chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given Fluzone Quadrivalent standard dose in error as the patient qualifies for FLUZONE HD with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] standard dose in error as the patient qualifies for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route, administration site and lot number not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient was given fluzone quadrivalent standard dose in error as the patient qualifies for fluzone hd with no reported adverse event (wrong product administered) (unknown latency).  Action taken was not applicable with both the suspects.  It was not reported if the patient received a corrective treatment for the event.  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.
Patient received the Pfizer vaccine for his Primary series dose 1 and dose 2.  He was given Moderna for dose 3 of the primary series instead of the Pfizer vaccine -- this wasn't a booster dose. Patient had no adverse events and was notified.  This patient received 2 booster doses of Moderna, but the 2nd booster dose was given too early.  No adverse events from this.
chills; Fever; Headaches; Sick for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 36 hours), CHILLS (chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021. Concomitant products included QUINAPRIL, PRAVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced ILLNESS (Sick for 36 hours). On an unknown date, the patient experienced CHILLS (chills), PYREXIA (Fever) and HEADACHE (Headaches). On 10-Aug-2021, ILLNESS (Sick for 36 hours) had resolved. At the time of the report, CHILLS (chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-321146.
Face swelling, tongue swelling evening after vaccine.  2 days after vaccine until now, I have had an increase in fatigue that I normally have due to long covid (original infection 8/13/2020).
Patient presented with bilateral blurry peripheral vision that resolved over several days. He was found to have P1 PCA stenosis. Additional imaging showed this to be resolved and a normal variant.   Additionally, patient diagnosed with myopericarditis. Found to have elevated troponin up to 6, diffuse ST segment elevation on EKG and chest pain. Started on ibuprofen and colchicine with relief. Discharged from the hospital on hospital day 2.
patient doesn't remember vaccine name unsteadiness and dizziness with any head movement, pulse 110, could not sit up without feeling like falling over, dry heaving, called PCP on Tuesday and PA suggested no ER visit necessary. Symptoms lasted 5 days
she received Fluzone Quadrivalent and is currently pregnant with no reported adverse event; Initial information was received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 30 years old female patient who was currently pregnant and exposed to influenza quadrival A-B vaccine [Fluzone quadrivalent]with no reported advesre event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 29-Oct-2023, the patient received a 0.5 ml, total (once) dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot UT8144NA, expiry date: 30-Jun-2024, strength: standard) via unknown route in unknown administration site for Immunization and she received fluzone quadrivalent and is currently pregnant with no reported advesre event (exposure during pregnancy) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
11/9/22 I started out with a very bad sore throat, body aches, bad  headache, sinus pressure and upper respiratory symptoms, my chest ached worse than I have ever had. I was seen by a doctor on 11/10/22 and they told me it was a virus.  I was given lidocaine viscus oral rinse and told me to come back in a few days if I was not better. I went back in a few days.  They did a CT scan and diagnosed me with a sinus infection.  I was prescribed Levaquin. I began taking it that day. I was able to use the oral rinse.  Because of my asthma, when I get a cold it will go into an upper respiratory and sinus infection.  By Day 5, I began to feel better. I have recovered.
still sick; also got covid 19; COVID arm; feeling out of it; itching; fatigue / tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (feeling out of it), PRURITUS (itching) and FATIGUE (fatigue / tired). On 26-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19). At the time of the report, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick), EXPOSURE TO SARS-COV-2 (also got covid 19) and FATIGUE (fatigue / tired) had resolved.            This case was linked to MODERNATX, INC.-MOD-2021-090448 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended; Sender's Comments:  MODERNATX, INC.-MOD-2021-090448:Case of son
This spontaneous report has been received from a consumer who was a 64 years old male patient with high blood pressure and drug allergy to neomycin. The patient was vaccinated SC with a dose of ZOSTAVAX on 01-DEC-2012, frequency reported as  3 years. Concomitant medications included medicines for blood pressure. On 01-JAN-2012 the patient began to join pain then his knees and ankles to point where he had trouble getting his pants on. The outcome of the patient was unknown. No treatment was given for adverse event. No lab diagnostics studies performed. Additional information has been requested.
