chrisvoncsefalvay/vaers-outcomes huggingface dataset:
81 year old female patient was given Flublok Quad instead of Fluzone HD, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 81 year old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] ] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  Medical history, medical treatment, concomitant medication and family history were not provided. Patient had received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] for the last 10 years.   On 06-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered. It was reported that he had received Flublock Quad instead of Fluzone HD. The nurse who administered the vaccine told him that he received it so early that by the time the flu season hits he'll have developed enough antibodies.  At the time of report no adverse event was 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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent conditions or medical history were not reported. On 20-MAY-2015, the patient was inadvertently administered one dose of expired MMR II (Batch # J006140, lot # 1720AA, expiration date 17-APR-2015) (route unspecified). No adverse effects were reported. Additional information has been requested.
Patient (Husband) received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine) outcome was unknown.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-543577, MOD-2022-543586 (Patient Link).
TONIC CLONIC SEIZURE WITH STATUS EPILEPTICUS X 1 HOUR.  PATIENT TRANSPORTED TO HOSP VIA AMBULANCE WHERE HE WAS INTUBATED AND PUT ON A VENTILATOR. TRANSPORTED TO ANOTHER HOSPITAL AND ADMITTED TO ICU.  11/12 and 11/17/09 Medical records and discharge summary received for DOS 11/7/09.  Final DX: Status epileptics.   Facial puckering assoc w/emesis x1. Full body shaking. Intubated. Acidosis. PICU. Head CT WNL. CXR R LL pneumonia. CSR RBC (+). Resp failure. Status epileptics. Back to baseline.
ITCHING AND REDNESS ON INJECTION SITE, NEXT DAY GENERALIZED ITCHING. DIARRHEA.
Started with rash on lower forearm/wrists.  Within the next two days, developed rash on upper arm near site of vaccine with pain.  Eventually hospitalized the following week with severe pain in arm.  Eventually, developed chronic pain/CRPS.
3/18/03 received smallpox vaccination, 3/20/03 bumps appeared on arm 3/21/03 bumps appeared on chest 3/22/03 bumps appeared on head and mouth
Patient received in error the Flublok by manufacturer Sanofi Pasteur. Physician spoke with patient mother on date of injection in the evening: at this time mother reported no issues. Physician provided mother with her personal cell to call if any questions or issues arise. Office spoke with mother the next day as a check in and no adverse effects noted.
Patient reports headache, chills, fever of 101.5, and right sided upper back pain when she woke up at 0500. Patient received J&J vaccine yesterday 1850. Symptoms of feeling flushed and headache started at 2130 last night.
Pt was given vaccine and during this time the pt was serious and calm. The pt and mother left. 3-5 minutes later the office was told the pt had fainted in the car and the mom stated "she does this all the time."
Blister to Lip 2 days after COVID Vaccine. C/W herpes labialis also (R) sided chest pain, mild, unclear causality. Also induration & swelling (L) injection site. NO skin redness (-) axillary temperature. TxT with acyclovir.
Initial unsolicited report received from a physician on 15-Oct-2016. This case involves a patient (unknown age and gender), who was vaccinated with FLUZONE HD (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unknown date. The medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient had developed serum sickness and had a reaction. Lab test and the corrective treatment was not reported. The outcome of the events was not reported. Documents held by sender: none.
Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of VAQTA. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame: 0°C to 1°C for 2.5 hours 9°C to 25°C (9.36C) for 8.75 hours No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003498: US-009507513-1706USA008767:
Pain in L Pinky, L ring finger (left side) and numbness in L outer portion of hand, below the pinky finger.
Fast heartbeat, dizziness, weakness, severe aches, intermittent hives (appear and disappear).
VOMITTING, DIARRHEA, HEADACHE, HUGE LUMP AND REDNESS AT INJECTION SITE
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: sore throat-Medium.
About 5.5 hours after receiving my 1st does of the vaccine a rash on my inner left upper arm appeared. There was no rash at the site of the injection and I did not have any other severe or non-severe allergic reactions to the vaccine. I did feel tired more than usual and had a slight headache. I also experienced some body aches and weakness later in the evening. I took Benadryl for the allergic reaction and the rash has improved. I took 600mg Ibuprofen at 6pm for the head and body aches.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.
Right away felt vac.  moving down to arms and vaginal area especially on left side of body. Swollen glands on neck made it  hard to swallow. Took Benadryl states that nurse gave vac higher than should and hit nerve. Felt a bit tired on afternoon so slept more than normal. Had loss of appetite. Next day had racing heart, called clinic. Felt bruised underarm. Doctor order an EKG (130) and set pt to hospital. Took high blood pressure medication, Lanoxin, left on Thursday afternoon. Got exhausted easily during last week of October.
