chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little bump at the injection site; Bump turned more circler; Bump covered the deltoid; Bump was red; Bump was painful; Lymph nodes under arm painful; Lymph nodes under arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red) and PAIN (Bump was painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen). At the time of the report, INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include allergy medicine.  Treatment information was not provided.   Reporter did not allow further contact
On 11/01/2022, the first thing I noticed was what I thought was a lump on my chest. The doctor thought it was more likely some sort of cyst than something cancerous. That is still there but is shrinking. At the same time, I noticed a lump on my labia. I was also experiencing some various pains in different parts of my stomach. I set up some appointments to have these issues checked out. However, I went out of town before the appointments and while out of town, I became ill and had severe diarrhea with blood. While driving home, I stopped at an urgent care clinic, and they did multiple tests. They informed me that there were so many irregularities that I needed to be seen at a hospital. Around 2 days later, I was feeling so badly, that I did end up going to the local emergency room. They treated me for dehydration. They also took an EKG, and CT scan which they had also done at the urgent care clinic. I was admitted to the hospital due to the abnormalities they found. They were concerned that there was some sort of cancer that needed to be looked into further. They gave me the choice of remaining in hospital or going home. I went home around 11/25/2022. So far, I have seen a gynecologist and a surgeon. I've had a number of different CAT scans taken and am due to have a colonoscopy and transvaginal ultrasound. I also have to have some additional blood work done and a biopsy on my stomach and liver. In my mind, I felt like this was all too severe to be connected to the vaccine. On 12/01/2022, I was having a lot of stomach pain and I ended up going back to the emergency room where they did additional blood work and prescribed some medication for the pain.
Got the shot and immediately got shingles; This non-serious 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 Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got the shot and immediately got shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:28-FEB-2023 The case  was received from the patient via interactive digital media. The patient reported that his/her friends who got Shingles shot and immediately got shingles. The reporter stated that no thanks. The reporter had shingles and he/she was not risking getting it again. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038026, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038026:Same reporter
15APR93 t103.4 Ax APAP dec fever slightly; 16APR93 sponged, APAP 7PM sz by amublance to hosp t104.4 ax; 19APR93 rash beginning on face & neck generalized saw MD pt cranky, eating poorly;
Patient recieved the Shingrix series twice. First series (dose 1 and 2) administered on 5/12/2018 and 7/14/2018. Series administered again by mistake on 1/26/23 (dose 1) and 3/31/23 (dose 2). Patient did not report any adverse effects or issues.
Patient had a wave of dizziness & nausea 10 minutes after vaccination. Pt did fall without losing consciousness. Had pt sit down with head between her legs. Monitored respirations, BP & pulse.
Left arm injection on 12/2/21. On 12/4/21, the arm became sore in the shoulder, By 12/5/21, limitation with movement and will constant pain. Contacted provider on 12/8/21. Patient took tylenol with codeine and it provided minimal relief.
Administered Covid-19 vaccine to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female, who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection at the age of 17-year-old.  Action taken with mRNA-1273 in response to the events was resolved.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of 17-year-old, female administered mRNA-1273 (lot # 026L20A) at inappropriate age (inappropriate age at vaccine administration). There were no associated adverse events with the event of inappropriate age at vaccine administration
SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (emphysema).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1808609 expiry: UNKNOWN) once a total dose was not reported, administered on 21-MAR-2021 on at left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO. On 19th September 2017, the patient received BEXSERO. On 19th September 2017 10:30, 4 hrs after receiving BEXSERO, the patient experienced fever, chills, nausea, headache, pain, knee pain, sweating and clamminess. The patient was treated with ibuprofen. In September 2017, the outcome of the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess were recovered/resolved. It was unknown if the reporter considered the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess to be related to BEXSERO. Additional details were provided as follows: The patient experienced knees hurt. The healthcare professional stated, the patient's mother gave her an ibuprofen and it took all those symptoms away. The HCP reported that, the patient's symptoms were completely gone the next day as well. No further information was provided.
Left upper arm began to feel sore and swell; warm to touch. Swelling also under arm. States used ice packs and heat and Motrin without relief. Worsened over weekend. Unable to lift arm, swelling red and size of an egg.  Red patches also seen one lower arm. Referred to PP or emergency room.
