joint pain, fever, chills, and a rash extending to chest and elbow. The area was very painful and itchy. 7 days later, the rash and pain are gone, but the area is still itchy.
Received vaccine Thursday afternoon. Waited for a half hour after receiving the vaccine, as there is a history of anaphylaxis. On the drive home lips began to swell and the lips felt numb. Patient went home and took some Benadryl which seemed to help.  Friday 3/5  Patient woke and her arm was swollen at the injection site and was very painful. Patient also complained of a headache at that time. Later that same day, Patient developed a rash at the injection site and intense itching all over her body including her face. Patient went to the Medical Center ER. At ER the staff evaluated her and administered IV steroids and Benadryl and sent her home with instructions to return in worsens. Saturday Patient complained that her throat began swelling and so she went back to the ER. The  ER gave more IV steroids and Benadryl, a breathing treatment (nebulizer), and gave 2 doses of epinephrine. Due to Patient's continued symptoms and gradual worsening condition the medical provider at ER felt  it necessary for Patient to be admitted, however, due to the smaller size and limited resources at ER it was decided for Patient to be transported to Hospital. Patient has remained admitted at Hospital since then, and yesterday (Sunday) she required another dose of epinephrine due to tongue swelling.  Patient reports that she is being given IV Benadryl and steroids, and she will not be discharged today. Today Patient is also reporting a burning sensation with urination.
p/vax pt devel rash reportedly dx as granuloma annulare on extremities, trunk, back & face;rash was still present 3 years later;6 months p/vax pt devel Crohn's disease;