chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abdominal pain- feels like pulled muscles/like I got kicked in the stomach; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection at the age of 35-years-old, via an unspecified route of administration on 27Jan2021 at 1:15 PM at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient experienced abdominal pain which felt like she pulled a muscle, like she got kicked in the stomach on 02Feb2021 at 3:00 PM. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered. The event was assessed as non-serious.   Information on the lot/batch number has been requested.
Got the two vaccines but it does not give any improvement/Suspected Vaccination Failure; 3 years ago he/she had shingles; Burning; Itching; Pain; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the two vaccines but it does not give any improvement/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: 3 years ago he/she had shingles), burning sensation (Verbatim: Burning), pruritus (Verbatim: Itching) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the burning sensation, pruritus and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that almost 3 years ago he/she had shingles and still feel the burning and itching.  His/her physician prescribed pills and the patient already got the two vaccines shot of Shingles vaccine but it did not gave him/her any improvement.  The patient still had burning and itching day and night and he/she had both shot of Shingles vaccine, but it was an insupportable pain.  This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported.  The follow-up could not be possible as no contact details were available.
I experienced swollen and painful lymph nodes, aches, soreness in my arm and sickness.
Fever of 99.4 the evening of the vaccine; and a fever of 101.2 the next morning. Nausea
Patient has shingles and is taking an antiviral, she is not sure if she should get her scheduled; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient has shingles and is taking an antiviral, she is not sure if she should get her scheduled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BENRALIZUMAB (FASENRA) for Asthma, VALACYCLOVIR [VALACICLOVIR] for Shingles.    On 09-Feb-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 HERPES ZOSTER (Patient has shingles and is taking an antiviral, she is not sure if she should get her scheduled). At the time of the report, HERPES ZOSTER (Patient has shingles and is taking an antiviral, she is not sure if she should get her scheduled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  Patient gave consent for safety to Follow-up.
Fever, erythematous papules on trunk, face, extremities. Some vesicles scabbed over.
Moderna COVID-19 Vaccine EUA  pain in injection site, fatigue, sneezing, runny nose
This case was reported by a consumer via call center representative and described the occurrence of increased bronchial secretion in a male patient who received ANORO ELLIPTA inhalation powder for chronic obstructive pulmonary disease. Co-suspect products included FLUARIX. Concurrent medical conditions included lung cancer. Concomitant products included FLOVENT, LIPITOR, metoprolol, MVI, oxygen and PLAVIX. On 1st August 2015, the patient started ANORO ELLIPTA (inhaled) 1 puff(s) once daily. In September 2015, the patient received FLUARIX (injection). In September 2015, an unknown time after receiving ANORO ELLIPTA and FLUARIX, the patient experienced increased bronchial secretion, sinus disorder, tachypnea and cold. On an unknown date, the patient experienced productive cough. ANORO ELLIPTA was continued with no change. FLUARIX was continued with no change. On an unknown date, the outcome of the increased bronchial secretion, sinus disorder, tachypnea, cold and productive cough were not recovered/not resolved. The reporter considered the increased bronchial secretion to be related to ANORO ELLIPTA and FLUARIX. The reporter considered the sinus disorder, tachypnea and cold to be possibly related to ANORO ELLIPTA and FLUARIX. It was unknown if the reporter considered the productive cough to be related to ANORO ELLIPTA and FLUARIX. Additional information: This case was received via call center representative on 12 October 2015. Caller reported that he was switched from SPIRIVA to ANORO around the first of August. Around or about the first of September he began to notice increase mucous in his lungs, panting in his breathing, cold and sinus problems. He noted he had also gotten a flu shot by unknown manufacturer at a pharmacy around that first of September also. He made a phone call and spoke to his Internist's nurse who prescribed an antibiotic but after taking that there was no improvement. He then called back and asked for a steroid and after taking that also still no improvement. He will be traveling back to his hometown this Friday and was encouraged to see his physician. He noted the flu shot was the senior dose, but didn't know any other details of the vaccine. He also stated that he does use oxygen when he walks on his treadmill. He stated the mucous makes it feel as if his lungs are full and it rattles when he coughs but he can't cough it out. No further information was reported.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Very noticeable, unusual onset of fatigue immediately after injection. Continued fatigue has been evident most days for the last two years.
Upper Left arm: swollen, red, hot to touch.  Temperature: 97.9 (oral), not indurated.  Approximate area of erythema 3in x 1.5in.  Saw in office 07/09/2003.
Patient reported red rash at injection site (about 4" diameter - visually reviewed by pharmacist). Described as mildly painful. Felt tired and had a headache as well.
Within 5 minutes of vaccination, patient's upper left arm began to get a red and blotchy rash around injection sites.  Patient's Pediatrician assessed him, no shortness of breath, upon MD's assessment.  No itchiness at site reported by child.  Per MD order, gave child Benadryl 12.5 mg by mouth and watched child for approximately 20 minutes. Rash/blotchy areas had almost disappeared before child left the clinic.
Lip went numb about a day later lasted full time for three days then it happens on and off still both top and bottom lip.
