chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Soon after administering the vaccine the patient stated the the shot hurt. He began to feel nauseated and he stated his hearing was "funny like an echo". and he vomited twice. His pulse was 65 BPM's. and his breathing was normal. An ice pack was placed on the back of his neck. After about 10 minutes he began to feel better. He remained in the pharmacy for an additional 30 minutes after he began to feel better. After the 30 minutes he left and was feeling better. He was accompanied by his father the whole time.
Received varicella vaccine on 10-25-12. (Went out of town) states had redness at injection site - hard, approximate size of a softball. Mild itching no medication used. Returned to work on 10/31/12: 1st day redness resolved.
no adverse event; the patient recived improperly stored dose of Proquad; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S035100, expiration date was not reported but upon internal validation, it was established as 03-MAY-2021 for prophylaxis (exact dose, vaccine schedule, route of administration and anatomical location were not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT).  The temperature excursion was from 15 degrees Fahrenheit (F) to 46 degrees Fahrenheit (34.5 F) for 1 hr 22 min and 30 sec minutes. The previous temperature excursions was reported as following: form 6 degrees Fahrenheit to 14 degrees Fahrenheit (9 F) for 52 min. The digital data logger was involved. No adverse symptoms were reported.
patient who received 1st dose in 2021 and returned today (12-OCT-2023) for 2nd 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 25-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: patient who received 1st dose in 2021 and returned today (12-OCT-2023) for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The pharmacist requested data on administration of Engerix-B dose to a patient who received 1st dose in 2021 and returned today (on the day of reporting) for 2nd dose.  The reporter wanted to know did the patient need to restart the series. The pharmacist indicated that patient did not receive 1st Engerix-B dose at their pharmacy, exact date of administration unknown. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Engerix B adult, which led to incomplete course of vaccination.
Patient said her and her husband both got side effects.  Hers was mostly pain where her kidneys where which moved more to the right side as time progressed.  She also was very tired and had a bad headache.  Pain was bad enough didn't want to walk or get out of bed.  Still has symptoms but getting better.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and department of health, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
swollen lymph note; fever; chills; site of the injection was hot; swelling; hard; usual pain associated with a shot/njection was burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder. Concomitant products included allergens (nos) (Allergy Injection).   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 2nd November 2019, the patient experienced fever, chills, injection site warmth, injection site swelling and injection site induration. On 4th November 2019, the patient experienced enlargement of lymph nodes. On 3rd November 2019, the outcome of the fever and chills were resolved with sequelae. On 4th November 2019, the outcome of the injection site pain was resolved with sequelae. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fever, chills, injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination had pain, chills and fever. The patient had injection site was hot and burning and became swollen, hard and hot to the touch. The patient also noticed that her lymph node on the side in which the injection was given was swollen. The patient received her weekly allergy shot on the same day but does not think this had anything to do with her side effects. The patient consented to follow up.
Fever 5/1/07 --> 5/5/07 (99.8), large, painful gland base of neck. Treatment: lemon juice. Saw chiropractor - detox treatment, lives meridian bio-resonance therapy. Pain relieved after treatment.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown date (within an 18-month period), the patients were vaccinated with improperly stored doses of GARDASIL (dose, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52 degrees Fahrenheit (the highest temperature) and 29 degrees Fahrenheit (the lowest temperature), for an unspecified period of time. It was unspecified, if the data logger was involved. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB lot#L042836, expiry date:24-AUG-2018  lot#M034188, expiry date: 20-MAY-2019 (dosing details and route of administration were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 13 C (range:>8C and <25C) during a time frame of 14 hours. Previous temperature excursion included: at 12 C (range: >8C and <25C) during a time frame of 14 hours and 13 C (range:>8C and <25C) during a time frame of 62 hours. No adverse effects were reported. There was no digital data logger involved. There were no product quality complaints (PQC) involved. Additional information has been requested.
Patient received his 4th dose of Pfizer yesterday before his PCP appointment.   He  denied flu-like/COVID-like symptoms or any adverse reactions from the first previous Pfizer vaccines he received.  When vital signs were taken his  HR was  in 130s-140s. PCP nto sure if it was vaccine related or not but decided to send him to ER across the clinic for further evaluation.
