chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got Shingles vaccine,gotShingles/Suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Shingles vaccine,gotShingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that patient took Shingles vaccine and broke out with bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Within 24 hr of vax, pt devel cellulitis from elbow to wrist on injected arm. Tx w/antibiotic. This is 1of 2 pts from this site to devel cellulitis following this vax & lot#. See comments
One week later itching and redness occurred on upper arm (approx. 2 in. wide x 7 in. length) of vaccination site. Symptoms lasted one week. Fatigue occurred for two weeks.
103 Fever for 48 hours, Swollen neck on left side began December 19 until December 24, all over Body and join pain December 17 - 24, rash on right side of body December 19 - 26  swollen lymph nodes under left arm December 17 - still unresolved as of March 10th, 2022
This spontaneous report was received from a pharmacist referring to a currently 61 year old female patient who on an unknown date, was vaccinated with an unspecified dose of M-M-R II (lot # not reported). On an unknown date, the patient received an additional dose (unspecified dose) of M-M-R II after child birth on an unspecified date. This was due to the patient experienced an antibody test abnormal (reported as "could not keep up resistance after child was born"). The outcome of antibody test abnormal was unknown. Additional information has been requested.
my arm is feeling sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the vaccine and she wanted to know if she can take Tylenol for the pain on her arm. Her arm is feeling sore. Event outcome was unknown.  Information about Lot/Batch has been requested.
real dark black stools; Shortness of breath; face got really red and swollen; face got really red and swollen; Chills; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen), ERYTHEMA (face got really red and swollen), FAECES DISCOLOURED (real dark black stools) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen) and ERYTHEMA (face got really red and swollen). On an unknown date, the patient experienced FAECES DISCOLOURED (real dark black stools). At the time of the report, DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen), ERYTHEMA (face got really red and swollen) and CHILLS (Chills) had resolved and FAECES DISCOLOURED (real dark black stools) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BARELY WALKED AND WALKED IN AN ODD AND STRANGE WAY; TINGLING WENT UP TO ARMS AND LEGS; LOST THE ABILITY TO WALK; FINGERS TINGLING; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cancer of the kidney, and 2 strokes, and concurrent conditions included: non-alcohol user, and smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced fingers tingling. On NOV-2021, the patient experienced lost the ability to walk. On an unspecified date, the patient experienced barely walked and walked in an odd and strange way, and tingling went up to arms and legs. Laboratory data (dates unspecified) included: EKG (NR: not provided) ECG was okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fingers tingling, tingling went up to arms and legs, lost the ability to walk, and barely walked and walked in an odd and strange way. This report was non-serious.
Patient reported intermittent headaches for about 1 month on 4/27/2021, after she received the first dose of Moderna COVID-19 vaccine on 3/22/2021. It is located on the left side, no throbbing, and denies sensitivity to sound and light. She has been taking Ibuprofen 600mg Q6H as needed for headache with minimal relief. She also complains of lymph nodes behind her ears for about 1 week. She reports that they are getting smaller and are tender to touch. She denies sore throat, ear infection, fever, cough, or tooth pain. She also reports left-sided skin rashes with burning. The headache persisted so she went to her PCP for evaluation at which time she discovered she was pregnant.  Vitals: 4/27/21: 158/87, 68, 18 Provider recommended to switch from Ibuprofen to Tylenol and to return in 2 weeks or if symptoms worsen or fail to improve. Subsequent provider visits related to pregnancy.
Information has been received from a health worker (medical assistant) regarding patients of unknown age and gender. Since 31-DEC-2014, improperly stored ROTATEQ (strength and dose were not reported) lot K006456, expiration date 08-MAR-2016 were administered to unspecified patients. No adverse effects were reported. The outcome of the events reported were unknown. This case is linked to the cases 1503USA006429, 1502USA000168 via same reporter link. Additional information has been requested.
About six weeks ago, I was having some problems with my right leg. I am still having problems, but it is not bad as it was. It frightened me because years ago, I went through deep vein thrombosis. But this wasn't really painful, but was heavy and tired from the knee up. I went to the vein clinic and they didn't see any blood clots, so I'm waiting to hear back some more information from my doctor and am still trying to figure out what exactly is going on.
Bell's palsy; tongue tingling, "weird taste" starting May 22, developed left sided Bell's palsy May 31
Hot to the touch; Knot; itchiness at the injection site; Hard; Rash; Soreness day of injection; Swollen (area around injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE RASH (Rash) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard), VACCINATION SITE RASH (Rash), VACCINATION SITE PAIN (Soreness day of injection) and VACCINATION SITE SWELLING (Swollen (area around injection)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard), VACCINATION SITE RASH (Rash), VACCINATION SITE PAIN (Soreness day of injection) and VACCINATION SITE SWELLING (Swollen (area around injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.
Possible reaction to Smallpox vaccine.  Achiness, headache, swollen glands to throat and left arm pit.
