chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Accidentally administering Fluzone high dose quadrivalent to patient who received Fluzone high dose quadrivalent vaccine 10 days earlier with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via Information (under reference 00838776).  This case involves a 65 years old female patient who accidentally received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and she already received same vaccine 10 days earlier (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) [lot number and expiration date were not reported] via unknown route in an unknown administration for Prophylactic vaccination.  On 01-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ741AA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Caller would like safety information."  At time of reporting, no reported adverse event 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 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.
After Moderna vaccine series, pt. never felt ?right.?  He had headaches, fatigue, and some ?fuzzy-headedness.?  Then May, 2021 he felt worse with worsening of above and dizziness, visual misperception. Symptoms waxed and waned for months. In June he started to develop diffuse muscle fasciculations that  got progressively worse for months. Throughout the following months  he also had sleep disturbances. By the end of November, he had developed mood swings, agitation, and suicidal ideation followed but severe visual misperception that prevented him from further driving. 12/28/2021 he was diagnosed with DPPX AUTOIMMUNE ENCEPHALITIS
11/11/23  8:30 am Rash + red swelling both feet  11/11/23  430pm Vision in left eye circle cloudy hazy vision in center and kept moving around - vision still blurry 11/13/23  Appt with eye doctor                 did all test they can do in office 11/14 woke up with body rash - still have rash.
Patient began to experience syncope with diaphoresis. We had the patient rest for 15 minutes and gave him cold water and fruit smoothie.
today he is experiencing pain at the injection site; body aches; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 12-JUN-2023, the patient received the 1st dose of Shingrix. On 13-JUN-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: today he is experiencing pain at the injection site) and general body pain (Verbatim: body aches). The outcome of the injection site pain and general body pain were not resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 13-Jun-2023 The patient was Doctor of Medicine. Today (on the day of reporting), the patient experienced pain at the injection site and the body aches. The reporter did not consent to follow up.
Swelling of Half of Lower Lip; eyelid swelling; swelling of ears; swelling of palms; This spontaneous case was reported by a health care professional and describes the occurrence of LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Idiopathic urticaria. Concomitant products included OMALIZUMAB (XOLAIR), CETIRIZINE HYDROCHLORIDE (CETRIZINE), RANITIDINE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms). At the time of the report, LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms) outcome was unknown.        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 treatment drugs were reported.
After 15 min had no reaction 25 min later my upper lip swelled slightly and had numbness feeling around my mouth
itch; then a blister formed in the palm of her right hand and then changed to a cluster of blisters and then migrated to pinky and then up her arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in Arm Left on 03Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient experienced itch, then a blister formed in the palm of her right hand and then changed to a cluster of blisters and then migrated to pinky and then up her arm. Reporter stated her reaction started 8-10 days after the first dose and was still evident today. It was very painful and sensitive to touch. She bandaged it today because it felt better that way. She had some other systemic reactions but they were so little and she felt they were nothing to report and went away in a few days. Reporter would like to know if she should receive her second dose this Saturday. The events were considered as non-serious. The outcome of the events were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness, listlessness, sleepy, odd behavior (going from crying to laughing back & forth). Symptoms resolved spontaneously on their own.
L thigh with large erythematous edematous puritic patch around site of DTaP & varicella injections -> 5" wide x 4" long; To ER + office.
Burning sensation at injection site. Weakness. Whole arm pain can't lift up without pain. Headache. Fatigue. Flu like symptoms.
runny nose; left arm little sore; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MYALGIA (left arm little sore) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and MYALGIA (left arm little sore). On 26-Mar-2021, RHINORRHOEA (runny nose) and MYALGIA (left arm little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   This case was linked to MOD-2021-201025 (Patient Link).
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Fainted after vaccine administered (about 10minutes) Fell out of chair and hit head on a shelf. EMT were called and patient released on her own accord.
Pneumovax given in right arm in AM.  Patient came back approximately 25 hours with redness, swelling, tenderness and itching to deltoid muscle.  Patient seen by MD.
My arm became very itchy and red at the site of the vaccine about 8 days after the shot. I?m 12 weeeks pregnant as of 3/27/21. Due date 10/8/21
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.    A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 16:00 (Lot number: EN6207) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart failure" (ongoing), notes: Verbatim: Heart failure, Started about a year ago. Concomitant medication(s) included: SYNTHROID; ENTRESTO taken for cardiac failure; CORLANOR taken for cardiac failure. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6203), administration date: 04Mar2021, when the patient was 80 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.    Additional information: Patient has received both doses of the Pfizer Covid Vaccine. after her first vaccine, she didn't have any side effects. Caller states after her second vaccine, she has had a headache everyday. Caller states she has several heart medications, but she doesn't have her list of medications in front of her. States she is on a blood pressure pill and water pill. About headache, reporter states some days it is worse than others. States it is not severe but moderate. States she takes Tylenol every once in a while. States she doesn't like to take it so much but when it gets really bad, she has to take it. States one day when her headache was worse than others, she took an Excedrin.    No follow-up attempts are possible. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for Diverticulitis of large intestine with perforation without bleeding within 6 weeks of receiving COVID vaccination.
