chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered an expired Adacel vaccine this morning with no reported AE; Initial information received on 09-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of unknown demographics who received expired diphtheria-2 /tetanus/5 AC pertussis vaccine [Adacel] this morning with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, patient received an unknown dose of suspect diphtheria-2 /tetanus/5 AC pertussis vaccine, suspension for injection (lot number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.  Caller stated that she administered an expired Adacel vaccine this morning (expired product administered) (latency same day).and is calling for the next steps." The caller stated that the patient would be coming in for a well child appointment. The caller was asked for additional AE information, but she declined and stated that she had to get back to her patient.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired adacel vaccine this morning with no reported ae.  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.  Based on information previously received, case validity has been amended from non valid to valid with no AE. Text updated accordingly.
RIGHT GLAND BESIDE THROAT WAS SORE AND TENDER TO TOUCH BUT TOLERABLE; SLIGHT AND INTERMITTENT HEADACHE; FELT LIKE WHOLE MUSCLE EXPANDED AFTER THE INJECTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included rheumatoid arthritis, and sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced felt like whole muscle expanded after the injection. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced right gland beside throat was sore and tender to touch but tolerable. On 22-MAR-2021, the subject experienced slight and intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like whole muscle expanded after the injection, and right gland beside throat was sore and tender to touch but tolerable on 24-MAR-2021, and had not recovered from slight and intermittent headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
A few minutes after receiving the shot, I felt a tingling in the top f my head. It felt like electrical charges, not an ordinary headache. I felt disorientated. I then had nausea. I had difficulty focusing to drive home. Within 1 hour I continued to have electrical charges in my head. This lasted for 6 hours. After 1 hour of getting home, I got severe chills. My teeth were chattering and my body was extremely cold, except for my feet and that was unusual. My hands were very cold. My body was shivering. This lasted for 1 hour. I was able to sleep normally. The next morning I woke up with extreme fatigue headache and a normal body temperature and nauseas. Those symptoms lasted until the next morning. I had disorientation and dizziness starting within 15 minutes of getting shot in my arm. After 48 hours of getting the shot, the only symptoms left was a very sore arm for 1 week and extreme fatigue for 10 days. I have had 2 episodes of extreme chills after getting the shot. It feels like my body thermostat has been thrown off a bit.
Acute bilateral pulmonary embolism and acute right leg deep vein thrombosis, both of unknown etiology
Patient came to vaccine clinic to receive 1st dose of Moderna COVID-19 vaccine on Saturday, May 08, 2021 with lot number 043B21A at 12:40PM right deltoid. Patient is a Spanish-speaking and fire fighters on duty helped with the interpretation. Patient stated that she does not have any health issues nor allergies to any medications as evidenced by answering all screening questions as ?No?. Patient stated that she ate breakfast but feeling anxious before coming to the vaccine site. At 12:56 pm, pt experienced tightness on her throat and felt vitals were checked as follows: BP: 145/100 on right arm, PR: 92 bpm, O2 sat: 99% RA. Patient was further assessed together with fire fighters on duty, then, Ambulance was called since the patient. Patient was anxious but oriented to time and place. Patient continuously felt anxious due to the situation but was re-assured and throat started to be itching. Patient stated that she started to feel dizzy and having blurred vision. No coughing and no chest pain noted. Vitals were at re-checked at 1:01PM as follows: BP: 145/97 on right arm, PR: 114 bpm, O2 sat: 98% RA.  Ambulance came at 1:03PM at the scene and did the assessment. Recommended to bring her to hospital for further evaluation.
couple hours after the shot, my throat felt swollen and chest felt tight, and sudden laryngitis and some hoarse voice. Till today still feels swollen and hoarse.
Patient fainted shortly after receiving vaccine. She was sitting on bench next to her brother and slowly began to slide down the bench.  She felt extremely dizzy so laid on the floor with her feet on the bench for a short time until she felt ok to sit up.  She was given water and sat with her mother for an extra 15 minutes or so until she felt well enough to leave.
soreness following immun for chickenpox;26OCT98 mom noticed redness & swelling of upper arm down to elbow;no fever;will see MD;dx cellulitis;
This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a male patient. On an unspecified date, the patient received the AFLURIA. On an unspecified date, the patient developed pain in the left arm. Outcome was not reported.
arm hot; Rash; feverish; Size of a tomato at injection site; red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red). At the time of the report, FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
SORE ARM AND SHOULDER,  VERY LETHARGIC, CHEST CONGESTION,  NO APPETITE,   HEADACHE, UPSET STOMACH.  DID  NOT SEEK MEDICAL ATTENTION.. GETTING BETTER.  ACCEPTED AS PART OF IT SINCE I HAD HEARD STORIES THAT THE SECOND VACINE WAS GOING TO BE WITH  MORE SIDE EFFECTS.