Fever averaging 101 F for 36 hours, muscle aches, headache, chills, painful swelling and restricted movement of shoulder at injection site, red skin 10 sq in around injection site, fatigue, mild nausea
Janssen COVID-19 Vaccine EUA: patient with metastatic cholangiocarcinoma on chemotherapy hospitalized for COVID-19 infection (myalgias, fever) and e.coli bacteremia. Administered remdesivir and antibiotics and improved. Discharged to home medically stable.
Child received all due vaccines, and immediately became nauseous. Child did not vomit. Complained of feeling sick to stomach.
On 5/25/99, the pt received his first injection of Lymerix, with localized soreness which resolve. On 6/26/95, he received the second dose, and 23 days post vax he experienced a bull's eye rash between two toes on his left foot. Also, the pt experienced testicular pain, headache, fever, and heavy joint pain; and went to his MD. Blood work was performed on 7/8/99 which tested positive for Lyme disease. The pt received a prescription for antibiotics which were to be taken for 10-14 days. On 10/16/99, the pt received the third injection  and has not gone back to the MD.   The information received on 3/16/00 provides no further information.
Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD in July 1968. Concomitant products included TIMOLOL for Glaucoma.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad"). At the time of the report, VACCINATION SITE PAIN (Within hours after his 1st shot his left shoulder started to ache and "sometimes it's pretty bad") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient reported that it felt better.   This case was linked to MOD-2021-339295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Patients race, ethnicity, Relevant medical history, concomitant medications, Event outcome and event assessment updated.
On April 8th, I woke up and went to the bathroom to blow my nose. I blew once (not a strong blow) and my nose started pouring blood. It was so much blood that it ran down my throat and out of my mouth even while leaning forward. It bled for approximately an hour and a half before stopping
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 13:15 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 at 15:00 as dose 2, single (Lot number: ER8737), in left arm and on 29Dec2021 at 15:00 as dose 3 (booster) single (Lot number: FJ8757) at the age of 39 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient received other medication in 2 weeks. Anti viral details for COVID-19 treatment included PAXLOVID (Lot number: PAA183761), treatment start date was on 04Jun2022. While taking medication, on 04Jun2022 at 04:00 PM, lost appetite and had dizziness and blurred vision for short periods of time. No follow-up attempts are needed. No further information is expected.
Fever?Tylenol Sore arm Flushed face Sore muscle? back?+same side as injection Painful to take deep breaths
Started having chills at night; could not sleep; Then had a high fever; Back ache; pain in the arm; This is a spontaneous report from a contactable consumer.  A 36-year old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 17Feb2021 (age at the time of vaccination was 36-year-old) at 8:00, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot number was EL9264) via unspecified route in left arm on 27Jan2021 (age at the time of vaccination was 36-year-old) at 17:00 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 17Feb2021, at 22:00, the patient experienced, Started having chills at night and could not sleep, Then had a high fever, back ache and pain in the arm by vaccine site. Outcome of all the events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
RECEIVED 7 ANTHRAX SHOT, LAST SHOT (#6) WAS 15 FEB 00.  AFTER EACH PREVIOUS SHOT, ARM BECAME INCREASING INFLAMED AND IRRITATED.  ON THE 15 FEB 00 SHOT INFLAMATION WAS FROM SHOLDER DOWN PAST ELBOW.  AFTER 18 SEP 02 VAC SWELLING OCCURED WITHIN 1HR HR FROM ARM PIT TO RIGHT ABOVE ELBOW.  AFTER 48 HRS SEEN BY  HOSIPITAL.  DOCTOR NOT CONCERNED EVEN GIVEN PREVIOUS HISTORY OF INCREASING SERVERNESS IN SWELLING AND INFLATION AT SHOT LOCATION.  PERSCRIBED CETIRIZINE 10MG FOR ITCHING AND SWELLING.  ON 21 SEP SWELLING INCREASED TO MAX SIZE FROM ELBOW TO ARMPIT AND THE ENTIRE INSIDE BICEP OF ARM.  SWELLING BEGAN TO REDUCE THAT EVENING. MINOR REDNESS TODAY 2X4 SECTION ON INNER BICEP AND MARBLE SIZE LUMP AT INJECTION SITE 23 SEP 02.  NO REACTION TO MENIGITUS SHOT IN OTHER ARM.
