chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a MENACTRA vaccine at age 11 (08-Aug-2016), age 16 (24-Sep-2021) and MENQUADFI at age 18 (13Feb2023) with no reported adverse event; patient received a MENACTRA vaccine at age 11 (08-Aug-2016), age 16 (24-Sep-2021) and MENQUADFI at age 18 (13Feb2023) with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient and it was reported patient received a meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] at age 11 (08-aug-2016), age 16 (24-sep-2021) and Menquadfi at age 18 (13-feb-2023) with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2016, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (batch/lot number, expiry date, strength and route: not reported) in unknown administration site at age 11, on 24-Sep-2021 she received another dose of the same vaccine at age 16 both for immunization and Menquadfi at age 18 (13-feb-2023) with no reported adverse event (inappropriate schedule of product administration) (product administered to patient of inappropriate age) (unknown latency).  It was reported that MA states that they have a patient who was accidentally injected with MENQUADFI instead of a Meningococcal B vaccine. The MA asks if there is an issue with taking MENQUADFI so close together, what to expect, and how long they should wait until they give the Meningococcal B vaccine.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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.; Sender's Comments:  01491174:
Hospitalization: 12/22/2022 -  Presentation to the ED: weakness x few days, syncopal episode w/ bright red BM, hit back of head and forehead while on the toilet.  COVID + date: 12/22/22 Treatment: no treatment. patient "did not have any significant symptoms".  Discharge to: Home.  013M20A 3/1/2021 048A21A 3/29/2021
During summer of 2021 began feeling off. In December of 2021 began checking blood pressure and realizing it was running extremely high.
shingles; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 25Apr2021 at 12:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation, administered at the pharmacy or drug store. Medical history included diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of bnt162b2 in the left arm for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient developed shingles the day after the second dose (26Apr2021 at 12:00). The patient received treatment for the event which included anti-viral medication. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the event was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
pt recv vax 2JAN97 & was recriminated because prev recv fluogen that was recalled by FDA;3JAN97 pt reportedly did not feel well;4JAN97 c/o chills, nausea, vomiting, diarrhea, h/a;
Slight pain in left forearm and hand. Hand felt like I had squeezed a ball a thousand times in a row. Feeling lasted apx 15 minutes. No pain since.
at about 4 hours after vaccine I thought I was having a stroke. The right side of my face went numb and felt like it was drooping, my right arm went numb, my right leg and foot went numb. But I could still talk and make a smile face so I did not go to ER. Gradually both of my legs became very weak and then my hands became very weak. This lasted for over a week/ten days. By the first night I couldn't sleep because my brain could not seem to get into a deep sleep pattern, had body aches and sore arm but not dreadful, and by the next day had a fever which maxed at 101 degrees ( my normal is 97.2-97.4). Had a low grade fever for 10 days! Also by the 2nd day I had swollen glands in my right neck and armpit, and pain from my  right elbow to my neck. My usual level of unstable balance was MUCH worse for at least a week and my usual tinnitus was MUCH louder than usual for about 10 days! Night 3 I had a very bad episode of something like restless leg which also extended not just in my legs but also into my head! Very bizarre! By day 4 I was having episodes of near fainting, often. This lasted for about another week. All in all it was a dreadful experience, which I believe was related to issues with my already compromised nervous system due to the Parkinson's/MSA. I will NEVER have another one fetes vaccines or booster shots if those become available. I am quite frightened that the next vaccine could result in me actually having a stroke or other serious consequence.
It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown.  Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot.   No follow-up attempts are needed. No further information is expected.
FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Itchy skin started 10 days post moderna booster shot. No visible rash, when I scratch my skin becomes red and irritated.  Antihistamine has seemed to help.  It has been 3+ weeks of this itchyness.
Child presented to our office 3 days after vaccine administration with complaints of bilateral upper arm swelling, erythema, tenderness and pruritus. The erythema and swelling extended approx. 5 cm in diameter from injection sites of bilateral upper arms. Mom applied cool compresses with mild improvement. The child was instructed to give 12.5 mg BENADRYL tablet every 6-8 hours prn, ibuprofen 400mg for every 6-8 hours prn for pain, cool compresses three times daily, and hydrocortisone cream twice three times daily to affected areas.
Some vaccine leaked onto arm of patient when administered; Some vaccine leaked onto arm of patient when administered; This spontaneous case was reported by a nurse and describes the occurrence of   in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. Treatment information include HCP will administer a 2nd Dose in the opposite arm.
Patient reported at a well visit on 9/15/08 that she has had tingling and skin color change (pale) since her 2nd Gardasil - she also plays volleyball.
Vaccine was administered at 11:12 AM and at 11:14 AM the patient began to complain of "feeling funny" further identified as clammy skin, visible perspiration on his neck and forehead, dizziness, anxious, tingling in legs and arms. After applying two ice packs to the patient's neck and forehead, instructing him to take deep breaths, and him drinking 2 bottles of cold water (approximately 15 minutes), the patient reported feeling like normal. He waited in the observation area for an additional 15 minutes until 11:45 and was driven home by his wife with reports of feeling fine.