This spontaneous report as received from a pharmacist refers to a 74-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in 2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection, 0.65 ml, administered subcutaneusly, reported as "the normal way" (lot# L031272, expiration date: 19-NOV-2016). No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Patient was given Moderna COVID-19 vaccination as first dose and was given Pfizer Biotech as the second dose erroneously. Patient showed no adverse reaction. He was monitored per protocol and went home after 15 minutes.
In November, 2012, I experienced malaise and fatigue. In December, 2012 I discovered the manufacturer of my Levothyroxine was changed without my knowledge. I originally attributed my fatigue to that change. All subsequent tests related to my thyroid were in the normal range. In the months that followed, my fatigue persisted and became more severe. I informed my doctor that my symptoms appeared to match Chronic Fatigue Syndrome. Over the next 2 years, my doctor ordered tests for increasingly improbable causes of my fatigue, often under protest that I had no symptoms of the disease being tested. My doctor insisted that he must follow protocol to conclude a diagnosis of Chronic Fatigue. After exhausting all recommended tests, my doctor informed me that he does not make diagnoses of Chronic Fatigue. I recently learned that research is currently examining Chronic Fatigue symptoms following the Hepatitis B vaccine. I recalled and confirmed that I had received the Hep B vaccine on 04/12 and 07/12. My Chronic Fatigue symptoms developed months after I received the Hepatitis B vaccine.
This spontaneous report was received from a physician and refers to a 26 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
No adverse advents.  Patient was mistakenly given an 3rd booster at 1 month after his 2nd booster
Sore arm quarter sized red bump on arm that was warm to touch, itchy and red. it has now turned into about 3x4 in a oval shape
pt recv vax & exp a severe case of hives;pt sought unspecified medical attention;
My arm was very sore the evening of vaccine and the next day.  Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved.  It has been one week.
Mild to moderate dizziness and nausea for three days starting 01/06/2021.  Reported it to a advice nurse and a physician on 01/08/2021 . Meclizine and Ondansetron was used immediately.  Scopolamine was prescribed by the physician on 01/08/2021,  picked and used on 01/09/2021; felt better . Residual dizziness remains after use.     P.S. I do have a medical history of BPPV for the last 2-3 years and have been treated for it. Generally speaking my BPPV symptoms resolve themselves quickly after treatment. This current episode has lasted  forthree days.
Breakthrough case admission after 3 vaccines Pfizer 1/27/21 lot# El9261;  Pfizer 2/16/21 lot# EN6201;  Pfizer 10/18/21 lot# FH8020
left arm  became red like the size of her palm; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch). At the time of the report, ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was stated it been 2 weeks since she got her 1st shot and this the first time she has seen it.   No concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N013695 expiry date: 21-MAR-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Patient received the Janssen COVID 19 vaccine at approximately 3:10 pm. After her vaccination, she walked to the observation area and sat down in a chair. Within 5 minutes, she had a vasovagal response, lost consciousness, fell to the floor. Nurses in the observation area assessed her. She was responsive within a few seconds. Patient was transferred to a cot by nurses where she continued to be observed. She stated she remembered "everything going dark." Patient denied any pain, had no obvious injuries. It was unknown if patient hit her head so EMS was called to evaluate her. EMS arrived within 5 minutes of the call and assessed patient. She was medically cleared. Her husband picked her up and stated he would drive her home.
Received vaccines 7-11-02 around 10:30 a.m.--developed hives Friday 7-12-02 early afternoon, no other signs/symptoms.  Took 2 Benadryl tabs 7-14-02, Called health dept 7-15-02 to report, hives no better and no worse.  Occuring on legs, back and abdomen.  Husband had same and he also received vaccines
Widespread mild hives on limbs, chest, groin.  Some mild itching on arms and legs.  Went to bed (no difficulty falling asleep); upon awakening at 5:30 AM the following morning, the hives had resolved.