This spontaneous report was received from a physician referring to a 15 year old female patient. The patient's medical history or concurrent conditions were not reported. On 20-DEC-2016, the patient was vaccinated with GARDASIL 9 (which had the lot # M036059, expiration date unknown) in the left deltoid, (dose and route were not informed). Information regarding concomitant medication was not provided. The physician reported that on 30-DEC-2016, the patient returned and was admitted to hospital because of symptoms, (swelling, fever, redness, and pain in left shoulder and swelling, redness, and pain in right hand, wrist, and elbow). It was also confirmed that the patient presented with pain at both injection site and in the opposite upper extremity. In the hospital, deep vein thrombosis (DVT) was diagnosed. Therefore, anticoagulation therapy with LOVENOX 60mg twice daily for 3 months was initiated. Finally the patient was discharged on 31-DEC-2016. At the time of reporting, the outcome of deep vein thrombosis was reported as recovering. The causality assessment between the event and therapy with GARDASIL 9 was not provided. Upon internal review the event  deep vein thrombosis was determined to be medically significant. Additional information has been requested.
pt in hospice; respiratory failure due to COVID 19; PMH breast CA, HTN, DM, leukemia, dementia; DNR/DNI; on BiPAP; pt continued to decline; family wanted to take pt home; comfort care measures; pt died @ home shortly after arriving
he received the first dose of Shingrix about 5 years ago but never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he received the first dose of Shingrix about 5 years ago but never got the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6th Oct 2023 A retired pharmacist states that he received the first dose of Shingrix about 5 years ago but never got the second dose. The reporter asked if he needs to restart the series. The reporter did not provide information about the first dose given (lot number, exp date). The reporter consented to follow up. Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 31-JUL-2017, received a dose of improperly stored LIQUID PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 476 hours. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767.
I developed an oval shaped rash that was itchy and burning around the site of the shot (a week after receiving it). A day later and I still have it but it?s getting better.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 1 minute. Patient presented symptoms 10 min after injection while being observed. Called 911 but patient recovered fairly quickly with no need for hospitalization.  Was told after event that patient has fainted in past due to being cut but never while being vaccinated.
Swollen  of left leg and foot, took her to Delnor Hospital ER and they ran test.
Patient was given a high dose flu vaccine, she is not 65. Patient is 42 and should have been given the standard flu injection.
Breast swelling, breast pain. Breast itching, swollen lymph node,  mastitis.
Adverse event: Rash at injection site hours after injection.  Treatment: medicated with Benadryl and Tylenol  Outcome: ongoing observation follow up in 48 hours
Headache, Myalgia, Fatigue, chills Narrative: Missed one day of work after first dose due to arm soreness and myalgias.
pt recv vax 19NOV96 & about 3hr later devel a fever of 104, chills, rales & cold sores (herpes like rash) around the mouth;pt to ER w/T104.8 & adm for observation over night;7JAN97 BP was reported as 223/87, 201/87, pulse 108, resp 24;
There was a big amount of blood in the stool and the next day there was blood too; scared; This is a spontaneous report from a contactable consumer (patients son). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6266), via an unspecified route of administration in the left arm on 06Mar2021 at 08:30 as SINGLE DOSE for covid-19 immunisation. On 27Mar2021, at 08:30 the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration in the left arm as SINGLE DOSE for covid-19 immunisation. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 09Mar2021, three days after getting the first shot of vaccine, there was a big amount of blood in the stool and the next day there was blood too, he was scared and never mentioned until 30Mar2021. The event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The clinical outcome of events was unknown.