Pt reported a large reddened area at injection site, 2X3cm, warm and tender to touch, itching and nodule size of a quarter.  Pt recovered.
1402: Patient reports redness/itchiness on face like when one has an allergic reaction to pork. BP: 120/78, O2 SATS 98 percent, P: 83.  Member at bedside.  1416: Patient denies any worsening of symptoms. 1424: Benadryl 25 mg PO given. Patient is ready to leave. Per member, patient is stable and okay to leave. Patient is going to mom's house, which is 5 miles away. Patient told to follow-up with PCP.
Nausea, Vomiting, Diarrhea, Dizziness, Headaches, Body Aches, Fever, Chills.  Treated with Tylenol
Patient fainted after a few minutes of receiving vaccine.  After regaining consciousness the patient was very pale, sweating, and nauseous.  We tried to take the patients blood pressure but it was low enough to cause an error reading on the monitor and her pulse was weak.  The patient remained very slow to respond and emergency was call and patient was taken to the ER.
Calf and forearm muscle stiff and harden, numbness on fee and hand and fuzzy feeling on leg and arm. Fingertips tingling, leg cramp if walk, can't form word, sharp pain on collar bone (only happen once). Janssen vaccine was administered on Apr 12, 2021. On the same day I have severe headache and mild pain on muscle. Severe headache extends to the next day and occasionally happen during the first week along with mild to moderate muscle pain. On the second week (Apr 19 to Apr 23, 2021) have frequent muscle pain, muscle on calf becomes stiff and harden and occur more frequent. It alternates between right calf and right forearm. I also often have tingling on fingertips, numbness on hand and feeling fuzzy on arm, legs. Symptoms comes and goes but get worse if have short walk. Foot and back of the knee on right leg cramp and more stiffness and more pain. On May 2, I woke up with numbness on my right foot and discover red spot on the instep. This prompt me to go to Urgent care. Since numbness and feeling of fuzzy along arms and legs but at the urgent care could not diagnose since they don't have tools to run the test so they advise if it bothers me, I should go to the ER. I worry about high cost of ER so I went home and plan to go see family doctor on Monday but just 5 minutes away from urgent care, I have trouble saying out the word that I want to say. It just doesn't come out although I try to form a word. At that point I more concern if I would have stroke so I ask my husband to turn around to go to Emergency Room. While waiting to be treated, numbness occurs more on feet and under of the forearms, Doctor run blood test, order ultrasounds, MRI scan on the head and EKG. All result came back normal but numbness and headache still persistent. I was discharge in the evening but still have no idea what cause it. The discharge paper indicate that it is "Paresthesia" and I believe Janssen vaccine is the cause for all the symptoms that I have. I still have numbness on feet and leg stiffness still occur even sit down for less than 5 minutes. Should the staff administered the Moderna type that I have signed up for. I believe this side effect won't happen to me. I signed up for Moderna but after check in, the staff show a note "L@837" to the fire fighter. I don't know what it means but heard their conversation that "We don't do that today" then after vaccine was administered, I found out that it is Janssen that I have not signed up for.
Client felt clammy, almost faint. Tingle in legs and felt nauseous. Evaluated by EMS. BP 100/60 P 72 Felt better and went home with mom.
Patient had pain and swelling up to twice the normal size in the lower half of her left arm.
Woke up to left arm hurting and soreness. It has red patches and swollen. My shoulder is throbbing.
Severe chills (could NOT get warm), extreme bone/joint pain particularly both hips but all joints, bad headache, extreme fatigue, weakness, dizziness, difficult sleeping for 4 days - miserable!!! Won't get 2nd vaccination until May- June 2022!   (I got COVID November 2020 and TESTED Positive Twice, before getting a Clearance, NEGATIVE Test on 12/26/2020!)   While + COVID, was prescribed Zpack & 2 inhalers!
Headache, DYSURIA, INJECTIONS SITE PAIN, NECK & SHOULDER PAIN Narrative:
The pt experienced a rash 48-72 hours post vax. On 6/1/01 after a sunburn the rash appeared again in the same place. The left shoulder had a vesicular rash with erythematous base.
Got the shots, still got Shingles/suspected vaccination failure; Shingles/ still got shingles; pain/random stabbing pain/painful/felt punch in gut/At its worst (usually at night) the lightest touch to my back or torso felt like I was being punched in the gut; keep me awake trough night; so nauseated; lost 13 pounds in one week; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain, sleeplessness, nausea and weight loss. On an unknown date, the outcome of the vaccination failure, shingles, sleeplessness, nausea and weight loss were unknown and the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, sleeplessness, nausea and weight loss to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and still got shingles. The patient have had the pain for two months now. The patient told that it could last for much longer, at its worst (usually at night) the lightest touch to his/her back or torso felt like the patient was being punched in the gut.  The patient would get random stabbing pains that would keep him/her awake through the night. The antiviral med that was prescribed to the patient made so nauseated that the patient lost 13 pounds in one week. The patient had no idea how extremely painful shingles could be. Additional supportive information: It was unknown if the reporter considered the nausea and weight loss to be related to antiviral med.   This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient received his second dose of the Moderna Vaccine one day early. Patient contacted to inform of early administration.  Action plan discussed with clinical team in an effort to prevent future early administrations.