Patient developed a bright red, irregular shaped, warm, slightly itchy, bumpy, firm and slightly raised area around her second Varicella vaccine, about 2 in X 1 inch. I called the nurse on call, since it was 2230 at night when my daughter discovered the area--2 days after the vaccine was given.  She suggested we mix up a solution of 1 quart warm water and 2 Tbsp salt.  Soak a washcloth in the solution and apply it to the irritated area for 15 min. then apply an antibiotic ointment.  We did this and by morning, the site did look better.  The mark was a pink color, but still present.  We followed up with Dr. that morning who said we were doing the right things since the site was looking better.  It is now the 4th day after the vaccine and the mark is still present but light pink and not as firm. We continue to put the salt water solution and antibiotic ointment on twice a day.  She also complained of a stuffy nose at the onset of the inflammed area.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On multiple unspecified dates the patients were administered with improperly stored VARIVAX (Merck) (lot # L049534, expiration date 08-DEC-32017). The temperature excursion was -14 Celsius degree with time frame of 2 hours. There was previous temperature excursion: -11.4 Celsius degree for 5 hours. No adverse effects were reported. Additional information has been requested.
No adverse effects reported; He inadverntently administered a dose of MMRII intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.     The pharmacist reported that on 08-AUG-2019, he inadvertently administered a dose o f measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031628, expiration date; 01-NOV-2020) intramuscularly rather than subcutaneously for prophylaxis. No adverse effect were reported.
broke out into hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (reported as Thursday) as dose 1, single for COVID-19 immunisation. Medical history included that the patient normally gets hives when she gets a virus, that was how the virus processes out of her body. She also got the virus from different allergic reactions and penicillin and sulfa antibiotics and she could not take those medications anymore. The patient's concomitant medications were not reported. The patient reported that she got the COVID-19 vaccine on 18Mar2021 (Thursday). On 20Mar2021 (Saturday) morning, she broke out into hives. The patient stated that she was nervous about going back for the second vaccine since she had hives this time around. The patient called the health department, but they were no help and they told her because it was so new and they did not have a lot of data, they were not sure what she should do. She also spoke with the pharmacist. The patient stated that she was told they (the pharmacist) do not think she should receive the second vaccine. The patient was told to contact Pfizer. The patient was worried about the anaphylactic thing, the second one had a lot more side effects, the first one was kind of easy to get through. The patient wanted to know if she should get the second vaccine, and she did not know if she should. The outcome of the event broke out into hives was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report was received from nurse practitioner and refers to a patient on unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the vaccine was under temperature excursion with a temperature of 0.5°C for 168 hours. Previous to this, there was no temperature excursion.   On 24-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1dose administered for prophylaxis (strength, and route of administration were not provided; lot #1775808, has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) , expiration date reported as 31-AUG-2022, but upon internal validation established as20-AUG-2023). No adverse events were reported.; Sender's Comments:  US-009507513-2202USA003856: US-009507513-2202USA003818:
Pt recvd 3 doses of Engerix-B, 3rd dose given OCT90; Pt punctured lt index finger w/dirty skin hook & when titers were checked it was determined pt had none; F/U booster given 19MAR91;
patient received influenza and pneumonia vaccines. both vaccines given in left deltoid. very reddened and swollen. temperature 101.5
Large area of swelling, erythema and pain over area of injection site. Low grade fever, fatigue, diffuse arthralgia.
No related effects noted.; 1 of 3 patients that received dose of VARIVAX after short dated from previous excursion. Initial temperature excursion (TE) completed on line -47 to 77 Fahrenheit degrees (F) for 1 Hour 22 Minute; This spontaneous report was received from a Non-Medical Healthcare Worker, referring to a 4-year-old patient of unspecified gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (involved lot # was W031815, expiration date established and confirmed as 05-OCT-2024 upon internal validation, but also an additional expiration date was reported as 19-JUL-2023 [conflicting information for an expired dose administered with the involved lot #]); given as prophylaxis (strength, route, and site of administration were not provided). Initial temperature excursion (TE) completed on line -47 to 77 Fahrenheit degrees (F) for 1 Hour 22 Minutes. There was no report of side effects, nor product quality complaint was involved.   This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2309USA003050: US-009507513-2309USA002813: US-009507513-2309USA002813:
Breakthrougn case admission after 4 vaccines Moderna 3/19/21 Lot# 0044A21A;  Moderna 4/16/21 Lot# 025B21A;  Moderna 11/17/21 Lot# 077C21B;  Moderna 9/15/22 Lot# AS7148B
Patient started to experience upper body pain (shoulders, spine) which then progressed to widespread body pain. This affected daily activities including working due to pain.  Patient felt fatigued.