Per patient: "The injection in my right arm swelled and is black and blue. It kept me awake last night with fever and chills and a headache. My arm was so painful I could not sleep. It was very uncomfortable to shake uncontrollably."
p/2nd immun pt had tremors over entire body approx 24 hrs later, lasting approx 30 mins; pt alert @ time;
Suspected vaccination failure; Shingles; raised itchy dots; itchy dots; two small patches; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), raised rash (Verbatim: raised itchy dots), itchy rash (Verbatim: itchy dots) and patchy rash (Verbatim: two small patches). The outcome of the vaccination failure was unknown and the outcome of the shingles, raised rash, itchy rash and patchy rash were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, raised rash, itchy rash and patchy rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, raised rash, itchy rash and patchy rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-JUN-2023 The case was received from the patient interactive digital media. The patient stated that not true, as he/she got the shots to prevent getting them.  The patient got the shingles anyway but it was nothing like it could had been.  The patient stated that his/her showed up as two small patches (about size of courter), the patches looking like mosquito bites, raised itchy dots.  There was no pain associated but the itchiness was like a mosquito bite and that did not went away.  The physician told to patient that had he/she not gotten the preventative shots it could had been dreadful.  He said getting the preventative shot probably saved him/her from the horrors of the shingles.  He did seem surprised that did not had pain with his/her only itchiness.  The patient highly recommended that you get the shots (there were two taken 1 shot, then 30 days 2nd shot).  The patient stated that shots do not guarantee that you would not get them but can drastically affect how badly you suffer if you do get them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Within 10 minutes of receiving vaccination, I started to sweat profusely. almost immediately  pain started in my Lt eye which progressed to my Lt side of the head and Lt side of the neck started to stiffen up. About 20-25 minutes later, I started to feel tingly (like goosebumps) on my Lt side of the body and felt cold on the same side. All these symptoms lasted for the whole night but did not get any worse though.
Fever, neck pain, headache. Started within eight hours of vaccine administration persistent into the next day, but had improved after 24 hrs. Treated with Motrin.
death Narrative: Pt received 1st moderna covid vaccine 2/12/2021 and passed away of unknown causes 2/12/2021 Pt 76 year old with AAA,HTN,CKD,COPD
Entire was itching, redness on face, chest, arms - in the evening had extremely fast heartbeat last for 2-3 hours - unable to breathe - rapid heartbeat - temp was 101, nausea.
Erythematous, pruritic rash on bilateral ventral surfaces of arms. No dyspnea, no palpitations, no chest pain, no wheezing. No desquamation. The patient's mother had the same reaction after the 1st vaccine. Benadryl advised. The pt will go to the ER with severe symptoms. I called in the afternoon and the patient's pruritis had resolved with Benadryl. Rash was still present. They will call back if symptoms change and go to ER for any severe changes.
Suspected vaccination failure\Shingrix in September. Was diagnosed with Shingles for the first time last week; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The case has been considered as suspected vaccination failure being full schedule was unknown.
just a little arm soreness; arm was bothering me; little numb the night of the shot/ leg on that side wan't completely numb; It was difficult to walk to the bedroom couldn't walk to her room; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (little numb the night of the shot/ leg on that side wan't completely numb), GAIT DISTURBANCE (It was difficult to walk to the bedroom couldn't walk to her room), PAIN IN EXTREMITY (just a little arm soreness) and LIMB DISCOMFORT (arm was bothering me) in a 41-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (little numb the night of the shot/ leg on that side wan't completely numb), GAIT DISTURBANCE (It was difficult to walk to the bedroom couldn't walk to her room) and LIMB DISCOMFORT (arm was bothering me). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (just a little arm soreness). On 26-Mar-2021, HYPOAESTHESIA (little numb the night of the shot/ leg on that side wan't completely numb) had resolved, GAIT DISTURBANCE (It was difficult to walk to the bedroom couldn't walk to her room) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (just a little arm soreness) and LIMB DISCOMFORT (arm was bothering me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
The day after the injection I had severe abdominal and chest pain, and nausea. The  pain resolved on it?s own by the 25th hour after receiving the vaccine. On June 17, 2021 I began having tinnitus and severe to profound hearing loss in my left ear. This was diagnosed on 6/28/2021.  I received oral steroids and intratympanic membrane steroid injection with no resolve. An MRI ruled out a tumor of the left auditory.
she did faint but came around after a couple of minutes. She told me ahead of time that she may faint and if she did it was no ?big deal?. She was able to talk to me the whole time. We did call EMS but refused any treatment .
Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium
called to register for the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination.     Previously administered products included for an unreported indication: substance use (Marijuana -Prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FERROUS SULFATE and LAMOTRIGINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications was provided by the reporter. Patient reported use of substance  Marijuana prior use.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 27-Jul-2021 resulted in updates to the pregnancy details.
Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2021 as dose 2 (booster), single (Lot number: JC359), in right arm and on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jun2022 at 10:00 as dose 4 (booster), single (Lot number: 060A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pollen allergies" (unspecified if ongoing); "Grass allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering"; DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID 19 from 13Apr2023 to 18Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167757 same patient, different dose/events;
2nd shot 2 & 1/2 years after the first shot?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date 2 and half years ago).   On an unknown date, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On an unknown date, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The age at vaccination was not applicable for this report. The reporter enquired that could a patient receive their second shot 2 and 1/2 years after the first shot of Havrix. Till the time of reporting patient did not receive 2nd dose of Havrix vaccine, which led to incomplete course of vaccination. No further details were provided via form; specialist submitting all details available. The reporter consented to follow up.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M038227, expiration date 06-MAR-2018 and lot # M011661, expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6-14 degrees Fahrenheit for 9 hours and 15 minutes. Data logger was involved in recording of the temperature excursions. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005091.