Swelling and tenderness at site of injection and in arm pit. Soreness noted in the AM after getting the vaccination. Parent report starting Tylenol regiment and began monitoring. Parents felt the symptoms would subside after a few days but 3 days after the immunization the pain and swelling persist. swelling is not sever and grimace noted to touch by provider. Ice and montrin were recommended
23 y/o complained of heart palpitations, heart pounding after 1st dose of Pfizer vaccine. Service was rendered to patient by EMT and Nurse Practitioner on site.  According to notes on report, after examination, pt was breathing adequately, 3 lead EKG was normal sinus rythim,  Pt. feels better and is observed for another 30 minutes. He refused transport to hospital. He was advised to follow up w/PCP.
This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
I began having a high heart rate and I felt my heart beating out of my chest. Heart rate was up to 115. I felt pretty weird. I went to cardiologist and had all the cardiac tests done: wore a heart monitor for 48 hours, echocardiogram, several EKG's, and a stress test. All the tests came back normal. But I still didn't feel good. Cardiologist put me on Bystolic and it helps.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: patient conplaint of difficulty breathing and itchy face 2 mins post vaccination. RPh administered 50mg benadryl. no patient complaint 9.5hrs post vaccination
Headache; Body ache; Sore throat; Chills; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 1283, expiration date: unknown), via an unspecified route of administration on 01Mar2021 (at the age of 39-years-old) at 1st dose, single dose in right arm for covid-19 immunization at clinic. The patient has no known allergies. The patient did not have COVID prior to vaccination.The patient medical history was not reported. Concomitant medication included metoprolol. It was reported that the patient was not pregnant. On 02Mar2021, the patient experienced headache, body ache, sore throat, and chills. The patient has not been tested for COVID post vaccination. Outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacy student concerning a patient of unknown gender and age. In January 2013 the patient was vaccinated with one dose of PNEUMOVAX23 (route and lot number not reported)) and was inadvertently administered a second dose of PNEUMOVAX23 (route and lot number not reported) in April 2013. No adverse effects were reported. Additional information is not expected.
On 4/22, patient came to her scheduled visit to receive 2nd dose of Moderna vaccine. During intake, patient stated that she had symptoms concerning of an allergic reaction after receiving the first dose.  We informed patient that she would not receive the planned 2nd dose.  On 4/23, I called patient to obtain more information. Pt stated that after she received the vaccine, she felt some immediate tingling in her tongue and left side, but that it was not very bad.  The next day when she awoke, her right eye was red and she continued to have tongue numbness and left sided tingling.  No trouble breathing.  She also had a headache and she called the clinic for guidance.  She was encouraged to go the the hospital, but she did not go. She took aspirin to help her symptoms.  She stated that her headache has persisted since she got the vaccine, and is still very painful. I informed patient that she should go to an Emergency Room today for further evaluation.
mild erythema Lt deltoid 11.5 cm x 19 cm-improving cellulitis vs allergic Tx Augmentin 600 mg BID x 10 day
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 23-JUN-2011. The patient was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported) late on 10-JUL-2012. The patient was not experiencing any known symptoms. Additional information is not expected.
Dose 1 received on 12/6/21. Patient's mother called pharmacy on 12/14 to report that on 12/13 patient experienced left facial numbness and shortness of breath lasting around 10 minutes. It resolved on its own and he did not seek medical attention. I advised mother to have patient seek medical attention.
Rash after 24 hours with pain and subsiding rash after 48 hours all at injection site.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 1st April 2018, the patient received SHINGRIX .5 ml. On 2nd April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. Twenty four hours after vaccination, the patient experienced redness, tenderness and hot to the touch at the injection site. There were no hives or signs of anaphylactic reaction. The reporter did not know which arm she was vaccinated. There was no information regarding resolution. The nurse had limited information. The nurse only had another healthcare professional's notes.
With initial vaccine on 20 Dec 2020 I had immediate tingling and numbness of left upper and lower lip. I went home and took a 60 mg Allegra and 1 Aleve. It subsided. I woke in the morning and the numbness returned so I took 1/2 60 mg Allegra and it subsided. No additional problems from 1st dose. I received 2nd dose on 12 Feb 2021. I felt fine initially. I woke the following day and had completely lost far vision. I could see up close but could not see far and my eyes felt very swollen. I also had right sided headache. The symptoms resolved later that day on 13 Feb 2021 at 5 pm.