My ribcage below my breasts on both side became very sore; after rubbing the area it began to itch; I had 101 fever; Felt very foggy for several days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 76 years old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: yes). No known allergies. Concomitant medications taken within two weeks included patient blood pressure medicine. Patient did not received other vaccine within four weeks of COVID vaccine. The patient experienced my ribcage below my breasts on both side became very sore, after rubbing the area it began to itch, i had 101 fever, felt very foggy for several days on 06Mar2021 17:00. Adverse event reported as, patient ribcage below his breasts on both side became very sore. Like someone beat him up and after rubbing the area it began to itch she used some ointment she had for pain and it helped. She had 101 fever and many other listed side effects. Felt very foggy for several days after. Now she was concerned about taking shot two. Therapeutic measures were taken as a result of after rubbing the area it began to itch. No treatment received for other events. The patient underwent lab tests and procedures which included body temperature: 101 on 06Mar2021. Patient did not tested for COVID post vaccination. Outcome of all the events were recovered with sequel on Mar2021.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Increased heart rate. Like an anxiety attack but almost constant. It's been over a week. Most noticed while resting, after eating, while walking and after smoking.
On Dec. 24th I started to develop pain with breathing.  No other symptoms. I was unable to take deep breaths and felt SOB because of that.  I was evaluated in the emergency room on Mon 28th.  Full workup completed, cardiac and PE.  Work up negative and Covid test negative. I was diagnosed with pleurisy.
On 30Dec2021 covid test done and it was positive; On 30Dec2021 covid test done and it was positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 15:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 19Jan2021 (Lot number: EL1283) as dose 2, single and intramuscular, administered in arm left, administration date 23Dec2020 (Lot number: EK5370) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "On 30Dec2021 covid test done and it was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. No family history of autoimmune disease, no personal history of autoimmune disease and blood work for another etiology all negative. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior to vaccine. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
This case was reported by a healthcare professional  and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 1 of 5 (see case IDs A0949593A-A0949596A for details of the other reports).
Unlike the initial two injections in early and late March, this injection was sore immediately. Over a month later there is still soreness and a small scab which did not appear on the first two doses.
Rotating hives started on my left arm, then went to right upper back (2 hives), then left leg (2 hives), right leg chest and then face. Every day a different day. Brain fog started with Zyrtec and Pepcid changed to Claritin A and Pepcid. Low histamine diet. This started after the second dose of vaccination (a few days after). As of 12/26/2021, I am still experiencing same symptoms.
achy; sleeping a lot; headache; chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VOMITING (Vomiting), MYALGIA (achy), HYPERSOMNIA (sleeping a lot) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048a21a and 023m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (type 1 diabetic.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced CHILLS (chills), VOMITING (Vomiting) and HEADACHE (headache). On 10-Apr-2021, the patient experienced MYALGIA (achy) and HYPERSOMNIA (sleeping a lot). On 10-Apr-2021, CHILLS (chills), VOMITING (Vomiting), MYALGIA (achy) and HYPERSOMNIA (sleeping a lot) outcome was unknown. On 11-Apr-2021, HEADACHE (headache) outcome was unknown.            Blood sugar 99 when vomiting. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. CONCOMITANT PRODUCT IS NOT PROVIDED. TREATMENT IS NOT PROVIDED.
Less than 5 minutes after the injection, patient began to develop a rash on her torso.  The rash began to spread, so she was given a 25mg tablet of diphenhydramine 7-8 minutes after the injection.  The rash continued to spread, so an ambulance was called around 10 minutes after the injection.  The paramedics arrived within 5 minutes and took the patient's vitals.  They reported that she was showing signs of confusion.  She was given a ride to the Medical Center by her manager around 20 minutes after the vaccination.  Called the ER to follow up, patient is fine per (Name).
Patient c/o shortness of breath, vertigo, followed vasovagal. While medical was making attempt to call medical and 911 patient fell from chair and landed on his knees and head. Patient became conscious in less than a minute. Medical Code Blue team showed up in less than a minute to help with the situation. Patient after waiting 30 minutes was very normal and declined to be assisted by 911.
hard to swallow/feeling of something in my throat, constantly gagging, a lot of excess phlegm and spitting to clear throat, left lymph gland swollen and shooting pain to left ear, sore throat, hurts when swallowing food
Body aches, chills and rigors, extreme fatigue for 24 hours. No fever.  Took 3 grams Tylenol over 24 hours to help alleviate symptoms. Tylenol moderately helped.