chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose in april, unaware there was a 2nd; shingles on back and chest; is painful; Lung cancer; This case was reported by a consumer via call center representative and described the occurrence of lung cancer in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lung cancer (diagnosed with lung cancer 1 month ago).   In April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2022, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lung cancer (serious criteria GSK medically significant). On 15th November 2022, the patient experienced shingles and pain. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir (Valacyclovir), acyclovir and trolamine salicylate (Aspercreme). On an unknown date, the outcome of the lung cancer, shingles and pain were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the lung cancer, shingles and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on the left arm. The patient developed shingles. The patient had not one ever told him there was a second Shingrix vaccine (Inappropriate Schedule of Vaccine).  The patient had shingles on back and chest that was painful.  The healthcare professional started patient with Valacyclovir tabs and Acyclovir Ointment about 4 days ago.  The pharmacist gave him Aspercreme spray to use topically.  The pharmacist told that the patient could get shingles from the vaccine.  Informed caller that this was a non-live vaccine.  The pharmacist reported the patient cannot start chemotherapy until shingles would cleared up.  The reporter consented to follow up.  The reporter gave permission for GSK to contact the physician and the pharmacy healthcare professional info redacted. Between 6 and 8 months, the patient experienced shingles and pain.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
A report has been received from a Health Professional. The report concerns a 7 years old female patient. No information regarding relevant medical history, concomitant disease was provided. Concomitant medication include cetirizine hydrochloride. On 03-Nov-2012, patient received nasal FLUMIST. The patient test was positive for influenza A on 16-Dec-2012. Patient was treated with TAMIFLU. Action taken with FLUMIST was Not applicable. The outcome of the event of tested positive for influenza A was recovered. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 24-Jan-2013 from Health Professional: New reporter added as Health Professional. Event outcome was updated from unknown to recovered. Concomitant drug was added. Patient details added. Reporter's details updated. County of administration was added. Corrected report 29-Jan-2013: Manufacturer name added. Associated case ID added. Lab details added. Corrected report on 01-Mar-2013: event coding changed, narrative updated.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received vaccine FLUZONE HIGH DOSE lot number not reported via unknown route in the left deltoid (dose and expiry date not reported) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose and inappropriate age at vaccine administration. No symptoms were reported. 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 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. Documents held by sender: none
It was bleeding; It left a big bruise on her; She is starting to get red spots; a red rash and streaks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MWA) for COVID-19 vaccination.     Concurrent medical conditions included Gastroparesis and Blood pressure high.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks). At the time of the report, INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Prior to shot pt was anxious and expressing his anxiety towards needles.  He appeared a little sweaty and anxious but able to respond to me as I was talking to him to keep him distracted as the pharmacy student was administering the vaccine.  The shot was administered and I was acknowledging it was over patient's head leaned back and he shut his eyes but then his body kind of jerked almost like he was awaking abruptly from sleep,  but then he would go back out of conscious-this happened repeatedly.  According to the student the patient had described it as feeling like he was on a roller coaster and that's definitely the way his body was moving.  This didn't persist longer than a minute but close to. Following patient very pale and sweaty but was able to drink fluids and responsive-we  applied the ice pack and he physically started to come around. Patient refused an ambulance but did agree to have a family member pick  him up.
Reaction from second covid vaccination; worst reaction being diarrhea, which was around 2100 on 1/22/21
Body aches; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Lot number: 3707080) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "Chills". No follow-up attempts are possible. No further information is expected.
Onset 9/20/23 with numbness in 2 fingers, followed over next 5 days with lower leg & perioral numbness progressing to ascending paralysis of all 4 extremities and left facial paralysis. Diagnosis of Guillain-Barré Syndrome made on 9/25/23. Treated with IVIG 9/25-29/23. Currently recovering in rehabilitation facility
possible Shingles; burning; pins and needles feeling; very sensitive skin; This case was reported by a consumer via call center representative and described the occurrence of possible shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles, burning sensation, pins and needles and sensitive skin. On an unknown date, the outcome of the shingles, burning sensation, pins and needles and sensitive skin were unknown.   It was unknown if the reporter considered the shingles, burning sensation, pins and needles and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix in mid December 2019 and experienced burning, pins and needles feeling, very sensitive skin. The patient ask question can you get shingles even if you've had the 1st dose 4 months ago? The patient was experiencing symptoms of Shingles after first dose of the Shingrix vaccine.