Patient returned to the pharmacy on 11/16/15 stating she was still having pain in her left arm where the shot was given. There is no redness nor bruising but she was still complaining of muscle pain on 11/16/15.
4 hours after the vaccine my son started becoming very irritable and  grabbing his leg where he got the shot.  By Sunday, my son had a fever of 102.2 and was coughing and showed signs of trouble breathing and grabbing his ear expressing his ear was hurting.
immediate after vaccination, patient reported dizziness, nausea, vomit, difficulty breathing. patient increasing sleepiness and drowsiness.  denied chest pain,
Malaise, loss of appetite, chills, aches,  just did not feel like doing anything except trying to get warm under a blanket on the sofa. i was freezing. I am due for the 2nd vaccine this month and I am not looking forward to it. i did not have any problems with the original Shingles vaccine.
Arm was swelling at local site of injection. After 2 hours the swelling spread to upper arm on the same side of the injection with itching and redness. Patient took Tylenol and put cold compress at the site of swelling. Patient was informed to also take Benadryl if itching and swelling persists.
Information has been received from a physician concerning a female who in approx. 5/96, was vaccinated with a dose of rubella virus vaccine live (second generation). Subsequently, pt found out she was 10 days pregnant at the time of vaccination. The pregnancy was uneventful other than the development of gestational diabates which was well controlled. On 2/1/97, the female gave birth to a male child. The child was born with disabilities including: mental retardation and muscular skeletal problems, specifically balance and hypotonia. F/U states that a pregnancy test was not performed prior to vaccination and that the pt received the vaccine prior to missing her menstrual period. The child was delivered by C-scetion (due to failure in progress). It was reported that the child has been seen by a neurologist; however, he has been unable to dx the child with a definite syndrome. It was also noted that the physician thought that the child would continue to require custodial care. Upon internal review, the child's experience of mental retardation was determined to be an "Other Important Medical Event". F/u info has been received and indicated that no additional info was available pertaining to this event.
Extreme anxiety; Diarrhea; Insomnia; Lack of Appetite; Sinus arrhythmia; Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received BNT162B2,  (Lot number was not reported), via an unspecified route of administration, administered in left arm, on 12Jul2021 17:00 (at the age of 34 years old), as dose 1, single for COVID-19 immunisation.  Medical history included bradycardia from an unknown date. Patient had COVID-19 prior to vaccination. There were no concomitant medications received within 2 weeks of vaccination.  The patient had known allergies of Wellbutrin and Prozac.  The patient experienced extreme anxiety, diarrhea, insomnia , lack of appetite, sinus arrhythmia and heart palpitations on 15Jul2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was reported that COVID was not tested post vaccination. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The next day after getting H1N1 vaccine caller started getting shortness of breath, "wheeziness in lungs" with crackling, stuffy/runny nose, loss of voice, also she stated" back hurt really bad this morning".  She also had a cough she described as "somewhat dry and productive".  She has felt warm, but she hasn't checked her temperature. Numerous attemtps were made to contact the caller, numerous messages were left, no return calls were received, no further information is available.
Skin reaction; Prickly; Itching; Burning red rash on chest and back; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Skin reaction), MILIARIA (Prickly), PRURITUS (Itching) and RASH (Burning red rash on chest and back) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SKIN REACTION (Skin reaction), MILIARIA (Prickly), PRURITUS (Itching) and RASH (Burning red rash on chest and back). At the time of the report, SKIN REACTION (Skin reaction), MILIARIA (Prickly), PRURITUS (Itching) and RASH (Burning red rash on chest and back) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-061043.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L015046, expiry date 29-APR-2017 that may have been exposed to temperatures outside of the recommended range and no adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
On Wednesday, March 31,  I noticed that my arm was itching and went to scratch it and then, noticed that it was very warm and reddish  with a rash in the area of where I received my shot on March 22nd.  After my shot I only had a bit of soreness, but it went away.  However, there was a 'bump' or swelling but it didn't bother me.  After this itching on the 31st, I found, today, April 1st, that the 'bump' or swelling was gone, but the area still has this reddish rash and at times it feels a little itchy.  I didn't know if I should report it or not, but my husband felt I should.
