chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A consumer report has been received. The report concerns a Male consumer, who had been receiving nasal FLUMIST (intranasal) started on an unknown date. The patient experienced decreased appetite, moderate low fever, Vomiting, Moderate achey; lethargic. The outcome of the event decrease appetite is unknown and the patient recovered from the event of low fever, vomited, achey and lethargic on 06-NOV-2014. The report was considered to be non-serious. The reporter considered that there was no casual relationship between low fever and FLUMIST, vomited and FLUMIST, achey and FLUMIST and lethargic and FLUMIST.
Vaccinee experienced "...failure to achieve antibody titers p/3 doses of Engerix-B."
Fever, Chills, Cough, Irritability, Hives, Cellulitis. Friday-4/6/18 Fever, Cough, Lethargy. Saturday-4/7/18 Fever, Cough, Irritability, Hives. Sunday-4/8/18 Fever, Chills, Aversion to Food, Cough, Irritability, Cellulitis. Monday-4/9/18 Fever, Lethargy, Cellulitis.
redness on top of her entire arm; arm was warm to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix (had original Shingles vaccines in the past.).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced redness on top of her entire arm, and it was warm to touch after getting the first dose of Shingrix vaccine. Patient stated she has had original Shingles vaccines in the past. The reporter consented to follow up. Caller did not provide any other details, caller disconnected prior to gathering any additional information.
nausea tired raised red hive surrounding  vaccine site. Warm to touch. knot in muscle
was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient called the pharmacy to report a bad reaction from an injection last week. Last Monday he had both the flu ad seasonal flu vaccine and his 3rd dose of Moderna Covid-19 vaccine as he is a transplant patient.  He stated the following morning he got dizzy and sat down in a chair. Then fell out of the chair hitting his head but was ok from that. When he went to get up he could not move his arms and legs to roll over. He called for his wife and laid there for a while until he could work his way up to a stool and eventually a chair.  He was extremely weak in his arms and could not even hold his upper body up.  After about 18 hours and calling his doctor, he started to feel better.  He called today a week later to report the effect.  No history of bad reaction like this from previous vaccinations
Symptoms began on 01/10/2021 around 3:30-4:00 AM PST. I had body aches for 2 days. I woke up on 01/11/2021 with soreness in my right arm pit. I woke up today, 01/12/2021 and had pain and swelling in my right arm pit. I went to my employer's employee health services and was checked out by a provider. I was told that he didn't see anything, and he minimized my symptoms. He didn't seem like he wanted to evaluate me from the time he walked in the exam room. He told me "what do you want us to do? It looks normal." He then went on to tell them he's not going to give me time off for work aside from today. I did not ask for any time off once during the evaluation. I recheck my arm pit when I got home, and noticed the swelling is approx. 3"x 3"s. It was not hard to see when I rechecked. I have noticeable pain the swollen area as well. The swelling is visible when I extend my right arm all the way up above my head. I attempted to tell the employee health provider this, but he preferred to check in a manner that does not show the swelling. I am slightly muscular and when my arm is down, you can only feel soft tissue. Employee health gave me Ibuprofen to treat my Sx's.  I called my primary physician's office and am waiting for a call back to be either scheduled for an evaluation or receive medical advice.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported, orally). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd HIB then had 3 days of fever (102) & was irritable;
Never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The pharmacist stated that the patient never received the second dose. The reporter did not consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination.
Breaking out rash; This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 09:00 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced breaking out rash on an unspecified date with outcome of unknown.    Information about lot/batch number has been requested.
got a light case; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient only received one shot of shingles and before the second dose, the patient experienced light case of shingles.
Began 8/9/14 with a slight bump and redness at the site of the varicella injection. Had fever (101.4) and chills early in the morning 08/10/14 (12 - 4 am). Redness and swelling spread from site of injection (upper outer right arm) down toward elbow and up toward shoulder. Arm hurt. Saw a physician 8/12/2014. Treated with Bactrim DS and Tylenol. 8/19/2014 - Symptoms completely resolved.
Large local reaction. Initial PNEUMOVAX given in 2001 at age 68. This vaccination was "booster."
red itchy spot; Swelling; red itchy spot; Sore arm; Tired; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease since 31-May-1999 and Penicillin allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced HEADACHE (Slight headache). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (red itchy spot), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. On 15-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot) outcome was unknown.            Treatment information included ice area for swelling.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021. Case was updated with additional events of vaccination site redness, itching and pruritus. Rechallenge information and causality for the event arm pain was updated.
has been diagnosed with Type II diabetes; Fatigue; Extreme Thirst; Frequent Urination; Lack of Energy; Dizziness; Difficulty Focusing; Unexplained Weight Loss; blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing), notes: Slightly overweight according to BMI. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer ), for COVID-19 Immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "has been diagnosed with Type II diabetes"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; THIRST (non-serious), outcome "unknown", described as "Extreme Thirst"; POLLAKIURIA (non-serious), outcome "unknown", described as "Frequent Urination"; ASTHENIA (non-serious), outcome "unknown", described as "Lack of Energy"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Difficulty Focusing"; ABNORMAL LOSS OF WEIGHT (non-serious), outcome "unknown", described as "Unexplained Weight Loss"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure". Therapeutic measures were taken as a result of type 2 diabetes mellitus, blood pressure abnormal. Clinical course: Patient was on blood pressure medications and insulin pills.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a health professional concerning an 8 year old female with no known medical history or allergies who "several years ago" was vaccinated with a 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 627868/1258H). There was no concomitant medication. On 11 February 2006, the patient developed 20 vesicular lesions that crusted over during the next few days. Unspecified medical attention was sought. No other symptoms were noted. The patient was treated with diphenhydramine hydrochloride and calamine lotion. NO laboratory diagnostic test were performed. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Information has been received from an office manager and a female patient, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old pregnant female patient with drug allergies to DAYQUIL and COMPAZINE and no pertinent medical history who on 14-OCT-2010 was vaccinated with the first dose of GARDASIL (lot number reported as 0644Z), 0.5 ml (also reported as 0.5mg) by intramuscular injection. Her last menstrual period (LMP) was approximately on 19-AUG-2010, and estimated delivery date (EDD) was on 05-JUN-2011. It was stated that the patient was supposed to be received a "ROGAM" shot and received GARDASIL instead, accidentally. The following Saturday, which was on 16-OCT-2010 (also reported as on 14-OCT-2010), the patient's eyes were kind of blurry and her left arm was shaky. There was no concomitant medication. The patient did not seek medical attention and lab diagnostics studies were not performed. At the time of the report, the outcome was unknown. Follow up information has been received from the office manager who reported that it was a case of the wrong thing was pulled off the shelf and it was not product confusion. Additional information is not expected.