Arm was sore immediately, became extremely sore by 6AM the next morning Muscle aches, general feeling of unwellness, malaise/fatigue started at 6AM the next morning Minor headache at 6AM the next morning
I had a mild case of Covid. I had a 2 days of fever, body aches and cold symptoms. After taking Paxlovid, I was tired and I lost my sense of smell 100% and taste probably 70%.  I felt better after a few days, but didn't regain smell and taste for about 3-4 weeks.
Patient became dizzy a few seconds after vaccine was administered, and experienced two episodes of syncope. She continued to feel dizziness and abdominal pain, and called 911.
Achy joints, stabbing pains in joints, ankles, knees, low back, hips, shoulders.  Slight headache, dry mouth, dry and bloody nose.  Chills but did not register an elevated temperature.
The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; had the COVID vaccine her third COVID shot; had the COVID vaccine her third COVID shot; This is a spontaneous report from a contactable consumer (reported for wife). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date as single dose for COVID-19 immunization. It was reported that, the wife of reporter "had the COVID vaccine her third COVID shot" (yesterday) and "the site where shot is the red and swollen and tender" on an unspecified date. It was reported that, the patient took the third shot, she took the booster. The reporter was asking if anything could be put on her arm to help with the swelling, and the redness and the tenderness. Reporter was informed about the role of Pfizer Drug Safety. Further probing could not be done as the reporter hung up the call abruptly. Hence limited information available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Starting in the afternoon the date of the vaccine, patient says she had redness, itching, described the area as hard, and it was difficult to raise her arm.
Dizzy; Nausea; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), the patient's wife.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 10:00 (Batch/Lot number: unknown) at the age of 81 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "(Diabetes) Blood sugar" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Dizzy"; NAUSEA (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Vomiting". Therapeutic measures were not taken as a result of dizziness, nausea, vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Tuesday, Feb. 8th 2022 at approximately 13:00. Patient and her mother Attended the local vaccination clinic. I was the Clinic Manager of this clinic. Pt and mother both received vaccination and while they were sitting in observation, Staff RN informed me that Pt. is 17 years old, but received a 1st dose of Moderna Vaccine. According to CDC Directives and Medical Teams policy, patients under 18 should only receive Pfizer brand COVID-19 Vaccination. I informed the patient and her mother of this mistake. The mother stated that they were also aware of the CDC directive, but wanted to receive Moderna due to advice from a Physician Friend. I informed them that we can not give pt. a second dose of Moderna until she was 18 years old, and they both understood. I informed them that I would follow up with them later via phone after, I receive counsel from Program Manager. Both patients finished their observation period and departed from the clinic site.
An avid crossword puzzle worker for 50 yrs, suddenly doesn't work them anymore. Short-term memory is worse than before.  Left side of the mouth droops.  Weight loss. Confused. Complained about leg weakness, legs and knees hurt, hard to walk, being tired, drooling, dry mouth, mind not right.
petechial rash with bilateral lower extremity edema, abdominal pain, back pain, fatigue.
Patient received the Covid-19 vaccine. She reports symptoms of Other: burning and warmth in chest and throat.. I have observed slight hives on neck. Treatment/intervention  Vaccination 0845 PO 25 mg benadryl 0917  Vital signs: 0914 - 124/82 HR 63, POX 97 0936 - 138/86 HR 61, POX 97 and 132/82, HR 63, POX 96  0936 patient states symptoms subsiding 0945 patient reports sx resolved and was discharged home.
101.1° fever for approximately 18 hrs. Worst headache of my life. Extreme muscle pain and body aches, especially in hips. Drenched in sweat overnight. Dizziness. Chills. Palpitations for a short time. Symptoms have since subsided.
LIPS SWELLING AND NUMBNESS, ARM PAIN (PERSISTING 2 WEEKS AFTER ADMINISTRATION) ON RIGHT ARM (FLU)
Case was vaccinated and boosted by 10/22/21, then hospitalized for Covid on 12/31/21. Admitted for shortness of breath and hypoxia. Treated with dexamethosone, and discharged home.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 39 years old female patient who experienced chest tightness, right side of her face went numb and chest pain, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18 Oct 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE lot number not reported. On an unknown date, five minutes post vaccination patient developed a non-serious chest tightness, right side of her face went numb, chest pain. (Other relevant tests included no lab data.) Final diagnosis was chest pain, right side of her face went numb and chest tightness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for right side of her face went numb and for chest pain and not recovered for chest tightness.
Vaccine Administration error. Patient was under age of authorized EUA age limit. Parents were contacted of the minor to explain the error. As per our health officer, the recommended guidance is to vaccinate the individual for their second dose in 4 weeks.