After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via Company (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907370 and 201907371 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain was assessed as related to Flucelvax Quadrivalent.
anal bleeding/when she pooped and there was blood/it was only on her rectum; blood in her stool; anal bleeding/when she pooped and there was blood/it was only on her rectum; she peed and the water was red like she was on her period/ went to pee and there was blood; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 05May2021 10:00 at single dose for COVID-19 immunisation at the age of 50-year old. Medical history reporter as none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) in the Arm Left on 05Apr2021 at the age of 50-year old for COVID-19 immunization. The patient was not received additional other vaccines on same day of the BNT162B2 vaccination. The caller received her second dose of the vaccine yesterday 05May2021 at 10:00 am. Stated caller woke up today 06May2021 at 05:00 a.m. and noticed she was bleeding. Stated she first noticed it when she pooped and there was blood, she didn't specify if the blood was in the water or in the stool.  A few minutes later, she peed and the water was red like she was on her period. Caller said anal bleeding but didn't specify more. Caller clarified, at 5:00 a.m. in the morning,  when she went to the bathroom and evacuated she realized there was blood in her stool and a moment ago she went to pee and there was blood, like she was on her period. Caller stated when she peed she didn't have any blood coming out of her vagina, it was from her rectum because when she was cleaning the vagina, there was no blood, it was only on her rectum. Treatment: None. Caller stated this had never happened to her before, and the only thing that was different was the vaccine. Stated she thought it was due to that because she hasn't ingested anything. Stated she wanted to make an appointment with her doctor but he doesn't open until 1:00 p.m. The events were not resulted in Emergency Room or Physician Office visit. Family Medical History Relevant to adverse events reported as none. Relevant Tests reported as none. Event onset date reported as 06May2021 05:00. No treatment received for the events. The outcome of the events was unknown.
This spontaneous case, initially received from other health professional (pharmacist), on 12-Oct-2018, concerns a 47-year-old, adult male patient. On 12-Oct-2018, the patient received expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse events were reported by the patient after the vaccination. The reporter assessed the case as non-serious. This case '201804448' was linked to '201804445' due to same reporter. Follow up received from the pharmacist on 31-Oct-2018: Updated patient's date of birth and age (47 years) was added in the patient's tab. Added batch number (195245) in the product tab. The narrative was amended accordingly.
Two days after vaccine, patient noticed he hadn't taken off the bandage, when he did he saw a large red area around the site of venipuncture. It was hot to the touch. There were no other symptoms noted.
injection site reactions worse; injection site red; injection site a little swollen; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reactions worse), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE SWELLING (injection site a little swollen) and INJECTION SITE PRURITUS (injection site itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE SWELLING (injection site a little swollen) and INJECTION SITE PRURITUS (injection site itchy). On 12-Apr-2021, the patient experienced VACCINATION SITE REACTION (injection site reactions worse). At the time of the report, VACCINATION SITE REACTION (injection site reactions worse), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE SWELLING (injection site a little swollen) and INJECTION SITE PRURITUS (injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were provided. No treatment drugs were reported.
After 15 minute observation period, patient stood to return his timer to staff and became dizzy, stumbling and falling to corner of wall.  As a result, he sustained minor laceration injury to eyebrow and broken eyeglasses.  He was assisted to the floor by myself and a customer in the store.  EMS protocol activated.  Patient's mother contacted and arrived at the scene.  Vital signs monitored until EMS arrived.  Patient remained alert and oriented during time resting on floor.  EMS crew assessed patient .  He was able to stand on his own and left with the assistance of his mother.
91 Y/O male, PMHx of CKD, HTN, Multiple myeloma, and macular degeneration, admitted for weakness on 11/7/21. Pt tested positive for Covid19 in mid-October. Hypoxic at 87% on room air when EMS arrived. Chest x-ray shows patchy bilateral infiltrates consistent with Covid19 pneumonia.  Pt treated with abx for possible superimposed bacterial infection and supportive measures. Discharged to skilled nursing facility on 11/14/21.