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 18-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, dose number, injection site and lot # not reported). On 18-NOV-2014, the patient presented with "excessive swelling and induration" after receiving PNEUMOVAX23. The patient sought medical attention. The outcome of event was unknown. Additional information has been requested.
10 minutes after receiving vaccine pt reports feeling flushed, like her heart is beating fast. Pt states its the same feeling she gets when she  gets novicaine at the dentist. Seat reclined in car. 1331:HR 92,BP 190/78. Pt reports baseline HTN.Monitored in car by RN.1340: Pt reports feeling better, wants to have more observation.1350: Pt sat up from reclined seat and reports return of symptoms. HR 74, BP 170/80.Continued to observe for total of 1 hour.Pt states feels much better but not 100%,encouraged pt to have someone pick her up,pt states her son is available.1430:Son arrived to drive patient's car home, pt escorted to passenger side seat by this RN without issue.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 26-JAN-2015, the patient was inoculated with ZOSTAVAX at a public health center for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician at the office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Received DTD on 2/7/09.  Mom up pts feet dizzy after leaving clinic & laid down rest of day.  Arm was sore that even. & by next day was red & swollen from shoulder to elbow.  Hurt to move arm.  Was encouraged to move arm.  On children's MOTRIN & alternated warm & cold compresses for 2-3 da.  Saw NP. Friend from church- who said not to do any more tetanus shouts in the future- TC to mom on 2-18-08.  Arm better in past 2-3 days.
he had severe chills, 101.7 F; He has been very fatigued and in bed all day; threw up small amount of fluid twice and then everything came up; This is a spontaneous report from a contactable consumer (patient's husband). A 88-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received second dose on Sunday. Monday evening after dinner he had severe chills, 101.7 F, his wife gave him some acetaminophen (TYLENOL). The patient threw up small amount of fluid twice and then everything came up. The patient went to bed from 11:30pm, woke up at 8am and had a temperature of 99.4 F. He took morning pills and fruit juice, and one spoon of oatmeal and some glasses of water. He had been very fatigued and in bed all day, which was not like him. He was usually very active. The outcome of events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
On 07/13/2001 the patient experienced joint pain in right knee. Joint pain increased along with redness and swelling and extended to left knee, wrist and hands and the patient could hardly walk. The patient was treated with ibuprofen, ice, heat and rest. At the time of acute symptoms the patient reported her hand grip was about 20%. Feels much better today, 07/18/2001 and reports her hand grip at 90%. The patient is recovering.
This spontaneous report was received from a medical assistant and refers to multiple 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 PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 17-AUG-2017, a 62 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
pt recvd flu vax on 30OCT92 devel cold sx on 31OCT92 then devel into flu sx; MD  gave ATB; pt reports "went to races & sat in the cold the next day p/shot & had to hold a handkerchief to nose all day;
gas on her stomach; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported for herself. A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 05Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient was experiencing like she had a gas on her stomach.  Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt experienced severe headache, arm sore, fatigue, chest tightness and left arm numbness.
Client noticed swelling and redness at injection site.  States arm is achy. Checked on 09/28/2016 at 4 pm and noted wheal approx. 45 X 48 mm with erythema.  Lateral and proximal to injection site noted small amount of redness with pustule.  Denies itching.
arm turned red and itchy below the injection site; arm turned red and itchy below the injection site; Injection site Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Ulcerative colitis (Ulcerative colitis flare.) from 18-Dec-2020 to 20-Dec-2020 and Ulcerative colitis (Ulcerative colitis ; mild.) in 1974. Concomitant products included LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS) for Probiotic therapy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling). At the time of the report, VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling) had resolved.            No Treatment information has been provided. Action take n with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received included reporter information, patient medical history, concomitant medication, doses information and event start date.
PATIENT REPORTED FEELING ACHY BODY, DIZZINESS, AND PASSED OUT. THIS ALL OCCURED THE FOLLOWING MORNING AFTER ADMINISTRATION. PATIENT PASSED OUT WHILE MOWING THE GRASS.
Initial report was received from a health care professional on 20 September 2011. A one-year-old patient (gender not reported) had received on 19 September 2011 FLUZONE (lot number, route and site of administration not reported) and PENTACEL (lot number, route, and site of administration not reported) and four to six hours later experienced febrile seizures. The patient was evaluated in the ER (emergency room) by the reporting physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Persistent (> 4 weeks) right shoulder pain and weakness with certain movement of the arm/shoulder as well as a full pain at rest. This is not a report of the typical soreness after a shot.  Concern for tendonitis/shoulder injury from the shot itself or a complication thereafter.  I have been taking ibuprofen around the clock.  The normal soreness after the shot started around 12 hrs.  These subsequent pain/weakness issues continued on after that point