Pt recvd 2nd dose of vax & devel redness, warmth, & soreness @ inject site; following 3rd dose, pt failed to seroconvert; following 4th dose, the redness, warmth, & soreness @ inject site recurred;
I received a Moderna COVID-19 booster on 10/29/2021. On 5/4/2022, I noticed that I had a throat irritation and had to clear my throat repeatedly. Overnight, it developed into a loss of voice, and I was unable to speak on 5/5/2022. On 5/5/2022, I underwent both a rapid test and a PCR test at a clinic. Within an hour, I learned that I had a positive result. On 5/5/2022 and 5/6/2022, the symptoms worsened. My voice was back, but then I developed fatigue and a cough. The cough didn't finally go away until 5/20/2022. However, the fatigue lingered for about 2 weeks after that. I never had a fever, though.
bruising at injection site; redness at injection site; bumpy rash above left elbow and below shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   On 22nd July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site bruising, injection site erythema and papular rash. On an unknown date, the outcome of the injection site bruising, injection site erythema and papular rash were unknown.   It was unknown if the reporter considered the injection site bruising, injection site erythema and papular rash to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced bruising and redness at the Shingrix injection site. The pharmacist reported that the patient also experienced bumpy rash on left arm above elbow and below shoulder. The reporter consented to follow up.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004186, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Presented to ED s/p ground level fall sustaining large left pneumothorax; incidental finding of COVID-19; asymptomatic
s/p vaccine administration c/o dizziness, chills, chest tightness. No intervention required
This study case was received from the investigator on 04 June 2012. A subject received the following vaccinations on 10 February 2012: an injection of ACAM2000 (lot number not reported), varicella (manufacturer and lot number not reported), anthrax (manufacturer and lot number not reported), hepatitis A (manufacturer and lot number not reported), hepatitis B (manufacturer and lot number not reported) and DT absorbed (manufacturer and lot number not reported). The subject also received a dose of ACAM2000 (lot number not reported) on 23 February 2012. On 23 February 2012, the subject was diagnosed with unspecific disease of pericardium. Medical history was not reported. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Patient received, TDAP, Varivax and Gardasil immunization.  After receiving Gardasil, patient stated that hurt worse.  She then moaned and fell on her side lying on table, eyes rolled back and fainted after 20 seconds.  Received orange juice, water and granola bar.  Blood pressure taken before patient left was 70/40.  Original blood pressure 80/50.  Patient was in stable condition upon leaving per doctor.
This is my booster for covid-19,  I'm a nurse.  I also received my flu vaccine.  My first  covid-19 was  Johnson and Johnson,  March 19th 2021. Became quite ill about 8 hours later.
6 mos had 3 seizures following 6 mos vaccines lasting 1 1/2-2 min. 1st was tonic clonic. 2nd was clonic with staring. 3rd was a staring spell witnessed by ER personnel. Admitted MRI (-) LP (-) EEG pending.  4/29/09 Received hospital medical records of 4/16-4/17/2009. FINAL DX: febrile & afebrile seizures Records reveal patient experienced irritability, fever, staring, LOC, generalized tonic-clonic seizure w/postictal period.  Exam in ER WNL.   D/C to home w/PCP f/u next day; however, had 2 more seizures while afebrile, returned to ER 4/17 & admitted overnight.  Neuro consult & LP done.  Tx w/antibiotics.
Myalgia Narrative: dose 1 -day 1-pain/discomfort inj site; day 2-3-bodyache; fatigue
PATIENT CAME ON 12/16/2022 AND REPORTED THAT HIS LEFT MIDDLE TOE PAIN. He had so much pain that he could not move
Fever 99.5, onset 8 hours after shot, 10:30 pm Difficulty sleeping that night Fever 100.7 next morning, headache, muscle aches, fatigue Symptoms subsided 36 hours after shot, disappeared 48 hours after shot
Flu like symptoms and orthostatic hypotension. A week later developed dry mouth, eyes and nares.  Producing very little saliva.
I am anxious about my sinus allergies; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I am anxious about my sinus allergies) and INJECTION SITE PAIN (Arm tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic sinusitis (just stuffy nose and a bit of drainage).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced INJECTION SITE PAIN (Arm tenderness). On an unknown date, the patient experienced ANXIETY (I am anxious about my sinus allergies). At the time of the report, ANXIETY (I am anxious about my sinus allergies) outcome was unknown and INJECTION SITE PAIN (Arm tenderness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       6 hours after the vaccination Patient experienced  tenderness in the arm.No concomitant medications were reported. No treatment medications were reported.
Pt is GCS 15 and A&Ox4. Skin is P/W/D to pt ethnicity. Neuro intact and PERRLA. Respirations are regular/equal and non-labored. pt states he's had left sided facial droop for 2 days and a sore throat for 5 days. pt denies any other symptoms at this time. pt appears to have bells palsy. Dr. was contacted and she ruled out a stroke. Symptoms started 1 week after the completion of vaccine.
Muscle soreness; Redness; Itching; Warm to touch at injection site; Swollen lymph node on her neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle soreness), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE WARMTH (Warm to touch at injection site) and LYMPHADENOPATHY (Swollen lymph node on her neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Body aches and pains; Sluggishness; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever). At the time of the report, PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided.
arm being sore; numbness with that shot/numbness in the lips or in the nose; numbness in the lips or in the nose; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number EW0187, Expiration Date 31Aug2021) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced side effects. Patient enquired if this side effect beside the arm being sore was this side effect of though have you heard of numbness with that shot or no. Have you heard of numbness in the lips or in the nose. Patient had side effects when had first shot and was wondering if you have heard of this before with other people or not. Patient enquired whether second dose can be taken or not. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Projectile Vomiting, Fever, Rash all over body measles like rash. Lasted Two days weak could not even move. Then, lost all eye contact skills learned and lost all speech he had all 250 words. Now non verbal and disabled.
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.