Very severe pain in left shoulder.  Physician treated me at Urgent Care. He believes I had a blood clot in the muscle. Injection site was one slim finger width below bone. Followed up at Orthopedic Clinic twice. MRI scheduled 4/5/21. Some tingling and numbness going down to hand and pain extending up from shoulder to neck and jaw. Unable to sleep on left side currently.
My arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th May 2022, the patient received Shingles vaccine. On 16th May 2022, less than a day after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine today (day of reporting) and felt his/her arm was killing him/her. Additional supportive information: The follow-up would not possible as no contact details were available.
A patient who was too young received a dose of Kinrix; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix at an unknown dose and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: This case was reported by GlaxoSmithKline representative on behalf of healthcare professional. The age at vaccination was not reported.  The patient was too young received a dose of Kinrix, which led to inappropriate age at vaccine administration. The contact information was for the healthcare professional. The reporter consented to follow up. No further information was reported.
Fever, chills, arm soreness, nausea, headache, eyes hurt, back pain, dizziness, feel bad
Patient noticed that while receiving the vaccine it was administered "at the uppermost level of arm in the joint, not the deltoid muscle".  Vaccine was administered around 3:00 pm and by 6:00 pm she was experiencing tenderness, 10/10 pain and difficulty extending her arm.  Patient used acetaminopehn every 6 hours along with icy hot and a sling to immobilize the arm.  Three days later patient still experienced these symptoms and an inability to rotate her shoulder.
Patient has bruising and swelling at injection site. Recommended ice, topical BENADRYL, and ALLEGRA. Followed up with patient the next day and swelling has gone down.
tested positive for COVID illness; tested positive for COVID illness; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband). This is the second (husband) of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history included came in contact with COVID-19 on Apr2021. The patient's concomitant medications were not reported. The reporter and her husband (patient) received their first doses of the Pfizer-Biontech Covid19 vaccine 2 weeks ago (Apr2021) and have since tested positive for COVID illness. They believed their exposure was the day they received their vaccination (on Apr2021). The reporter wanted to know the guidance for this situation. It was reported that the patient came in contact with COVID-19 the same day. The patient had 2 negative tests then they both tested positive, all on Apr2021. It was reported that their second doses are scheduled for 23Apr2021, but their quarantine last longer than that. The reported asked for guidance if they can't get their second doses at 21 days as scheduled. The outcome of the event tested positive for COVID illness was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021416805 Same reporter/drug/ event, different patient
PC from mother at 0800 11/19/07 - states received immun 11/16/07 - (Pediarix, Hib, PCV-7) by 11/16/07 pm - had increased temp of 101-102 - sometime Sun am (11/18/07) went to 104 for several hrs. Went to ER Sun AM - antibiotics were given. Mother states had hoarse cough as well. 1st set of immun. Denied any recurrent illness. Has reflux - vomiting with formula problems. No temp since 11/18/07 PM.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On 01-SEP-2015, the patients were vaccinated with doses of improperly stored VARIVAX lot # K010440, expiry date 22-JUL-2016, K011084, expiry date 08-AUG-2016 or 1004653, expiry date 11-FEB-2017 and no adverse effects were reported. The outcome of the events were unknown. Additional information has been requested.
2nd dose has not been given after 43 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not  provide any causality assessments   This case was linked to MOD-2021-077613 (E2B Linked Report).; Sender's Comments:  MOD-2021-077613:
the patient had hepatitis B titers checked as a requirement for employment and titers showed up as "not immune" on an unspecified date.; Nurse reported the 47 year old patient was inadvertently administered a pediatric dose ofEngerix B (lot YL2L3) on 10/23/2019.; This spontaneous report was received from a licensed practical nurse referring to a 47 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) series as a child for prophylaxis. On an unknown date, the patient had hepatitis B titers checked as a requirement for employment and titers showed not immune. On 23-OCT-2019, the patient was inadvertently administered a pediatric dose of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (lot# YL2L3; strength, vaccine dosage detail, route of administration and expiration date were not reported) (incorrect dose administered) for prophylaxis. On 23-NOV-2019, the patient was administered an adult dose of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (lot# B39CM; strength, vaccine dosage detail, route of administration and expiration date were not reported) for prophylaxis.  The outcome of the events was unknown. The causality between hepatitis B titers showed up as not immune and the therapies was not provided.