Sore and slightly red arm on Saturday; Slightly red arm on Saturday.; Felt sluggish all day; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration on 12Nov2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD6955) via an unspecified route of administration on 23Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 13Nov2021 (Saturday), the next day after the vaccine (given on Friday), the patient experienced sore and slightly red arm on Saturday. The patient also felt sluggish all the day. Fully recovered on the next day (Sunday) (on 14Nov2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore and slightly red arm, felt sluggish all the day was resolved on 14Nov2021.
4MAY92 recvd 1st dose of Engerix-B & w/in 24 hrs devel nausea, fatigue, diarrhea, & dizziness; no tx given;
After patient received his second dose of the COVID vaccine, patient was sitting in the hallway for the 15 minute period to monitor for any allergic reactions. Patient began to feel not well, was sweating and felt as if he was going to faint. Patient's wife alerted Walgreens staff and the immunizing pharmacist went to check on the patient. Patient was moved to the front of the pharmacy where there was more open space and cooler air. Patient felt dizzy and felt as if he was going to faint but did not actually faint. Patient was given water and Gatorade and had a fan pointed towards his direction to cool him down. Blood pressure was also taken. Paramedics were called and took his blood pressure and sugar levels. Patient was advised to go to the ER and patient and his wife agreed. Patient has history of fainting due to extreme heat but not previously after receiving a vaccine.
Redden induration on L outer arm of 55mm. 1/27/03 client back into clinic. Noted induration on reactive area diminished to reddened area approx 20mm.
a raised, firm area about 1X1 inch; red spot below the injection site; Feeling a little tired; Soreness in arm; A spontaneous report was received from a healthcare facility staff member (United States) concerning a 52-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter   The patient received their first of two planned doses of mRNA-1273 (LOT# 039K20A) on 28-Dec-2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   Patient reported receiving the Moderna vaccine on 28-Dec-2020 in the left deltoid. He stated the he initially experienced arm soreness which resolved by 29-Dec-2020. On 05-Jan-2021, he stated that he noticed a red spot below the injection site along with a firm, raised area measuring about 1 x 1 inch and he also reported feeling a little tired.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired, was not provided.   The event, soreness in my arm, was considered recovered/resolved. The outcome of the events, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired, was not reported.   The reporter did not provide a causality assessment of the events, soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: About 4 to 5 days post vaccination, the patient developed a rash on her neck. The rash continued to get worse as the months passed. It went to her left shoulder, then right shoulder. It went to her left thigh, then right thigh. Around October 2018, the rash went crazy and now her whole back was full of rash. She saw a dermatologist for this rash, but nothing has gotten it under control. The reporter did not consent to follow-up.
Information has been received from a consumer concerning her granddaughter (age unspecified), who on an unspecified date, was vaccinated with the first dose of Gardasil (Lot # not provided). Following the vaccination, the granddaughter felt dizzy, was exhausted, and had pains in her side; she was diagnosed with mononucleosis. No further details were provided. No further information is available.
after imz, next day had 5am hot and cold flashes.  brain pain (distinctly not a headache) which aspirin and tylenol did not resolve, fatigue feeling tired like heart/bp wouldnt keep up, then metallic taste for 3 days.
17 year old patient inadvertently given the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently given the Moderna vaccine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
1/26/16 Pt. came to the Imm. clinic to update immunizations related to his annual physical and job description. Pt. stated he began itching that evening and developed a rash on his rt. lower leg and left ankle. 1/28/16 Pt. alerted Imms clinic about the rash and itching. Pt. chose to see personal PCP after 1/28/16.
PER PT, SORE, WARM, SWOLLEN, REDNESS ON LEFT ARM THAT IS 4 INCHES IN LENGTH AND SPREADING. ADVISED PT TO SEE DOCTOR IMMEDIATELY. PT HAS NOT TRIED ANYTHING TO RELIEVE SYMPTOMS. OUTCOMES PENDING.
This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of MMR II lot # L020188, expiry date: 03-JUN-2017 (dose, route, site of administration and dose# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation". No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports from the same reporter.
Combined central retinal vein and artery occlusion; Combined central retinal vein and artery occlusion; This is a spontaneous report from a contactable physician. A 34-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, expiration date- unknown), via intramuscular, administered in right arm on 22Mar2021 12:00 (at the age of 34-years-old) as a single dose for covid-19 immunisation. Patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6198), via intramuscular, administered in right arm on 01Mar2021 12:00 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received other vaccine within 4 weeks prior to the vaccine and no other medications in two weeks. On 07Apr2021 12:00, the patient had combined central retinal vein and artery occlusion. The patient received treatment with Hyperbaric oxygen, aflibercept, steroid. The seriousness of the event was considered as disability and resulted in other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event combined central retinal vein and artery occlusion cannot be completely excluded. The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or around 2013, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE.  I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE ,  THANK YOU,
W/in 24 hrs of receiving vax developed 5mm ("1/4 in) bullous lesion, swelling of rt upper lip; First occasion had such a lesion; Lesion was "mild", included subcutaneous swelling; P/2 wks condition resolved; 2nd & 3rd doses are on hold;
That night, besides having serious chills for about a half hour (which WAS an expected side effect) and chattering teeth, I vomited my dinner, and was vomiting throughout the early morning, and even some dry heaving into the day. It occurred over the course of about 12 - 14 hours. I at least returned to the toilet to vomit four times. I had to keep a bag by my bed.  So far, I'm the only one of several people I know who have had either the Moderna or Pfizer vaccine and had vomiting.
Body aches, head ache, fever (103° F), chills, incontinence, and brain fog.