Patient complained of lightheadedness, slight vision loss, and feeling overheated. This lasted for maybe a few minutes; laying down on his back helped relieve the symptoms.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23. Other concomitant therapy included a dose of influenza virus vaccine (unspecified), an illegible therapy and budesonide (NASOCORT). On 17-FEB-2006, the patient experienced an injection site rash. Within 2 to 3 weeks (also reported as "a few days"), the patient recovered. The physician also reported on the patient's experienced with montelukast sodium (WAES # 0607USA00837). Additional information is not expected.
temperature excursion for fluzone QIV at a high temperature of 72.7F out of range for 7 weeks with no reported adverse event; Fluzone QIV administered post temperature excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 46 years old male patient and reporter reported temperature excursion for influenza quadrival A-B vaccine [Fluzone QIV] at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event and fluzone QIV administered post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Caller reported that influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml total (lot UT8055JA, expiry date- 30-JUN-2024) via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion being left out at room temperature at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event (product storage error) (unknown latency) and On 03-OCT-2023, fluzone qiv administered post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).    Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.; Sender's Comments:  US-SA-2023SA305541:01790050 US-SA-2023SA304864:01789997
On day #2 her white count fell significantly. She did get quite delirious and was up in her room, no longer requiring oxygen, though her sats were about 89%
Patient became dizzy and had a vasovagal response. His heart rate dropped between 40-50 and did not increase how EMS had expected. Patient began to vomit and was transported.
One week after the shot, my arm swell iin & around the vicinity of where the shot was given. itching occurred & spread each day. Symptoms still active on Marxh 17, 2021. Concerns about taking 2nd dose.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/01/2021.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A 82-year-old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)  at single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. The patient experienced pneumonia on Dec2017 with outcome of recovering. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Arthritis; Upset stomach; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy). On 23-Mar-2021, the patient experienced ARTHRITIS (Arthritis). On 16-Mar-2021, ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy) had resolved. At the time of the report, ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications information were not provided.  Patient called in and received her 1st dose of the Moderna COVID-19 vaccine on 15-Mar-2021. The following day,16-Mar-2021 she developed an upset stomach and felt dizzy. The event start date and stop date of the dizziness subsided, 2 hours later it returned. She decided to lay down and went to slept for about 3 hours. Once she did that she had no other signs of dizziness was on 16-MAR-2021. She was calling to report the symptoms and inquire if she will experience them again. She also inquired about taking Celebrex for her arthritis if it will have any affect with the vaccine.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-JUN-2021 contains Non significant or no new information.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn(s) Disease" (unspecified if ongoing), notes: Crohn(s) Disease. Concomitant medication(s) included: JUNEL, start date: 20Nov2020; STELARA, start date: 10Apr2020. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Anti viral details.  Patient received Other medication in 2 weeks Anti viral details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day after vaccine patient reported headache, trouble breathing, numbness in hands and feet, and high fever. Patient states she does have COPD and it felt more of an exacerbation, but she states her COPD has been controlled for a while and has not had trouble breathing like this in a long time. Patient has recovered from all symptoms besides numbness in hands. Patient did not seek treatment becuase "she didn't want to".
Initial day not problematic.   On the 8th day I developed a 2 inch oval spot of redness at the injection site, plus heat and itching , swellling and soreness. This all dissapated after 4 more days.
large circular skin rash with itching and blisters where injected; redness and hard as a brick to the touch; elevated temperature; smaller oblong rash appeared beside the large circular rash
Pt stated his throat felt tight. Approximately 30 minutes after giving HPV (GARDASIL) and MENVEO vaccines. Vital signs were stable BENADRYL 50mg was given. Pt fully recovered.
Tdap vaccine given on 11/4/14. Pt. now with redness, swelling and upper arm hot to touch.
3 hours after receiving vaccine pt started having extreme "ticks". He stared out ticking for an hour and half straight! Then he would rest 3-4 min and start again. On the 2nd day we reported it to the md because it continued. We were able to send her videos and she proceeded to pass to other md's. His ticks were extreme for 3 days and then slowly started to fade. Symptoms lasted a total of 13 days.
Pt vomited 3 hours after injections and again at 3 1/2 hours.
Area around injection sites of Engerix-B are hard and have small circles when medication was injected.
Redness noted L arm. Warm to touch. Pt c/o of itching.
11/14/2021 PM Arm Sore from injection  11/15/2021 7Am-3pm increased Arm soreness, increased difficulty to move 4pm- bruising and redness to the area 11/17/2021 Red splotches shoulder, neck, chest
Had Adacel 10/22 - on 10/27 developed pain and redness around vaccine site - now with 6cm no induration -
Exactly 7 hours after administration of the vaccine (4pm) I developed the following symptoms; Fever which reached 101 degrees, painful headache, fatigue and a slightly sore arm. The next morning 7:30am I was extremely fatigued and had a sensitivity to light and had a headache and was slightly nauseous. I took my morning medication and ate a small amount and returned to bed. My temperature was 100 degrees and continue to reduce through out the day I took another nap in the afternoon but felt better in the evening with a small amount of fatigue. On Sunday morning I woke up with a rash on my left arm and my arm was extremely hot but otherwise I felt fine. On Monday morning the rash on my arm had spread and continued to be hot and sensitive to the touch. I did not contact my doctor and did not feel the need to seek medical assistance.
Received second dose of Moderna vaccine in left arm 19 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of Moderna vaccine in left arm 19 days after first dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of Moderna vaccine in left arm 19 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of Moderna vaccine in left arm 19 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided No concomitant medications were provided
Patient had an episode of fainting about 10 mins after vaccine administration. after regaining consciousness he had rolling eyes and seizure and 2nd episode of fainting. The fainting episodes were for  few seconds (30-45 sec). Patients feet were elevated and paramedics were called. while waiting for the paramedics we had patient drink  water and orange juice  as he was on diet and had taken only 300 calories per patient. Used cold compress on his face and neck, patient was comprehending well afterwards. paramedics arrived and examined the patients vital and asked if he would like to go to the hospital even though patient seemed fine. Patient denied going to the hospital and paramedics left afterwards. patient waited for 30 minutes afterwards and then left. we called the patient later and he was doing fine.
This infant was unresponsive within less than 2 minutes, followed by tonic clonic seizures, vomiting. Oxygen was applied, 911 called to the ER.