Rash - erythematous maculopapular on both cheeks and all over trunk and extremities.  Swollen-nontender (R) thigh.
PATIENT ADMINISTERED WRONG DOSE OF 1ML INSTEAD OF 0.5ML. NO S/SX OF ADVERSE REACTION NOTED.
Swollen lymph nodes under the arm in the arm pit area.  Very painful and swollen Swollen lymph node in the neck right above the clavicle.  Very painful and swollen Started about around 24-27 hours after the injection Ice bags on both sites at least 2 times per day since symptoms started Took to iuphopens  to help with pain/swelling
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: ek5730), on 09Jan2021 as dose 2, single (Lot number: e11283), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 301356a), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; XYZAL; MONTELUKAST; BREO ELLIPTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive; (22Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks: Losartan, Xyzal, Montelukast and Breo. Patient had no known allergies. Patient received Paxlovid (anti-viral) from 12Jul2022 to 17Jul2022 for COVID-19 treatment. Patient reported positive abbot home test 12Jul2022 after 5 days Paxlovid resolution symptoms followed return of symptoms on 22Jul2022 and positive test. Symptoms mild runny nose no fever.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
The next day after the patient received her flu shot the patient experienced the following symptoms: redness to whole upper arm, swelling, hard, fever, and hot to the touch. Patient went to the doctor and was prescribed an antibiotic and medrol dosepack.
Patient fainted (lost consciousness) about a minute after receiving the vaccine and was helped to a chair. She did not fall. After about 30 seconds she regained consciousness. She drank a bottle of water and after resting in the chair for about 15 minutes and not complaining of any discomfort, she left. I called and checked on her 2 hours later and she reported no discomfort.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unkonwn). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Her motor skills were affected per days; She could not remember; It affected her brain; Woke up holding to the walls to be able walk; for 2 days she could not put a telephone number, she could read that the number was 3 but she pushed 8 instead; Her fricking brain didn't work; Is terrified of getting the second dose/it's been more than 36 days since she got the first dose and still hasn't got the second; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Her motor skills were affected per days), MEMORY IMPAIRMENT (She could not remember), CEREBRAL DISORDER (It affected her brain), GAIT DISTURBANCE (Woke up holding to the walls to be able walk) and FEELING ABNORMAL (for 2 days she could not put a telephone number, she could read that the number was 3 but she pushed 8 instead) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Her motor skills were affected per days), MEMORY IMPAIRMENT (She could not remember), CEREBRAL DISORDER (It affected her brain), GAIT DISTURBANCE (Woke up holding to the walls to be able walk), FEELING ABNORMAL (for 2 days she could not put a telephone number, she could read that the number was 3 but she pushed 8 instead), DISTURBANCE IN ATTENTION (Her fricking brain didn't work), PRODUCT DOSE OMISSION ISSUE (Is terrified of getting the second dose/it's been more than 36 days since she got the first dose and still hasn't got the second), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Her motor skills were affected per days), MEMORY IMPAIRMENT (She could not remember), CEREBRAL DISORDER (It affected her brain), GAIT DISTURBANCE (Woke up holding to the walls to be able walk), FEELING ABNORMAL (for 2 days she could not put a telephone number, she could read that the number was 3 but she pushed 8 instead), DISTURBANCE IN ATTENTION (Her fricking brain didn't work), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Is terrified of getting the second dose/it's been more than 36 days since she got the first dose and still hasn't got the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. The event of Transient Ischaemic Attack was not coded as it was not diagnosed according to the information available, Further information has been requested.
A 12 year old male pt with a history of asthma and GERD had received a dose of the study vaccine, Menactra, on an unspecified date. The lot number, route and site of administration were not provided. On 3/28/06 at 3:00am the subject developed a fever of 103.0 degrees Fahrenheit. He was treated at home with Advil around 4:15 am. The subject was subsequently seen in the ER at 5:15 am with complaints of bilateral shoulder pain. His temperature at that time was 99.0 degrees Fahrenheit. On examination, no redness or swelling was noted to the painful area, only mild tenderness. The subject was discharged from the emergency the emergency room and his recovery status was not reported. Per the investigator, the events were considered non serious, but related to the study product.
Admitted for resp failure and afib RVR, multiple comorbidities. COVID swab positive after admit and dx w COVID pna. Given zinc, vit-c and d, steroids, pepcid. Progress to intubated/vent support. Care eventually withdrawn and pt expired in hospital.